| ID | Age | Sex | State | Date ▼ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | 💀 | 🏥 | 🚑 | ♿ | ⚠️ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2855448 | F | 08/25/2025 |
VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK |
Asthenia, Gait inability, Herpes zoster, Pain, Rash; Vaccination failure; Asthen...
Asthenia, Gait inability, Herpes zoster, Pain, Rash; Vaccination failure; Asthenia, Gait inability, Herpes zoster, Pain, Rash; Vaccination failure
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Suspected vaccination failure; Shingles/ rash / pain; weakness; could not walk; This serious case w...
Suspected vaccination failure; Shingles/ rash / pain; weakness; could not walk; 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 (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, 2 months 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), shingles (Verbatim: Shingles/ rash / pain), weakness (Verbatim: weakness) and unable to walk (Verbatim: could not walk). The patient was treated with gabapentin and ferric ammonium citrate, methionine, vitamin b nos (Geritol). The outcome of the vaccination failure, shingles, weakness and unable to walk were not reported. It was unknown if the reporter considered the vaccination failure, shingles, weakness and unable to walk 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, weakness and unable to walk to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a patient via interactive digital media. The patient stated they had both injections of Shingles vaccine and two months later had shingles. The rash was minor and gone in a few weeks. The doctor prescribed gabapentin along with another medication, which the patient could not recall. The patient stated they were bedridden for a month, sleeping 10 to 12 hours a day, and experienced very little pain. The patient mentioned it was weakness and could not walk. A friend recommended taking Geritol tablets, which the patient believes have saved him/her. The patient was ashamed about going to Walmart for medication, as people would often ask what had happened to them. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2). US-GSK-US2025AMR104473:Report from same reporter
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| 2855449 | M | 08/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Herpes zoster, Impaired work ability, Vaccination failure; Herpes zoster, Impair...
Herpes zoster, Impaired work ability, Vaccination failure; Herpes zoster, Impaired work ability, Vaccination failure
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Suspected vaccination failure; Shingles; was out of work; This serious case was reported by a consu...
Suspected vaccination failure; Shingles; was out of work; 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 (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, 2 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), shingles (Verbatim: Shingles) and impaired work ability (Verbatim: was out of work). The patient was treated with gabapentin. The outcome of the vaccination failure and shingles were not reported and the outcome of the impaired work ability was resolved (duration 5 days). It was unknown if the reporter considered the vaccination failure, shingles and impaired work ability to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and impaired work ability to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a patient's wife via interactive digital media. The reporter and the patient received both injections of the vaccine and two months later had shingles. The patient was out of work 5 days. The doctor prescribed gabapentin and something else. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with case US2025AMR104472 from the same reporter for herself.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, medical history, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).
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| 2855450 | 08/25/2025 |
VARZOS VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK UNK |
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administ...
Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure; Extra dose administered, Herpes zoster, Vaccination failure
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suspected vaccination failure; shingles after 1st original shot; shingles after 2nd original shot; s...
suspected vaccination failure; shingles after 1st original shot; shingles after 2nd original shot; shingles after 1st newer shot; shingles after 2nd newer shot; received 1st newest shot; received 2nd newest shot; 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, Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine, the 3rd dose of Shingles vaccine and the 4th dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles after 1st original shot), shingles (Verbatim: shingles after 2nd original shot), shingles (Verbatim: shingles after 1st newer shot), shingles (Verbatim: shingles after 2nd newer shot), extra dose administered (Verbatim: received 1st newest shot) and extra dose administered (Verbatim: received 2nd newest shot). The outcome of the vaccination failure was not reported and the outcome of the shingles, shingles, shingles and shingles were resolved and the outcome of the extra dose administered and extra dose administered were not applicable. It was unknown if the reporter considered the vaccination failure, shingles, shingles, shingles and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles, shingles and shingles to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine. 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, Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, shingles, shingles and shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles, shingles and shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles and 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: 10-AUG-2025 This case was reported by the patient via interactive digital media. The patient had both the original shot and the newer 2 shot course, which led to an extra dose administered. The patient got shingles after each but only the mildest, most confined cases and gone quickly. The patient said that vaccines worked just fine. 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, 2, 3 & 4).
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| 2855451 | 08/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Influenza like illness, Pain in extremity
Influenza like illness, Pain in extremity
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vaccinated arm was very painful; felt like had bad flu; This non-serious case was reported by a cons...
vaccinated arm was very painful; felt like had bad flu; 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. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: vaccinated arm was very painful) and influenza (Verbatim: felt like had bad flu). The outcome of the pain in arm was not reported and the outcome of the influenza was resolved (duration 1 week). It was unknown if the reporter considered the pain in arm and influenza to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and influenza to be related to Shingles vaccine. Additional Information: GSK receipt date: 11-AUG-2025 This case was reported by a patient via interactive digital media. The patient reported that 1 day or two after the vaccine were very rough. The arm that received the vaccine was very painful for days. The patient felt like he/she had a bad flu for almost a week.
