| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2843371 | IL | 05/30/2025 |
VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. |
Y003892 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
|
No Side effects or symptoms reported.; HCP called to report one patient received VARIVAX after a tem...
No Side effects or symptoms reported.; HCP called to report one patient received VARIVAX after a temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-May-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) injection (lot #Y003892, expiration date: 06-Feb-2026) 0.5 mL as prophylaxis, the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported) which experienced a temperature excursion (Improper storage of product in use) at 14.2F for 1 hour 3 minutes 0 seconds. No previous excursions. No Side effects or symptoms reported (No adverse event).
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| 2843373 | F | CO | 05/30/2025 |
HEPA |
MERCK & CO. INC. |
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Crying, Decreased appetite, Fontanelle depressed, Pyrexia
Crying, Decreased appetite, Fontanelle depressed, Pyrexia
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not eating very well; potential dehydration.; meant to receive VAXELIS but received VAQTA; Inconsola...
not eating very well; potential dehydration.; meant to receive VAXELIS but received VAQTA; Inconsolable the night after the administration; HCP called to report a 2-month-old patient was administered a VAQTA vaccine and experienced a fever and was inconsolable the night after the administration. HCP states the patient was meant to receive VAXELIS but received VAQTA instead and is now pre; Fever; Slightly sunken fontanelle; This spontaneous report was received from a physician and refers to a 2-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported. On 28-May-2025, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) at a dose of 0.5 mL, administered intramuscularly for vaccination (lot number and expiration date were not reported), instead of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate], and Hepatitis B [Recombinant] Vaccine (VAXELIS) (dose, indication, lot number, and expiration date were not reported). (Wrong product administered, Product administered to patient of inappropriate age). On 28-May-2025, the patient experienced fever (pyrexia) and was inconsolable the night after the administration (emotional distress). On 29-May-2025 (reported as a day later), the patient went to the emergency room, afebrile (conflicting information, fever was also reported as not recovered), not eating very well (decreased appetite), and with a slightly sunken fontanelle (fontanelle depressed) that indicated potential dehydration. At the time of the report, the patient had not recovered from the events. The causal relationship between the events and Hepatitis A Vaccine, Inactivated was not provided.; Reporter's Comments
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| 2843374 | GA | 05/30/2025 |
FLUN4 |
MEDIMMUNE VACCINES, INC. |
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Computerised tomogram head normal, Fall, Head injury, Syncope
Computerised tomogram head normal, Fall, Head injury, Syncope
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FALL; HEAD STRUCK THE FLOOR; SYNCOPE VASOVAGAL; A literature report has been received. The article w...
FALL; HEAD STRUCK THE FLOOR; SYNCOPE VASOVAGAL; A literature report has been received. The article was published in Vaccine. The report concerns a female adult patient. Reviewed and summarized reports of syncope after live attenuated influenza vaccine, intranasal (LAIV) administered as the sole vaccine (i.e., no concomitant injections). From June 17, 2003 (date of LAIV licensure in the US) through May 31, 2024, VAERS received 50 reports of syncope after LAIV. Nearly half (23; 46 percent) pertained to individuals 10-19 years of age. While the vast majority of reports (35; 70 percent) did not describe any injuries, 15 people (30 percent) were injured, most commonly by falling and hitting their head or face. Twenty-two people (44 percent) required evaluation in the emergency department or doctor's office, including an individual who lost consciousness while he was driving home from the vaccination appointment. He did not report any injuries, but the car was severely damaged. Nearly three-quarters of people (37; 74 percent) developed syncope within 15 min after vaccination, but fewer than half of reports (24; 48 percent) stated that the patient had waited in the observation area for at 15 min. Based on approximately 111.9 million doses of LAIV distributed in the US during the same time period, the reporting rate is approximately 0.4 per million doses, suggesting that syncope following LAIV is rare. The information summarized here may enable clinicians, patients, and caregivers to make a more informed decision regarding preventing injuries that may occur following LAIV-related syncope. Only one described an injury: an adult fell, and her head struck the floor. She required medical attention, including head CT that did not reveal any acute findings. No medical history was reported. No concomitant products were reported. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, for influenza prophylaxis on an unknown date. One described an injury described an injury: an adult fell (preferred term: Fall), and her head struck the floor (preferred term: Head injury). She required medical attention, including head CT that did not reveal any acute findings. On an unknown date, the patient experienced syncope vasovagal (preferred term: Syncope) Of the 50 reports of syncope, 43 stated that the person had recovered by the time the report was submitted, and 7 reports did not indicate recovery status. Treatment of syncope included observation, repositioning, and encouraging the person to eat or drink. Of the events that were not deemed to be vasovagal syncope, most were near-syncope, allergic reactions, seizures, or other conditions (e.g., migraine headache). Notably, near-syncope was sometimes associated with falls or other injuries, i.e., people who experienced vasovagal responses sometimes fell, even if they did not actually lose consciousness. The outcome of the event(s) of fall, head struck the floor and syncope vasovagal was unknown. The events were considered serious (Medically Significant). The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): fall, head struck the floor and syncope vasovagal. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): fall, head struck the floor and syncope vasovagal. The company physician did not consider that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): fall and head struck the floor. The company physician did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): fall and head struck the floor. The company physician considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): syncope vasovagal. The company physician considered that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent and the following event(s): syncope vasovagal. Laboratory values are available. Device Information: Combination Product Report: Yes Product As Reported: Flumist Quadrivalent Brand Name: FLUMIST QUADRIVALENT Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Authors comment: Syncope after LAIV/LAIV4 is rare, and related injuries are even less common. Nevertheless, since syncope-related injuries are potentially preventable, we believe that the information summarized here may enable clinicians, patients, and caregivers to make a more informed decision regarding preventing injuries that may occur following LAIV-related syncope. Minor correction on 18-Sep-2024: Vaccine reporter added. narrative updated. Minor correction on 30-Sep-2024: Vaccine field updated due to NACK Minor correction on 31-Dec-2024: Case needs to be re-routed Case Receipt, as the Primary ReporterοΏ½s E-mail field needs to be updated as requested by the MC. Corrected Report on 12-MAY-2025: Suspect drug recoded. Narrative updated.; Sender's Comments: Syncope, head injury and fall are not listed in the company core datasheet of flumist, influenza virus vaccine polyvalent, q/laiv. Due to limited information on circumstances leading to events, onset date and outcome of events, start date of the suspect drug, clinical course, treatment provided, risk factors, relevant medical history, concurrent conditions and concomitant medications, detailed diagnostic and etiologic workup, the evaluation did not find the evidence to exclude a causal relationship between the event (syncope) and suspect drug. The evaluation did not find evidence to suggest a causal relationship between the events (head injury and fall) and suspect drug.
