| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2830191 | 03/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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I got my Shingles booster at 6 months and 1 week after original shot; This non-serious case was repo...
I got my Shingles booster at 6 months and 1 week after original shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I got my Shingles booster at 6 months and 1 week after original shot). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 24-FEB-2025 The patient self-reported this case. The patient got Shingles vaccine (Shingrix) booster at 6 months and 1 week after original shot and asked will it work. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule
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| 2830192 | 03/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Hypersensitivity
Hypersensitivity
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Nees allergy; This non-serious case was reported by a consumer via interactive digital media and des...
Nees allergy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced allergy (Verbatim: Nees allergy). The outcome of the allergy was not reported. It was unknown if the reporter considered the allergy to be related to Arexvy. It was unknown if the company considered the allergy to be related to Arexvy. Additional Information: GSK Receipt Date: 27-FEB-2025 The reporter reported that patient received Arexvy vaccine and experienced allergy and needs alleygy information.
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| 2830193 | 03/07/2025 |
RVX |
UNKNOWN MANUFACTURER |
UNK |
Respiratory syncytial virus infection, Vaccination failure
Respiratory syncytial virus infection, Vaccination failure
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Suspected vaccination failure; I had the vaccine last fall and just got over it after 2 weeks of ago...
Suspected vaccination failure; I had the vaccine last fall and just got over it after 2 weeks of agony; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: I had the vaccine last fall and just got over it after 2 weeks of agony). The outcome of the vaccination failure was not reported and the outcome of the respiratory syncytial virus infection was resolved (duration 2 weeks). It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine. The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine. Additional Information: GSK Receipt Date: 28-FEB-2025 This case was reported by a patient via interactive digital media. The patient had the RSV vaccine last fall and just got over it after 2 weeks of agony. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection 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 RSV vaccine.
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| 2830194 | 03/07/2025 |
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
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Suspected vaccination failure; shingles; It is what you get after three vaccinations; came up with t...
Suspected vaccination failure; shingles; It is what you get after three vaccinations; came up with two vaccinations one month apart; 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: shingles), extra dose administered (Verbatim: It is what you get after three vaccinations) and drug dose administration interval too short (Verbatim: came up with two vaccinations one month apart). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered and drug dose administration interval too short 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 to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 01-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she received three vaccinations which led to extra dose administered. The first one admittedly (by provider) did not work so came up with two vaccinations one month apart which led to drug dose administration interval too short. It was reported that it was not so good as well. The patient had shingles three times after all was said and done. The follow-up could not be possible as no contact details were available. 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 dose 1, Shingles vaccine dose 2 and Shingles vaccine dose 3.
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| 2830195 | F | 03/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspect vaccination failure; i know of a vaccinated lady who just got shingles; This serious case wa...
suspect vaccination failure; i know of a vaccinated lady who just 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 (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspect vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i know of a vaccinated lady who just 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 Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 03-MAR-2025 This case was reported by a consumer via interactive digital media. The reporter knew the vaccinated patient who just got shingles. 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 Shingles vaccine.
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| 2830196 | 03/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspect vaccination failure; i took the shingles vaccine and still got a bad case of shingles; This ...
suspect vaccination failure; i took the shingles vaccine and still got a bad case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspect vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i took the shingles vaccine and still got a bad case of shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 03-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that no more vaccines for him/her, he/she took the shingles vaccine and still got a bad case of shingles. 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 Shingles vaccine.
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| 2830197 | M | 03/07/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Pain, Vaccination failure
Herpes zoster, Pain, Vaccination failure
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Suspected vaccination failure; had them on his back/most painful/even the slightless breeze make the...