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| 2855452 | M | 08/25/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster
Herpes zoster
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shingles; This non-serious case was reported by a consumer via interactive digital media and describ...
shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. In JUL-2025, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). 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: 14-AUG-2025 This case was reported by a patient's wife via interactive digital media. The reporter's husband had the 1st of the 2 shots around three weeks ago in July 2025and now had shingles.
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| 2855453 | F | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; Shingles shot 4 years ago unfortunately got shingles; This serious ca...
Suspected vaccination failure; Shingles shot 4 years ago unfortunately got shingles; 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. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles shot 4 years ago unfortunately got shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 20-AUG-2025 This case was reported by a patient via interactive digital media. The patient mentioned she got (Shingrix) shingles shot 4 years ago and had shingles on the left side of body around breast and upper back and was so painful it over one month on back and still have some pain. 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 Shingrix vaccine.
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| 2855454 | 08/25/2025 |
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; have had shingles several times; This serious case was reported by a...
Suspected vaccination failure; have had shingles several times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 77-year-old 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: have had shingles several times). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 18-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles several times in last thirty years plus two vaccine shots. The patient was 77 years and see no future without them. Never really bad but different locations. 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, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2855455 | 63 | F | IN | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
432T3 |
Expired product administered
Expired product administered
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Expired Dose Administered; This non-serious case was reported by the other health professional via c...
Expired Dose Administered; This non-serious case was reported by the other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 432T3, expiry date 18-AUG-2024) for prophylaxis. On 17-JUL-2025, the patient received Shingrix. On 17-JUL-2025, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was not applicable. Linked case(s) involving the same patient: US2023AMR123970 Additional Information: GSK Receipt Date: 28-JUL-2025 There was administration of an expired dose of Shingrix which led to expired vaccine used Consented to follow up.
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| 2855456 | 59 | F | PA | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
93N4J |
Product preparation error
Product preparation error
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Shingrix diluted with sterile water administered; Shingrix diluted with sterile water administered; ...
Shingrix diluted with sterile water administered; Shingrix diluted with sterile water administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J, expiry date 25-APR-2027) for prophylaxis. On 23-JUL-2025, the patient received Shingrix. On 23-JUL-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix diluted with sterile water administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix diluted with sterile water administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-JUL-2025 The registered nurse explained that on 23-Jul-2025, they gave a Shingrix vaccine in the office, but it was not diluted with the diluent that comes in the box, but with sterile water which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Consented to follow up.
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| 2855457 | 5 | F | KY | 08/25/2025 |
DTAPHEPBIP TDAP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK X449Y |
Incomplete course of vaccination, Wrong product administered; Incomplete course ...
Incomplete course of vaccination, Wrong product administered; Incomplete course of vaccination, Wrong product administered
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Incomplete vaccination schedule for Pediarix only two dose schedule; Maladministration of Boostrix i...
Incomplete vaccination schedule for Pediarix only two dose schedule; Maladministration of Boostrix instead of DTAP on a 5 year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 5-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y, expiry date 20-OCT-2026) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis. Previously administered products included Pediarix (received 1st dose on an unknown date), Pediarix (received 2nd dose on an unknown date) and Kinrix. On 01-AUG-2025, the patient received Boostrix, the patient did not receive Infanrix and the 3rd dose of Pediarix. On 01-AUG-2025, the patient experienced wrong vaccine administered (Verbatim: Maladministration of Boostrix instead of DTAP on a 5 year old patient). the patient experienced incomplete course of vaccination (Verbatim: Incomplete vaccination schedule for Pediarix only two dose schedule). The outcome of the wrong vaccine administered and incomplete course of vaccination were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 01-AUG-2025 General response center (the colleague did not raise the adverse event report) transferred a registered nurse called about a situation where a five-year-old patient was given a tetanus, diphtheria, and pertussis vaccine (Boostrix) instead of Diphtheria, Tetanus, and acellular Pertussis (Infanrix), which led to wrong vaccine administered. Registered nurse looked for guidance or whether to revaccinate this patient. No further information was reported. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 3rd dose of Pediarix, which led to an incomplete course of vaccination.
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| 2855458 | CA | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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has some patients that get the first dose but then they don't give a Second one; This non-serio...
has some patients that get the first dose but then they don't give a Second one; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in an unspecified number of patients who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patients did not receive the 2nd dose of Shingrix. The patients had incomplete course of vaccination (Verbatim: has some patients that get the first dose but then they don't give a Second one). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 11-AUG-2025 The reporter reported that the Shingrix being a 2-dose vaccine, he had some patients that get the first dose but then they don't give a second one and he wanted to know that how far in-between were they good to get that Second dose and without unaffecting anything. The reporter said that technically to be 8 months or more, but he wanted to talk to a Medical Sciences Liaison.
