| ID | Age | Sex | State | Date โผ | Onset Days | Vaccine | Manufacturer | Lot # | Symptoms | Narrative | ๐ | ๐ฅ | ๐ | โฟ | โ ๏ธ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2842332 | 4 | M | CA | 05/22/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
5g23d |
Erythema, Mass
Erythema, Mass
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redness with a bump
redness with a bump
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| 2842333 | 3 | M | CA | 05/22/2025 |
DTAPHEPBIP |
GLAXOSMITHKLINE BIOLOGICALS |
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Injection site erythema, Injection site urticaria
Injection site erythema, Injection site urticaria
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hive with erythema to the injection site
hive with erythema to the injection site
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| 2842334 | 33 | M | TN | 05/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Atrial fibrillation, Cardiac ablation, Dyspnoea, Electrocardiogram abnormal, Ele...
Atrial fibrillation, Cardiac ablation, Dyspnoea, Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal
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I had no pre existing conditions. Around 8/30/2023 I began having shortness of breath and using my S...
I had no pre existing conditions. Around 8/30/2023 I began having shortness of breath and using my Smart Watch it showed me in A-fib. I messaged my doctors office and they called me immediately to set up an appointment. I had an ECG and it confirmed/diagnosed Atrial Fibrillation. I was set up with a Cardiologist at the Hospital on 8/31/23 and wore a Holter Monitor for a week which saw me in and out of A-fib. I was sent to Electrophysiologist at the Hospital for appt 1/10/2024 and told I needed an Ablation to correct it. I had the Ablation procedure 10/3/2024. I have all paperwork associated if needed. The procedure fixed most of the Afib but I still have residual afib according to my Smart Watch
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| 2842335 | 1.42 | M | MT | 05/22/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
BR2GD |
Inappropriate schedule of product administration
Inappropriate schedule of product administration
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Gave dose 2 of Hepatitis A too early. Previous dose given 1/20/2025, was not due until 6/20/2025, b...
Gave dose 2 of Hepatitis A too early. Previous dose given 1/20/2025, was not due until 6/20/2025, but was accidently given on 4/14/2025.
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| 2842336 | 65 | F | TN | 05/22/2025 |
UNK UNK UNK UNK |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
W027449 W027449 Unknown Unknown |
Fatigue, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, N...
Fatigue, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Neck pain; Pain in extremity, Sleep disorder; Fatigue, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Neck pain; Pain in extremity, Sleep disorder
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9-12-2023: After returning from the Dr. office where I received the vaccine, I felt very fatigued an...
9-12-2023: After returning from the Dr. office where I received the vaccine, I felt very fatigued and took a nap. I was awakened by severe pain in my right arm and realized my right arm was completely numb and I was unable to move it. I took scheduled doses of ibuprofen, using ice/heat on my arm while having to keep it close to my right side to lessen the pain. The pain went down to my fingers and up to the right side of me neck. After hard night of trying to rest, on 9/13/2023 I contacted PCP's office with my symptoms, treatment I had done, and current status of right arm; elbow down was somewhat better, upper arm was still restrictive/painful. The response said I was doing all I could-going to take time. After much time my right arm became less restrictive, allowing cautious use, but intermittent pain in the bicep of arm and the area where shoulder meets the deltoid part of arm. At 4/2024 appt. with PCP, I discussed this. PCP showed me an excersise to use on my arm, which I did. At 11/2024 appt. with PCP, I discussed the continued symptoms from the 4/2024 visit I was still having. PCP sent referral for Physical Therapy. Received 9 PT treatments with some improvement esp. with bicep. Currently, I have intermittent pain/soreness in right bicep again with shoulder/deltoid area intermittently "catching and popping".
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| 2842338 | 05/22/2025 |
HPV9 |
MERCK & CO. INC. |
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Incomplete course of vaccination, No adverse event
Incomplete course of vaccination, No adverse event
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Consumer calling to report that they did not receive their 2nd and 3rd dose of GARDASIL 9. Patient d...
