| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2836478 | 0.58 | M | TX | 04/17/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
B532G |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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patient received 3rd dose a week early and a day; This non-serious case was reported by a other heal...
patient received 3rd dose a week early and a day; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a 7-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number B532G, expiry date 11-APR-2027) for prophylaxis. Previously administered products included Pediarix (received 1st dose of vaccine on an unknown date). Concomitant products included Pediarix. On 20-FEB-2025, the patient received the 3rd dose of Pediarix (left thigh). On 20-FEB-2025, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: patient received 3rd dose a week early and a day). The outcome of the drug dose administration interval too short 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: 09-APR-2025 The nurse had given it too soon, the second dose was given on 23rd January and the third dose was administered on 20th February 2025, a week and a day early, which led to Drug dose administration interval too short.
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| 2836479 | F | 04/17/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Rash vesicular; Rash vesicular
Rash vesicular; Rash vesicular
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Herpes-Zoster like rash; This non-serious case was reported by a physician via sales rep and describ...
Herpes-Zoster like rash; This non-serious case was reported by a physician via sales rep and described the occurrence of vesicular rash in a female 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, 12 months after receiving Shingrix and Shingrix, the patient experienced vesicular rash (Verbatim: Herpes-Zoster like rash). The outcome of the vesicular rash was resolved. The reporter considered the vesicular rash to be related to Shingrix and Shingrix. The company considered the vesicular rash to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 09-APR-2025 The Healthcare professional shared his wife developed a minor Herpes-Zoster like rash that appeared even after having gotten both doses of Shingrix, approximately 12-18 months ago.
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| 2836480 | 04/17/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Erythema, Herpes zoster, Pain, Paraesthesia, Sleep disorder; Vaccination failure
Erythema, Herpes zoster, Pain, Paraesthesia, Sleep disorder; Vaccination failure
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Suspected Vaccination failure; got shingles; have not slept much; This serious case was reported by ...
Suspected Vaccination failure; got shingles; have not slept much; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got shingles) and difficulty sleeping (Verbatim: have not slept much). The outcome of the vaccination failure and difficulty sleeping were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine. The company considered the vaccination failure, shingles and difficulty sleeping to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vaccine but also got shingles going on for 4 weeks now. The patient reported he/she never really got the blisters, just a small red patch, but dealing with the burning tingly pain just the same. The patient stated it hurts more at night and she/he have not slept much. Further, patient stated that it probably would have been a lot worse if did not have the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster and Insomnia are unlisted events which are considered unrelated to GSK Shingles vaccine."
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| 2836481 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected Vaccination failure; shingles twice since the vaccine; This serious case was reported by a...
Suspected Vaccination failure; shingles twice since the vaccine; 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. The patient's past medical history included shingles (had shingles once prior to vaccine). 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 twice since the vaccine). 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: 09-APR-2025 This case was reported by a patient via interactive digital media. The patient wished the vaccine worked for him/her. The patient got shingles once prior to vaccine and shingles twice since the vaccine. The patient stated that their immune system had failed them. 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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| 2836482 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Burning sensation, Neuralgia
Burning sensation, Neuralgia
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get nerve pain; back was burning; This non-serious case was reported by a consumer via interactive d...
get nerve pain; back was burning; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles). Previously administered products included Shingles vaccine (had first dose on an unknown date.). 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 nerve pain (Verbatim: get nerve pain) and burning sensation (Verbatim: back was burning). The outcome of the nerve pain was not reported and the outcome of the burning sensation was not resolved. It was unknown if the reporter considered the nerve pain and burning sensation to be related to Shingles vaccine. It was unknown if the company considered the nerve pain and burning sensation to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that she/he had Shingles and it was bad then got both shots (Shingles vaccine). The patient reported that now she/he got nerve pain and it feels like back is burning that was where they had it (shingles). The patient asked for help to stop the burning.
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| 2836483 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Chills, Herpes zoster, Pain, Vaccination failure
Chills, Herpes zoster, Pain, Vaccination failure
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Suspected vaccinaion failure; Shingles; This serious case was reported by a consumer via interactive...
Suspected vaccinaion 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 vaccinaion failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with lidocaine. 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: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient had received the shingles vaccine but still got shingles. He/she used lidocaine cream for the pain, which helped a little, but it did not provide relief for the chills. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2836484 | M | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; grandpa got singles; This serious case was reported by a consumer via...
Suspected vaccination failure; grandpa got singles; 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: grandpa got singles). The outcome of the vaccination failure and shingles were not reported. 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. The company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that his/her grandpa got shingles from the vaccine and it was so painful. They were fine before it. 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. This case is linked with US2025AMR045180, reported by same reporter.; 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 US-GSK-US2025AMR045180:Same reporter/ different patient
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| 2836485 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Blister, Nerve injury
Blister, Nerve injury
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nerve damage; occasional blister; This non-serious case was reported by a consumer via interactive d...
nerve damage; occasional blister; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a 62-year-old 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 nerve damage (Verbatim: nerve damage) and blister (Verbatim: occasional blister). The outcome of the nerve damage and blister were not reported. It was unknown if the reporter considered the nerve damage and blister to be related to Shingles vaccine. It was unknown if the company considered the nerve damage and blister to be related to Shingles vaccine. Additional Information: GSK receipt date: 11-APR-2025 This case was reported by a patient via interactive digital media. The patient got shingles last year and said that it sucks. The symptoms didn't just went away. They lingered on for months. The doctor told that if he/she took the vaccination, he/she would have 98 percent chance of it not coming back. The patient did take the vaccination and still had nerve damage and occasional blister that breaks out. The patient reported that he/she has fingers crossed that eventually it won't come back.
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| 2836486 | 04/17/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failu...
Herpes zoster, Pain, Vaccination failure; Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; a year later I had the shingles; This serious case was reported by a ...