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| 2843375 | 05/30/2025 |
FLUN3 |
MEDIMMUNE VACCINES, INC. |
WF2582 |
Influenza like illness
Influenza like illness
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Patient has flu-like symptoms and feels like she got the flu from FluMist; A spontaneous report has ...
Patient has flu-like symptoms and feels like she got the flu from FluMist; A spontaneous report has been received from a other health professional. The report concerns a female patient (age 62 years). The patient's past and current medical history included fainting (dates not reported). No concomitant products were reported. The patient received Flumist (batch number(s) WF2582), via nasal use on 30-OCT-2024. The patient received 1 dose(s). It is unknown who administered Flumist to the patient. On an unknown date, the patient experienced patient has flu-like symptoms and feels like she got the flu from flumist (preferred term: Influenza). Action taken with suspect is not applicable. The outcome of the event(s) of patient has flu-like symptoms and feels like she got the flu from flumist was unknown. The event was considered non-serious. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUENZ TETRA, FLUENZ TETRA, FLUMIST Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No; Sender's Comments: This case does not meet the criteria for company clinical comment
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| 2843376 | NY | 05/30/2025 |
FLUN4 |
MEDIMMUNE VACCINES, INC. |
Unknown |
Expired product administered, Inappropriate schedule of product administration
Expired product administered, Inappropriate schedule of product administration
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On 15Dec2024 patient received dose of FluMist that expired on 09Dec2024; C: Nurse at HCP office admi...
On 15Dec2024 patient received dose of FluMist that expired on 09Dec2024; C: Nurse at HCP office administered expired dose of FluMist; A spontaneous report has been received from a other health professional. The report concerns a female patient born in 1990. No medical history was reported. No concomitant products were reported. The patient received Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv (batch number(s) Unknown) (expiration date(s) 09-DEC-2024), via unspecified route, on 15-DEC-2024. The patient received 1 dose(s). On an unknown date, the patient experienced on 15dec2024 patient received dose of flumist that expired on 09dec2024 (preferred term: Expired product administered) and c: nurse at hcp office administered expired dose of flumist (preferred term: Wrong technique in product usage process). At the time of reporting, the event c: nurse at hcp office administered expired dose of flumist was ongoing. The outcome of the event(s) of on 15dec2024 patient received dose of flumist that expired on 09dec2024 was unknown. The events were considered non-serious. This case was marked as suppressed due to Misuse/Product use issues with no associated AE. Device Information: Combination Product Report: Yes Product As Reported: Flumist, Influenza Virus Vaccine Polyvalent, Q/Laiv Brand Name: FLUMIST, INFLUENZA VIRUS VACCINE POLYVALENT, Q/LAIV Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use:No Corrected report the event inappropriate schedule of drug administration deleted as it was already coded in the event expired product administered and Flumist was re coded correctly. Narrative was updated., case suppressed due to Misuse/Product use issues with no associated AE. Case corrected in response to data correction request DCR-011041-A
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| 2843377 | 71 | F | PA | 05/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
AHACIMBM51LI |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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The patient received the second dose of Shingrix on 22 May 2025; This non-serious case was reported ...
The patient received the second dose of Shingrix on 22 May 2025; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number AHACIMBM51LI) for prophylaxis. Previously administered products included Shingrix (patient received the first dose of Shingrix on 20 January 2020). On 22-MAY-2025, the patient received the 2nd dose of Shingrix. On 22-MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received the second dose of Shingrix on 22 May 2025). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK receipt date: 26-MAY-2025 The reporter was the patient. Patient asked what information do we currently have regarding Shingrix effectiveness when the two doses are widely separated, in my instance by more than five years? The patient received the first dose of Shingrix on 20th January 2020. The patient received the second dose of Shingrix on 22th May 2025, which led to drug dose administration interval too long
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| 2843378 | F | IA | 05/30/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
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Reporting because the vaccine was expired by 8 days; This non-serious case was reported by a nurse v...
Reporting because the vaccine was expired by 8 days; This non-serious case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 21-year-old female patient who received HBV (Engerix B adult) (expiry date MAY-2025) for prophylaxis. On 28-MAY-2025, the patient received Engerix B adult. On 28-MAY-2025, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Reporting because the vaccine was expired by 8 days). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 28-MAY-2025 The nurse reported because the vaccine was expired by 8 days and which was administered by patient, which led to expired vaccine used.
