| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2855241 | 10 | F | MO | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was...
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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| 2855242 | 11 | M | TX | 08/22/2025 |
MNQ TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8573AA H4279 |
Erythema, Swelling, Tenderness; Erythema, Swelling, Tenderness
Erythema, Swelling, Tenderness; Erythema, Swelling, Tenderness
|
Right arm REDNESS, SWELLING, Tenderness. Resolving on its own. Ibuprofen prescribed.
Right arm REDNESS, SWELLING, Tenderness. Resolving on its own. Ibuprofen prescribed.
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| 2855243 | 11 | F | MO | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was...
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
More
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| 2855244 | 5 | M | MO | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was...
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
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| 2855245 | 58 | M | IA | 08/22/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300216A |
Night sweats, Pruritus, Pyrexia, Swelling
Night sweats, Pruritus, Pyrexia, Swelling
|
Patient reports he started having symptoms of a mild fever, localized swelling and localized "i...
Patient reports he started having symptoms of a mild fever, localized swelling and localized "itchiness" 24 hours after receiving anthrax dose. Patient stated that the swelling and itching subsided 10 days after the injection but is still experiencing a low grade fever and "night sweats". The fever started 12 to 24 hrs following the shot and continued until current (14 days). Patient additionally reports that they have previously dealt with neuropathy of lower extremities and after receiving the anthrax shot that the neuropathy becomes worse. Patient was instructed to report to their provider is symptoms worsen or respiratory issues/allergic reaction occurs.
More
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| 2855246 | 11 | M | IL | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2045 |
No adverse event, Product storage error
No adverse event, Product storage error
|
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was...
Vaccine given more than 10 weeks after it thawed from frozen and stored in refrigerator. Vaccine was not past the expiration date shown on box. There was NO adverse reaction or illness that took place.
More
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| 2855247 | 28 | F | KY | 08/22/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8352AA U8352AA |
Aphasia, Cold sweat, Eye movement disorder, Hyperhidrosis, Pallor; Posture abnor...
Aphasia, Cold sweat, Eye movement disorder, Hyperhidrosis, Pallor; Posture abnormal, Tremor, Unresponsive to stimuli
More
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PATIENT BECAME NON VERBAL, UNABLE TO FOLLOW VERBAL COMMANDS. PALE, SWEATY AND CLAMMY, EYE ROLLING, A...
PATIENT BECAME NON VERBAL, UNABLE TO FOLLOW VERBAL COMMANDS. PALE, SWEATY AND CLAMMY, EYE ROLLING, ARMS DRAWN UP TO CHEST AND SHAKING.
More
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| 2855248 | 38 | F | IA | 08/22/2025 |
ANTH ANTH |
EMERGENT BIOSOLUTIONS EMERGENT BIOSOLUTIONS |
300216A 300216A |
Arthralgia, Chest pain, Injection site pain, Night sweats, Pain; Pruritus, Pyrex...
Arthralgia, Chest pain, Injection site pain, Night sweats, Pain; Pruritus, Pyrexia, Swelling
More
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Pt reports she started having symptoms of a mild fever, localized swelling and localized "itchi...
Pt reports she started having symptoms of a mild fever, localized swelling and localized "itchiness" 24 hours after receiving anthrax dose. Pt stated that the swelling and itching subsided 7 days after the injection but is still experiencing a low grade fever and "night sweats". Pt also reported some pain that radiated from the localized injection site to upper shoulder and chest area. This started on the 9th of August and lasted until the 13th of August. The fever started 12 to 24 hrs following the shot and continued until current (14 days). Pt was instructed to report to their provider if symptoms worsen or respiratory issues/allergic reaction occurs.
More
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| 2855249 | 40 | M | IA | 08/22/2025 |
ANTH |
EMERGENT BIOSOLUTIONS |
300126A |
Pruritus, Pyrexia, Swelling
Pruritus, Pyrexia, Swelling
|
Patient reports he started having symptoms of a mild fever, localized swelling and localized "i...
Patient reports he started having symptoms of a mild fever, localized swelling and localized "itchiness" 24 hours after receiving anthrax dose. Patient reported to urgent care for symptoms, here he was given oral Benadryl to help with the swelling. Patient stated that the swelling and itching subsided the day after taking the over the counter medication. Patient states they are no longer experiencing symptoms. Patient was instructed to report to their provider is symptoms worsen or respiratory issues/allergic reaction occurs.
More
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| 2855250 | 63 | F | MD | 08/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
e754f |
Pruritus
Pruritus
|
Per patient, 2 days after receiving the vaccine, she experienced uncontrollable itchiness on both of...
Per patient, 2 days after receiving the vaccine, she experienced uncontrollable itchiness on both of her forearms (more on the left arm than right). This itchiness persisted for 6 weeks. she used some OTC hydrocortisone 1% cream for relief. she didn't inform her provider until about 1 week ago. her provider motivated her to get the 2nd shot to complete the series.
More
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| 2855251 | 18 | F | LA | 08/22/2025 |
MENB MENB |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
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Blood test normal, Burning sensation, Muscle atrophy, Muscle fatigue, Rash eryth...