Suspected vaccination failure; had them on his back/most painful/even the slightless breeze make them hurt; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had them on his back/most painful/even the slightless breeze make them hurt). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 02-MAR-2025 This case was reported by a patient's wife via interactive digital media The reporter saw what shingles could do to a person. The patient received the shingles vaccine and had them (shingles) on his back and he told that the most painful thing to have, even the slightless breeze would make them hurt. The patient did not want to have shingles again. 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. US-GLAXOSMITHKLINE-US2021AMR202845:Same reporter/ Wife case (Dose 1) US-GLAXOSMITHKLINE-US2021AMR202848:Same reporter/ Wife case (Dose 2)
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| 2830198 | 03/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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miss second shot of shingrix; This non-serious case was reported by a consumer via interactive digit...
miss second shot of shingrix; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (Patient received first dose in APR-2024). 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: miss second shot of shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 04-MAR-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient asked if they missed the second dose, do they need to restart regime again. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
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| 2830199 | F | PA | 03/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
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Off label use
Off label use
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Prescription for Arexvy for patient under 60; This non-serious case was reported by a pharmacist via...
Prescription for Arexvy for patient under 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced off label use (Verbatim: Prescription for Arexvy for patient under 60). The outcome of the off label use was not applicable. Additional Information: GSK Receipt Date: 26-FEB-2025 The pharmacist stated that a doctor wanted to administer Arexvy to a special need of patient who was 38 years old, which led to off label. The adverse event report completed as there was an active prescription. The Vaccine Administration Facility is the same as Primary Reporter.
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| 2830200 | 32 | M | CA | 03/07/2025 |
HEP HEP |
DYNAVAX TECHNOLOGIES CORPORATION GLAXOSMITHKLINE BIOLOGICALS |
Y014323 |
Interchange of vaccine products; Interchange of vaccine products
Interchange of vaccine products; Interchange of vaccine products
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Heplisav-B on October 21st 2024 and a dose of Engerix-B on January 24th 2025.; This non-serious case...
Heplisav-B on October 21st 2024 and a dose of Engerix-B on January 24th 2025.; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 32-year-old male patient who received HBV (Engerix B) (batch number Y014323, expiry date 12-FEB-2027) for prophylaxis. Co-suspect products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b) for prophylaxis. On 24-JAN-2025, the patient received Engerix B. On 21-OCT-2024, the patient received Heplisav b. On 24-JAN-2025, an unknown time after receiving Engerix B, the patient experienced interchange of vaccine products (Verbatim: Heplisav-B on October 21st 2024 and a dose of Engerix-B on January 24th 2025.). The outcome of the interchange of vaccine products 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: 27-FEB-2025 The nurse mentioned that a patient got Heplisav-B on October 21st 2024 and a dose of Engerix-B on January 24th 2025, which led to interchange of vaccine products.
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| 2830201 | F | NJ | 03/07/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
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Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected Vaccination failure; Shingles breakout; This serious case was reported by a pharmacist via...
Suspected Vaccination failure; Shingles breakout; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JUL-2023, the patient received the 2nd dose of Shingrix. On 02-JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles breakout). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 03-MAR-2025 The pharmacist reported that it was uncertain if a patient had received the 2 doses of Shingrix and according to reporter, the 1st dose was administered to the patient and the second dose was potentially administered, but pharmacist told it was not confirmed. Also, reporter mentioned that patient had a shingles breakout (no date specified). The Vaccine Administration Facility is the same as Primary Reporter. This case was considered as suspected vaccination failure since the details regarding the 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix and Shingrix.
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| 2830202 | 6 | F | ID | 03/07/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34MF9 |
Extra dose administered
Extra dose administered
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second dose of Kinrix; This non-serious case was reported by a nurse via call center representative ...
second dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. Concomitant products included Kinrix. On 19-FEB-2025, the patient received the 2nd dose of Kinrix. On 19-FEB-2025, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: second dose of Kinrix ). 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: 03-MAR-2025 Nurse called to report that they administered a dose of Kinrix to a 6 years 11 months old female patient on 28 JAN-2025 and then on 19-FEB-2025 the patient received another dose of Kinrix. Patient received the second dose ok Kinrix, which led to extra dose administered.
