| ID | Age | Sex | State | Date βΌ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | π | π₯ | π | βΏ | β οΈ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2848476 | MD | 07/04/2025 |
FLUN3 |
MEDIMMUNE VACCINES, INC. |
Unknown |
Arthralgia, Ear pruritus, Throat irritation, Urticaria
Arthralgia, Ear pruritus, Throat irritation, Urticaria
|
Hives; itchy throat; Itchy ears; acid reflux; joint pain; A spontaneous report has been received fro...
Hives; itchy throat; Itchy ears; acid reflux; joint pain; A spontaneous report has been received from a non-health professional. The report concerns a female adult patient of (withheld) ethnic origin born in 2000 (age 24 years, height 167 cm, weight 56.699 kg). No medical history was reported. No concomitant products were reported. The patient received Flumist (batch number(s) Unknown), via nasal use on 08-OCT-2024. The patient received 1 dose(s). On 14-OCT-2024, the patient experienced acid reflux (preferred term: Gastrooesophageal reflux disease),hives (preferred term: Urticaria),itchy ears (preferred term: Ear discomfort),itchy throat (preferred term: Throat irritation),joint pain (preferred term: Arthralgia). It is unknown if any action was taken with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv). At the time of reporting, the event acid reflux, hives, itchy ears, itchy throat and joint pain was improving. The events were considered non-serious. The reporter considered that there was a reasonable possibility of a causal relationship between Accuspray Single Dose and the following event(s): acid reflux, hives, itchy ears, itchy throat and joint pain. The reporter considered that there was a reasonable possibility of a causal relationship between Flumist and the following event(s): acid reflux, hives, itchy ears, itchy throat and joint pain. Device Information: Product As Reported: Accuspray Single Dose Product Role:Suspect Manufacturer Name:ASTRAZENECA Labeled for single use: Yes
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| 2848477 | M | 07/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Herpes zoster
Herpes zoster
|
Shingles in on his back and on his front; This non-serious case was reported by a consumer via call ...
Shingles in on his back and on his front; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 20-JUN-2025, the patient received Shingrix. In JUN-2025, less than a week after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles in on his back and on his front). The outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 24-JUN-2025 The patient received a dose of the Shingrix vaccine on Friday. It was not stated if it was the first or second dose. On Saturday (21-JUN-2025) or Sunday (22-JUN-2025), the patient began to break out in a full case of Shingles. The Shingles in on his back and on his front. The patient was taken to an urgent care facility and was prescribed an antiviral.
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| 2848478 | F | NY | 07/04/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
2G273 |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
patient was suppose to boostrix but was administered with Pediarix in error; patient was supposed to...
patient was suppose to boostrix but was administered with Pediarix in error; patient was supposed to boostrix but was administered with Pediarix in error; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2G273, expiry date 15-APR-2027) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 10-JUN-2025, the patient received Pediarix (left deltoid). On an unknown date, the patient did not receive Boostrix. On 10-JUN-2025, immediately after receiving Pediarix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: patient was suppose to boostrix but was administered with Pediarix in error) and inappropriate age at vaccine administration (Verbatim: patient was supposed to boostrix but was administered with Pediarix in error). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:01-JUL-2025 The reporter HCP found out about it when they were doing their audit. The patient was supposed to Boostrix but was administered with Pediarix in error and no symptoms had been reported by the patient. The patient wanted to get it as a prevention but instead of Boostrix, Pediarix was administered in error, which led to wrong vaccine administered and inappropriate age at vaccine administration.
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| 2848479 | 07/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Physical disability
Physical disability
|
I got this new vaccine 4 years ago and it Crippled; This non-serious case was reported by a consumer...
I got this new vaccine 4 years ago and it Crippled; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of physical disability 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 physical disability (Verbatim: I got this new vaccine 4 years ago and it Crippled). The outcome of the physical disability was not reported. It was unknown if the reporter considered the physical disability to be related to Shingles vaccine. It was unknown if the company considered the physical disability to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-JUN-2025 The patient got the Shingles vaccine 4 years ago and it crippled. The patient was curse the day got that shot.
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| 2848480 | 56 | M | IL | 07/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
97D52 |
Product preparation issue
Product preparation issue
|
Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being ...
Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis. On 20-FEB-2025, the patient received Shingrix. On 20-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments: US-GSK-US2025061270:same reporter differnt patient
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| 2848481 | 58 | F | IL | 07/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
97D52 |
Product preparation issue
Product preparation issue
|
Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being ...
Adjuvant was given without being mixed with the active ingredient; Adjuvant was given without being mixed with the active ingredient; This non-serious case was reported by a other health professional and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 97D52, expiry date 16-SEP-2025) for prophylaxis. Concurrent medical conditions included hypertension, blood cholesterol increased and obesity. Concomitant products included lisinopril dihydrate (Lisinopril), atorvastatin calcium (Atorvastatin), pioglitazone hydrochloride (Pioglitazone) and tirzepatide (Mounjaro). On 07-APR-2025, the patient received Shingrix. On 07-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Adjuvant was given without being mixed with the active ingredient) and inappropriate dose of vaccine administered (Verbatim: Adjuvant was given without being mixed with the active ingredient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 26-JUN-2025 The reporter stated that the Shingrix adjuvant was given to the patient without being mixed with the active ingredient, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.; Sender's Comments: US-GSK-US2025061270:same reporter differnt patient
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| 2848482 | 07/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; 2 minor flare ups since being vaxxed; This serious case was reported ...
Suspected vaccination failure; 2 minor flare ups since being vaxxed; 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: 2 minor flare ups since being vaxxed). 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: 26-JUN-2025 This case was reported by a patient via interactive digital media. Patient had two minor flare-ups since being vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine.