Suspected vaccination failure; a year later I 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. 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, 1 year after receiving Shingles vaccine and an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: a year later I had the shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving. 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: 10-APR-2025 The case was received from the patient via interactive digital media. The patient had the shingles shot and the booster shot and a year later he/she had the shingles, that was 6 weeks ago. The patient starting to recover. It has been painful, so having the shot doesn't keep you from getting the shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (dose 1 and 2).
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| 2836487 | M | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Gait inability, Herpes zoster, Muscle disorder, Vaccination failure, Wheelchair ...
Gait inability, Herpes zoster, Muscle disorder, Vaccination failure, Wheelchair user
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Suspected vaccination failure; kept getting shingles; he could no longer walk; This serious case was...
Suspected vaccination failure; kept getting shingles; he could no longer walk; 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: kept getting shingles) and unable to walk (Verbatim: he could no longer walk). The outcome of the vaccination failure, shingles and unable to walk were not reported. It was unknown if the reporter considered the vaccination failure, shingles and unable to walk to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and unable to walk to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 11-APR-2025 This case was reported by a consumer via interactive digital media. Reporter refused this dad got the shot for shingles and kept getting shingles and he got to where he needed wheel chair he could no longer walk and they called it something in muscles. So he/she will be refused. 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. This was 1 out of 3 linked cases, reported by same reporter different patient.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR045181:same reporter /different patient US-GSK-US2025AMR045186:same reporter /different patient
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| 2836488 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; shingles; This serious case was reported by a consumer via 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 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 and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. Patient had the vaccine and have 2 cases since the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine"
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| 2836489 | 04/17/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; still got them; This serious case was reported by a consumer via inte...
Suspected vaccination failure; still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got them). 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 10-APR-2025 The case was received from the patient via interactive digital media. The patient got the two shots and still got them. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine" US-GSK-US2025AMR045315:Same reporter
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| 2836490 | F | TN | 04/17/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
UNK UNK |
Extra dose administered, Off label use; Extra dose administered, Off label use
Extra dose administered, Off label use; Extra dose administered, Off label use
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Because of her inability to maintain antibodies she is re-vaccinated with Meningococcal vaccines; Th...
Because of her inability to maintain antibodies she is re-vaccinated with Meningococcal vaccines; This non-serious case was reported by a physician via sales rep and described the occurrence of off label use in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Co-suspect products included Men B NVS (Bexsero) for prophylaxis. The patient's past medical history included dialysis (The patient also undergoes dialysis for treatment of this syndrome) and henoch-schonlein purpura. Concurrent medical conditions included autoimmune disorder. On an unknown date, the patient received Menveo and Bexsero. On an unknown date, an unknown time after receiving Menveo and Bexsero, the patient experienced off label use (Verbatim: Because of her inability to maintain antibodies she is re-vaccinated with Meningococcal vaccines). The outcome of the off label use 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 : 08-APR-2025 Adult Female had an autoimmune syndrome. The syndrome ends in Purpura (possibly Henoch-Schonlein purpura). Over time her therapy to treat the syndrome had decreased her immune system's ability to maintain antibodies. The patient also undergoes dialysis for treatment of this syndrome. Because of her inability to maintain antibodies she was re-vaccinated with Meningococcal vaccines (unknown if Menveo or Bexsero or both) every 2 to 4 years which led to off label use.
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| 2836491 | 0.17 | M | KS | 04/17/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
JT347 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Underage administration (2 month old patient); This non-serious case was reported by a other health ...
Underage administration (2 month old patient); 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 2-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number JT347, expiry date 30-SEP-2025) for prophylaxis. On 19-MAR-2025, the patient received Menveo. On 19-MAR-2025, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Underage administration (2 month old patient)). The outcome of the inappropriate age at vaccine administration was not applicable. Additional Information: GSK Receipt Date: 07-APR-2025 The other health professional reported that since in the audit just found a male two month old patient was administered a Menveo 1 vial vaccine which led to inappropriate age at vaccine administration.
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| 2836492 | 04/17/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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Maladministration of Priorix intramuscular; This non-serious case was reported by a pharmacist via c...
Maladministration of Priorix intramuscular; 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 an unspecified number of patients who received MMR (Priorix) 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: Maladministration of Priorix intramuscular). 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: 07-APR-2025 Pharmacist reported that she and several colleagues administer Priorix IM instead of SC to adult patients, which led to subcutaneous injection formulation administered by other route. No further information provided. Did not consent to follow-up.
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| 2836493 | 11 | F | PA | 04/17/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB056A |
Product preparation error
Product preparation error
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powder portion was drowning up with normal saline; powder portion was drowning up with normal saline...
powder portion was drowning up with normal saline; powder portion was drowning up with normal saline; 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 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On 01-APR-2025, the patient received Menveo. On 01-APR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: powder portion was drowning up with normal saline) and inappropriate dose of vaccine administered (Verbatim: powder portion was drowning up with normal saline). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 07-APR-2025 Other HCP reported that they received a box with 2 vials presentation (Menveo), one the powder one the liquid, and when drowning up to give to a patient, powder portion was drowning up with normal saline and the liquid was completely not given. Menveo reconstituted with normal saline instead of the supplied CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
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| 2836494 | TN | 04/17/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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patient that received one dose of Shingrix in 2018/ did not receive 2nd dose; This non-serious case ...
patient that received one dose of Shingrix in 2018/ did not receive 2nd dose; This non-serious case was reported by a other health professional 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 one dose in 2018). On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient that received one dose of Shingrix in 2018/ did not receive 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 08-APR-2025 The reporter reported that he/she had a patient that received one dose of Shingrix in 2018. The reporter wanted to know did the series need to be restarted since so much time has elapsed for the second shot. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination.
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| 2836495 | F | 04/17/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Food allergy, Ocular hyperaemia, Periorbital swelling, Rash, Rash pruritic; Skin...