Blood test normal, Burning sensation, Muscle atrophy, Muscle fatigue, Rash erythematous; Rash papular, Rash pruritic, Tremor, Vomiting
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Full body raised rash bright red, started on face, spread to eyes, over scalp, down neck, chest, arm...
Full body raised rash bright red, started on face, spread to eyes, over scalp, down neck, chest, arms and torso. Small red dots appeared on legs and thighs. Extremely itchy and burning sensation on rash cites. Went to ER twice and was turned away and refused treatment by being told it ?was an allergic reaction to my shampoo?. Rash lasted over two months with extreme muscle fatigue and deterioration. I couldn?t even pick up a glass of water for over a year without shaking and threw up if I tried to workout or do any physical exercise. The Dr I saw was not my PCP and said it was all in my head and I was making myself sick. I made her do blood work, tests came back clear. Was referred to a Dermatologist and had to wait over a month for my appointment. By the time I saw the dermatologist, the rash had cleared up and they said it was not HIV or an allergic reaction but to come back straight away if it reappeared. The next three years the rash would come back with any little sign of stress, I found that taking sulfur tablets helped relieve symptoms and the burning sensation. Used Gold?s bond lotion on the rash, it cooled the pain and kept the rash from getting raised. Symptoms began to fade over the next 5 years and I stopped taking sulfur tablets in 2022.
More
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| 2855252 | 1 | M | TX | 08/22/2025 |
MMRV |
MERCK & CO. INC. |
Y010050 |
Developmental regression, Language disorder, Motor dysfunction, Staring
Developmental regression, Language disorder, Motor dysfunction, Staring
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Within 2 days of the vaccination, mother reports that child started having staring spells, developme...
Within 2 days of the vaccination, mother reports that child started having staring spells, developmental regression with loss of motor and language skills. The motor skills have since returned, but the language skills have not.
More
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| 2855253 | 78 | F | NJ | 08/22/2025 |
PNC21 |
MERCK & CO. INC. |
Y011819 |
Injection site inflammation, Injection site pruritus
Injection site inflammation, Injection site pruritus
|
Patient had injection site reaction. Injection site was inflamed and itchy - about 2 inches x 4 inch...
Patient had injection site reaction. Injection site was inflamed and itchy - about 2 inches x 4 inches patch on 8/22/25. Started roughly 5 days after vaccine administration (on 8/21/25).
More
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| 2855254 | 54 | F | WI | 08/22/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
332L4 332L4 |
Injection site erythema, Injection site pain, Injection site swelling, Injection...
Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain; Sleep disorder
More
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Area around injection site was warm, swollen, and reddened. Pt said it was painful to reach with the...
Area around injection site was warm, swollen, and reddened. Pt said it was painful to reach with the arm and felt like she had gotten punched in it. Said it was too painful to sleep on her left side the night after the injection. Pt felt vaccine during injection saying it burned and hurt. Pt treated with Tylenol, ibuprofen, and cold packs. As of this time the site is still warm, red, and some pain. She is able to sleep on it now.
More
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| 2855255 | 7 | M | WA | 08/22/2025 |
DTAP |
SANOFI PASTEUR |
3ca55c1 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
no symptoms
no symptoms
|
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| 2855256 | 62 | M | MI | 08/22/2025 |
PNC20 TDAP |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LN4928 37R35 |
No adverse event, Wrong product administered; No adverse event, Wrong product ad...
No adverse event, Wrong product administered; No adverse event, Wrong product administered
More
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Provider ordered Prevnar-20 vaccine, mistakenly pulled Tdap and was administered to patient. Provide...
Provider ordered Prevnar-20 vaccine, mistakenly pulled Tdap and was administered to patient. Provider was aware and patient and provider agreed to administer Prevnar-20 at visit. Previous Tdap was on 08/17/23. No adverse reaction noted at time of visit, Manufacturer was contacted and they stated risk of a local reaction, patient was also aware of this information.
More
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| 2855257 | 11 | M | MT | 08/22/2025 |
HPV9 MENB TDAP |
MERCK & CO. INC. PFIZER\WYETH SANOFI PASTEUR |
y007197 gx1463 u8564aa |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
More
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I gave an 11 year old boy a Men B vaccine instead of a Men Quadfi
I gave an 11 year old boy a Men B vaccine instead of a Men Quadfi
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| 2855258 | 12 | F | AK | 08/22/2025 |
DTPPVHBHPB HPV9 MNQ |
MSP VACCINE COMPANY MERCK & CO. INC. SANOFI PASTEUR |
U7899AA y013565 u8375AA |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
More
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Vaxelis should have been Boostrix, will require additional vaccine
Vaxelis should have been Boostrix, will require additional vaccine
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| 2855259 | 75 | F | OH | 08/22/2025 |
PNC20 |
PFIZER\WYETH |
LJ5283 |
Injection site pruritus, Injection site rash, Injection site swelling
Injection site pruritus, Injection site rash, Injection site swelling
|
Pt stopped into pharmacy on Wed 8/20/25, saying she started to experience a small rash and itching l...