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| 2855459 | 1 | F | CA | 08/25/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect dose administered
Incorrect dose administered
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Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatr...
Maladministration of adult dose to a pediatric patient; Maladministration of adult dose to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old female patient who received HAV (Havrix adult) for prophylaxis. On 20-JUN-2025, the patient received the 1st dose of Havrix adult. On 20-JUN-2025, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Maladministration of adult dose to a pediatric patient) and adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient). The outcome of the overdose and adult product administered to child were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date:13-AUG-2025 Registered nurse called to asked about safety concerns on five patients vaccination schedule (potential first dose) with the maladministration of an adult dose of Havrix, they just noticed due to a billing review, which led to an adult product administered to child and overdose. Registered nurse called on behalf of another site where the incident happened. No further information was obtained. This was 1 of 5 linked cases, reported by the same reporter.
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| 2855460 | 1 | F | CA | 08/25/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect dose administered
Incorrect dose administered
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Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of ...
Maladministration of adult dose to a pediatric patient (potential First Dose); Maladministration of adult dose to a pediatric patient (potential First Dose); This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old female patient who received HAV (Havrix adult) for prophylaxis. On 29-JUL-2025, the patient received the 1st dose of Havrix adult. On 29-JUL-2025, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)) and adult product administered to child (Verbatim: Maladministration of adult dose to a pediatric patient (potential First Dose)). The outcome of the overdose and adult product administered to child were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 13-AUG-2025 Registered nurse called to asked about safety concerns on five patients vaccination schedule (potential first dose) with the maladministration of an adult dose of havrix which led to adult product administered to child and overdose. Vaccination dates and partial patient demographics (only gender and age) were obtained in this call. No vaccine detail was obtained in this call. No further information was obtained in this call.; Sender's Comments: US-GSK-US2025104626:same reporter different patient US-GSK-US2025104616:same reporter different patient US-GSK-US2025104628:same reporter different patient
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| 2855461 | M | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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late for 2nd dose/Did not received 2 nd dose; This non-serious case was reported by a pharmacist via...
late for 2nd dose/Did not received 2 nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (had a Shingrix shot over a year ago). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: late for 2nd dose/Did not received 2 nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-AUG-2025 Pharmacist was reported to asked if patient had a Shingrix shot over a year ago, so he need to restart series or he could finish the series with a second shot or not. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Pharmacist did not have any further details.
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| 2855462 | MI | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Product preparation issue
Product preparation issue
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We have a patient where only the adjuvant suspension component was given and not mixed with the Lyop...
We have a patient where only the adjuvant suspension component was given and not mixed with the Lyophilized IGE antigen component in a Shingles vaccine; We have a patient where only the adjuvant suspension component was given and not mixed with the Lyophilized IGE antigen component in a Shingles vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: We have a patient where only the adjuvant suspension component was given and not mixed with the Lyophilized IGE antigen component in a Shingles vaccine) and inappropriate dose of vaccine administered (Verbatim: We have a patient where only the adjuvant suspension component was given and not mixed with the Lyophilized IGE antigen component in a Shingles vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 18-AUG-2025 The pharmacist mentioned that a patient where only the adjuvant suspension component was given and not mixed with the lyophilized IGE antigen component in a Shingles vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. It was clarified during chat that vaccine involved was Shingrix. Pharmacist did not have demographics for the patient, date of administration, lot number or expiration date for the vaccine.
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| 2855463 | 18 | M | MD | 08/25/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
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Extra dose administered
Extra dose administered
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Extra Vaccine Administered (Trumenba); This non-serious case was reported by a physician via call ce...
Extra Vaccine Administered (Trumenba); This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (1st dose received on 13-JUN-2024 under the old schedule). Concomitant products included Meningococcal vaccine B rfHbpA/fHbpB (Trumenba). On 12-MAR-2025, the patient received the 2nd dose of Bexsero. On 12-MAR-2025, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: Extra Vaccine Administered (Trumenba)). The outcome of the extra dose administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 19-AUG-2025 The patient who received the 1st dose of Bexsero under the old schedule and received Trumenba. The patient received 2nd dose of Bexsero, which led extra dose administered. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025AMR108524:same reporter different patient
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| 2855464 | F | HI | 08/25/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVB056A |
Incorrect dose administered
Incorrect dose administered
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INCORRECT PREPARATION; This non-serious case was reported by a other health professional via call ce...
