| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2834454 | M | 04/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Drug ineffective, Herpes zoster, Incomplete course of vaccination
Drug ineffective, Herpes zoster, Incomplete course of vaccination
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Lack of drug effect/shingles; This non-serious case was reported by a consumer via call center repre...
Lack of drug effect/shingles; 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 an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Lack of drug effect/shingles). 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:19-MAR-2025 The reporter was a friend of the consumer. The consumer informed the reporter that he had one dose of Shingrix administered and then he got shingles (lack of effect). The reporter stated that the consumer only had one dose administered (missed dose). The reporter declined to provide any demographic information for himself or information regarding the consumer. No other information provided/obtained including patient initials, DOB, HCP information/consent, lot number, date vaccinated, date diagnosed with shingles, outcome, dose, or route of administration.
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| 2834455 | 12 | F | WI | 04/07/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Expired product administered, Inappropriate schedule of product administration; ...
Expired product administered, Inappropriate schedule of product administration; Expired product administered, Inappropriate schedule of product administration
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administer an Engerix-B vaccine and it was expired, it expired 09-Mar-2025; received Engerix B on 29...
administer an Engerix-B vaccine and it was expired, it expired 09-Mar-2025; received Engerix B on 29th July 2024 and 23 OCT 2024; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received HBV (Engerix B) (expiry date 09-MAR-2025) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b). On 18-MAR-2025, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, the patient received the 2nd dose of Engerix B. On 23-OCT-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: received Engerix B on 29th July 2024 and 23 OCT 2024). On 18-MAR-2025, the patient experienced expired vaccine used (Verbatim: administer an Engerix-B vaccine and it was expired, it expired 09-Mar-2025). The outcome of the expired vaccine used and drug dose administration interval too long were not applicable. Additional Information: GSK Receipt Date: 19-MAR-2025 The patient received 2nd dose of Engerix B later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received expired dose of Engerix B, which led to expired vaccine used.
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| 2834456 | 16 | F | PA | 04/07/2025 |
MEN MEN MENB MENB |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
UNK UNK UNK UNK |
Injection site cellulitis, Injection site erythema, Injection site pain, Injecti...
Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Pain in extremity; Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth; Pain in extremity
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cellulitis; This non-serious case was reported by a physician via other manufacturer and described t...
cellulitis; This non-serious case was reported by a physician via other manufacturer and described the occurrence of cellulitis in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis. On an unknown date, the patient received Bexsero (left arm) and Menquadfi (left arm). On an unknown date, less than a day after receiving Bexsero, the patient experienced cellulitis (Verbatim: cellulitis). The patient was treated with ibuprofen (Advil), paracetamol (Tylenol) and cephalexin. The outcome of the cellulitis was not resolved. It was unknown if the reporter considered the cellulitis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. It was unknown if the company considered the cellulitis to be related to Bexsero and Bexsero 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: 20-MAR-2025 The patient received Bexsero and Menquadi administered and after injection site was wiped with alcohol swab. The patient experienced significant pain started in left arm less than 5 hours after shot, advil provided around 8pm due to pain. Pain continued 16-March-2025, advil administered around 6am, alieve around 11am, and tylenol around 3pm. Touching/bumping arm caused significantly more pain. Rash, that was swollen, pink, and hot to the touch noted on arm around 8pm approximately 2cm below the injection site. On 15-March-2025, 8 am pain persisted, rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before. On 15-March-2025 at 11am, diagnosed with cellulitis. Rash measured approximately 8 cm by 6cm. Oral cephalexin prescribed. It was unknown if the reporter considered the cellulitis to be related to Menquadfi.
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| 2834457 | 04/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pyrexia
Pyrexia
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feverish; This non-serious case was reported by a consumer via interactive digital media and describ...
feverish; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: feverish). The outcome of the fever was not reported. It was unknown if the reporter considered the fever to be related to Shingles vaccine. It was unknown if the company considered the fever to be related to Shingles vaccine. Additional Information: GSK Receipt Date:21-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter stated that go ahead and get the new shots. The patient was feverish and schlepped around after the second one but didn't fret because he/she knew it was just his/her immune system revving up like a car in a passing lane.
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| 2834458 | 04/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Allergy to vaccine
Allergy to vaccine
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I'm allergic to the vaccine; This non-serious case was reported by a consumer via interactive d...