Food allergy, Ocular hyperaemia, Periorbital swelling, Rash, Rash pruritic; Skin warm
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eyes it is very red in a weird pattern; developed rashes galore after having the first dose of Enger...
eyes it is very red in a weird pattern; developed rashes galore after having the first dose of Engerix-B; also swelling around her eyes; food allergy; itch rash; quite warm; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye red in a 2-year-old female patient who received HBV (Engerix B) for prophylaxis. On 12-FEB-2025, the patient received the 1st dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced eye red (Verbatim: eyes it is very red in a weird pattern), rash (Verbatim: developed rashes galore after having the first dose of Engerix-B), periorbital swelling (Verbatim: also swelling around her eyes), food allergy (Verbatim: food allergy), itchy rash (Verbatim: itch rash) and skin warm (Verbatim: quite warm). The outcome of the eye red and periorbital swelling were resolving and the outcome of the rash was unknown and the outcome of the food allergy, itchy rash and skin warm were not reported. It was unknown if the reporter considered the eye red, periorbital swelling, food allergy, itchy rash and skin warm to be related to Engerix B and Engerix B Pre-Filled Syringe Device. The reporter considered the rash to be possibly related to Engerix B. It was unknown if the reporter considered the rash to be related to Engerix B Pre-Filled Syringe Device. It was unknown if the company considered the eye red, periorbital swelling, food allergy, itchy rash and skin warm to be related to Engerix B and Engerix B Pre-Filled Syringe Device. The company considered the rash to be possibly related to Engerix B. It was unknown if the company considered the rash to be related to 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:08-APR-2025 A customer called in behalf of her daughter to ask questions related to Engerix-B. The caller (grandmother of the patient) was from one country, the daughter and her granddaughter were from another country. She asked for a list of all ingredients of Engerix-B, what page could they found the list of ingredients in the PI of Engerix-B. The grandchild of the caller could possibly have developed rashes after having the first dose of Engerix-B, the female patient was 2 and a half years old. The first dose of Engerix-B was administered and under the course of the next 3 weeks she has got rashes galore and she has never had any problems before. The grandmother says it could be a coincidence because the family have sensitive skin. The rash comes in certain spots and then heal and goes away. The rash is going away was in different places of her body, they had putted cortisone to treat this rash. The grandchild was also having swelling around her eyes it was very red in a weird pattern but it was getting better. They were getting ready just in case because the patient will need the next doses. They first thought it was an itch rash when it started because it was behind her neck and it was quite warm at touch that day. Now the rash was in her legs. Their Dr said it could be a food allergy. The reporter did not consent to follow-up.
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| 2836496 | F | TX | 04/17/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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would they have to restart the dose or will they still proceed getting their 2nd dose; This non-seri...
would they have to restart the dose or will they still proceed getting their 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 01-JAN-2021). 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: would they have to restart the dose or will they still proceed getting their 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 09-APR-2025 The health care professional reported that a patient had her 1st (Shingrix) dose in 2021, would they have to restart the dose or will they still proceed getting their 2nd dose. At the beginning of the call, HCP mentioned that this was about Shingrix only mentioned 2021 as the vaccination date for 1st dose, but she did not have the specific date (reporter set this as 01-01-2021 due to the system did not allow only the year). Health care professional mentioned that the patient is not immunocompromised. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2836497 | F | NY | 04/17/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
955E2 |
Incorrect route of product administration
Incorrect route of product administration
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A 60 years old female patient received a dose of Priorix via IM instead of subcutaneous.; This non-s...
A 60 years old female patient received a dose of Priorix via IM instead of subcutaneous.; 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 60-year-old female patient who received MMR (Priorix) (batch number 955E2, 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 60 years old female patient received a dose of Priorix via IM instead of subcutaneous.). 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: 10-APR-2025 The reporter called to report that a patient received Priorix IM instead of SQ and asked if it was ok, which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up.
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| 2836498 | 59 | M | OH | 04/17/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
LG749 |
Underdose
Underdose
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Engerix-B- Pediatric dose administered to an adult patient; Engerix-B- Pediatric dose administered t...
Engerix-B- Pediatric dose administered to an adult patient; Engerix-B- Pediatric dose administered to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 59-year-old male patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. On 11-APR-2025, the patient received the 1st dose of Engerix B pediatric. On 11-APR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B- Pediatric dose administered to an adult patient) and accidental underdose (Verbatim: Engerix-B- Pediatric dose administered to an adult patient). The outcome of the adult use of a child product and accidental underdose were not applicable. Additional Information: GSK Receipt Date: 11-APR-2025 Nurse reported that on 11th April 2025, an adult male patient had erroneously received the first dose of Engerix-B pediatric, which led to Adult use of a child product and Accidental underdose.
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| 2836499 | 79 | F | HI | 04/17/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
J942L |
Incorrect route of product administration
Incorrect route of product administration
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Priorix intramuscularly instead of subcutaneously administration; This non-serious case was reported...
