| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2841677 | 70 | F | 05/19/2025 |
MMR |
MERCK & CO. INC. |
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No adverse event, Product administered to patient of inappropriate age
No adverse event, Product administered to patient of inappropriate age
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No adverse event; Consumer is 70 years old and on 5/1/25 received a titer test for measles, mumps an...
No adverse event; Consumer is 70 years old and on 5/1/25 received a titer test for measles, mumps and rubella. The test showed zero immunity, so she was vaccinated with MMR-II. Caller stated that she is not aware of she ever received an MMR vaccine. States that she wa; This spontaneous report was received from a consumer or other non health professional and refers to a(n) 70-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included antibody test negative. Concomitant therapies were not reported. On 01-May-2025, the patient received a titer test for measles, mumps and rubella. The test showed zero immunity, so she was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), administered for vaccination (strength, dose, route, lot# and expiation date were not reported) (Inappropriate age at vaccine administration). Reporter stated that she was not aware of she ever received an MMR vaccine and stated that she was probably not vaccinated as child, but that she cannot be sure. Her mother did not keep records and she was no longer living. No additional information on AE (No adverse event). Lot# is being requested and will be submitted if received.
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| 2841678 | NM | 05/19/2025 |
MMR |
MERCK & CO. INC. |
X008385 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No adverse event; HCP called to report inadvertent administration of expired MMR-II to a patient. MM...
No adverse event; HCP called to report inadvertent administration of expired MMR-II to a patient. MMR-II expired on 21MAR2025 and was administered to a patient on 28MAR2025. No additional AE/PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 28-Mar-2025, the patient was vaccinated with expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot #X008385, expiration date: 21-Mar-2025 for prophylaxis (exact dose, route of administration and anatomical location were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (expired vaccine used). No additional adverse event reported (no adverse event).
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| 2841679 | TX | 05/19/2025 |
HEPA HPV9 PNC15 PPV RVX |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. UNKNOWN MANUFACTURER |
Y015027 Y013565 X026480 X022827 2032352 |
No adverse event, Product storage error; No adverse event, Product storage error...
No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error; No adverse event, Product storage error
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No additional AE; a potential adverse event regarding improperly stored and administered vaccines: R...
No additional AE; a potential adverse event regarding improperly stored and administered vaccines: ROTATEQ, VAQTA, GARDASIL 9, VAXNUEVANCE, PNEUMOVAX 23.; This spontaneous report was received from medical assistant and refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On May-2025, the patient was vaccinated with improperly stored and administered vaccines, which underwent temperature excursion on 07-MAY-2025: Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (valid lot #Y013565, expiration date: 01-Feb-2027) 0.5 mL (Two or Three dose series), with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (valid lot #X026480, expiration date: 12-Jan-2026) 0.5 mL (Four dose series); with Hepatitis A Vaccine, Inactivated (VAQTA) (valid lot #Y015027, expiration date: 06-Feb-2026) 0.5 mL (Two dose series), with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (valid lot #X022827, expiration date: 14-Aug-2025) 0.5 mL (once) with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (valid lot #2032352, expiration date: 21-Oct-2025) 2 mL (three dose series) (product storage error). All suspect vaccines were administrated as prophylaxis. No additional information provided. No additional adverse event (AE) was reported. The case was considered as non-valid due to multiple patients without identifiers.
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| 2841680 | TX | 05/19/2025 |
HEPA |
MERCK & CO. INC. |
Y013274 |
Circumstance or information capable of leading to medication error, Underdose
Circumstance or information capable of leading to medication error, Underdose
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The caller she knows it was less than the recommended dose of VAQTA; No additional AE reported.; Thi...
The caller she knows it was less than the recommended dose of VAQTA; No additional AE reported.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA), (valid lot #Y013274, expiration date: 26-Dec-2025) for prophylaxis. During vaccination the patient moved. The caller said due to the child moving she believed the patient received half the dose of Hepatitis A Vaccine, Inactivated (VAQTA), but the caller did not know the exact dose amount the patient received. The caller she knew it was less than the recommended dose of Hepatitis A Vaccine, Inactivated (VAQTA) (accidental underdose). No additional adverse event (AE) was reported.
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| 2841681 | M | FL | 05/19/2025 |
MMR MMR VARCEL VARCEL |
MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. MERCK & CO. INC. |
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Inappropriate schedule of product administration, No adverse event; Inappropriat...
Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event; Inappropriate schedule of product administration, No adverse event
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No adverse event; patient formerly received MMRII and VARIVAX at another clinic on 2/1/2024,; This s...
No adverse event; patient formerly received MMRII and VARIVAX at another clinic on 2/1/2024,; This spontaneous report was received from a medical assistant on 13-MAY-2025 and refers to a 4-year-old male patient. The patient's medical, concurrent conditions and concomitant therapies were not reported. On 01-FEB-2024, the patient was vaccinated at the same time with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) , sterile diluent (MERCK STERILE DILUENT) (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) , Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) ) (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) and sterile diluent (MERCK STERILE DILUENT) (dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of product administration). No additional adverse event or PQC was reported. This is one of several report for the same patient (case #: 2286272).
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| 2841682 | 7 | M | NJ | 05/19/2025 |
HEP MMRV |
MERCK & CO. INC. MERCK & CO. INC. |
X002469 Y013582 |
No adverse event, Product storage error; No adverse event, Product storage error
No adverse event, Product storage error; No adverse event, Product storage error
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No additional AE/No PQC reported; vaccine storage issue; This spontaneous report was received from a...