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| 2830203 | F | MI | 03/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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did not received her second dose within the recommended period; This non-serious case was reported b...
did not received her second dose within the recommended period; This non-serious case was reported by a pharmacist 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 (received 1st dose of shingrix 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: did not received her second dose within the recommended period). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date : 04-MAR-2025 The pharmacist mentioned that they did not have date of birth or initials for the patient, and they did not know date of administration, lot number or expiration date for the first dose. They did not know if the first dose was administered at their facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix within the recommended period, which led to incomplete course of vaccination. This case was linked with US2021AMR128772, US2020221334 and US2020019136, reported by same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR128772:same reporter US-GSK-US2020221334:same reporter US-GLAXOSMITHKLINE-US2020019136:same reporter
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| 2830204 | 23 | F | TX | 03/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
47XP4 |
Underdose
Underdose
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Engerix-B Pediatric Dose on a female adult patient; Engerix-B Pediatric Dose on a female adult patie...
Engerix-B Pediatric Dose on a female adult patient; Engerix-B Pediatric Dose on a female adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 23-year-old female patient who received HBV (Engerix B pediatric) (batch number 47XP4, expiry date 16-JUL-2026) for prophylaxis. On 04-MAR-2025, the patient received Engerix B pediatric. On 04-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B Pediatric Dose on a female adult patient) and underdose (Verbatim: Engerix-B Pediatric Dose on a female adult patient). The outcome of the adult use of a child product and underdose 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 04-MAR-2025 Registered Nurse called to report the maladministration of an Engerix-B pediatric dose on a female adult patient and was seeking for advice on this situation (revaccination/how to proceed).
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| 2830205 | 47 | F | MS | 03/07/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
95D74 |
Underdose
Underdose
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Engerix-B pediatric dose to adult patient; Engerix-B pediatric dose to adult patient; This non-serio...
Engerix-B pediatric dose to adult patient; Engerix-B pediatric dose to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis. On 14-FEB-2025, the patient received Engerix B pediatric. On 14-FEB-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Engerix-B pediatric dose to adult patient) and underdose (Verbatim: Engerix-B pediatric dose to adult patient). The outcome of the adult use of a child product and underdose 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: 05-MAR-2025 The nurse reported that a pediatric dose of Engerix-B vaccine was given to an adult patient, which led to adult use of a child product and underdose The Vaccine Administration Facility was the same as Primary Reporter.
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| 2830206 | F | NE | 03/07/2025 |
HEP HEP |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
7NX57 4D333 |
Extra dose administered; Extra dose administered
Extra dose administered; Extra dose administered
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Engerix-B - Extra doses; Engerix-B - Extra doses; This non-serious case was reported by a other heal...
Engerix-B - Extra doses; Engerix-B - Extra doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received HBV (Engerix B) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number 4D333, expiry date 14-AUG-2026) for prophylaxis. On 04-MAR-2025, the patient received the 6th dose of Engerix B. On 15-NOV-2024, the patient received the 5th dose of Engerix B. On 15-NOV-2024, not applicable after receiving Engerix B and 365 days after receiving Engerix B, the patient experienced extra dose administered (Verbatim: Engerix-B - Extra doses). On 04-MAR-2025, the patient experienced extra dose administered (Verbatim: Engerix-B - Extra doses). The outcome of the extra dose administered and extra dose 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: 05-MAR-2025 The health care provider reported that a patient received a fifth and sixth dose of Engerix-B, which led to extra dose administered. The patient received three doses in but due to lack of records this patient received a fifth and a sixth dose. The patient was currently 5 years 11-month-old. The fifth dose was administered on 11/15/2024 and the sixth dose was given on 3/4/2025.
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| 2830207 | 63 | M | 03/07/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
4T5B5 |
Expired product administered
Expired product administered
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an expired dose of Arexvy was administered to a 63 years old male patient; This non-serious case was...
an expired dose of Arexvy was administered to a 63 years old male patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4T5B5, expiry date 02-MAR-2025) for prophylaxis. On 05-MAR-2025, the patient received Arexvy. On 05-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: an expired dose of Arexvy was administered to a 63 years old male patient). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 05-MAR-2025 The medical assistant called to reported that they administered an expired dose of Arexvy patient on the day of reporting which led to, expired vaccine used. The reported wanted to know was there any supplemental potency data.