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| 2843379 | 05/30/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Cough, Respiratory syncytial virus infection, Vaccination failure
Cough, Respiratory syncytial virus infection, Vaccination failure
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Suspected vaccination failure; Respiratory syncytial virus infection; This serious case was reported...
Suspected vaccination failure; Respiratory syncytial virus infection; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2023, the patient received RSV vaccine. On 08-APR-2025, between 1 and 2 years after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported. It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date:08-MAY-2025 This case was reported by a consumer via interactive digital media. The patient got the RSV vaccine and immunity only lasted 2 years. The reporter stated that you could only get it once. The patient got RSV, and it was horrible and now he/she had a constant chronic cough. Pulmonologist said this cough might last for months. This case was considered as suspected vaccination failure as details regarding laboratory test confirming respiratory syncytial virus infection was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine
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| 2843380 | 74 | M | 05/30/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Dizziness, Injection site erythema, Injection site pain, Injection site swelling...
Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Malaise; Respiratory tract congestion
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Injection site pain; redness at the injection site; swelling at the injection site; redness at the i...
Injection site pain; redness at the injection site; swelling at the injection site; redness at the injection site that spread to the top of his left shoulder; swelling at the injection site that spread to the top of his left shoulder; dizzy spell; general malaise; joint pain; throat congestion; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in FEB-2025, for tolerance refer linked case US2025063423). On 19-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm) .5 ml. On 20-MAY-2025, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site erythema (Verbatim: redness at the injection site), injection site swelling (Verbatim: swelling at the injection site), erythema of extremities (Verbatim: redness at the injection site that spread to the top of his left shoulder), swelling arm (Verbatim: swelling at the injection site that spread to the top of his left shoulder), dizzy spells (Verbatim: dizzy spell), general malaise (Verbatim: general malaise), joint pain (Verbatim: joint pain) and upper respiratory tract congestion (Verbatim: throat congestion). The patient was treated with celecoxib (Celebrex). Rechallenge with Shingrix was positive. The outcome of the injection site pain, injection site erythema, injection site swelling, erythema of extremities, swelling arm, general malaise, joint pain and upper respiratory tract congestion were not resolved and the outcome of the dizzy spells was resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, erythema of extremities, swelling arm, dizzy spells, general malaise, joint pain and upper respiratory tract congestion to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, erythema of extremities, swelling arm, dizzy spells, general malaise, joint pain and upper respiratory tract congestion to be related to Shingrix. Linked case(s) involving the same patient: US2025063423 Additional Information: GSK Receipt Date: 21-MAY-2025 The patient self-reported this case for himself. The patient reported he received the second Shingrix vaccine and the next day he had injection site pain, redness and swelling at the injection site that spread to the top of his left shoulder that has not resolved. The patient had a dizzy spell when getting off his bike that has resolved in MAY-2025. The patient felt general malaise and joint pain that has not resolved. The patient also reported throat congestion that might or might not be related to the Shingrix. The patient took a Celebrex yesterday (day before reporting). The patient would contact his HCP if these symptoms were not resolved.; Sender's Comments: US-GSK-US2025063423:case for 1st dose
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| 2843381 | 05/30/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; friend of mine got the two shot and ended up with Shingles a year lat...
Suspected vaccination failure; friend of mine got the two shot and ended up with Shingles a year later.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: friend of mine got the two shot and ended up with Shingles a year later.). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 25-MAY-2025 This case was reported by a patient via interactive digital media. A friend of a reporter got the two shot and ended up with Shingles. It wasn't too bad but still you can get Shingles no matter what. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding exact time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2843382 | F | 05/30/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain, Rash
Pain, Rash
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I have a friend that wishes she never got the shots as they only suppressed the rash; only suppresse...
I have a friend that wishes she never got the shots as they only suppressed the rash; only suppressed the rash, not the pain and it will keep coming back for the rest of her life; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: I have a friend that wishes she never got the shots as they only suppressed the rash) and pain (Verbatim: only suppressed the rash, not the pain and it will keep coming back for the rest of her life). The outcome of the rash was resolving and the outcome of the pain was not reported. It was unknown if the reporter considered the rash and pain to be related to Shingles vaccine. It was unknown if the company considered the rash and pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 24-MAY-2025 This case was reported by a consumer via interactive digital media. They advised not to get the shots, and instead to see a physician on the first day of the rash, as it usually cleared up quickly for most people. They mentioned having a friend who wished she had never received the shots, as they had only suppressed the rash but not the pain, and the condition kept recurring for the rest of her life.
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| 2843383 | 05/30/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; still got shingles very bad; This serious case was reported by a cons...
Suspected vaccination failure; still got shingles very bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles very bad). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 27-MAY-2025 This case was reported by a patient via interactive digital media. Patient took both shingles vaccine and still got shingles very bad. Patient wished someone could have told them that the drugs they were on could have cancelled out the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
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| 2843384 | M | 05/30/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product preparation issue
Product preparation issue
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only a diluent was given; only a diluent was given; This non-serious case was reported by a physicia...
only a diluent was given; only a diluent was given; This non-serious case was reported by a physician via interactive digital media and described the occurrence of inappropriate preparation of medication in a male patient who received MMR (Priorix) for prophylaxis. On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: only a diluent was given) and inappropriate dose of vaccine administered (Verbatim: only a diluent was given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 23-MAY-2025 This case was reported via (Chatbot) interactive digital media. The healthcare professional reported that the patient was given only the diluent of the Priorix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
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| 2843385 | 05/30/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Mycoplasma infection, Pain in extremity
Mycoplasma infection, Pain in extremity
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leg pains are unbearable/it gave me the micro plasma; This non-serious case was reported by a consum...
leg pains are unbearable/it gave me the micro plasma; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mycoplasma infection in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced mycoplasma infection (Verbatim: leg pains are unbearable/it gave me the micro plasma). The outcome of the mycoplasma infection was not reported. It was unknown if the reporter considered the mycoplasma infection to be related to RSV vaccine. It was unknown if the company considered the mycoplasma infection to be related to RSV vaccine. Additional Information: GSK receipt date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The truth was that ever since he/she received the vaccines, the leg pain had become unbearable. He/she developed a mycoplasma infection afterward, and it was worse than anything he/she had experienced before. He/she had never had lung issues or cataracts prior to this. Since the vaccination, the symptoms had been horrible. However, he/she did not blame the vaccines themselves.