Priorix intramuscularly instead of subcutaneously administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 79-year-old female patient who received MMR (Priorix) (batch number J942L, expiry date 08-NOV-2026) for prophylaxis. On 11-APR-2025, the patient received Priorix (intramuscular). On 11-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix intramuscularly instead of subcutaneously 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: 11-APR-2025 Pharmacy Technician wanted to know how to proceed after giving Priorix intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2836500 | M | 04/17/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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contracted Covid-19; This spontaneous case was reported by a patient family member or friend and des...
contracted Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (contracted Covid-19) in a male patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: spikevax NOS (in the previous years.). Past adverse reactions to the above products included No adverse effect with spikevax NOS. In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) outcome was unknown. Concomitant product use was not provided by the reporter. Patient and their spouse both have received Spikevax in November 2024 as well as in the previous years. They both contracted Covid-19. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided. Reporter causality was not reported. This case contains information for the 2nd patient out of 2 patients. This case was linked to US-MODERNATX, INC.-MOD-2025-784847 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784847:Patient 2 of 2
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| 2836501 | F | 04/17/2025 |
COVID19 |
MODERNA |
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COVID-19
COVID-19
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contracted Covid-19; This spontaneous case was reported by a patient and describes the occurrence of...
contracted Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (contracted Covid-19) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS. Past adverse reactions to the above products included No adverse effect with Spikevax NOS. In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted Covid-19). At the time of the report, COVID-19 (contracted Covid-19) outcome was unknown. The concomitant medication was not reported. Patient and her spouse both had received Spikevax in November 2024 as well as in the previous years. It was unknown if the patient experienced any additional symptoms/events. The treatment drug information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-784855 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784855:Patient 1 of 2
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| 2836502 | F | IA | 04/17/2025 |
COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FC3182 FC3182 FC3182 |
Body height, Childhood asthma, Dyspnoea, Infantile diarrhoea, Infantile vomiting...
Body height, Childhood asthma, Dyspnoea, Infantile diarrhoea, Infantile vomiting; Maternal exposure during breast feeding, Nasal congestion, Rash, Screaming, Weight; Weight gain poor
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I was breastfeeding at the time; asthma/wheezing; extreme stuffiness in her nose; she was having tro...
I was breastfeeding at the time; asthma/wheezing; extreme stuffiness in her nose; she was having trouble breathing in the middle of the night; Vomiting; Had green slimy diarrhea; She quit gaining weight; She would wake up in the middle of the night with high pitched scream; She developed these weird red patchy rashes; This is a spontaneous report received from a Nurse, Program ID. A 3-month-old female patient was exposed to BNT162b2 (BNT162B2), transmammary, administration details for the mother: not provided, on 03Sep2021 as dose number unknown, single (Lot number: FC3182) for covid-19 immunisation. The patient's and the mother's relevant medical history and concomitant medications were not reported. The following information was reported: MATERNAL EXPOSURE DURING BREAST FEEDING (hospitalization), outcome "unknown", described as "I was breastfeeding at the time"; CHILDHOOD ASTHMA (hospitalization), outcome "unknown", described as "asthma/wheezing"; NASAL CONGESTION (non-serious), outcome "unknown", described as "extreme stuffiness in her nose"; DYSPNOEA (non-serious), outcome "unknown", described as "she was having trouble breathing in the middle of the night"; INFANTILE VOMITING (non-serious), outcome "unknown", described as "Vomiting"; INFANTILE DIARRHOEA (non-serious), outcome "unknown", described as "Had green slimy diarrhea"; WEIGHT GAIN POOR (non-serious), outcome "unknown", described as "She quit gaining weight"; SCREAMING (non-serious), outcome "unknown", described as "She would wake up in the middle of the night with high pitched scream"; RASH (non-serious), outcome "unknown", described as "She developed these weird red patchy rashes". The patient was hospitalized for childhood asthma (start date: May2022). The patient underwent the following laboratory tests and procedures: Body height: 98 percentile; Weight: 8 lbs. Therapeutic measures were taken as a result of childhood asthma. Therapeutic measures were not taken as a result of nasal congestion. Clinical course: the patient's mother was breastfeeding at the time and told by patient's (daughter) doctor that it would be okay but the mother was pretty concerned about that as well and the mother believe the patient having the adverse reaction from the breastfeeding from the milk as well but the pharmacist told mother that it would be safe for 15 minutes he read in the study etc. The mother ended up taking this and the mother stayed in the store for 15 minutes like them they told her to. The mother ended up taking this (Pfizer COVID-19 Vaccine). The patient started problems the night of mother's shot, she was 16 pounds at that time, she was, she had just doubled her weight, she was born at 8 pounds but could not tell how long she was. She was then like 98 percentile for length so. The patient started out with like extreme stuffiness in her nose like when she was breathing and the mother asked her husband like do you think that she was having a history making problem for this and he thought the mother was being crazy after time but it all makes sense now. She had not been sick, they had been isolated for a year so within that evening of the patient getting it, the mother got it late afternoon. The patient was having trouble breathing in the middle of the night, was like being off, stuffed up and then it progressed from there. The patient did not get anything for the stuffiness but she started vomiting after that, for several months. She had green slimy diarrhea for several months, she quit gaining weight and she developed asthma within a month. Once she was diagnosed with asthma for the following month, she was wheezing pretty bad and she was put on breathing treatments (Unspecified medication) and steroid (Clarified as Prednisolone) and then she had a problem with asthma after that, several times. She was hospitalized "the next year in May". So, right around when she was year old, she was in the hospital, needed oxygen, breathing treatments and steroid. The steroid she was given each time was Prednisolone, the Orapred. Just to finish up the patient, she did follow with pulmonology now because she had been diagnosed asthma which she had never had an issue before mother breastfeeds and no one in her family had asthma, no asthma, nothing. The mother just thought of something else that happened to the patient. She never had done this before, neither had any of mother's other kids but right after she breastfed, right after the mother got the shot, she would wake up in the middle of the night with high pitched scream. You are going to think this was weird. The patient could not talk, so it's hard to say but that's just what we knew. The patient did not get eczema after the shot but she developed these weird red patchy rashes all the time, out of no where, when she was probably from the time she started breastfeeding after the mother got the shot (Pfizer COVID-19 Vaccine) "two year old". Amendment: This follow-up report is being submitted to amend previously reported information: event term "asthma" was updated to "infantile asthma".; Sender's Comments: As there is limited information in the case provided, the causal association between the event childhood asthma and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101381462 maternal case;
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| 2836503 | 64 | NJ | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
LM2216 |
COVID-19, Drug ineffective, SARS-CoV-2 test
COVID-19, Drug ineffective, SARS-CoV-2 test
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got Pfizer's shot / had COVID / It did not work; got Pfizer's shot / had COVID / It did no...