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| 2848483 | 07/04/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactiv...
Suspected vaccination failure; 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: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. 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: 26-JUN-2025 This case was reported by a patient via interactive digital media. Patient had also had the shots and had shingles now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine.
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| 2848484 | F | OR | 07/04/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
57H54 |
Product storage error
Product storage error
|
Menveo (1 vial) administration after temperature excursion; This non-serious case was reported by a ...
Menveo (1 vial) administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 57H54, expiry date 31-JAN-2026) for prophylaxis. On 18-JUN-2025 08:40, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo (1 vial) administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 24-JUN-2025 The pharmacist called to verify if doses of vaccines that had been exposed to low temperatures (26.5οΏ½ Fahrenheit). On 18 June 2025 at 08:40 am was administered to the patient which led to incorrect storage of drug. The reporter wanted to know if the dose should be repeated. The Vaccine Administration Facility is the same as Primary Reporter.; Sender's Comments: US-GSK-US2025079375:Same reporter different patient GSK-US2025079381:Same reporter different patient US-GSK-US2025079378:Same reporter different patient US-GSK-US2025079384:Same reporter different patient US-GSK-US2025079387:Same reporter different patient
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| 2848485 | F | OR | 07/04/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
9X7CD |
Product storage error
Product storage error
|
Menveo administration after temperature excursion; This non-serious case was reported by a pharmacis...
Menveo administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 9X7CD, expiry date 31-JAN-2026) for prophylaxis. On 16-JUN-2025 08:30, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Menveo administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK receipt date: 24-JUN-2025 The pharmacist called to verify if doses of vaccines that have been exposed to low temperatures should be repeated. The patient was given the vaccine after temperature excursion which led to incorrect storage of drug. This was 1 of the 6 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025079375:Same reporter different patient US-GSK-US2025079376:Same reporter different patient US-GSK-US2025079381:Same reporter different patient US-GSK-US2025079387:Same reporter different patient US-GSK-US2025079378:Same reporter different patient
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| 2848486 | M | OR | 07/04/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
EB499 |
Product storage error
Product storage error
|
Boostrix plus Administration after temperature excursion; This non-serious case was reported by a ph...
Boostrix plus Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis. On 18-JUN-2025 09:40, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix plus Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUN-2025 Administration after temperature excursion which led to incorrect storage of drug. Pharmacist called to verify if doses of vaccines that had been exposed to low temperatures should be repeated.
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| 2848487 | F | OR | 07/04/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
EB499 |
Product storage error
Product storage error
|
Boostrix Administration after temperature excursion; This non-serious case was reported by a pharmac...
Boostrix Administration after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis. On 20-JUN-2025 09:30, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 24-JUN-2025 Pharmacist called to verify if doses of vaccines that had been exposed to low temperatures should be repeated. Boostrix was administered after temperature excursion which led to Incorrect storage of drug.; Sender's Comments: US-GSK-US2025079387:same reporter /different patient US-GSK-US2025079386:same reporter /different patient US-GSK-US2025079384:same reporter /different patient US-GSK-US2025079385:same reporter /different patient US-GSK-US2025079382:same reporter /different patient US-GSK-US2025079374:same reporter /different patient US-GSK-US2025079376:same reporter /different patient US-GSK-US2025079375:same reporter /different patient US-GSK-US2025079378:same reporter /different patient
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| 2848488 | 11 | M | IL | 07/04/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9PT2F |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
Maladministration in a eleven year old patient (Age administration error/Underdose); was given a Dta...
Maladministration in a eleven year old patient (Age administration error/Underdose); was given a Dtap instead of Tdap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9PT28, expiry date 10-MAR-2026) and (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis. Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On 24-JUN-2025, the patient received Infanrix (intramuscular use) .5 ml. On an unknown date, the patient received Tdap Vaccine. On 24-JUN-2025, an unknown time after receiving Infanrix and not applicable after receiving Tdap Vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: Maladministration in a eleven year old patient (Age administration error/Underdose)) and wrong vaccine administered (Verbatim: was given a Dtap instead of Tdap). The outcome of the inappropriate age at vaccine administration and wrong 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-JUN-2025 and 26-JUN-2025 The patient had no adverse effects, was given a Dtap instead of Tdap, whc=ich led wrong vaccine administered. Infanrix vaccine administered to an eleven year old patient, which led inappropriate age at vaccine administered, with the dosage difference, The reporter asked how effective it was. The reporter reported he/she gave the lower dose he/she guesses. The reporter asked was there any advice for this. The reporter consented to follow up.
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| 2848489 | 53 | F | MD | 07/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
55TH4 |
Product preparation issue
Product preparation issue
|
Only diluent administered.; Only diluent administered; This non-serious case was reported by a pharm...
Only diluent administered.; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis. On 25-JUN-2025, the patient received the 2nd dose of Shingrix. On 25-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered.) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 25-JUN-2025 Other HCP reported that earlier on the day of reporting, they had administered only the diluent of Shingrix to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Reporter mentioned that after realizing this medication error, they administered on that same visit a valid dose of Shingrix. No further details were obtained.
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| 2848490 | 23 | F | FL | 07/04/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4n222 |
Incorrect route of product administration
Incorrect route of product administration
|
received Priorix IM instead of SC; This non-serious case was reported by a pharmacist via call cente...
received Priorix IM instead of SC; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 23-year-old female patient who received MMR (Priorix) (batch number 4n222, expiry date 13-SEP-2026) for prophylaxis. On 15-APR-2025, the patient received Priorix (intramuscular use). On 15-APR-2025, an unknown time after receiving Priorix, the patient experienced intramuscular formulation administered by other route (Verbatim: received Priorix IM instead of SC). The outcome of the intramuscular formulation administered by other route 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: 26-JUN-2025 The patient received Priorix intramuscularly instead of subcutaneous, which led intramuscular formulation administered by other route. The reporter consented to follow up.
