| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2860804 | 70 | M | FL | 09/23/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Late 2nd and 3rd dose; This non-serious case was reported by a pharmacist via call center representa...
Late 2nd and 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received in November 2024). On 16-SEP-2025, the patient received the 2nd dose of Twinrix. On 16-SEP-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd and 3rd dose). The outcome of the drug dose administration interval too long 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:18-SEP-2025 The patient received the first dose of the Twinrix vaccine in November 2024. However, the patient then they forgot to come back and gave them a 2nd dose on 16-Sep-2025.
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| 2860805 | IL | 09/23/2025 |
COVID19 |
MODERNA |
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Dyschromatopsia
Dyschromatopsia
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White vision; This spontaneous case was reported by a non-health professional and describes the occu...
White vision; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSCHROMATOPSIA (White vision) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSCHROMATOPSIA (White vision). At the time of the report, DYSCHROMATOPSIA (White vision) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. The patient experienced issues with white vision and eye sight was recovered. Treatment medications were provided. This case contains information pertaining to the 1st of 2 patients described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-432334 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Upon internal review on 19-Sep-2025, significant correction was performed to update the case type as valid from invalid and add No patient identifiers classification in the case.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-432334:Patient 2
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| 2860806 | AR | 09/23/2025 |
COVID19 |
MODERNA |
041J21A |
Nausea, Palpitations
Nausea, Palpitations
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Racing heart; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrenc...
Racing heart; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (Racing heart) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Racing heart) and NAUSEA (Nausea). At the time of the report, PALPITATIONS (Racing heart) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not reported. This case contains information about the second patient out of the 3 patients as described by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-436397 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2021: Upon internal review on 18-Sep-2025, significant correction was performed to update the case type as valid from invalid and add No patient identifiers classification in the case.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-436397:Patient 1
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| 2860807 | SC | 09/23/2025 |
COVID19 |
MODERNA |
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Chills, Fatigue, Pyrexia
Chills, Fatigue, Pyrexia
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Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrenc...
Fever; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment medication was not reported. This case contains information for the 2nd of 2 patients described by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. This case was linked to US-MODERNATX, INC.-MOD-2021-789336 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Upon internal review on 18-Sep-2025, significant correction was performed to update the case type as valid from invalid and added No patient identifiers classification.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-789336:Patient 1 of 2
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| 2860808 | F | 09/23/2025 |
COVID19 |
MODERNA |
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Magnetic resonance imaging, Multiple sclerosis relapse
Magnetic resonance imaging, Multiple sclerosis relapse
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Moderna Vaccine activated her MS/low energy; This spontaneous case was reported by a consumer and de...
Moderna Vaccine activated her MS/low energy; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Moderna Vaccine activated her MS/low energy) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer covid vaccine (Dose 1, Lot: EM9810, Site: Injection in the arm) on 03-Feb-2021, Pfizer vaccine (Dose 1, Lot: EM9810, Site: Injection in the arm) on 03-Feb-2021, Pfizer vaccine (Dose 2, Lot: EN6198, Site: Injection in the arm) on 26-Feb-2021, Pfizer covid vaccine (Dose 2, Lot: EN6198, Site: Injection in the arm) on 26-Feb-2021, Pfizer covid vaccine (Dose 3, Lot: FH8027, Expiry: 28Feb2022, Site: Injection in the Right arm) on 22-Oct-2021, Pfizer vaccine (Dose 3, Lot: FH8027, Expiry: 28Feb2022, Site: Injection in the Right arm) on 22-Oct-2021, Pfizer covid vaccine (Dose 4, Lot: FN2908, Site: Injection in the arm) on 10-May-2022, Pfizer vaccine (Dose 4, Lot: FN2908, Site: Injection in the arm) on 10-May-2022, Pfizer covid vaccine (Dose 5, Lot: C1 or CJ3270, Site: Injection in the arm) on 19-May-2023, Pfizer vaccine (Dose 5, Lot: C1 or CJ3270, Site: Injection in the arm) on 19-May-2023, Pfizer vaccine (Dose 6, Lot: 6JZ524 or 6J2524, Date: 13Sep2022) on 13-Sep-2023, Pfizer covid vaccine (Dose 6, Lot: 6JZ524 or 6J2524 and Date: 13Sep2022) on 13-Sep-2023. Past adverse reactions to the above products included Pain in arm with Pfizer covid vaccine, Pfizer covid vaccine, Pfizer covid vaccine, Pfizer covid vaccine, Pfizer covid vaccine and Pfizer covid vaccine; and Strength loss of with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Multiple sclerosis (she had MS for 30 years.). On an unknown date, the patient received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Moderna Vaccine activated her MS/low energy) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Moderna Vaccine activated her MS/low energy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Stable and did not show any active lesions or anything. Concomitant medication was not provided. It was reported that the patient was 68-69 years old at onset and reported her weight as too much and stated that she was completely mobile. It was reported that the patient had MS for 30 years and had received original covid vaccine in 2020. She had received 6 booster doses from Pfizer and reported that she had not experienced any problems and was doing well. She also reported that she had experienced a flu shot type response with the Pfizer covid vaccines. She had received her 7th booster dose from Moderna, and the Moderna vaccine had activated her MS leading to a robust response for which she had to go on corticosteroids due to MS complications. The complications included low energy and difficulty getting out of bed. Her neurologist had advised her against getting another covid vaccine which had been 2 years ago. She was ambulant but did not want to risk activating her MS and she was seeking advice on whether or not to get the new vaccine. She was worried about having a robust response to the COVID vaccine and did not want to aggravate her MS. It was also reported that she was on an immunosuppressant at the time she had the Moderna vaccine but was modulated. She clarified that she had a sore arm and down with energy a little bit for a day or so after receiving the Pfizer Covid-19 Vaccines which she was described as not a big deal and did not consider it as a negative outcome. She had stated that she did not want a recurrence of severe reaction she experienced with moderna vaccine, where she had struggled to get out of bed for a couple of weeks. The response to the Pfizer vaccine was described as level 1-2 compared to level 9-10 she had with Moderna. She noted that the difference was significant. It was way less than the shingles vaccines. It was not even on her radar. The patient also stated that the Moderna Covid-19 Vaccine had kicked her butt. The patient was not sure of lot number for 5th and 6th dose of Pfizer vaccin; Reporter's Comments: The previous vaccination with Pfizer vaccines and medical history of multiple sclerosis were assessed as confounding factors for reporting event of multiple sclerosis relapse. The benefit-risk relationship of product is not affected by this report.