Consumer calling to report that they did not receive their 2nd and 3rd dose of GARDASIL 9. Patient did not report any side effects. Permission to contact HCP was not given. No Additional AE/ No PQC; No adverse event; This spontaneous report was received from 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 started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), administered by intravenous route (dose, anatomical location, lot # and expiration date were not reported) as HPV vaccine. It was reported that the patient did not receive their 2nd and 3rd dose of the suspect vaccine (incomplete course of vaccination). In addition, the patient did not report any side effects. Additional information is not expected.
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| 2842339 | TX | 05/22/2025 |
RV5 |
MERCK & CO. INC. |
2096663 |
No adverse event, Syringe issue, Underdose
No adverse event, Syringe issue, Underdose
|
No adverse event; Nurse reported that near the "neck or side" of the ROTATEQ ODT, the solu...
No adverse event; Nurse reported that near the "neck or side" of the ROTATEQ ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child.; Nurse reported that near the "neck or side" of the ROTATEQ ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child. The previous 9 tubes did not have any issues. The product was discarded so it can not be returned a; This spontaneous report was received from a nurse and refers to a Child patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 29-APR-2025, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (valid lot #2096663, expiration date reported and confirmed as 17-MAY-2026; exact dose not provided) administered by oral route as prophylaxis. On that same day, the nurse reported that near the "neck or side" of the suspect vaccine ODT, the solution "shot out" from a tiny hole while administering the vaccine to a child (syringe issue / accidental underdose). The previous 9 tubes did not have any issues. The product was discarded so it could not be returned. No adverse event reported.
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| 2842340 | F | TX | 05/22/2025 |
HPV9 |
MERCK & CO. INC. |
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Injection site discharge
Injection site discharge
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The patient did not complain about the injection or any other issues.; The pharmacist is unsure if t...
The patient did not complain about the injection or any other issues.; The pharmacist is unsure if the problem was the prefilled Gardasil 9 syringe or something else but a significant amount of the medication came out of the injection site.; significant amount of the medication came out of the injection site; Does the syringe have a broken component? YES; The cap came off of the the syringe prior to administration and the pharmacist needed to put the cap and the syringe in the sharps container/LUER LOCK DETACHED; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not provided. On 26-APR-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9), administered by intramuscular route in the left arm for prophylaxis (lot # and expiration date were not reported). The pharmacist was unsure if the problem was the prefilled Human Papillomavirus 9-valent Vaccine, Recombinant Suspension for injection (GARDASIL 9) or something else, but a significant amount of the medication came out of the injection site (Accidental underdose); it leaked from the same location, also potentially due to a luer lock breakage during administration, however HCP could not confirm the exact malfunction (Syringe issue, Poor quality device used). The patient did not complain about the injection or any other issues (No adverse event). The pharmacist also stated that another prefilled syringe of the suspect vaccine from the same box had an issue, but was not administered to a patient; the luer lock fell off and became detached from the rest of the syringe/ the cap came off of the syringe prior to administration and the pharmacist needed to put the cap and the syringe in the sharps container (Device connection issue). The syringe carton was not damaged prior to use. The syringe tray was intact and undamaged on receipt. Products and pictures were not available. At the reporting time, the outcome of the events was not known. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported but established as not applicable.
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| 2842341 | 1 | F | NJ | 05/22/2025 |
HIBV MMRV PNC20 UNK |
MERCK & CO. INC. MERCK & CO. INC. PFIZER\WYETH UNKNOWN MANUFACTURER |
Y007178 Y014440 |
Product storage error; Product storage error; Product storage error; Product sto...
Product storage error; Product storage error; Product storage error; Product storage error
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No AE; vaccine storage issue; This spontaneous report was received from a nurse practitioner and ref...
No AE; vaccine storage issue; This spontaneous report was received from a nurse practitioner and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 31-Mar-2025, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y007178, expiration date: 07-Nov-2026), the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y014440, expiration date: 22-Feb-2026) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported), the first dose of Hepatitis A vaccine) (lot# DN273, expiration date: 28-Aug-2026) and the third dose of Pneumococcal vaccine conj 20v (CRM197) (lot# LK6653, expiration date: 30-Jun-2026) all administered by intramuscular route for prophylaxis. On 09-Apr-2025, at compliance visit, upon review by state, temperature excursion was noted from 03-Mar-2025 to 10-Mar-2025 (product storage error). Upon further investigation and review by the DDL manufacturer, it was noted as a "glitch" "most likely caused by an electronical interference". The VFC program advised revaccination and that process was currently in progress with the patients involved. No adverse event was reported. This is one of several cases from the same reporter.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-05-14 , MNSC number : 02785949 , CLIC number : , ESTAR number : , IRMS number : , Central date : 2025-05-13 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
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| 2842342 | 1.08 | M | VA | 05/22/2025 |
MMR |
MERCK & CO. INC. |
Y015995 |
Cough, Morbillivirus test positive, Pyrexia, Rash
Cough, Morbillivirus test positive, Pyrexia, Rash
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patient they had recently vaccinated with MMR II tested positive for measles.; This spontaneous repo...