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| 2843386 | 05/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
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I'M STILL SICK; This non-serious case was reported by a consumer via interactive digital media ...
I'M STILL SICK; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: I'M STILL SICK). The outcome of the sickness was not resolved. The reporter considered the sickness to be related to Shingrix. The company considered the sickness to be related to Shingrix. Additional Information: GSK Receipt Date: 27-MAY-2025 The reporter stated that he/she was not taking because he/she was still sick from the first one.
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| 2843387 | IA | 05/30/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Underdose
Underdose
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got inadequate dose; This non-serious case was reported by a consumer via sales rep and described th...
got inadequate dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of underdose in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced underdose (Verbatim: got inadequate dose). The outcome of the underdose was not applicable. Additional Information: GSK Receipt Date: 27-MAY-2025 Reporter stated that essentially someone got an inadequate dose and cannot figure out what patient it was. Also asked are there recs on re-vaccinating with not knowing what patient it was. They narrowed it down to about 10 patients, no more data was provided. Patient received inadequate dose, which led to underdose.
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| 2843388 | 1 | F | KS | 05/30/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
Y49BZ |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Administration at inappropriate age; This non-serious case was reported by a nurse via call center r...
Administration at inappropriate age; 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 16-month-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis. On 27-MAY-2025, the patient received Kinrix. On 27-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration at inappropriate age). 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: 28-MAY-2025 The nurse informed that they gave a Kinrix to a 16 month old child (patient), which led to an inappropriate age ta vaccine administration. The vaccine administration facility was the same as primary reporter.
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| 2843389 | KS | 05/30/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
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Inappropriate schedule of product administration, Product administered to patien...
Inappropriate schedule of product administration, Product administered to patient of inappropriate age
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Inappropriate schedule of DTap series.; Kinrix administered too early in the series; This non-seriou...
Inappropriate schedule of DTap series.; Kinrix administered too early in the series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis. On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: Inappropriate schedule of DTap series.) and inappropriate age at vaccine administration (Verbatim: Kinrix administered too early in the series). The outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were 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:28-MAY-2025 A pharmacy director called to inform that for Kinrix. It was administered too early in the series, before it should, which led to inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. There were multiple patients. Reporter mentioned that there were 31 patients, no details about each of the patients were provided, as well as lot numbers. However, healthcare professional agreed to follow-up by Safety team to provide additional details. The Vaccine Administration Facility was same as Primary Reporter.
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| 2843390 | M | 05/30/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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Patient didn't get COVID, but eventually got it but just last year; This spontaneous case was r...
Patient didn't get COVID, but eventually got it but just last year; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient didn't get COVID, but eventually got it but just last year) in a male patient of an unknown age 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. In 2024, the patient experienced COVID-19 (Patient didn't get COVID, but eventually got it but just last year). At the time of the report, COVID-19 (Patient didn't get COVID, but eventually got it but just last year) outcome was unknown. Concomitant product use was not provided by the reporter. The reporter stated that her mom, her dad and her whole family got the Moderna COVID vaccine and almost all of them did not get sick. They didn't get COVID, but her parents eventually got it but just last year. Her parents had received Moderna since the beginning. The reporter refused to provide initials and DOB for her parents. No other details provided. Treatment information was not provided. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-786994 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786994:Reporter father case
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| 2843391 | F | 05/30/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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They didn't get COVID, but my parents eventually got it but just last year; This spontaneous ca...
They didn't get COVID, but my parents eventually got it but just last year; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (They didn't get COVID, but my parents eventually got it but just last year) in a female patient of an unknown age 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. In 2024, the patient experienced COVID-19 (They didn't get COVID, but my parents eventually got it but just last year). At the time of the report, COVID-19 (They didn't get COVID, but my parents eventually got it but just last year) outcome was unknown. Concomitant product use was not provided by the reporter. The reporter stated that her mom got the Moderna COVID vaccine and she did not get sick. She didn't get COVID but got it but just last year. She received Moderna since the beginning. The reporter refused to provide initials and DOB for her parents. No other details provided. Treatment information was not provided. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-786994 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786994:Reporter mother case
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| 2843392 | F | 05/30/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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Patient just recently got COVID 2 months ago, but she also had her shots; This spontaneous case was ...