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| 2860809 | 81 | M | 09/23/2025 |
COVID19 |
MODERNA |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19...
got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got COVID) in an 81-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In April 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2025, the patient experienced COVID-19 (got COVID). At the time of the report, COVID-19 (got COVID) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2025, SARS-CoV-2 test: (Positive) a very dark thick line. Patient had no vaccines prior to the Spikevax in April 2025. No concomitant medication was reported. Patient had the vaccine at the same time as his wife in April 2025. Patient had COVID right till the day of reporting. Patient did not wear his mask in the gym anymore and had it (COVID). Moderna did a perfect job, keeping him safe. His COVID test was a very dark thick line, and he was apparently the person who gave it to his wife because he stopped wearing his mask in the gym. The patient sneezes a lot. He had no sore throat and his voice was very raspy. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789526 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789526:Husband case
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| 2860810 | 58 | F | ME | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8855DA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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None at this time
None at this time
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| 2860811 | 32 | F | CA | 09/23/2025 |
COVID19 COVID19 FLU3 FLU3 |
PFIZER\BIONTECH PFIZER\BIONTECH SEQIRUS, INC. SEQIRUS, INC. |
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Chills, Feeling cold, Headache, Insomnia, Nausea; Pyrexia; Chills, Feeling cold,...
Chills, Feeling cold, Headache, Insomnia, Nausea; Pyrexia; Chills, Feeling cold, Headache, Insomnia, Nausea; Pyrexia
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Extreme cold chills, fever of 101, nausea, headache, insomnia. Chills lasted several hours about 11 ...
Extreme cold chills, fever of 101, nausea, headache, insomnia. Chills lasted several hours about 11 hours onset after receiving vaccinations, the other symptoms off and on about 11 hours after receiving vaccinations to now 23 hours later except for headache that has been consistent since 11 hours onset after receiving vaccinations to now 23 hours later
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| 2860812 | 16 | F | NC | 09/23/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5XA2J |
Arthralgia, Mobility decreased
Arthralgia, Mobility decreased
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Left shoulder pain and decreased range of motion starting the evening or day following the injection...
Left shoulder pain and decreased range of motion starting the evening or day following the injection, not improved after 1 week.
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| 2860813 | 41 | F | 09/23/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
3052671 |
Dizziness, Feeling abnormal, Muscle twitching, Paraesthesia; Dizziness, Feeling ...
Dizziness, Feeling abnormal, Muscle twitching, Paraesthesia; Dizziness, Feeling abnormal, Muscle twitching, Paraesthesia
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kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house w...
kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor; like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on; This spontaneous case was reported by an other health care professional and describes the occurrence of PRESYNCOPE (kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor) and PARAESTHESIA (like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on) in a 41-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052671) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine inact sAg 4v (Cell based quadrivalent influenza vaccine) for an unknown indication. The patient's past medical history included COVID-19 in February 2025. Previously administered products included for Product used for unknown indication: Pfizer vaccine; for Drug use for unknown indication: Paxlovid. Past adverse reactions to the above products included No adverse effect with Paxlovid and Pfizer vaccine. Concurrent medical conditions included Postural orthostatic tachycardia syndrome, Hypotension and Marfan's syndrome (Mildly). On 09-Sep-2025, the patient received dose of Influenza vaccine inact sAg 4v (Cell based quadrivalent influenza vaccine) (unknown route) 1 dosage form. On 09-Sep-2025 at 9:30 AM, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 09-Sep-2025, the patient experienced PRESYNCOPE (kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor) and PARAESTHESIA (like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on). At the time of the report, PRESYNCOPE (kind of like a blacking out low blood pressure type of sensation/to lie down on the floor in house where she was working like 3 or 4 times in the last 3 hours/light lightheadedness/feeling really spacey/overcome by the urge to just lie down on floor) and PARAESTHESIA (like jaw and face tingling that's pretty substantial feeling really spacey or twitchy kind of things go on) had not resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medication was reported. The patient initially received some Pfizer doses, but mostly it had been Moderna since then. The patient received a lot of Moderna shots. It was reported that the patient had inquired regarding antibody response following the vaccine administration and stated that she was definitely having a response. It was explained that it was similar but slightly stronger compared to the prior one, so the patient was not sure and did not want anybody to think she was having an adverse event that needed follow-up. It was also reported that the patient was happy to share the information with the company. It was reported that the patient had strong responses to vaccines, though most people only noticed that she was a little tired. It was explained that it was common and that she sometimes got pretty dramatic symptoms and described that it was just slightly different this time, enough that it made her check online, as it did not feel like the previous Spikevax. It was reported that the patient was trying to get a good primary care doctor for some time but had not yet succeeded. It was reported that it was kind of like a blacking out low blood pressure type of sensation, but patient was not even sure that her blood pressure was dropping. Patient just have had to lie down on the floor in the house where she was working like 3 or 4 times and that was in the last 3 hours and patient got it at 9:30 in morning on 09-SEP-2025 and patient had like light lightheadedness before or like jaw and face tingling that was pretty substantial feeling really spacey or twitchy kind of things go on. Patient was just standing at her desk looking at her phone and overcame the urge to just lie down on the floor at the time of report. It kind of made a little goofy and it was usually short-lived. No treatment medication was reported. This case was linked to MOD-2025-789307, MOD-2025-789350 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2025: Live follow-up received contains non-significant information reference added.; Reporter's Comments: Co-suspect product Influenza vaccine inact sAg 4v, past medical history included COVID-19 and Concurrent medical conditions Postural orthostatic tachycardia syndrome, Hypotension and Marfan's syndrome are confounders for the events. The benefit -risk relationship of product is not affected by this report.
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| 2860814 | 36 | F | OR | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
my9550 |
Erythema, Peripheral swelling, Product administered at inappropriate site
Erythema, Peripheral swelling, Product administered at inappropriate site
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Patient received vaccine on Saturday 9/20/25 and came into pharmacy to let us know that they got swe...
Patient received vaccine on Saturday 9/20/25 and came into pharmacy to let us know that they got swelling and redness in their arm. Patient stated that their provider said that the vaccine wasn't administered in the correct location. Location of injection appeared to be lower down the arm and not into the deltoid muscle
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| 2860815 | 73 | F | FL | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
UT8781 |
Contusion, Pain in extremity
Contusion, Pain in extremity
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Patient had a painful arm and it was bruised
Patient had a painful arm and it was bruised
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| 2860816 | 42 | F | MD | 09/23/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH SANOFI PASTEUR |
NA0738 UT8792NA |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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patient received second dose of flu shot at this visit (patient was already vaccinated with flu shot...
patient received second dose of flu shot at this visit (patient was already vaccinated with flu shot for this season), no signs and symptoms or reaction noted during the 15 min wait, Doctor on duty notified, patient advised to call if any reaction occurs
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| 2860817 | 22 | F | CA | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
na0738 |
Injection site erythema, Injection site pain, Injection site swelling
Injection site erythema, Injection site pain, Injection site swelling
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I am not the one who the patient reported to. The other pharmacist is not available. This is from he...