patient they had recently vaccinated with MMR II tested positive for measles.; This spontaneous report was received from a Physician and refers to currently 1-year old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 29-APR-2025, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, lot #Y015995, expiration date was not reported, but upon internal validation was established as 24-SEP-2026, diluted with sterile diluent (MERCK STERILE DILUENT) (Lot #, expiration date, dose, frequency were not reported) administered subcutaneously for Prophylaxis. In 2025, the patient presented symptoms like rash, cough and high fever. The patient was seen in an emergency room and tested positive for measles. The patient was not admitted to the hospital. At the reporting time, the outcome event was unknown. An epidemiologist reported that was the third case reported from this lot number. The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was unknown. This is one of several cases from the same reporter.; Reporter's Comments: Keywords : MUL
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| 2842343 | F | MN | 05/22/2025 |
HEPA |
MERCK & CO. INC. |
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Expired product administered, No adverse event
Expired product administered, No adverse event
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No side effects/symptoms reported; HCP called to report a patient received pediatric VAQTA that expi...
No side effects/symptoms reported; HCP called to report a patient received pediatric VAQTA that expired on 5/17/2025 and was administered on 5/19/2025.; This spontaneous report was received from a medical assistant and refers to a 12-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 19-May-2025, the patient was vaccinated with pediatric Hepatitis A Vaccine, Inactivated (VAQTA), (expiration date: 17-May-2025) (dose, strength, route, lot # were not reported) for prophylaxis (expired product administered). Expired Hepatitis A Vaccine, Inactivated (VAQTA) dose was supported by post expiry memo. No side effects/symptoms reported (no adverse event). Lot# is being requested and will be submitted if received.
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| 2842344 | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Contusion
Contusion
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serious bruise; This serious case was reported by a consumer via interactive digital media and descr...
serious bruise; This serious case was reported by a consumer via interactive digital media and described the occurrence of contusion in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced contusion (Verbatim: serious bruise) (serious criteria other: Serious as per reporter). The outcome of the contusion was not resolved. It was unknown if the reporter considered the contusion to be related to Shingrix. The company considered the contusion to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 12-MAY-2025 This case was reported by the reporter via (Pharmacy Shingrix Program) interactive digital media. The reporter stated patient still have a serious bruise on his/her arm from the 1st Shingrix shot he/she received from. The patient would be going elsewhere for his/her 2nd shot.; Sender's Comments: Contusion is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
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| 2842345 | M | 05/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Death, Parkinsonism
Death, Parkinsonism
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some man who got Parkinson like symptoms from his Shingles It developed within two daysof the but he...
some man who got Parkinson like symptoms from his Shingles It developed within two daysof the but he died 3 years later.; I took care of some man who got Parkinson like symptoms from his Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death 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, 3 years after receiving Shingles vaccine, the patient experienced unknown cause of death (Verbatim: some man who got Parkinson like symptoms from his Shingles It developed within two daysof the but he died 3 years later.) (serious criteria death and GSK medically significant) and parkinsonism (Verbatim: I took care of some man who got Parkinson like symptoms from his Shingles) (serious criteria GSK medically significant). The outcome of the parkinsonism was not reported. The reported cause of death was unknown. It was unknown if the reporter considered the unknown cause of death and parkinsonism to be related to Shingles vaccine. The company considered the unknown cause of death and parkinsonism to be unrelated to Shingles vaccine. Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter reported that we all had it latent in our bodies Vitamins A and C and boosting immunity helped prevent severe cases. The reporter reported that he/she took care of some man who developed Parkinson-like symptoms from his shingles vaccine. The symptoms appeared within two days of the vaccine, and he passed away three years later. The reporter had advised if someone had the (MTHFR) methylenetetrahydrofolate reductase gene, they were more likely to have vaccine reactions.; Sender's Comments: Death and Parkinsonism are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine US-GSK-US2025AMR062976:Same Patient/ Different reporter; Reported Cause(s) of Death: Unknown cause of death
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| 2842346 | F | LA | 05/22/2025 |
VARZOS VARZOS VARZOS VARZOS VARZOS VARZOS |
GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS GLAXOSMITHKLINE BIOLOGICALS |
UNK UNK UNK UNK UNK UNK |
Asthenia, Back pain, Blister rupture, Exposure during pregnancy, Flank pain; Her...