got Pfizer's shot / had COVID / It did not work; got Pfizer's shot / had COVID / It did not work; This is a spontaneous report received from a Consumer or other non HCP. A 64-year-old patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 15Feb2025 as dose 1, 0.3 ml single (Lot number: LM2216) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; LISINOPRIL. The patient also took other concomitant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "got Pfizer's shot / had COVID / It did not work". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) COVID; (10Apr2025) still had COVID; (05Apr2025) COVID. Therapeutic measures were not taken as a result of drug ineffective, covid-19. The clinical course was reported as follows: Patient got the Pfizer's shot and now had COVID. I did not work. No blood work, patient did go to complete care to get checked for see if she/he had COVID. The patient was told that she/he had COVID and patient checked it the home test and she/he had COVID. Then the patient did one in the morning of 10Apr2025 which was five days later and still had COVID.
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| 2836504 | F | TX | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I've had two. We use Pfizer/ both got Covid; I've had two. We use Pfizer/ both got Covid; ...
I've had two. We use Pfizer/ both got Covid; I've had two. We use Pfizer/ both got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've had two. We use Pfizer/ both got Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.
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| 2836505 | F | VA | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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We never got the virus until this week; We never got the virus until this week; This is a spontaneou...
We never got the virus until this week; We never got the virus until this week; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 66-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "We never got the virus until this week". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The husband reported that they got Covid last week. They got the medicine today from the doctor's prescription, Pax Covid. Both got the Pfizer vaccine when it first came out. And had all the vaccines until the pandemic was over. They never got the virus until this week. Fortunately they had the medicine, and they had the testing and everything was already in place and got the medication easily. 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-PV202500044564 same reporter/drug/event different patient;
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| 2836506 | 69 | F | CA | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Vaccination failure
COVID-19, Vaccination failure
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she had Covid; she had Covid; The initial case was missing the following minimum criteria: Unspecifi...
she had Covid; she had Covid; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 09Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 69-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 02Mar2025 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation, reaction(s): "No adverse effect". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Mar2025, outcome "recovering" and all described as "she had Covid". Therapeutic measures were taken as a result of covid-19. Clinical details: the patient had a letter from Pfizer due to a reaction from a Covid Vaccine. She got a reaction to Covid Vaccine in Mar2025; she had on the 2nd, her last one. She's had everyone, which she was ok. And then, two weeks after that, she had Covid. The patient stated she is doing better. She was taking Paxlovid. It got rid of all her symptoms, its like a heavy duty drug. She's fully vaxxed too. She's just glad the Paxlovid worked for her right away. 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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| 2836507 | TN | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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Tinnitus
Tinnitus
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pulsitile tinnitus; The initial case was missing the following minimum criteria: unspecified product...
pulsitile tinnitus; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "pulsitile tinnitus". 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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| 2836508 | F | FL | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I keep getting Covid, even though I took six of the Pfizer vaccines; I keep getting Covid, even thou...
I keep getting Covid, even though I took six of the Pfizer vaccines; I keep getting Covid, even though I took six of the Pfizer vaccines; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 75-year-old female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), 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: COVID three times already, once in 2022 and Mar2024, Apr2024. The patient's concomitant medications were not reported. Vaccination history included: Pfizer covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 3, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 4, SINGLE), for COVID-19 immunisation; Pfizer covid-19 vaccine (DOSE 5, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "I keep getting Covid, even though I took six of the Pfizer vaccines". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: The patient stated, "I just signed up for assistance to the patient assistance program to obtain Paxlovid 'cause I keep getting Covid, even though I took six of the Pfizer vaccines, I keep getting Covid. This is my third time for the year." When asked if the patient had taken Paxlovid before, the patient stated, "Yes, this is going to be my third time. Actually the fourth, this is going to be the fourth" When asked when the first time was that the patient took Paxlovid, the patient said, "2022 I had it in Mar of this year, and then Apr of this year, and now Jul2024. I took this (inaudible) two shots, I took four booster shots, but the thing is I would sneeze a lot and headache and runny nose."
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| 2836509 | M | CA | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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Covid-19/I have had all covid 19 vacciantions and boosters; Covid-19/I have had all covid 19 vaccian...
Covid-19/I have had all covid 19 vacciantions and boosters; Covid-19/I have had all covid 19 vacciantions and boosters; This is a spontaneous report received from a Consumer or other non HCP. A 71-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; COVID-19 vaccine nrvv ad26 (jnj 78436735) (VACUNA COVID-19 JANSSEN), in Dec2020 as dose number unknown, single) for covid-19 immunisation. The patient's relevant medical history included: "cholesterol increased" (unspecified if ongoing); "Blood pressure increased" (unspecified if ongoing); "seasonal allergies" (ongoing), notes: Still having allergy symptoms due to seasonal allergies. Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased; LISINOPRIL taken for blood pressure increased; VITAMIN B12 [COBAMAMIDE]; CLARITIN [LORATADINE] taken for seasonal allergy. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19/I have had all covid 19 vacciantions and boosters". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking any other medications within 2 weeks prior to the event onset. The patient is not allergic to any previous vaccination, medications, food or other products. There are no any other diagnosed illnesses / medical history / chronic health conditions to report. Have had all Covid 19 vaccinations and boosters. Even participated in clinical Trial of J& J vaccine in Dec2020. Had avoided getting Covid for 4+ years even when my wife had it twice. 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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| 2836510 | F | NH | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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I've had the Pfizer vaccine/ this is my second bout with Covid; I've had the Pfizer vaccin...