I am not the one who the patient reported to. The other pharmacist is not available. This is from her note. Patient reported redness, tenderness, and raised at injection site two days later.
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| 2860818 | 74 | F | VA | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
u8837aa |
Injection site erythema, Injection site induration, Injection site warmth
Injection site erythema, Injection site induration, Injection site warmth
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Patient reported to notice redness, hardness and warmth on the side of injection (deltoid) and it sp...
Patient reported to notice redness, hardness and warmth on the side of injection (deltoid) and it spread to her elbow. The reaction slowly went away after day 4
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| 2860819 | 0.75 | F | MI | 09/23/2025 |
RV5 |
MERCK & CO. INC. |
2139674 |
Pain, Product administered to patient of inappropriate age, Pyrexia
Pain, Product administered to patient of inappropriate age, Pyrexia
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he child got a rotavirus vaccine orally at 9 months of age .the doctor, management and the hea...
he child got a rotavirus vaccine orally at 9 months of age .the doctor, management and the health department was notified .the health department said this should not have an effect on the child apart from the normal vaccinereactions. The patients mother was called and she said was sore and had a slight fever form the vaccinations given(rotavirus,vaxelis and pcv20) .The mom was advised to contact the medical office incase of any questions and concerns.
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| 2860820 | 4 | M | NY | 09/23/2025 |
HEP |
MERCK & CO. INC. |
Y018844 |
Asthenia, Hyporesponsive to stimuli, Lethargy, Vomiting
Asthenia, Hyporesponsive to stimuli, Lethargy, Vomiting
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became weak, vomiting, lethargic, almost unresponsive
became weak, vomiting, lethargic, almost unresponsive
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| 2860821 | 1.42 | M | NM | 09/23/2025 |
DTAPHEPBIP FLU3 HEPA VARCEL |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. |
TE4992227 UHH27AA Z005472 Z003883 |
Febrile convulsion; Febrile convulsion; Febrile convulsion; Febrile convulsion
Febrile convulsion; Febrile convulsion; Febrile convulsion; Febrile convulsion
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two febrile seizures within 24 hours
two febrile seizures within 24 hours
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✓ | |||||
| 2860822 | 69 | M | AZ | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
U883AA |
Chills, Myalgia, Pain in extremity, Tremor
Chills, Myalgia, Pain in extremity, Tremor
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Chills, uncontrollable shaking, and muscle aches eight hours after the injection. Also next morning ...
Chills, uncontrollable shaking, and muscle aches eight hours after the injection. Also next morning had severe pain in arm of the injection.
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| 2860823 | 16 | M | NJ | 09/23/2025 |
MMR TDAP |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
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Echocardiogram normal, Electrocardiogram, Intensive care, Myopericarditis, Tropo...
Echocardiogram normal, Electrocardiogram, Intensive care, Myopericarditis, Troponin increased; Echocardiogram normal, Electrocardiogram, Intensive care, Myopericarditis, Troponin increased
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myopericarditis requiring PICU admission for work up and management
myopericarditis requiring PICU admission for work up and management
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✓ | |||||
| 2860824 | 64 | F | AL | 09/23/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3052669 409413 |
Product administered at inappropriate site; Product administered at inappropriat...
Product administered at inappropriate site; Product administered at inappropriate site
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Patient received two vaccines in the same arm and complained that the initial vaccine (Flucelvax) wa...
Patient received two vaccines in the same arm and complained that the initial vaccine (Flucelvax) was given too low. She expressed her concerns to the pharmacist.
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| 2860825 | 55 | F | IL | 09/23/2025 |
FLU3 PNC21 |
SEQIRUS, INC. MERCK & CO. INC. |
407002 z006076 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
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warm, tender, swollen at injection site with an over 2 inch radius of pink discoloration that got wo...
warm, tender, swollen at injection site with an over 2 inch radius of pink discoloration that got worse over a couple of days
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| 2860826 | 17 | F | NM | 09/23/2025 |
HPV9 MENB MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
Y015179 LT7C9 U8558BA |
Malaise, Pallor, Syncope; Malaise, Pallor, Syncope; Malaise, Pallor, Syncope
Malaise, Pallor, Syncope; Malaise, Pallor, Syncope; Malaise, Pallor, Syncope
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Pt seated on exam table for immunizations. Pt tolerated well. approxamatley 3-4 min after last vacci...
Pt seated on exam table for immunizations. Pt tolerated well. approxamatley 3-4 min after last vaccine administered (Gardasil- 9). Pt stated she did not feel well. Pt provided water to sip and was being assisted by nurse to rest in low fowlers position on exam bed, when pt became pale and fainted for approxamately 20 seconds. Pt awoke to verbale stimuli, responed accuratley and appropriately for age, mother at side. Pt remained in low fowlers position, stated "I haven eaten in all day". snack provided for pt, mother remained at side. Pt observed for 30 min no further symptoms noted. Pt stated she felt better and was assisted to stand slowly from exam bed. Pt had good balance and gait. Released to mothers care.
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| 2860827 | 10 | F | CO | 09/23/2025 |
FLU3 HEPA TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
2ng23 mb599 4k7jp |
Incorrect route of product administration, Product preparation error, Wrong prod...
Incorrect route of product administration, Product preparation error, Wrong product administered; Incorrect route of product administration, Product preparation error, Wrong product administered; Incorrect route of product administration, Product preparation error, Wrong product administered
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Patient was supposed to recieve an MMR vaccine but inadv3rtently recieved a Menigococcal Conjugate (...
Patient was supposed to recieve an MMR vaccine but inadv3rtently recieved a Menigococcal Conjugate (Menveo), but is was diluted with a sterile dilutent of sterile water prior to administering the 0.5 cc of the vaccine to the R arm as a sub-q injection.
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| 2860828 | 8 | F | MA | 09/23/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
Y7JC3 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
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Patient is 8 years old and should have received Tdap.
Patient is 8 years old and should have received Tdap.
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| 2860829 | 79 | F | CA | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0589 |
Rash
Rash
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Patient said she had rash on her leg on night from Friday 9/18/25 until Monday 09/22/25. She used co...
Patient said she had rash on her leg on night from Friday 9/18/25 until Monday 09/22/25. She used cortisone to resolved it
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| 2860830 | 33 | F | CA | 09/23/2025 |
FLU3 |
SEQIRUS, INC. |
407265 |
Unevaluable event
Unevaluable event
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N/A
N/A
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| 2860831 | 62 | F | CA | 09/23/2025 |
FLU3 |
SANOFI PASTEUR |
U8830AA |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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Fluzone High-dose single dose for 65 years & up was administered to patient who is 62 years old....
