| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2835222 | 3 | M | CA | 04/09/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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administration of Kinrix to a 3 year old patient; This non-serious case was reported by a other heal...
administration of Kinrix to a 3 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. On 01-APR-2025, the patient received the 1st dose of Kinrix. On 01-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 3 year old patient). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 01-APR-2025 The clinic manager reported that they had a patient on the day of reporting and he was a 3 year old, little boy and they gave him Kinrix the IPV and DTAP which led to, inappropriate age at vaccine administration. The reporter stated that they know the vaccine was recommended for 4 year and above so, they just wanted to get the recommendations on that.
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| 2835223 | 0.75 | M | NY | 04/09/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Kinrix vaccine was administer to a 9 months male baby; This non-serious case was reported by a nurse...
Kinrix vaccine was administer to a 9 months male baby; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-month-old male patient who received DTPa-IPV (Kinrix) (batch number 42Y93, expiry date 05-JUN-2026) for prophylaxis. Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) and Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (IPV). On 11-MAR-2025, the patient received Kinrix. On 11-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix vaccine was administer to a 9 months male baby). The outcome of the inappropriate age at vaccine administration was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 02-APR-2025 The nurse reported that the patient received Kinrix vaccine and was administered to a 9 months old patient and with this last vaccine the patient had 3 Dtap and 3 IPV doses The Vaccine Administration Facility was the same as Primary Reporter. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
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| 2835224 | F | PA | 04/09/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
2JX7Y |
Product storage error
Product storage error
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Vaccine stored outside recommended conditions and administered to patient.; This non-serious case wa...
Vaccine stored outside recommended conditions and administered to patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 14-year-old female patient who received MMR (Priorix) (batch number 2JX7Y) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient.). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-APR-2025 Other HCP reported that the Priorix vaccines were exposed to a temperature of minus 23.5 degree celsius. Vaccine stored outside recommended conditions and administered to patient, which led to incorrect storage of drug. Reporter had received a new MMR vaccine with a different brand that was not supposed to be frozen and accidentally gave to patient the MMR. It was reported that administered vaccine was Priorix. This case is linked with US2025039710 reported by same reporter.; Sender's Comments: US-GSK-US2025039710:SAME REPORTER
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| 2835225 | F | NY | 04/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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missed the second dose of Shingrix; This non-serious case was reported by a other health professiona...
missed the second dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received the 1st dose of Shingrix vaccine 13 months ago with batch number 274YD and expiry date 15 September 2025). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed the second dose of Shingrix ). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 02-APR-2025 The physician assistant reported that a 73 years old female patient missed the second dose of Shingrix, it had been almost 13 months since dose 1. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2835226 | GA | 04/09/2025 |
HEPA HEPAB |
UNKNOWN MANUFACTURER GLAXOSMITHKLINE BIOLOGICALS |
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Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
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Interchangeability; This non-serious case was reported by a pharmacist via call center representativ...
Interchangeability; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a adult patient who received HAB (Twinrix) for prophylaxis. Co-suspect products included Hepatitis a vaccine for prophylaxis. In FEB-2025, the patient received the 1st dose of Twinrix. On an unknown date, the patient received the 1st dose of Hepatitis a vaccine. In FEB-2025, an unknown time after receiving Twinrix, the patient experienced interchange of vaccine products (Verbatim: Interchangeability). The outcome of the interchange of vaccine products was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 04-APR-2025 The pharmacist stated that an adult patient (unknown specific age) received what it seems to be first dose of Hepatitis A vaccine (unknown brand name or lot number) on 2017 (unknown specific date), and on February 2025 (not specific date) the patient got first dose of Twinrix, which led to interchange of vaccine products. Since pharmacist was calling on behalf of another facility, they did not have patient demographics or additional details of the scenario.
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| 2835227 | M | NY | 04/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received a dose of Shingrix in 2018 and has not received another dose yet; This non-serious case was...
received a dose of Shingrix in 2018 and has not received another dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in 2018). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received a dose of Shingrix in 2018 and has not received another dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 The pharmacist reported that a patient received a dose of Shingrix in 2018 and had not received another dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2835228 | F | VA | 04/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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received the first dose of Shingrix in September 2023 and hasn't received a second dose yet; Th...
received the first dose of Shingrix in September 2023 and hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in SEP-2023). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Shingrix in September 2023 and hasn't received a second dose yet). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 The pharmacist reported that a patient received 1st dose of Shingrix in September 2023 and had not received second dose yet. The Vaccine Administration Facility is the same as Primary Reporter Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2835229 | 54 | F | OR | 04/09/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
TY7MZ |
Incorrect route of product administration
Incorrect route of product administration
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Wrong Route of Administration; This non-serious case was reported by a nurse via call center represe...
Wrong Route of Administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number TY7MZ) for prophylaxis. On 03-APR-2025, the patient received the 1st dose of Shingrix. On 03-APR-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong Route of Administration). The outcome of the intramuscular formulation administered by other route was not applicable. Additional Information: GSK Receipt Date: 04-APR-2025 The registered nurse reported that the patient given Shingrix with subcutaneous route by accident and wanted to know if there was any protocol for this, which led to intramuscular formulation administered by other route.
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| 2835230 | 72 | F | PA | 04/09/2025 |
CHIK CHIK CHIK |
VALNEVA USA, INC. VALNEVA USA, INC. VALNEVA USA, INC. |
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Arthralgia, Asthenia, Blood pressure increased, Brain fog, Dizziness; Feeling ab...
Arthralgia, Asthenia, Blood pressure increased, Brain fog, Dizziness; Feeling abnormal, Headache, Malaise, Mobility decreased, Nausea; Pain, Pustule, Pyrexia, Rash
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Rash (rash started faint, like raised bumps or pustules up the arm and down the legs); Brain Fog; Ma...
Rash (rash started faint, like raised bumps or pustules up the arm and down the legs); Brain Fog; Malaise; Did not feel like herself; High fever (38.9 degree Celsius); Headache; Light-headedness; Incredible joint pain, could not get up and down out of a chair; Debilitated; Felt achy; Positional nausea; Blood pressure went higher (140s systolic) because of the response to the NSAIDS; The following information was received from a nurse on 13 Mar 2025. A 72-year-old female vaccinee received one dose of IXCHIQ (Chikungunya virus vaccination (CHIKV), batch number not provided) into her left arm on 13 Feb 2025. Concomitant medication included Lipitor (atorvastatin), Allegra (fexofenadine), B12 (cobalamin), Tylenol ES as needed (acetaminophen), nasal spray for allergies (NOS), Benadryl (diphenhydramine, indication reported as for sleep [most likely sleep disorder]), and Zantac (ranitidine) for rash post vaccination. Relevant past medication included COVID vaccine Moderna. The vaccinee stated that she has no medical history with exception of borderline cholesterol. Relevant medical episodes included past medical history of COVID-19 immunisation, and brain fog (after COVID immunisation) and the current diseases/conditions borderline hypercholesterolaemia, sleeping disorder (NOS), as well as rash post vaccination (NOS). Approximately two days after vaccination ('15 Feb 2025 - 16 Feb 2025'), she experienced malaise. She 'did not feel like herself'. On 'approximately 18 Feb 2025 - 22 Feb 2025', she experienced high fever (38.9 degrees Celsius) along with headache and light headedness. Approximately five days post vaccination, she experienced 'incredible joint pain and could not get up and down out of a chair'. She had been debilitated for 24 hours, then it got better, and she just felt achy. This pain has lasted for approximately five days. On 21 Feb 2025 - 23 Feb 2025, the woman experienced nausea, when she laid down, stated as 'positional nausea', and took an Advil (ibuprofen) at night. However, her blood pressure went higher (140s systolic) reportedly 'because of the response to the NSAIDS'. On 26 Feb 2025, the vaccinee experienced a rash. The rash started faint, like raised bumps or pustules up the arm and down the legs. She also experienced brain fog, which was treated with Zantac (ranitidine) and Allegra (fexofenadine). Outcome in general was stated as '90% resolved' and outcome for brain fog was specifically stated as 'not resolved'. Case is linked to US-INTERCELLP-6750 (same reporter).; Sender's Comments: Company' medical assessment: This case refers to a 72-year-old female vaccinee who was vaccinated with IXCHIQ on 13 Feb 2025. After vaccination she experienced malaise, high fever, headache, light headedness, joint pain, asthenia, pain, nausea, elevated blood pressure, rash and brain fog. The causality of the reported events is assessed as possibly related to IXCHIQ, as time to onset is plausible (first events started 2 days past vaccination). The occurrence of all events can be seen in the context of a systemic vaccination reaction, but the relatively high age of the vaccinee, the sleep disorder and the concomitant medication, especially atorvastatin should be taken into consideration, too, as e.g. malaise, pyrexia, rash, dizziness, headache, pain, arthralgia, and asthenia are explicitly listed for atorvastatin.
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| 2835232 | 04/09/2025 |
COVID19 |
MODERNA |
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Myocarditis
Myocarditis
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A kid died from myocarditis; This spontaneous case was reported by a patient family member or friend...
A kid died from myocarditis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDITIS (A kid died from myocarditis) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (A kid died from myocarditis) (seriousness criteria death and medically significant). The reported cause of death was died from myocarditis. It is unknown if an autopsy was performed. Not Provided No concomitant medications were reported. No treatment medications were reported. Company comment: Reportedly, it was stated that the patient died from myocarditis after vaccination, however, no additional details regarding medical history of the patient, clinical course of the event, treatment details, as well as temporal relationship between vaccination and the event of myocarditis were provided. It remained unknown if an autopsy was performed. The benefit-risk relationship of the product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2021-307118 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2025: Live non-significant follow up received: reference numbers were added.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-307118:Master case; Reported Cause(s) of Death: Died from myocarditis
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| 2835233 | 73 | F | MI | 04/09/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
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Ageusia, Anosmia, Anxiety, Asthenia, Balance disorder; Blood pressure measuremen...