I've had the Pfizer vaccine/ this is my second bout with Covid; I've had the Pfizer vaccine/ this is my second bout with Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old female 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: "covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I've had the Pfizer vaccine/ this is my second bout with Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient mentioned she had really good luck. She has had the Pfizer vaccine and this is her second bout with Covid so this will be the second time taking the medicine.
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| 2836511 | M | TX | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, Drug ineffective
COVID-19, Drug ineffective
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He's had three shots. We use Pfizer/ both got Covid; He's had three shots. We use Pfizer/ ...
He's had three shots. We use Pfizer/ both got Covid; He's had three shots. We use Pfizer/ both got Covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 63-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cancer patient" (ongoing); "very low immune system" (ongoing); "Covid-19", start date: 2023 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2024, outcome "unknown" and all described as "He's had three shots. We use Pfizer/ both got Covid". Therapeutic measures were taken as a result of drug ineffective, covid-19.
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| 2836512 | M | VA | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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We never got the virus until this week; We never got the virus until this week; This is a spontaneou...
We never got the virus until this week; We never got the virus until this week; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2024, outcome "recovered" and all described as "We never got the virus until this week". The patient underwent the following laboratory tests and procedures: Investigation NOS: Unknown results, notes: they had the testing and everything was already in place. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reporter stated that they got Covid last week. They got the medicine today from the doctor's prescription, Pax Covid. Both got the Pfizer vaccine when it first came out. And had all the vaccines until the pandemic was over. They never got the virus until this week. Fortunately they had the medicine, and they had the testing and everything was already in place and got the medication easily. 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-202500079122 same reporter/drug/event different patient;
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| 2836513 | F | CT | 04/17/2025 |
COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH |
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Blindness, COVID-19, Dizziness, Drug ineffective, Headache; Migraine, Nausea, Vi...
Blindness, COVID-19, Dizziness, Drug ineffective, Headache; Migraine, Nausea, Vision blurred
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had Covid; had Covid; lost my eyesight; felt like someone hit me with something really hard in the l...
had Covid; had Covid; lost my eyesight; felt like someone hit me with something really hard in the lower quadrant in the back of my head/headache; completely dizzy; it went into a fog; I had a migraine for five straight months-night; nausea; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 54-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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "had Covid"; BLINDNESS (medically significant), outcome "unknown", described as "lost my eyesight"; HEADACHE (non-serious), outcome "unknown", described as "felt like someone hit me with something really hard in the lower quadrant in the back of my head/headache"; DIZZINESS (non-serious), outcome "unknown", described as "completely dizzy"; VISION BLURRED (non-serious), outcome "unknown", described as "it went into a fog"; MIGRAINE (non-serious), outcome "unknown", described as "I had a migraine for five straight months-night"; NAUSEA (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: My wife and I tested positive for covid. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: During an inbound call for assistance with a voucher not working at the pharmacy, the reporter stated, "It's hard to concentrate. I just feel so bad, I'm really losing it here. I just felt so bad all night, neither one of us can think." The reporter then referred to her own experience by stating, "I'm afraid to take the medicine, but I'll do it if I have to. The first time I had Covid, I took Paxlovid. Paxlovid will make you feel so sick while you're on it, that you almost wish that you just tried to ride it out and see how it will go. It's a tough drug. Halfway through that medicine, I was so dried out. That alone makes you feel like you don't breathe well. It's a strong drug. It must help people who need it. It probably helped me, so I can't complain, but it's a strong medicine." The reporter then stated, "I got the Pfizer shot and after I got that shot it felt like someone hit me with something really hard in the lower quadrant in the back of my head. It felt like someone hit me in the lower left side of my head. It hurt so bad, but I didn't say anything to anyone there. And so, I came home. I started to walk; I couldn't walk a straight line. I was completely dizzy. All of a sudden, the whole room started to disappear. I completely lost my eyesight; it went into a fog. It was very scary. I don't know if I had enough time to be scared when it happened, but afterwards, when I thought about it, you lost your eyesight. And the headache, it came back." The reporter further stated, "I was very dizzy. I was so dizzy I couldn't believe it. I had a migraine for five straight months - day, all day long nausea. My whole head was killing me, five months. I never went back for another vaccine for Covid again. I want to get this medicine especially for him, he's a heart patient, he had a heart attack."
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| 2836514 | F | 04/17/2025 |
COVID19 |
PFIZER\BIONTECH |
|
COVID-19, COVID-19 pneumonia, Drug ineffective
COVID-19, COVID-19 pneumonia, Drug ineffective
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positive for Covid and prescribed Paxlovid/pneumonia; positive for Covid and prescribed Paxlovid; pn...
positive for Covid and prescribed Paxlovid/pneumonia; positive for Covid and prescribed Paxlovid; pneumonia; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 76-year-old female 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 and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete.), for Covid-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: COVID-19 PNEUMONIA (medically significant) with onset 01Apr2024, outcome "unknown", described as "pneumonia"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "positive for Covid and prescribed Paxlovid/pneumonia"; COVID-19 (medically significant), outcome "unknown", described as "positive for Covid and prescribed Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, covid-19 pneumonia. Clinical course: It was clarified that the patient and her husband are both positive for Covid and both prescribed Paxlovid. The patient have a sinus infection and pneumonia and so she's on day 11 now (12Apr2024). On 12Apr2024 is 11 days ago with the pneumonia, sinus infection and so the patient was done antibiotics and steroids and all that kind of stuff. So, she don't need it (Paxlovid) at this point. She think it's too late for her. The patient had Paxlovid before and it made such a difference. The patient stated that she thinks that she and her husband have had it (Paxlovid) one other time. And they've had all the Pfizer vaccines too.