I'm allergic to the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine 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 allergy to vaccine (Verbatim: I'm allergic to the vaccine). The outcome of the allergy to vaccine was not reported. It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine. It was unknown if the company considered the allergy to vaccine to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAR-2025 This case was reported by a patient via interactive digital media. The patient got Shingles vaccine and was allergic to the vaccine.
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| 2834459 | M | 04/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Rash
Rash
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Rash; This non-serious case was reported by a consumer via interactive digital media and described t...
Rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: Rash). The outcome of the rash was not reported. It was unknown if the reporter considered the rash to be related to Shingles vaccine. It was unknown if the company considered the rash to be related to Shingles vaccine. Additional Information: GSK Receipt Date:19-MAR-2025 This case was reported by a patient's wife via interactive digital media. The patient had it and got the shot. He didn't have pain and just had a little rash. The reporter advised to get the shots.
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| 2834460 | 04/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
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very ill; This non-serious case was reported by a consumer via interactive digital media and describ...
very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in an unspecified number of patients 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 unwell (Verbatim: very ill). The outcome of the unwell was not reported. The reporter considered the unwell to be related to Shingles vaccine. The company considered the unwell to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-MAR-2025 The reporter reported everyone that he/she knows that's gotten the shingles shot, has been very ill from it. This case was linked with case US2025AMR034450 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025AMR034450:Same reporter.
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| 2834461 | M | 04/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure, Visual impairment
Herpes zoster, Vaccination failure, Visual impairment
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Suspected Vaccination failure; almost lost his eyesight; got the shingles so bad on his face; This s...
Suspected Vaccination failure; almost lost his eyesight; got the shingles so bad on his face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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, more than 9 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), loss of vision (Verbatim: almost lost his eyesight) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: got the shingles so bad on his face). The outcome of the vaccination failure, loss of vision and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure, loss of vision and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure, loss of vision and facial herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 21-MAR-2025 This case was reported by a patient's brother via interactive digital media. The patient got the Shingles shot and then 9 months to a year later got the shingles so bad on his face and he almost lost his eyesight. The reporter stated that don't get any jabs and said god did not create us that way, traditional medicine did. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule 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 the completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Blindness are unlisted events which are considered unrelated to GSK Shingles vaccine."
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| 2834462 | 04/07/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Blister, Erythema, Herpes zoster, Vaccination failure; Blister, Erythema, Herpes...
Blister, Erythema, Herpes zoster, Vaccination failure; Blister, Erythema, Herpes zoster, Vaccination failure
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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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and more than a year 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 and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 22-MAR-2025 This case was reported by a patient via interactive digital media. Patient had both shingles shots back in 2019. The year after, he/she got shingles, but it was such a mild case that he/she had to have his/her physician verify that it had truly been shingles. It was one patch of red approximately one and one-half inches by one inch with one tiny little blister just below his/her waist on his/her left side. Patient experienced no pain, no itching, and absolutely no discomfort. He/she was so glad he/she had gotten the vaccine. The reporter asked what could had been agony turned out to be no big deal. The vaccine had worked. 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 vaccine Shingles vaccine (1st dose)and Shingles vaccine( 2nd dose).
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| 2834463 | 04/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; had the shingles; This serious case was reported by a consumer via in...
Suspected vaccination failure; had the 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: had the 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: 23-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that get the vaccine, he/she did and had the shingles but a less severe case. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2834464 | 04/07/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Stress, Vaccination failure; Herpes zoster, Stress, Vaccination f...
Herpes zoster, Stress, Vaccination failure; Herpes zoster, Stress, Vaccination failure
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suspected vaccination failure; got the shingles; lot of stress; This serious case was reported by a ...
suspected vaccination failure; got the shingles; lot of stress; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got the shingles) and stress (Verbatim: lot of stress). The outcome of the vaccination failure and stress were not reported and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure, shingles and stress to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAR-2025 This case was reported by a patient via interactive digital media. The patient received both shots of Shingles vaccine, also but after a lot of stress the patient got the shingles. The patient was thankful for the shots as the shingles were very much lighter and have not last as long. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This is 1 of the 3 cases reported by the same reporter.; 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster and Stress are unlisted events which are considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR036152:Different Patient US-GSK-US2025AMR036211:Different Patient
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| 2834465 | 04/07/2025 |
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; come down with the shingles; This serious case was reported by a cons...