Fluzone High-dose single dose for 65 years & up was administered to patient who is 62 years old. No adverse reaction noted
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| 2860832 | 49 | F | TN | 09/23/2025 |
COVID19 COVID19 FLU3 FLU3 |
MODERNA MODERNA SANOFI PASTEUR SANOFI PASTEUR |
my9547 my9547 Tfaa2536 Tfaa2536 |
Erythema, Mobility decreased, Nausea, Pain in extremity, Peripheral swelling; Vo...
Erythema, Mobility decreased, Nausea, Pain in extremity, Peripheral swelling; Vomiting; Erythema, Mobility decreased, Nausea, Pain in extremity, Peripheral swelling; Vomiting
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Patient stated that she experienced extreme nausea and vomiting. She also stated that her arm was v...
Patient stated that she experienced extreme nausea and vomiting. She also stated that her arm was very sore and the area was swollen and red. She stated that she could not lift her arm due to it being so sore
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| 2860833 | 89 | M | MO | 09/23/2025 |
COVID19 |
MODERNA |
3052731 |
Delirium, Mobility decreased, Tremor
Delirium, Mobility decreased, Tremor
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Patient could not get out of bed very delirious and was shaking
Patient could not get out of bed very delirious and was shaking
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| 2860834 | 85 | M | 09/23/2025 |
COVID19 COVID19 |
MODERNA UNKNOWN MANUFACTURER |
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Basal cell carcinoma, Eye disorder, Heart rate, Malignant melanoma stage 0, Squa...
Basal cell carcinoma, Eye disorder, Heart rate, Malignant melanoma stage 0, Squamous cell carcinoma; Basal cell carcinoma, Eye disorder, Heart rate, Malignant melanoma stage 0, Squamous cell carcinoma
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squamous cell cancer; basal cell cancers; some abnormalities in eyes; About 3 or 4 months ago had a ...
squamous cell cancer; basal cell cancers; some abnormalities in eyes; About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0; This spontaneous case was reported by a physician and describes the occurrence of MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0), SQUAMOUS CELL CARCINOMA (squamous cell cancer) and BASAL CELL CARCINOMA (basal cell cancers) in an 85-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 vaccine mRNA for an unknown indication. The patient's past medical history included Atrial fibrillation (it was up to 41% of the time. Did not had a fibrillation now for about a year and a half), Nosebleed (ENT consultation for a nosebleed and was going to go on anticoagulants (Eliquis)), Cardiac pacemaker insertion, Cardiac ablation and Cardiac operation NOS (3 cardiac procedures). Previously administered products included for Product used for unknown indication: Shingrix on 02-Feb-2022 and Pfizer COVID-19 vaccine (late of 2023) in 2023. Past adverse reactions to the above products included No adverse effect with Pfizer COVID-19 vaccine and Shingrix. Family history included Rheumatic heart disease (Mother-in-law) since an unknown date, Atrial fibrillation (Mother-in-law) since an unknown date, Clot blood (formed a clot/ went to her brain and killed mother-in-law) since an unknown date and Malignant melanoma stage III (daughter; was on the buttock/ serious melanoma, a stage 3). Concurrent medical conditions included Hypertension, Supraventricular tachycardia, Sick sinus syndrome (was going to do a cardiac ablation, but then he developed a very slow heart rate, 28 per minute due to what was called sick sinus syndrome), Pre-diabetes and Telangiectasia (took care of that, so he was able to go on the anticoagulant). Concomitant products included Apixaban (Eliquis) for an unknown indication. On 24-Jun-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 27-Sep-2024, the patient received dose of COVID-19 vaccine mRNA (unknown route) 1 dosage form. In 2025, the patient experienced MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0) (seriousness criterion medically significant). On an unknown date, the patient experienced SQUAMOUS CELL CARCINOMA (squamous cell cancer) (seriousness criterion medically significant), BASAL CELL CARCINOMA (basal cell cancers) (seriousness criterion medically significant) and EYE DISORDER (some abnormalities in eyes). The patient was treated with Surgery (Melanoma surgery) for Malignant melanoma stage 0; Surgery (Melanoma surgery for squamous cell cancer) for Squamous cell carcinoma and Surgery (Melanoma surgery for basal cell cancers) for Basal cell carcinoma. At the time of the report, MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0), SQUAMOUS CELL CARCINOMA (squamous cell cancer), BASAL CELL CARCINOMA (basal cell cancers) and EYE DISORDER (some abnormalities in eyes) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 255 heart beats per minute and 28 heart beats per minute. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter considered EYE DISORDER (some abnormalities in eyes) to be not related. No further causality assessments were provided for MALIGNANT MELANOMA STAGE 0 (About 3 or 4 months ago had a melanoma surgery due to a discovery of a mole at the tip of nose/ melanoma in situ, that was called stage 0), SQUAMOUS CELL CARCINOMA (squamous cell cancer) and BASAL CELL CARCINOMA (basal cell cancers). The patient had 3 vaccinations with Shingles vaccines- Shingrix on 02-Feb-2022 and 2 other shingles shots, which were also given 7 to 8 years ago but were not as effective as Shingrix vaccine. Patient had undergone melanoma surgery for basal cell cancers and a squamous cell cancer which was performed since the patient has had his last dose. The patient had some abnormalities in his eyes and would be seeing the ENT physician in about 2 weeks for an annual checkup. The reporter stated that when the patient was getting to be 85 years old, patient would just start falling apart. About 3 or 4 months ago, patient had undergone a melanoma surgery due to the discovery of a mole at the tip of nose which patient found an unusual place to have melanoma as well as an obvious site, so it was discovered early. The reporter mentioned it as melanoma in situ, stage 0. That meant it was almost pre-cancerous. The patient wanted to find mNEXSPIKE in the country. The patient had received a total of 6 COVID-19 shots. The patient had not received any COVID-19 shots in the past 6 months but probably a year since his last COVID-19 vaccine. He had the COVID-19 vaccines when they had first started to make it available which was 3-4 months since the first release making sure that people were not having horrendous reactions. The patient thought that it was back in 2021. He had the first series with Pfizer, and the third shot was Moderna and then every other one as one Moderna dose and one Pfizer dose afterwards. The patient did not experience any additional symptoms/events. No treatment drug was reported.; Reporter's Comments: Co-suspect non-company product COVID-19 vaccine is a confounder for the events. Due to lack of biological plausibility, the causality of the events malignant melanoma stage 0, squamous cell carcinoma and basal cell carcinoma were assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
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| 2860835 | 82 | F | 09/23/2025 |
COVID19 |
MODERNA |
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Hypoacusis
Hypoacusis
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a little hard of hearing; This spontaneous case was reported by a consumer and describes the occurre...
a little hard of hearing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (a little hard of hearing) in an 82-year-old female patient 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HYPOACUSIS (a little hard of hearing). At the time of the report, HYPOACUSIS (a little hard of hearing) outcome was unknown. No concomitant medication was reported. The patient had a little hard of hearing. She had nothing but Moderna shots since the pandemic came along, except for one last 2-Dec-2024 she had Pfizer. She was looking for mNEXSPIKE. She had been able to tolerate the vaccine before fairly well; she was just hoping that mNEXSPIKE might had a little bit less side effects, such as maybe 2 days in bed instead of 3 days in bed or something like that compared to Spikevax. It was unknown if the patient experienced any additional symptoms or events. No treatment medication was reported.
