| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2500225 | 1 | M | IL | 11/07/2022 |
MMR HEPA HEPA MMR MMR PNC13 PNC13 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
W006214 W006214 U039909 U039909 FH9982 FH9982 |
Endotracheal intubation, Seizure; Electroencephalogram normal, Laboratory test n...
Endotracheal intubation, Seizure; Electroencephalogram normal, Laboratory test normal, Laryngoscopy normal, Mechanical ventilation, Respiratory pathogen panel; Seizure; Electroencephalogram normal, Laboratory test normal, Laryngoscopy normal, Mechanical ventilation, Respiratory pathogen panel; Seizure; Electroencephalogram normal, Laboratory test normal, Laryngoscopy normal, Mechanical ventilation, Respiratory pathogen panel; Seizure
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the child suffered a seizure and was admitted to the hospital; This spontaneous report was received ...
the child suffered a seizure and was admitted to the hospital; This spontaneous report was received from the patient's mother and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 14-OCT-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided). On 23-OCT-2022, the patient experienced a seizure and was admitted to the hospital. The patient was intubated for two days while on oxygen. Treatment also included unspecified steroids and antibiotics. On an unknown date in October 2022, the patient was discharged from the hospital. At the time of reporting, the patient had not recovered from the event of seizure. The causal relationship between the seizure and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown. Upon internal review, the event seizure was determined to be medically significant. The reporter considered the event seizure to be life threatening.
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โ | โ | ||||
| 2830245 | 70 | F | 03/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient received a second dose of the Arexvy on 9/8/24, no AE at this time
Patient received a second dose of the Arexvy on 9/8/24, no AE at this time
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| 2830253 | 11 | M | CA | 03/07/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LP1776 FJ47R |
Pyrexia; Pyrexia
Pyrexia; Pyrexia
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Per patient's mom, patient had a fever that lasted 30 minutes after vaccination, and now fully ...
Per patient's mom, patient had a fever that lasted 30 minutes after vaccination, and now fully recovered from it.
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| 2830255 | 48 | F | FL | 03/07/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
3ZH27 |
Erythema, Induration, Pain, Peripheral swelling, Pyrexia
Erythema, Induration, Pain, Peripheral swelling, Pyrexia
|
PATIENT'S ARM WAS SWOLLEN, RED, AND HARD. SHE SAYS SHE ALSO HAD A FEVER. PATIENT WAS ADVISED T...
PATIENT'S ARM WAS SWOLLEN, RED, AND HARD. SHE SAYS SHE ALSO HAD A FEVER. PATIENT WAS ADVISED TO TAKE IBUPROFEN TO HELD WITH FEVER AND PAIN/SWELLING AND TO APPLY A COLD COMPRESS. PATIENT DID NOT EXPERIENCE ANY SWELLING IN THE MOUTH, TONGUE, OR THROAT OR HAVE ANY PROBLEMS BREATHING.
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| 2830256 | 75 | M | TN | 03/07/2025 |
COVID19 |
MODERNA |
3043823 |
Pain in extremity
Pain in extremity
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Patient received two covid vaccines. 1 on 1/24 and 1 on 3/5. Patient only complained of sore arm
Patient received two covid vaccines. 1 on 1/24 and 1 on 3/5. Patient only complained of sore arm
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| 2830257 | 65 | F | CA | 03/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Cough, Feeling abnormal, Feeling of body temperature change, Pain, Pyrexia
Cough, Feeling abnormal, Feeling of body temperature change, Pain, Pyrexia
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About 12 hours after receiving the shot I had bodyaches. Body aches the whole next day in the evenin...
About 12 hours after receiving the shot I had bodyaches. Body aches the whole next day in the evening 99.9๏ฟฝ fever slight cough. I feel bad. Hot, then cold
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| 2830258 | 61 | F | TX | 03/07/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Asthenia, Chills, Cough, Gait disturbance, Headache; Myalgia, Nausea, Oropharyng...
Asthenia, Chills, Cough, Gait disturbance, Headache; Myalgia, Nausea, Oropharyngeal pain, Pain, Pyrexia
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Started with chills and fever. Advil every 4 hours did not work. Fever continued to climb along with...
Started with chills and fever. Advil every 4 hours did not work. Fever continued to climb along with nausea (took Pepto Bismol which did not help, Diarrhea - took immodium which did not work. Severe weakness, muscle aches, body aches, difficulty walking and thinking clearly. Headache, dry nose, sore throat. Fever climbed to 103.2 at 4:00AM. I considered calling an ambulance. I got into a cool bath and my temperature slowly declined. This was WAY worse than my first Shingles shot.
