| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2842851 | M | CA | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Burning sensation, Erythema, Pain, Pruritus
Burning sensation, Erythema, Pain, Pruritus
|
Pain; Itching; burning; Redness; This non-serious case was reported by a physician via call center r...
Pain; Itching; burning; Redness; This non-serious case was reported by a physician via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included herpes zoster (The patient had reported an episode of zoster before receiving the Shingrix doses). Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX). In MAR-2021, the patient received the 2nd dose of Shingrix. In MAY-2025, more than 2 years after receiving Shingrix, the patient experienced pain (Verbatim: Pain), pruritus (Verbatim: Itching), burning sensation skin (Verbatim: burning) and erythema (Verbatim: Redness). The patient was treated with triamcinolone. The outcome of the pain, pruritus, burning sensation skin and erythema were unknown. It was unknown if the reporter considered the pain, pruritus, burning sensation skin and erythema to be related to Shingrix. It was unknown if the company considered the pain, pruritus, burning sensation skin and erythema to be related to Shingrix. Additional Information: GSK Receipt Date: 23-MAY-2025 The reporter, an HCP (physician), stated that he had received two doses of Shingrix, his initial dose in December 2020 and his second in March 2021. The previous night, he had developed pain, redness, itching, and burning on the left side of his upper abdomen, which was about 4 inches wide. He had applied triamcinolone to the area. He did not know if it was shingles. The patient had reported an episode of zoster before receiving the Shingrix doses.
More
|
|||||||
| 2842852 | M | IL | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
|
Missed dose; This non-serious case was reported by a consumer via call center representative and des...
Missed dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose of vaccine on an unknown date). 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: Missed dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 23-MAY-2025 The customer stated that he did not remember if he had received the second dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
More
|
|||||||
| 2842853 | 05/27/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
|
Suspected vaccination failure; I have an extreme case; This serious case was reported by a consumer ...
Suspected vaccination failure; I have an extreme case; 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: I have an extreme case). 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. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAY-2025 This case was reported by the patient via interactive digital media. The patient stated that, according to his/her physician he/she had an extreme case of shingles and patient got the 2 shots. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming 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 (dose 1) and Shingles vaccine (dose 2).
More
|
|||||||||
| 2842854 | 05/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Fatigue, Herpes zoster, Stress, Vaccination failure
Fatigue, Herpes zoster, Stress, Vaccination failure
|
Suspected vaccination failure; now on my face; This serious case was reported by a consumer via inte...
Suspected vaccination failure; now on my face; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 63-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (first time was about 4 years ago). Concurrent medical conditions included stress (job always brought some stress). 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 facial herpes zoster (Verbatim: now on my face). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 17-MAY-2025 This case was reported by a patient via interactive digital media. Patient went through his/her second round of shingles. The first time was about four years ago. Then, he/she got the shots and thought he/she had been protected about two years ago. Well, it came back, and this time, it was on his/her face. He/she had completed week one and had hoped it would not last too long. He/she was fatigued and stressed and could not understand why he/she had been feeling that way, but then it made sense. His/her job had always brought him/her some stress. He/she had needed a good, long week off work just to crawl into a dark hole somewhere and sleep. He/she was not young anymore, so he/she had hoped to get through it quickly. 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.
More
|
|||||||||
| 2842855 | 05/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Product use in unapproved indication, Varicella
Product use in unapproved indication, Varicella
|
got the shot for it and still here; I had chickenpox 3 times and got the shot for it and still here;...
got the shot for it and still here; I had chickenpox 3 times and got the shot for it and still here; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included chickenpox (had chickenpox 3 times). Concurrent medical conditions included immunocompromised (No immunity). On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chickenpox (Verbatim: got the shot for it and still here) and product use in unapproved indication (Verbatim: I had chickenpox 3 times and got the shot for it and still here). The outcome of the chickenpox was not resolved and the outcome of the product use in unapproved indication was not applicable. It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine. It was unknown if the company considered the chickenpox to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 18-MAY-2025 This case was reported by a patient via interactive digital media. The reporter said that he/she in the middle of having it in my head, the worst place. The patient had chickenpox 3 times and got the shot for it and still here, which led to product used for unapproved indication. No immunity. The doctor said that could get it again.
More
|
|||||||||
| 2842856 | M | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Oral herpes zoster, Vaccination failure
Herpes zoster, Oral herpes zoster, Vaccination failure
|
Suspected vaccination failure; still got shingles on his face and tongue; This serious case was repo...
Suspected vaccination failure; still got shingles on his face and tongue; 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. 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 facial herpes zoster (Verbatim: still got shingles on his face and tongue). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure and facial herpes zoster to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the facial herpes zoster to be related to Shingrix. Additional Information: GSK receipt date: 21-MAY-2025 This case was reported by a patient's sibling via interactive digital media. The reporter reported that his/her brother had the Shingrix vaccines and still got shingles on his face and tongue which he was still suffering from for over 2 months at this point. 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 Shingrix
More
|
||||||||
| 2842857 | 05/27/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Extra dose administered, Herpes zoster, Inappropriate schedule of product admini...
Extra dose administered, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure; Extra dose administered, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure; Extra dose administered, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
More
|
Suspected vaccination failure; still get them; I had the first shot years ago; just got the 2 new on...
Suspected vaccination failure; still get them; I had the first shot years ago; just got the 2 new ones last year; 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 and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still get them), drug dose administration interval too long (Verbatim: I had the first shot years ago) and extra dose administered (Verbatim: just got the 2 new ones last year). The outcome of the vaccination failure and shingles were not reported and the outcome of the drug dose administration interval too long and extra dose administered were not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date :22-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had the first shot years ago and just got the 2 new ones last year and still get them which led to extra dose administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. 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. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
More
|
|||||||||
| 2842858 | 50 | 05/27/2025 |
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
More
|
suspected vaccination failure; shingles currently for the 2nd time; This serious case was reported b...
suspected vaccination failure; shingles currently for the 2nd time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had shingles 15 years ago). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 5 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles currently for the 2nd time). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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: 21-MAY-2025 This case was reported by a patient via interactive digital media. Patient had shingles for the 2nd time and first time was about 15 years ago. Patient was 50 then, had both vaccines 5 years ago. Also state that it was very painful. 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (1st dose)and Shingles(2nd dose)
More
|
||||||||
| 2842859 | F | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Myalgia
Myalgia
|
my mother have muscle pain in the arm for a month and a half since the vaccine was given.Muscle pain...
my mother have muscle pain in the arm for a month and a half since the vaccine was given.Muscle pain since vaccine administration one month ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis. In APR-2025, the patient received Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced muscle pain (Verbatim: my mother have muscle pain in the arm for a month and a half since the vaccine was given.Muscle pain since vaccine administration one month ago). The outcome of the muscle pain was not resolved. It was unknown if the reporter considered the muscle pain to be related to Shingrix. It was unknown if the company considered the muscle pain to be related to Shingrix. Additional Information: GSK Receipt Date: 23-MAY-2025 The patient had muscle pain in the arm for a month and a half since the vaccine was given one month ago.