Suspected vaccination failure; come down with the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In AUG-2024, the patient received the 2nd dose of Shingrix. In FEB-2024, the patient received the 1st dose of Shingrix. In MAR-2025, between 6 and 8 months after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: come down with the 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 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: 24-MAR-2025 The case was received from the patient via (Shingrix GSK CHATBOT) interactive digital media. The patient had both Shingrix shots and in March of 25 he/she come down with the shingles. The patient was wondering when or if he/she should another shot. This case was considered as suspected vaccination failure as details regarding completion laboratory confirmation regarding shingles was unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
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| 2834466 | 10 | F | CA | 04/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
EP274 |
Expired product administered
Expired product administered
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Engerix-B admisnitered after given an expired dose; This non-serious case was reported by a nurse vi...
Engerix-B admisnitered after given an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old female patient who received HBV (Engerix B) (batch number EP274, expiry date 14-MAR-2025) for prophylaxis. On 19-MAR-2025, the patient received Engerix B. On 19-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-B admisnitered after given an expired dose). The outcome of the expired vaccine used 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: 19-MAR-2025 A registered nurse wanted to know the efficacy on Engerix-B immunization after given an expired dose to patient after the expiration date (less than 30 days), which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. This case was linked with case US2025033673 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025033673:Same reporter/Different patient
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| 2834467 | F | VA | 04/07/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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missed her 2nd dose, and is almost time for her 3rd dose of Twinrix"; This non-serious case was...
missed her 2nd dose, and is almost time for her 3rd dose of Twinrix"; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old female patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (1st dose received on 16-SEP-2024, batch number-344J3 and expiry date 12-SEP-2026). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: missed her 2nd dose, and is almost time for her 3rd dose of Twinrix"). The outcome of the incomplete course of vaccination 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: 20-MAR-2025 The patient that missed her 2nd dose, and was almost time for her 3rd dose of Twinrix. Till the time of reporting the patient had not received the second dose of Twinrix, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
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| 2834468 | 67 | F | WA | 04/07/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
42ZS4 |
Incorrect route of product administration
Incorrect route of product administration
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Incorrect Route of Administration; This non-serious case was reported by a pharmacist via call cente...
Incorrect Route of Administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 67-year-old female patient who received MMR (Priorix) (batch number 42ZS4) for prophylaxis. On 19-MAR-2025, the patient received Priorix (intramuscular). On 19-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Incorrect Route of Administration). The outcome of the subcutaneous injection 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: 20-MAR-2025 Pharmacist called and reported recently received the MMR vaccine, the Priorix administered to patient at pharmacy intramuscularly instead of Subcutaneously, which led subcutaneous injection formulation administered by other route and just wondering if that dose has been studied that way or it has to be readministered. The reporter consented to follow up.
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| 2834469 | F | PA | 04/07/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
4N222 |
Incorrect route of product administration
Incorrect route of product administration
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A patient received a dose of Priorix via Intramuscular instead of subcutaneous injection; This non-s...
A patient received a dose of Priorix via Intramuscular instead of subcutaneous injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis. On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A patient received a dose of Priorix via Intramuscular instead of subcutaneous injection). The outcome of the subcutaneous injection 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: 21-MAR-2025 A pharmacist reported that a female patient received Priorix intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administered by other route. The reporter wanted to know if it was going to be harmful for the patient.
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| 2834470 | IL | 04/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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there is no record of a second dose administered, so caller is not sure if the patient got the secon...
there is no record of a second dose administered, so caller is not sure if the patient got the second dose at the appropriate time; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: there is no record of a second dose administered, so caller is not sure if the patient got the second dose at the appropriate time). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 28-MAR-2025 The pharmacist mentioned that a patient got their first dose of Shingrix on 2020, and patient was sure that they got their second dose, but when they went to the pharmacy, there is no record of a second dose administered, The reporter not sure if the patient got the second dose at the appropriate time which led to incomplete course of vaccination. They thought on administering a dose now (not administered yet, at the moment of the call), but not sure in case they do it, that would be a late second dose or an extra dose. The pharmacist did not have additional details and offered to bring the patient to the line, but since it was also requested Medical Information, agent decided to start providing the Medical Information data since that is exclusively for Healthcare Providers and not for patients, but pharmacist got impatient and decided to only receive information via email and ended the call
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| 2834471 | 47 | F | NJ | 04/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthralgia
Arthralgia
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she had joint pain with the "first series" of covid vaccines which was awhile; This is a s...