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| 2830347 | 16 | F | FL | 03/07/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
DD72H |
Injection site urticaria
Injection site urticaria
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Hives at vaccine site - Took Benadryl with relief. Patient/Parent then stated pt had hives after fir...
Hives at vaccine site - Took Benadryl with relief. Patient/Parent then stated pt had hives after first Men-B vaccine but did not think it was related.
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| 2830348 | 66 | F | NY | 03/07/2025 |
PNC20 |
PFIZER\WYETH |
LJ5283 |
Erythema, Infection, Pain, Skin warm
Erythema, Infection, Pain, Skin warm
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Vaccine administered 2-27-2027 few days later adverse event started area Red + Hot to touch swollen,...
Vaccine administered 2-27-2027 few days later adverse event started area Red + Hot to touch swollen, pain. Patient went to doctor and was pescribed steroids and abx for infection on 3-5-2025.
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| 2832492 | IL | 03/07/2025 |
FLU3 |
GLAXOSMITHKLINE BIOLOGICALS |
72RF2 |
Contusion, Dizziness, Fatigue, Malaise
Contusion, Dizziness, Fatigue, Malaise
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lightheadedness; phantom bruising all over the body; severe fatigue; malaise; This non-serious case ...
lightheadedness; phantom bruising all over the body; severe fatigue; malaise; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of light headedness in a patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number 72RF2, expiry date 30-JUN-2025) for prophylaxis. On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced light headedness (Verbatim: lightheadedness), contusion (Verbatim: phantom bruising all over the body), fatigue (Verbatim: severe fatigue) and malaise (Verbatim: malaise). The outcome of the light headedness, contusion, fatigue and malaise were not reported. The reporter considered the light headedness, contusion, fatigue and malaise to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. The company considered the light headedness, contusion, fatigue and malaise to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device. 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: 21-OCT-2024 and 28-OCT-2024 The health care professional reported that a patient received Fluarix and had phantom bruising all over the body, severe fatigue, malaise and lightheadedness and patient went to emergency department. The reporter stated that particular batch (Lot: 72RF2) was causing the adverse events. This case was one of the four linked cases, reported by the same reporter for different patient. Follow up information received on 04-NOV-2024 The case reported was an human safety information only with no defined quality defect and therefore this case does not qualify as a customer complaint as per GQP 8203 definitions and scope. Summary of changes: Event deleted and narrative were updated. Upon internal review case was updated on: 06-MAR-2025 The suspect was coded as Fluarix 2024-2025. Summary of changes: Product tab, event details and narrative were updated.; Sender's Comments: US-GSK-US2024AMR131526:Original Case : US2024129463 US-GSK-US2024AMR131525:Original Case : US2024129463 US-GSK-US2024133757:Same reporter
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| 2829835 | F | CA | 03/06/2025 |
MEA MEA |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Eye pain; Eye pain
Eye pain; Eye pain
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Eye Pain; Eye pain; This spontaneous report was received from a Consumer regarding to a female patie...
Eye Pain; Eye pain; This spontaneous report was received from a Consumer regarding to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (Manufacturer unknown), (lot #, expiration date, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis. On an unknown date, the patient experienced eye pain, she felt like being stabbed in the eye. On an unknown date, a month later, she received the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), Solution for injection, lot #, expiration date, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis; on an unknown date, the patient experienced eye pain like being stabbed in the eye so bad that she had to go to the emergency room (ER). On an unknown date, the patient was admitted into the hospital due to the event. At the reporting time, the patient recovered from the events of Eye Pain on an unspecified date. The causal relationship between both events of Eye Pain and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) were unknown. Lot # is being requested and will be submitted if is reported.
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| 2829836 | 17 | F | NY | 03/06/2025 |
HPV9 |
MERCK & CO. INC. |
Y010656 |
Product storage error
Product storage error
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he HCP stated that no patients reported any adverse issues or side effects from any of the administe...
he HCP stated that no patients reported any adverse issues or side effects from any of the administered doses.; Temperature of fridge went up to 48 F excursion; This spontaneous report has been received from a medical assistant regarding a 17-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included meningococcal vaccine B rfHbp/NadA/NHBA OMV (BEXSERO). On 03-JAN-2025, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered intramuscularly in the left arm as the second dose (lot number reported as Y010656, which has been verified as valid, expiration date reported and validated as 29-NOV-2026) (dose was not reported). The administered dose was exposed to a temperature that went up to 48 Fahrenheit degrees (F) (Product storage error). The vaccine was determined good for further use. The reporter stated that no patients reported any adverse issues or side effects from any of the administered doses.
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| 2829837 | CA | 03/06/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Received One Dose on HEPLISAV B on 12/11/2024, and Then a Dose Engerix on 1/15/2025; Initial report ...