Asthenia, Back pain, Blister rupture, Exposure during pregnancy, Flank pain; Herpes zoster, Neuralgia, Oral herpes, Pain, Pain in extremity; Pain of skin, Vaccination failure; Asthenia, Back pain, Blister rupture, Exposure during pregnancy, Flank pain; Herpes zoster, Neuralgia, Oral herpes, Pain, Pain in extremity; Pain of skin, Vaccination failure
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pregnant patient received Shingrix vaccine; Nerve pain; suspected vaccination failure; At this time ...
pregnant patient received Shingrix vaccine; Nerve pain; suspected vaccination failure; At this time the neuropathy diagnosis was ruled out and she was diagnosed with shingles; This serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included diabetes. Concomitant products included INFLUENZA VACCINE, metformin and insulin glargine (Toujeo). On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and Shingrix (intramuscular). In SEP-2024, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: At this time the neuropathy diagnosis was ruled out and she was diagnosed with shingles). In OCT-2024, the patient experienced post herpetic neuralgia (Verbatim: Nerve pain). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pregnant patient received Shingrix vaccine). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the post herpetic neuralgia was not resolved and the outcome of the vaccine exposure during pregnancy was not applicable. It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix and Shingrix. Pregnancy exposure: Pregnancy Exposure (Shingrix): Trimester unknown Pregnancy Exposure (Shingrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing Additional Information: GSK receipt date: 15-MAY-2025 The reporter was the husband of the patient. The patient had received both doses of Shingrix in late 2022. He remarked that they had received a flu shot about one month before the Shingrix vaccine. He did not know which flu shot or manufacturer it was. In September 2024, the patient experienced her "first ever" fever blister, which lasted about four days. In October 2024, she began feeling pain in her back that radiated down her right leg. She also began feeling less energetic at that time and complained of pain in her side. There was no rash at that time. In November 2024, she was originally diagnosed with neuropathy caused by her diabetes until two "dots" appeared on her back near her rib cage and on her buttock. At that point, the neuropathy diagnosis was ruled out, and she was diagnosed with shingles. The dots went away about two to three weeks later. The dot on her ribcage appeared like a blister that had popped. The patient reported that her ongoing intermittent pain occurred between the dot location on her ribcage and the dot location on her buttock. She continued to complain of intermittent pain when clothing touched her skin. The HCP noted in the report was her Primary Care Physician. His wife was her gynecologist. They shared the same office contact information. The pregnant patient received Shingrix vaccine which led to, vaccine exposure during pregnancy. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, 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 primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
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| 2842347 | F | NY | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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She has not yet had the second dose; This non-serious case was reported by a consumer via call cente...
She has not yet had the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose in MAR-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: She has not yet had the second dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 19-MAY-2025 The patient received her first Shingrix dose and she has not yet had the second dose, which led to an incomplete course of vaccination.