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| 2848491 | 85 | F | 07/04/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
|
COVID-19; COVID-19
COVID-19; COVID-19
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COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ...
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 85-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Previously administered products included for Drug use for unknown indication: Paxlovid. Past adverse reactions to the above products included No adverse effect with Paxlovid. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient had covid again despite of the vaccination (Unspecified Vaccine) and everything. The patient had mixed vaccines some of Pfizer and Moderna both were unspecified. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787883 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787883:Male patient
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| 2848492 | M | 07/04/2025 |
COVID19 COVID19 |
MODERNA PFIZER\BIONTECH |
|
COVID-19; COVID-19
COVID-19; COVID-19
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COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ...
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Previously administered products included for Drug use for unknown indication: Paxlovid. Past adverse reactions to the above products included No adverse effect with Paxlovid. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medication was reported. The patient had covid again despite of the vaccination (Unspecified Vaccine) and everything. The patient had mixed vaccines some of Pfizer and Moderna both were unspecified. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787882 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787882:Male patient
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| 2848493 | 26 | F | NY | 07/04/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
Fm0173 Fm0173 Fm0173 Fm0173 |
Adrenal disorder, Anxiety, Balance disorder, Brain fog, Chest pain; Exercise tol...
Adrenal disorder, Anxiety, Balance disorder, Brain fog, Chest pain; Exercise tolerance decreased, Fatigue, Hypoaesthesia, Loss of consciousness, Loss of personal independence in daily activities; Magnetic resonance imaging heart abnormal, Migraine, Mood altered, Pulmonary mass, Tachycardia; Tilt table test positive, Tremor
More
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Severe anxiety, numbness over entire body , migraines , sudden mood changes, loss of balances , extr...
Severe anxiety, numbness over entire body , migraines , sudden mood changes, loss of balances , extreme fatigue and brain fog , tachycardia, tremors, adrenaline issues, severe chest pain, inability to exercise or engage in daily tasks. I still experience many of these symptoms 3 years later
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| 2848494 | 33 | F | NY | 07/04/2025 |
COVID19 |
MODERNA |
|
Paralysis
Paralysis
|
Mounjaro 7.5mg causes temporary paralysis in legs and spine which may become permanent.
Mounjaro 7.5mg causes temporary paralysis in legs and spine which may become permanent.
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| 2848495 | 44 | M | IN | 07/04/2025 |
COVID19 |
MODERNA |
|
Catheterisation cardiac normal, Chest discomfort, Chest pain, Magnetic resonance...
Catheterisation cardiac normal, Chest discomfort, Chest pain, Magnetic resonance imaging heart normal, Troponin increased
More
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Myocarditis Event on March 23. Chest pain and tightness, went to the ER, initially thought to be a n...
Myocarditis Event on March 23. Chest pain and tightness, went to the ER, initially thought to be a non-Stemi heart attack, troponin level went over 5.2. Heart Cath done, no major blockages. MRI the next day, ruled Myocarditis
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β | |||||
| 2848496 | 34 | F | 07/04/2025 |
HPV9 |
MERCK & CO. INC. |
|
Dizziness, Injection site pain, Injection site warmth, Pain in extremity
Dizziness, Injection site pain, Injection site warmth, Pain in extremity
|
Arm soreness lasting >1 week, soreness spreading to whole arm outside of the injection site. Warm...
Arm soreness lasting >1 week, soreness spreading to whole arm outside of the injection site. Warmth at injection site. Vaccine administration technique was appropriate, injection site not too high up on the arm. Patient also complaining of feeling lightheaded the past week or so as well.
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| 2848497 | 65 | F | NY | 07/04/2025 |
PNC21 VARZOS |
MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS |
Z004302 EK225 |
Injection site erythema, Injection site swelling, Injection site warmth; Injecti...
Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth
More
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Red, swollen, warm at the area where 2 injection occured
Red, swollen, warm at the area where 2 injection occured
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| 2848498 | 60 | F | 07/04/2025 |
PNC21 PNC21 VARZOS VARZOS |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y011819 Y011819 PJ353 PJ353 |
Chills, Injection site erythema, Injection site pain, Injection site warmth, Pru...
Chills, Injection site erythema, Injection site pain, Injection site warmth, Pruritus; Pyrexia; Chills, Injection site erythema, Injection site pain, Injection site warmth, Pruritus; Pyrexia
More
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Patient had a reaction of redness around the injection site which seems like spreading but slowly, t...
Patient had a reaction of redness around the injection site which seems like spreading but slowly, tenderness with warm touch, fever, chills, and itchiness. Patient started to react around 3rd day of injection, and it has not healed after a week. Recommended patient to apply cold compresses and to take ibuprofen, Tylenol to help reach remission of fever and chills. Also, asked them to get medical attention but patient refused.
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| 2848499 | 27 | F | AZ | 07/04/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
EL0143 EL19261 |
Ectopic pregnancy, Human chorionic gonadotropin increased, Maternal exposure bef...
Ectopic pregnancy, Human chorionic gonadotropin increased, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal; Ectopic pregnancy, Human chorionic gonadotropin increased, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
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Ectopic pregnancy
Ectopic pregnancy
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β | β | ||||
| 2848500 | 58 | M | CO | 07/04/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5J959 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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PT WAS 58 YEARS OF AGE AT TIME OF VACCINE AND DID NOT HAVE A PRESCRIPTION FROM PHYSICIAN, FAMILY HAD...