she had joint pain with the "first series" of covid vaccines which was awhile; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:. A 47-year-old female patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "little bit fat" (unspecified if ongoing), notes: no significant health conditions other than being a "little bit fat". The patient's concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "she had joint pain with the "first series" of covid vaccines which was awhile". Additional information: She also noted that she had joint pain with the "first series" of covid vaccines which was awhile. The first and second dose in the fall of the first year it was approved for emergency use authorization. She wants to know if she should be concerned about getting another vaccine booster and if the forehead numbness could be a build up of too much of the spike proteins. Her pharmacist said not to worry about the forehead numbness as they had heard about this before. Caller states she has no significant health conditions other than being a "little bit fat". The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500069769 Same patient and product; different dose and event;US-PFIZER INC-202500069770 Same patient and product; different dose and event;
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| 2834472 | F | 04/07/2025 |
PNC20 |
PFIZER\WYETH |
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Discomfort, Injection site mass, Injection site pain, Injection site rash, Rash ...
Discomfort, Injection site mass, Injection site pain, Injection site rash, Rash erythematous
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soreness at the injection site/she is feeling deep aching soreness; discomfort; developed a slight, ...
soreness at the injection site/she is feeling deep aching soreness; discomfort; developed a slight, pinkish rash and burning sensation underneath the skin.; developed a slight, pinkish rash and burning sensation underneath the skin.; My shoulder, a deep soreness, a deep ache in the muscle of the lower deltoid region.; had notices a small miniature lump that feels to the effect of a really bad mosquito bite; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Mar2025 as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Mar2025, 3 weeks after the suspect product(s) administration, outcome "not recovered", described as "My shoulder, a deep soreness, a deep ache in the muscle of the lower deltoid region."; RASH ERYTHEMATOUS (non-serious), SKIN BURNING SENSATION (non-serious) all with onset Mar2025, latency 1 week after the suspect product(s) administration, outcome "recovered" (Mar2025) and all described as "developed a slight, pinkish rash and burning sensation underneath the skin."; VACCINATION SITE DISCOMFORT (non-serious) with onset Mar2025, outcome "recovered" (Mar2025), described as "discomfort"; LIMB MASS (non-serious) with onset Mar2025, 3 weeks after the suspect product(s) administration, outcome "not recovered", described as "had notices a small miniature lump that feels to the effect of a really bad mosquito bite"; VACCINATION SITE PAIN (non-serious) with onset Mar2025, outcome "recovered" (Mar2025), described as "soreness at the injection site/she is feeling deep aching soreness". Therapeutic measures were taken as a result of myalgia. Additional information: patient received the Prevnar 20 vaccine and has had a reaction to it where she is feeling deep aching soreness and also had notices a small miniature lump that feels to the effect of a really bad mosquito bite. Patient had soreness at the injection site, discomfort. Like from a bee sting. It wasn't a big deal. Patient got the shot in early 04Mar2025. About 1 week later, patient developed a slight, pinkish rash and burning sensation underneath the skin. That went away. About 1 week later, patient had a burning under the skin, like a sunburn deep in the skin, like a radiation burn. That went away too for 1-2 weeks. Patient plays the piano a lot. About 1 week ago, patient played for about 3-4 hours, the next day, it reminded her of the soreness that she had initially. She never had problems with her shoulder, but the next day she had soreness in her shoulder. She stayed away from the piano for a few days. She went back 3-4 days ago and it seemed to be ok, but yesterday (30Mar2025), it was the same feeling. It seems like it hurts when she stretches her arms out. Her shoulder was bothering her before she went for a long drive. Her shoulder, a deep soreness, a deep ache in the muscle of the lower deltoid region. She felt the area with her hand it almost felt like a quarter size lump, the feel after a mosquito. Patient would like to know if this symptoms of the vaccine or what might be in the vaccine causing this issue. Patient associates this with Prevnar 20, and noticed a pattern, the soreness and achiness seems to be any activity. Patient took a walk about 2-3 days ago for about 1 mile. 30Mar2025, patient drove and felt very sore was to the equivalence to a "bad bruise". With motion and weight, she seems to feel it. It comes and goes, depending on what she was doing. Patient had to take some Tylenol for pain. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2834473 | F | MD | 04/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Muscle spasms, Pain in extremity, Vaccination site mass, Vaccination site pain
Muscle spasms, Pain in extremity, Vaccination site mass, Vaccination site pain
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constant pain/the second dose was very painful/Spot where she had the 2nd one that every now and the...