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| 2836515 | M | 04/17/2025 |
MEN |
UNKNOWN MANUFACTURER |
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Injection site pain, Injection site reaction
Injection site pain, Injection site reaction
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injection site reaction and it began spreading; it hurt really bad; Initial information received on ...
injection site reaction and it began spreading; it hurt really bad; Initial information received on 04-Apr-2025 regarding an unsolicited valid non-serious case received from a patient's relative. This case involves an Adolescent male patient (154.94 cm and 61.82 kg) who had injection site reaction and it began spreading and it hurt really bad while receiving vaccine MENINGOCOCCAL VACCINE and while treated with DUPILUMAB [DUPIXENT] delivered via dupilumab prefilled syringe. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing allergies: johnson grass 1:20 vial. Concomitant medications included Levocetirizine dihydrochloride (Levocetirizine dihydrochloride). On an unknown date, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection (strength: 200mg/1.14ml) at a dose 200 mg QOW subcutaneous for undefined delivered via dupilumab prefilled syringe. On 31-Mar-2025, the patient received a dose of suspect MENINGOCOCCAL VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date the patient developed a non-serious event "injection site reaction and it began spreading" (injection site reaction) (unknown latency) following the first dose intake (batch number: 4L240Z and expiry date on 31-Mar-2027) of DUPILUMAB and (with unknown batch number and expiry date) of MENINGOCOCCAL VACCINE . On an unknown date the patient developed a non-serious event "it hurt really bad" (injection site pain) (unknown latency) following the first dose intake (batch number: 4L240Z and expiry date on 31-Mar-2027) of DUPILUMAB and (with unknown batch number and expiry date) of MENINGOCOCCAL VACCINE . It was reported "meningococcal vaccine was taken on 31-Mar and patient did not respond well per mother. patient had injection site reaction and it began spreading. it was getting better. patient told his mom it hurt really bad". Action taken with DUPILUMAB: Unknown for both the events. Action taken with MENINGOCOCCAL VACCINE: Not applicable for both the events. Corrective treatment: Not reported for both the events. Outcome: Recovering / Resolving for the event injection site reaction and Unknown for the event injection site pain.
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| 2836518 | F | 04/17/2025 |
DTAP |
SANOFI PASTEUR |
C5281AA |
Liquid product physical issue
Liquid product physical issue
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deteriorated vaccine administered with no reported adverse event; Initial information received on 06...
deteriorated vaccine administered with no reported adverse event; Initial information received on 06-Apr-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional This case involves an unknown age female patient who had deteriorated DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] administered 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 a deteriorated dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5281AA, Expiry: 05-Oct-2019) via unknown route in unknown administration site for prophylactic vaccination as white particles were noticed to be floating in the vials when administering (poor quality product administered) (latency: same day). It was reported, before this issue was identified 5 vials was already administered to 5 patients. Reporter also asked, I would like to have the following Lot's checked. Concerning as my daughter received the same lot. Can a few batches be contaminated, while others are ok and the Lot's: C5281AA, C5307AA & C5367AA. Action taken: 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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| 2836519 | 21 | F | MD | 04/17/2025 |
YF |
SANOFI PASTEUR |
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Expired product administered
Expired product administered
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expired YF-Vax was administered with no reported adverse event; Initial information received on 10-A...
expired YF-Vax was administered with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 years old female patient to whom expired yellow fever vaccine [YF-VAX] was administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Apr-2025, the patient was administered an expired dose of suspect yellow fever vaccine (Solution for injection) (expiry date: 31-Mar-2025) strength; lot number not reported) via unknown route in unknown administration site for Immunisation with no reported adverse event (expired product administered) (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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| 2836520 | 19 | F | SC | 04/17/2025 |
MEN MMR |
UNKNOWN MANUFACTURER MERCK & CO. INC. |
U7852AB |
No adverse event, Product preparation error; No adverse event, Product preparati...
No adverse event, Product preparation error; No adverse event, Product preparation error
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had a "vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly...
had a "vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II administered this mixture to patient, with no reported adverse event; had a "vaccine mix-up" and that the MENQUADFI was beside the diluent for MMR-II/mistakenly combined the MENQUADFI with the MMR-II administered this mixture to patient, with no reported adverse event; Initial information received on 10-Apr-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to US-SA-2025SA105763 (Cluster case). This case involves a 19 years old female patient who experienced a vaccine mix-up" and that the Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] was beside the diluent for MMR-II/mistakenly combined the menquadfi with the MMR-II and the patient was administered this mixture, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Apr-2025, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot U7852AB , Expiry: 31-Oct-2025) (Strength: Standard) via intramuscular route in the left arm as immunization which was mistakenly mixed with MMR-II as diluent, the menquadfi was beside the diluent for MMR-II with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day). Reportedly, they said that these patients did not need MENQUADFI. Pharmacist said that patients did not report any adverse events. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2025SA105763:patient 2
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| 2836521 | MA | 04/17/2025 |
IPV |
SANOFI PASTEUR |
X1C891M |
No adverse event, Product storage error
No adverse event, Product storage error
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Ipol was given post excursion to one patient with no reported adverse event; Initial information rec...
Ipol was given post excursion to one patient with no reported adverse event; Initial information received on 11-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient to whom received IPV (Vero) [Ipol] was given post excursion to one patient 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, in Apr-2025 ,the patient received a unknown dose of suspect IPV (Vero) Suspension for injection (strength: unknown, expiry date: 31-Oct-2026 and lot X1C891M) via unknown route in unknown administration site as prophylactic vaccination (immunization) and was given post excursion to one patient with no reported adverse event (poor quality product administered) (same day latency). Reportedly: Max/low temperature reached: 10 MINS 8.8C Reason: Unknown, Human error: No, the extended stability data cover the excursion all except for the open IPOL. The caller reported that the excursion took place on 04Apr2025; that they were made are of the incident after the vaccine was administered; that there is no more information available for this report due to the caller's computer was down at the time of the call. Action taken: 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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| 2836522 | NC | 04/17/2025 |
HIBV |
SANOFI PASTEUR |
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No adverse event, Product preparation error
No adverse event, Product preparation error
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acthib was diluted with sterile water instead of 0.4% sod chloride and given to a patient with no re...