PT WAS 58 YEARS OF AGE AT TIME OF VACCINE AND DID NOT HAVE A PRESCRIPTION FROM PHYSICIAN, FAMILY HAD REQUESTED VACCINES AT NURSING HOME AND I DID NOT REALIZE HE HAD NO PRESCRIPTION REQUEST.
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| 2848501 | 84 | M | CO | 07/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
5A4XG |
Extra dose administered
Extra dose administered
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PATIENT REQUESTED SHINGRIX SHOT AT CLINIC, IT WAS GIVEN BUT UPON BILLING I DISCOVERED THAT HE HAD RE...
PATIENT REQUESTED SHINGRIX SHOT AT CLINIC, IT WAS GIVEN BUT UPON BILLING I DISCOVERED THAT HE HAD RECEIVED BOTH DOSES IN 2018
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| 2848502 | 1 | M | TX | 07/04/2025 |
HEPA HEPA HEPA HEPA HIBV HIBV HIBV HIBV MMRV MMRV MMRV MMRV PNC13 PNC13 PNC13 PNC13 |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR SANOFI PASTEUR MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
W006214 W006214 W006214 W006214 UJ637AA UJ637AA UJ637AA UJ637AA W006587 W006587 W006587 W006587 FH9982 FH9982 FH9982 FH9982 |
Antisocial behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, ...
Antisocial behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, Derealisation; Developmental delay, Developmental regression, Fine motor delay, Gait disturbance, Gross motor delay; Head banging, Language disorder, Malaise, Pyrexia, Respiratory distress; Sensory processing disorder, Sleep disorder, Stereotypy, Unresponsive to stimuli; Antisocial behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, Derealisation; Developmental delay, Developmental regression, Fine motor delay, Gait disturbance, Gross motor delay; Head banging, Language disorder, Malaise, Pyrexia, Respiratory distress; Sensory processing disorder, Sleep disorder, Stereotypy, Unresponsive to stimuli; Antisocial behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, Derealisation; Developmental delay, Developmental regression, Fine motor delay, Gait disturbance, Gross motor delay; Head banging, Language disorder, Malaise, Pyrexia, Respiratory distress; Sensory processing disorder, Sleep disorder, Stereotypy, Unresponsive to stimuli; Antisocial behaviour, Aphasia, Autism spectrum disorder, Decreased eye contact, Derealisation; Developmental delay, Developmental regression, Fine motor delay, Gait disturbance, Gross motor delay; Head banging, Language disorder, Malaise, Pyrexia, Respiratory distress; Sensory processing disorder, Sleep disorder, Stereotypy, Unresponsive to stimuli
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Following this set of vaccinations, child became extremely ill within 3 weeks. He developed a high f...
Following this set of vaccinations, child became extremely ill within 3 weeks. He developed a high fever and respiratory distress, which lasted over 2 weeks - far more severe than any prior illness. After recovering from the physical symptoms, he did not return to his prior developmental state. He had previously been meeting and exceeding milestones, but after this illness, we observed the following regressions: lost all previously acquired speech, stopped making eye contact, no longer responded to his name, began repetitive hand-flapping, begin banging head on objects, developed sleep disturbances, appeared disconnected, as if trapped in his own body. Symptoms have persisted long-term. He was formally diagnosed on August 7, 2023, with: level 2 nonverbal autism (F84.0) As well as mixed receptive-expressive language disorder (F82.0), lack of expected normal physiological development in childhood (R62.50), abnormality of gait and mobility (R26.89). He currently presents with significant impairments in language, gross motor, fine motor, sensory processing, and social responsiveness. Currently receiving support therapies.
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β | |||||
| 2848503 | 27 | F | NY | 07/04/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
EL0142 EL0142 EL9261 EL9261 |
Computerised tomogram head, Dizziness, Headache, Hemiparaesthesia, Magnetic reso...
Computerised tomogram head, Dizziness, Headache, Hemiparaesthesia, Magnetic resonance imaging head; Magnetic resonance imaging spinal, Scan with contrast, Vertigo; Computerised tomogram head, Dizziness, Headache, Hemiparaesthesia, Magnetic resonance imaging head; Magnetic resonance imaging spinal, Scan with contrast, Vertigo
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Full body left sided paresthesia, worked up for rule out stroke or TIA. Vertigo/dizziness/headache. ...
Full body left sided paresthesia, worked up for rule out stroke or TIA. Vertigo/dizziness/headache. Referred to ENT after hospitalization.
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β | |||||
| 2848504 | 73 | M | CA | 07/04/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PJ353 |
Injection site pruritus, Injection site rash, Injection site reaction, Injection...
Injection site pruritus, Injection site rash, Injection site reaction, Injection site swelling
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Patient had injection site reaction: swelling, redness, itchiness
Patient had injection site reaction: swelling, redness, itchiness
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| 2848505 | 72 | F | PR | 07/04/2025 |
PNC20 VARZOS |
PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
LP4947 GJ952 |
Injection site erythema, Injection site pain, Injection site swelling; Injection...
Injection site erythema, Injection site pain, Injection site swelling; Injection site erythema, Injection site pain, Injection site swelling
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Date of immunization: 6/28/2025, date of symptoms: 7/4/2025, symptoms: area of vaccination redness,...