No additional AE/No PQC reported; vaccine storage issue; This spontaneous report was received from a nurse practitioner (also was vaccine provider) and referred to a 7-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid) (TDAP) (lot# 67983AA), Hepatitis A vaccine (lot# DN273), Influenza vaccine inact split 3v (FLULAVAL) (lot# 4LM54), Polio vaccine inact (IPV) (lot# X1C891M). No illness at time of vaccination. On 21-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y013582, expiration date was reported as 02-FEB-2026, but upon internal validation established as: 03-FEB-2026; strength and dose were not reported) administered via intramuscular (IM). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). On the same day, the patient was also vaccinated with Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #X002469, expiration date: 22-MAY-2025; strength and dose were not reported) via IM, all products were used for prophylaxis at a hospital clinic. The vaccines were involved in temperature excursion and storage issue (Product storage error). It was also reported it was a data logger discrepancy not a true excursion as the fridge and freezer never alarmed At compliance visit on 09-APR-2025, upon reviewed by store, temperature excursion noted on 03-MAR-2025 to 10-MAR-2025. Upon further investigation, and reviewed by the DDL manufacturer, it was noted as a "glitch", most likely caused by an electrical interference. The VFC program advised revaccination and that process was currently in progress with the patient involved. No adverse event was reported. This is one of several reports received from the same reporter.
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| 2841683 | 11 | F | HI | 05/19/2025 |
HPV9 |
MERCK & CO. INC. |
Z005055 |
Hypoaesthesia
Hypoaesthesia
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Caller stated after leaving the office the patient lost feeling from her left elbow to her fingers, ...
Caller stated after leaving the office the patient lost feeling from her left elbow to her fingers, patient tried to open the car door and could not feel the handle prior to returning back in the office; This spontaneous report was received from a Nurse and refers to an 11-year-old female patient. The patient's medical history, concurrent conditions past drug reactions and allergies were reported as no. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (MENQUADFI) and Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (TDAP). On 08-MAY-2025, the patient visited the doctor๏ฟฝs office for a physical and was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringe, 1 dosage form, administered in the left deltoid as prophylaxis (lot number Z005055 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 27-FEB-2026; route of administration, exact dose and vaccination scheme frequency were not reported). On that same date, after leaving the office, the patient lost feeling from her left elbow to her fingers. Patient tried to open the car door and could not feel the handle prior to returning back in the office (Sensory loss). The patient was seen by the doctor and was given two tablets of 200mg ibuprofen as treatment for the event. Approximately 20 minutes later, there was no change; doctor then recommended hot and cold compress during the night. At approximately 19:00 on that same date, the patient๏ฟฝs father contacted the office and stated that hot and cold compresses were applied, and patient was able to feel a little bit. On 09-MAY-2025, approximately at 6:00, the patient๏ฟฝs father contacted the office again and stated the patient fully recovered from the event. No additional information provided. The causal relationship between Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the event of Sensory loss was not reported.
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| 2841684 | AZ | 05/19/2025 |
HEPA |
MERCK & CO. INC. |
X026485 |
Expired product administered, No adverse event
Expired product administered, No adverse event
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No additional AE reported.; Customer called and reported that a dose of VAXTA expired on 5/11/2025 a...
No additional AE reported.; Customer called and reported that a dose of VAXTA expired on 5/11/2025 and was administered on 5/15/2025. No temperature excursions through date of administration.; This spontaneous report was received from a physician assistant (reported as medical assistant) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported. On 15-May-2025, the patient was vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA) 1 mL, administered as prophylaxis (Lot No. X026485 has been verified to be a valid lot number for [hepatitis a vaccine, inactivated], expiration date reported and upon internal validation established as 11-May-2025) (strength, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided) (expired product administered) No additional adverse event was reported (No adverse event).
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| 2841686 | 70 | F | NY | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain, Injection site swelling, Injection site warmth, Mobility de...
Injection site pain, Injection site swelling, Injection site warmth, Mobility decreased, Myalgia
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had trouble lifting her arm/range of motion is not there/decreased range of motion; Injection site p...
had trouble lifting her arm/range of motion is not there/decreased range of motion; Injection site pain; Injection site warmth; Injection site swelling; deltoid muscle was very sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-MAY-2025, the patient received Shingrix (intramuscular, left deltoid). On 08-MAY-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site warmth (Verbatim: Injection site warmth), injection site swelling (Verbatim: Injection site swelling) and muscle soreness (Verbatim: deltoid muscle was very sore). On 09-MAY-2025, the patient experienced mobility decreased (Verbatim: had trouble lifting her arm/range of motion is not there/decreased range of motion). The outcome of the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased were not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site warmth, injection site swelling, muscle soreness and mobility decreased to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAY-2025 The patient reports that she received her Shingrix dose. That evening of vaccination she noticed pain, swelling and warmth at the injection site. The following day her left deltoid muscle was very sore and she had trouble lifting her arm. States that the range of motion was not there. She states that all symptoms were ongoing. She states that there was no other activity or medication that could have contributed to the symptoms.
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| 2841687 | F | 05/19/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Breast swelling, Headache
Breast swelling, Headache
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headache; swell right breast; This non-serious case was reported by a consumer and described the occ...
headache; swell right breast; This non-serious case was reported by a consumer and described the occurrence of breast swelling in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 05-MAY-2025, the patient received Shingles vaccine. On 06-MAY-2025, 1 days after receiving Shingles vaccine, the patient experienced breast swelling (Verbatim: swell right breast). On an unknown date, the patient experienced headache (Verbatim: headache). The outcome of the breast swelling was not resolved and the outcome of the headache was resolved with sequelae. It was unknown if the reporter considered the breast swelling and headache to be related to Shingles vaccine. It was unknown if the company considered the breast swelling and headache to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 14-MAY-2025 The patient was a reporter. The patient experienced swell right breast and headache. Were the symptoms treated (swell right breast) was reported as no.
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| 2841688 | F | DE | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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inappropriate schedule of vaccine/never received the second shot for several reasons and didn't...
inappropriate schedule of vaccine/never received the second shot for several reasons and didn't realize it until recently/she has not received the 2nd dose of the vaccine due to personal reasons; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 24th April 2023, 0.5 mL administered intramuscularly). 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: inappropriate schedule of vaccine/never received the second shot for several reasons and didn't realize it until recently/she has not received the 2nd dose of the vaccine due to personal reasons). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 The customer reported that she received the vaccine at a local pharmacy but did not recall in which arm. The patient reported that she had not received the 2nd dose of the vaccine due to personal reasons and inquired if she should get the second dose or start over the series. No additional medical history or medications information were provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2841689 | 05/19/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Blister, Herpes zoster, Vaccination failure; Blister, Herpes zoster, Vaccination...