More
|
||||||||
| 2842860 | F | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
|
Suspeceted vaccination failure; I got shingles after the Shingrix vaccines; This serious case was re...
Suspeceted vaccination failure; I got shingles after the Shingrix vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles after the Shingrix vaccines). 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: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that she got shingles after the administration of Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
More
|
||||||||
| 2842861 | 05/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Fatigue, Pain in extremity
Fatigue, Pain in extremity
|
far just very sore arm; fatigue; This non-serious case was reported by a consumer via interactive di...
far just very sore arm; fatigue; 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 Shingrix with an associated reaction of adverse event (received 1st dose of vaccine on an unknown date and had terrible reaction). On 23-MAY-2025, the patient received the 2nd dose of Shingles vaccine. In MAY-2025, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: far just very sore arm) and fatigue (Verbatim: fatigue). The outcome of the pain in arm and fatigue were not reported. It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine. It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient via interactive digital media. Patient had a terrible reaction to the first dose. He/she received the second dose that day (date of reporting). He/she experienced a very sore arm and fatigue. Hoped that this one would not be as severe. The important thing was that it was done.
More
|
|||||||||
| 2842862 | 05/27/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Malaise
Malaise
|
shingles vaccine made me pretty sick for 2-3 days after; This non-serious case was reported by a con...
shingles vaccine made me pretty sick for 2-3 days after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included COVID-19 VACCINE. 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 sickness (Verbatim: shingles vaccine made me pretty sick for 2-3 days after). The outcome of the sickness was resolved. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that everybody reacts differently to drugs and vaccines. Covid vaccines did not make him/her felt a thing but both doses of the shingles vaccine made him/her pretty sick for 2-3 days after. It was still worth it because shingles could be really terrible and last a long time (like a year for some people).
More
|
|||||||||
| 2842863 | M | MO | 05/27/2025 |
MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS |
AMVBO44A |
Product storage error
Product storage error
|
Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-seri...
Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVBO44A) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 and 16-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheits as the lowest reached for following product Menveo, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. No expiration date was given for the vaccines nor date of administration. This is one of 5 linked cases reported by same reporter.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient US-GSK-US2025061564:Same reporter,Different patient US-GSK-US2025061538:Same reporter,Different patient
More
|
|||||||
| 2842864 | M | IL | 05/27/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
|
Blister, Herpes zoster, Rash, Rash pruritic, Scab; Stress, Vaccination failure; ...
Blister, Herpes zoster, Rash, Rash pruritic, Scab; Stress, Vaccination failure; Blister, Herpes zoster, Rash, Rash pruritic, Scab; Stress, Vaccination failure
More
|
Suspected vaccination failure; Shingles; driving me out of my mind; This serious case was reported b...
Suspected vaccination failure; Shingles; driving me out of my mind; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included dry skin (history of (moderate) dry skin). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 month 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 feeling abnormal (Verbatim: driving me out of my mind). The outcome of the vaccination failure and feeling abnormal were not reported and the outcome of the shingles was resolving. The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles and feeling abnormal to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 and 16-MAY-2025 The patient self reported this case for himself Patient does not remember having chicken pox (as a child). Reporter thought he might have had a possible after effect from the shingles shot. he had a rash that he had been getting off and on since he had received the shingles shot. The reporter had received the Shingrix shot 1 and shot 2. He did not know the dates or lot numbers of the injections. About a month or so after receiving the second shot, he went to see his physician for a rash on his left leg. His doctor diagnosed it as shingles. When he first saw the physician, there had been about a dozen spots. About 3 to 5 spots remained. The spots were itchy and felt a bit scabby. He had also experienced fluid filled blisters on his left butt cheek, which had been driving him out of his mind. He said that the blisters had been somewhat similar to what he had on his leg. Additionally, he had developed a rash on the top of his head that he had never had before. He had been seeing a dermatologist and had been using 3 to 4 unspecified creams and salves, as well as taking showers with liquid soap, but the event had not resolved. This case was considered as suspected vaccination failure as details 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 Shingrix. Herpes zoster and Feeling abnormal are unlisted events which are considered unrelated to GSK Shingrix.
More
|
|||||||
| 2842865 | MI | 05/27/2025 |
HIBV |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product preparation error
Product preparation error
|
but we are missing two of these sterile saline diluents; This non-serious case was reported by a nur...
but we are missing two of these sterile saline diluents; 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 patient who received Hib (Hiberix) for prophylaxis. On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: but we are missing two of these sterile saline diluents). The outcome of the wrong solution used in drug reconstitution was not applicable. Additional Information: GSK Receipt Date :21-MAY-2025 Nurse reported that they had the Hiberix vaccine at their clinic and they had an issue with an sterile diluent what, they did not know if it filled out of the container but they were missing two of these sterile saline diluents and unfortunately, they did not want to waste these two doses of the lyophilized vaccine and just wondered if they were able to use a regular sterile saline that they had in vials, in replacement of the sterile saline that comes with the hiberix vaccine which led to Wrong solution used in drug reconstitution.
More
|
||||||||
| 2842866 | F | OH | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
47N3Y |
Product preparation issue
Product preparation issue
|
Shingrix - Administration of only the adjuvant component; patient received only the adjuvant portion...
Shingrix - Administration of only the adjuvant component; patient received only the adjuvant portion of Shingrix without the lyophilized component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 47N3Y, expiry date 30-MAR-2027) for prophylaxis. On 21-MAY-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix - Administration of only the adjuvant component) and inappropriate dose of vaccine administered (Verbatim: patient received only the adjuvant portion of Shingrix without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 21-MAY-2025 A pharmacist reported that a patient received only the adjuvant portion of Shingrix without the lyophilized component. The pharmacist asked if they could reconstitute the powder with a different diluent such as sterile water and then administered this solution to the patient. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
More
|
|||||||
| 2842867 | 11 | M | NJ | 05/27/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
9KB9G |
Wrong product administered
Wrong product administered
|
Maladministration INFANRIX instead of BOOSTRIX; This non-serious case was reported by a other health...