Received One Dose on HEPLISAV B on 12/11/2024, and Then a Dose Engerix on 1/15/2025; Initial report received on 20-Feb-2025. A pharmacist reported that a patient (age, gender, race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given ENGERIX-B as the second dose. No medical history or concomitant medications were reported. On 11-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, NDC #, route, and site not available)]. On 15-Jan-2025, 35 days after having been vaccinated with HEPLISAV-B, the patient was given ENGERIX-B (lot #, expiration date, NDC #, route, and site not available). No adverse events were reported. No additional information is available. Company Comment: ?The company assessed the event as non-serious.; Sender's Comments: ? The company assessed the event as non-serious.
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| 2829838 | M | OH | 03/06/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
944917 |
Incomplete course of vaccination
Incomplete course of vaccination
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The 2nd Dose of HEPLISAV-B was Confirmed to be Missed; Initial report received on 20-Feb-2025. A ...
The 2nd Dose of HEPLISAV-B was Confirmed to be Missed; Initial report received on 20-Feb-2025. A pharmacist reported that a 43-year-old male (race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet. No medical history or concomitant vaccines were reported. On 24-Sep-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 43528-003-05, expiration date 16-Nov-2026, NDC # 43528-003-05)] intramuscularly in the left arm. At the time of the report, the patient has not received the second dose. It was confirmed to be missed. Additional information was not provided. Company Comment: ? The company assessed the event as non-serious.; Sender's Comments: ? The company assessed the event as non-serious.
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| 2829839 | M | MO | 03/06/2025 |
HEP |
DYNAVAX TECHNOLOGIES CORPORATION |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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15 Year Received Heplisav-B; Initial report received on 25-Feb-2025. A nurse reported that a 15-yea...
15 Year Received Heplisav-B; Initial report received on 25-Feb-2025. A nurse reported that a 15-year-old male patient received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while at an inappropriate age. No medical history or concomitant medications were reported. On 25-Feb-2025, the patient received a dose of a hepatitis B vaccine [HEPLISAV-B (NDC # 43528-002-01, lot #, expiration date, route, and site not available). The patient was 15 years old when he received HEPLISAV-B. There were no adverse events reported. No additional information was reported. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
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| 2829840 | M | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Pyrexia
Pyrexia
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Fever; This non-serious case was reported by a consumer and described the occurrence of fever in a 6...
Fever; This non-serious case was reported by a consumer and described the occurrence of fever in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included arthritis. Concomitant products included methotrexate. On 25-FEB-2025, the patient received Shingrix. On 26-FEB-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not resolved. It was unknown if the reporter considered the fever to be related to Shingrix. It was unknown if the company considered the fever to be related to Shingrix. Additional Information: GSK Receipt Date: 26-FEB-2025 The patient self-reported this case for himself. The patient received Shingrix vaccine and experienced fever. The symptoms were treated.
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| 2829841 | F | NY | 03/06/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
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Syncope
Syncope
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syncope after the administration/Fainting; This serious case was reported by a pharmacist via call c...
syncope after the administration/Fainting; This serious case was reported by a pharmacist via call center representative and described the occurrence of syncope in a 34-year-old female patient who received HBV (Engerix B) (expiry date 11-JUL-2026) for prophylaxis. On 25-FEB-2025, the patient received Engerix B. In FEB-2025, less than a week after receiving Engerix B, the patient experienced syncope (Verbatim: syncope after the administration/Fainting) (serious criteria GSK medically significant). The outcome of the syncope was unknown. It was unknown if the reporter considered the syncope to be related to Engerix B and Engerix B Pre-Filled Syringe Device. The company considered the syncope to be unrelated to Engerix B and Engerix B Pre-Filled Syringe Device. 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: 26-FEB-2025 Other HCP wanted to know the percentage of patients fainting after receiving Engerix-B. Information found in the prescribing information about syncope after the administration was given and also offered to be escalated to a second line specialist, but declined it. Reporter mentioned that the vaccine was administered in a facility different than the one registered in the system and provided only the zip code of this administration site. Reporter did not knew the batch number because she was not in that facility and had nothing from the product to find out the lot number.; Sender's Comments: Syncope is a listed event which, due to the following criteria ((insufficient information provided about the clinical description, medical history, concurrent conditions, concomitant medications, lab results) is considered unrelated to GSK vaccine Engerix B and Engerix B PRE-FILLED SYRINGE DEVICE.
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| 2829842 | FL | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature...
SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s). An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025503 Same article/event and different patient;
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| 2829843 | FL | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature...