Blister, Herpes zoster, Vaccination failure; Blister, Herpes zoster, Vaccination failure
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Suspected vaccination failure; I've got a milder case of shingles right now; This serious case ...
Suspected vaccination failure; I've got a milder case of shingles right now; 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. The patient's past medical history included chemotherapy (I had chemo 3 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, 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've got a milder case of shingles right now). 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 : 09-MAY-2025 This case was reported by a patient via interactive digital media Reporter reported that he/she got a milder case of shingles right now. He/she had small blisters from his/her wrist to his/her arm pit. He/she also had both shingles vaccines and he/she had chemo 3 years ago. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
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| 2841690 | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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a patient that went beyond 6 months for the second dose of Shingrix; This non-serious case was repor...
a patient that went beyond 6 months for the second dose of Shingrix; This non-serious case was reported by a consumer via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 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: a patient that went beyond 6 months for the second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 07-MAY-2025 The reporter (office staff) reported that the physician had a patient that went beyond 6 months for the second dose of Shingrix. He wanted a medial inquiry to answer if the patient needed to re-start the 2-dose series over or if the patient could just get the second dose even though it was past 6 months. Till the time of reporting the patient did not receive the second dose of Shingrix, which led to an incomplete course of vaccination.
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| 2841691 | M | 05/19/2025 |
VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Herpes zoster, Pain, Rash, Vaccination failure; Herpes zoster, Pain, Rash, Vacci...
Herpes zoster, Pain, Rash, Vaccination failure; Herpes zoster, Pain, Rash, Vaccination failure
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Suspected vaccination failure; still gets the shingles; This serious case was reported by a consumer...
Suspected vaccination failure; still gets the shingles; 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. 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. In APR-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still gets the shingles). The patient was treated with lidocaine. The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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: 12-MAY-2025 This case was reported by a wife of the patient via interactive digital media. Reporter reported that her husband (patient) had the vaccine and booster and still got the shingles. He just got it 5 weeks ago (from the date of reporting) they were finally not hurting him anymore. His physician gave him a prescription immediately and they gently put lidocaine on the rash to help numb the pain. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (1st dose)and Shingles vaccine(2nd dose).
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| 2841692 | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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am I too late to get the second dose now that it's May, 2025; This non-serious case was reporte...
am I too late to get the second dose now that it's May, 2025; 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 had first Shingrix shot in September of 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: am I too late to get the second dose now that it's May, 2025). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date: 09-MAY-2025 Patient stated that they had first Shingrix shot in September of 2024; and asked whether its too late to get the second dose as it was May, 2025. Till the time of reporting patient did not receive second dose of vaccination which led to incomplete course of vaccination.
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| 2841693 | M | 05/19/2025 |
VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK |
Asthenia, Blindness, Deafness unilateral, Fatigue, Illness; Impaired work abilit...
Asthenia, Blindness, Deafness unilateral, Fatigue, Illness; Impaired work ability, Loss of personal independence in daily activities, Nerve injury, Vaccination failure, Zoster sine herpete
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Suspected vaccination failure; I have lost sight in my eye; lost hearing in my right ear; still have...
Suspected vaccination failure; I have lost sight in my eye; lost hearing in my right ear; still have them/feel like it killing me from the inside out/shingles never came out but stay on inside instead of shingles; got nerve damage bad; i can't work anymore or do things with my kids or grandkids; Sickness; Tiredness; Weakness; 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), loss of vision (Verbatim: I have lost sight in my eye) (serious criteria GSK medically significant), hearing loss unilateral (Verbatim: lost hearing in my right ear) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: still have them/feel like it killing me from the inside out/shingles never came out but stay on inside instead of shingles), nerve damage (Verbatim: got nerve damage bad), activities of daily living impaired (Verbatim: i can't work anymore or do things with my kids or grandkids), sickness (Verbatim: Sickness), tiredness (Verbatim: Tiredness) and weakness (Verbatim: Weakness). The outcome of the vaccination failure, loss of vision, hearing loss unilateral, nerve damage, activities of daily living impaired, sickness, tiredness and weakness were not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure, loss of vision, hearing loss unilateral, zoster sine herpete, nerve damage, activities of daily living impaired, sickness, tiredness and weakness to be related to Shingrix. The company considered the vaccination failure, loss of vision and hearing loss unilateral to be unrelated to Shingrix. It was unknown if the company considered the zoster sine herpete, nerve damage, activities of daily living impaired, sickness, tiredness and weakness to be related to Shingrix. Additional Information: GSK Receipt Date:12-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that his/her friend told to get the vaccine, and did shingles never came out but stay on inside. The patient mentioned that had gone thru five years of hell and still had them. He had also lost sight in eye and lost hearing in right ear to and now doctors say he got nerve damage bad plus the shot made so sick. The patient thought was going died now just felt like it killing him from the inside out and could not work anymore or do things with kids or grandkids and mentioned so tired and weak and he was fine before the shot patient mentioned wish to god and never got the vaccine. The patient also mentioned after his close friend developed shingles, he saw how painful it could really be, live a full life, and mentioned did not want shingles to get in the way. Here's story on why the patient was started a conversation with doctor about the shingles risk. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Blindness and Deafness unilateral are unlisted events which are considered unrelated to GSK Shingrix."
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| 2841694 | F | TN | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Fatigue, Injection site swelling, Pyrexia, Vaccine positive rechallenge
Fatigue, Injection site swelling, Pyrexia, Vaccine positive rechallenge
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swelling around the injection siteand mad a motion of about a 6 circle on her arm; fever; fatigue; T...
swelling around the injection siteand mad a motion of about a 6 circle on her arm; fever; fatigue; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site swelling (received first dose on an unknown date for tolerance of first dose refer case US2025AMR059471). 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 injection site swelling (Verbatim: swelling around the injection siteand mad a motion of about a 6 circle on her arm), fever (Verbatim: fever) and fatigue (Verbatim: fatigue). Rechallenge with Shingrix was positive. The outcome of the injection site swelling was not reported and the outcome of the fever and fatigue were resolved (duration 1 day). It was unknown if the reporter considered the injection site swelling, fever and fatigue to be related to Shingrix. It was unknown if the company considered the injection site swelling, fever and fatigue to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR059471 Additional Information: GSK Receipt Date: 09-MAY-2025 The patient of approximately 55 age took the 2 dose series of Shingrix vaccine. The reporter stated that after each dose the patient experienced swelling around the injections site and mad a motion of about a 6 inch circle on her arm. She also experienced fever, fatigue that lasted about a day each time.