INCORRECT PREPARATION; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB056A, expiry date 31-AUG-2025) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incomplete dose administered (Verbatim: INCORRECT PREPARATION). The outcome of the incomplete dose administered was not applicable. Additional Information: GSK Receipt Date: 19-AUG-2025 The reporter was reported regarding Menveo, specifically the Menveo kids so, they had a kind of a situation right now where while they were doing their monthly inventory of our vaccines they ended up with one powder vial which told that group of five did not get fully vaccinated. The question was because they did want to revaccinate all five patients because they did not know which of the five received the incomplete vaccine, so, what was the timeframe for them to revaccinate a 12 years old.
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| 2855465 | 5 | M | PA | 08/25/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
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Product storage error
Product storage error
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Administration after temp. excursion; This non-serious case was reported by a other health professio...
Administration after temp. excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis. On 21-AUG-2025 14:48, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: Administration after temp. excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 21-AUG-2025 A practice operations manager reported that they had an excursion, and a vaccine (Pediarix) was given to a patient, which led to incorrect storage of drug. The reporter just wants to make sure that it was okay, that it was viable. The vaccine administration facility was the same as primary reporter. The reporter informed that the excursion and vaccination date was on the same day (21-Aug-2025), but the excursion occurred in the morning, and the vaccination at 02:48 PM.
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| 2855466 | 08/25/2025 |
COVID19 |
MODERNA |
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Retinal vascular thrombosis
Retinal vascular thrombosis
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Has developed blood clots in one of their eyes just days after receiving the vaccine; This spontaneo...
Has developed blood clots in one of their eyes just days after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) (seriousness criterion medically significant). At the time of the report, RETINAL VASCULAR THROMBOSIS (Has developed blood clots in one of their eyes just days after receiving the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not reported. Patient took the vaccine and had developed blood clots in one of their eyes just days after receiving the vaccine back in 2021. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788794 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788794:Reporter case
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| 2855467 | 08/25/2025 |
COVID19 |
MODERNA |
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Visual impairment
Visual impairment
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a rapid decline in their vision and has slowly been losing their eyesight ever since to the point wh...
a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021, the patient experienced VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) (seriousness criterion medically significant). At the time of the report, VISUAL IMPAIRMENT (a rapid decline in their vision and has slowly been losing their eyesight ever since to the point where they are seeing just glows of white) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown. Concomitant medication was not reported. It was reported that patient took the Covid-19 vaccine back in Fall of 2021 due to it being mandated by their job. After the patient took vaccine, a rapid decline in their vision was noticed and had slowly been losing their eyesight ever since to the point where they were seeing just glows of white. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-788797 (E2B Linked Report).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-788797:case for family member
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| 2855468 | M | 08/25/2025 |
COVID19 |
MODERNA |
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Lethargy, Pain
Lethargy, Pain
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felt achy/felt under the weather; lethargic/felt under the weather; This spontaneous case was report...
felt achy/felt under the weather; lethargic/felt under the weather; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer (he had slight fever and "could feel his immune system working). Past adverse reactions to the above products included Slight fever with Pfizer. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather). At the time of the report, PAIN (felt achy/felt under the weather) and LETHARGY (lethargic/felt under the weather) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. No concomitant medication was reported. It was stated patient had better reaction to Moderna's vaccine over Pfizer's. It was stated with Moderna's vaccine he had no fever but "felt under the weather". Probed was asking for details then it was stated patient felt achy and lethargic. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
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| 2855469 | 60 | F | NY | 08/25/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
FH8028 FH8028 FH8028 FH8028 |
Abdominal pain upper, Back pain, Body temperature, Cerebral haemorrhage, Compute...
Abdominal pain upper, Back pain, Body temperature, Cerebral haemorrhage, Computerised tomogram; Deep vein thrombosis, Fall, Head injury, Influenza, Loss of consciousness; Pain in extremity, Pulmonary thrombosis, Pyrexia, Sepsis, Thrombosis; Urinary bladder haemorrhage, Weight
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blood clot on the renal gland; blood clot on the renal gland. Which traveled to the lung and in the ...