SARS-CoV-2 infection; SARS-CoV-2 infection; This is a literature report for the following literature source(s). An adult patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "solid organ transplant recipients" (unspecified if ongoing), notes: with a functional graft. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "SARS-CoV-2 infection". Additional information: the patient age was over 18 years. SOT recipients with a functional graft, recipients beyond one month of transplant. At least one-month post second dose of BNT162b2 vaccine. The patient received the 3rd dose of BNT162b2 then got SARS-COV-2 infection before 6th month blood draw after dose 3.; Sender's Comments: A lack of efficacy with BNT162B2 cannot be completely excluded. The patient's underlying medical condition being solid organ transplant recipient contribute to suboptimal response after vaccination.,Linked Report(s) : US-PFIZER INC-PV202500025503 Same article/event and different patient;
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| 2829856 | 82 | M | MA | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
24M7E |
Rash, Rash pruritic
Rash, Rash pruritic
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Rash has flared back up on his arms in the last; itchy rash on the top of his left arm/on the top of...
Rash has flared back up on his arms in the last; itchy rash on the top of his left arm/on the top of his right arm from his wrist to elbow; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number 24M7E, expiry date 06-APR-2026) for prophylaxis. The patient's past medical history included cardiac arrest. Concurrent medical conditions included mitral valve incompetence (10 years ago) and heart disorder. Concomitant products included propranolol, losartan, furosemide and warfarin. On 21-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, right arm). In SEP-2024, 2 weeks after receiving Shingrix, the patient experienced itchy rash (Verbatim: itchy rash on the top of his left arm/on the top of his right arm from his wrist to elbow). In FEB-2025, the patient experienced condition aggravated (Verbatim: Rash has flared back up on his arms in the last). The outcome of the itchy rash and condition aggravated were not resolved. It was unknown if the reporter considered the itchy rash and condition aggravated to be related to Shingrix. It was unknown if the company considered the itchy rash and condition aggravated to be related to Shingrix. Additional Information: GSK Receipt Date: 25-FEB-2025 and 03-MAR-2025 The patient self-reported this case. The patient received the first dose of Shingrix for shingles prevention and a couple of weeks after receiving the first dose he had an itchy rash on the top of his right arm from his wrist to his elbow and that around the end of November 2024 to early December 2024 (no specific date provided) he also had this itchy rash on the top of his left arm from his wrist to his elbow and on the top of his chest from below his neck to about the end of of his chest cage. By the top of his arms, the patient meant the top side of his forearms. The patient still had all of these same itchy rash areas today (on the reporting day) The patient reported that the rash seemed to start to dissipate, but had flared back up on his arms in the last week or so (no specific dates provided) and the presentation on his left arm at first was not as bad as the presentation on his right arm at first. The patient had seen 3 healthcare providers about this itchy rash. One provided him a topical (Unknown Product Information) that he used for a month and it helped a little bit. The patient has tried over the counter salves and lotions (Unknown Products Information) and right now was using topical Aloe (Unknown Product Information). The patient reported that he blew his mitral valve 10 years ago and flat lined 24 hours later (Pre Existing Shingrix). The patient did not had any paper work to provide, but said he received the vaccine from his Pharmacist. The patient had been on all of his concurrent medications for 10 years, all pre-existing receiving Shingrix, but took them all the day the vaccine was received.
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| 2829857 | 03/06/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; got Shingles; This serious case was reported by a consumer via intera...
Suspected vaccination failure; got Shingles; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got Shingles). 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. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she took the Shingles shot and got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary 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.
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| 2829858 | 45 | F | LA | 03/06/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
42B22 |
Underdose
Underdose
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Patient given pediatric Hep B vaccine instead of adult Hep B vaccine. Patient monitored post injecti...
Patient given pediatric Hep B vaccine instead of adult Hep B vaccine. Patient monitored post injection, no adverse reactions noted.
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| 2829859 | 10 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered
Expired product administered
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Vaccination given past 10 week refrigerated expiratory date.
Vaccination given past 10 week refrigerated expiratory date.
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| 2829860 | 41 | F | LA | 03/06/2025 |
HEP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
42B22 L5229 |
No adverse event, Underdose; No adverse event, Underdose
No adverse event, Underdose; No adverse event, Underdose
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No adverse events noted, patient was monitored post injection. Patient was given pediatric Hep B vac...
No adverse events noted, patient was monitored post injection. Patient was given pediatric Hep B vaccine instead of adult Hep B vaccine.
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| 2829861 | 10 | F | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered
Expired product administered
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Vaccination given past 10 week refrigerated expiratory date.
Vaccination given past 10 week refrigerated expiratory date.
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| 2829862 | 10 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered
Expired product administered
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Vaccination given past 10 week refrigerated expiratory date.
Vaccination given past 10 week refrigerated expiratory date.