acthib was diluted with sterile water instead of 0.4% sod chloride and given to a patient with no reported adverse event; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who was given experienced HIB (PRP/T) VACCINE [ACT-HIB] which was diluted with sterile water instead of 0.4% sodium chloride 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 was given unknown dose of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (strength, lot number and expiry date not reported) via unknown route in unknown administration site for immunization which was diluted with sterile water instead of 0.4% sodium chloride with no reported adverse event (product preparation error) (same day: latency). Action taken: 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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| 2836523 | 1 | F | LA | 04/17/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK110A |
No adverse event, Product preparation issue
No adverse event, Product preparation issue
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patient only received one of the two vials they were supposed to with no adverse event; Initial info...
patient only received one of the two vials they were supposed to with no adverse event; Initial information received on 14-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient who received only one of the two vials for diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)], they were supposed to with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) and pneumococcal vaccine, both for Immunisation. On 04-Apr-2025, the patient received only one of the two vials for Dose 4 of 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine Suspension for injection of standard strength with lot UK110A and expiry date 31-Aug-2025 via intramuscular route in the left vastus lateralis for Immunization they were supposed to with no adverse event (single component of a two-component product administered) (Latency same day). Reportedly, reporter stated that it is possible that instead of reconstituting the 2 vials together, only one was reconstituted with sterile water and administered 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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| 2836531 | 49 | F | NJ | 04/17/2025 |
COVID19 |
MODERNA |
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Arthralgia, Muscle disorder, Pain in extremity, Rheumatoid factor
Arthralgia, Muscle disorder, Pain in extremity, Rheumatoid factor
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Sore hand joints, then sore feet, then sore legs, sore hips, loss of muscular control from waist dow...
Sore hand joints, then sore feet, then sore legs, sore hips, loss of muscular control from waist down
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✓ | |||||
| 2836541 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Paralysis
Paralysis
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I know someone who took it and was paralyzed; This serious case was reported by a consumer via inter...
I know someone who took it and was paralyzed; This serious case was reported by a consumer via interactive digital media and described the occurrence of paralysis 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 paralysis (Verbatim: I know someone who took it and was paralyzed) (serious criteria GSK medically significant). The outcome of the paralysis was resolved. It was unknown if the reporter considered the paralysis to be related to Shingles vaccine. The company considered the paralysis to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The reporter knew someone who took it and was paralyzed. They had a long journey to recover from vaccine injury. The patient had to have lots of therapy and had to learn to walk again. This case was linked with US2025AMR045208 from the same reporter.; Sender's Comments: Paralysis is a listed event which is considered related to a GSK vaccine Shingles vaccine US-GSK-US2025AMR045208:Same reporter
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| 2836542 | 60 | M | TX | 04/17/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Dizziness, Myalgia
Dizziness, Myalgia
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he began experiencing dizziness; Muscle pain; This non-serious case was reported by a consumer via c...
he began experiencing dizziness; Muscle pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included blood pressure, benign prostatic hyperplasia and anticoagulant therapy. Concomitant products included nebivolol, morniflumate (Flomax), aspirin, acetylcysteine (N Acetyl Cystein) and collagen. On 02-APR-2025, the patient received Shingrix (intramuscular, left deltoid). On 02-APR-2025, less than a day after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle pain). On 04-APR-2025, the patient experienced dizziness (Verbatim: he began experiencing dizziness). The outcome of the dizziness was not resolved and the outcome of the muscle pain was resolved. It was unknown if the reporter considered the dizziness and muscle pain to be related to Shingrix. It was unknown if the company considered the dizziness and muscle pain to be related to Shingrix. Additional Information: GSK Receipt Date: 07-APR-2025 The patient self-reported this case for himself. The patient received his Shingrix vaccine in his left deltoid. He states that two days later he began experiencing dizziness, which was worse when he was lying flat. The patient had seen his primary care physician who performed the Epley maneuver and administered a steroid shot. He also saw a chiropractor and received a neck adjustment. The patient stated that there has been no improvement. He also reported muscle pain which began the day of the vaccination and went away within a couple of days.
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| 2836543 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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I have shingles now. 3rd time and I had the vaccine; This non-serious case was reported by a consume...
I have shingles now. 3rd time and I had the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I have shingles now. 3rd time and I had the vaccine). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 07-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she had shingles at the time of reporting third time and patient had the vaccine. This time it was the worst patient ever had, also indicated that it was not fun. On meds and will be getting 2nd vaccine after these are gone. Patient would not wish this on worst enemy.
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| 2836544 | F | 04/17/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Visual impairment;...
Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Visual impairment; Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Visual impairment
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Suspected vaccination failure; shingles on the left side of her face and neck and it affected the vi...
Suspected vaccination failure; shingles on the left side of her face and neck and it affected the vision in her left eye; she got shingles on the left side of her face and neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles on the left side of her face and neck and it affected the vision in her left eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: she got shingles on the left side of her face and neck). The outcome of the vaccination failure, ophthalmic herpes zoster and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient's nephew/niece via interactive digital media. The patient got both doses of the Shingrix shot and a few months after the second shot she got shingles on the left side of her face and neck and it affected the vision in her left eye and the shots did not helped her. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Herpes zoster and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingrix."
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| 2836545 | 04/17/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Pain in extremity
Pain in extremity
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my arm was sore is all I get my 2nd shot in may; This non-serious case was reported by a consumer vi...
my arm was sore is all I get my 2nd shot in may; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine (received 1st dose on an unknown date). In MAY-2024, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm was sore is all I get my 2nd shot in may). The outcome of the pain in arm was not reported. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. It was unknown if the company considered the pain in arm to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The arm of the patient was sore all and get 2nd shot in may.
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