blood clot on the renal gland; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis; Had high fever, fever was 102 or 104 for 10 days; feeling like had the flu; stomach pains; DVT; Blacked out; hit head; fell since was standing; brain bleed, brain is obviously fine/Then had second bleed; back pain; leg pain; This is a spontaneous report received from a Consumer or other non HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ER8733, Upper arm, at Clinic), administration date: 30Mar2021, when the patient was 59-year-old, for Covid-19 Immunization; BNT162b2 (DOSE 2, SINGLE; lot number: EW0170, Upper arm, at Clinic), administration date: 20Apr2021, when the patient was 59-year-old, for Covid-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "leg pain"; DEEP VEIN THROMBOSIS (hospitalization) with onset Feb2025, outcome "recovered", described as "DVT"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 27May2025, outcome "unknown", described as "Blacked out"; CEREBRAL HAEMORRHAGE (hospitalization) with onset 27May2025, outcome "unknown", described as "brain bleed, brain is obviously fine/Then had second bleed"; FALL (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "fell since was standing"; HEAD INJURY (hospitalization, medically significant) with onset 27May2025, outcome "unknown", described as "hit head"; URINARY BLADDER HAEMORRHAGE (hospitalization), outcome "recovered", described as "blood clot on the renal gland"; PULMONARY THROMBOSIS (hospitalization), THROMBOSIS (hospitalization), SEPSIS (hospitalization), outcome "recovered" and all described as "blood clot on the renal gland. Which traveled to the lung and in the blood, turned to sepsis"; PYREXIA (hospitalization), outcome "recovered", described as "Had high fever, fever was 102 or 104 for 10 days"; INFLUENZA (hospitalization), outcome "unknown", described as "feeling like had the flu"; ABDOMINAL PAIN UPPER (hospitalization), outcome "unknown", described as "stomach pains". The patient was hospitalized for deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, pyrexia, influenza, abdominal pain upper (start date: 22Feb2025, hospitalization duration: 18 day(s)); for loss of consciousness, head injury, fall, cerebral haemorrhage (start date: 27May2025, hospitalization duration: 10 day(s)). The events "feeling like had the flu" and "stomach pains" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: 102 or 104, notes: for 10 days; Computerised tomogram: found blood clot on the renal gland; saw brain bleed; was not clearing up, notes: second bleed; Weight: 158 lbs; 138 lbs; Weight: Lost 10 first time; Lost all this weight; Lost 10 pounds in May. Therapeutic measures were taken as a result of deep vein thrombosis, urinary bladder haemorrhage, pulmonary thrombosis, thrombosis, sepsis, cerebral haemorrhage, pyrexia. Clinical information: The patient reported that he ended up with a DVT in Feb2025. In 22Feb2025, the patient went to doctor feeling like had the flu, but the doctor said no, he/she saw something in urine. The patient went to the hospital and took CAT scan and found blood clot on the renal gland which traveled to the lung and in the blood, turned to sepsis. The patient had high fever, fever was 102 or 104 for 10 days. He was on all kinds of blood thinners, injections, in the stomach. After the cultures and all the medications, it had gone. He went home with PICC line. He reported he made a mistake, at first did midline, so he had to get it changed the day he was leaving, it was kind of painful taking it out. He reported his DVT is not ongoing, he has remains of an abscess in the kidney which is starting to resolve itself. He will go back to his urologist on 21Aug2025. With third one (vaccination), he had back pain and leg pain. Feeling like had the flu: he clarified and confirmed he was admitted into the hospital when had feeling of flu, had stomach pains, and that is when found the blood clot. He was admitted on 22Feb2025 then 18 days later discharged. Blacked out, hit head on 27May2025; he blacked out, then fell since he was standing. He was put on blood thinners when he went home, they wanted to keep him on blood thinners for 6 months. During the 3rd month, the patient blacked out, hit head. Not a 100% sure if it was the blood thinners. Due to this illness, he had to be on blood thinners for a while. Cardiologist said to be on blood thinners 6 months, hematologist said 3 months. This happened at the end of 3 months. He was down in basement with his daughter, he felt a little funny, then blacked out. He woke up 2 minutes later, had big nice sized egg on top of head. Ambulance came since he hit his head. He had CAT scans where they saw brain bleed. He reported his life was saved by the doctor. Then he had second bleed and was rushed as well. He had more CAT scans, and found it was not clearing up. He had a big to do surgery where they had to cut his skull. It was very uncomfortable. He got the bleed in the head, which then had to have surgery that night, 27May2025, after 35 or 40 staples in the head. He was admitted on 27May2025 and 10 days later was discharged, possibly 06Jun2025. He came home with walker, had no energy, no strength.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500166581 same patient, and drug; different vaccine dose and event;US-PFIZER INC-202500166582 same patient, and drug; different vaccine dose and event;
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| 2855470 | 69 | F | NV | 08/25/2025 |
COVID19 |
PFIZER\BIONTECH |
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Ankylosing spondylitis
Ankylosing spondylitis
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spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received ...