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| 2829863 | 7 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
Expired product administered
Expired product administered
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BioNTech use for COVID-19 under Emergency Use Authorization (EUA): Vaccination given past 10 week re...
BioNTech use for COVID-19 under Emergency Use Authorization (EUA): Vaccination given past 10 week refrigerated expiratory date.
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| 2829865 | 41 | F | OH | 03/06/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Computerised tomogram thorax, Computerised tomogram thorax abnormal, Extra dose ...
Computerised tomogram thorax, Computerised tomogram thorax abnormal, Extra dose administered, Pulmonary embolism; Computerised tomogram thorax, Computerised tomogram thorax abnormal, Extra dose administered, Pulmonary embolism
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Patient admitted to the hospital on 2/14/2025 with pulmonary Embolus. on 12/4/2024 her pharmacy acci...
Patient admitted to the hospital on 2/14/2025 with pulmonary Embolus. on 12/4/2024 her pharmacy accidentally gave her 2 Pfizer Comirnaty immunizations. Other risk factors include OCP, obesity, recent hysterectomy.
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| 2829866 | 68 | F | NY | 03/06/2025 |
FLUX FLUX FLUX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
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Acute kidney injury, Arthralgia, Bladder catheterisation, Bladder scan, Blood te...
Acute kidney injury, Arthralgia, Bladder catheterisation, Bladder scan, Blood test; Constipation, Decreased appetite, Discomfort, Dizziness, Malaise; Oliguria, Pyrexia, Thirst decreased, Ultrasound abdomen, Urinary retention
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I am a 68 year old woman with diabetes mellitus Type 2, high blood pressure and high cholesterol. I ...
I am a 68 year old woman with diabetes mellitus Type 2, high blood pressure and high cholesterol. I take: metformin HCL 1000 mg BID; januvia 100 mg; QD amitriptyline 10 mg; QD fenofibrate 160 mg; QD lisinopril 20 mg, BID; omeprazole 20mg; QD toprol Xl, 25 mg. QD On September 29, 2021, I was prescribed clindamycin 300 mg every 6 hours for an abscessed tooth. On the 30th September we flew to (redacted). During the flight, I began to experience excessive thirst and dry mouth, as well as high blood sugar. Also, I noticed that my vision changed. Where I had needed reading glasses to read a book, I could read without glasses. I later discovered that where my distance vision had been in focus, it was suddenly blurry. That night, I discovered that I had no appetite and no stamina. I was exhausted more than usual. I could not walk very far without having to rest. I also discovered that I had to urinate every 2 hours. The abscessed tooth did not get better. It got worse. My entire right cheek swelled, and there was pain across my cheekbone. The pain got worse daily, as well as the swelling. I was taking Tylenol very four hours for the pain and discomfort. I finished the course of treatment on October 6. The swelling began to go down by the 8th, and the pain began to subside. Also, the thirst began to abate, the dry mouth ended, and I did not have to urinate as frequently. I still had no appetite, and my belly felt full. I was noticing changes in my bowels. I was having smaller, more frequent bowel movements. I was also going to sleep earlier, and taking naps during the day. As we were on vacation, I could not consult my doctor. I monitored my symptoms daily. We arrived home on October 16. I had no more bowel movements. I called my dentist on the 18th and reported my reaction to the clindamycin and requested a different antibiotic. She prescribed Amoxicillin 500 mg every 8 hours. On the 19th I received my annual flu shot, and on the 20th I developed a low grade fever and my joints ached. I was more uncomfortable than I had been. The next day, I stayed in bed most of the day, feeling sick. On the 22nd, I got up at 4 a.m. to urinate, and discovered that I could only pass about a teaspoonful. I was dizzy after being upright for a few minutes. At 8 a.m., I once again tried to urinate, and still only passed a teaspoonful. I was dizzy again. It was decided that I needed to visit the ER. At the ER, the doctor ordered bloodwork and an abdominal ultrasound. I was asked to provide a urine sample, but once again I could produce only a teaspoonful of urine. Once he had the test results, he ordered an IV at a fast drip, with the goal to rehydrate me and see if that would help. I had received nothing to eat or drink for 8 hours, and was neither thirsty or hungry. After a second bag of IV fluids, he decided to admit me so that I could receive more IV fluids. After I was admitted, the doctor ordered a bladder scan. Unfortunately, they could not find the bladder. The doctor next ordered a foley catheter. Once that was inserted, urine filled the bag. I was given magnesium citrate for the constipation. As the symptoms subsided, I began to feel better. I continued to receive IV fluids. I was released from the hospital on October 23 with a diagnosis of Acute Kidney Injury. I was advised to discontinue the metformin and lisinopril, and to not finish the amoxicillin. I was also told to call my Primary Care Provider and report my hospital stay. My doctor may have to find other medications to prescribe. I am assuming that the AKI was caused by clindamycin. I do not understand why it happened, but I am assuming it was either because I am Type 2, or it was an interaction with the metformin. I just wanted to make you aware of this experience. Hopefully you can do further research and discover why I had such a reaction to the medication. If you do wish to research my reaction and need
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| 2829867 | 27 | F | CT | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
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Exposure during pregnancy, Neonatal disorder
Exposure during pregnancy, Neonatal disorder
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I was pregnant while receiving the Covid vaccine. Child was born 9/XX/XX, with a large swollen head ...