Maladministration INFANRIX instead of BOOSTRIX; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9KB9G, expiry date 07-JUL-2026) for prophylaxis. On 22-MAY-2025, the patient received Infanrix. On 22-MAY-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration INFANRIX instead of BOOSTRIX). The outcome of the wrong vaccine administered was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date:22-MAY-2025 Medical Assistant calls to report the maladministration of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (INFANRIX) instead of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX) on a eleven year old male patient which led to Wrong vaccine administered. Medical Assistant requires guidance on this patient๏ฟฝs vaccination schedule. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call.
More
|
||||||
| 2842868 | F | MO | 05/27/2025 |
MENB |
NOVARTIS VACCINES AND DIAGNOSTICS |
|
Immunodeficiency
Immunodeficiency
|
immunocompromised; This serious case was reported by a pharmacist via call center representative and...
immunocompromised; This serious case was reported by a pharmacist via call center representative and described the occurrence of immunocompromised in a female patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included ravulizumab (Ultomiris). On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced immunocompromised (Verbatim: immunocompromised) (serious criteria GSK medically significant). The outcome of the immunocompromised was not reported. It was unknown if the reporter considered the immunocompromised to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the immunocompromised to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 22-MAY-2025 The pharmacist called to ask if a patient who was currently taking Ultomiris could receive a booster dose of Bexsero or what was the dosing schedule for boosters. Patient was fully vaccinated for Meningococcal B about 4 years ago. The reporter described that after the 2 doses of Bexsero the patient was taking Ultomiris and was immunocompromised. Health care professional was aware about centers for disease control guidance on this topic.; Sender's Comments: Immunodeficiency is an unlisted event which is considered unrelated to GSK vaccine Bexsero and Bexsero Pre-Filled Syringe Device.
More
|
|||||||
| 2842869 | 0.5 | M | TX | 05/27/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
J3952 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Unapproved vaccine administration; Overdose; This non-serious case was reported by a other health pr...
Unapproved vaccine administration; Overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 6-month-old male patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis. On 15-OCT-2024, the patient received the 2nd dose of Engerix B adult. On 15-OCT-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Unapproved vaccine administration) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose 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: 23-MAY-2025 Health Care Provider called to inform that during an audit it was found an adult dose of Engerix-B was administered to a child which led adult product administered to child and overdose. She wanted safety data for infants that received Engerix-B adult dose. The reporter consented to follow up.
More
|
||||||
| 2842870 | 05/27/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
|
Incorrect route of product administration
Incorrect route of product administration
|
intramuscular administration of Priorix-inappropriate route of administration; This non-serious case...
intramuscular administration of Priorix-inappropriate route of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient 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: intramuscular administration of Priorix-inappropriate route of administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-MAY-2025 Anonymous healthcare provider called to report the maladministration of Priorix, it was given Intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route. No vaccination date, no vaccine detail and no patient demographics were obtained in this call. No further information was obtained in this call.
More
|
|||||||||
| 2842871 | MD | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Product preparation issue
Product preparation issue
|
Maladministration of the AS01B Adjuvant of Shingrix Alone; Patient may only have received Shingrix d...
Maladministration of the AS01B Adjuvant of Shingrix Alone; Patient may only have received Shingrix diluent vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in two patients 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: Maladministration of the AS01B Adjuvant of Shingrix Alone) and inappropriate dose of vaccine administered (Verbatim: Patient may only have received Shingrix diluent vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK receipt date: 23-MAY-2025 The reporter reported that a patient may only had received Shingrix diluent vaccine. Do not have the information on the patient at this time or if this was a first or second dose. Two diluents missing from the box and two powders left, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter.
More
|
||||||||
| 2842872 | 1.58 | M | IL | 05/27/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
cx4hl |
Product administered to patient of inappropriate age, Wrong product administered
Product administered to patient of inappropriate age, Wrong product administered
|
Administration in 19 month old; Use Boostrix as the 4th dose in Dtap series/accidentally received do...
Administration in 19 month old; Use Boostrix as the 4th dose in Dtap series/accidentally received dose of Boostrix; 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 19-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number cx4hl, expiry date 19-JAN-2026) for prophylaxis. Previously administered products included DTaP (received first 3 doses). On 22-MAY-2025, the patient received the 1st dose of Boostrix. On 22-MAY-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration in 19 month old) and wrong vaccine administered (Verbatim: Use Boostrix as the 4th dose in Dtap series/accidentally received dose of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-MAY-2025 Healthcare professional called in to report that a 19 month old patient initially received their first 3 doses as DTaP and accidentally received a dose of Boostrix, which led wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
More
|
||||||
| 2842873 | 11 | F | TX | 05/27/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
J3952 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
|
Engerix-B second adult dose administration to a pediatric patient; adult dose of Engerix-B to an 11-...
Engerix-B second adult dose administration to a pediatric patient; adult dose of Engerix-B to an 11-year-old patient as a second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 11-year-old female patient who received HBV (Engerix B) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis. Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date). On 30-SEP-2024, the patient received the 2nd dose of Engerix B. On 30-SEP-2024, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: Engerix-B second adult dose administration to a pediatric patient) and overdose (Verbatim: adult dose of Engerix-B to an 11-year-old patient as a second dose). The outcome of the adult product administered to child and overdose 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: 23-MAY-2025 The medical assistant asked for side effects and how to proceed with the third dose after giving an adult dose of Engerix-B to an 11-year-old patient as a second dose, which led to adult product administered to child and overdose. On 30th September 2024 the patient correctly received the first pediatric dose. The Vaccine Administration Facility is the same as Primary Reporter.
More
|
||||||
| 2842874 | UT | 05/27/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
|
Rash
Rash
|
Rashes appearance two weeks after vaccine administration; This non-serious case was reported by a ph...
Rashes appearance two weeks after vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced rash (Verbatim: Rashes appearance two weeks after vaccine administration). The outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 23-MAY-2025 The reporter got somebody and experienced rashes after two weeks after getting the Shingrix vaccine. The reporter want to know if this was related to the vaccine administration or not. The reporter did not consent to follow-up.