Date of immunization: 6/28/2025, date of symptoms: 7/4/2025, symptoms: area of vaccination redness, soreness and swelling, recommendation: apply ice pack wrapped in a dry cloth to avoid direct contact to the area and over the counter medication: ibuprofen
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| 2848522 | 79 | F | OH | 07/04/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chills, Fatigue, Headache, Myalgia, Nausea
Chills, Fatigue, Headache, Myalgia, Nausea
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Chills, extreme fatigue, headache, muscle aches, nausea
Chills, extreme fatigue, headache, muscle aches, nausea
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| 2848570 | 17 | F | CT | 07/04/2025 |
MENB MENB MNQ MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR SANOFI PASTEUR |
DD72H DD72H U48494AA U48494AA |
Erythema, Injection site warmth, Pain, Pain in extremity, Peripheral swelling; U...
Erythema, Injection site warmth, Pain, Pain in extremity, Peripheral swelling; Urticaria; Erythema, Injection site warmth, Pain, Pain in extremity, Peripheral swelling; Urticaria
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patient states she woke up 7/2 with hives but they resolved on own, both arms were sore but @ 9pm pa...
patient states she woke up 7/2 with hives but they resolved on own, both arms were sore but @ 9pm pain got worse and she felt shooting pain down right arm both arms red, swollen, warm to touch at injection site
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| 2848226 | 71 | F | TX | 07/03/2025 |
COVID19 |
PFIZER\BIONTECH |
6H9703 |
COVID-19, SARS-CoV-2 test
COVID-19, SARS-CoV-2 test
|
I took it again on yesterday (25Jun2025) and It was positive; This is a spontaneous report received ...
I took it again on yesterday (25Jun2025) and It was positive; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID. A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Lot number: 6H9703) at the age of 71 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, SINGLE, Vaccination site: Left arm, Lot number: EN6202), administration date: 03Mar2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Vaccination site: Left arm, Lot number: EP6955, Expiration Date: 30Jun2021), administration date: 21Mar2021, when the patient was 69-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccination site: Left arm, Lot number: FF8841), administration date: 15Oct2021, when the patient was 70-year-old, for COVID-19 Immunization. The following information was reported: COVID-19 (non-serious) with onset 25Jun2025, outcome "unknown", described as "I took it again on yesterday (25Jun2025) and It was positive". Relevant laboratory tests and procedures are available in the appropriate section. Product Quality Group provided investigational results on 27Jun2025 for BNT162B2 (Lot#EP6955): Investigation Summary and Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EP6955 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EP6955, fill lot EP6954, and the formulated drug product lot EP6953. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Additional information: It was reported that the patient explained more about her experience with taking the vaccines from Pfizer (Covid Vaccine). She does currently has covid and is trying to get financial assistance for the Paxlovid. The reporter stated that it has been a few years since she has taken them. So, she has not had any issues in the meantime except when she was to a family reunion this past weekend. It was clarified that this is the first time the reporter has ever had COVID. She just tested yesterday (25Jun2025) (Clarified age as 74 years at the time of event). The reporter stated that she was hard to ever sick. she was not sick usually. She was sick on when she took the test on the 23Jun2025 which was Monday and it was negative and then she took it again on yesterday (25Jun2025) and it was positive. There's another Pfizer that she took. It looks like 6H9703. It could be a 4, these are handwritten. So, it looks like, she think it is 6H9703 and stated that these were all injections in her left arm for the anatomical site. Samples was not Available for Lot Number: FF8841, EN6202 and EP6955.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500077806 same patient/drug, different AE/dose;
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| 2848255 | 0.17 | F | NC | 07/03/2025 |
HBHEPB |
MERCK & CO. INC. |
T005735 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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patient was administered PEDVAX HIB on 5/27/2025 it was noted that the vaccine had expired on 6/12/2...
patient was administered PEDVAX HIB on 5/27/2025 it was noted that the vaccine had expired on 6/12/2022.; No additional AE details reported; PEDVAX HIB packaging had the following lot and expiration: Y003144 9/11/2026. Could the vial have been labeled in error by the manufacturer? We are puzzled by the expiration date of almost 3 years ago.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 27-May-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), 0.5 mL as prophylaxis, it was noted that the vaccine had expired on 16-Jun-2022 (expired product administered). The packaging had the following lot and expiration: (lot #Y003144, expiration date: 11-Sep-2026), however, the administered vial label had the following lot and expiration: (lot #T005735, expiration date: 12-Jun-2022) and it was enquired if the vial had been labeled in error by the manufacturer (product label issue). It was reported that the carton contained all the same product/lot, and the name was "PEDVAX HIB 0.5ML DOSE 10 SINGLE DOSE VIALS", one vial lot was #T005735, expiration date: 12-Jun-2022 and all other 9 vials were lot #Y003144, expiration date: 11-Sep-2026. The vaccine was administered to patient and a few moments later and then realized the expiration date was years over. This product had been stored in the original carton in the refrigerator, the reporter did not known what date was the carton or tray first opened. The carton was not glue sealed, in addition, multiple people had access to the product and it was checked with all personnel who had access if they could had inadvertently caused the mix. No damage noticed to the shipping carton on arrival to site or noted on the shipping carton's contents on arrival. No adverse event. Follow-up information was received from the nurse on 25-Jun-2025. Patient's identifiers were provided (previously invalid due to unknown patient). This report was regarding a 10-week-old female patient. Her birth weight was 9 lbs 8 oz, number of sibblings:1. No illness at time of vaccine administration. Concomitant medications included Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) Pediarix (Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast);Pertussis vaccine acellular 3-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid), Prevnar 20 (Pneumococcal vaccine conj 20v (CRM197)). The patient was in office for a 2-month well child visit. She received 4 vaccines (as previously reported); this was the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) administered to the patient and it was given in a private doctor's office/hospital by a healthcare professional in the left vastus lateralis (lot #T005735, expiration date: 12-Jun-2022). After that, the medical assistance was documenting the vaccines in the electronic medical record system and realized that Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) was expired. She returned to the box the vial came from but the other vaccines were not expired and all other vaccines in the box matched the lot number on the box, the medication error occurred during the administration (as previously reported). No drug treatment was prescribed. The action taken with the vaccine was reported as "pulled box", the box and the sticker were available to be returned. The patient had no reaction, no side effects from vaccine administration.