I was pregnant while receiving the Covid vaccine. Child was born 9/XX/XX, with a large swollen head and a normal trunk/legs that looked tiny compared to her head. We had concerns about child's growth and development. By 16 months of age, we brought child to the hospital because of polyps and extreme discharge coming out of her ear, which resulted in a CT scan determining large lesions that had been growing for many months. She was diagnosed with a slow growing rare cancer called Langerhans Cell Histiocytosis, which had taken up her whole right mastoid (and coming out of her ear), her left mastoid, her spleen, and liver shadows. This disease was in her body for a long period of time and continued progressing. Now that research is coming out about Covid vaccines and rare complications such as LCH, I am concerned about my child's future because of the 2 vaccines I received while pregnant. The vaccines were pushed on me to be ?safe and effective? yet it was such a new vaccine that more research should have been done to safely say the warnings and concerns. I have been saying since day 1 of her diagnosis that it was the vaccine when I was pregnant (and I am pro-vaccine!).
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| 2829868 | 15 | F | NY | 03/06/2025 |
HPV9 |
MERCK & CO. INC. |
1957404 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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Client was inadvertently given the Gardasil vaccine, dose #3, too soon. It was not due until June. ...
Client was inadvertently given the Gardasil vaccine, dose #3, too soon. It was not due until June. There were no adverse effects. Client was made aware and she is scheduled to come back in June for the 3rd dose.
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| 2829869 | 75 | F | CA | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LN0591 |
Erythema, Pain in extremity, Peripheral swelling
Erythema, Pain in extremity, Peripheral swelling
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redness on right arm, slight swelling, soreness. NO evidence of fever or other systemic related sy...
redness on right arm, slight swelling, soreness. NO evidence of fever or other systemic related symptoms
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| 2829870 | 0.58 | F | IL | 03/06/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7921AA |
Syringe issue
Syringe issue
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RN was administering the vaccine to patient. She injected it into left thigh. As she pushed plunger ...
RN was administering the vaccine to patient. She injected it into left thigh. As she pushed plunger down to administer vaccine, the vaccine sprayed out of the syringe. After looking close after the event, there appeared to be a crack in syringe. Our VFC program advised us to report this to VAERS. Vaccine manufacturer is also aware of this, and the syringe has been sent in to Sanofi.
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| 2829871 | 28 | F | AL | 03/06/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site induration, Injection site swelling, Injection site warmth
Injection site induration, Injection site swelling, Injection site warmth
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Injection site raised, firm, and warm to touch.
Injection site raised, firm, and warm to touch.
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| 2829872 | 16 | F | MD | 03/06/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
A274J |
Injection site erythema, Injection site pain, Shoulder injury related to vaccine...
Injection site erythema, Injection site pain, Shoulder injury related to vaccine administration
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Shoulder Injury Related to Vaccine Administration (SYMPTOMS: inflammation, redness and painful site ...
Shoulder Injury Related to Vaccine Administration (SYMPTOMS: inflammation, redness and painful site of injection)
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| 2829873 | 4 | M | ME | 03/06/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
42Y93 |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Patient was given Kinrix (combo vaccine which includes Dtap and Polio) on 03/05/2025. However when I...
Patient was given Kinrix (combo vaccine which includes Dtap and Polio) on 03/05/2025. However when Immpact was updated after vaccine was given it listed the Kinrix as NOT VALID. I called Immpact on 03/05/2025 but was not able to speak with anyone; I had to leave a voicemail. When I spoke to Immpact on 03/06/2025 I was told that the Kinrix was NOT VALID because it's only licensed to be the 5th Dtap dose and the 4th or 5th Polio dose for a patient. Immpact told me that despite that the doses the patient received yesterday ARE VALID but Immpact cannot change how it's listed in the patient's immunization record in Immpact.
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| 2829874 | 43 | M | IA | 03/06/2025 |
COVID19 COVID19 COVID19 |
MODERNA MODERNA MODERNA |
041LZVA 041LZVA 041LZVA |
Chest pain, Confusional state, Fatigue, Headache, Hip arthroplasty; Impaired wor...