Patient just recently got COVID 2 months ago, but she also had her shots; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient just recently got COVID 2 months ago, but she also had her shots) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse effect with Pfizer. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In March 2025, the patient experienced COVID-19 (Patient just recently got COVID 2 months ago, but she also had her shots). At the time of the report, COVID-19 (Patient just recently got COVID 2 months ago, but she also had her shots) outcome was unknown. Concomitant product use was not provided by the reporter. Patient just recently got COVID, 2 months ago, but she also had her shots. The patient got Pfizer at the beginning and then Moderna after. The reporter stated that none of her family gets sick after their COVID vaccines. Treatment information was not provided. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-786994 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786994:Reporter sister case
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| 2843393 | M | 05/30/2025 |
COVID19 |
MODERNA |
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Cranial nerve disorder
Cranial nerve disorder
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from the vaccination would have any medical issues with the cranial 3 nerve; This spontaneous case w...
from the vaccination would have any medical issues with the cranial 3 nerve; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CRANIAL NERVE DISORDER (from the vaccination would have any medical issues with the cranial 3 nerve) in a male patient of an unknown age 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 CRANIAL NERVE DISORDER (from the vaccination would have any medical issues with the cranial 3 nerve). At the time of the report, CRANIAL NERVE DISORDER (from the vaccination would have any medical issues with the cranial 3 nerve) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medications were reported. It was reported that the reporter was checking if any side effects from the vaccination would have caused any medical issues related to the cranial 3 nerve. Reporter's husband was experiencing recurring problems. Reporter also enquired if anyone else also experienced the same problem. It was unknown if the patient experienced any additional symptoms or events No treatment medications were reported.
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| 2843394 | 78 | F | 05/30/2025 |
COVID19 |
MODERNA |
029L208 |
Alopecia, Condition aggravated
Alopecia, Condition aggravated
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She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair starte...
She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches"; She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches"; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") and CONDITION AGGRAVATED (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L208) for COVID-19 prophylaxis. Concurrent medical conditions included Hair loss (patient on Finasteride for hair fall). On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced ALOPECIA (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") and CONDITION AGGRAVATED (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches"). The patient was treated with Finasteride for Hair loss, at an unspecified dose and frequency. At the time of the report, ALOPECIA (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") and CONDITION AGGRAVATED (She then states that 2 weeks after the first COVID vaccine she took in February 2021 her hair started falling "in bunches") had not resolved. No concomitant medication was reported. It was reported that 2 weeks after the first COVID vaccine she took in Feb-2021 her hair started falling in bunches. She took other doses later, and she regrets doing so because she did not know how it would affect her, and she should not have done it. She took vaccine doses on 2-Nov-2021 with lot 016MZ0A, then on 15-Aug-2022 with lot 088021 and then on 28-Oct-2022 with lot 013h22a. It was unknown if the patient experienced any additional symptoms or events. This case was linked to US-MODERNATX, INC.-MOD-2025-786999 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786999:Invalid case
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| 2843395 | F | 05/30/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
203523A 203523A |
Body temperature, Carpal tunnel syndrome, Gait disturbance, Pain, Pyrexia; SARS-...
Body temperature, Carpal tunnel syndrome, Gait disturbance, Pain, Pyrexia; SARS-CoV-2 test
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body pains; low grade fever (100'F); she cannot walk; she has carpal tunnel; This spontaneous c...
body pains; low grade fever (100'F); she cannot walk; she has carpal tunnel; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body pains), PYREXIA (low grade fever (100'F)), GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 203523A) for COVID-19 prophylaxis. No Medical History information was reported. In July 2024, the patient received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to .5 milliliter. On an unknown date, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body pains), PYREXIA (low grade fever (100'F)), GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel). At the time of the report, PAIN (body pains) and PYREXIA (low grade fever (100'F)) had resolved and GAIT DISTURBANCE (she cannot walk) and CARPAL TUNNEL SYNDROME (she has carpal tunnel) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 Farad. On an unknown date, SARS-CoV-2 test: Negative. No concomitant medication was reported. She had received 7 Moderna COVID-19 vaccines, and she was the only one that didn't get sick (COVID) and she got vaccines consistently. If she got a runny nose, she would test for COVID consistently and was always negative. The reporter stated that with every shot, except for her last one in July 2024 with lot number 203523A she experienced body pains, like she cannot walk for 24 hours, and a low-grade fever (100'F) that starts within 6 hours and goes away after about 12-24 hours. She had carpal tunnel. She was not diagnosed it before any COVID shots. 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-2025-786996, US-MODERNATX, INC.-MOD-2025-786997, US-MODERNATX, INC.-MOD-2025-786998 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786998:Reporter sister case US-MODERNATX, INC.-MOD-2025-786997:Reporter mother case US-MODERNATX, INC.-MOD-2025-786996:Reporter father case
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| 2843397 | M | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Aortic valve replacement, Cardiac pacemaker insertion
Aortic valve replacement, Cardiac pacemaker insertion
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Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace ma...
Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement; Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement; This is a spontaneous report received from a Physician from medical information team, Program ID. A 75-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27Aug2024 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: comirnaty (DOSE 5 (BOOSTER), SINGLE), administration date: 03Apr2022, for COVID-19 immunization; BNT162b2 (DOSE 6 (BOOSTER), SINGLE), administration date: 14Sep2023, for COVID-19 immunization; Moderna (DOSE 1, SINGLE), administration date: Jan2021, for COVID-19 immunization; Moderna (DOSE 2, SINGLE), administration date: Feb2021, for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE), administration date: Aug2021, for COVID-19 immunization; Comirnaty (DOSE 4 (BOOSTER), SINGLE), administration date: Mar2022, for COVID-19 immunization. The following information was reported: AORTIC VALVE REPLACEMENT (medically significant), CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown" and all described as "Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, TAVR aortic valve replacement". Clinical course: Caller is a HCP and a patient, confirmed above inquiry. His last dose of COVID-19 vaccine was on 27Aug2024 which was the Comirnaty 12 plus. Asked if the caller has any comorbidities or immunocompromised, caller stated that he has a pace maker, (withheld) valve replacement. Caller also stated that he had a total of 7 covid-19 vaccinations. He is 75 years old turning 76. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on known nature of the events and limited information available, the events are assessed as not related to BNT162b2 omicron (kp.2), and more likely due to underlying medical conditions. 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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| 2843398 | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Blood glucose, Diabetes mellitus
Blood glucose, Diabetes mellitus
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git a Glucose spike/Diabetic; This is a spontaneous report received from a Consumer or other non HCP...