spondyloarthropathy with ankylosing attributes or conditions; This is a spontaneous report received from a Consumer or other non HCP. A 73-year-old female patient received BNT162b2 (BNT162B2), on 17Sep2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "mild fibromyalgia" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "unknown", described as "spondyloarthropathy with ankylosing attributes or conditions". Therapeutic measures were taken as a result of ankylosing spondylitis. Clinical course: Medication was Pfizer covid vaccination from 2021. She has lots of things that happened after the vaccination that has now caused her lots of health problems and was on lots of medications. She wants to tell Pfizer what the vaccine did to her and her health for the last two, three or four years, clarifies as since 2021 since she got the second vaccination. She has very mild fibromyalgia intermittently that only affected her arm joint that was she confirms was diagnosed prior to the covid vaccine. She did not have immediate issues after the first dose then states she cannot delineate since the doses were weeks apart but immediately after the second dose, her entire body was on fire on the inside and every joint in her body awakened with pain, joints that she had never felt before. Her primary doctor had never heard of this. She went to the fibromyalgia website and there are hundreds of reports of fibromyalgia patients experiencing the same thing. No further details provided. Treatment: did not know what treatment to get. When querying outcome states she was taking biologic medication now since the covid vaccine caused spondyloarthropathy with ankylosing attributes or conditions, states she did not know what its called. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
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| 2855472 | 75 | F | TX | 08/25/2025 |
TDAP |
SANOFI PASTEUR |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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Intentional Age Prescription by HCP: The patient is 75 years old. Per package insert, Adacel is appr...
Intentional Age Prescription by HCP: The patient is 75 years old. Per package insert, Adacel is approved for use in persons 10through 64 years of age with no reported Adverse event; Initial information received on 19-Aug-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 75-year-old female patient who had intentional age prescription by hcp (healthcare professional): per package insert, diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] is approved for use in persons 10 through 64 years of age 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, 75-year-old female patient who had intentional age prescription by hcp (healthcare professional): per package insert, diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] Suspension for injection 0.5 ml via intramuscular route (expiry date, lot, administration site: not reported) for helps protect against tetanus, diphtheria, and pertussis disease (immunisation) and is approved for use in persons 10 through 64 years of age with no reported adverse event (off label use) (unknown latency). Action taken was not applicable. Information regarding batch number corresponding to the one at time of event occurrence will not be available.
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| 2855473 | 0.58 | F | NY | 08/25/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
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Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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received PENTACEL at 3 months, 5 months and 6 months. Patient's mother was concerned about the ...
received PENTACEL at 3 months, 5 months and 6 months. Patient's mother was concerned about the patient's 3rd dose because it only has a 1 month interval from the second dose with no reported adverse event; Initial information received on 21-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 7 months old female patient who received 3 doses of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] at 3 months, 5 months and 6 months, patient's mother was concerned about the patient's 3rd dose because it only has a 1 month interval from the second dose 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 3 doses of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization at 3 months, 5 months and 6 months, patient's mother was concerned about the patient's 3rd dose because it only has a 1 month interval from the second dose with no reported adverse event (inappropriate schedule of product administration) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
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| 2855474 | 1.08 | F | MI | 08/25/2025 |
HEPA MMR VARCEL |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
|
Extra dose administered; Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered; Extra dose administered
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Patient received 12-month vaccines twice, 8 weeks apart. patient had 12month well visit on 06/20/202...
Patient received 12-month vaccines twice, 8 weeks apart. patient had 12month well visit on 06/20/2025 and 08/08/2025.
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| 2855475 | 6 | M | KY | 08/25/2025 |
COVID19 |
PFIZER\BIONTECH |
ME6072 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Didn't pay attention to the vaccine age limit. Patient was given the 12+ years Pfizer vaccine.
Didn't pay attention to the vaccine age limit. Patient was given the 12+ years Pfizer vaccine.
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| 2855476 | 65 | F | MI | 08/25/2025 |
CHOL |
PAXVAX |
4344102 |
No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No adverse event noted/occurred
No adverse event noted/occurred
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| 2855477 | 1.25 | F | CT | 08/25/2025 |
DTAPIPVHIB |
SANOFI PASTEUR |
UK232AB |
Circumstance or information capable of leading to medication error, Incorrect do...
Circumstance or information capable of leading to medication error, Incorrect dose administered
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Patient pulled away from needle immediately after inserted in arm. Administration of vaccine had ...
Patient pulled away from needle immediately after inserted in arm. Administration of vaccine had just commenced when arm pulled away, significant amount of vaccine ejected onto patient's skin and into air. Unclear how much if any of vaccine was administered to patient.
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| 2855478 | 56 | F | CA | 08/25/2025 |
TDAP |
SANOFI PASTEUR |
|
Photopsia, Vitreous detachment, Vitreous floaters
Photopsia, Vitreous detachment, Vitreous floaters
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Left eye, posterior vitrious detachment, seen in ER then opthalmologist office. Flashing lights, flo...
Left eye, posterior vitrious detachment, seen in ER then opthalmologist office. Flashing lights, floaters.