Chest pain, Confusional state, Fatigue, Headache, Hip arthroplasty; Impaired work ability, Laboratory test, Muscle atrophy, Osteonecrosis, Pain; Palpitations, Pyrexia, Rash, Weight decreased
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First 24 hours severe body aches, HA, fever, some of the typical reactions I had heard being a physi...
First 24 hours severe body aches, HA, fever, some of the typical reactions I had heard being a physician myself. Chest pain and palpitations started within 48 hours. Lasted months. Work up normal. Months later began having sores on toes c/w vasculitis. Chronic fatigue that seems to greatly worsen anytime sick. Extreme weight loss and muscle wasting. Confusion to the point I can not work as a physician at times. Tends to correlate with illness and extreme fatigue. Unable to work 12 hours shifts I did prior to vaccine. After 4 years finally have been forced to work a much reduced schedule. All symptoms started prior to actually having covid itself which I have had only once and basically had allergy symptoms for a day. Avascular necrosis found in hip in 2022. Hip replaced that year.
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| 2829875 | 17 | F | MI | 03/06/2025 |
COVID19 FLU3 MENB MNQ |
PFIZER\BIONTECH SANOFI PASTEUR NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
LN0588 U8523BA 95NJ4 LN75D |
Dizziness, Dyspnoea, Headache, Pain; Dizziness, Dyspnoea, Headache, Pain; Dizzin...
Dizziness, Dyspnoea, Headache, Pain; Dizziness, Dyspnoea, Headache, Pain; Dizziness, Dyspnoea, Headache, Pain; Dizziness, Dyspnoea, Headache, Pain
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2230 patient complained to her mom of headache, body aches and shortness of breath. She used her inh...
2230 patient complained to her mom of headache, body aches and shortness of breath. She used her inhaler and took some Tylenol, then while heading back to her room she became lightheaded.
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| 2829876 | 0.67 | F | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Expired 6m-4y covid administered on 1/22/25, it was discovered on 2/11/25. Parent/ patient made awar...
Expired 6m-4y covid administered on 1/22/25, it was discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, but parent stated they would call back to schedule. Per parent, patient did not experience any adverse reactions/ negative symptoms post vaccine.
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| 2829877 | 17 | M | FL | 03/06/2025 |
MENB |
PFIZER\WYETH |
LF5308 |
Fatigue, Headache, Pyrexia, Respiratory viral panel, Vomiting
Fatigue, Headache, Pyrexia, Respiratory viral panel, Vomiting
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Patient began with fever, headache, vomiting & fatigue the next day after vaccine- 3/4/25. He wa...
Patient began with fever, headache, vomiting & fatigue the next day after vaccine- 3/4/25. He was seen in office on 3/5/25. A viral respiratory panel was done to rule out viral illness, this was negative.
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| 2829878 | 3 | F | 03/06/2025 |
COVID19 FLU3 HEPA |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
LN8272 CZ47E Y013274 |
Expired product administered, Malaise, Ocular hyperaemia, Pyrexia; Expired produ...
Expired product administered, Malaise, Ocular hyperaemia, Pyrexia; Expired product administered, Malaise, Ocular hyperaemia, Pyrexia; Expired product administered, Malaise, Ocular hyperaemia, Pyrexia
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Expired 6m-4y covid administered on 1/24/25, it was discovered on 2/11/25. Parent/ patient made awar...
Expired 6m-4y covid administered on 1/24/25, it was discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, but parent stated they would call back to schedule. Per parent, patient was "sick for 3 days" with a fever in the evenings and red eyes.
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| 2829879 | 46 | F | TX | 03/06/2025 |
COVID19 |
MODERNA |
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Limb mass, Rash
Limb mass, Rash
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Covid arm- with rash 11 days later after first vaccine. Then a mass developed and now has moved &quo...
Covid arm- with rash 11 days later after first vaccine. Then a mass developed and now has moved "up" my arm to shoulder blade.
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| 2829880 | 2 | F | 03/06/2025 |
COVID19 FLU3 HEPA |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
CZ47E Y013274 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered
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Expired 6m-4y covid administered 1/24/25. Event discovered on 2/11/25. Attempted to call parent x2 a...
Expired 6m-4y covid administered 1/24/25. Event discovered on 2/11/25. Attempted to call parent x2 and database message sent to have parent call clinic back. No call/ message back. Patient will need to be revaccinated.
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| 2829881 | 0.5 | M | NH | 03/06/2025 |
DTAPHEPBIP FLU3 HIBV PNC20 |
GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH |
D252F UT8468JA UK169AC LC5484 |
Product preparation issue; Product preparation issue; Product preparation issue;...