git a Glucose spike/Diabetic; This is a spontaneous report received from a Consumer or other non HCP from medical information team. 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: DIABETES MELLITUS (medically significant), outcome "not recovered", described as "git a Glucose spike/Diabetic". The patient underwent the following laboratory tests and procedures: Blood glucose: Spike, notes: He states he has talked to 2 other friends and they git a Glucose spike, one went from 100 to 267 and another went up to 460. Clinical information: Caller states he has gotten so many problems from the Pfizer Covid 19 Vaccine. Caller states he just got his Glucose tested and it went from 100 to 402 and he is passing out. Caller states his doctor said it was from the Covid Vaccine. He states he has talked to 2 other friends and they git a Glucose spike, one went from 100 to 267 and another went up to 460 and his sister's went up to 367. What is the deal with the Covid Vaccine spiking Glucose that you guys said it was safe and effective? Caller states they are Diabetic now, everybody is Diabetic now. Caller states his Doctor said he has shortened his life by 5 years, 5-10 years. Caller states 3 other friends got the same glucose spike that he just talked to. 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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| 2843399 | M | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Bone cancer
Bone cancer
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one guy got a super cancer in his spine; This is a spontaneous report received from a Consumer or ot...
one guy got a super cancer in his spine; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 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 and concomitant medications were not reported. The following information was reported: BONE CANCER (medically significant), outcome "unknown", described as "one guy got a super cancer in his spine". Clinical course: Caller stated one guy got a super cancer in his spine. 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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| 2843400 | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Taste disorder
Taste disorder
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why did the covid shots mess up my sense of taste; This is a spontaneous report received from a Cons...
why did the covid shots mess up my sense of taste; 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: TASTE DISORDER (non-serious), outcome "unknown", described as "why did the covid shots mess up my sense of taste". Additional information: The reporter asked why did the covid shots mess up my sense of taste. 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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| 2843401 | F | CA | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Limb mass, Thrombosis
Limb mass, Thrombosis
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got a lump in her leg that was a blood clot; got a lump in her leg that was a blood clot; This is a ...
got a lump in her leg that was a blood clot; got a lump in her leg that was a blood clot; This is a spontaneous report received from a Consumer or other non HCP. 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: THROMBOSIS (medically significant), LIMB MASS (non-serious), outcome "unknown" and all described as "got a lump in her leg that was a blood clot". Clinical course: The reporter mentioned that her neighbor got the Covid-19 shot and she got a lump in her leg that was a blood clot. 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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| 2843402 | F | NJ | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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the patient also had some reaction to the Paxlovid medication; the patient also had some reaction to...
the patient also had some reaction to the Paxlovid medication; the patient also had some reaction to the Paxlovid medication; This is a spontaneous report received from an Other HCP. A 62-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "the patient also had some reaction to the Paxlovid medication". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Vaccine efficacy varies from person to person and is subject to many other factors. The association between the event lack of effect (COVID-19) with BNT162b2 NOS can not be fully excluded.,Linked Report(s) : US-PFIZER INC-202300011455 same patient, different dose/event;
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| 2843403 | 76 | F | PA | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Chills, Fatigue, Headache
Chills, Fatigue, Headache
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Headache; severe fatigue; chills; This is a spontaneous report received from a Nurse. A 76-year-old...
Headache; severe fatigue; chills; This is a spontaneous report received from a Nurse. A 76-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Lichens planopilaris" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "OAB" (unspecified if ongoing); "Adhesive tape allergy" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: 06Sep2006. Past drug history included: Anticholinergics, reaction(s): "Drug hypersensitivity"; Fosamax, reaction(s): "Drug hypersensitivity"; Lisinopril, reaction(s): "Drug hypersensitivity". The patient did not receive other vaccines on the same date as the vaccine(s) reported. The patient did not receive other vaccines within 4 weeks prior to the vaccine(s) reported. The following information was reported: HEADACHE (non-serious) with onset 28May2025, outcome "unknown"; CHILLS (non-serious) with onset 28May2025, outcome "unknown"; FATIGUE (non-serious) with onset 28May2025, outcome "unknown", described as "severe fatigue". Therapeutic measures were taken as a result of headache, fatigue, chills. Treatment received for the adverse event included Tylenol and rest. 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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| 2843404 | 05/30/2025 |
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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I am positive for COVID, and I was on the Pfizer vaccination trial as well; I am positive for COVID,...
I am positive for COVID, and I was on the Pfizer vaccination trial as well; I am positive for COVID, and I was on the Pfizer vaccination trial as well; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 46-year-old 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 "I am positive for COVID, and I was on the Pfizer vaccination trial as well". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I am positive for COVID. Clinical information: During an inbound call for financial assistance, the patient, Name withheld, stated that patient needed some assistance in getting a prescription for Paxlovid. The patient was then unemployed and did not have access to health insurance. The patient did not even have access to a doctor at the moment, but the patient was positive for COVID, and patient was on the Pfizer vaccination trial as well." When discussing the cost of seeing a doctor, Name withheld stated,". The patient had to spend a bunch of money patient did not have because patient was sick." When offered to transfer to the Drug and Safety department, Name withheld stated, "Probably after patient recover, the patient did not had the patience for that to be honest, sorry." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2843405 | F | CO | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Goitre, Pancreatic cyst, Uterine leiomyoma, Vaginal haemorrhage
Goitre, Pancreatic cyst, Uterine leiomyoma, Vaginal haemorrhage
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Cyst on her Pancreas; Enlarged Thyroid; Vaginal Bleeding; Fibroid; This is a spontaneous report rece...