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| 2848256 | 63 | M | MT | 07/03/2025 |
MMR YF |
MERCK & CO. INC. UNKNOWN MANUFACTURER |
Y010372 UK134AA |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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No additional AE/PQC reported.; Email received in email to case que on 6/17/2025 11:29 AM with a sca...
No additional AE/PQC reported.; Email received in email to case que on 6/17/2025 11:29 AM with a scanned document from SANOFI; This spontaneous report was received from other healthcare professional and refers to a 63-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reconstituted with sterile diluent (MERCK STERILE DILUENT), administered for prophylaxis (dose, route of administration, anatomical site of injection, lot # and expiration date were not provided). On an unknown date (reported as two weeks after the patient received the MMR II vaccine), the patient was vaccinated with the yellow fever vaccine (trade name not provided), lot #UK134AA (dose, route of administration, anatomical site of injection, indication and expiration date were not reported) (Inappropriate administration interval between different vaccines). The patient did not experience any adverse effects from the vaccination (no adverse events). Follow up information has been received from the nurse on 27-JUN-2025. The patient was vaccinated on 15-APR-2025, with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot number Y010372 has been verified to be valid, expiration date reported as 05-JUN-2026). On that same day, he also received hepatitis B vaccine (recombinant) suspension for injection (RECOMBIVAX HB) (lot number Y018229, has been verified to be valid, expiration date reported as 31-MAY-2027), Pneumococcal vaccine conj 20v (other manufacturer) (lot number LJ5283, expiration date 31-MAY-2026), and Diphtheria vaccine toxoid (+) Pertussis vaccine acellular 5-component (+) Tetanus vaccine toxoid (TDAP) (other manufacturer) (lot number U8352AA, expiration date 31-DEC-2026). The vaccines were administered from a vaccine provider and vaccinated at public health clinic/hospital and purchased with private funds. The operator of device was a health professional. The adverse event was previously reported to health department and to manufacturer. Moreover, it was reported that the patient was aware that he will need to complete a blood test or receive a second yellow fever vaccine to ensure he have adequate immunity against yellow fever.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02823591-02823541 , CLIC number : , ESTAR number : , IRMS number : 500UW00000dWnIlYAK|30062025230049|1867 , Central date : 2025-07-01 , Classification : DMC, Attachment description : NSC Call , Safety case number : 2297631 , MNSC case number : 02823591 , MNSC interaction number : 02823541 , Integration log UniqueID : 500UW00000dWnIlYAK|30062025230049|1867 , Service cloud CaseID : 500UW00000dWnIlYAK
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| 2848257 | 07/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Accidental overdose; Accidental overdose
Accidental overdose; Accidental overdose
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Double dose of Shingrix by mistake; This non-serious case was reported by a consumer via interactive...
Double dose of Shingrix by mistake; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of accidental overdose in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix and Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced accidental overdose (Verbatim: Double dose of Shingrix by mistake). The outcome of the accidental overdose was not applicable. Additional Information: GSK Receipt date:25-JUN-2025 This case was reported by a consumer via (shingrix GRC Chatbot) interactive digital media. The patient had been given two doses of Shingrix together by mistake, he/she wanted to know possible adverse effects, which led to accidental overdose.
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| 2848258 | 07/03/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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I received a first dose in 2021 from my PCP; This non-serious case was reported by a consumer via in...
I received a first dose in 2021 from my PCP; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine (received a first dose in 2021 from his/her primary care physician). On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after not receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I received a first dose in 2021 from my PCP). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date:25-JUN-2025 This case was reported by a consumer via (shingrix GRC Chatbot) interactive digital media. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine which led to incomplete course of vaccination.
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| 2848287 | 33 | F | AL | 07/03/2025 |
COVID19 COVID19 COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
301258A 301258A 301258A 301258A 301258A 301258A |
Angiogram cerebral abnormal, Aphasia, Disturbance in attention, Dizziness, Dysar...
Angiogram cerebral abnormal, Aphasia, Disturbance in attention, Dizziness, Dysarthria; Gait disturbance, Head discomfort, Hemiplegia, Hyperacusis, Hyporeflexia; Intracranial venous sinus stenosis, Laboratory test abnormal, Lumbar puncture normal, Magnetic resonance imaging abdominal abnormal, Magnetic resonance imaging head normal; Mast cell activation syndrome, May-Thurner syndrome, Memory impairment, Muscular weakness, Neurological symptom; Paraplegia, Photophobia, Seizure, Thrombosis, Tinnitus; Tunnel vision, Visual impairment, Wheelchair user
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40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel visio...
40 minutes after receiving the vaccine, I started with severe head pressure, dizziness, tunnel vision. I was told headache was expected and could last 3 days. I saw my pcp office 3 days later when it had not subsided. I continued with symptoms that were severe, called pcp again 3 days later and was told to be seen again. I was seen 2 days after that. Had imaging performed and was negative. I started with bilateral leg weakness 8 days after the vaccine. 10 days after the vaccine, my right leg started to drag. I was seen by my pcp 3 days later as that continued to progress. Reflexes were decreased and I was hospitalized at (withheld) General Hospital for 5 days. I was told it was similar to Guillain Barre but not Guillain barre. I was told it was a severe immune response to the covid vaccine. My condition continued to worsen despite treatment. My left leg became so weak and was dragging as well, I was wheelchair bound from January 10, 2022 until January 15, 2025. I was told I was paralyzed from my belly button down. I also started having seizures April 2022 which continued to worsen as many as 5 per day. I also experienced severe sound sensitivity, light sensitivity, memory and concentration problems, ringing in my ears, vision changes. I had a couple stroke like episodes where my entire left side would become paralyzed, had slurred speech and once had aphasia. I was living in (withheld state) at the time, but have since moved to (withheld state) to be treated by Dr. (withheld) for my covid vaccine injury. I have been found to have severe micro clots, severe iliac vein compression, stenosis of the Left sinus which was filled with blood clots, mast cell activation syndrome. I am no longer paralyzed and have not had any further seizures since March 2025.