Pt stopped into pharmacy on Wed 8/20/25, saying she started to experience a small rash and itching last Fri/Sat 8/15-8/16/25, on her left upper arm where she received her pneumonia vaccine on Mon 8/11/2025. Pt says she's only tried putting Vaseline on the area after showering since the rash started, and she says she hasn't had any changes in soaps/lotions/laundry detergent in the last couple weeks either. Advised pt to take Benadryl and use topical Hydrocortisone cream to resolve rash/itching and if not better in 24-48 hours or gets worse to contact primary MD for evaluation. Followed up with pt on Fri 8/22/25- she said after a 24-36 hours of trying Benadryl and Hydrocortisone the rash didn't seem to be getting better and seemed to be swelling more so she went to urgent care and was prescribed a Medrol dose pak for 6 days and Atarax tabs for itching.
More
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| 2855260 | 18 | F | CA | 08/22/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
5XA2J |
Hyperhidrosis, Hypotension, Unresponsive to stimuli
Hyperhidrosis, Hypotension, Unresponsive to stimuli
|
Approximately 15 minutes after dose pt was diaphoretic and unresponsive to verbal stimuli. Patient a...
Approximately 15 minutes after dose pt was diaphoretic and unresponsive to verbal stimuli. Patient assessed by MD, found to be hyptotensive for 20 min. Ambulance called to transport to ED. Patient refused and remained in the clinic under observation. Pt left clinic for home with parent.
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| 2855261 | 20 | F | ME | 08/22/2025 |
PNC21 |
MERCK & CO. INC. |
y011819 |
Loss of consciousness, Respiratory rate increased, Vomiting
Loss of consciousness, Respiratory rate increased, Vomiting
|
Within a minute of vaccination, the patient passed out. The patient was passed out for about 1 minut...
Within a minute of vaccination, the patient passed out. The patient was passed out for about 1 minute and I was able to have them come to. Patient was breathing fast but we practiced normal breathing and she calmed down. then she told me she was going to be sick and did vomit mostly clear fluids. I called her Mother into the room. she began to feel better over them next 5 minutes and by 15 minutes I felt she could leave the Pharmacy in the care of her Mother.
More
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| 2855262 | 1 | M | 08/22/2025 |
HEPA MMR UNK VARCEL |
UNKNOWN MANUFACTURER MERCK & CO. INC. UNKNOWN MANUFACTURER MERCK & CO. INC. |
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Altered state of consciousness, Diarrhoea, Irritability, Pyrexia; Altered state ...
Altered state of consciousness, Diarrhoea, Irritability, Pyrexia; Altered state of consciousness, Diarrhoea, Irritability, Pyrexia; Altered state of consciousness, Diarrhoea, Irritability, Pyrexia; Altered state of consciousness, Diarrhoea, Irritability, Pyrexia
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getting his vaccines along with dupixent; fever and diarrhea after getting his vaccines; fever ans d...
getting his vaccines along with dupixent; fever and diarrhea after getting his vaccines; fever ans diarrhea after getting his vaccines; more fussy and "not like self after getting the vaccine"; more fussy and "not like self after getting the vaccine"/ cranky; fussiness and crankiness to patient teething; This spontaneous report was received from a consumer via other company and refers to a 1-year-old male patient. His medical history was not reported. The patient's concurrent conditions included ongoing multiple food allergies. Concomitant therapies were not reported. On 31-Dec-2024, the patient started therapy with Dupixent (Dupilumab) solution for injection 200 mg (strength 200mg), administered by subcutaneous route for the treatment of eczema (lot # and expiration date were not reported). On 08-Jun-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); Hepatitis A Vaccine, Inactivated (manufacturer unknown), administered by unknown route as prophylaxis (lot # and expiration date were not reported); and with Typhoid Conjugate Vaccine (reported as TCV vaccine) administered by unknown route (lot # and expiration date were not reported). Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) and Varicella Virus Vaccine Live (Oka-Merck) (manufacturer unknown) were reconstituted with sterile diluent (no details provided). On 08 -JUN-2025, per mom, the patient had a fever and diarrhea after getting his vaccines. They did not know about avoiding live vaccines regarding Dupixent injection (contraindicated product administered). She stated patient did seem more fussy and "not like self" after getting the vaccines (altered state of consciousness) (onset: 2025), fever and diarrhea had resolved the next day, on 09-JUN-2025 (reported also as 7/9/2025, discrepancy). The patient was administered Tylenol (date unknown). He was still a little fussy and cranky (irritability) (onset: 2025) but better, the fussiness and crankiness were attributed to the patient's teething (irritability) (onset: 2025). The action taken was not applicable for all of the vaccines. Dupilumab was continued for all events. The patient recovered from the event of fever and diarrhea after getting his vaccines on 09-Jun-2025. At the reporting time, the patient was recovering from irritability. The outcome of the patient's teething and altered state of consciousness was unknown. The causal relationship between the events and the suspect vaccines was not provided. Upon internal review, all of the events were determined to be medically significant.
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| 2855265 | M | SC | 08/22/2025 |
HPV9 HPV9 |
MERCK & CO. INC. MERCK & CO. INC. |
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Incomplete course of vaccination; Incomplete course of vaccination
Incomplete course of vaccination; Incomplete course of vaccination
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HCP confirmed he was not aware of any symptomatic side effects from the first two doses of GARDASIL-...