Cyst on her Pancreas; Enlarged Thyroid; Vaginal Bleeding; Fibroid; This is a spontaneous report received from a Pharmacist from medical information team, Program ID. A female patient 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: PANCREATIC CYST (non-serious), outcome "unknown", described as "Cyst on her Pancreas"; GOITRE (non-serious), outcome "unknown", described as "Enlarged Thyroid"; VAGINAL HAEMORRHAGE (non-serious), outcome "unknown", described as "Vaginal Bleeding"; UTERINE LEIOMYOMA (non-serious), outcome "unknown", described as "Fibroid". Additional information: pharmacist wanted to know how frequent the adverse effect of Pfizer Covid-19 vaccine is and how they can manage those effects because they have a patient who got adverse effects. She would like to see if there is any information on the things the patient is experiencing and how they can manage those side effects. Caller states the patient has a cyst on her pancreas, enlarged thyroid, vaginal bleeding that she believes is from a fibroid that started after the Pfizer Covid vaccine and it has been happening for 2 years. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2843406 | 1.25 | IN | 05/30/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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Product preparation error
Product preparation error
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nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liqui...
nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported ae; nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported ae; Initial information received on 20-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case was linked with US-SA-2025SA154169. This case involves a 15 months old patient with unknown gender for whom nurse reconstituted the hib powder portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] with an unknown liquid and liquid dtap/ipv portion not administered with no reported adverse event. Reportedly, there was no parental drug exposure. The patient have unknown medical history/condition, concomitant disease and risk factor or lab tests. Reporter reported that the suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) for Immunization for patient 15 months old (Immunisation) and nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported adverse event (single component of a two-component product administered), (product preparation error) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA154169:
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| 2843407 | 42 | F | 05/30/2025 |
UNK |
UNKNOWN MANUFACTURER |
No batch number |
Guillain-Barre syndrome
Guillain-Barre syndrome
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Guillain-Barre Syndrome; This spontaneous case, initially received on 28-May-2025, was reported by a...
Guillain-Barre Syndrome; This spontaneous case, initially received on 28-May-2025, was reported by a non health professional and concerns an adult female patient. Relevant History and concomitant medication were reported as unknown. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for influenza prophylaxis, Dose regimen: not reported, Route of administration: not reported, Anatomical location: not reported, Lot number: Not reported and requested upon follow-up. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Guillain-Barre Syndrome (Medically Significant, outcome: Recovering/resolving). Case was upgraded to serious upon company assessment of the reported event's clinical significance. An adverse event related to the administration of Flucelvax was reported. Physician informed that one of his patients had experienced an adverse event after receiving the vaccine. The patient was an adult female who developed Guillain-BarrοΏ½ Syndrome following her vaccination with Flucelvax. Doctor recognized the adverse event promptly and provided the necessary care, which improved the patient's outcome Flucelvax (TIV) action taken: Not Applicable Reporter's assessment: The reporter considered the causality and seriousness of the event Guillain-Barre Syndrome as unknown; Reporter's Comments: Causality: Due to the spontaneous nature of the case, the event is considered related for reporting purposes. Related considering biological plausibility, however there is insufficient information about precise event latency, therapy details, clinical course, medical history and concomitant medication which precludes a sound medical assessment. According to the Brighton Collaboration criteria, the case meets Level 4 diagnostic certainty for the event of Guillain-Barre Syndrome (there is lack of sufficient information to meet any level of case diagnostic criteria)
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| 2843408 | F | KS | 05/30/2025 |
HEP HIBV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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No other AE/No PQC; Patient did have all childhood vaccinations at the time that they were due when ...
No other AE/No PQC; Patient did have all childhood vaccinations at the time that they were due when she was a child so this PEDVAXHIB is an extra dose; This spontaneous report was received from a nurse regarding to a 22-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-MAY-2025, the patient was vaccinated with haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) at a dose of 0.5 mL (strength, route of administration, anatomical injection site, lot # and expiration date were not reported), for prophylaxis; and with hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) (strength, dose, route of administration, anatomical injection site, lot #, expiration date and indication were not reported). The reporter stated that patient was inadvertently given haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) that was not due. The patient was also vaccinated with hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) at the same time as the haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB). Hepatitis b vaccine rHBsAg (yeast) (ENGERIX B) was due and was given appropriately. Patient did have all childhood vaccinations at the time that they were due when she was a child so this haemophilus b Conjugate Vaccine (meningococcal protein conjugate) (LIQUID PEDVAX HIB) was an extra dose. No other information provided. No other AE/No PQC. Lot # is being requested and will be submitted if received.
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| 2843409 | 73 | M | NJ | 05/30/2025 |
HEPAB VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
P2443 3273H |
Limb mass, Pruritus; Limb mass, Pruritus
Limb mass, Pruritus; Limb mass, Pruritus
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pt called saying he had a total of 9 raised bumps total on both arms and they itched. shot was give...
pt called saying he had a total of 9 raised bumps total on both arms and they itched. shot was given mid morning and he called about 5pm same day
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| 2843410 | 66 | F | AL | 05/30/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
XX9N4 |
Product preparation issue
Product preparation issue
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Priorix antigen was not reconstituted with diluent prior to administration. Patient only received di...