More
|
||||||||
| 2842875 | 0.42 | F | NV | 05/27/2025 |
DTAPHEPBIP DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
5J7EF 3RT93 |
Product administered to patient of inappropriate age, Wrong product administered...
Product administered to patient of inappropriate age, Wrong product administered; Product administered to patient of inappropriate age, Wrong product administered
More
|
Pediarix late second dose; Kinrix wrong age; received a dose of Kinrix instead of Pediarix; This non...
Pediarix late second dose; Kinrix wrong age; received a dose of Kinrix instead of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 5-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5J7EF, expiry date 29-NOV-2026) for prophylaxis. Co-suspect products included DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis. Previously administered products included Pediarix (1st dose received on 09-SEP-2024 with batch number-9P329 and expiry date-06-MAR-2026). On 17-MAR-2025, the patient received the 2nd dose of Pediarix. On 17-DEC-2024, the patient received the 1st dose of Kinrix. On 17-DEC-2024, not applicable after receiving Pediarix and an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix wrong age) and wrong vaccine administered (Verbatim: received a dose of Kinrix instead of Pediarix). On 17-MAR-2025, the patient experienced drug dose administration interval too long (Verbatim: Pediarix late second dose). The outcome of the drug dose administration interval too long, inappropriate age at vaccine administration and wrong vaccine administered were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-MAY-2025 The patient received a dose of Kinrix instead of their corresponding second dose of Pediarix which led wrong vaccine administered and inappropriate age at vaccine administration. The reporter explained that patient got a first dose of Pediarix on 9th September 2024, and since they were not aware of the mistake with Kinrix vaccine at that time, a late second dose of Pediarix was administered which led to lengthening of vaccination schedule. The reporter consented to follow up.
More
|
||||||
| 2842876 | 70 | M | 05/27/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
|
Acquired haemophilia, Factor VIII activity test, Laboratory test, Liver function...
Acquired haemophilia, Factor VIII activity test, Laboratory test, Liver function test, Platelet count; Renal function test, White blood cell count
More
|
diagnosed with acquired hemophilia A; This spontaneous case was reported by a non-health professiona...
diagnosed with acquired hemophilia A; This spontaneous case was reported by a non-health professional and describes the occurrence of ACQUIRED HAEMOPHILIA (diagnosed with acquired hemophilia A) in an 8-decade-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACQUIRED HAEMOPHILIA (diagnosed with acquired hemophilia A) (seriousness criterion medically significant). The patient was treated with Cyclophosphamide at an unspecified dose and frequency. At the time of the report, ACQUIRED HAEMOPHILIA (diagnosed with acquired hemophilia A) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Factor VIII activity test: improved and 1 % crucial protein involved in forming blood clots to stop bleeding, levels were only at one percent in his body. On an unknown date, Laboratory test: Tests revealed he was suffering from hemophilia A. On an unknown date, Liver function test: Appeared Normal. On an unknown date, Platelet count: Appeared Normal and Normal. On an unknown date, Renal function test: Appeared Normal. On an unknown date, White blood cell count: Appeared Normal and Normal. It was reported that patient went to hospital after he saw blood in his stool. Patient thought it was due to the colonoscopy (results not provided) that he had the day before. During examination doctor noticed large, dark bruises on both of patient arms that had developed within the span of a few days. Initially patient went to the doctors, and his white blood cell count, platelets count, liver and kidney function all appeared normal during tests. However, patient continued bruising on his arms and which worsen. Patient developed large marks on his left knee two weeks later. Hence doctor ordered more intensive blood tests which included a plasma test. Results showed that while his white cell and platelets counts were normal, they were certain antibodies present in his plasma that were not allowing the body's clotting process to function. Further test showed that his body's FVIII, crucial protein involved in forming blood clots to stop bleeding, levels were only at one percent in his body. As a result, he was diagnosed with acquired hemophilia A - which was known to primarily target the FVIII protein in the body. Patients also develop also complications associated with abnormal, uncontrolled bleeding into the muscles, skin, and soft tissue that could occur spontaneously, during surgery or following trauma. Tests revealed that patient suffered from hemophilia A, where the body prevents blood from clotting, and it caused excessive bleeding from wounds for days at end. It was reported that this prolonged bleeding could cause blood to accumulate beneath the skin and which formed a bruise. Additionally, it was also reported that bruise can caused more susceptible to injuries. Patient had sustained wounds from a colorectal procedure, they were mostly bleeding internally, and the blood was only visible in the stool. The patient had no family history of the condition and was not actively bleeding, according to a medical report about his case. However, it was reported that patient symptom onset was a week after patient had received his Moderna Covid vaccine booster as his fifth dose. The experts theorized that it was possible the shot triggered his immune system to produce antibodies against his body's clotting process and caused the disorder. For treatment, patient was asked to visit a hematology clinic every week and patient started to take cyclophosphamide. The doctors progressively decreased his treatment medication cyclophosphamide dosage regimen as his FVIII levels improved and he showed signs of recovery. Along with this, patient was also given with unspecified treatment medications to prevent fungal infections and protect the stomach. This case was linked to US-MODERNATX, INC.-MOD-2025-786649, US-MODERNATX, INC.-MOD-2025-786855, US-MODERNATX, INC.-MOD-2025-786865, US-MODERNATX, INC.-MOD-2025-786854, US-MODERNATX, INC.-MOD-2025-786866, US-MODERNATX, INC.-MOD-2025-786867, US-MODERNATX, INC.-MOD-2025-786853, US-MODERNATX, INC.-MOD-2025-786851, US-MODERNATX, INC.-MOD-2025-786868, US-MODERNATX, INC.-MOD-2025-786869, US-MODERNATX, INC.-MOD-2025-786856, US-MODERNATX, INC.-MOD-2025-786859, US-MODERNATX, INC.-MOD-2025-786861, US-MODERNATX, INC.-MOD-2025-786862, US-MODERNATX, INC.-MOD-2025-786870, US-MODERNATX, INC.-MOD-2025-786860, US-MODERNATX, INC.-MOD-2025-786858, US-MODERNATX, INC.-MOD-2025-786857, US-MODERNATX, INC.-MOD-2025-786852, US-MODERNATX, INC.-MOD-2025-786871, US-MODERNATX, INC.-MOD-2025-786872 (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-2025-786649:Same reporter different patient US-MODERNATX, INC.-MOD-2025-786859:Patient 20 of 22 US-MODERNATX, INC.-MOD-2025-786861:Patient 21 of 22 US-MODERNATX, INC.-MOD-2025-786856:Patient 19 of 22 US-MODERNATX, INC.-MOD-2025-786853:Patient 15 US-MODERNATX, INC.-MOD-2025-786851:Patient 14 US-MODERNATX, INC.-MOD-2025-786867:Patient 12 of 21 US-MODERNATX, INC.-MOD-2025-786855:Patient 17 US-MODERNATX, INC.-MOD-2025-786854:Patient 16 US-MODERNATX, INC.-MOD-2025-786869:Patient 6 of 21 US-MODERNATX, INC.-MOD-2025-786865:Patient 10 of 21 US-MODERNATX, INC.-MOD-2025-786866:Patient 11 of 21 US-MODERNATX, INC.-MOD-2025-786868:Patient 13 of 21 US-MODERNATX, INC.-MOD-2025-786862:Patient 22 of 22 US-MODERNATX, INC.-MOD-2025-786870:Patient 7 of 21 US-MODERNATX, INC.-MOD-2025-786858:Patient 4 of 22 US-MODERNATX, INC.-MOD-2025-786852:Patient 2 of 22 US-MODERNATX, INC.-MOD-2025-786860:Patient 5 of 22 US-MODERNATX, INC.-MOD-2025-786871:Patient 8 of 21 US-MODERNATX, INC.-MOD-2025-786857:Patient 3 of 22 US-MODERNATX, INC.-MOD-2025-786872:Patient 9 of 21
More
|
|||||||
| 2842878 | F | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Anaphylactic reaction
Anaphylactic reaction
|
anaphylactic reaction; This is a spontaneous report received from a Pharmacist from medical informat...