HCP confirmed he was not aware of any symptomatic side effects from the first two doses of GARDASIL-9.; Inbound call from pharmacist calling to inquire if a patient can still receive a 3rd dose of GARDASIL-9 after having his series interrupted. Caller states that patient received his first dose on 10-JUN-2024 and his 2nd dose on 9-SEP-2024. HCP did n; This spontaneous report was received from pharmacist and refers to a male patient of unknown age. The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 10-Jun-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), suspension for injection, 1 dosage form (anatomical location, route of administration, lot # and expiration date were not reported), as prophylaxis. On 09-Sep-2024, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), suspension for injection, 1 dosage form (anatomical location, route of administration, lot # and expiration date were not reported), as prophylaxis. Then on 20-AUG-2025, the pharmacist inquired if the patient could still receive the third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) after having his series interrupted. The pharmacist did not know why the patient had delayed his 3rd dose and he was not aware of any symptomatic side effects from the first two doses of the vaccine. Lot # is being requested and will be submitted if received.
More
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| 2855266 | F | WI | 08/22/2025 |
HEP HEPAB HEPAB HEPAB |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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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; Extra dose administered, No adverse event
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No additional AE; HCP states patient received 3 dose of TWINRIX "(1st dose on 11/2024, 2nd on 1...
No additional AE; HCP states patient received 3 dose of TWINRIX "(1st dose on 11/2024, 2nd on 1/6/2025 and 3rd on 2/6/2025") as well as a dose of RECOMBIVAX on 7/3/2025.; This spontaneous report was received from a pharmacist regarding a 58-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date in November 2024, the patient was vaccinated with the first dose of Hepatitis a vaccine inact (+) Hepatitis b vaccine rHBsAg (yeast) (TWINRIX) 1 dosage form, administered as vaccination (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On 06-JAN-2025, the patient was vaccinated with the second dose of Hepatitis a vaccine inact (+) Hepatitis b vaccine rHBsAg (yeast) (TWINRIX) 1 dosage form, administered as vaccination (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On 06-FEB-2025, the patient was vaccinated with the third dose of Hepatitis a vaccine inact (+) Hepatitis b vaccine rHBsAg (yeast) (TWINRIX) 1 dosage form, administered as vaccination (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported). On 03-JUL-2025, the patient was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), 1 dosage form, administered as vaccination (strength, dose, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (Extra dose administered). The reporter is planning to administer dose of Hepatitis A Vaccine, Inactivated (VAQTA) due to variation from approved Hepatitis a vaccine inact (+) Hepatitis b vaccine rHBsAg (yeast) (TWINRIX) vaccination schedule. No additional adverse events were reported.
More
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| 2855268 | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Bell's palsy
Bell's palsy
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Bells palsy; This serious case was reported by a consumer via interactive digital media and describ...
Bells palsy; This serious case was reported by a consumer via interactive digital media and described the occurrence of bell's palsy 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 bell's palsy (Verbatim: Bells palsy) (serious criteria GSK medically significant). The outcome of the bell's palsy was not reported. It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine. The company considered the bell's palsy to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 09-AUG-2025 This case was reported by a patient via interactive digital media. Bell's palsy had been his/her reward for getting the shingles vaccine.; Sender's Comments: A case of Bell's palsy, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
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| 2855269 | M | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Death, Herpes zoster, Vaccination failure
Death, Herpes zoster, Vaccination failure
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passed away 2 years ago; Suspected vaccination failure; worst case of shingles; This serious case wa...
passed away 2 years ago; Suspected vaccination failure; worst case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a male 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 unknown cause of death (Verbatim: passed away 2 years ago) (serious criteria death and GSK medically significant), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: worst case of shingles). The outcome of the vaccination failure and shingles were not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine. The company considered the unknown cause of death and vaccination failure to be unrelated to Shingles vaccine. The company considered the shingles to be possibly related to Shingles vaccine. Additional Information: GSK Receipt Date: 12-AUG-2025 This case was reported by son-in-law or daughter-in-law of the patient via interactive digital media. The reporter reported his/her father-in-law (patient) got the jab and came down with the worst case of shingles he/she had ever seen. In reporter's opinion the jab caused. Further reporter said, sadly the patient passed away 2 years ago (from the date of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Death, unknown time after receiving Shingles vaccine in a male patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. 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.; Reported Cause(s) of Death: Unknown cause of death
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| 2855270 | F | PA | 08/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Shingles; This serious case was reported by a consumer via sales rep...
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included cholesterol. Concomitant products included simvastatin (Statin). On an unknown date, the patient received Shingrix. On 10-AUG-2025, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 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 Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 10-AUG-2025 The reporter wanted to know why the device/medicine was defective. The patient diagnosed with shingles after having taken the shingrix vaccine a few years back. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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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| 2855271 | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Arthralgia
Arthralgia
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My shoulder is a little sore; This non-serious case was reported by a consumer via interactive digit...
My shoulder is a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 23-JUL-2025, the patient received Shingles vaccine. In JUL-2025, an unknown time after receiving Shingles vaccine, the patient experienced shoulder soreness (Verbatim: My shoulder is a little sore). The outcome of the shoulder soreness was not reported. It was unknown if the reporter considered the shoulder soreness to be related to Shingles vaccine. It was unknown if the company considered the shoulder soreness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-JUL-2025 This case was reported by a patient via interactive digital media. The patient had booster the day before reporting and shoulder was a little sore, but it was a whole lot better than shingles nerve pain.