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| 2842348 | F | FL | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
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Herpes zoster, Rash
Herpes zoster, Rash
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shingles/ a rashon her right buttock; This non-serious case was reported by a consumer via call cent...
shingles/ a rashon her right buttock; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of herpes zoster (received 1st dose on an unknown date and 2 days after dose, she experienced a rash on her right buttock that was diagnosed as shingles, refer case US2025060452). Concurrent medical conditions included blood cholesterol increased and blood pressure high. Concomitant products included atenolol, losartan, simvastatin and acetylsalicylic acid (Aspirin). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles/ a rashon her right buttock). The patient was treated with calamine and aciclovir sodium (Acyclovir). Rechallenge with Shingrix was positive. The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Linked case(s) involving the same patient: US2025060452 Additional Information: GSK receipt date: 15-MAY-2025 The reporter was the patient who received 2 doses of Shingrix last year. 2 days after each dose, she experienced a rash on her right buttock that was diagnosed as shingles. It was the size of a silver dollar and in both instances, the rash was in the same spot. It did not get bigger or spread. Her doctor prescribed acyclovir 400 mg and the rash went away after 1 or 2 weeks. She also applied calamine lotion to the rash in addition to taking acyclovir. One day prior to the reporting date, she saw redness in the same spot and on the day of reporting, the rash reappeared on her right buttock.; Sender's Comments: US-GSK-US2025060452:same patient/Dose 1
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| 2842349 | 05/22/2025 |
RVX RVX |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK |
Cough, Influenza, Lacrimation increased, Oropharyngeal pain, Pain; Rhinorrhoea
Cough, Influenza, Lacrimation increased, Oropharyngeal pain, Pain; Rhinorrhoea
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flu; This non-serious case was reported by a consumer via interactive digital media and described th...
flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza 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 influenza (Verbatim: flu). The outcome of the influenza was not reported. It was unknown if the reporter considered the influenza to be related to RSV vaccine. It was unknown if the company considered the influenza to be related to RSV vaccine. Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient had been coughing for months and initially blamed it on pollen. Then the cough worsened, and his/her eyes and nose started running. He/she developed a sore throat, along with body aches and pain. He/she was planning to see the doctor in the morning (On the day of reporting). He/she had already received an RSV shot but was worried that it might have been the flu.
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| 2842350 | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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been over six months since my first shot of shingrix; This non-serious case was reported by a consum...
been over six months since my first 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 (received first dose over six months 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: been over six months since my first shot of shingrix). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 18-MAY-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient mentioned that it has been over six months since his/her first shot of Shingrix vaccine which led to incomplete course of vaccination. The patient enquired if is was too late to get the second dose of Shingrix vaccine.
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| 2842351 | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Blister
Blister
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Took the shot when I first saw the blisters and have had the 2nd shot; This non-serious case was rep...
Took the shot when I first saw the blisters and have had the 2nd shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug use for unapproved indication in a patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included rash, pain (Then the wrap around pain on the left side of my thorax was unbearable as well), pruritus (internal itching on the left side of my thorax), breast pain (I still feel it in my breast), skin pain (skin is very tender), nerve pain (Deep nerve pain starting in the armpit), breast lump (5 clusters on the left breast), knee replacement (I've had 2 knee replacements), cesarean section (I've had 2 knee replacements and 2 cesarean) and shingles (in July 2024 had shingles). On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug use for unapproved indication (Verbatim: Took the shot when I first saw the blisters and have had the 2nd shot). The patient was treated with pregabalin (Lyrica). The outcome of the drug use for unapproved indication was not applicable. Additional Information: GSK receipt date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that it was meant to take out the nerve pain so at least she/he could sleep again. He had it in July 2024 it ran from deep in his/her armpit across his/her left breast and gave him/her five clusters on the left breast. Initially, he/she thought he/she was having a heart attack because of the intense, deep feeling he/she was experiencing. By morning, he/she had developed a rash. That rash felt like somebody had dragged me on a gravel road behind a truck. Then the wrap-around pain and internal itching on the left side of my thorax became unbearable as well. He/she still felt it in his/her breast, and his/her skin remained very tender at times, with the internal itching still present. He/she had not been vaccinated in time. He/she took the shot when he/she first saw the blisters and later received the second shot. The pain would take his/her breath away. It used to wake him/her up screaming in pain. His/her physician prescribed Lyrica, which helped tremendously. It was prescribed for shingles. The pain without Lyrica was the worst he/she had ever been through and he/she had undergone two knee replacements and two cesarean sections. He/she could only imagine what people went through before treatments like this existed.
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| 2842352 | 05/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspeceted vaccination failure; i got shingles after taking vaccine; This serious case was reported ...