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| 2830208 | 47 | M | PA | 03/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EY253 |
Product preparation issue
Product preparation issue
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given a vaccine diluent of Shingrix without being reconstituted; given a vaccine diluent of Shingrix...
given a vaccine diluent of Shingrix without being reconstituted; given a vaccine diluent of Shingrix without being reconstituted; 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 47-year-old male patient who received Herpes zoster (Shingrix) (batch number EY253, expiry date 16-JUL-2026) for prophylaxis. On 18-FEB-2025, the patient received Shingrix. On 18-FEB-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: given a vaccine diluent of Shingrix without being reconstituted) and inappropriate dose of vaccine administered (Verbatim: given a vaccine diluent of Shingrix without being reconstituted). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 05-MAR-2025 Reporter had a patient who was given a vaccine diluent (Shingrix) without being reconstituted, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. Reporter was enquiring if he/she can revaccinate at any time and are there any potential concerns he should be notified if he only received diluent.
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| 2830209 | 28 | F | IL | 03/07/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
232Z3 |
Underdose
Underdose
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Pediatric dose to an adult patient; Pediatric dose to an adult patient; This non-serious case was re...
Pediatric dose to an adult patient; Pediatric dose to an adult patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 28-year-old female patient who received HAV (Havrix pediatric) (batch number 232Z3, expiry date 14-NOV-2025) for prophylaxis. On 04-MAR-2025, the patient received the 2nd dose of Havrix pediatric. On 04-MAR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose to an adult patient) and underdose (Verbatim: Pediatric dose to an adult patient). The outcome of the adult use of a child product and underdose 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: 05-MAR-2025 The registered pharmacist reported that they had a adult patient came for Havrix vaccine and they were given the 2nd pediatric dose, which led to adult use of a child product and underdose. The Vaccine Administration Facility was the same as Primary Reporter.
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| 2830210 | M | 03/07/2025 |
COVID19 COVID19 |
MODERNA MODERNA |
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Anosmia, Brain fog, Illness, Immunisation reaction, Insomnia; Tinnitus
Anosmia, Brain fog, Illness, Immunisation reaction, Insomnia; Tinnitus
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still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other i...
still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues; after receiving the 2023 dose patient began a 1 and half year battle with sickness; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced ILLNESS (after receiving the 2023 dose patient began a 1 and half year battle with sickness). On an unknown date, the patient experienced INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues). At the time of the report, INSOMNIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), ANOSMIA (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), TINNITUS (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues), BRAIN FOG (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) and IMMUNISATION REACTION (still suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues) had not resolved and ILLNESS (after receiving the 2023 dose patient began a 1 and half year battle with sickness) outcome was unknown. Relevant medical history of the patient was reported as unknown. Concomitant product use was not provided by the reporter. It was reported that patient had sickness 2 weeks after receiving the vaccine on an unspecified date of Sep-2023. Patient was battling with sickness for 1 and a half year. Patient never had covid however vaccine had made him sick. At the time of the reporting patient was suffering with problems like foggy head, insomnia, loss of smell, tinnitus and several other issues. It was unknown if the patient experienced any additional symptoms or events. Treatment information was not provided. Reporter causality was not reported. This case was linked to MOD-2025-782987 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
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| 2830211 | M | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
FF8841 |
Biopsy brain, Investigation, Vasculitis
Biopsy brain, Investigation, Vasculitis
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Vasculitis; This is a spontaneous report received from a Consumer or other non HCP. An 83-year-old ...