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| 2855272 | FL | 08/22/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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received only the diluent portion of the vaccine; received only the diluent portion of the vaccine; ...
received only the diluent portion of the vaccine; received only the diluent portion of the vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 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: received only the diluent portion of the vaccine) and inappropriate dose of vaccine administered (Verbatim: received only the diluent portion of the vaccine). 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: 24-JUL-2025 The pharmacist called in to request data about the possible administration of Priorix after a patient received only the diluent portion of the vaccine. The patient received only diluent of Priorix , which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with case US2025095529, reported by the same reporter.; Sender's Comments: US-GSK-US2025095529:Separate case is created for unknown patient
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| 2855273 | 08/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache, Hypoaesthesia
Headache, Hypoaesthesia
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frozen arm travelled up to neck and head; Headache; This non-serious case was reported by a consumer...
frozen arm travelled up to neck and head; Headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of numbness of upper extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingles vaccine (patient had shingles vaccine 10 years ago). On an unknown date, the patient received Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced numbness of upper extremities (Verbatim: frozen arm travelled up to neck and head) and headache (Verbatim: Headache). The outcome of the numbness of upper extremities was not reported and the outcome of the headache was resolved (duration 3 months). It was unknown if the reporter considered the numbness of upper extremities and headache to be related to Shingrix. It was unknown if the company considered the numbness of upper extremities and headache to be related to Shingrix. Additional Information: GSK receipt date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The hospital gave patient live shingles vaccine, no side effects were reported. And 10 years later the same va- said that patient needed the new dna or mrna , covid, Shingrix shot , even though patient was fully protected by the original, live vaccine. The right arm shot of Shingrix froze my entire right arm traveled up my neck to the back of my head and gave me a head ache that lasted 3 months. The Shingrix shot was a death shot.
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| 2855274 | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
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did have some pain; This non-serious case was reported by a consumer via interactive digital media a...
did have some pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a elderly 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 pain (Verbatim: did have some pain). The outcome of the pain was not reported. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 06-AUG-2025 This case was reported by a patient via interactive digital media. Patient had shots and never broke out but did have some pain.
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| 2855275 | F | TX | 08/22/2025 |
VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
UNK UNK UNK |
Herpes zoster, Skin swelling, Vaccination failure; Herpes zoster, Skin swelling,...
Herpes zoster, Skin swelling, Vaccination failure; Herpes zoster, Skin swelling, Vaccination failure; Herpes zoster, Skin swelling, Vaccination failure
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Suspected vaccination failure; had 3 additional episodes of shingles; This serious case was reported...
Suspected vaccination failure; had 3 additional episodes of shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis. The patient's past medical history included facial herpes zoster (outbreak of shingles (on my face which is quite dangerous for my right eye) in 2008). On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Zostavax. On an unknown date, more than 2 years after receiving Shingrix and Shingrix and an unknown time after receiving Zostavax, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 3 additional episodes of 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 Shingrix, Shingrix and Zostavax. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Zostavax. It was unknown if the company considered the vaccination failure to be related to Zostavax. Additional Information: GSK Receipt Date: 09-AUG-2025 The case was self-reported by patient. The patient had received the full series of Shingrix (2 doses) and before that received Zostavax. The patient had an outbreak of shingles (on the face, which was quite dangerous for the right eye) in 2008, and after recovering received Zostavax. The patient completed the Shingrix series of two doses in 2019 and interested in a third dose, as have had three additional episodes of shingles this year (the area gets puffy, but did not blister. The reporter wanted to know did they had any research on the third dose of Zostavax. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingrix vaccine (Dose 1 & 2) and Zostavax.
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| 2855276 | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain
Pain
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Severe pain; This non-serious case was reported by a consumer via interactive digital media and desc...
Severe pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (Patient had shingles 9 years ago). On an unknown date, the patient received Shingles vaccine. In AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Severe pain). The outcome of the pain was not resolved. It was unknown if the reporter considered the pain to be related to Shingles vaccine. It was unknown if the company considered the pain to be related to Shingles vaccine. Additional Information: GSK receipt date: 12-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles about 9 years ago and got vaccine. The patient asked was it possible to have the pain only? The patient have had severe pain for 11 days now with no outbreak. The patient had been on muscle relaxers.
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| 2855277 | F | TN | 08/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Malaise
Malaise
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not feeling well for about 12 hours after each dose; This non-serious case was reported by a consume...
not feeling well for about 12 hours after each dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling unwell in a 55-year-old female 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 feeling unwell (Verbatim: not feeling well for about 12 hours after each dose). The outcome of the feeling unwell was resolved (duration 12 hrs). It was unknown if the reporter considered the feeling unwell to be related to Shingrix. It was unknown if the company considered the feeling unwell to be related to Shingrix. Additional Information: GSK receipt date: 12-AUG-2025 The patient got the 1st dose of Shingrix and was not feeling well for about 12 hours after the dose but recovering the next day.
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| 2855278 | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I had the shot and less than a year later i had shingles; This seriou...