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| 2841695 | M | TN | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Injection site pain, Malaise, Pyrexia, Vaccine positive rechallenge
Injection site pain, Malaise, Pyrexia, Vaccine positive rechallenge
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patient experienced injection site pain; fever; felt like crap; This non-serious case was reported b...
patient experienced injection site pain; fever; felt like crap; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on an unknown date (refer case US2025AMR059456)). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: patient experienced injection site pain), fever (Verbatim: fever) and feeling abnormal (Verbatim: felt like crap). Rechallenge with Shingrix was positive. The outcome of the injection site pain, fever and feeling abnormal were resolved (duration 36 hrs). It was unknown if the reporter considered the injection site pain, fever and feeling abnormal to be related to Shingrix. It was unknown if the company considered the injection site pain, fever and feeling abnormal to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR059456 Additional Information: GSK Receipt Date: 08-MAY-2025 Patient was approximately 60 years old. Patient had been vaccinated with Shingrix and a few hours after the injections the patient experienced injection site pain, within a few hours experienced fever and felt like crap. The symptoms lasted about 36 hours and patient is fully recovered.
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| 2841696 | 47 | F | SC | 05/19/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
4D333 |
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 other health professional 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 4D333) for prophylaxis. On 09-MAY-2025, the patient received Engerix B pediatric. On 09-MAY-2025, an unknown time after receiving Engerix B 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: 09-MAY-2025 On 09-May-2025, a call was received and mentioned that one of their clients administered an Engerix-B pediatric dose to an adult patient which led to adult use of a child product and underdose. They had a new employee, adult employee, and they need the Hep B vaccine (Engerix-B), but the ped-adolescent one was given, so they are wondering what were the next steps that needs to be done, like if they can give another one will it equal out to the adult. The Vaccine Administration Facility is the same as Primary Reporter. The vaccine was administered on 09th May 2025.
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| 2841697 | F | 05/19/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
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Exposure during pregnancy
Exposure during pregnancy
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Probable Twinrix administration to a pregnant woman; This non-serious prospective pregnancy case was...
Probable Twinrix administration to a pregnant woman; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received HAB (Twinrix) for prophylaxis. On an unknown date, the patient received Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced vaccine exposure during pregnancy (Verbatim: Probable Twinrix administration to a pregnant woman). The outcome of the vaccine exposure during pregnancy was not applicable. Pregnancy exposure: Pregnancy Exposure (Twinrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 09-MAY-2025 A Health Care Professional reported claiming to be a "physician who wants to speak with a Doctor of Medicine and know his license number and qualifications", mentioning that he had previously had a call that had not gone well. The agent was asked him if he had a case number, which he denied. The agent subsequently asked if he wanted to ask his question and then try to connect him with a Doctor of Medicine, but the Health Care Professional asked how he did not know his question since he had already called, although he mentioned that it was about "Twinrix in the context of pregnancy" to which the agent explained that without a case number could not be aware of it, but having already mentioned his question in a general way, he could try to connect him to a Doctor of Medicine, however, before the agent could finish this phrase, the Health Care Professional asked in a rude tone if the agent would help him or instead continue giving him "rubbish" to which the agent explained that of course will help, as long as both parties could communicate in a nice and polite manner, which finally led to him ending the call. No contact details or further information was than "Twinrix in the context of pregnancy" was given, which led to Vaccine exposure during pregnancy.
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| 2841698 | F | NC | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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has not received a second dose; This non-serious case was reported by a pharmacist via call center r...
has not received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on 12-MAY-2022 of batch number of DC434 and expiry date of 03 June 2023). 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: has not received a second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 12-MAY-2025 The pharmacist called today to report about a female patient who received a first dose of Shingrix on May 12, 2022 and has not received a second dose yet which led to incomplete course of vaccination.
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| 2841699 | MI | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Immunodeficiency
Immunodeficiency
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Becomes immunocompromised following vaccination with Shingrix; This serious case was reported by a p...
Becomes immunocompromised following vaccination with Shingrix; This serious case was reported by a physician via call center representative and described the occurrence of immunocompromised 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 immunocompromised (Verbatim: Becomes immunocompromised following vaccination with Shingrix) (serious criteria GSK medically significant). The outcome of the immunocompromised was unknown. It was unknown if the reporter considered the immunocompromised to be related to Shingrix. The company considered the immunocompromised to be unrelated to Shingrix. Additional Information: GSK Receipt Date : 12-MAY-2025 The physician inquired what was the recommendation if somebody did complete a Shingrix vaccine series but then at some point later became immunocompromised because of disease or therapy was there a recommendation to re-vaccinate for booster for immune compromised patients.; Sender's Comments: Immunodeficiency is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2841700 | 05/19/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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If I administered a dose intramuscularly instead of subcutaneously; This non-serious case was report...
If I administered a dose intramuscularly instead of subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 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: If I administered a dose intramuscularly instead of subcutaneously). 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 : 13-MAY-2025 Healthcare professional reported that if they administered a dose intramuscularly instead of subcutaneously which led to Subcutaneous injection formulation administered by other route. Anonymous Healthcare provider did not consent follow-up from Safety Department. No vaccination date, vaccine detail or patient demographics were obtained in this call.