Vasculitis; This is a spontaneous report received from a Consumer or other non HCP. An 83-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Lot number: FF8841), in arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Polymyalgia" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (DOSE 2; EM9809, administered in arm), administration date: 05Feb2021, for Covid-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VASCULITIS (death, prolonged hospitalization, life threatening) with onset Nov2021, outcome "fatal". The clinical course was reported as follows: The patient died from vasculitis on 03Jul2022 after suffering a debilitating death. Treatment included unspecified medication. He ran a thriving auto agency 5 days a week and cut wood and grew a huge garden on weekends. He was a very active, healthy man prior to the vaccine. The patient underwent the following laboratory tests and procedures: Biopsy brain: unknown results; many test: unknown results. Therapeutic measures were taken as a result of vasculitis. The patient date of death was 03Jul2022. Reported cause of death: "Vasculitis". It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Vasculitis
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| 2830212 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830213 | 67 | M | NM | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death, Eyeball avulsion, Mobility decreased, Peritonitis bacterial
Death, Eyeball avulsion, Mobility decreased, Peritonitis bacterial
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Bacterial peritonitis; Lost an eye; Lost full-body mobility; Died; This is a spontaneous report rece...
Bacterial peritonitis; Lost an eye; Lost full-body mobility; Died; This is a spontaneous report received from a consumer. A 67-year-old male patient received BNT162b2 Omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 30Aug2024 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Liver cirrhosis" (unspecified if ongoing); "Liver cancer" (unspecified if ongoing); "Immunocompromised" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. No other vaccine was administered in four weeks and on the same date with the Pfizer suspect vaccine. The facility where the vaccine was administered was in a pharmacy or drugstore. The following information was reported: PERITONITIS BACTERIAL (hospitalization, disability, life threatening) with onset 31Aug2024, outcome "not recovered", described as "Bacterial peritonitis"; EYEBALL AVULSION (hospitalization, disability, life threatening) with onset 31Aug2024, outcome "not recovered", described as "Lost an eye"; MOBILITY DECREASED (hospitalization, disability, life threatening) with onset 31Aug2024, outcome "not recovered", described as "Lost full-body mobility"; DEATH (death) with onset 21Feb2025, outcome "fatal", described as "Died". After receiving the vaccine (fourth COVID-19 vaccine), the patient felt ill in less than 24 hours. The symptoms were similar to those reported for a COVID-19 reaction but, when they became worse after 4 days, turned out to be spontaneous bacterial peritonitis. The patient had diabetes related liver cirrhosis and liver cancer. The patient was admitted to a hospital, but was med flighted to another place. The patient lost an eye and full-body mobility to the infection. The patient was referred to hospice and died on 21Feb2025. Some doctors thought the COVID-19 vaccine triggered the peritonitis in this immunocompromised patient. The patient was hospitalized for peritonitis bacterial, eyeball avulsion, mobility decreased (hospitalization duration: 40 day(s)). Therapeutic measures were taken as a result of peritonitis bacterial, avulsion of eye, and mobility decreased (various). The patient date of death was 21Feb2025. The reported cause of death was unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Died
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| 2830214 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830215 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830216 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830217 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830218 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830219 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830220 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830221 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830222 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830223 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830224 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830225 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830226 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830227 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830228 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
|
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830229 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
|
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830230 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
|
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830231 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
|
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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โ | |||||||
| 2830232 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
|
Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830233 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830234 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500025640 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830235 | CA | 03/07/2025 |
COVID19 |
PFIZER\BIONTECH |
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Death
Death
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killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a C...