Suspeceted vaccination failure; i got shingles after taking vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: i got shingles after taking vaccine). 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 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: 17-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles after taking the Shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2842353 | 05/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Eczema
Eczema
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eczema outbreak; This non-serious case was reported by a consumer via interactive digital media and ...
eczema outbreak; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of eczema 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 eczema (Verbatim: eczema outbreak). The outcome of the eczema was not reported. The reporter considered the eczema to be related to Shingles vaccine. The company considered the eczema to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The patient said that don't do it (don't do the vaccine). He/she still blame his/her eczema outbreak on it.
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| 2842354 | 05/22/2025 |
VARZOS VARZOS VARZOS |
UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER UNKNOWN MANUFACTURER |
UNK UNK UNK |
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes z...
Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure
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Suspected vaccination failure; just got Shingles Mild on top of my head; This serious case was repo...
Suspected vaccination failure; just got Shingles Mild on top of my head; 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 VARICELLA ZOSTER VACCINE for prophylaxis and VARICELLA ZOSTER VACCINE for prophylaxis. On an unknown date, the patient received Shingles vaccine, the 2nd dose of VARICELLA ZOSTER VACCINE and the 1st dose of VARICELLA ZOSTER VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, VARICELLA ZOSTER VACCINE and VARICELLA ZOSTER VACCINE, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: just got Shingles Mild on top of my head). 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: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient got 2 shot in 2019 and improved version in 2023. The patient got Shingles mild on top of the head. The doctor said that it would have been worse if he/she would not vaccinated. It was reported as ten percent patients could get even vaccinated. The reporter was one of them. It was unknown if the reporter considered the vaccination failure and shingles to be related to Varicella zoster vaccine. 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 Shingles vaccine.
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| 2842355 | 05/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
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Suspected vaccination failure; still got shingles/itching, burning, and the worst agonizing pain; Th...
Suspected vaccination failure; still got shingles/itching, burning, and the worst agonizing pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles/itching, burning, and the worst agonizing pain). 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. 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: 15-MAY-2025 This case was reported by the patient via interactive digital media. The patient got the Shingles vaccine, but he/she still got shingles, and now he/she had this terrible itching, burning and the worst agonizing pain ever had. The patient would not wish shingles on his/her enemies if he/she had any. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
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| 2842356 | 05/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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Suspected vaccination failure; Got shingles again anyway; This serious case was reported by a consum...
Suspected vaccination failure; Got shingles again anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. 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: Got shingles again anyway). 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: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient got shingles and then got the shot and got shingles again anyways. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2842357 | 05/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Herpes zoster, Vaccination failure
Herpes zoster, Vaccination failure
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suspected vaccination failure; shingles; This serious case was reported by a consumer via interactiv...
suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure 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: 18-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine and still got the shingles and stated it was horrible. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
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| 2842358 | F | 05/22/2025 |
VARZOS |
UNKNOWN MANUFACTURER |
UNK |
Chills, Malaise
Chills, Malaise
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feeling unwell; chills; This non-serious case was reported by a consumer via other manufacturer and ...
feeling unwell; chills; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included pulmonary embolism. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz). In JAN-2025, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: feeling unwell) and chills (Verbatim: chills). The outcome of the feeling unwell and chills were resolved (duration 1 day). It was unknown if the reporter considered the feeling unwell and chills to be related to Shingles vaccine. It was unknown if the company considered the feeling unwell and chills to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-MAY-2025 The patient reported that the start of xeljanz 5 mg tablet by mouth twice daily, many years, at least 10 years, est 2015, for rheumatoid arthritis. The patient reported in 2015 was diagnosed with a pulmonary embolism, she was unable to recall if this was before or after start of xeljanz therapy, no further occurrences, md aware, first dose of shingles vaccine given in January 2025 (after start of therapy), exact date unknown, after vaccine one evening if chills, not feeling well, resolved by next day, patient reports taking her xeljanz during this time, unknown if md aware, advised to update.