anaphylactic reaction; This is a spontaneous report received from a Pharmacist from medical information team. An adult female patient received BNT162b2 (BNT162B2), 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown". Clinical course: Pharmacist states that her patient previously experienced an anaphylactic reaction to the 2021 COVID vaccine. She states that the patient is recommended to get vaccinated again and she wants to know if there is any overlap with the ingredients of the 2021 formulation and current 2024-2025 Comirnaty PFS formulation. Caller is requesting information on the active and inactive ingredients. Caller did not specify any ingredient as they are unsure which component of the vaccine the patient is allergic to.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile.
More
|
||||||||
| 2842879 | M | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Autoimmune arthritis, Autoimmune hepatitis, Inflammation, Sjogren's syndrom...
Autoimmune arthritis, Autoimmune hepatitis, Inflammation, Sjogren's syndrome, Weight decreased
More
|
giving him issues like systemic inflammation; Sjogren's; Autoimmune Liver; Autoimmune Arthritis...
giving him issues like systemic inflammation; Sjogren's; Autoimmune Liver; Autoimmune Arthritis; lost 40 pounds; Covid Spike Protein Test/tested very high,over 2500 way over that; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart attack prior to getting the vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SARS-COV-2 ANTIBODY TEST POSITIVE (medically significant) with onset 2025, outcome "unknown", described as "Covid Spike Protein Test/tested very high,over 2500 way over that"; INFLAMMATION (medically significant), outcome "unknown", described as "giving him issues like systemic inflammation"; SJOGREN'S SYNDROME (medically significant), outcome "unknown", described as "Sjogren's"; AUTOIMMUNE HEPATITIS (medically significant), outcome "unknown", described as "Autoimmune Liver"; AUTOIMMUNE ARTHRITIS (medically significant), outcome "unknown"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lost 40 pounds". The events "covid spike protein test/tested very high,over 2500 way over that", "giving him issues like systemic inflammation", "sjogren's", "autoimmune liver" and "autoimmune arthritis" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (2025) very high, over 2500 way over that; Weight decreased: (unspecified date) 40 lbs. Clinical course: Agent states the patient states it was the first one that came out, the double shot. Agent states the caller wants to know more information about the Covid Spike Protein Test, because he had a blood test done and he tested very high. Caller states he has already went to multiple Doctors. He states he had a heart attack prior to getting the vaccine and he has been sick ever since then. He states it seems like all the lights turned on to autoimmune things with him, he now has Sjogren's, Autoimmune Arthritis, Autoimmune Liver. Caller states he wanted to know what was going on with him, so he got tested 2-3 months ago, maybe longer, for the Covid Spike Protein and he tested very high and was told it was very high, over 2500 way over that, and after having a heart attack that is not a good thing. Caller states he lot of money to just see a functional med doctor and get tests. He had one of the first Pfizer vaccines when they came out with the double shot, clarified as the Pfizer covid vaccine. He had a heart attack right before the covid outbreak or during the covid outbreak. He has been sick ever since the vaccine and has had autoimmune issues happening since then. Recently within last 3 months, he had a blood test done for covid spike protein and he tested very high and it is giving him issues like systemic inflammation and states this is very bad for people that have had heart attacks since its inflammatory. States it brought up other autoimmune diseases like rheumatoid arthritis and sjogrens. He has been reading online recently that the covid spike protein by the covid vaccine does cause these autoimmune issues and they are very inflammatory. He is in bad shape and getting worse, he lost 40 pounds and its not a good thing. He has to get rid of the covid spike protein. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
More
|
||||||||
| 2842880 | M | NC | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Visual impairment
Visual impairment
|
Just in reading glasses, now in stronger reading glasses, vision got worse; This is a spontaneous re...
Just in reading glasses, now in stronger reading glasses, vision got worse; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "Just in reading glasses, now in stronger reading glasses, vision got worse". Therapeutic measures were taken as a result of visual impairment. Additional information: Caller's friend, his dad had recently passed and when caller was telling her symptoms, that's really weird. Caller's friend had a similar experience. Just in reading glasses, now in stronger reading glasses, vision got worse. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499225 same reporter/drug, different patient/event;
More
|
|||||||
| 2842881 | 75 | F | CA | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
ER8735 |
Gait inability, Renal cancer
Gait inability, Renal cancer
|
Surgery to remove cancerous kidney; couldn't walk at all; This is a spontaneous report received...