killed 23 of my friends with your covid hoax vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "killed 23 of my friends with your covid hoax vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500050283 Same reporter/product/event, different patients;US-PFIZER INC-202500051107 Same reporter/product/event, different patients.;US-PFIZER INC-202500051103 Same reporter/product/event, different patients.;US-PFIZER INC-202500051111 Same reporter/product/event, different patients.;US-PFIZER INC-202500051100 Same reporter/product/event, different patients.;US-PFIZER INC-202500051110 Same reporter/product/event, different patients.;US-PFIZER INC-202500051102 Same reporter/product/event, different patients.;US-PFIZER INC-202500051118 Same reporter/product/event, different patients.;US-PFIZER INC-202500051108 Same reporter/product/event, different patients.;US-PFIZER INC-202500051120 Same reporter/product/event, different patients.;US-PFIZER INC-202500051104 Same reporter/product/event, different patients.;US-PFIZER INC-202500051117 Same reporter/product/event, different patients.;US-PFIZER INC-202500051116 Same reporter/product/event, different patients.;US-PFIZER INC-202500051105 Same reporter/product/event, different patients.;US-PFIZER INC-202500051113 Same reporter/product/event, different patients.;US-PFIZER INC-202500051109 Same reporter/product/event, different patients.;US-PFIZER INC-202500051112 Same reporter/product/event, different patients.;US-PFIZER INC-202500051106 Same reporter/product/event, different patients.;US-PFIZER INC-202500051119 Same reporter/product/event, different patients.;US-PFIZER INC-202500051114 Same reporter/product/event, different patients.;US-PFIZER INC-202500051115 Same reporter/product/event, different patients.;US-PFIZER INC-202500051101 Same reporter/product/event, different patients.;; Reported Cause(s) of Death: Unknown cause of death
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| 2830236 | M | 03/07/2025 |
MEN |
UNKNOWN MANUFACTURER |
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Loss of consciousness, Seizure
Loss of consciousness, Seizure
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passed out 3 separate times; 3 separate seizure; Initial information received on 02-Mar-2025 regardi...
passed out 3 separate times; 3 separate seizure; Initial information received on 02-Mar-2025 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp. This case involves Adolescent male patient who had passed out 3 separate times and 3 separate seizure after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect lot number meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot number, strength, expiry date-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested corresponding to the one at time of event occurrence. On an unknown date the patient developed a serious passed out 3 separate times (loss of consciousness), 3 separate seizure (seizure) (unknown latency). Reportedly- lingering neurological problems, passed out on the pediatricians floor. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Seriousness criteria: These events are medically significant.; Sender's Comments: Sanofi company comment dated 03-Feb-2025: This case involves Adolescent male patient who had passed out 3 separate times and 3 separate seizure after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [MenquadfI]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2830237 | M | 03/07/2025 |
COVID19 UNK |
PFIZER\BIONTECH UNKNOWN MANUFACTURER |
LM2210 94612 |
Cough, Fatigue, Nasal congestion, SARS-CoV-2 test positive, Vaccination failure;...
Cough, Fatigue, Nasal congestion, SARS-CoV-2 test positive, Vaccination failure; Cough, Fatigue, Nasal congestion, SARS-CoV-2 test positive, Vaccination failure
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Product lack efficiacy/ did not work as expected; Coughing; Fatigue; Congestion; COVID antigen home ...