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| 2842359 | F | TN | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Headache, Pain in extremity
Headache, Pain in extremity
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severe headache (it resolved with Tylenol); She also complained of arm soreness.; This non-serious c...
severe headache (it resolved with Tylenol); She also complained of arm soreness.; This non-serious case was reported by a nurse via sales rep and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: severe headache (it resolved with Tylenol)) and pain in arm (Verbatim: She also complained of arm soreness.). The patient was treated with paracetamol (Tylenol). The outcome of the headache was resolved and the outcome of the pain in arm was not reported. It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix. It was unknown if the company considered the headache and pain in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 20-MAY-2025 The patient was approximately 55 years old The nurse reported that she took Shingrix herself and she developed a severe headache (it resolved with Tylenol). She also complained of arm soreness.
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| 2842360 | M | TN | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Chills
Chills
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He reported experiencing chills about 6 hours after both doses of Shingrix; This non-serious case wa...
He reported experiencing chills about 6 hours after both doses of Shingrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of chills (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced chills (Verbatim: He reported experiencing chills about 6 hours after both doses of Shingrix). Rechallenge with Shingrix was positive. The outcome of the chills was not reported. It was unknown if the reporter considered the chills to be related to Shingrix. It was unknown if the company considered the chills to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR063168 Additional Information: GSK Receipt Date: 20-MAY-2025 The patient experiencing chills about 6 hours after both doses of Shingrix.; Sender's Comments: US-GSK-US2025AMR063168:Same patient/another dose
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| 2842361 | M | TN | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Chills
Chills
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He reported experiencing chills about 6 hours after both doses of Shingrix.; This non-serious case w...
He reported experiencing chills about 6 hours after both doses of Shingrix.; This non-serious case was reported by a nurse via sales rep and described the occurrence of chills in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced chills (Verbatim: He reported experiencing chills about 6 hours after both doses of Shingrix.). The outcome of the chills was not reported. It was unknown if the reporter considered the chills to be related to Shingrix. It was unknown if the company considered the chills to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR063165 Additional Information: GSK Receipt Date: 20-MAY-2025 The reporter reported that the patient took both doses of Shingrix. He reported experiencing chills about 6 hours after both doses of Shingrix. This case is linked with US2025AMR063165, reported by same reporter.
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| 2842362 | F | MO | 05/22/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
44TR9 |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-seri...
Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 44TR9) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 The registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported of 29.9 degree Fahrenheit as the lowest reached for these products that were administered to a patient which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments: US-GSK-US2025061537:same reporter US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient
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| 2842363 | F | MO | 05/22/2025 |
RSV |
GLAXOSMITHKLINE BIOLOGICALS |
DL32D |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case ...
Administration after a below temperature excursion of 29.9 degree Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) for prophylaxis. On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree Fahrenheit). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 The nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Arexvy. The Vaccine Administration Facility was the same as Primary Reporter; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
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| 2842364 | F | MO | 05/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
39LB7 |
Product storage error
Product storage error
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Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non...
Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Boostrix, which led to incorrect storage of vaccine. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
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| 2842365 | F | MO | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
M7G39 |
Product storage error
Product storage error
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administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non...
administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Shingrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061547:Same patient,different suspect US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient
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| 2842366 | M | MO | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
M7G39 |
Product storage error
Product storage error
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administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.; This non-ser...
administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: administration after a below temperature excursion of 29.9๏ฟฝF as the minimum reached.). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Shingrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments: US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient
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| 2842367 | F | TN | 05/22/2025 |
HEP |
GLAXOSMITHKLINE BIOLOGICALS |
UNK |
Incomplete course of vaccination
Incomplete course of vaccination
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late second dose; This non-serious case was reported by a pharmacist via call center representative ...
late 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 55-year-old female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B (1st dose received on 08 February 2024, with batch number XS27B and expiry date 17 March 2025). On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: late second dose). The outcome of the incomplete course of vaccination 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: 16-MAY-2025 Medical Information Canada transferred a pharmacist that wanted to report an Engerix-B late second dose which led to incomplete course of vaccination. Pharmacist said, can the patient receive Twinrix since the patient wanted to have protection also for Hepatitis A? Which guidance can we have on this topic? Vaccination date, vaccine detail and patient demographics were obtained in this call.
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| 2842368 | 54 | F | WV | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PC6573 |
Product storage error
Product storage error
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Vaccine stored outside recommended conditions and administered to patient; This non-serious case was...