constant pain/the second dose was very painful/Spot where she had the 2nd one that every now and then has pain there; hand pain with cramping; hand pain with cramping; spot there is a boil or a bump at the injection site/bump started coming up 2 weeks ago; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 71-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 omicron (kp.2) (dose 1), for COVID-19 immunization, reaction(s): "everything was ok". The following information was reported: VACCINATION SITE MASS (non-serious) with onset Mar2025, outcome "unknown", described as "spot there is a boil or a bump at the injection site/bump started coming up 2 weeks ago"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "constant pain/the second dose was very painful/Spot where she had the 2nd one that every now and then has pain there"; PAIN IN EXTREMITY (non-serious), MUSCLE SPASMS (non-serious), outcome "unknown" and all described as "hand pain with cramping". Additional information: Patient is currently taking a blood pressure medication. Patient had three of the Pfizer Covid vaccines. The first one and third one were fine. The second was very painful and took a long time before the pain went away. Spot where she had the 2nd one that every now and then has pain there that comes and goes. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (01Apr2025): This is a spontaneous follow-up report received from a Consumer or other non HCP. Updated information: reporter contact details, event Pain recoded to Vaccination site pain, Vaccination site mass verbatim updated, clinical course. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2834474 | F | NM | 04/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Drug ineffective, Suspected COVID-19
Drug ineffective, Suspected COVID-19
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she might have COVID too; she might have COVID too; This is a spontaneous report received from a Con...
she might have COVID too; she might have COVID too; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), for covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she might have COVID too". The clinical course was reported as follows: the patient's husband had COVID, and the reporter stated she might have COVID too. They got all those COVID-19 shots; they were all Pfizer. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2834475 | M | 04/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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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: . An 80-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Brought COVID-19 home from the gym ", start date: 16Feb2024 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Feb2024, 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: (19Feb2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient's wife was to enroll the patient. A year ago, the physician prescribed nirmatrelvir/ritonavir (PAXLOVID) to patient in case they got it, but did not get it. Both the patient and wife have COVID-19, and they are currently sharing a box and the physician called in another prescription for PAXLOVID for both of them to take together. It was further reported that they got a box about a year and a half ago (2022) because they were going on vacation and then they didn't use it. And so, the patient brought COVID-19 home from the gym on Friday (16Feb2024). And so, on Saturday (17Feb2024), the patient's wife started to feel sick. Yesterday (19Feb2024), they took the test, and they were both positive so they shared the beginning of the first box and so by tomorrow night there will be like one sheet left. They were splitting the first box. By tomorrow (21Feb2024) after the morning dosage, only one of them would be able to go another day. This area was supposed to have really high COVID-19. Neither the patient nor his wife has ever gotten it. They' had all the vaccines, every single one of them.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500070647 Same reporter, product, and event; different patient;
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| 2834476 | M | NM | 04/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consu...
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. A 78-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2022 (unspecified if ongoing), notes: He wound up in the hospital three times three years ago. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete), 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) all with onset 2025, outcome "unknown" and all described as "diagnosed with COVID-19". The clinical course was reported as follows: The patient's wife reported that her husband was recently diagnosed with COVID-19. He contracted it again, and his doctor prescribed nirmatrelvir;ritonavir (PAXLOVID) to him on the morning of 01Apr2025. He has not been sleeping well and was quite sick. The reporter mentioned that they got all those COVID-19 shots; he must have had seven of them; they were all Pfizer. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2834477 | MI | 04/07/2025 |
FLU3 |
SANOFI PASTEUR |
|
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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have given Fluzone HD to patients younger than indicated with no adverse event; Initial information ...
have given Fluzone HD to patients younger than indicated with no adverse event; Initial information received on 27-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-heathcare professional. This case involves Adult and unknown gender patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone high dose] younger than indicated with no 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 1ml dose (once) of suspect influenza USP trival A-B high dose subvirion vaccine, Suspension for injection in pre-filled syringe, unknown strength and expiry date, lot number not reported via intramuscular route in unknown administration site for flu vaccine (flu immunisation) earlier than indicated age with no adverse event (product administered to patient of inappropriate age) (latency same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. No follow-up is possible as Reporter cannot be contacted by Sanofi
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| 2834478 | 65 | F | NY | 04/07/2025 |
PNC21 PNC21 |
MERCK & CO. INC. MERCK & CO. INC. |
Y019157 Y019157 |
Cough, Headache, Injection site erythema, Injection site pain, Nausea; Oropharyn...