Product lack efficiacy/ did not work as expected; Coughing; Fatigue; Congestion; COVID antigen home test positive; This spontaneous case, initially received on 24-Feb-2025, was reported by a non health professional and concerns an adult male patient. No any medical history, chronic condition to report. Drug history included Covid-19 Pfizer (Booster, left deltoid, Lot number: 6J6739) Covid-19 Pfizer (Booster, left deltoid, Lot number: HF9298) No any allergic to this vaccination. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): On 03-Oct-2024, the patient received Flucelvax (TIV) for Indication not reported, Dose regimen: 0.5 ml, Route of administration: Intramuscular, annual booster, Anatomical location: Right Deltoid, Lot number: 94612. CSL batch number unable to match. Non-company suspect drugs: On 03-Oct-2024, the patient received Pfizer BioNTech COVID-19 vaccine (Tozinameran) for Indication not reported, booster dose , Anatomical location: Left upper deltoid, Lot number: LM2210 Adverse reactions/events and outcomes: On 01-Jan-2025, the patient experienced Coughing (outcome: Recovered / Resolved), Fatigue (outcome: Recovered / Resolved), Congestion (outcome: Recovered / Resolved). On an unknown date, the patient experienced Product lack efficiacy/ did not work as expected (Medically Significant, outcome: Not Reported) On 01-Jan-2025, patient had COVID positive (outcome: Not Reported) Patient did not received any other vaccine within 4 weeks prior to the first administration of suspect vaccine. Primary infection site was not known. There were no any predisposing factors. Culture was not performed. No any antipyretic product used around the date of vaccination. Adverse event did not required to visit emergency room.. No physician office visit. On 01-Jan-2025, LUCIRA by Pfizer COVID-19 & Flu Home Test shows COVID positive, Flu A, Flu B negative. On 05-Jan-2025, COVID antigen home test: COVID positive. On 08-Jan-2025, COVID antigen home test: COVID positive. On 15-Jan-2025, Flowflex COVID antigen home test: COVID negative. Flucelvax (TIV) action taken: Not Applicable Treatment medication: Dayquil As needed, Nyquil As needed Reporter assessment: The reporter considered the event as non serious and did not report the causality assessment for the events.; Reporter's Comments: Due to the spontaneous nature of the case, it is considered related for reporting purposes. However, the reported symptoms coughing, fatigue and congestion are attributed to covid antigen test positive. Hence, Vaccination failure is more plausibly explained by covid antigen positive and attributed to non-company Covid-19 vaccine.
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| 2830242 | 56 | F | TX | 03/07/2025 |
HEPA PNC21 |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
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Chills, Injection site erythema, Injection site pain; Chills, Injection site ery...
Chills, Injection site erythema, Injection site pain; Chills, Injection site erythema, Injection site pain
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Patient received the havrix (2nd dose)and capvaxine on the same arm as pt has a hormonal patch on ...
Patient received the havrix (2nd dose)and capvaxine on the same arm as pt has a hormonal patch on the other arm. Two vaccines were given IM spaced at least 1'' apart. Before giving the vaccine, pharmacist already counseled patient over potential side effects (sore arm, redness, body aches, mild fever, or chills) and what to do to help with it (massaging, icepack to relieve soreness, and tylenol if fever). Patient called again on 3/7/25 to report red pump, soreness on injected area and chills. Patient told that the soreness and redness was subsidized and getting better. patient doesn't have trouble breathing, and pt is doing well. Patient just wants to call and let the pharmacy know. Pharmacist already counseled patient again such as using icepacks to soothe the soreness and redness.
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| 2830243 | 66 | F | CA | 03/07/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
KB2YT |
Pain in extremity, Radiotherapy
Pain in extremity, Radiotherapy
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Patient called the pharmacy seven days following administration complaining of pain in the arm that...
Patient called the pharmacy seven days following administration complaining of pain in the arm that radiates to the neck which has not subsided. Pain started three days after administration.
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| 2830244 | 14 | M | OR | 03/07/2025 |
COVID19 FLU3 HPV9 |
MODERNA SANOFI PASTEUR MERCK & CO. INC. |
8081260 UT8514ja x024560 |
Blepharospasm, Feeling abnormal, Loss of consciousness, Musculoskeletal stiffnes...
Blepharospasm, Feeling abnormal, Loss of consciousness, Musculoskeletal stiffness, Seizure; Blepharospasm, Feeling abnormal, Loss of consciousness, Musculoskeletal stiffness, Seizure; Blepharospasm, Feeling abnormal, Loss of consciousness, Musculoskeletal stiffness, Seizure
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after giving all vaccines, he stated that the last one HPV felt a little weird he laid his head agai...
after giving all vaccines, he stated that the last one HPV felt a little weird he laid his head against the wall and his eyes started twitching, body got tense, had a mini seizure the whole thing lasted 15-20 seconds. Once he gained conciseness he laid down and we got his Pulse and oxygen levels and gave him water and he asked for pretzels. He stayed in clinic for 10 extra minutes so we can keep an eye out and after Dr. saw him again she said it was ok for him to go as he was feeling better.
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