Surgery to remove cancerous kidney; couldn't walk at all; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 75-year-old female patient received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Lot number: ER8735) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "colon cancer", start date: 2009 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0150), administration date: 12Apr2021, when the patient was 75-year-old, for Covid-19 immunization. The following information was reported: RENAL CANCER (medically significant) with onset 2021, outcome "unknown", described as "Surgery to remove cancerous kidney"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "couldn't walk at all". Therapeutic measures were taken as a result of renal cancer. Clinical course: In Sep2021, patient was walking 40 minutes each day. In Sep2021, Surgery to remove cancerous kidney after which she couldn't walk at all. Oct2021 to Sep2022 gradually increased walking from zero to 20 minutes per day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500052642 Same patient, different dose and event;
More
|
||||||
| 2842882 | 50 | F | NC | 05/27/2025 |
COVID19 COVID19 COVID19 COVID19 |
PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH PFIZER\BIONTECH |
|
Eye disorder, Eyelash discolouration, Investigation, Menstruation irregular, Top...
Eye disorder, Eyelash discolouration, Investigation, Menstruation irregular, Topography corneal; COVID-19, Vaccination failure; Eye disorder, Eyelash discolouration, Investigation, Menstruation irregular, Topography corneal; COVID-19, Vaccination failure
More
|
right eye went down hill again; Period absolutely stopped /Had been regular every 3 weeks for life. ...
right eye went down hill again; Period absolutely stopped /Had been regular every 3 weeks for life. After moved out of her house her period came back for 3 months and then was gone; Graying of eyelashes on the right side; This is a spontaneous report received from a Consumer or other non HCP. A 50-year-old female patient received BNT162b2 (BNT162B2), on 21May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 24Apr2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "her vision in her right eye was blurrier", "her vision in her right eye was blurrier/her right eye got aggravated and red", "Eye started getting really red and irritated; it was just inflamed", "low grade temperature; 99.2-99.5.", "slept a lot", "body ache", "Fatigue", "Diarrhea", "Elevated temperature", "Confusion", "her vision in her right eye was blurrier/her right eye got aggravated and red/Eye started getting really red and irritated; it was just inflamed", "her vision in her right eye was blurrier/her right eye got aggravated and red/Eye started getting really red and irritated; it was just inflamed", "elevation of the IgM antibodies", "corneal inflammation to the inner side of her right eye", "Fever", "period absolutely just stopped/After moved out of her house her period came back for 3 months and then was gone", "Joint pain"; Flu vaccine (Last time had the flu vaccine was 2017. Got it every year.), administration date: 2017, for immunization; Hep a (sometime had one of the two Hep A), administration date: 2002, for immunization; Hep b (2 of the 3 of Hep B.), administration date: 2002, for immunization. The following information was reported: EYELASH DISCOLOURATION (non-serious) with onset Apr2022, outcome "unknown", described as "Graying of eyelashes on the right side"; EYE DISORDER (non-serious), outcome "unknown", described as "right eye went down hill again"; MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "Period absolutely stopped /Had been regular every 3 weeks for life. After moved out of her house her period came back for 3 months and then was gone". The events "graying of eyelashes on the right side" and "right eye went down hill again" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eyelash discolouration, eye disorder. Additional information: Caller was trying to find out, the vision got better to the point of only having to wear reading glasses on the computer. But caller got covid in Sep2022 and right eye went down hill again. Trying to figure out; has to wear glasses now, all the time due to vision in the right eye. Is there anything similar reported and what did they do with it. The second covid vaccine was done at a (withheld) and got it like a prescription. Confirmed both doses were the Pfizer Covid Vaccine. 1st covid vaccine: Documented in formal field. 2nd covid vaccine: Caller can't find vaccine card, it is in a zip lock, plus with the moving and stuff. Date: Had to wait 10 days and not wanting to wear a mask with clients. It was sometime at the end of May2021. Somewhere around 21May2021. It would be on file with (withheld). At the time had a hard time getting to the adverse event line. Graying of eyelashes of the right side. Came and went. Did not report in the initial report. Probably occurred in Apr2022, when caller went back to work on the computer. As an immunologist that is; also had just turned 50 and her period absolutely just stopped when got the covid vaccine. Had been regular every 3 weeks for life. After moved out of her house her period came back for 3 months and then was gone. The patient received any other vaccines on the same date as the Pfizer vaccine and the patient taking any other medications within 2 weeks prior to the event onset were reported as no. AE require a visit to a Physician's Office was reported as right eye. Treatment received for the adverse event/incident was specified as eye drops. Caller has been to 3 different eye doctors and need to gather all the that information and try to get it to Pfizer. Trying to piece it all together. Trying to figure out an eye doctor that she can go to. Is this a immunological reaction of some sort. Outbound call made for report 2 of 2 and caller provided additional information during outbound call. When onboarding with Pfizer, they talked about reactions. It is not Pfizer's fault. Any product has the potential for reactions. Maybe there is, don't think it is just the vaccine, maybe there's something immunological with me. That maybe the immune system sees as a threat. Caller asked if call handler remembers 5G and people talking about getting the virus through 5G. After the vaccine and got covid, now caller gets it. Body can mistake certain wavelengths. A chemical exposure. Some reaction that with mistake the computer as something that it is not. There's inflammation there. Maybe need to be back to the eye doctor, maybe an immunological one.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499225 same reporter/patient/drug, different dose/event;
More
|
||||||
| 2842883 | F | 05/27/2025 |
PNC20 |
PFIZER\WYETH |
|
Erythema, Pain in extremity, Peripheral swelling
Erythema, Pain in extremity, Peripheral swelling
|
left arm is red and swollen, as well as painful; left arm is red and swollen, as well as painful; le...
left arm is red and swollen, as well as painful; left arm is red and swollen, as well as painful; left arm is red and swollen, as well as painful; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), outcome "not recovered" and all described as "left arm is red and swollen, as well as painful". Additional information: the pain has not relented at all, and it has continued past 48 hours after the vaccine was administered. The patient mentioned it was red and swollen, and she expected it to be less red and warm than the previous day. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
||||||||
| 2842884 | M | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Fungal infection
Fungal infection
|
Genital Yeast Infection; I have like a very foul odor that is coming from like my groin area; My pen...