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β | β | β | |||
| 2848293 | M | AZ | 07/03/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; developed Shingles last year, and again this year; This serious case ...
Suspected vaccination failure; developed Shingles last year, and again this year; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed Shingles last year, and again this year). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. 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 and Shingrix. Additional Information: GSK receipt date: 30-JUN-2025 The patient received 2 doses of Shingrix 4 years ago. The patient developed shingles last year, and again this year. This case was considered as suspected vaccination failure as details regarding 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 vaccines Shingrix.
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| 2848294 | 67 | M | WI | 07/03/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
N733B |
Syringe issue
Syringe issue
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started leaking on the side of it, and the needle and everything was attached correctly; Pharmaceuti...
started leaking on the side of it, and the needle and everything was attached correctly; Pharmaceutical product complaint; half of it, not sure, probably more; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 67-year-old male patient who received HBV (Engerix B) (batch number N733B, expiry date 27-AUG-2027) for prophylaxis. This case was associated with a product complaint. On 20-JUN-2025, the patient received Engerix B. On 20-JUN-2025, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: half of it, not sure, probably more). On an unknown date, the patient experienced syringe leak (Verbatim: started leaking on the side of it, and the needle and everything was attached correctly) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the underdose, syringe leak and pharmaceutical product complaint were not applicable. It was unknown if the reporter considered the syringe leak to be related to Engerix B and Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the syringe leak to be related 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: 23-JUN-2025 Other HCP was giving Engerix-B vaccine on 20th June 2025 on Friday, and then as reporter was administering the vaccine half of it or they were not sure, probably more, just started leaking on the side of it, and the needle and everything was attached correctly. Reporter stated that liquid leaked out from the syringe, not from the site of injection.
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| 2848295 | 46 | F | IL | 07/03/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
J942L |
Product preparation error
Product preparation error
|
Vaccine reconstituted with unapproved diluent; Vaccine reconstituted with unapproved diluent; This ...
Vaccine reconstituted with unapproved diluent; Vaccine reconstituted with unapproved diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 46-year-old female patient who received MMR (Priorix) (batch number J942L, expiry date 08-NOV-2026) for prophylaxis. On 23-JUN-2025, the patient received Priorix. On 23-JUN-2025, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vaccine reconstituted with unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: Vaccine reconstituted with unapproved diluent). The outcome of the wrong solution used in drug reconstitution 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-JUN-2025 The Nurse Practitioner explained that on 23rd June 2025, patient had been vaccinated with Priorix doses that had been accidentally reconstituted with sterile water from Merck Sharp & Dohme vaccines instead of the Priorix corresponding diluent that had been provided by Glaxo Smith Kline, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
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| 2848296 | CA | 07/03/2025 |
YF |
SANOFI PASTEUR |
UK137AA |
No adverse event, Product preparation error
No adverse event, Product preparation error
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pharmacist reports that a staff member administered the yf-vax (yellow fever) but used a different d...
pharmacist reports that a staff member administered the yf-vax (yellow fever) but used a different diluent solution with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administered Yellow Fever Vaccine - [Yf-Vax] but a different diluent solution was used with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection, lot UK137AA (unknown strength and expiry date) via unknown route in unknown administration site for Immunization but a different diluent solution was used with no reported adverse event (product preparation error) (Latency Same day). Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2848297 | CA | 07/03/2025 |
YF |
SANOFI PASTEUR |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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sterile water was used as a diluent, confirmed that the incorrectly reconstituted YF VAX was adminis...
sterile water was used as a diluent, confirmed that the incorrectly reconstituted YF VAX was administered with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who received Yellow Fever Vaccine - [YF-Vax] which was reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization which was reconstituted with sterile water with no reported adverse event (product preparation error) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence will not be available. Reportedly, Sterile water was used as diluent in reconstitution of vaccine. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. No routine follow up possible as reporter did not consent to be contacted.
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| 2848298 | 53 | F | GA | 07/03/2025 |
PNC20 PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH PFIZER\WYETH |
LK6655 LK6655 LK6655 |
Carotid artery aneurysm, Cervical spinal stenosis, Computerised tomogram, Diarrh...
Carotid artery aneurysm, Cervical spinal stenosis, Computerised tomogram, Diarrhoea, Hemiplegia; Magnetic resonance imaging, Muscle spasms, Muscular weakness, Myelitis transverse, Nausea; Scan with contrast, Sensory loss, Syncope, Vomiting
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Nausea, Vomiting, Muscle Cramps, Diarhea, Uncontrolable Muscle Spasms, Right side Paralysis temporay...
Nausea, Vomiting, Muscle Cramps, Diarhea, Uncontrolable Muscle Spasms, Right side Paralysis temporay, Weakness lower body and Right Arm x 9 days . on the 10th day Paralysis right side and weakness no sensation lower body and syncope
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| 2848325 | 59 | F | VA | 07/03/2025 |
HPV9 |
MERCK & CO. INC. |
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Pollakiuria
Pollakiuria
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Consumer advised she is 59 years old; she received the GARDIL 9 vaccine and Felt like she had to use...