Priorix antigen was not reconstituted with diluent prior to administration. Patient only received diluent.
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| 2843411 | 18 | M | CO | 05/30/2025 |
HPV9 MNQ TDAP |
MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR |
Y014510 U8438AA U8389AA |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
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Patient was due for Tdap and HPV. I gave Meningococcal by mistake. I notified my provider and superv...
Patient was due for Tdap and HPV. I gave Meningococcal by mistake. I notified my provider and supervisor and reported it to all the appropriate people. Patient did not show any signs of adverse reactions.
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| 2843412 | 77 | F | CO | 05/30/2025 |
COVID19 |
PFIZER\BIONTECH |
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Injection site hypoaesthesia, Injection site pain, Injection site swelling
Injection site hypoaesthesia, Injection site pain, Injection site swelling
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Patient complained about having mild swelling, pain and numbness at the injection site.
Patient complained about having mild swelling, pain and numbness at the injection site.
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| 2843419 | 46 | F | OH | 05/30/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
Pfizer Pfizer |
Blood test, Carditis, Catheterisation cardiac, Computerised tomogram, Electrocar...
Blood test, Carditis, Catheterisation cardiac, Computerised tomogram, Electrocardiogram; Magnetic resonance imaging, Ultrasound scan
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Heart inflammation
Heart inflammation
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β | β | β | |||
| 2843420 | 84 | F | LA | 05/30/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
7L3ST |
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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Patient reported that she couldn't move her arm the day after the vaccine. Her whole arm was in...
Patient reported that she couldn't move her arm the day after the vaccine. Her whole arm was in pain up to her hand.
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| 2843421 | 10 | F | CA | 05/30/2025 |
YF |
SANOFI PASTEUR |
UK134AA |
Syncope
Syncope
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PATIENT FAINTED AFTER RECEIVING VACCINE
PATIENT FAINTED AFTER RECEIVING VACCINE
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| 2843422 | 54 | M | MI | 05/30/2025 |
PNC21 PNC21 VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y019157 Y019157 G97Y2 G97Y2 |
Chills, Headache, Injection site erythema, Injection site pain, Injection site s...
Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling; Palpitations, Pyrexia; Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling; Palpitations, Pyrexia
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The arm where he had the pneumonia shot swelled up to softball size, was red and painful. He also no...
The arm where he had the pneumonia shot swelled up to softball size, was red and painful. He also noted that he experienced side effects of fever, chills, headache, racing heart. Patient called and informed us 4 days after the vaccine so it is not clear exactly when his symptoms began. he did not seek medical evaluation.
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| 2843423 | 31 | F | CO | 05/30/2025 |
CHIK CHIK YF YF |
VALNEVA USA, INC. VALNEVA USA, INC. SANOFI PASTEUR SANOFI PASTEUR |
N/A N/A UK134AA UK134AA |
Blood test, Chills, Dyspnoea, Fatigue, Lymphadenopathy; Pain, Pyrexia; Blood tes...
Blood test, Chills, Dyspnoea, Fatigue, Lymphadenopathy; Pain, Pyrexia; Blood test, Chills, Dyspnoea, Fatigue, Lymphadenopathy; Pain, Pyrexia
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5/23: Fever, chills, body aches, fatigue, 5/24 - 5/30 (date reporting): swollen lymph nodes, severe ...
5/23: Fever, chills, body aches, fatigue, 5/24 - 5/30 (date reporting): swollen lymph nodes, severe body aches, fatigue, shortness of breath
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| 2843424 | 70 | F | TX | 05/30/2025 |
RSV RSV RSV RSV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4b22t 4b22t 4B22T 4B22T |
Contusion, Muscle spasms; Muscle spasms, Pain, Skin discolouration; Contusion, M...
Contusion, Muscle spasms; Muscle spasms, Pain, Skin discolouration; Contusion, Muscle spasms; Muscle spasms, Pain, Skin discolouration
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Right arm hand had a severe cramp at thumb 5 minutes after injection. Bruised thumb pad of lower h...
Right arm hand had a severe cramp at thumb 5 minutes after injection. Bruised thumb pad of lower hand .
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| 2843425 | 1 | F | PA | 05/30/2025 |
HEPA MMRV VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
Y011731 Y018156 Y011018 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event
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She had no signs or symptoms.
She had no signs or symptoms.
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| 2843426 | 71 | M | NC | 05/30/2025 |
COVID19 |
MODERNA |
3042645 |
Expired product administered
Expired product administered
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Vaccination was expired at time of administration.
Vaccination was expired at time of administration.
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| 2843427 | 70 | M | NC | 05/30/2025 |
COVID19 |
MODERNA |
3042645 |
Expired product administered
Expired product administered
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Vaccination was expired at time of administration.
Vaccination was expired at time of administration.
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| 2843428 | 11 | F | CA | 05/30/2025 |
VARCEL |
MERCK & CO. INC. |
Y005920 |
Extra dose administered
Extra dose administered
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Patient's mother came in requesting Varicella vaccine for her daughter in addition to the sched...
Patient's mother came in requesting Varicella vaccine for her daughter in addition to the scheduled Tdap appointment. Pharmacist proceeded to look up on database whether patient is eligible to receive Varicella. Per database, patient was overdue for Varicella, so pharmacist continued to process and administer vaccine. After injection, patient's mother handed pharmacist the vaccination yellow card to fill out. Upon reviewing the yellow card, pharmacist sees that patient already completed their Varicella series.
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