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| 2860836 | 68 | M | CA | 09/23/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Chills, Fatigue, Headache, Nausea, Pain; Pyrexia, Tenderness, Underdose, Vomitin...
Chills, Fatigue, Headache, Nausea, Pain; Pyrexia, Tenderness, Underdose, Vomiting
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body ache; ARM TENDERNESS LASTED A COUPLE OF DAYS; fever; chills; fatigue; headache; NAUSEA AND VOMI...
body ache; ARM TENDERNESS LASTED A COUPLE OF DAYS; fever; chills; fatigue; headache; NAUSEA AND VOMITING LASTING 2 DAYS; NAUSEA AND VOMITING LASTING 2 DAYS; Patient received dose 0.2 mL; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), PAIN IN EXTREMITY (ARM TENDERNESS LASTED A COUPLE OF DAYS), PYREXIA (fever), CHILLS (chills) and FATIGUE (fatigue) in a 68-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .2 milliliter. On 13-Sep-2025, after starting mRNA-1273.251 (Spikevax LP.8.1 PFS), the patient experienced UNDERDOSE (Patient received dose 0.2 mL). On 14-Sep-2025, the patient experienced PAIN (body ache), PAIN IN EXTREMITY (ARM TENDERNESS LASTED A COUPLE OF DAYS), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), HEADACHE (headache), VOMITING (NAUSEA AND VOMITING LASTING 2 DAYS) and NAUSEA (NAUSEA AND VOMITING LASTING 2 DAYS). On 16-Sep-2025, PAIN (body ache), PAIN IN EXTREMITY (ARM TENDERNESS LASTED A COUPLE OF DAYS), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), VOMITING (NAUSEA AND VOMITING LASTING 2 DAYS) and NAUSEA (NAUSEA AND VOMITING LASTING 2 DAYS) had resolved. On 17-Sep-2025, FATIGUE (fatigue) had resolved. At the time of the report, UNDERDOSE (Patient received dose 0.2 mL) outcome was unknown. Concomitant medication was not reported. The fatigue event lasted one more day in comparison to other symptoms. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
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| 2860837 | 73 | F | OR | 09/23/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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Covid-19 in approximately 2024; This spontaneous case was reported by a consumer and describes the o...
Covid-19 in approximately 2024; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 in approximately 2024) in a 73-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced COVID-19 (Covid-19 in approximately 2024). At the time of the report, COVID-19 (Covid-19 in approximately 2024) had resolved. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as none. No concomitant medication was reported. The patient was very healthy. The patient contracted Covid-19 in approximately 2024 after received Moderna's Covid vaccines in the past. She reported that not remembering the dates of her previous Covid vaccinations, it was all a blur. She had COVID once, but she had the shots, so it wasn't as bad as it could be, and she didn't get any long COVID effects. So, Moderna had been pretty good so far for her. Not right after that. She did get it at one point, but she recovered and, it's just a high fever for a few days but no long-term effects from it. No treatment medication was reported.
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| 2860838 | 71 | M | 09/23/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Arthralgia, Myalgia
Arthralgia, Myalgia
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hip pain/ muscle and joint pain; This spontaneous case was reported by a consumer and describes the ...
hip pain/ muscle and joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip pain/ muscle and joint pain) in a 71-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 12-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced ARTHRALGIA (hip pain/ muscle and joint pain). At the time of the report, ARTHRALGIA (hip pain/ muscle and joint pain) had not resolved. The concomitant medication was not reported by the reporter. It was reported that the patient had hip pain after receiving mNEXSPIKE on 12-Sep-2025. He said he knew that one of the side effects was muscle and joint pain. He felt pain in his hip. Later, he mentioned that he had received the vaccine in his left arm and said the hip pain was also located on the left side. It was unknown if the patient experienced any additional symptoms or events. The treatment medication was not reported by the reporter.
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| 2860839 | 76 | F | 09/23/2025 |
COVID19 |
MODERNA |
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COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
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She states she got COVID; This spontaneous case was reported by a consumer and describes the occurre...
She states she got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She states she got COVID) in a 76-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. No Medical History information was reported. In April 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In September 2025, the patient experienced COVID-19 (She states she got COVID). At the time of the report, COVID-19 (She states she got COVID) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2025, SARS-CoV-2 test: (Positive) Mild. No concomitant medication was reported. The patient had no vaccines 4 weeks prior to the Spikevax in Apr-2025. The patient was a retired medical professional. She was sick and not completely well yet. She had only ever gotten Moderna vaccines and said all were good, she did not have COVID for 5.5 years. She got the vaccines every 6 months. She got COVID about 4 or 5 days ago and she was mildly positive. She was looking for the lot number and stated it made her felt pretty upset because her mind was not working very well. Nothing works, her mind and everything else. She felt like her hands were tied". Her ongoing symptoms were, a sore throat on one side of her throat, coughing, fatigue, she did not have shortness of breath, it was not a productive cough, a little bit of a loss of appetite, didn't want to eat". The coughing for her was the worst. She said she usually did not sneeze that hardly at all in life, but she had the urge to. She said on 17-Sep-2025, she started to sneeze every second and she had to hold her nose before she blew out one of the veins in there from sneezing so much. She stated that she looked it up and found out that sneezing related to COVID because COVID got to the neuroreceptors in nose, stimulates them and causes them to sneeze. Her voice was very raspy too. She stated that nothing really bad though, she hoped that at least all her vaccines will prevent her from having shortness of breath or whatever. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-789527 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789527:Husbaend case
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| 2860840 | F | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Diabetes mellitus inadequate control, Immunodeficiency, Insulin-requiring type 2...