Suspected vaccination failure; I had the shot and less than a year later i had 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, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the shot and less than a year later i had 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: 14-AUG-2025 This case was reported by a patient via interactive digital media. Consumer reported that had the shot and less than a year later had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; 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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| 2855279 | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Discomfort, Herpes zoster, Vaccination failure
Discomfort, Herpes zoster, Vaccination failure
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Suspected Vaccination failure; still got shingles twice; but still uncomfortable; This serious case...
Suspected Vaccination failure; still got shingles twice; but still uncomfortable; 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), shingles (Verbatim: still got shingles twice) and discomfort (Verbatim: but still uncomfortable). The outcome of the vaccination failure and shingles were not reported and the outcome of the discomfort was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and discomfort 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 and discomfort to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-AUG-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine and still got shingles twice. The patient had mild cases, but still uncomfortable. The patient don't ever remember having chicken pox as a child and mom said he/she never did. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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 vaccine Shingles vaccine.
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| 2855280 | 08/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; I had shingles this summer; This serious case was reported by a cons...
Suspected vaccination failure; I had shingles this summer; 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: I had shingles this summer). 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: 15-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated h/she had shingles this summer and have had the shingle shots. 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, regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2855281 | F | WA | 08/22/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Wrong product administered
Wrong product administered
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the patient was supposed to get meningococcal group A but instead got meningococcal group B (Bexsero...
the patient was supposed to get meningococcal group A but instead got meningococcal group B (Bexsero); This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A for prophylaxis. On an unknown date, the patient received Bexsero and did not receive Meningococcal vaccine A. On an unknown date, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: the patient was supposed to get meningococcal group A but instead got meningococcal group B (Bexsero)). The outcome of the wrong vaccine administered 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: 23-JUL-2025 The reporter reported that the patient received Bexsero vaccine for meningococcal, the patient was supposed to get meningococcal group A but instead got meningococcal group B, which led to wrong vaccine administered.
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| 2855282 | F | PA | 08/22/2025 |
DTAPHEPBIP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
9k745 |
Inappropriate schedule of product administration, Incorrect dose administered; I...
Inappropriate schedule of product administration, Incorrect dose administered; Inappropriate schedule of product administration, Incorrect dose administered
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Pediarix and Engerix-B on the same clinic day; drug dose interval too long; This non-serious case wa...
Pediarix and Engerix-B on the same clinic day; drug dose interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 2-month-old female patient who received HBV (Engerix B) (batch number 9k745, expiry date 27-OCT-2025) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 24-JUL-2025, the patient received the 2nd dose of Engerix B and the 1st dose of Pediarix. On 24-JUL-2025, an unknown time after receiving Engerix B and Pediarix, the patient experienced overdose (Verbatim: Pediarix and Engerix-B on the same clinic day) and drug dose administration interval too long (Verbatim: drug dose interval too long). The outcome of the overdose and drug dose administration interval too long 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: 24-JUL-2025 Reporter stated that on a 2 months old baby received Pediarix and Engerix-B on the same clinic day, which led to overdose. Also stated that baby already had Hep B birth dose on 20-MAY-2025. The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccinations schedule.
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| 2855283 | CA | 08/22/2025 |
RV1 |
GLAXOSMITHKLINE BIOLOGICALS |
3C34X |
Vomiting
Vomiting
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a patient received a dose of rotarix and vomited after that; This non-serious case was reported by a...
a patient received a dose of rotarix and vomited after that; This non-serious case was reported by a other health professional via call center representative and described the occurrence of vomiting in a patient who received Rota (Rotarix liquid formulation) (batch number 3C34X, expiry date 09-NOV-2026) for prophylaxis. On an unknown date, the patient received Rotarix liquid formulation. On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced vomiting (Verbatim: a patient received a dose of rotarix and vomited after that). The outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device. It was unknown if the company considered the vomiting to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator 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: 12-AUG-2025 A vaccine coordinator called to know how to proceed after a patient received a dose of Rotarix and vomited after that. She wanted to know if the dose should be repeated. No demographics (age, gender, date of birth) or date of administration were provided because she refused to share the information.
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| 2855284 | M | CA | 08/22/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
|
Incorrect dose administered
Incorrect dose administered
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Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of ...
Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of adult dose to a pediatric patient (potential First Dose); This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix adult) for prophylaxis. On 22-JUL-2025, the patient received the 1st dose of Havrix adult. On 22-JUL-2025, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)) and adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)). The outcome of the overdose and adult product administered to child 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: 13-AUG-2025 The registered nurse reported that the patients vaccination schedule (potential first dose) with the maladministration of an adult dose of Havrix vaccine to the pediatric patient, which led to adult product administered to child and overdose. They just noticed due to a billing review registered nurse calls in behalf of another site where the incident happened. Vaccination dates and partial patient demographics (only gender and age) were obtained in this call. No vaccine detail was obtained in this call. No further information was obtained in this call. No further information was obtained in this call.
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| 2855285 | M | GA | 08/22/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, SARS-CoV-2 test; Body height, Drug ineffective, Susp...