Ageusia, Anosmia, Anxiety, Asthenia, Balance disorder; Blood pressure measurement, Cough, Crying, Decreased appetite, Rhinorrhoea; Vertigo, Vomiting
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Off balance -Fall down; Crying; Runny nose; High anxiety; Vertigo; Weakness; No smell; No Appetite; ...
Off balance -Fall down; Crying; Runny nose; High anxiety; Vertigo; Weakness; No smell; No Appetite; No taste; Coughing; vomit; This spontaneous case was reported by a patient and describes the occurrence of BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety) and VERTIGO (Vertigo) in an elderly female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Pfizer (Dose 4, Batch no: GH9702) on 08-Nov-2022, Morphine and codeine. Past adverse reactions to the above products included No adverse effect with Pfizer; and Sickness with Morphine and codeine. Concurrent medical conditions included Drug allergy (Codeine made patient sick), Drug allergy (Morphine made patient sick), COVID-19 since 05-Jan-2020, High cholesterol since 10-Jun-1969, Post-traumatic stress disorder since 30-Nov-1970, Thyroid disorder since 15-Jun-1965, Stomach ache and Constipation. Concomitant products included Docusate sodium (Colace) from 01-Jan-2020 to an unknown date for Constipation, Calcium carbonate (Tums) from 01-Jan-2020 to an unknown date for Stomach ache. On 21-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit). At the time of the report, BALANCE DISORDER (Off balance -Fall down), CRYING (Crying), RHINORRHOEA (Runny nose), ANXIETY (High anxiety), VERTIGO (Vertigo), ASTHENIA (Weakness), ANOSMIA (No smell), DECREASED APPETITE (No Appetite), AGEUSIA (No taste), COUGH (Coughing) and VOMITING (vomit) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: blood pressure up. The events cause the patient to seek medical care. No other factors that could had led to the adverse event. The patient experienced similar events in past. No treatment information was reported. This case was linked to MOD-2025-782752 (Patient Link).; Reporter's Comments: Previously given Pfizer vaccination (unknown indication) can be contributing factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.
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| 2835235 | F | 04/09/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Alopecia, Bedridden, Condition aggravated, Gait disturbance, Headache; Monoplegi...
Alopecia, Bedridden, Condition aggravated, Gait disturbance, Headache; Monoplegia, Nervous system disorder, Pain, Tinnitus, Tooth loss
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her one leg is paralyzed; bedridden at this time and is in critical condition as a result of the Mod...
her one leg is paralyzed; bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine; ears ringing; she is in extreme pain everyday; hair has fallen out, not all of it - most of it; she has lost teeth; barely able to walk anymore; It has just gotten worse and worse over the years; Neurological disorders; patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head; This spontaneous case was reported by an other health care professional and describes the occurrence of MONOPLEGIA (her one leg is paralyzed) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced MONOPLEGIA (her one leg is paralyzed) (seriousness criterion medically significant), BEDRIDDEN (bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine), TINNITUS (ears ringing), PAIN (she is in extreme pain everyday), ALOPECIA (hair has fallen out, not all of it - most of it), TOOTH LOSS (she has lost teeth), GAIT DISTURBANCE (barely able to walk anymore), CONDITION AGGRAVATED (It has just gotten worse and worse over the years), NERVOUS SYSTEM DISORDER (Neurological disorders) and HEADACHE (patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head). At the time of the report, MONOPLEGIA (her one leg is paralyzed), BEDRIDDEN (bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine), TINNITUS (ears ringing), PAIN (she is in extreme pain everyday), ALOPECIA (hair has fallen out, not all of it - most of it), TOOTH LOSS (she has lost teeth), GAIT DISTURBANCE (barely able to walk anymore), CONDITION AGGRAVATED (It has just gotten worse and worse over the years), NERVOUS SYSTEM DISORDER (Neurological disorders) and HEADACHE (patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter considered MONOPLEGIA (her one leg is paralyzed), BEDRIDDEN (bedridden at this time and is in critical condition as a result of the Moderna COVID-19 vaccine), TINNITUS (ears ringing), PAIN (she is in extreme pain everyday), ALOPECIA (hair has fallen out, not all of it - most of it), TOOTH LOSS (she has lost teeth), GAIT DISTURBANCE (barely able to walk anymore), CONDITION AGGRAVATED (It has just gotten worse and worse over the years), NERVOUS SYSTEM DISORDER (Neurological disorders) and HEADACHE (patient has stabs in her head, feels like somebody is biting her/her head feeling like there is cement in her head) to be related. Concomitant medication was not reported. Patient's year of birth was reported as 1956. Patient was severely injured by vaccine. Patient started having side effects 4 years ago. Patient was bedridden and was in critical condition as a result of the Moderna COVID-19 vaccine. Patient has been seen by probably 100 physicians over the last 4 years, and they thought there was some hope for recovery when it was on the news that there was a new drug out to reverse this vaccine. Caller stated patient has stabs in her head, feels like somebody is biting her, she has lost most of her hair, her teeth have fallen out, she can't walk, she has a lot of neurological issues as a result of the vaccine. Caller added the patient's side effects started first day headache, then it went to her ears ringing, then it went to her head feeling like there was cement in her head. Eventually over the last 4 years, her hair has fallen out, not all of it - most of it, she has lost teeth, she was in extreme pain every day, excruciating as she describes it, barely able to walk anymore, her one leg was paralyzed. It had just gotten worse and worse over the years, and she had seen so many physicians, and no one had an answer on how to stop what was happening to her. Treatment medication was not reported.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
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| 2835236 | F | WA | 04/09/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
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Immunisation reaction, Upper limb fracture; Immunisation reaction, Upper limb fr...
Immunisation reaction, Upper limb fracture; Immunisation reaction, Upper limb fracture
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a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad s...
a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna; broke my arm; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna) and UPPER LIMB FRACTURE (broke my arm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna) and UPPER LIMB FRACTURE (broke my arm). At the time of the report, IMMUNISATION REACTION (a side effect from Moderna/ have a lot to say regarding your side effects/Those are all really bad side effects from Moderna) and UPPER LIMB FRACTURE (broke my arm) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. Date of administration reported as 2020, 2021, and 2022 in years. It was reported that so if wanted to believe that it's, that it was dangerous, then they went for research that. And if wanted to believe in the power of whatever, getting immunized and was doing what's best for country, and then making that into some sort of judgment on somebody's Character for personality, testing and 23 and testing, those were all the side effects of that. It was also added "That was a side effect of Moderna and Johnson and Johnson and Pfizer. That's also an ethical and compliance concern, Patient stated she had "numerous vaccines. that's a really negative side effect. Patient broke arm and patient wanted to learn how to write with left hand. She added, "she didn't go with Johnson Johnson. It was unknown if the patient experienced any additional symptoms/events No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2025: Significant follow-up information received. New event (Arm fracture) added, and reference numbers added. On 25-Mar-2025: Non-significant information received new information received. On 25-Mar-2025: Non-significant information received new information received. On 25-Mar-2025: Non-significant information received new information received. On 25-Mar-2025: Significant follow-up information received: reference numbers added, and narrative was updated.
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| 2835237 | 04/09/2025 |
COVID19 |
MODERNA |
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Complement analysis, Flow cytometry, Immune-mediated adverse reaction
Complement analysis, Flow cytometry, Immune-mediated adverse reaction
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Unexpected immunological response; This spontaneous case was reported by a patient and describes the...
Unexpected immunological response; This spontaneous case was reported by a patient and describes the occurrence of IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Kidney transplant (First kidney transplant. Currently being evaluated for a second transplant). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) (seriousness criterion medically significant). At the time of the report, IMMUNE-MEDIATED ADVERSE REACTION (Unexpected immunological response) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Complement analysis: Positive. On an unknown date, Flow cytometry: Positive. Concomitant medication was not reported. Patient had received three doses of Moderna Covid-19 vaccine. After vaccination, CDC (Complement-Dependent Cytotoxicity) and Flow Crossmatch tests returned positive results. The patient had been evaluated for 2nd kidney transplant, but this unexpected immunological response had raised serious concerns and significantly impacted patient's health and quality of life. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Past medical history of Kidney transplant is a confounder for the event. The benefit -risk relationship of product is not affected by this report.
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| 2835238 | 77 | F | 04/09/2025 |
COVID19 |
MODERNA |
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Chills, Dysstasia, Loss of consciousness, Pain
Chills, Dysstasia, Loss of consciousness, Pain
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leaving her too weak to stand for several minutes; chills; passed out the following morning/weak; bo...
leaving her too weak to stand for several minutes; chills; passed out the following morning/weak; body aches; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out the following morning/weak) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 04-Oct-2024, the patient experienced LOSS OF CONSCIOUSNESS (passed out the following morning/weak) (seriousness criterion medically significant), PAIN (body aches) and CHILLS (chills). On an unknown date, the patient experienced DYSSTASIA (leaving her too weak to stand for several minutes). At the time of the report, LOSS OF CONSCIOUSNESS (passed out the following morning/weak), PAIN (body aches), DYSSTASIA (leaving her too weak to stand for several minutes) and CHILLS (chills) outcome was unknown. No concomitant medications were reported. Patient received all recommended doses and confirmed no other vaccines were received in the past four weeks. The doctor advised not to get another dose in April (appointment already scheduled) unless the formula had been updated. Patient was unsure of full vaccination history but had received all recommended doses. No lot number was provided. Patient was inquired whether can take Pfizer vaccine instead of moderna vaccine since experienced severe side effects with the last dose of modern vaccine. It is unknown if the patient experienced any additional symptoms/events. Reporter causality was not reported. No treatment medications were reported. Reporter did not allow further contact; Reporter's Comments: The age is a contributor for the events. The benefit -risk relationship of product is not affected by this report.