Genital Yeast Infection; I have like a very foul odor that is coming from like my groin area; My penis smells like really bad stinky feet; This is a spontaneous report received from a Consumer or other non HCP. A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FUNGAL INFECTION (non-serious), outcome "unknown", described as "Genital Yeast Infection; I have like a very foul odor that is coming from like my groin area; My penis smells like really bad stinky feet". Additional information: when the patient went to see the doctor, she was doing an examination and she was telling him that she was really concerned because he had like a very foul odor that was coming from like his groin area and she was telling him also that she thinks that his penis smelled like really bad stinky feet and she did not think that the patient did any cleaning or anything like that because he was not circumcised but she told him that when she was doing the exam, when she was smelling his penis head, she said it smelled like really bad stinky feet. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
More
|
||||||||
| 2842885 | OH | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Chronic fatigue syndrome, Malaise
Chronic fatigue syndrome, Malaise
|
don't feel good; chronic fatigue syndrome; This is a spontaneous report received from a Consume...
don't feel good; chronic fatigue syndrome; 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. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "don't feel good"; CHRONIC FATIGUE SYNDROME (non-serious), outcome "unknown". Additional information: The patient reported that after they took the COVID vaccines, they didn't feel good and experienced chronic fatigue syndrome. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
More
|
||||||||
| 2842886 | F | MN | 05/27/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Myocardial injury, Postural orthostatic tachycardia syndrome
Myocardial injury, Postural orthostatic tachycardia syndrome
|
bad heart; POTS; This is a spontaneous report received from a Consumer or other non HCP, Program ID....
bad heart; POTS; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 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: MYOCARDIAL INJURY (medically significant), outcome "unknown", described as "bad heart"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "POTS". Clinical course: Three high school sport athlete and two college sport daughters had to give up their swimming and track career after taking Pfizer Covid shot. One now had a bad heart and had POTS. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
More
|
|||||||
| 2842887 | 0.25 | M | KS | 05/27/2025 |
PNC20 |
PFIZER\WYETH |
LJ5280 |
Infant irritability, Pyrexia
Infant irritability, Pyrexia
|
Within 24 hours of the vaccine he started throwing his head back and forth from side to side against...
Within 24 hours of the vaccine he started throwing his head back and forth from side to side against the bed/floor. He was fussy/irritable/hard to console. Had fever. All symptoms lasted 3 days.
More
|
||||||
| 2842888 | 0.17 | M | OK | 05/27/2025 |
DTPPVHBHPB FLU3 RV5 |
MSP VACCINE COMPANY GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
u8267aa ae2j7 Y011483 |
Wrong product administered; Wrong product administered; Wrong product administer...
Wrong product administered; Wrong product administered; Wrong product administered
More
|
It was discovered through cross comparison of billing report and VFC vaccine data entry that patient...
It was discovered through cross comparison of billing report and VFC vaccine data entry that patient was given a different vaccine than what was ordered. No documentation in chart of concern from parents after vaccinations on 4/23/25 and Dr reached out to mom today to let her know what happened.
More
|
||||||
| 2842889 | 88 | F | TN | 05/27/2025 |
PNC21 |
MERCK & CO. INC. |
z004301 |
Purpura, Rash, Rash erythematous
Purpura, Rash, Rash erythematous
|
Purpuric rash circumferential left upper extremity, with notable erythema, pain and pruritic.
Purpuric rash circumferential left upper extremity, with notable erythema, pain and pruritic.
|
||||||
| 2842901 | 51 | M | NC | 05/27/2025 |
UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
6H9697 6H9697 |
Arthralgia, Brain fog, Disturbance in attention, Dizziness, Fatigue; Headache, M...
Arthralgia, Brain fog, Disturbance in attention, Dizziness, Fatigue; Headache, Memory impairment, Tinnitus
More
|
Joint pain, headache, tinnitus, brain fog, dizziness, memory and concentration issues, fatigue. All ...
Joint pain, headache, tinnitus, brain fog, dizziness, memory and concentration issues, fatigue. All ongoing.
More
|
โ | |||||
| 2842902 | 5 | F | AZ | 05/27/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
U7536AA |
Wrong product administered
Wrong product administered
|
Patient was scheduled for flu vaccine and Vaxelis was inadvertently administered. Client left the of...
Patient was scheduled for flu vaccine and Vaxelis was inadvertently administered. Client left the office prior to becoming aware wrong vaccine was given. Supervisor was notified and I was advised to contact parent to let them know. I left VM for guardian to contact office to inform them of incident. I have not received a call back. Several days later mother returned call and she is out of town, so she advised nurse she would call her father to bring in the patient for correct vaccine.
More
|
||||||
| 2842904 | 51 | F | CA | 05/27/2025 |
VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
4h79y 4h79y UNK UNK |
Rash maculo-papular, Rash pruritic, Varicella; Rash pruritic, Varicella; Rash ma...
Rash maculo-papular, Rash pruritic, Varicella; Rash pruritic, Varicella; Rash maculo-papular, Rash pruritic, Varicella; Rash pruritic, Varicella
More
|
Pruritic macularpapular rash approximately 1 week after receiving Shingrix vaccination. Progressive...
Pruritic macularpapular rash approximately 1 week after receiving Shingrix vaccination. Progressive since then. Son has now developed a rash which his pediatrician diagnosed as chickenpox.
More
|
||||||
| 2842905 | 16 | F | WA | 05/27/2025 |
MENB MNQ |
NOVARTIS VACCINES AND DIAGNOSTICS NOVARTIS VACCINES AND DIAGNOSTICS |
PX7E2 AMXB056A |
Fall, Loss of consciousness, Malaise, Nausea; Fall, Loss of consciousness, Malai...
Fall, Loss of consciousness, Malaise, Nausea; Fall, Loss of consciousness, Malaise, Nausea
More
|
Bexsero and Menveo Vial 1 only was given to Patient on her left arm Intramuscularly at around 4.55 p...
Bexsero and Menveo Vial 1 only was given to Patient on her left arm Intramuscularly at around 4.55 pm. Pt was advised to stay at medical facility for 15 minutes. She was staying in our waiting room. After about 10 minutes she started complaining of nauseated and all at sudden she fell on ground and passed out for around 30-60 seconds then she was feeling all good. We told her not to get up in the mean time we called 911 and so care unit came and an medical officer checked her very throughlly and allowed her to leave. She was doing ok when she left
More
|
||||||
| 2842915 | 18 | F | AL | 05/27/2025 |
COVID19 |
MODERNA |
B0004 |
Expired product administered, No adverse event
Expired product administered, No adverse event
|
Vaccine expired 5/23/25 - given 5/27/25. No adverse reaction reported from patient.
Vaccine expired 5/23/25 - given 5/27/25. No adverse reaction reported from patient.
|
||||||
| 2842916 | 30 | F | CA | 05/27/2025 |
IPV |
SANOFI PASTEUR |
Y1A201M |
No adverse event, Wrong product administered
No adverse event, Wrong product administered
|
Patient notified of error of vaccine administration Polio given instead of Tuberculin placement and ...
Patient notified of error of vaccine administration Polio given instead of Tuberculin placement and asked to come back in to office for evaluation.