Diabetes mellitus inadequate control, Immunodeficiency, Insulin-requiring type 2 diabetes mellitus
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she has insulin-dependent type-2 diabetes and is fragile; she has insulin-dependent type-2 diabetes ...
she has insulin-dependent type-2 diabetes and is fragile; she has insulin-dependent type-2 diabetes and is fragile; took Pfizer covid-19 vaccine and she is immunocompromised; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 68-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: Bnt162b2 (Primary Immunization series completed.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: INSULIN-REQUIRING TYPE 2 DIABETES MELLITUS (medically significant), DIABETES MELLITUS INADEQUATE CONTROL (medically significant), outcome "unknown" and all described as "she has insulin-dependent type-2 diabetes and is fragile"; IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "took Pfizer covid-19 vaccine and she is immunocompromised". Clinical information: The patient was interested in information regarding whether Comirnaty (2025-2026 formula) was a combination vaccine (either COVID-19 and influenza or COVID-19 and RSV). Caller did mention that, to her understanding, there was a combination vaccine that passed one clinical phase and failed another (Phase 2 or Phase 3) and expressed interest in this information because she has an appointment with her PCP today and wants information regarding the vaccines she needs and the required timing between these before she goes to the appointment, as she wants to be best informed. Caller also stated that she has insulin-dependent type-2 diabetes and is fragile and has also had all the [Pfizer] COVID-19 vaccines, because it is the only company she trusts. caller took Pfizer covid-19 vaccine and she is immunocompromised. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2860841 | F | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Erythema, Pruritus, Swelling
Erythema, Pruritus, Swelling
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her arm was a little red with swelling. Now it's further down the arm, with swelling, and itche...
her arm was a little red with swelling. Now it's further down the arm, with swelling, and itches; her arm was a little red with swelling. Now it's further down the arm, with swelling, and itches; her arm was a little red with swelling. Now it's further down the arm, with swelling, and itches; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 65-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERYTHEMA (non-serious), SWELLING (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "her arm was a little red with swelling. Now it's further down the arm, with swelling, and itches". Therapeutic measures were not taken as a result of erythema, swelling, pruritus. No follow-up attempts are possible. Additional information: Reporter calling because she got one our shots today, the Covid 19 Vaccine. She clarified the other vaccine she received was the Flu shot. Batch/lot number is not provided, and it cannot be obtained. Follow up (18Sep2025): This is a spontaneous report received from a Consumer or other non HCP from medical information team. Updated information included: patient details, event details updated.
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| 2860842 | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Balance disorder, Ear disorder
Balance disorder, Ear disorder
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fluid in my ear; balance issues; This is a spontaneous report received from a Consumer or other non ...
fluid in my ear; balance issues; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), 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: EAR DISORDER (non-serious), outcome "unknown", described as "fluid in my ear"; BALANCE DISORDER (non-serious), outcome "unknown", described as "balance issues". Additional information: Consumer stated, I have had Pfizer COVID shots (clarified and captured as COVID Vaccine in tab) many times so, but this time I don't know if it is connected but I had like a fluid in my ear and I am calling to see if that's a common side effect of the drug? consumer stated, Yes, that's my question, I don't even know if I have fluid but I have balance issues, I just and the doctor thinks it is fluid in my ear. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860843 | F | 09/23/2025 |
RSV |
PFIZER\WYETH |
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Hypertension
Hypertension
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sustained hypertension; This is a spontaneous report received from a Pharmacist. A 29-year-old fema...
sustained hypertension; This is a spontaneous report received from a Pharmacist. A 29-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Sep2025 as dose number unknown, single (Batch/Lot number: unknown) for maternal immunisation. The patient was 36 weeks pregnant at the event onset. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERTENSION (non-serious) with onset Sep2025, 18 hrs after the suspect product(s) administration, outcome "recovered" (Sep2025), described as "sustained hypertension". The event "sustained hypertension" required physician office visit. Therapeutic measures were taken as a result of hypertension. Additional information:Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting?: Unknown,Did the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting?: Unknown,Were you/Was the patient taking any other medications within 2 weeks of the event starting?: Unknown,Reported Event: Patient reported side effect occurring approximately 18-24 hours after receiving the Abrysvo vaccination (Maternal indication). Side effect included sustained hypertension, resulting in a clinic visit and physician consultation. 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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| 2860844 | F | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective, Malignant melanoma, Recurrent cancer
COVID-19, Drug ineffective, Malignant melanoma, Recurrent cancer
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Covid infection; Covid infection; horrible skin melanoma; horrible skin melanoma; This is a spontane...
Covid infection; Covid infection; horrible skin melanoma; horrible skin melanoma; This is a spontaneous report received from a Consumer or other non HCP. An adult female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Melanoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALIGNANT MELANOMA (medically significant, life threatening), RECURRENT CANCER (medically significant, life threatening) all with onset 17Sep2025 at 19:15, outcome "unknown" and all described as "horrible skin melanoma"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid infection". Clinical course: One of the reporter's students got horrible skin melanoma after taking the Pfizer vaccine. The doctors initially suspected it might have developed following her Covid infection, but now they suspect it might be related to the Covid vaccine itself. It was reported that skin melanoma resulted in life threatening illness (immediate risk of death from the event). It was unknown if therapeutic measures were taken as a result of malignant melanoma, recurrent cancer. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
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| 2860845 | F | CA | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood immunoglobulin M increased, Condition aggravated, Epistaxis, Haemorrhagic ...
Blood immunoglobulin M increased, Condition aggravated, Epistaxis, Haemorrhagic disorder
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She has some kind of unknown bleeding disorder; nose bleeds; nose bleeds/bleeding disorder; IgM numb...