Cough, Headache, Injection site erythema, Injection site pain, Nausea; Oropharyngeal pain, Pain, Pain in extremity, Swelling
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Developed cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at inje...
Developed cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at injection site. (Baseball size) Self treated with Tylenol and OTC cold medicine. arm redness, swelling went down within 24 hours. Declined office visit to assess.
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| 2834479 | 68 | F | MI | 04/07/2025 |
COVID19 |
MODERNA |
8081260 |
Injection site erythema, Injection site mass, Injection site swelling, Injection...
Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
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Lump, hot, redness/swelling. Large but localized to vaccine site.
Lump, hot, redness/swelling. Large but localized to vaccine site.
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| 2834480 | 75 | M | MI | 04/07/2025 |
COVID19 |
MODERNA |
8081260 |
Injection site erythema, Injection site mass, Injection site swelling, Injection...
Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
More
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Lump, hot to touch, red, swollen area. Large but localized to injection site.
Lump, hot to touch, red, swollen area. Large but localized to injection site.
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| 2834481 | 88 | F | MI | 04/07/2025 |
COVID19 |
MODERNA |
8081260 |
Injection site erythema, Injection site mass, Injection site swelling, Injection...
Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
More
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Lump, hot to touch, red, swollen area. Large but localized to injection site.
Lump, hot to touch, red, swollen area. Large but localized to injection site.
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| 2834482 | 48 | F | SC | 04/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
ER8731 EW0182 |
Cardiac failure, Cerebrovascular accident; Cardiac failure, Cerebrovascular acci...
Cardiac failure, Cerebrovascular accident; Cardiac failure, Cerebrovascular accident
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stroke and heart failure
stroke and heart failure
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✓ | ✓ | ✓ | |||
| 2834483 | 86 | M | MI | 04/07/2025 |
COVID19 |
MODERNA |
8081260 |
Injection site erythema, Injection site mass, Injection site swelling, Injection...
Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
More
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Lump, hot to touch, red, swollen area. Large but localized to injection site.
Lump, hot to touch, red, swollen area. Large but localized to injection site.
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| 2834484 | 75 | F | IL | 04/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chest discomfort, Dyspnoea, Throat tightness, Tongue disorder
Chest discomfort, Dyspnoea, Throat tightness, Tongue disorder
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pt says she began having shortness of breath and her chest became tight. She noticed her throat star...
pt says she began having shortness of breath and her chest became tight. She noticed her throat started closing. She took a Benadryl and then about an hour and half later she took another Benadryl. Her throat is still tight and her tongue feels thick but she is not having any trouble breathing. She is going to reach out to the pharmacy and her allergist.
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| 2834485 | 61 | F | FL | 04/07/2025 |
COVID19 |
MODERNA |
049E21A |
Generalised tonic-clonic seizure
Generalised tonic-clonic seizure
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The patient stated that she has been on Keppra since having a grand mal seizure 3 weeks to a month a...
The patient stated that she has been on Keppra since having a grand mal seizure 3 weeks to a month after receiving her third covid vaccination (first booster) on 8/14/21 at pharmacy (Moderna) Lot 049E21A
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✓ | |||||
| 2834486 | 73 | F | VT | 04/07/2025 |
COVID19 |
MODERNA |
3042648 |
Rash
Rash
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Rash
Rash
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| 2834487 | 11 | M | VA | 04/07/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
Y012865 U8370AA |
Dizziness, Hyperhidrosis, Pallor, Vision blurred; Dizziness, Hyperhidrosis, Pall...
Dizziness, Hyperhidrosis, Pallor, Vision blurred; Dizziness, Hyperhidrosis, Pallor, Vision blurred
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Approxametly 4 minutes post vaccination, student felt dizzy, starting looking pale when he stood up ...
Approxametly 4 minutes post vaccination, student felt dizzy, starting looking pale when he stood up after vaccination and quickly lost his footing. RN vaccinating helped the patient lay down on the floor with support by another nurse. Student reported having blurry vision, "not feeling good," diaphoretic. BP taken laying down 90/110. Legs slightly elevated to increase blood flow, pt laid down for about 5minutes. He was able to sit up and tolerate drinking juice box, BP rechecked 100/70. Student ambulated with stand-by assist to bed-cot with RN and rested for 10min before returning to class. Parents were notified. BP rechecked 102/70 9:25. Returned to class 9:28am.