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| 2841701 | OH | 05/19/2025 |
MMR |
GLAXOSMITHKLINE BIOLOGICALS |
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Incorrect route of product administration
Incorrect route of product administration
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patient had been administered Priorix intramuscularly; This non-serious case was reported by a pharm...
patient had been administered Priorix intramuscularly; 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: patient had been administered Priorix intramuscularly). 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: 13-MAY-2025 The pharmacist reported that a patient had been administered Priorix intramuscularly, which led to subcutaneous injection formulation administered by other route
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| 2841702 | F | AL | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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asked how to proceed with the second dose of Shingrix after a patient received the first dose one ye...
asked how to proceed with the second dose of Shingrix after a patient received the first dose one year and a half ago; 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 the first dose one year and a half 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: asked how to proceed with the second dose of Shingrix after a patient received the first dose one year and a half ago). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-MAY-2025 The registered pharmacist asked how to proceed with the second dose of Shingrix after a patient received the first dose one year and a half ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2841703 | CA | 05/19/2025 |
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; still having shingles outbreak; This serious case was reported by a o...
Suspected vaccination failure; still having shingles outbreak; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 2nd dose of Shingrix and 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: still having shingles outbreak). 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 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 : 14-MAY-2025 An immunocompromised patient already received 2 dose series of Shingrix and because of immunocompromised still had shingles outbreak. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
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| 2841704 | GA | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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Longer than recommended interval; This non-serious case was reported by a consumer via sales rep and...
Longer than recommended interval; This non-serious case was reported by a consumer via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 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: Longer than recommended interval). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 14-MAY-2025 The reporter reported that if a patient received their first Shingrix dose, but three years has lapsed and they did not receive their second dose do they have to start the series over. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
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| 2841705 | F | 05/19/2025 |
COVID19 |
MODERNA |
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Post-acute COVID-19 syndrome
Post-acute COVID-19 syndrome
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Long COVID; This spontaneous case was reported by a consumer and describes the occurrence of POST-AC...
Long COVID; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Long COVID) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long COVID). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Long COVID) outcome was unknown. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. Concomitant medication was not provided. It was reported that the caller knows a woman who developed long covid following vaccination which reporter described as a form of AIDS. Treatment information was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-786451 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-786451:Master case (Reporter case)
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| 2841706 | M | CA | 05/19/2025 |
COVID19 COVID19 COVID19 COVID19 |
MODERNA MODERNA PFIZER\BIONTECH PFIZER\BIONTECH |
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Alopecia, Asthenia, COVID-19, Disease recurrence, Drug ineffective; Illness, Int...
Alopecia, Asthenia, COVID-19, Disease recurrence, Drug ineffective; Illness, Interchange of vaccine products, SARS-CoV-2 test; Alopecia, Asthenia, COVID-19, Disease recurrence, Drug ineffective; Illness, Interchange of vaccine products, SARS-CoV-2 test
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Interchange of vaccine products; Tested positive for COVID-19 despite being fully vaccinated and boo...
Interchange of vaccine products; Tested positive for COVID-19 despite being fully vaccinated and boosted; Tested positive for COVID-19 despite being fully vaccinated and boosted; Sick; Hair is falling out; All his energy has been zapped; COVID-19 three times; COVID-19 or flu again; This is a spontaneous report received from a Physician and Consumer or other non HCPs from License Party, Program ID. An 81-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose number unknown (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Jul2024, outcome "unknown", described as "COVID-19 three times; COVID-19 or flu again"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "recovering"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Tested positive for COVID-19 despite being fully vaccinated and boosted"; ILLNESS (medically significant), outcome "unknown", described as "Sick"; ALOPECIA (non-serious), outcome "unknown", described as "Hair is falling out"; ASTHENIA (non-serious), outcome "unknown", described as "All his energy has been zapped". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jun2022) Positive; (26Jul2022) Negative; (27Jul2022) Negative; (28Jul2022) Negative; (30Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: In Jun2022, the patient tested positive for COVID-19 despite being fully vaccinated and boosted. On an unspecified date, the patient still tested positive for COVID-19. On 26Jul2022, 27Jul2022, and 28Jul2022, the patient tested negative for three consecutive days then became positive again on 30Jul2022 in rapid antigen test. The patient has had all vaccines and still got COVID-19, then had nirmatrelvir/ritonavir (PAXLOVID) as treatment and was hit again. Per reporter, it did not work and that was verified by "murdering someone". Too many of the reporter's friends have died from this jab. Those shots and boosters have worked so well for some people. On an unspecified date, the patient was sick, hair was falling out also, and all his energy has been zapped. As of 02Sep2022, it was reported that people who got the COVID-19 shots had gotten Omicron, other COVID-19 vaccines. Double vaccination and double boosted still gets the virus, takes the pills to help. Stated that it was a good idea but had a relapse. Remember getting the shot and the person will be protected how many times. Per reporter, the company said that a person will not get COVID-19 if he was vaccinated, turned out to be untrue, as 2 patients both got it. Doctor said she knew the jabs won't work. Masks don't work either. It was reported that the vaccine that causes harm and does nothing good. Per reporter, the vaccine doesn't prevent COVID-19 though as 2 patients even contracted COVID-19 after being vaccinated. As of 27Oct2022, the reporter stated