COVID-19, Drug ineffective, SARS-CoV-2 test; Body height, Drug ineffective, Suspected COVID-19, Vertigo, Vomiting; COVID-19, Drug ineffective, SARS-CoV-2 test; Body height, Drug ineffective, Suspected COVID-19, Vertigo, Vomiting; COVID-19, Drug ineffective, SARS-CoV-2 test; Body height, Drug ineffective, Suspected COVID-19, Vertigo, Vomiting
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contracted COVID twice after vaccination and boosters; contracted COVID twice after vaccination and ...
contracted COVID twice after vaccination and boosters; contracted COVID twice after vaccination and boosters; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu vaccine (got a shot in the arm), administration date: 2000, when the patient was 49 years old, for Immunization, reaction(s): "lost central vision", "AMPPE", a decade ago he got a flu vaccine, the flu vaccine threw his immune system into overdrive, 3 months later he developed AMPPE (Acute Multifocal Placoid Pigment Epitheliopathy) where he lost his central vision. It was gradual, plague builds up in layers of retina and gradually expands. Where central vision was focused goes into shadow, if you move vision to left side and couldn't see the left side. Move to right side and could't see right side. His was more prominent in central vision. As a result of that, he was on massive doses of steroids for probably 6-7 months. As a result of the AMPPE he now has adorated macular degeneration which he gets injections into his eyes every 12 weeks. When he was first in the hospital his dose was 100mg a day and he was in hospital for about 3-4 days. When released from hospital was on 80mg a day. That lasted at least 6 months. It took another month to lower the dosage of steroids it was either 10 or 20mg decrease per week so another month to wean off the steroids. After treatment with high dose steroids, he was able to regain his vision, although his stomach still reels from side effects. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "contracted COVID twice after vaccination and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Clinical course: Patient received total 2 original doses of Pfizer Covid vaccines and 3 boosters, he got Covid after the 1st booster. Therapeutic measures included paxlovid were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166730 same patient, different dose/event;US-PFIZER INC-202500166729 same patient/event, different dose;
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| 2855286 | 59 | F | NY | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8733 |
Palpitations
Palpitations
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heart palpitations; This is a spontaneous report received from a Consumer or other non HCP. A 59-ye...
heart palpitations; This is a spontaneous report received from a Consumer or other non HCP. A 59-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset Mar2021, outcome "unknown", described as "heart palpitations". Additional information: first couple of shots caller was sick the next day with heart palpitations.
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| 2855289 | F | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Vaccination failure
COVID-19, Vaccination failure
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took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed...
took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid; took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Sep2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Symbicort. The patient's concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), for Covid-19 Immunization; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2025, outcome "unknown" and all described as "took her last injection of the Pfizer Covid 19 vaccine on Sep2024/was recently, last week, diagnosed with covid". The clinical course was reported as follows: The patient had not received any recent immunizations since last year (2024). The patient took her last injection of the Pfizer Covid 19 vaccine on Sep2024 and wanted to know if there was a new immunization available, with a different variant. Most of her injections were Pfizer, except for the first one that was Moderna. The patient was recently, last week, diagnosed with covid and, where she got her medication, they told her they run out of medication because it seemed everybody was getting covid. The patient never had covid since 2020 until last week. She didn't have it before, and she was not exposed to it. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2855290 | M | VA | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Anosmia
Anosmia
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has no sense of smell post Covid vaccine in 2021; This is a spontaneous report received from an Othe...
has no sense of smell post Covid vaccine in 2021; This is a spontaneous report received from an Other HCP. A 55-year-old male patient received BNT162b2 (BNT162B2), in 2021 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: ANOSMIA (non-serious) with onset Jun2025, outcome "unknown", described as "has no sense of smell post Covid vaccine in 2021". It was unknown if therapeutic measures were taken as a result of anosmia.
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| 2855291 | F | GA | 08/22/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
|
Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a consumer,...
Positive for COVID-19; Positive for COVID-19; This is a spontaneous report received from a consumer, Program ID. A 42-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER)), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Positive for COVID-19". The event "positive for covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. A day before the reporting, the patient's husband got a prescription to get nirmatrelvir/ritonavir (PAXLOVID) tablet for the patient. She got positive for COVID-19, and they had an appointment with the health provider, and he prescribed PAXLOVID tablet. The patient was really sick, she actually needs this medicine and that's why the provider prescribed it last night; the medicine is prescribed for 15 days. Now that the patient is already detected with COVID-19, the patient's husband asked after how many days they can take the COVID-19 vaccine again, because they missed it for the last two years, and in 2023 they had all the Pfizer vaccines, you know taken correctly with the booster, but for 2024 and 2025 they didn't take any vaccines, and looks like she just got diagnosed with COVID-19. So now, after this medicine course has been completed, the patient's husband asked if they could take the vaccine immediately, or they have to wait for maybe 16 or 30 days. The patient's husband thinks he will get the medicine now, because the patient was already having trouble, and then he'll talk to his healthcare provider.
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| 2855292 | 17 | F | NC | 08/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0196 EW0196 |
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; ...
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; Pyrexia
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Gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extrem...
Gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 17-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0196) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The reporter stated that every time the patient takes the vaccine, she gets a fever of around 103 and has always pain in arm. The patient is 21 (at the time of report). Every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the reporter massaged it as gently as she could, not really pushing, just trying to make her feel better. When they came home from getting the vaccine, the patient was generally okay at first and then a couple of hours will go by and then she started getting really hot and flushed and her arm would hurt a lot; she was having a more of extreme pain in her arm and it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105 but was able to get it down pretty quickly with Tylenol. So, within half an hour she got down, but the fever has held on for a while.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167459 same patient, drug, and event, different dose;US-PFIZER INC-202500167457 same patient, drug, and event, different dose;US-PFIZER INC-202500167458 same reporter, patient, product, event; different dose;
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| 2855293 | 17 | F | NC | 08/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EW0181 EW0181 |
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; ...
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; Pyrexia
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Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her a...
Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 21-year-old female patient received BNT162b2 (BNT162B2), on 21Jul2021 as dose 2, single (Lot number: EW0181) at the age of 17 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in arm", "Pain in her arm; Very hard for her to move it", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
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| 2855294 | 18 | F | NC | 08/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
FM9992 FM9992 |
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; ...
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; Pyrexia
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Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her a...
Every time that she has ever gotten the vaccine, she has gone through very high fever; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm; Started getting really hot and flush; Started getting really hot and flush; This is a spontaneous report received from a Consumer or other non HCP. A 21-year-old female patient received BNT162b2 (BNT162B2), on 06May2022 as dose 3 (booster), single (Lot number: FM9992) at the age of 18 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 1; Lot: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush"; BNT162b2 (Dose: 2; Lot: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for Covid-19 Immunization, reaction(s): "very high fever", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm", "hot and flush", "hot and flush". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Every time that she has ever gotten the vaccine, she has gone through very high fever"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; Very hard for her to move it; Having a more of extreme pain in her arm"; FEELING HOT (non-serious), FLUSHING (non-serious), outcome "unknown" and all described as "Started getting really hot and flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional information: The patient has been receiving the Pfizer vaccine since COVID began, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was on 104 and its two days in bed. Even with Naproxen or Tylenol, the pain in her arm never ceased for the whole two days. It's very hard for her to move it and mother massaged it as gently as she could, trying to make her feel better. She was feeling tortured basically by getting the vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 same reporter, patient, product, event; different dose;
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| 2855295 | 19 | F | NC | 08/22/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
GL0447 GL0447 |
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; ...
Body temperature, Feeling hot, Flushing, Mobility decreased, Pain in extremity; Pyrexia
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Very high fever; between 102 and 104; fever of around 103; 105; Pain in her arm; very hard for her t...
Very high fever; between 102 and 104; fever of around 103; 105; Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm; Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm; Hot; Flush; This is a spontaneous report received from a consumer. A 19-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Mar2023 as dose 4 (booster), single (Lot number: GL0447) at the age of 19 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EW0196), administration date: 30Jun2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)"; BNT162b2 (DOSE 2; Lot Number: EW0181), administration date: 21Jul2021, when the patient was 17-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)"; BNT162b2 (DOSE 3 (BOOSTER); Lot Number: FM9992), administration date: 06May2022, when the patient was 18-year-old, for COVID-19 immunization, reaction(s): "Very high fever", "Pain in her arm", "Hot", "Flush", "Hard for her to move it (arm)". The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Very high fever; between 102 and 104; fever of around 103; 105"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "unknown" and all described as "Pain in her arm; very hard for her to move it; having a more of extreme pain in her arm"; FEELING HOT (non-serious), outcome "unknown", described as "Hot"; FLUSHING (non-serious), outcome "unknown", described as "Flush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, pain in extremity, mobility decreased. Additional Information: She is healthy, no other medication. The patient has taken the Comirnaty vaccine (Pfizer COVID-19 Vaccine) before or the Boosters (Pfizer COVID-19 Vaccine) and they said that every time she takes the vaccine, she gets a fever of around 103 and she was always in pain, her arm. So, the patient's mother wanted to go ahead and report that. The patient has been taking the Pfizer vaccine since COVID began, when they first started in Jun2021, but every time that she has ever gotten the vaccine, she has gone through very high fever. The highest that she got, she was at 104 and it's two days in bed. Even with naproxen or paracetamol (TYLENOL), the pain in her arm never ceased for the whole two days. It's very hard for her to move it and the patient's mother massaged it as gently as she could, not really pushing, just trying to make her feel better kind of thing. When they came home from getting the vaccine, she was generally okay at first and then a couple of hours will go by and then the patient started getting really hot and flush and her arm would hurt a lot more than the patient's mother. She was having a more of extreme pain in her arm and to the mother's memory it was always in her left arm but the fever that she would get ranged somewhere between 102 and 104. She did go to 105, but the mother was able to get it down pretty quickly when she gave the patient TYLENOL. So, within half an hour she got down, but the fever has held on for a while. She was feeling tortured basically by getting the vaccine, but the patient's mother had autoimmune diseases, so the patient knows that she has to take it. Financially, the patient is now in a different situation, she is currently 21 but she is in an appointment where they are not giving her medical insurance. So, she has no coverage, and she was trying to figure out, do they really fight to try and find help for her to getting the Pfizer vaccine or should she change vaccine at this point because this is what's happening every time the patient gets home.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500167445 Same patient and product; different event and dose;
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