More
|
||||||
| 2842622 | CA | 05/26/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
2345B |
Product label issue
Product label issue
|
Havrix-Adult box has a sticker that says contains latex. PI inside this box states that the prefille...
Havrix-Adult box has a sticker that says contains latex. PI inside this box states that the prefilled syringe is latex-free; Product complaint/ Pictures of this discrepancy-sticker on box, PI, product; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product label confusion in an unspecified number of patients who received HAV (Havrix adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis. This case was associated with a product complaint. On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced product label confusion (Verbatim: Havrix-Adult box has a sticker that says contains latex. PI inside this box states that the prefilled syringe is latex-free) and pharmaceutical product complaint (Verbatim: Product complaint/ Pictures of this discrepancy-sticker on box, PI, product). The outcome of the product label confusion and pharmaceutical product complaint 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: 15-MAY-2025 The reporter was the HCP (health care professional). He was a medication safety pharmacist with 300 pharmacies. One of his pharmacists informed him that a box of Havrix-adult had a contains latex sticker on the front. The PI (product information) included inside this box reads: the tip cap and rubber plunger stopper of the prefilled syringe were not made with natural rubber latex. Pictures of this discrepancy (sticker on box, PI, product) would be sent to referencing the case number, which led to product label confusion and pharmaceutical product complaint. Confirmed that all operations were performed appropriately before defect was discovered. The Havrix-Adult box has a sticker that said contains latex. The PI inside this box stated that the prefilled syringe was latex-free. After partial use of the multi pack, the defect discovered. The product was administered. The box or carton and PI components was involved in the complaint Per QA Liaison, no return of suspect product or packaging was requested at this time. The reporter did not know how many doses have been used from the box. The customer 1 was the pharmacy that had the suspect product. For now, their information was here rather than in the HCP section as the reporter's email address needed to be noted for follow-up. Unspecified number of Havrix doses administered. There was a product complaint to report and complaint ID was reported.
More
|
||||||||
| 2842623 | M | 05/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Haemorrhage, Pruritus
Haemorrhage, Pruritus
|
Extreme itching, bleeding; Bleeding; This non-serious case was reported by a consumer and described ...
Extreme itching, bleeding; Bleeding; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cardiac stent placement (Heart stent operation in January). Concurrent medical conditions included blood pressure high and blood cholesterol increased. Concomitant products included prasugrel hydrochloride (Effient), morniflumate (Flomax), rosuvastatin, losartan, acetylsalicylic acid (Asprin), pantoprazole sodium (Pantoprazole) and vitamins. On 12-MAY-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: Extreme itching, bleeding) and hemorrhage (Verbatim: Bleeding). The patient was treated with hydrocortisone acetate;pramocaine hydrochloride (Hydroxine). The outcome of the pruritus and hemorrhage were not resolved. It was unknown if the reporter considered the pruritus and hemorrhage to be related to Shingrix. It was unknown if the company considered the pruritus and hemorrhage to be related to Shingrix. Additional Information: GSK Receipt Date: 18-MAY-2025 The patient was also on Effient for a heart stent operation in January. Other medications were reported as one a day Vitamin, Flomax, Hydroxine, Rousuvastatin, Losartan, Asprin, Pantoprozole. The patient wanted to know if this was a reaction to Shingrix and how long it would last. If there was any antidotes to cancel the allergic reaction. (Extreme itching, bleeding) Were the symptoms treated was reported as no.
More
|
||||||||
| 2842624 | 45 | M | MN | 05/26/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Expired product administered
Expired product administered
|
The vaccine had expired one month earlier; This non-serious case was reported by a consumer via call...
The vaccine had expired one month earlier; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received HBV (Engerix B adult) (expiry date APR-2025) for prophylaxis. On 08-MAY-2025, the patient received the 3rd dose of Engerix B adult. On 08-MAY-2025, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: The vaccine had expired one month earlier). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 19-MAY-2025 This report was submitted via the online direct entry reporting system. The reporter was the patient. The patient received his third Engerix-B adult dose and the vaccine had expired one month earlier, which led to expired vaccine used. The vaccinator did not provide him with the lot number and exact expiration date. The formulation was unknown. Doctor's office recommended the expired dose be repeated, but the patient has not yet decided if he would do this. Nothing else was reported. The patient/reporter did not provide lot number to the patient.
More
|
||||||
| 2842625 | FL | 05/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Product preparation issue
Product preparation issue
|
she incorrect reconstituted Shingrix; Inappropriate dose of vaccine administered; This non-serious c...
she incorrect reconstituted Shingrix; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional 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: she incorrect reconstituted Shingrix) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 20-MAY-2025 This report was submitted via the online direct entry reporting system. Healthcare professional (HCP) was the reporter. Healthcare professional reported she incorrect reconstituted Shingrix (reconstitution error), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided/obtained.
More
|
||||||||
| 2842626 | F | MD | 05/26/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incorrect dose administered
Incorrect dose administered
|
not sure if she ever went back to receive the second dose; This non-serious case was reported by a c...
not sure if she ever went back to receive the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (patient received first dose 2 to 3 years ago). 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: not sure if she ever went back to receive the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 20-MAY-2025 This report was submitted via the online direct entry reporting system. The patient did not have any lot number information to provide. The reporter was a patient that received her first dose of Shingrix 2 to 3 years ago from her pharmacist at her local pharmacy, and was not sure if she ever went back to receive the second dose. The patient reported that she normally received vaccines in her left arm, but this was not confirmed. The patient thought the Shingrix first dose was administered as an IM injection, but this was not confirmed. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
More
|
|||||||
| 2842627 | F | 05/26/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
5P4A5 |
Expired product administered
Expired product administered
|
administered expired Arexvy vaccine to 2 patients; This non-serious case was reported by a pharmacis...
administered expired Arexvy vaccine to 2 patients; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5P4A5, expiry date 27-MAR-2025) for prophylaxis. On 21-MAY-2025, the patient received the 1st dose of Arexvy (left arm). On 21-MAY-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: administered expired Arexvy vaccine to 2 patients). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 21-MAY-2025 The reporter reported that the patient who had received expired Arexvy vaccine which led to, expired vaccine used. As it was administered to 2 patients, there were 2 initials by pharmacist as they was husband and wife. This case had been link with US2025AMR064187, reported by the same reporter.; Sender's Comments: US-GSK-US2025AMR064187:Male patient
More
|