She has some kind of unknown bleeding disorder; nose bleeds; nose bleeds/bleeding disorder; IgM number really goes up; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 94-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Waldenstrom macroglobulinemia" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "bleeding disorder", notes: since about 20-25+ years ago; Advil, reaction(s): "bleeding disorder", notes: since about 20-25+ years ago. Vaccination history included: Bnt162b2, for covid-19 immunisation. The following information was reported: HAEMORRHAGIC DISORDER (medically significant), outcome "unknown", described as "She has some kind of unknown bleeding disorder"; EPISTAXIS (medically significant), outcome "unknown", described as "nose bleeds"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "nose bleeds/bleeding disorder"; BLOOD IMMUNOGLOBULIN M INCREASED (non-serious), outcome "unknown", described as "IgM number really goes up". The events "she has some kind of unknown bleeding disorder", "nose bleeds" and "nose bleeds/bleeding disorder" required physician office visit. Therapeutic measures were taken as a result of haemorrhagic disorder, epistaxis, condition aggravated. Clinical Course: She has some kind of unknown bleeding disorder. She passed all tests for bleeding disorder and is not on blood thinner but they are calling it unknown bleeding disorder. Does it have same action as taking Aspirin or Advil. Those are medications that seem to bring on bloody noses for her. She had no problem with previous vaccines. Patient has a question about the most recent Pfizer Covid shot. he read something about medical conditions such as bleeding disorder or blood thinners. Her last Pfizer Covid 19 vaccine was in Nov2024. Reported "I have a preexisting condition, before receiving the COVID vaccines, called Waldenstrom macroglobulinemia, a rare lymphoma, but not on treatment because I don't have any symptoms and on a watch and wait. I also have a bleeding disorder or reaction to aspirin and Advil or NSAIDs (also preexisting condition to COVID vaccines) since about 20-25 plus years ago, that if i take more than a couple of them, I would have nose bleeds. I am not on a blood thinner. The last bad one was in Jan or Feb2025, every couple of weeks but one day, it was like a terrible hemorrhaging nose bleed that lasted 24 hours. It started with blood just coming down to the floor and I had a towel and holding my nostril for hours and bought nose clips and finally got it under control. Eventually it stopped. I went to a throat doctor to cauterize it. It happened again after the cauterization but eventually it stopped. I don't have that high of a blood pressure but on high blood pressure medication and perhaps it is related to that. My platelets are fine and I clot well if I have an injury or if I get a scratch or cut. My doctor says I have a blood disorder of unknown cause. My immune system is not that good because of this Waldenstroms disease and since my IgMs go up with my disease, we have to watch that. When I get a vaccine, the IgM number really goes up and then it goes down within months. This is what happened after the last Pfizer Covid 19 vaccine in Nov2024, my IgM numbers went up after the vaccine and then the IgM numbers went down over time. " 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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| 2860846 | 43 | F | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
NA0587 |
Pain in extremity
Pain in extremity
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sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 43-year-old fem...
sore arm; This is a spontaneous report received from a Consumer or other non HCP. A 43-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 17Sep2025 at 09:00 as dose 1, single (Lot number: NA0587) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Sep2025 at 06:00, outcome "recovered" (19Sep2025), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: No Hospitalization Prolonged. The patient not received any other vaccines on the same date, not received any other vaccines within 4 weeks prior to the vaccine, not taking any other medications within 2 weeks of the event starting. No follow-up attempts are possible
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| 2860847 | F | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Anxiety, Fatigue, Influenza like illness, Laryngitis
Anxiety, Fatigue, Influenza like illness, Laryngitis
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Having a little bit more expression; Having laryngitis that started the day after received the vacci...
Having a little bit more expression; Having laryngitis that started the day after received the vaccine; Had a lot of fatigue; Needed to sleep a lot; Flu-like symptoms; This is a spontaneous report received from a Pharmacist. An 84-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: ANXIETY (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Having a little bit more expression"; LARYNGITIS (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Having laryngitis that started the day after received the vaccine"; FATIGUE (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Had a lot of fatigue; Needed to sleep a lot"; INFLUENZA LIKE ILLNESS (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Flu-like symptoms". Additional information: the patient had some concern about some side effects she was experiencing the day after getting her COVID vaccine, so the latest formulation of the Comirnaty and she wanted the reporter (pharmacist) to reach out and see if it is normal. The reporter thought that it is just that she was elderly. The patient was 84 years old, and reporter thought that she was just having a little bit more expression of it, but essentially she was stating that she was having laryngitis that started the day after received the vaccine and that she had a lot of fatigue where she needed to sleep a lot, like 6 hours the first day, 3 hours the next day, she was able to speak to the reporter on the phone, so the reporter believed everything was improving. So, the reporter thought that it was fine that she had what reporter like to call flu-like symptoms. The reporter did not believe she was contagious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860848 | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP...
got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789364 (Moderna). 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 included: "Crohn's disease" (unspecified if ongoing); "colitis" (unspecified if ongoing); "SVT", start date: Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: janssen COVID-19 vaccine (DOSE 1, SINGLE), administration date: 10Mar2021, for covid-19 immunisation; spikevax (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Dose: 0.5ml), administration date: 26Oct2021, for covid-19 immunisation; spikevax (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Dose: 0.5ml), administration date: 31Mar2022, for covid-19 immunisation; spikevax (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Dose: 0.5ml), administration date: 20Sep2022, for covid-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick with all four doses". Additional information: The reporter states that received four doses of Pfizer COVID vaccine and got sick with all four doses. Spikevax NOS 26Oct2021, 31Mar2022, 20Sep2022 and "two others not documented on shot record but on a vaccine sheet received", received first dose of Johnson and Johnson COVID vaccine and states that when that vaccine was nolonger available started getting the Moderna COVID vaccine. The reporter states that is what they consider high risk as has an underlying condition and is disabled. The reporter states that Crohn's and otherhealth issues were pre-existing before any COVID vaccine, however was diagnosed with SVT with heart in February 2022. Thereporter states that this condition may have pre-existing as went to the hospital and they diagnosed it, has had the same symptoms entire life and they always diagnosed it as was having an anxiety attack. The reporter states that the symptoms would not stop and has been since diagnosed with SVT. It is unknown if the patient experienced any additional symptoms/events. Batch/lot number is not provided, and it cannot be obtained.
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| 2860849 | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP...
got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789364 (Moderna). 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 included: "Crohn's" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "SVT", start date: Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: janssen COVID-19 vaccine (DOSE 1, SINGLE), administration date: 10Mar2021, for COVID-19 Immunisation; spikevax (DOSE NUMBER UNKOWN (BOOSTER), SINGLE. Dose: 0.5 ml), administration date: 26Oct2021, for COVID-19 Immunisation; spikevax (DOSE NUMBER UNKOWN (BOOSTER), SINGLE. Dose: 0.5 ml), administration date: 31Mar2022, for COVID-19 Immunisation; spikevax (DOSE NUMBER UNKOWN (BOOSTER), SINGLE. Dose: 0.5 ml), administration date: 20Sep2022, for COVID-19 Immunisation; Bnt162b2 (DOSE NUMBER UNKOWN, SINGLE), for COVID-19 Immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick with all four doses". Additional information: The reporter stated that received four doses of Pfizer COVID vaccine and got sick with all four doses. The reporter also stated that knew other people who got the Pfizer and got sick too. Spikevax NOS, Lot/Batch Number: Unk, Expiration Date: Unk, Dose: 0.5mls, Dates of Administration: 26Oct2021, 31Mar2022, 20Sep2022 and two others not documented on shot record but on a vaccine sheet received. The reporter stated that has Crohn's and Colitis and received first dose of Johnson and Johnson COVID vaccine on 10Mar2021. The reporter stated that when the vaccine was no longer available started getting the Moderna COVID vaccine. The reporter stated that is what they consider high risk as has an underlying condition and was disabled. The reporter stated that Crohn's and other health issues were pre-existing before any COVID vaccine, however was diagnosed with SVT with heart in Feb2022. The reporter stated that this condition may have pre-existing as went to the hospital and they diagnosed it, has had the same symptoms entire life and they always diagnosed it as was having an anxiety attack. The reporter stated that the symptoms would not stop and has been since diagnosed with SVT. Batch/lot number is not provided, and it cannot be obtained
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| 2860850 | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP...