Product preparation issue; Product preparation issue; Product preparation issue; Product preparation issue
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It was discovered on 2/21/25 that PT only received the sterile solution portion of the Hib vaccine ...
It was discovered on 2/21/25 that PT only received the sterile solution portion of the Hib vaccine on 2/20/25 around 10AM This was verified via immunization sheet as it has only the sterile solution sticker. RN noticed the count was off for the Hib vaccine (dilutent vs powder) and discussed with MA, and she checked the completed immunizations vaccine folder and found this patients immunizations sheet and confirmed with myself, and someone else the following work day. The event was discussed with Quality, the ordering Provider and the manufacturer and it was recommended that patient be vaccinated with a Hiberix properly. The event was discussed with mom, her concern was to make sure that patient was not vaccinated twice. We assured mom that our documented immunization sheets proved that patient did not recieve the activated vaccination, just the sterile solution. Mom made a nurse visit for 2/26/25 and patient recieved the activated immunization.
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| 2829882 | 4 | F | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Expired 6m-4y covid administered on 1/24/25. Event discovered on 2/11/25. Parent/ patient made aware...
Expired 6m-4y covid administered on 1/24/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, patient scheduled for revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
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| 2829883 | 0.17 | M | NE | 03/06/2025 |
DTAPIPVHIB DTAPIPVHIB HEP HEP PNC13 PNC13 RV5 RV5 |
SANOFI PASTEUR SANOFI PASTEUR GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS PFIZER\WYETH PFIZER\WYETH MERCK & CO. INC. MERCK & CO. INC. |
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Apnoea, Blood test, Hypopnoea, Hypotonia, Hypotonic-hyporesponsive episode; Imag...
Apnoea, Blood test, Hypopnoea, Hypotonia, Hypotonic-hyporesponsive episode; Imaging procedure, Pallor, Pyrexia, Unresponsive to stimuli; Apnoea, Blood test, Hypopnoea, Hypotonia, Hypotonic-hyporesponsive episode; Imaging procedure, Pallor, Pyrexia, Unresponsive to stimuli; Apnoea, Blood test, Hypopnoea, Hypotonia, Hypotonic-hyporesponsive episode; Imaging procedure, Pallor, Pyrexia, Unresponsive to stimuli; Apnoea, Blood test, Hypopnoea, Hypotonia, Hypotonic-hyporesponsive episode; Imaging procedure, Pallor, Pyrexia, Unresponsive to stimuli
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11/07/2022 - Patient had a fever after getting his immunizations. We gave him 1 dose of infant'...
11/07/2022 - Patient had a fever after getting his immunizations. We gave him 1 dose of infant's tylenol before bed. 11/08/2022 - Hypotonic-Hyporesonsive Syndrome... (decreased muscle tone / extreme limpness, unresponsive to stimuli, [pallor] change in skin tone ). In addition, several moments (30-60 seconds) of not breathing, followed by about 5 minutes of very shallow breathing. Patient was rushed to the EMERGENCY ROOM via ambulance. Many tests were done at the hospital (blood work, imaging, etc.), but no diagnoses were made and, as a result, no treatments were given to patient. We were sent home with nothing, but a HUGE bill from the hospital...
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| 2829884 | 1 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Expired 6m-4y covid administered on 1/27/25. Event discovered on 2/11/25. Parent/ patient made aware...
Expired 6m-4y covid administered on 1/27/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, but parent would like to speak with PCP at next visit before revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
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| 2829885 | 3 | M | 03/06/2025 |
COVID19 FLU3 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS |
LN8272 774N2 |
Expired product administered, No adverse event; Expired product administered, No...
Expired product administered, No adverse event; Expired product administered, No adverse event
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Expired 6m-4y covid administered on 1/28/25. Event discovered on 2/11/25. Parent/ patient made aware...
Expired 6m-4y covid administered on 1/28/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, patient scheduled for revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
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| 2829886 | 3 | M | 03/06/2025 |
COVID19 |
PFIZER\BIONTECH |
LN8272 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Expired 6m-4y covid administered on 1/29/25. Event discovered on 2/11/25. Parent/ patient made aware...
Expired 6m-4y covid administered on 1/29/25. Event discovered on 2/11/25. Parent/ patient made aware, and revaccination recommended. Appointments offered, patient scheduled for revaccination. Per parent, no adverse reactions/ negative symptoms post vaccination.
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| 2829889 | 71 | F | MN | 03/06/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Headache, Musculoskeletal stiffness, Pain
Headache, Musculoskeletal stiffness, Pain
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Headache, body pain, stiffness, body aches
Headache, body pain, stiffness, body aches
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