that per company, these shots really work, to get the shot, get the booster not once but twice; but still get COVID-19. On 20Dec2022, the patient posted what if COVID-19 gave him the heart condition like many other people. He had COVID-19 3 times. Twice after being fully vaccinated. Even someone has said the vaccine doesn't work yet it was still being pushed. The patient just thinks COVID-19 was man made. As of 13Aug2024, despite six COVID-19 shots, he has had COVID-19 three times, the most recent time two weeks ago (2024). The COVID-19 shot is the most worthless shot in the history of medicine. The patient claimed that some physicians are getting hundreds of thousands of dollars to jab patients with lethal vaccines that do not work. As of 30Aug2024, the patient got all the shots and got COVID-19 three times. As of 14Sep2024, the patient has COVID-19 or flu again, vaccinated and had booster up. The only thing left that did work, were side effects. As of 23Sep2024, another reporter had COVID-19 but had not had any jabs and knew people who died from these shots. As per them, the boosters and shots don't work. Further questioned why the patient was getting sick with COVID-19 many times. As of 26Sep2024, the patient got the vaccine 5 times (as reported) and has gotten COVID-19 3 times. As of 12Oct2024, they wanted to bring back masks after contracting COVID-19 despite being vaccinated six times. As of 05Nov2024, the patient had 6 boosters (as reported) and COVID-19 3 times, so he remarked, why get the vaccine. According to patient on 11Dec2024: the company was so confident they assumed zero liability, even someone admitted getting it 4 times after 6 shots. As per them, the experimental gene therapy redefined as vaccine, don't change what it was. On 03Jan2025, stated by another reporter, the vaccinated people caught it multiple times also. A physician had it 3 times. On 21Jan2025: According to a doctor, "If you get the vaccine and the boosters, you will NOT get Covid-19". A doctor stated to have had Covid three times. A doctor stated "our vaccines clearly don't work because we literally did not do a single test, nor study, but try this pill and see what happens". On 15May2025, (Name withheld) has covid. He should have had 5 more boosters and worn 4 more masks. This could have been easily avoided. FU(13Jul2022): from a consumer: Updated info: new reporter. FU(20Jul2022): from a consumer. Updated info: new reporter & clinical course. FU(27Jul2022): from a consumer. Updated info: new reporter & clinical info. FU(28Jul2022 & 30Jul2022): from a consumer: Updated info: reporter info, patient age, lab test, event outcome & clinical course. FU(03Aug2022): from a consumer: Updated info: new reporter (consumer) & outcome of events updated to recovering. FU(04Aug2022): from a consumer: Updated info: new reporters (consumers), new events (asthenia & alopecia) & clinical course. FU(13Aug2022): from a consumer: Updated info: new reporter & clinical course. FU(15Aug2022): from a consumer: Updated info: new event (Disease recurrence). FU(14Aug2022): from a consumer: Updated info: new reporter's info & case identifiers. FU(19Aug2022): from a consumer: Updated info: new reporter & clinical course. FU(21Aug2022): from a consumer: Updated info: new reporter details & clinical details. FU(23Aug2022): from a consumer: Updated info: new reporter details. FU(24Aug2022): from a consumer: Updated info: reporter info. FU(26Aug2022): from a consumer: Updated info: reporter info. FU(30Aug2022): from a consumer: No field updated. FU(02Sep2022): from a consumer: Updated info: new reporter. FU(02Sep2022): from a consumer: Updated info: new reporter info & clinical course. FU(05Sep2022): from a consumer: Updated info: reporter info & lab test. FU(07Sep2022): from a consumer: Updated info: reporter info. FU(09Sep2022): from a consumer: Updated info: reporter info. FU(15Sep2022): FU attempts are completed. No further info is expected. FU(17Sep2022): from a consumer: Updated info: new reporter. FU(15Sep2022): from a consumer: Updated info: new reporter. FU(17Sep2022): from a consumer: Updated info: new reporter details. FU(10Oct2022): from a consumer: Updated info: new reporter details. FU(12Oct2022): from a consumer: Updated info: new true reporter & clinical course. FU(22Oct2022): from a consumer: Updated info: new reporter & clinical course. FU(27Oct2022): from a consumer: Updated info: reporter (consumer). FU(13Nov2022): from a consumer: Updated info: reporter (consumer). FU(10Dec2022): from a consumer: Updated info: new reporter details. FU(18Dec2022): from a consumer: Updated info: new reporter. FU(20Dec2022): from a consumer:Updated info: new reporter (consumer) & clinical course. FU(19Jun2023): This is a spontaneous FU report received in response to the mail trail sent. Updated info: new reporter. FU(27Jul2023): from a consumer: Updated info: reporter info (alternate email address). FU(22Aug2023): from a consumer: Updated info: reporter info. FU(13Jun2024): from a consumer: Updated info: new reporter. FU(13Aug2024): from a consumer: Updated info: new reporter & clinical course. FU(13Aug2024): from a consumer: Updated info: new reporter and event Disease Recurrence added. FU(28Aug2024): from a consumer: Updated info: new reporter added. FU(30Aug2024): from a consumer: Updated info: New reporter (Consumer) added. Clinical course updated. FU(14Sep2024): from a consumer: Updated info: course of events (covid/flu again). FU(12Sep2024): from a consumer: Updated info: reporter information. FU(23Sep2024): from a consumer: Updated info: Reporters (Consumers) and Event (Sickness) added. Clinical course updated. FU(26Sep2024): from a consumer: Updated info: Reporter (Consumer) added. Clinical course updated. Follow-up (12Oct2024): from a consumer: Updated info: Reporter (Consumer) added and Clinical course updated. FU(12Oct2024): This is a spontaneous follow-up report, updated information included: VAERS Primary Reporter Additional Qualification was updated from "patient" to "none of the patient or parent". FU(05Nov2024): from a consumer: Updated info: Reporter (Consumer) added and Clinical course updated. FU(16Nov2024): Follow-up attempts are completed. Batch/lot number is not provided, and it cannot be obtained. FU(18Nov2024): from a consumer: Updated info: Reporter (Consumer) added. FU(11Dec2024): from a consumer: Updated info: Reporter (Consumer) added. Clinical course updated. FU(03Jan2025): from a consumer: Updated info: new reporter and course of events. FU(03Jan2025): from a consumer: Updated info: Reporter (Consumer) added. FU(10Jan2025): from a consumer: Updated info: reporter details. FU(19Jan2025): from a consumer: Updated info: reporter information. FU(21Jan2025): from a consumer: Updated info: new reporter and course information added. FU(04Feb2025): from a consumer: Updated info: New reporter added (consumer). FU(15May2025): from a consumer: Updated info: New reporter added & clinical course.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events interchange of vaccine products, drug ineffective,covid-19, disease recurrence, and illness with suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200995953 Same reporter and product; different patient and events;US-PFIZER INC-2021109942 Same reporter and product; different patient and events;
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| 2841707 | F | LA | 05/19/2025 |
COVID19 |
PFIZER\BIONTECH |
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COVID-19, Drug ineffective
COVID-19, Drug ineffective
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The patient has had 7 Pfizer shots, and the patient still got COVID; The patient has had 7 Pfizer sh...