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| 2855479 | 11 | F | NC | 08/25/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
Z005486 U8508AA |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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Patient developed a red, raised area around the injection site of her right thigh. It started at 1 1...
Patient developed a red, raised area around the injection site of her right thigh. It started at 1 1/2" diameter area of redness and progressed to 4" diameter area 2 days later. Patient was given Benadryl orally and used hydrocortisone cream topically for itching as well as used a cold compress to the area. Right thigh is looking better today but area around injection site is still slightly raised even though redness has decreased.
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| 2855480 | 5 | M | MI | 08/25/2025 |
DTAPIPV |
SANOFI PASTEUR |
U8383AB |
Erythema, Skin warm, Swelling
Erythema, Skin warm, Swelling
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Redness/swelling/warm to touch/raised. Treatment, cold pack, motrin and time, then it resolved
Redness/swelling/warm to touch/raised. Treatment, cold pack, motrin and time, then it resolved
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| 2855481 | 73 | F | MI | 08/25/2025 |
RSV |
PFIZER\WYETH |
LL8381 |
Migraine, Visual impairment
Migraine, Visual impairment
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Migraines, Visual disturbance
Migraines, Visual disturbance
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| 2855482 | 9 | F | MN | 08/25/2025 |
COVID19 |
MODERNA |
3042999 |
Expired product administered
Expired product administered
|
vaccine was expired on 5/17/2025
vaccine was expired on 5/17/2025
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| 2855483 | 16 | M | NJ | 08/25/2025 |
MMR |
MERCK & CO. INC. |
Z003401 |
Syncope
Syncope
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FAINTED AFTER STANDING UP AFTER GETTING MMR VACCINE
FAINTED AFTER STANDING UP AFTER GETTING MMR VACCINE
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| 2855484 | 85 | M | FL | 08/25/2025 |
FLU3 |
SANOFI PASTEUR |
u8764cb |
Asthenia, Malaise, Pain, Pyrexia
Asthenia, Malaise, Pain, Pyrexia
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Patient's wife called and said he was experiencing adverse reactions (felt weak, fever, body ac...
Patient's wife called and said he was experiencing adverse reactions (felt weak, fever, body aches, and overall unwell). RPH explained to them that these are all expected typical side effects of this vaccine and to seek medical help if he feels worse.
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| 2855485 | 64 | M | SC | 08/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7523J 7523J |
Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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Pt was given 1st dose of Shingrix on 8/9/2025, and then given a 2nd dose of Shingrix on 8/23/25. He...
Pt was given 1st dose of Shingrix on 8/9/2025, and then given a 2nd dose of Shingrix on 8/23/25. He thought he was supposed to get them 2 weeks apart instead of the recommended interval of 2-6 months. Spoke with pt, he has not had any adverse effects or experienced any other side effects. Spoke with GSK rep and per CDC guidelines, pt will have to repeat the 2nd dose due to the inappropriate interval
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| 2855486 | 16 | F | NY | 08/25/2025 |
MNQ |
SANOFI PASTEUR |
|
Blood pressure decreased, Syncope
Blood pressure decreased, Syncope
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About 5 minutes after shot patient fainted and blood pressure dropped very low.
About 5 minutes after shot patient fainted and blood pressure dropped very low.
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| 2855487 | 14 | F | GA | 08/25/2025 |
MNQ |
SANOFI PASTEUR |
U8361AA |
Immediate post-injection reaction, Syncope, Tremor, Unresponsive to stimuli, Vom...
Immediate post-injection reaction, Syncope, Tremor, Unresponsive to stimuli, Vomiting
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Client syncope immediately after needle was removed from her left deltoid post injection. Client was...
Client syncope immediately after needle was removed from her left deltoid post injection. Client was not responsive to my words initially. I alerted staff in the building of medical emergency. I continued to talk to client as she began to respond. Client then begin the vomit and shake. Client was placed on the floor with legs elevated. CNM brought in pulse ox and vital signs monitor. Clients airway, breathing, and circulation was assessed and monitored. Clients vital signs were in range. Heart rate was only elevated as she was vommiting. Myself, CNM, and district STD Coordinator talked with client throughout this process and continued to monitor as client staying in supine position on the floor for approximately 10 mins. Client being to feel better, hands no longer numb, color returned, and vital signs assessed again all withing normal range. Client sat up with assisstance and leaned against the wall for about 5 mins before standing with assistance. Clients mother advised to follow up with PCP, and inform providers before any future vaccinations or blood draws about clients fainting history. Clients mother verbalized unerstanding. Client, her mother, brother, and father ambulated from clinic room 1 in stable condition.
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| 2855488 | 64 | M | IL | 08/25/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Chills, Diarrhoea, Fatigue, Headache, Pyrexia; Reaction to previous exposure to ...