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| 2834488 | 85 | F | IA | 04/07/2025 |
COVID19 |
MODERNA |
|
Death
Death
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Passed away
Passed away
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✓ | |||||
| 2834489 | 79 | M | FL | 04/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
99Y4J |
Injection site mass
Injection site mass
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The patient came to the pharmacy on 4/2/25 and stated that he has a bump on his arm on the spot that...
The patient came to the pharmacy on 4/2/25 and stated that he has a bump on his arm on the spot that he received a shingles vaccine 5 months prior on 11/8/24 and he thinks it's the adverse effect from that vaccine
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| 2834490 | 28 | F | TN | 04/07/2025 |
IPV MMR |
SANOFI PASTEUR MERCK & CO. INC. |
Y1A201M Y010372 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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This nurse inadvertently administered a third (not needed) dose of the MMR vaccine. It was administe...
This nurse inadvertently administered a third (not needed) dose of the MMR vaccine. It was administered as one of patient's two previously received doses was marked as invalid on patient's forecaster report. Patient had no symptoms/signs/no outcomes or treatment needed.
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| 2834492 | 77 | M | SC | 04/07/2025 |
PNC20 |
PFIZER\WYETH |
lx4482 |
Extra dose administered
Extra dose administered
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unneeded vax. Pt had already received 3/1/25
unneeded vax. Pt had already received 3/1/25
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| 2834493 | 4 | M | TN | 04/07/2025 |
DTAPIPV MMRV |
SANOFI PASTEUR MERCK & CO. INC. |
U8009AB Y103582 |
Extra dose administered, No adverse event; Extra dose administered, No adverse e...
Extra dose administered, No adverse event; Extra dose administered, No adverse event
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Patient received additional Quadracel and Proquad, no adverse reactions or symptoms.
Patient received additional Quadracel and Proquad, no adverse reactions or symptoms.
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| 2834494 | 45 | F | WA | 04/07/2025 |
UNK |
UNKNOWN MANUFACTURER |
|
Injection site pain, Product preparation issue
Injection site pain, Product preparation issue
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Patient was given the diluent of sterile water instead of the flu vaccine. Patient stated the inject...
Patient was given the diluent of sterile water instead of the flu vaccine. Patient stated the injection stung and hurt but no other effects.
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| 2834495 | 22 | F | WA | 04/07/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
|
Behcet's syndrome, Biopsy skin abnormal, Skin lesion, Ulcer; Behcet's ...
Behcet's syndrome, Biopsy skin abnormal, Skin lesion, Ulcer; Behcet's syndrome, Biopsy skin abnormal, Skin lesion, Ulcer
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Triggered autoimmune response. Lesions and ulcers.
Triggered autoimmune response. Lesions and ulcers.
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| 2834496 | 65 | F | PA | 04/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Injected limb mobility decreased, Pain in extremity
Injected limb mobility decreased, Pain in extremity
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I'm not sure of the exact date and time of the shot, but my arm is still sore after a month and...
I'm not sure of the exact date and time of the shot, but my arm is still sore after a month and I can't lift it as high as I could previously. It hurts if I try to lift it, or scratch my back. My left arm has has had more flexibility since I had a double neck fusion 15+ years ago, but now I can't do as much with it.
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| 2834497 | 35 | M | MI | 04/07/2025 |
TDAP |
SANOFI PASTEUR |
C5923A |
Expired product administered, No adverse event
Expired product administered, No adverse event
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Patient given expired vaccine, no symptoms. Patient informed. Patient scheduled to come back in 2 ...
Patient given expired vaccine, no symptoms. Patient informed. Patient scheduled to come back in 2 weeks to receive vaccine.
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| 2834498 | 18 | M | TX | 04/07/2025 |
HPV9 MENB MNQ TDAP |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS GLAXOSMITHKLINE BIOLOGICALS |
Y008119 Z39XM X4T99 9YB4G |
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, L...
Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness; Dizziness, Loss of consciousness
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After administration of HPV vaccine, patient stated he "feels woozy" then lost consciousne...