The patient has had 7 Pfizer shots, and the patient still got COVID; The patient has had 7 Pfizer shots, and the patient still got COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 74-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3), for COVID-19 Immunization; Bnt162b2 (DOSE 4), for COVID-19 Immunization; Bnt162b2 (DOSE 5), for COVID-19 Immunization; Bnt162b2 (DOSE 6), for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "The patient has had 7 Pfizer shots, and the patient still got COVID". The patient came to pick up a prescription of Paxlovid. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
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| 2841708 | F | 05/19/2025 |
TDAP |
SANOFI PASTEUR |
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Arm amputation, Injury
Arm amputation, Injury
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a very serious injury; Initial information received on 09-May-2025 regarding an unsolicited valid se...
a very serious injury; Initial information received on 09-May-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional). This case involves an unknown age female patient who experienced a very serious injury after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. 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 Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot number, expiry date and strength not reported) for Immunisation . On an unknown date the patient developed a very serious injury (injury) (unknown latency) because they lost their arm and shoulder in amputation following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. This event was leading to disability. Action taken was not applicable. It was reported that the patient had undergone amputation as a corrective treatment for the event. At time of reporting, the outcome was Recovered / Resolved With Sequelae on an unknown date for the event.; Sender's Comments: Sanofi company comment dated 16-MAY-2025: This case involves an unknown age female patient who experienced a very serious injury after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].. Further information regarding event details, onset latency, laboratory investigations, medical history, concomitant medication, administration technique and tolerance, excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
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| 2841710 | 86 | F | MN | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
EK225 |
Injection site discomfort, Injection site erythema, Injection site pruritus, Inj...
Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site warmth
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Patient reports redness to area of vaccine injection the size went from dime size to size of a fist....
Patient reports redness to area of vaccine injection the size went from dime size to size of a fist. Patient reports the area as uncomfortable. She reports that the site is hot to touch. Patient said the at first the site was very red and not today 5/19/25 the area is light pink. Patient has used ice, Zyrtec, and Sarna lotion for itching. Patient does have a picture of the site taken on 5/18/25.
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| 2841711 | 63 | F | 05/19/2025 |
MNQ |
SANOFI PASTEUR |
U8271AB |
No adverse event, Vaccination error
No adverse event, Vaccination error
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No adverse events, patient received this vaccine in error.
No adverse events, patient received this vaccine in error.
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| 2841712 | 62 | M | 05/19/2025 |
MNQ |
SANOFI PASTEUR |
U8271AB |
No adverse event, Vaccination error
No adverse event, Vaccination error
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No adverse events, patient received this vaccine in error.
No adverse events, patient received this vaccine in error.
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| 2841727 | 53 | F | NC | 05/19/2025 |
PNC20 |
PFIZER\WYETH |
LK6655 |
Chest discomfort, Haemoptysis, Respiratory tract congestion
Chest discomfort, Haemoptysis, Respiratory tract congestion
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Chest tightness but more congestion cough w/small amount of blood.
Chest tightness but more congestion cough w/small amount of blood.
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| 2841728 | F | KS | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
75D3A |
Pruritus, Skin ulcer
Pruritus, Skin ulcer
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Patient called in to report 2 itchy sores on her buttock that appeared the evening of the day she wa...
Patient called in to report 2 itchy sores on her buttock that appeared the evening of the day she was vaccinated. She did not come to clinic to have these evaluated.
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| 2841729 | 26 | F | NJ | 05/19/2025 |
UNK |
UNKNOWN MANUFACTURER |
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Chills, Headache, Pain in extremity, Pyrexia
Chills, Headache, Pain in extremity, Pyrexia
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101.5 fever, headache, chills and L arm pain.
101.5 fever, headache, chills and L arm pain.
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| 2841730 | 58 | F | CO | 05/19/2025 |
HEPAB |
GLAXOSMITHKLINE BIOLOGICALS |
797F9 |
Inappropriate schedule of product administration, No adverse event
Inappropriate schedule of product administration, No adverse event
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In 2024, patient had to follow the Twinrix accelerated schedule due to her travel needs. The acceler...
In 2024, patient had to follow the Twinrix accelerated schedule due to her travel needs. The accelerated schedule should be 3 doses at 0, 7, and 21-30 days, followed by a booster dose at 12 months. She had her vaccine on 2/28/2024 , 3/6/2024, 3/20/2024, and her next dose after that should be 12 months later in 2025 . However, she came to the pharmacy on 3/29/2024 and received another Twinrix dose. Patient did not complain about any side effects. When she visited pharmacy again for her last dose on 5/18/2025. We checked her previous record, and we found out she should not receive the dose on 3/29/2024.
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| 2841732 | 4 | F | 05/19/2025 |
COVID19 |
MODERNA |
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Expired product administered
Expired product administered
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Expired vaccine was given. Expire 5/17/25.
Expired vaccine was given. Expire 5/17/25.
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| 2841734 | 35 | F | NJ | 05/19/2025 |
COVID19 COVID19 |
JANSSEN JANSSEN |
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Activated partial thromboplastin time abnormal, Antiphospholipid syndrome, Blood...
Activated partial thromboplastin time abnormal, Antiphospholipid syndrome, Blood test abnormal, Impaired work ability, Laboratory test; Therapeutic procedure, Thrombosis, Venous occlusion
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Blood clots , aps , ablations ,
Blood clots , aps , ablations ,
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| 2841735 | 73 | M | CA | 05/19/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
KB2YT |
Extra dose administered, No adverse event
Extra dose administered, No adverse event
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no known ill effects. Patient was given a third dose of Shingrix vaccine. This was noticed upon chec...
no known ill effects. Patient was given a third dose of Shingrix vaccine. This was noticed upon checking the report when patient came to request dose #2
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| 2841736 | 19 | F | AZ | 05/19/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3043837 391637 |
Chest discomfort, Chest pain, Dyspnoea; Chest discomfort, Chest pain, Dyspnoea
Chest discomfort, Chest pain, Dyspnoea; Chest discomfort, Chest pain, Dyspnoea
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After about one week of receiving vaccines patient noticed chest pain-not constant, sharp and dull a...