Chills, Diarrhoea, Fatigue, Headache, Pyrexia; Reaction to previous exposure to any vaccine
More
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Fever, Headache, body aches, chills, fatigue, diarrhea
Fever, Headache, body aches, chills, fatigue, diarrhea
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| 2855489 | 59 | F | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
3273H |
Blister, Pain
Blister, Pain
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painful blister behind neck, lower back, perineal area for 1 week after receiving shingrix vaccine
painful blister behind neck, lower back, perineal area for 1 week after receiving shingrix vaccine
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| 2855490 | 6 | M | MN | 08/25/2025 |
MMRV |
MERCK & CO. INC. |
Y014307 |
Wrong product administered
Wrong product administered
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MMRV was accidentally given instead of MMR. The patient already had two doses of varicella, but only...
MMRV was accidentally given instead of MMR. The patient already had two doses of varicella, but only one dose of MMR, so only MMR was needed, but the nurse grabbed MMRV and didn't double check before administering MMRV. The patient's mom was told about the error and all pertinent resources, like the VIS for MMRV, were provided. There will be training held for all nurses to ensure this doesn't happen again.
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| 2855491 | 19 | F | MA | 08/25/2025 |
MENB TDAP |
NOVARTIS VACCINES AND DIAGNOSTICS SANOFI PASTEUR |
3R33K U8673AA |
Injection site erythema, Mobility decreased, Musculoskeletal pain, Neck pain, Pa...
Injection site erythema, Mobility decreased, Musculoskeletal pain, Neck pain, Pain; Injection site erythema, Mobility decreased, Musculoskeletal pain, Neck pain, Pain
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Patient states pain and limited ROM started just shortly after getting injections to her Left Deltoi...
Patient states pain and limited ROM started just shortly after getting injections to her Left Deltoid. Pain causing limited ROM and pain that radiates to her neck and scapula. Ibuprofen/Tylenol, rest, ice, heat all tried without relief of pain. Redness noted by parent at site of injection as well.
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| 2855492 | 70 | M | IA | 08/25/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
|
Resident expired
Resident expired
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| 2855493 | 71 | F | AL | 08/25/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
255t2 |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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Patient was informed by her Dr that she needed RSV shot. Pt came to the pharmacy stating they needed...
Patient was informed by her Dr that she needed RSV shot. Pt came to the pharmacy stating they needed RSV shot. Pt had received vaccine already on 4/8/24 and pharmacy staff did not investigate to see if shot had already been given and proceeded forward with shot. Pt is not experiencing any side effects currently.
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| 2855494 | 59 | F | MD | 08/25/2025 |
PNC20 |
PFIZER\WYETH |
LG5579 |
Injection site erythema, Injection site pain, Injection site swelling, Product a...
Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
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Patient reported pain at the time of injection. Reported pain, redness and swelling the day after in...
Patient reported pain at the time of injection. Reported pain, redness and swelling the day after injection. Vaccine was administered too high in the left deltoid.
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| 2855495 | 1.25 | M | KY | 08/25/2025 |
MMR |
MERCK & CO. INC. |
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Urticaria
Urticaria
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Hives major all over body and face patient was monitored closely by medical team for 30 minutes and...
Hives major all over body and face patient was monitored closely by medical team for 30 minutes and hives subsided
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| 2855496 | 81 | M | TN | 08/25/2025 |
PPV |
MERCK & CO. INC. |
x027348 |
Incorrect dose administered, No adverse event
Incorrect dose administered, No adverse event
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no adverse event. erroneous dose given
no adverse event. erroneous dose given
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| 2855497 | 67 | M | CA | 08/25/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
FT95N |
Erythema, Pain in extremity, Peripheral swelling
Erythema, Pain in extremity, Peripheral swelling
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Patient came to the clinic this morning on 08/25/2025 complaining of arm pain, redness, and swelling...
Patient came to the clinic this morning on 08/25/2025 complaining of arm pain, redness, and swelling. Patient's arm is visibly red and swollen.
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| 2855498 | 57 | F | MI | 08/25/2025 |
FLU3 PNC20 VARZOS |
SANOFI PASTEUR PFIZER\WYETH GLAXOSMITHKLINE BIOLOGICALS |
U8790AA LN4928 GJ952 |
Injection site erythema, Injection site pruritus; Injection site erythema, Injec...
Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus; Injection site erythema, Injection site pruritus
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Patient presented to the pharmacy with a large red local reaction on her right arm, which is where s...
Patient presented to the pharmacy with a large red local reaction on her right arm, which is where she was vaccinated with all three vaccines. She stated that she wasn't sure how long it had been there. Her arm had been itching the past couple days but her daughter noticed the redness today. I recommended hydrocortisone cream for the itching and to contact her doctor if the spot becomes larger or if she develops any new symptoms.
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