Consumer advised she is 59 years old; she received the GARDIL 9 vaccine and Felt like she had to use the bathroom frequently and had a urge to go number one after a couple of weeks of getting the vaccine; she received the GARDIL 9 vaccine and Felt like she had to use the bathroom frequently and had a urge to go number one after a couple of weeks of getting the vaccine; This spontaneous report was received from a 59-year-old female patient, who refers to herself. Her medical history included 4 screws and metal plate in her back. The patient's concurrent conditions was latex allergy. Concomitant therapies were not reported. On 12-MAY-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) suspension for injection, administered by unknown route (dose, strength, anatomical location, lot # and expiration date were not reported) as prophylaxis. On an unspecified date in 2025, the patient felt like she had to use the bathroom frequently and had an urge to go number one after a couple of weeks of getting the vaccine. The patient recovered from both events. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported but established as not applicable. The causal relationship between the events of feeling like she had to use the bathroom frequently and having urge to go number one and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIl9) was not provided.
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| 2848326 | F | 07/03/2025 |
HPV4 |
MERCK & CO. INC. |
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Pyrexia, Urticaria
Pyrexia, Urticaria
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Voice message received from SRP mailbox on 26JUN2025 at 703PM with following message verbatim: &quo...
Voice message received from SRP mailbox on 26JUN2025 at 703PM with following message verbatim: "Hi Good afternoon my name is {REDACTED} calling from REDACTED} our phone number is (REDACTED) again this is {REDACTED}from {REDACTED} our hum; low grad fever; This spontaneous report was received from other health professional and refers 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 started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9), dose number 1, (lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced low grade fever and hives (pyrexia and urticaria). At the reporting time, the outcome of the events was unknown. The causal relationship between the events and the vaccine was not provided. Lot # is being requested and will be submitted if received.
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| 2848327 | M | NJ | 07/03/2025 |
VARCEL |
MERCK & CO. INC. |
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Viral titre decreased
Viral titre decreased
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Pharmacist calling with a report of an adverse event regarding VARIVAX. Pharmacist stated that an a...
Pharmacist calling with a report of an adverse event regarding VARIVAX. Pharmacist stated that an adult, male patient came to their Pharmacy with a question on receiving a booster vaccination of VARIVAX after they were found to have low titers of th; This spontaneous report was received from a pharmacist and refers to a adult male patient. 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 started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), dose number 2, 0.5 mL (lot # and expiration date were not reported) that was reconstituted with sterile diluent (MERCK STERILE DILUENT) and administered as varicella vaccination. On an unknown date, the patient experienced low titers of the vaccine (Viral titre decreased). At the reporting time, the outcome of the event was unknown. The causal relationship between the event and the vaccine was not provided.
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| 2848328 | 50 | F | NJ | 07/03/2025 |
PNC21 PNC21 TDAP TDAP |
MERCK & CO. INC. MERCK & CO. INC. GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
Y019158 Y019158 |
Feeling cold, Feeling hot, Injection site erythema, Injection site swelling, Nas...
Feeling cold, Feeling hot, Injection site erythema, Injection site swelling, Nasopharyngitis; Pyrexia; Feeling cold, Feeling hot, Injection site erythema, Injection site swelling, Nasopharyngitis; Pyrexia
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"small bump" on her right arm; a fever and feeling chilly, cold, and warm; having redness ...
"small bump" on her right arm; a fever and feeling chilly, cold, and warm; having redness and swelling on her right arm; having redness and swelling on her right arm; This spontaneous report has been received from a pharmacist, regarding to a 50-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 26-JUN-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine, administered intramuscularly (IM) in the right arm, lot number Y019158, expiration date 20-MAY-2026 as routine administration (dosage, route of administration, and vaccination scheme frequency), on the same date, the patient received Boostrix (Diphtheria vaccine toxoid; Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (dose, route of administration, anatomical site of injection, vaccination scheme frequency, lot number, indication, and expiration date were not reported) . On 27-JUN-2025, the patient experienced a fever and feeling chilly, cold, and warm (Pyrexia), on the same date, the patient developed small bump (Vaccination site mass) on her right arm, also, she had redness and swelling (Vaccination site swelling and Vaccination site erythema). On an unknown date in 2025, the patient recovered from pyrexia. At the time of the report, the patient had not recovered from Vaccination site mass and Vaccination site erythema. The outcome of Vaccination site swelling was not provided. The causal relationship between the aforementioned events and the suspect vaccines was not provided.
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| 2848329 | 19 | F | TX | 07/03/2025 |
HPV9 |
MERCK & CO. INC. |
Y015179 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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No side effects reported; HCP is calling report an AE for a patient that received fourth dosage of...
No side effects reported; HCP is calling report an AE for a patient that received fourth dosage of GARDASIL 9 on 04/28/2025. No side effects reported. No additional details provided. No additional AE/PQC reported.; This spontaneous report was received from a Registered Nurse and refers to a 19-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Apr-2025, the patient was vaccinated with a fourth dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y015179, expiration date: 28-Jan-2027), dose number 1 for prophylaxis (extra dose administered). No adverse event was reported.
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| 2848330 | TX | 07/03/2025 |
MMRV |
MERCK & CO. INC. |
Y019171 |
Product storage error
Product storage error
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No additional AE; one patient who received improperly stored PROQUAD; This spontaneous report was re...
No additional AE; one patient who received improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-Jun-2025, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (valid lot #Y019171, expiration date: 18-May-2026) 0.5 mL for prophylaxis (product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided). Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored in temperature 6.3F for 16 minutes. There was not reported previous temperature excursion.
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