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| 2835239 | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; ...
Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500069078 same reporter/events, different patient;US-PFIZER INC-202500069065 same reporter/events, different patient;US-PFIZER INC-202500069064 same reporter/events, different patient;US-PFIZER INC-202500069066 same reporter/events, different patient;US-PFIZER INC-202500069067 same reporter/events, different patient;US-PFIZER INC-202500069039 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer
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| 2835240 | PA | 04/09/2025 |
PNC20 |
PFIZER\WYETH |
LK6653 |
Syringe issue
Syringe issue
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Broken vial or broken injection of Prevnar 20; Received a broken vial in a shipment; This is a spont...
Broken vial or broken injection of Prevnar 20; Received a broken vial in a shipment; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LK6653, Expiration Date: 30Jun2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Broken vial or broken injection of Prevnar 20; Received a broken vial in a shipment". Additional information: The reporter stated that they received some broken vial or broken injection of pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein). They wanted to know if they can get replacement. The vaccine was not given to patients. NDC Number: 00005-2000-10 The reporter considered "broken vial or broken injection of prevnar 20; received a broken vial in a shipment" not related to pneumococcal 20-val conj vac (dipht CRM197 protein). Causality for "broken vial or broken injection of prevnar 20; received a broken vial in a shipment" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Follow-up (07Apr2025): This is a follow-up report from product quality group providing investigation results. Updated information: narrative
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| 2835241 | 42 | M | GA | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Bursitis, Lumbar radiculopathy, Osteoarthritis, Spinal osteoarthritis
Bursitis, Lumbar radiculopathy, Osteoarthritis, Spinal osteoarthritis
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Spondylosis without myelopathy or radiculopathy, thoracic region; Lumbar radiculopathy; Osteoarthrit...
Spondylosis without myelopathy or radiculopathy, thoracic region; Lumbar radiculopathy; Osteoarthritis of Shoulder, Left; Right subacromial Bursitis/ Left subacromial Bursitis; This is a spontaneous report and received from Consumer or other non HCPs. A 45-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 29Mar2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "heart just started racing", "shortness of breath/Breath", "constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area", "constant pain in right side, where he got the shot/Pain on right side/Short right side"; BNT162b2 (DOSE 2, SINGLE), administration date: 10May2021, when the patient was 41-year-old, for Covid-19 immunization, reaction(s): "constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area", "shortness of breath/Breath", "heart just started racing", "constant pain in right side, where he got the shot", "constant pain in right side; towards the lungs, right where he got the shot, right near the buttocks/Pain on right side/Short right side"; influenza (annual), administration date: 02Sep2018, when the patient was 38-year-old, for immunization; influenza (annual), administration date: 15Oct2019, when the patient was 39-year-old, for immunization; mmr, administration date: 01Oct2020, when the patient was 40-year-old, for immunization; mmr, administration date: 14Oct2020, when the patient was 40-year-old, for immunization; mmr, administration date: 10Aug2022, when the patient was 42-year-old, for immunization; pneumococcal polysaccharide (pcv23), administration date: 15Oct2019, when the patient was 39-year-old, for immunization; tdap, administration date: 01Sep2017, when the patient was 37-year-old, for immunization; influenza quad (Influenza Quad, 6 mo - 64 years), administration date: 07Jan2021, when the patient was 41-year-old, for immunization; Bnt162b2 (DOSE 3), administration date: Nov2021, when the patient was 42 years old, for Covid-19 immunization, reaction(s): "constant pain in right side, where he got the shot and, back from lower area he got shot, towards the back and, all the way up, pain in that lower back area, the right side, basically, his lower area", "shortness of breath/Breath", "constant pain in right side; towards the lungs, right where he got the shot, right near the buttocks/Pain on right side/Short right side", "heart just started racing", "constant pain in right side, where he got the shot". The following information was reported: SPINAL OSTEOARTHRITIS (medically significant), outcome "unknown", described as "Spondylosis without myelopathy or radiculopathy, thoracic region"; LUMBAR RADICULOPATHY (medically significant), outcome "unknown"; OSTEOARTHRITIS (medically significant), outcome "unknown", described as "Osteoarthritis of Shoulder, Left"; BURSITIS (medically significant), outcome "unknown", described as "Right subacromial Bursitis/ Left subacromial Bursitis". Therapeutic measures were taken as a result of spinal osteoarthritis, lumbar radiculopathy, osteoarthritis, bursitis. Clinical course: The patient experienced Spondylosis without myelopathy or radiculopathy, thoracic region; Lumbar radiculopathy; Osteoarthritis of Shoulder, Left; and Right subacromial Bursitis/ Left subacromial Bursitis. OPERATIVE REPORT 13Feb2025: Pre-op. Diagnosis: Spondylosis without myelopathy or radiculopathy, thoracic region (M47.814). Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Right Thoracic Medial Branch Blocks at T10/11 T11/12 T12/L1 level. Anesthesia: local anesthesia. Details of Procedure: After a discussion of the risks and benefits, the patient consented to the procedure. The patient was taken to the procedure room and placed in the prone position. An AP fluoroscopic scout film was taken to identify the L4 and L5 vertebral bodies, the L4 and L5 pedicles and L5 and S1 superior articulating process. The skin was prepped with chlorhexidine and draped in the usual sterile fashion. The skin and subcutaneous tissue overlying the aforementioned anatomic targets were anesthetized using a 27-gauge 1-1/2 inch needle with 1% preservative-free lidocaine for a total volume of 2 mls. Then a 25-gauge 3 1/2 inch Quincke spinal needle was advanced under fluoroscopic guidance using an oblique view just inferior to the pedicle of the L4 and L5 level on the Left side. Then, utilizing AP and lateral fluoroscopic views, we confirmed the position of the needle tip to be within the neural foramen. After negative aspiration, 1 mls of iohexol 180 mg/ml contrast was injected under AP view at each level with live fluoro and confirmed adequate spread along the nerve root and in the epidural space. There was no evidence of intravascular uptake or intrathecal spread on imaging. A lateral view was also taken confirming adequate epidural spread. At this point, after negative aspiration, 1.5mL volume per level of treatment injectate (6mL total), consisting of 2mL of 1 mL of dexamethasone 4mg/mL, and 4mL of bupivacaine 0.25% was injected easily. There was no pain or resistance with injection. There was adequate anterior and posterior epidural spread. The needle was then restyletted and removed. The needle insertion site was dressed appropriately. Then the exact same steps and medication was completed on the contralateral side. The patient tolerated the procedure well and was to recovery in satisfactory condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOX3 conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: no JVD. MSK: Pt able to ambulate, limited ROM due to pain . PSYCH: Normal mood and affect. OPERATIVE REPORT 16Oct2024: Pre-op. Diagnosis: Lumbar Radiculopathy (M54.16). Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Bilateral Lumbar Transforaminal Epidural L4-5 and L5-S1. Anesthesia: local anesthesia. Details of Procedure: After a discussion of the risks and benefits, the patient consented to the procedure. The patient was taken to the procedure room and placed in the prone position. An AP fluoroscopic scout film was taken to identify the L4 and L5 vertebral bodies, the L4 and L5 pedicles and L5 and S1 superior articulating process. The skin was prepped with chlorhexidine and draped in the usual sterile fashion. The skin and subcutaneous tissue overlying the aforementioned anatomic targets were anesthetized using a 27-gauge 1-1/2 inch needle with 1% preservative-free lidocaine for a total volume Of 2 mls. Then a 25-gauge 3 1/2 inch Quincke spinal needle was advanced under fluoroscopic guidance using an oblique view just inferior to the pedicle of the L4 and L5 level on the Left side. Then, utilizing AP and lateral fluoroscopic views, we confirmed the position of the needle tip to be within the neural foramen. After negative aspiration, 1 mls of iohexol 180 mg/ml contrast was injected under AP view at each level with live fluoro and confirmed adequate spread along the nerve root and in the epidural space. There was no evidence of intravascular uptake or intrathecal spread on imaging. A lateral view was also taken confirming adequate epidural spread. At this point, after negative aspiration, 1.5mL volume per level of treatment injectate (6mL total), consisting of 2mL of 1 mL of dexamethasone 4mg/mL, and 4mL of bupivacaine 0.25% was injected easily. There was no pain or resistance with injection. There was adequate anterior and posterior epidural spread. The needle was then restyletted and removed. The needle insertion site was dressed appropriately. Then the exact same steps and medication was completed on the contralateral side. The patient tolerated the procedure well and was to recovery in satisfactory condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOX3 conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: no JVD. MSK: Pt able to ambulate, limited ROM due to pain. PSYCH: Normal mood and affect. OPERATIVE REPORT 17Jul2024: Pre-op. Diagnosis: Left shoulder pain; Osteoarthritis of Shoulder, Left. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Fluoroscopic guidance for needle placement and interpretation. Left Glenohumeral (Shoulder) Joint Steroid Injection. Anesthesia: Local. Indications: Shoulder Pain. Details of Procedure: After a discussion of the risks and benefits of the procedure, informed consent was obtained. The patient was taken to the procedure room and placed in a prone position. The Left shoulder was held at slightly internally rotated. The posterior shoulder area was prepped with chlorhexadine and draped in a sterile fashion. Using intermittent fluroscopic guidance, a 25 gauge 2 inch needle was inserted posteriorly approximately 1-2cm under the posterolateral angle of the acromion and was directed anteriorly and medially toward the coracoid process. After the bone (humeral head) was contracted, the needle was slightly withdrawn and redirected into the glenohumeral joint. Omnipague 1-2cc was injected and demonstrated appropriate arthropgram. After negative aspiration for blood, Decadron 4 mg/ml x 2 ml mixed with Bupivacaine 0.25% x 2 ml was injected into the glenohumeral joint without resistance or increased pain. The patient tolerated the injection well and was discharged in stable condition. Complications: None. Pre-procedural Assessment: GEN: AAOX3 conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: Palpable pulse w/ RRR. MSK: Pt able to ambulate, limited ROM due to pain. PSYCH: Normal mood and affect. OPERATIVE REPORT 09Apr2024: Pre-op. Diagnosis: Right shoulder pain; Right Subacromial Bursitis. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Right Shoulder Subacromial Steroid Injection. Anesthesia: Local. Indications: Pain. Details of Procedure: After a discussion of the risks and benefits of the procedure, informed consent was obtained. The patient was placed in a sitting position. The posterolateral edge of the acromion was palpated and marked. The posterolateral acromial area was prepped with chlorhexadine and draped in a sterile fashion. The Right shoulder was held at neutral position. A 25 gauge 1.5 inch needle was inserted towards the subacromial region immediately inferior to the posterolateral edge of the acromion. After negative aspiration for blood, a 4cc volume from a solution containing 1cc methylprednisolone 40 mg/mL mixed with 3cc lidocaine 1% was injected into the subacromial space easily without any resistance or pain. The patient experienced adequate relief (greater than 50%) immediately after the injection. The patient tolerated the treatment well and was discharged in stable condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOx3, conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: Palpable pulse w/ RRR. MSK: Pt able to ambulate, limited ROM due to pain, + shoulder impingement signs. PSYCH: Normal mood and affect. OPERATIVE REPORT 25Jan2024: Pre-op. Diagnosis: Left shoulder pain, Left Subacromial Bursitis. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Left Shoulder Subacromial Steroid Injection. Anesthesia: Local. Indications: Pain. Details! of Procedure: After a discussion of the risks and benefits of the procedure, informed consent was obtained. The patient was placed in a sitting position. The posterolateral edge of the acromion of the Left shoulder was palpated and marked. The posterolateral acromial area was prepped with chlorhexadine and draped in a sterile fashion. The affected shoulder was held at natural position. A 25 gauge 1.5 inch needle was inserted towards the subacromial region immediately inferior to the posterolateral edge of the acromion. After negative aspiration for blood, a 4cc volume from a solution containing 2 cc Dexamethasone 4mg/mL mixed with 2cc Lidocaine 1% was injected into the subaeromial space easily without any resistance or pain. The patient experienced adequate relief (greater than 50%) immediately after the injection. The patient tolerated the treatment well and was discharged in stable condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOx3, conversational, in no acute distress. ENT: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing, CTAB. CVS: S1, S2 RRR, no murmur, +palpable distal pulse. Abdom: Soft, ND, NT. MSK: Pt able to ambulate, limited left shoulder ROM due to pain, + shoulder impingement signs. PSYCH: Normal mood and affect. OPERATIVE REPORT 12Oct2023: Pre-op. Diagnosis: Lumbar Radiculopathy. Post-op. Diagnosis: Same as pre-op diagnosis. Operation: Bilateral Lumbar Transforaminal Epidural L4/5. Anesthesia: Local. Indications: Pain. Details of Procedure: After a discussion of the risks and benefits, the patient consented to the procedure. The patient was taken to the procedure room and placed in the prone position. The back was prepped with betadine and draped in sterile fashion. Local anesthetic wheal(s) were raised using Lidocaine 1% 5 ml. A 25 gauge 3.5 inch spinal needle was advanced toward the Bilateral L4/5 neural foramen until there was adequate placement in the superior aspect of the foramen under AP and lateral fluoroscopy. Omnipaque 180mg/ml x1mL was injected at each level with live fluoroscopy which showed dye spread in the epidural space and along the nerve root without any intrathecal or vascular uptake patterns. After negative aspiration for heme and CSF, I then administered 2mL volume from a solution containing 1mL dexamethasone 4 MG/ML and 3mL Bupivacaine 0.25% at the Right L4/5 neuroforamen and the remaining 2mL at the Left L4/5 neuroforamen. There was no pain or resistance with injection. There was adequate anterior and posterior epidural spread. The patient tolerated the procedure well and was discharged to recovery in satisfactory condition. Complications: None. Notes: Pre-procedural Assessment: GEN: AAOx3, conversational, in no acute distress. EM: EOMI, anicteric sclera, moist mucous membranes. RESP: Unlabored breathing. CVS: Palpable pulse w/ RRR. MSK; Pt able to ambulate, limited ROM due to pain. PSYCH: Normal mood and affect. The patient also received Gardasil 9 (PF) 0.5 ML intramuscular on 25Aug2023 (43 y.o.), on 22Sep2023 (43 y.o.); 30Jan2024 (44 y.o.); Heplisav- Hep B, Adult: 18Sep2023 (43 y.o.); 30Jan2024 (44 y.o.); Pneumococcal Conjugate 20-Valent: 16Aug2023 (43 y.o.)). The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.
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| 2835242 | NY | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome
COVID-19, Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome
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Debilitated by COVID-19 before; Debilitated by COVID-19 before; Severe long COVID-19 and had an acut...
Debilitated by COVID-19 before; Debilitated by COVID-19 before; Severe long COVID-19 and had an acute infection right now; Long COVID-19; This is a spontaneous report received from a consumer, Program ID. A 39-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Primary immune deficiency" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Debilitated by COVID-19 before"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "not recovered", described as "Long COVID-19"; DISEASE RECURRENCE (medically significant), outcome "not recovered", described as "Severe long COVID-19 and had an acute infection right now". The patient had COVID-19 before and is very sick. The patient needs nirmatrelvir/ritonavir (PAXLOVID) and also has other medical issues. During an inbound call for financial assistance, the patient had a prescription for nirmatrelvir/ritonavir (PAXLOVID). The patient had very severe long COVID-19 and had an acute infection right now. The patient had very severe primary immune deficiency. The patient had been so debilitated by COVID-19 before. The patient asked if it is five days that's covered. The patient's doctor said that she could only write 5 days at a time cause some people with long COVID-19 they find nirmatrelvir/ritonavir helps them a lot, so they take it for 5 days and then they take it for 5 more days. The patient asked if the company knows anything about the vaccine injuries from the COVID-19 vaccine. The patient didn't know that nirmatrelvir/ritonavir was made by Pfizer and had a really severe reaction to the COVID-19 vaccine, so the patient was just curious.
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| 2835243 | 43 | F | HI | 04/09/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Arthralgia, Arthritis, Gastrointestinal inflammation, Inflammation, Laboratory t...
Arthralgia, Arthritis, Gastrointestinal inflammation, Inflammation, Laboratory test; Musculoskeletal chest pain, Nerve compression, Pain in extremity, Radial nerve compression
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a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started ...
a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain; a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain; a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain; gut inflammation; a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain; a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain; causing other complications like radial tunnel syndrome; pinching the nerve; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 43-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, in arm for covid-19 immunisation. The patient had no relevant medical history. She was a healthy person and did not take any medications and has no history of any medical conditions. The patient is not allergic to any previous vaccination, medications, food or other products. There were no concomitant medications. The patient did not receive any other vaccines on the same date as the Pfizer vaccine, did not the patient receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine, was not taking any other medications within 2 weeks prior to the event onset. Vaccination history included: Bnt162b2 (DOSE 1, around the 30th or 31st of Dec2021/administered in her arm), administration date: Dec2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 2022, outcome "recovering", ARTHRALGIA (medically significant), MUSCULOSKELETAL CHEST PAIN (medically significant), INFLAMMATION (medically significant), ARTHRITIS (medically significant) all with onset 2022, outcome "unknown" and all described as "a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain"; RADIAL NERVE COMPRESSION (medically significant) with onset 2022, outcome "unknown", described as "causing other complications like radial tunnel syndrome"; GASTROINTESTINAL INFLAMMATION (medically significant) with onset 2022, outcome "unknown", described as "gut inflammation"; NERVE COMPRESSION (medically significant) with onset 2022, outcome "unknown", described as "pinching the nerve". The events "a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain", "gut inflammation", "causing other complications like radial tunnel syndrome" and "pinching the nerve" required physician office visit (for physical therapy and those types of things) and emergency room visit. The patient underwent the following laboratory tests and procedures: Lab test: had no food allergies. Therapeutic measures were taken as a result of pain in extremity, arthralgia, musculoskeletal chest pain, gastrointestinal inflammation, inflammation, arthritis, radial nerve compression, nerve compression. Clinical course: the patient was having inflammation and later clarified it is not lung inflammation but clarified it is gut inflammation she was having. This started in 2022 so it began about three years ago. She just felt she had a lot of inflammation and it was not with her lungs but started in the gut and lead to her extremities and was causing other complications like radial tunnel syndrome and she thinks the inflammation was persisting and at times would say it was worsened and probably in last month felt it was getting a little better but thinks it had worsened over the years. Initially she received the vaccine and she was one of the early patient's to receive vaccine because she worked at the hospital and so she had both doses and then after that probably within 5 months had a lot of gut inflammation and thought it was related to allergies and food allergies and was tested and had no food allergies and had no cause for the gut inflammation. So she then thought maybe it was stress and she changed jobs and later had inflammation and a lot of inflammation flare ups in her right extremities in her arm, wrist, forearm, and it started in her elbow and went up around the shoulder and side of the ribcage with shooting pain and so what was happening with the inflammation was pinching the nerve. The pain in the right extremities is improved but also she has done cortisol steroid injections in her arm and also had 6 months of physical therapy. First dose was around the 30th or 31st of Dec2021 and the 2nd vaccine was in Jan2022 as she remembers it more or less. She could go back and pull her labs but she does not have lab results or dates of the labs to provide at this time but it was standard care labs. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2835244 | 66 | F | CA | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Micturition urgency, Nocturia, Pollakiuria
Micturition urgency, Nocturia, Pollakiuria
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overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident;...
overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night; bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes/ lasted between 12-14 hours; This is a spontaneous report received from a Consumer or other non HCP. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NOCTURIA (non-serious) with onset 12Feb2021 at 13:00, outcome "recovered", described as "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; POLLAKIURIA (non-serious) with onset 12Feb2021 at 13:00, outcome "recovered", described as "bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes/ lasted between 12-14 hours"; MICTURITION URGENCY (non-serious) with onset 12Feb2021 at 13:00, outcome "recovered", described as "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident". Therapeutic measures were not taken as a result of micturition urgency, nocturia, pollakiuria. Additional information: The patient had no known allergies. Patient managed hypertension effectively with medication. Since receiving the initial COVID-19 vaccination in February 2021, she has had seven booster shots. After each Pfizer vaccination, patient experienced an intense and unusual side effect starting about 6-8 hours post-injection. She developed an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night. Despite trying to rest, she found it impossible due to the frequency and urgency of these episodes. Notably, after her first injection, this cycle lasted between 12-14 hours. These symptoms only occur following the vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500068560 same patient/event/product, different dose;US-PFIZER INC-202500068561 same patient/event/product, different dose;US-PFIZER INC-202500068562 same patient/event/product, different dose;US-PFIZER INC-202500068566 same patient/event/product, different dose;US-PFIZER INC-202500068564 same patient/event/product, different dose;US-PFIZER INC-202500068565 same patient/event/product, different dose;US-PFIZER INC-202500068563 same patient/event/product, different dose;
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| 2835245 | F | CA | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Micturition urgency, Nocturia, Pollakiuria
Micturition urgency, Nocturia, Pollakiuria
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overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident;...
overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; the need to urinate wakes her repeatedly throughout the night; Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: managed effectively with medication. Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE;LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Feb2021, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours". The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident"; NOCTURIA (non-serious), outcome "recovered", described as "the need to urinate wakes her repeatedly throughout the night"; POLLAKIURIA (non-serious), outcome "recovered", described as "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours". Therapeutic measures were not taken as a result of micturition urgency, nocturia, pollakiuria. Additional information: The patient had no known allergies. Manufacture for Atenolol, manufacture for HYDROCHLOROTHIAZIDE;LOSARTAN, manufacture for Atorvastatin. The patient's age was reported as 70-year-old at the time of reporting. Since receiving the initial COVID-19 vaccination in Feb2021, the patient has had seven booster shots. After each Pfizer vaccination, she experienced an intense and unusual side effect starting about 6-8 hours post-injection. She developed an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her bladder was completely full, and the urine was expelled rapidly. This cycle occurred approximately every 20 minutes and lasts for about 8 hours. It significantly disrupted her sleep, as the need to urinate woke her repeatedly throughout the night. Despite trying to rest, she found it impossible due to the frequency and urgency of these episodes. These symptoms only occurred following the vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500067929 same patient/event, different dose;
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| 2835246 | F | CA | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Micturition urgency, Nocturia, Pollakiuria
Micturition urgency, Nocturia, Pollakiuria
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overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident;...
overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours; It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: manage effectively with medication. Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE;LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Feb2021, when the patient was 66 years old, for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (Dose 2, single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 nos (Dose 3 (booster), single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; Bnt162b2 (Dose 3 (booster), single), for Covid-19 immunisation, reaction(s): "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 nos (Dose 4 (booster), single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; Bnt162b2 (Dose 4 (booster), single), for Covid-19 immunisation, reaction(s): "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 nos (Dose 5 (booster), single), for Covid-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; Bnt162b2 (Dose 5 (booster), single), for Covid-19 immunisation, reaction(s): "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours". The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident"; POLLAKIURIA (non-serious), outcome "recovered", described as "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night". Therapeutic measures were not taken as a result of micturition urgency, pollakiuria, nocturia. Additional information: the patient didn't receive any other vaccines on the same date or within 4 weeks PRIOR to the reported vaccine. The patient had no known allergy. Since receiving the initial COVID-19 vaccination in Feb2021, patient has had seven booster shots. After each Pfizer vaccination, she experienced an intense and unusual side effect starting about 6-8 hours post-injection. She develop an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night. Despite trying to rest, she found it impossible due to the frequency and urgency of these episodes. Notably, after her first injection, this cycle lasted between 12-14 hours. These symptoms only occur following the vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500067929 same patient/event, different dose;
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| 2835247 | F | CA | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Micturition urgency, Nocturia, Pollakiuria
Micturition urgency, Nocturia, Pollakiuria
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overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident;...
overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident; It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night; Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours; This is a spontaneous report received from a Consumer or other non HCP. A female patient in her 60's (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose 7(booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE;LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 12Feb2021, when the patient was 66-year-old, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes/ lasted between 12-14 hours"; Bnt162b2 (DOSE 2, SINGLE), when the patient was in their 60's, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 3(BOOSTER), SINGLE), when the patient was in their 60's, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 4(BOOSTER), SINGLE), when the patient was in their 60's, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 5(BOOSTER), SINGLE), when the patient was in their 60's, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours"; Bnt162b2 (DOSE 6(BOOSTER), SINGLE), when the patient was in their 60's, for COVID-19 immunisation, reaction(s): "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident", "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night", "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours". The following information was reported: MICTURITION URGENCY (non-serious), outcome "recovered", described as "overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident"; NOCTURIA (non-serious), outcome "recovered", described as "It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night"; POLLAKIURIA (non-serious), outcome "recovered", described as "Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours". Therapeutic measures were not taken as a result of micturition urgency, nocturia, pollakiuria. Additional information: The patient had no known allergies. Manufacture for Atenolol, manufacture for HYDROCHLOROTHIAZIDE;LOSARTAN, manufacture for Atorvastatin. Patient managed hypertension effectively with medication. Since receiving the initial COVID-19 vaccination in February 2021, she has had seven booster shots. After each Pfizer vaccination, patient experienced an intense and unusual side effect starting about 6-8 hours post-injection. She developed an overwhelming urge to urinate, to the point where she must rush to the restroom to avoid an accident. Each time, her bladder is completely full, and the urine is expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts her sleep, as the need to urinate wakes her repeatedly throughout the night. Despite trying to rest, she found it impossible due to the frequency and urgency of these episodes. Notably, after her first injection, this cycle lasted between 12-14 hours. These symptoms only occur following the vaccine. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500067929 same patient/event/product, different dose;
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| 2835248 | 70 | F | CA | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Micturition urgency, Pollakiuria, Sleep disorder
Micturition urgency, Pollakiuria, Sleep disorder
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After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 ho...
After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate/frequency and urgency of these episodes; It significantly disrupts my sleep, the need to urinate wakes me repeatedly throughout the night; After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate/frequency and urgency of these episodes; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Mar2025 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL, start date: Jan2024; HYDROCHLOROTHIAZIDE LOSARTAN, start date: Jan2022; ATORVASTATIN, start date: Jan2022. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: Feb2021, for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate"; Comirnaty (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate", "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate". The following information was reported: MICTURITION URGENCY (non-serious), POLLAKIURIA (non-serious) all with onset Mar2025, outcome "unknown" and all described as "After each Pfizer vaccination, I experience an intense and unusual side effect starting about 6-8 hours post-injection/overwhelming urge to urinate/frequency and urgency of these episodes"; SLEEP DISORDER (non-serious) with onset Mar2025, outcome "unknown", described as "It significantly disrupts my sleep, the need to urinate wakes me repeatedly throughout the night". Additional information: Patient did not receive any other vaccines on the same date as the Comirnaty vaccine. Patient did not receive any other vaccines within 4 weeks PRIOR to the Comirnaty vaccine. Patient with hypertension, which manage effectively with medication. Since receiving the initial COVID-19 vaccination in Feb2021, patient had seven booster shots. After each Pfizer vaccination, patient experience an intense and unusual side effect starting about 6๏ฟฝ8 hours post-injection. patient develop an overwhelming urge to urinate, to the point where patient must rush to the restroom to avoid an accident. Each time, patient bladder was completely full, and the urine was expelled rapidly. This cycle occurs approximately every 20 minutes and lasts for about 8 hours. It significantly disrupts patient sleep, as the need to urinate wakes me repeatedly throughout the night. Despite trying to rest, patient find it impossible due to the frequency and urgency of these episodes. Notably, after patient first injection, this cycle lasted between 12๏ฟฝ14 hours. These symptoms only occur following the vaccine. patient question was has anyone else experienced this Should patient continue using the Pfizer version of the vaccine. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500067929 same patient/event, different dose;
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| 2835249 | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; ...
Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer
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| 2835250 | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death, Death
Death, Death
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Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; ...