After administration of HPV vaccine, patient stated he "feels woozy" then lost consciousness. Patient transferred to bed and feet elevated above heart level and regain consciousness. Vitals checked: bp 109/69, hr 69, resp 20, and 02 sat 98% on ra. Mother and patient report that he did not eat breakfast and has had similar incidents at school when seeing blood. Patient given peanut butter crackers and water, and continued to rest for 10 minutes. Vitals rechecked bp 107/74, hr 85, resp 18, and O2 sats 98% on RA. Then slowly positioned to sitting position for 5 minutes then to standing. He became dizzy again, then positioned to a lying with elevated feet position again and allowed to rest for another 10 minutes. Slowly repositioned and states he was feeling better.
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| 2834499 | 28 | M | OR | 04/07/2025 |
TDAP |
SANOFI PASTEUR |
U8339BA |
Mobility decreased, Pain in extremity
Mobility decreased, Pain in extremity
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Pt received TDAP vaccine in L deltoid on 1/2/25, has been having arm pain and loss of ROM since inje...
Pt received TDAP vaccine in L deltoid on 1/2/25, has been having arm pain and loss of ROM since injection.
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| 2834500 | 1 | M | NY | 04/07/2025 |
DTAP DTAP HEPA HEPA HIBV HIBV PNC13 PNC13 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS SANOFI PASTEUR SANOFI PASTEUR PFIZER\WYETH PFIZER\WYETH |
9R2D7 9R2D7 F3Y25 F3Y25 UJ798AB UJ798AB GG6262 GG6262 |
Injection site erythema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular; ...
Injection site erythema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular; Tachycardia, Viral infection; Injection site erythema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular; Tachycardia, Viral infection; Injection site erythema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular; Tachycardia, Viral infection; Injection site erythema, Pyrexia, Rash, Rash erythematous, Rash maculo-papular; Tachycardia, Viral infection
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Fever onset 4 pm with rash. Maculopapular erythematous rash over abdomen, back and legs, not itchy, ...
Fever onset 4 pm with rash. Maculopapular erythematous rash over abdomen, back and legs, not itchy, redness at injection site also. T 103.5, tachycardia
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| 2834502 | 1 | F | TX | 04/07/2025 |
HEPA HEPA MMR MMR PNC20 PNC20 |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH PFIZER\WYETH |
|
Body temperature increased, Eye movement disorder, Fall, Hypotonia, Loss of cons...
Body temperature increased, Eye movement disorder, Fall, Hypotonia, Loss of consciousness; Vomiting; Body temperature increased, Eye movement disorder, Fall, Hypotonia, Loss of consciousness; Vomiting; Body temperature increased, Eye movement disorder, Fall, Hypotonia, Loss of consciousness; Vomiting
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Vaccine given on 4/2/2024, then on 4/8/2024 around 4:45 PM patient (1 year old) was playing with blo...
Vaccine given on 4/2/2024, then on 4/8/2024 around 4:45 PM patient (1 year old) was playing with blocks sitting on the floor with me (mom) and suddenly went unconscious and "fell" face forward to the ground, limp. I quickly picked her up and her eyes rolled to the back of her head and she was limp in my arms for 20-30 seconds. After that time passed she began throwing up. Her temperature was taken after the fact and it was around 101.2, I called the pediatrician who informed me to go to urgent care (it was after hours) so we did that. Her temperature at the urgent care was 99.68.
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| 2834503 | 69 | F | GA | 04/07/2025 |
PNC13 |
PFIZER\WYETH |
lk6655 |
Extra dose administered
Extra dose administered
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Vaccine had already been administered. Duplicate vaccine given. Patient received Prevnar 20 on 3/8/2...
Vaccine had already been administered. Duplicate vaccine given. Patient received Prevnar 20 on 3/8/2023.
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| 2834504 | 65 | F | WA | 04/07/2025 |
PNC20 |
PFIZER\WYETH |
|
Rotator cuff syndrome, Tendon pain
Rotator cuff syndrome, Tendon pain
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Rotator cuff tendinitis pain starting the day after injection, when there was none previously.
Rotator cuff tendinitis pain starting the day after injection, when there was none previously.
|
✓ | |||||
| 2834505 | 82 | M | ME | 04/07/2025 |
COVID19 |
MODERNA |
3043333 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Administration of vaccine past expiration date. No reaction reported.
Administration of vaccine past expiration date. No reaction reported.
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