After about one week of receiving vaccines patient noticed chest pain-not constant, sharp and dull at times, chest tightness, SOB. Still randomly experiences these events.
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| 2841738 | 66 | F | CA | 05/19/2025 |
PNC20 PNC20 |
PFIZER\WYETH PFIZER\WYETH |
LK6651 LK6651 |
Balance disorder, Chills, Erythema, Fatigue, Nausea; Pain, Peripheral swelling, ...
Balance disorder, Chills, Erythema, Fatigue, Nausea; Pain, Peripheral swelling, Pyrexia, Somnolence, Vomiting
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Pt reported the following symptoms on and off: fever 102.5F on first day, then fever, fatigue, and ...
Pt reported the following symptoms on and off: fever 102.5F on first day, then fever, fatigue, and sleepiness x4 days, and red swollen arm, body aches, chills, nausea, vomiting, and losing balance x10 days. Pt took tylenol and benadryl.
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| 2841745 | 11 | M | WI | 05/19/2025 |
HPV9 MNQ |
MERCK & CO. INC. NOVARTIS VACCINES AND DIAGNOSTICS |
Y014510 9M2R7 |
Injection site erythema, Injection site swelling; Injection site erythema, Injec...
Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling
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MENVO given May 16 L upper arm. Noted swelling and redness to site May 17-19. No Fever.
MENVO given May 16 L upper arm. Noted swelling and redness to site May 17-19. No Fever.
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| 2841746 | 72 | F | NY | 05/19/2025 |
COVID19 FLU3 |
MODERNA SEQIRUS, INC. |
3042558 388496 |
Injection site pain; Injection site pain
Injection site pain; Injection site pain
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arm started hurting at injection site on 9/18/24 and has not gone away. On 3/10/25 the patient stat...
arm started hurting at injection site on 9/18/24 and has not gone away. On 3/10/25 the patient stated to the pharmacy staff that her arm was still hurting from the vaccine administered on 9/18/24. As of today 5/19/25, the patient has still not recovered.
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| 2841749 | 2.5 | F | TX | 05/19/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
Y49B2 Y016874 |
Wrong product administered; Wrong product administered
Wrong product administered; Wrong product administered
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Mom placed wrong patient on exam table & 4 y/o vaccines given to the 30 m/o patient. Provider ad...
Mom placed wrong patient on exam table & 4 y/o vaccines given to the 30 m/o patient. Provider addressed patient & mother's concerns. See progress note.
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| 2841469 | 54 | M | AL | 05/18/2025 |
COVID19 |
PFIZER\BIONTECH |
Not available n |
Atrial fibrillation, Cardiac ablation, Cardiac pacemaker insertion, Condition ag...
Atrial fibrillation, Cardiac ablation, Cardiac pacemaker insertion, Condition aggravated
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Approximately 3-5 days after my second Pfizer COVID-19 vaccine my Atrial Fibrilation became uncontro...
Approximately 3-5 days after my second Pfizer COVID-19 vaccine my Atrial Fibrilation became uncontrollable with medication.
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| 2841471 | 64 | F | FL | 05/18/2025 |
TDAP TDAP |
SANOFI PASTEUR SANOFI PASTEUR |
U8015AA U8015AA |
Acoustic stimulation tests normal, Anxiety, Blood test normal, Computerised tomo...
Acoustic stimulation tests normal, Anxiety, Blood test normal, Computerised tomogram head normal, Laboratory test normal; Magnetic resonance imaging normal, Myocardial necrosis marker normal, Tinnitus, Vertigo
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On 3/31/25, five days after vaccine. Had vertigo and ringing in Left ear which then caused anxiety. ...
On 3/31/25, five days after vaccine. Had vertigo and ringing in Left ear which then caused anxiety. Went to nearest emergency room who did blood tests, cardiac enzymes, CT brain and monitored. Tests and labs negative, normal and was discharged home. Follow up with Primary care and two ENT since vertigo/ Left ear ringing continued.
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| 2841472 | 45 | F | FL | 05/18/2025 |
COVID19 HEPAB HPV9 |
PFIZER\BIONTECH GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
p2443 y009051 |
Expired product administered; Expired product administered; Expired product admi...
Expired product administered; Expired product administered; Expired product administered
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patient received expired comirnaty vaccine (expired 4/19/25) given 5/15/25
patient received expired comirnaty vaccine (expired 4/19/25) given 5/15/25
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| 2841473 | 54 | M | AK | 05/18/2025 |
COVID19 COVID19 FLU3 FLU3 UNK UNK |
PFIZER\BIONTECH PFIZER\BIONTECH SANOFI PASTEUR SANOFI PASTEUR UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
LN0590 LN0590 TFAA2433 TFAA2433 E754F E754F |
C-reactive protein, Computerised tomogram, Differential white blood cell count, ...
C-reactive protein, Computerised tomogram, Differential white blood cell count, Full blood count, Magnetic resonance imaging head; Metabolic function test, Peroneal nerve palsy, Red blood cell sedimentation rate, Walking aid user; C-reactive protein, Computerised tomogram, Differential white blood cell count, Full blood count, Magnetic resonance imaging head; Metabolic function test, Peroneal nerve palsy, Red blood cell sedimentation rate, Walking aid user; C-reactive protein, Computerised tomogram, Differential white blood cell count, Full blood count, Magnetic resonance imaging head; Metabolic function test, Peroneal nerve palsy, Red blood cell sedimentation rate, Walking aid user
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Lost use of left foot. Cannot move it side to side or up and down. Diagnosed as ๏ฟฝFoot Drop'...
Lost use of left foot. Cannot move it side to side or up and down. Diagnosed as ๏ฟฝFoot Drop'. Needs a cane or walker to safely walk. Had 3 days of steroid infusions on 5/8, 5/9 & 5/10. On 5/14 had a steroid injection and is taking 6 days of oral steroids. He will be seen by a neurologist next week and will start physical therapy soon. He currently is doing his own stretching exercises to keep his foot from curling permenantly. #17 Shingles (Shingrix - Glaxosmit). (this was not shown on the drop down list.
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