got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789364 (Moderna). 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 included: "crohn's disease" (unspecified if ongoing); "colitis" (unspecified if ongoing); "SVT", start date: Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: janssen COVID-19 vaccine (DOSE 1, SINGLE), administration date: 10Mar2021, for covid-19 immunisation; spikevax (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Dose: 0.5ml), administration date: 26Oct2021, for covid-19 immunisation; spikevax (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Dose: 0.5ml), administration date: 31Mar2022, for covid-19 immunisation; spikevax (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Dose: 0.5ml), administration date: 20Sep2022, for covid-19 immunisation; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for covid-19 immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick with all four doses". Additional information: The reporter states that received four doses of Pfizer COVID vaccine and got sick with all four doses. Spikevax NOS 26Oct2021, 31Mar2022, 20Sep2022 and "two others not documented on shot record but on a vaccine sheet received", received first dose of Johnson and Johnson COVID vaccine and states that when that vaccine was nolonger available started getting the Moderna COVID vaccine. The reporter states that is what they consider high risk as has an underlying condition and is disabled. The reporter states that Crohn's and otherhealth issues were pre-existing before any COVID vaccine, however was diagnosed with SVT with heart in February 2022. Thereporter states that this condition may have pre-existing as went to the hospital and they diagnosed it, has had the same symptoms entire life and they always diagnosed it as was having an anxiety attack. The reporter states that the symptoms would not stop and has been since diagnosed with SVT. No other details provided. It is unknown if the patient experienced any additional symptoms/events. Batch/lot number is not provided, and it cannot be obtained.
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| 2860851 | 09/23/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Chills, Fatigue, Headache, Illness, Myalgia; Underdose
Chills, Fatigue, Headache, Illness, Myalgia; Underdose
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fatigue; muscle aches; headaches; chills / teeth chattering; sick; second dose was less; This is a s...
fatigue; muscle aches; headaches; chills / teeth chattering; sick; second dose was less; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-773535 (Moderna Clinical Safety and Pharmacovigilance). This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering) in a patient who received mRNA-1273 (Moderna COVID-19 Vaccine). In January 2021, the patient received first dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches) and CHILLS (chills / teeth chattering). On an unknown date, the patient experienced ILLNESS (sick) and EXTRA DOSE ADMINISTERED ((redacted) said that is why (redacted) has stuck with Moderna and has gotten everything (every vaccine) plus (redacted) 'unauthorized one'). At the time of the report, ILLNESS (sick) had resolved and FATIGUE (fatigue), MYALGIA (muscle aches), HEADACHE (headaches), CHILLS (chills / teeth chattering) and EXTRA DOSE ADMINISTERED ((redacted) said that is why (redacted) has stuck with Moderna and has gotten everything (every vaccine) plus (redacted) 'unauthorized one') outcome was unknown. No concomitant medications were reported. No vaccines were administered within the past 4 weeks. It was reported that, other than the first 2 doses in January/February 2021, when (redacted) got Pfizer, (redacted) always gets Moderna. It was reported that, (redacted) would get the vaccine in the morning and by 3 in the afternoon, (redacted) started to get the fatigue, muscle aches, headaches and chills. Sometimes (redacted) got teeth chattering and was sick the day after the vaccine but by that evening, (redacted) was fine. (redacted) tried to plan (redacted) activities accordingly. (redacted) got Moderna vaccine every 6 months because (redacted) was old and it was what (redacted) physician recommended. Somewhere in the beginning, (redacted) snuck in an extra dose because (redacted) was so petrified. (redacted) believed it was when there was a 2nd dose, where the first dose was a higher amount and the second dose was less. It was unknown if the patient experienced any additional symptoms/events. No treatment information was provided. 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-PV202500113667 same patient, different dose/event;
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| 2860852 | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Myocarditis
Myocarditis
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Myocarditis; This is a spontaneous report received from a Consumer or other non HCP. A patient (age...
Myocarditis; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 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: MYOCARDITIS (medically significant), outcome "unknown". Clinical course: caller was having a bad experience for Pfizer Covid Vaccine and got a heart condition Myocarditis. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2860853 | 09/23/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP...
got sick with all four doses; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789364 (Moderna). 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 included: "Crohns" (unspecified if ongoing); "Colitis" (unspecified if ongoing); "SVT", start date: Feb2022 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: janssen COVID-19 vaccine (DOSE 1, SINGLE), administration date: 10Mar2021, for COVID-19 Immunisation; spikevax (DOSE NUMBER UNKOWN (BOOSTER), SINGLE. Dose: 0.5 ml), administration date: 26Oct2021, for COVID-19 Immunisation; spikevax (DOSE NUMBER UNKOWN (BOOSTER), SINGLE. Dose: 0.5 ml), administration date: 31Mar2022, for COVID-19 Immunisation; spikevax (DOSE NUMBER UNKOWN (BOOSTER), SINGLE. Dose: 0.5 ml), administration date: 20Sep2022, for COVID-19 Immunisation. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick with all four doses". Additional information: The reporter stated that received four doses of Pfizer COVID vaccine and got sick with all four doses. The reporter also stated that knew other people who got the Pfizer and got sick too. Spikevax NOS, Lot/Batch Number: Unk, Expiration Date: Unk, Dose: 0.5mls, Dates of Administration: 26Oct2021, 31Mar2022, 20Sep2022 and two others not documented on shot record but on a vaccine sheet received. The reporter stated that has Crohn's and Colitis and received first dose of Johnson and Johnson COVID vaccine on 10Mar2021. The reporter stated that when the vaccine was no longer available started getting the Moderna COVID vaccine. The reporter stated that is what they consider high risk as has an underlying condition and was disabled. The reporter stated that Crohn's and other health issues were pre-existing before any COVID vaccine, however was diagnosed with SVT with heart in Feb2022. The reporter stated that this condition may have pre-existing as went to the hospital and they diagnosed it, has had the same symptoms entire life and they always diagnosed it as was having an anxiety attack. The reporter stated that the symptoms would not stop and has been since diagnosed with SVT. Batch/lot number is not provided, and it cannot be obtained.
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