Seven family members died in the last three years because they have that Covid Vaccine from Pfizer; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Seven family members died in the last three years because they have that Covid Vaccine from Pfizer". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500066514 same reporter/events, different patient;; Reported Cause(s) of Death: Seven family members died in the last three years because they have that Covid Vaccine from Pfizer
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โ | ||||||||
| 2835251 | F | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Ageusia, Anosmia, Balance disorder, Balance disorder
Ageusia, Anosmia, Balance disorder, Balance disorder
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She said that she had no smell, no taste, and no balance after taking them; She said that she had no...
She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; She said that she had no smell, no taste, and no balance after taking them; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing); "cholesterol abnormal" (unspecified if ongoing). Concomitant medication(s) included: COLESTID taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "no taste", "no smell", "no balance". The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious), BALANCE DISORDER (non-serious), outcome "unknown" and all described as "She said that she had no smell, no taste, and no balance after taking them". Additional information: She was taking Colestid which was a medication for cholesterol. She took 2 packets of it every day then she was made to take these huge pills that she really has trouble swallowing. She also wanted to know if Pfizer had a program for Eliquis and Gemtesa where she could get them at a cheaper price. She further stated that she has multiple sclerosis, and she had to take three shots of the Pfizer COVID vaccine because she was in the (PRIVACY) and she could not get them to check her blood thinner without taking the shots. She said that she had no smell, no taste, and no balance after taking the Pfizer COVID vaccine. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500038008 Same patient/ product/ AEs, different doses.;US-PFIZER INC-202500069091 Same patient/ product/ AEs, different doses.;
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| 2835252 | F | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Ageusia, Anosmia, Balance disorder
Ageusia, Anosmia, Balance disorder
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no smell; no taste; no balance; This is a spontaneous report received from a Consumer or other non H...
no smell; no taste; no balance; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (ongoing); "cholesterol" (unspecified if ongoing). Concomitant medication(s) included: COLESTID taken for blood cholesterol abnormal. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunization, reaction(s): "no taste", "no smell", "no balance"; Bnt162b2 (dose 2, single), for covid-19 immunization, reaction(s): "no taste", "no smell", "no balance". The following information was reported: ANOSMIA (non-serious), outcome "unknown", described as "no smell"; AGEUSIA (non-serious), outcome "unknown", described as "no taste"; BALANCE DISORDER (non-serious), outcome "unknown", described as "no balance". Additional information: The caller (patient) stated that she has multiple sclerosis and she had to take three shots of the Pfizer COVID vaccine because she was in the state of PRIVACY and she could not get them to check her blood thinner without taking the shots. She said that she had no smell, no taste, and no balance after taking them. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500038008 Same patient/ product/ AEs, different doses.;US-PFIZER INC-202500069090 Same patient/ product/ AEs, different doses.;
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| 2835253 | M | NJ | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Exposure during pregnancy, Haemangioma, Ultrasound scan
Exposure during pregnancy, Haemangioma, Ultrasound scan
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She had to take the vaccine (2 doses of Pfizer COVID-19)/She had a baby boy; he had a segmental scro...
She had to take the vaccine (2 doses of Pfizer COVID-19)/She had a baby boy; he had a segmental scrotal hemangioma on R scrotum; This is a spontaneous report received from a Nurse. A neonate male patient was exposed to BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), transplacental, administration details for the mother: not provided as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The mother of the patient was 29 years old. The patient's relevant medical history was not reported. The mother's relevant medical history was not reported. The mother had no concomitant medications. No other vaccine same date. No other vaccine in four weeks. No other medications in two weeks. The mother's vaccination history included: Pfizer covid-19 vaccine (She had to take the vaccine (2 doses of Pfizer COVID-19).), for COVID-19 immunization. The following information was reported: HAEMANGIOMA (congenital anomaly) with onset 11Dec2024, outcome "recovering", described as "he had a segmental scrotal hemangioma on R scrotum"; EXPOSURE DURING PREGNANCY (congenital anomaly), outcome "recovering", described as "She had to take the vaccine (2 doses of Pfizer COVID-19)/She had a baby boy". The event "he had a segmental scrotal hemangioma on r scrotum" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (26Mar2025) Normal; (26Mar2025) Normal; (26Mar2025) Normal; (26Mar2025) Normal. Therapeutic measures were taken as a result of exposure during pregnancy, haemangioma. Clinical course: Patient's mom had to take the vaccine (2 doses of Pfizer COVID-19). She began working there in 2019. She had a baby boy. He was seen by a pediatric urologist as well as a pediatric dermatologist. He was put on topical timolol and the hemangioma is almost gone at dermatology f/u apt on 26Mar2025. He had a scrotal Ultrasound which was normal and on 26Mar2025 he also had an ultrasound of lumbar spine, kidney, and bladder to rule out lumbar syndrome. All ultrasounds were normal. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: There is not a reasonable possibility that the reported event scrotal hemangioma was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.,Linked Report(s) : US-PFIZER INC-202500069056 same reporter/drug, different patient/event (mom case);
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| 2835254 | F | 04/09/2025 |
RSV |
PFIZER\WYETH |
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Exposure during pregnancy
Exposure during pregnancy
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may have developed GBS; This is a spontaneous report received from a Pharmacist from a sales represe...
may have developed GBS; This is a spontaneous report received from a Pharmacist from a sales representative. An adult (18-64 years) female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "may have developed GBS". It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome. It was reported by a pharmacist that she knew someone who was pregnant that received Abrysvo and may have developed GBS. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Guillain-Barre syndrome and the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
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| 2835255 | 47 | F | NJ | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia
Arthralgia
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she had joint pain with the "first series" of covid vaccines which was awhile; This is a s...
she had joint pain with the "first series" of covid vaccines which was awhile; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 47-year-old female patient received BNT162b2 (BNT162B2), in Dec2020 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "little bit fat" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), administration date: Dec2020, when the patient was 47 years old, for Covid-19 Immunization, reaction(s): "she had joint pain with the "first series" of covid vaccines which was awhile". The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "she had joint pain with the "first series" of covid vaccines which was awhile". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500069247 same reporter/patient, different vaccine dose/event;
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| 2835256 | M | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Covid after Vaccine; Covid after Vaccine; This is a spontaneous report received from a Consumer or o...
Covid after Vaccine; Covid after Vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed; Manufacturer unknown), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid after Vaccine". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: the reporter (patient's wife) stated they both had covid and took Paxlovid. Reporter said she was having severe hip pain and her, and her husband had all their covid shots (Pfizer Shots) and she does not understand why she still got covid. They never had Covid, they took all the shots and everything they needed to do. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (03Apr2025): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500039765 Same reporter/product/event, different patient;
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| 2835257 | M | OH | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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Covid after Pfizer Covid vaccines; Covid after Pfizer Covid vaccines; This is a spontaneous report r...
Covid after Pfizer Covid vaccines; Covid after Pfizer Covid vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart condition" (unspecified if ongoing); "pacemaker defibrillator" (unspecified if ongoing); "Heart attack" (unspecified if ongoing); "anemia" (unspecified if ongoing); "pylori infection" (unspecified if ongoing); "cholesterol control" (unspecified if ongoing); "COVID-19", start date: 2021 (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS oral taken for myocardial infarction, start date: 2018 (ongoing); CLOPIDOGREL oral taken for anaemia, pyloric abscess, start date: 2015 (ongoing); ATORVASTATIN oral taken for blood cholesterol increased, start date: 2010 (ongoing). Past drug history included: Paxlovid for COVID-19 treatment. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 immunization; Comirnaty (DOSE 2), for COVID-19 immunization; Comirnaty (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Mar2025, outcome "unknown" and all described as "Covid after Pfizer Covid vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Mar2025) Positive. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2835258 | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Chest X-ray, Drug ineffective
COVID-19, Chest X-ray, Drug ineffective
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diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a Consumer or...
diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with Covid". The event "diagnosed with covid" required emergency room visit. The patient underwent the following laboratory tests and procedures: Chest X-ray: (2024) lung were fine, notes: had chest X-ray a year earlier to check for something and patient's lung were fine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical details: the patient started feeling bad, he/she went to a urgent care, they diagnosed the patient with Covid. He/She doesn't like being sick and he/she had the previous Pfizer Covid shots. They recommended Paxlovid and patient started taking it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2835259 | 04/09/2025 |
RSV |
PFIZER\WYETH |
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Device connection issue, Needle issue, Soft tissue foreign body
Device connection issue, Needle issue, Soft tissue foreign body
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needle stayed in patient's arm; This is a spontaneous report received from a Pharmacist. A pat...
needle stayed in patient's arm; This is a spontaneous report received from a Pharmacist. A patient (age and gender not provided) received respiratory syncytial virus vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "needle stayed in patient's arm". Additional information: It was reported that the needle stayed in patient's arm. Only luer lock and syringe came back from patient's arm. Reporter was unaware if patient was administered with the product or not, only that, the needle stayed in the patient's arm. Causality for "needle stayed in patient's arm" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The event needle device issue is assessed unrelated to the suspect product, possibly due to the device constituent
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| 2835260 | 79 | F | TX | 04/09/2025 |
PNC20 |
PFIZER\WYETH |
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Injection site reaction, Pyrexia, Rash, Rash erythematous, Rash pruritic
Injection site reaction, Pyrexia, Rash, Rash erythematous, Rash pruritic
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Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my lef...
Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm; a low grade fever; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Jan2025 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years, in left arm for immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Demerol, reaction(s): "Drug Allergy", notes: in the 1980's. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 13Jan2025 at 07:00, outcome "recovered" (07Feb2025) and all described as "Horrible red rash on the left upper arm, it was painful and itching/ rash extended all around my left upper arm"; PYREXIA (non-serious) with onset 2025, outcome "recovered" (2025), described as "a low grade fever". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site pain, vaccination site pruritus. Additional information: She took Prevnar 20 on 06Jan2025 at 10:00 AM. On 13Jan2025, she woke up with a horrible red rash on my left upper arm. It was painful and itching. As the day progressed the rash extended all around my left upper arm. She had the Prevnar vaccine on 06Jan2025 at the doctor's office. Benadryl and Advil relieved the symptoms some. She sent a message to the nurse practitioner and was instructed to monitor her arm, take the Benadryl and Papin relievers. Should she develop shortness of breath or other serious symptoms to go to an ER for treatment. The rash itched for approximately 2 weeks and the rash started fading after about a week. She continued taking the Benadryl and Advil for "203" weeks. The symptoms were reported to the doctor's office on the 13Jan2025 and an update reported through massaging on the 16Jan2025. She did develop a low-grade fever, and the itching continued over several weeks. It was reported that the patient did not receive any other vaccines on the same date as Prevnar 20. The patient was taking other medications within 2 weeks prior to the event onset date. The patient did not receive any other vaccines within 4 weeks prior to Prevnar 20. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2835261 | 78 | F | IL | 04/09/2025 |
PNC20 |
PFIZER\WYETH |
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Abdominal pain upper
Abdominal pain upper
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Horrible stomach pain which lasted probably 27 to 30 hours; This is a spontaneous report received fr...
Horrible stomach pain which lasted probably 27 to 30 hours; This is a spontaneous report received from a Consumer or other non HCP. A 78-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 02Apr2025 at 03:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 78 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Macular degeneration" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL] taken for vitamin d decreased; PEPCID [FAMOTIDINE] taken for gastrooesophageal reflux disease; AREDS taken for macular degeneration. The following information was reported: ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "Horrible stomach pain which lasted probably 27 to 30 hours". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of abdominal pain upper. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
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| 2835262 | F | TX | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Herpes zoster reactivation
Herpes zoster reactivation
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Shingles reactivation days after receiving the COVID-19 vaccine; This is a spontaneous report receiv...
Shingles reactivation days after receiving the COVID-19 vaccine; This is a spontaneous report received from a Nurse from a sales representative. A female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER REACTIVATION (non-serious), outcome "recovered", described as "Shingles reactivation days after receiving the COVID-19 vaccine". It was unknown if therapeutic measures were taken as a result of herpes zoster reactivation. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2835263 | M | AZ | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Pelvic pain
Pelvic pain
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severe pain in my pelvic area; The initial case was missing the following minimum criteria: Unspecif...
severe pain in my pelvic area; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 25Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PELVIC PAIN (medically significant) with onset 2021, outcome "not recovered", described as "severe pain in my pelvic area". Therapeutic measures were taken as a result of pelvic pain. Clinical course: Within weeks of taking the 2nd shot, the patient had severe pain in pelvic area. This has gone on for 3 years. It destroyed patient's life. The patient now getting treatment through removal of proteins from body, which has helped and would began additional treatment with weekly injections for the next 30 weeks. The patient thought the spike was supposed to stay in the arm. Also saw a video of an individual in your study that was paralyzed from after the second shot but this was never reported by you or to the public. The patient wanted to get information regarding an email that he thought he have received from Pfizer regarding his Pfizer Covid-19 Vaccination. He said it contains information regarding the vaccine such as the date and time and the vaccine number. He also said that he have received something from the mail from Pfizer but he have tossed it and not sure what it was. He wanted to find the email and if Pfizer have it on their records as well as the one he have received in the mail. He shared that he have experienced adverse events after getting the Pfizer Covid-19 vaccine such as his body still producing spike proteins, 3 years after getting the vaccine. He confirmed he have not reported these before as he was not sure if it was due to the vaccine that time. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2835265 | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Malaise
Malaise
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felt worse compared to actually catching the Covid-19 virus; This is a spontaneous report received f...
felt worse compared to actually catching the Covid-19 virus; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jul2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "felt worse compared to actually catching the Covid-19 virus". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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| 2835266 | 41 | M | GA | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Dyspnoea, Pain
Dyspnoea, Pain
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Breath (short right side); Pain on right side; This is a spontaneous report and received from consum...
Breath (short right side); Pain on right side; This is a spontaneous report and received from consumers. A 41-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient is not allergic to any previous vaccination, medications, food or other products. Vaccination history included: influenza vaccine (DOSE 1; MANUFACTURER UNKNOWN; annual), administration date: 02Sep2018, when the patient was 38-year-old, for Immunization; influenza vaccine (DOSE 2; MANUFACTURER UNKNOWN; annual), administration date: 15Oct2019, when the patient was 39-year-old, for Immunization; influenza vaccine (DOSE 3; MANUFACTURER UNKNOWN; annual), administration date: 07Jan2021, when the patient was 41-year-old, for Immunization; mmr vaccine (DOSE 1; MANUFACTURER UNKNOWN), administration date: 01Oct2020, when the patient was 40-year-old, for Immunization; mmr vaccine (DOSE 2; MANUFACTURER UNKNOWN), administration date: 14Oct2020, when the patient was 40-year-old, for Immunization; pcv23 (DOSE 1; MANUFACTURER UNKNOWN), administration date: 15Oct2019, when the patient was 39-year-old, for Immunization; tdap (DOSE 1; MANUFACTURER UNKNOWN), administration date: 01Sep2017, when the patient was 37-year-old, for Immunization; influenza quad (DOSE 1; MANUFACTURER UNKNOWN), administration date: 07Jan2021, when the patient was 41-year-old, for Immunization. The following information was reported: DYSPNOEA (disability) with onset 2021, outcome "not recovered", described as "Breath (short right side)"; PAIN (disability) with onset 2021, outcome "not recovered", described as "Pain on right side". The events "breath (short right side)" and "pain on right side" required physician office visit. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020171 Same patient and product; different dose and event;US-PFIZER INC-202500067033 Same patient and product; different dose and event;
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| 2835267 | F | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Headache, Illness, Influenza
Headache, Illness, Influenza
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flu; sick; headaches; This is a spontaneous report received from a Consumer or other non HCP, Progra...
flu; sick; headaches; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches"; INFLUENZA (non-serious), outcome "unknown", described as "flu"; ILLNESS (non-serious), outcome "unknown", described as "sick". Additional information: patient stated "I put the vaccine for the covid 3 times and make headaches. And the last year the flu and sick more." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2835268 | WI | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Deep vein thrombosis, Pulmonary embolism
Deep vein thrombosis, Pulmonary embolism
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It almost killed him/her. developed 3 pulmonary embolisms and 5 DVTs from it; It almost killed him/h...
It almost killed him/her. developed 3 pulmonary embolisms and 5 DVTs from it; It almost killed him/her. developed 3 pulmonary embolisms and 5 DVTs from it; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (medically significant, life threatening), DEEP VEIN THROMBOSIS (medically significant, life threatening), outcome "unknown" and all described as "It almost killed him/her. developed 3 pulmonary embolisms and 5 DVTs from it". The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2835269 | AR | 04/09/2025 |
RSV |
PFIZER\WYETH |
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Arthralgia, Gait disturbance, Mobility decreased, Nodule, Pain
Arthralgia, Gait disturbance, Mobility decreased, Nodule, Pain
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joints painful; knots in joints, on knees, elbows, fingers; hard to walk; hard to move arms fingers;...
joints painful; knots in joints, on knees, elbows, fingers; hard to walk; hard to move arms fingers; PAIN 8-10; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 02Mar2025 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2025, outcome "unknown", described as "PAIN 8-10"; MOBILITY DECREASED (non-serious) with onset 2025, outcome "unknown", described as "hard to move arms fingers"; GAIT DISTURBANCE (non-serious) with onset 2025, outcome "unknown", described as "hard to walk"; ARTHRALGIA (non-serious) with onset 2025, outcome "unknown", described as "joints painful"; NODULE (non-serious) with onset 2025, outcome "unknown", described as "knots in joints, on knees, elbows, fingers". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had problem after getting vax on 02Mar2025 Abrysvo, joints painful, knots in joints, on knees, elbows, fingers, ,hard to walk ,move arms fingers, now pain 8-10. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
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| 2835271 | F | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A female pat...
COVID-19; COVID-19; This is a spontaneous report received from a consumer, Program ID. A female patient received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included nirmatrelvir/ritonavir (PAXLOVID). Previously, they never had COVID-19, they took all the shots and everything they needed to do. The patient and her husband both had COVID-19 after the vaccine and took nirmatrelvir/ritonavir (PAXLOVID). The patient and her husband had all their COVID-19 shots, and she does not understand why she still got COVID-19. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500070471 Same reporter, product, and event; different patient;
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| 2835272 | F | 04/09/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
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Condition aggravated, Eczema, Exostosis, Fall, Fatigue; Glaucoma, Knee arthropla...
Condition aggravated, Eczema, Exostosis, Fall, Fatigue; Glaucoma, Knee arthroplasty, Macular degeneration, Meniscus injury, Pneumonia; Rash pruritic
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total knee replacement surgeryon her right knee; small outbreak of eczema on right thumb that is bei...
total knee replacement surgeryon her right knee; small outbreak of eczema on right thumb that is being stubborn/breakthrough eczema on her thumb; bone spurs as well that has gotten worse; Condition aggravated; fallen several times; tore meniscus on right knee; Pneumonia; right eye macular degeneration; glaucoma; had a reactions to the covid vaccine, she stated she had a rash for 4-5 days, and it itched for a few days longer than that; had aches ad pains and felt tired for 48 hours after; felt tired for 48 hours after; DUPIXENT MY WAY This is a solicited report and received from Consumer or other non HCPs from License Party. Other Case identifier(s): 2021SA091274 (SANOFI), AE-018669 (BioNTech). This case involves a 75-years-old female patient who had total knee replacement surgery on her right knee, glaucoma, had a reaction to the covid vaccine, she stated she had a rash for 4-5 days and it itched for a few days longer than that, had aches, and pains and felt tired for 48 hours after and felt tired for 48 hours after and small outbreak of eczema on right thumb that is being stubborn/breakthrough eczema on her thumb, bone spurs as well that has gotten worse, fallen several times, tore meniscus on right knee and while on dupilumab, COPD (chronic obstructive pulmonary disease) has improved and passed away due to pneumonia while she was treated with dupilumab (Dupixent) delivered via dupilumab prefilled syringe and covid-19 vaccine. The patient's past medical history included fall. The patient's past medical treatment (s) and family history were not provided. At the time of the event, the patient had ongoing osteoarthritis, exostosis, asthma and chronic obstructive pulmonary disease. Concomitant medications included: Probiotics nos, gabapentin, Levothyroxine sodium, Ascorbic acid, Betacarotene, Cupric oxide, Tocopheryl acetate, Zinc oxide (Preservision areds); Pramipexole dihydrochloride monohydrate (Mirapex), Rosuvastatin; Escitalopram oxalate (Lexapro); Latanoprost; Calcium citrate, Colecalciferol (Citracal + D3); Omeprazole, Vitamin d, Vitamins nos (multivitamin); Calcium; Fluticasone Furoate, Vilanterol trifenatate (Breo ellipta); Allopurinol and Flonase. On 04Nov2019, the patient started taking dupliumab solution for injection with strength 300mg/2mL at 600 mg as loading dose followed by 300 mg QOW subcutaneously in 2019 for atopic dermatitis unspecified and flexural eczema. First time product used: No. On an unknown date in 2021, the patient started taking covid-19 vaccine (with an unknown batch number, strength, form, dose route) for prophylactic vaccination. Patient stated she had a reaction to the COVID vaccine she had a rash for 4-5 days, and it itched for a few days longer than that (rash pruritic, start date:2021 and latency. few years approximately). She had aches and pains (pain. start date:2021, latency: few years approximately) and felt tired for 48 hours after (fatigue. start date:2021. latency: few years approximately). On an unknown date the patient experienced small outbreak of eczema on right thumb that was being stubborn (eczema) (latency few years approximately). In the last 6 months, she has developed glaucoma (onset: 2021, latency: approximately 2 years). And she also has right eye macular degeneration since unknown date (onset latency: unknown). She did not admit of having the family history and told that these may be age-related. Since unknown date for years, the consumer has osteoarthritis on her right knee, her right knee was then bone on bone and has bone spurs as well that has gotten worse (exostosis / Condition aggravated; unknown onset and latency). Before and after dupilumab, she had fallen several times (fall; unknown onset and latency). This last summer (unknown date), she fell and tore her meniscus on her right knee (meniscus Injury; unknown onset and latency). While being on dupilumab, her asthma and COPD (Chronic obstructive pulmonary disease) had Improved as well (therapeutic response unexpected; unknown onset and latency). She would have a right knee replacement surgery on 13Dec2021 and she is also on Prolia, she had osteoarthritis on her right knee, her right knee was now bone on bone and had bone spurs as well that had gotten worse: she had fallen several times: and she fell and tore her meniscus on her right knee. She had total knee replacement surgery on her right knee (Knee arthroplasty) on13Dec2021 (latency 2 years 1 month 9 days) she was admitted to the hospital because of this surgery. She had been discharged from the hospital on unknown date and was currently in rehab. The nurse received the information from her husband today. 23Dec2021. Patient eczema was 99 percent improved. Patients husband stated that his wife had passed away due to pneumonia (pneumonia) (event onset and unknown latency) (unknown batch number and expiry date for all events). Information on batch number and expiration date corresponding to the one at time of event occurrence was requested. Action taken: unknown for glaucoma, not applicable for therapeutic response unexpected and pneumonia No action taken for rest all the events associated with dupilumab and not applicable for all the events associated with covid-19 vaccine. Corrective treatment-Not reported for glaucoma, pneumonia, eczema, exostosis, fall, meniscus injury, rash pruritic, pain and fatigue. Outcome-unknown for glaucoma, fall, meniscus injury, not recovered/not resolved for exostosis, recovering/resolving for knee arthroplasty, eczema, rash pruritic, pain and fatigue and fatal for pneumonia. Reporter causality: unassessable for eczema: not related to knee arthroplasty, rash pruritic, pain, fatigue, not reported for rest of the events. Company causality: reportable for eczema: not reported for the other events. Seriousness criteria: hospitalization for knee arthroplasty, medical significant for glaucoma, macular degeneration and pneumonia and fatal for pneumonia. Additional information was received on 30Sep2021: company suspect drug therapy start date updated and a new event (eczema) added. Narrative amended accordingly. Additional information was received on 18Oct2021 from patient, based on this information case was updated as serious case due to addition of event glaucoma which is considered as medially significant text amended. Additional information was received on 21Oct2021 from patient. Outcome for event along with verbatim small outbreak of eczema on right thumb that is being stubborn/breakthrough eczema on her thumb was updated to recovering. Text amended. Additional information was received from patient via call center in 27Oct2021: medical history added, drug start date and clinical course updated new events (fall, meniscus injury, therapeutic response unexpected and exostosis) were added. Text amended accordingly. Additional information was received from patient's husband via call center on 23Dec2021. Event knee arthroplasty added. Clinical course updated. Text amended accordingly. Additional information was received on 06Mar2025 from patient's husband-added event-pneumonia, strength and formulation was added text amended accordingly. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. SUSPECT PRODUCT is under agreement with BIONTECH SE.; Sender's Comments: A causal attribution between the vaccination with BNT162B2 and the development of rash pruritus, pain and fatigue cannot be completely excluded, considering the known adverse event profile of the suspect vaccine and known adverse events profile. Other events including pneumonia, fall, arthroplasty, bone spurs, eczema, glaucoma and macular degeneration are intercurrent medical conditions or underlying diseases associated with predisposing factors such as old age, ongoing osteoarthritis, atopic dermatitis, asthma and chronic obstructive pulmonary disease.; Reported Cause(s) of Death: Pneumonia
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| 2835273 | F | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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COVID; COVID; This is a spontaneous report received from a Physician, Program ID. A female patient ...
COVID; COVID; This is a spontaneous report received from a Physician, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/drug ineffective (CoVID-19) with the suspect product BNT162B2 OMICRON (KP.2) cannot be fully excluded.
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| 2835274 | 25 | F | NJ | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
EJ1685 |
Intermenstrual bleeding
Intermenstrual bleeding
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2-3 Bleeding Breakthroughs per month; Additional information: The patient did not receive any other ...
2-3 Bleeding Breakthroughs per month; Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s). The patient did not receive any other vaccines within 4 weeks prior to the vaccine(s). Dose 2. was given on 14Jan2021 (Pfizer Covid shot) Lot #EL3302- given via intramuscular route in left deltoid. Patient was having regular periods on birth control pills around 2016-2020. Stopped birth control on 2019.
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| 2835275 | F | 04/09/2025 |
COVID19 |
PFIZER\BIONTECH |
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Hypersensitivity, Immune system disorder, Pruritus, Skin burning sensation, Skin...
Hypersensitivity, Immune system disorder, Pruritus, Skin burning sensation, Skin depigmentation
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covid shot affected her immune system; allergies every morning; skin went from itching to burning re...
covid shot affected her immune system; allergies every morning; skin went from itching to burning resulting in marks all over her body; skin went from itching to burning resulting in marks all over her body; skin went from itching to burning resulting in marks all over her body; This is a spontaneous report received from a Consumer or other non HCP from License Party. A 65-year-old female patient received BNT162b2 (BNT162B2), in 2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Jan2022 (ongoing) as 300 mg) subcutaneous for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "recovering", described as "covid shot affected her immune system"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies every morning"; PRURITUS (non-serious), SKIN BURNING SENSATION (non-serious), SKIN DEPIGMENTATION (non-serious), outcome "unknown" and all described as "skin went from itching to burning resulting in marks all over her body". The action taken for dupilumab was dosage not changed. Additional information: This case involves a 65 years old female patient who reported COVID-19 vaccine shot affected her immune system while being treated with DUPILUMAB [DUPIXENT] delivered via single dose prefilled syringe. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In January 2022, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection in prefilled syringe at dose 300 mg (unknown: strength, frequency) subcutaneously for Dermatitis atopic. In 2022, the patient started taking COVID-19 vaccine (at unknown dose, frequency, route, strength, device) for immunisation. On an unknown date the patient developed a non-serious event "covid shot affected her immune system "(immune system disorder) (unknown latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB and COVID-19 vaccine. On an unknown date the patient developed a non-serious event "allergies every morning" (hypersensitivity) (unknown latency) following the first dose intake (unknown expiry date, batch number) of DUPILUMAB and COVID-19 vaccine. On an unknown date the patient developed a non-serious event "skin went from itching to burning resulting in marks all over her body" (pruritus), (skin burning sensation) and (skin discolouration) (unknown latency) following the first dose intake (unknown expiry date, batch num ber) of DUPILUMAB and COVID-19 vaccine. Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. It was reported "having allergies every morning; Also, she received the Covid Shot in 2022; That affected her immune system and caused her skin to go from itching to burning resulting in marks all over her body. Missed Dose NOT reported.' Action taken with DUPILUMAB: no action taken for immune system disorder Action taken with COVID-19 vaccine: unknown for immune system disorder It was not reported if the patient received a corrective treatment for immune system disorder At time of reporting, the outcome was Recovering / Resolving for immune system disorder No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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