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PC6573) for prophylaxis. On 08-APR-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 19-MAY-2025 The health care professional reported that they got vaccines and did not know if they were familiar with that place or not but anyway. They got the Shingrix vaccine normally, it was supposed to be frozen however, they have an employee that did not know that so, she put it on the refrigerator. It have been refrigerated since we got it but it was not in frozen, so need to know if it was still be efficacy of it or they should get rid of it and order new and they have two people that were vaccinated with it, which led to incorrect storage of drug. Did they not, when it was not frozen, so need to you know if they need to be revaccinated. Besides the two patients reported, health care professional confirmed that no other patient was administered with Shingrix after being stored at non recommended temperatures. Medical information discussed with health care professional normal storage conditions for Shingrix. This case is linked with US2025062278, reported by same reporter.; Sender's Comments: US-GSK-US2025062278:same reporter,Different patient
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| 2842369 | 75 | F | WV | 05/22/2025 |
VARZOS |
GLAXOSMITHKLINE BIOLOGICALS |
PC65Y3 |
Product storage error
Product storage error
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Vaccine stored outside recommended conditions and administered to patient; This non-serious case was...
Vaccine stored outside recommended conditions and administered to patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number PC65Y3) for prophylaxis. On 08-APR-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 19-MAY-2025 The health care professional reported that they got vaccines and did not know if they were familiar with that place or not but anyway. They got the Shingrix vaccine normally, it was supposed to be frozen however, they have an employee that did not know that so, she put it on the refrigerator. It have been refrigerated since we got it but it was not in frozen, so need to know if it was still be efficacy of it or they should get rid of it and order new and they have two people that were vaccinated with it, which led to incorrect storage of drug. Did they not, when it was not frozen, so need to you know if they need to be revaccinated. Besides the two patients reported, health care professional confirmed that no other patient was administered with Shingrix after being stored at non recommended temperatures. Medical information discussed with health care professional normal storage conditions for Shingrix. This case is linked with US2025062275, reported by same reporter.; Sender's Comments: US-GSK-US2025062275:same reporter,Different patient
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| 2842370 | 4 | F | MD | 05/22/2025 |
DTAPIPV |
GLAXOSMITHKLINE BIOLOGICALS |
34MF9 |
Product storage error
Product storage error
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administration after temperature excursion; This non-serious case was reported by a other health pro...
administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa-IPV (Kinrix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis. On 19-MAY-2025, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 20-MAY-2025 Medical assistant called and reported an excursion for Kinrix vaccine a min. temperature of 31.8 degree F, for a cumulative 57 hours. Also mentioned they found out that it was given to a patient and asked what would happened if it was give it to a patient and do we need to give the patient the vaccine again. Patient received vaccine after temperature excursion, which led to incorrect storage of drug.
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| 2842371 | 0.5 | M | TX | 05/22/2025 |
HEPA |
GLAXOSMITHKLINE BIOLOGICALS |
DN273 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Unapproved age; This non-serious case was reported by a other health professional via call center re...
Unapproved age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received HAV (Havrix pediatric) (batch number DN273, expiry date 28-AUG-2026) for prophylaxis. On 05-MAR-2025, the patient received the 1st dose of Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age). The outcome of the inappropriate age at vaccine administration 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: 16-MAY-2025 The Medical Assistant was calling regarding a vaccine that was given too early. If there were any steps that were needed to be taken. Hepatitis A, Havrix was received by the patient of 6 months at the time and Hepatitis a was given along with MMR and Varicella, which led to inappropriate age at vaccine administration. It was given on 5th March 2025, patient was six months at the time, patient is 8 months now. No reactions or anything from it. So, believed they do go back to normal schedule, give him again at twelve months but was there anything on our end that we need to watch for.
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| 2842372 | MI | 05/22/2025 |
DTPPVHBHPB |
MSP VACCINE COMPANY |
u7921aa |
Product storage error
Product storage error
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No adverse event; patient received improperly stored vaccine; This Spontaneous Safety Report with re...
No adverse event; patient received improperly stored vaccine; This Spontaneous Safety Report with reference number:02789391 was received by a partner on 16-APR-2025 and forwarded on 16-APR-2025 from a medical assistant. Due to the nature of the event, the causality between the event "patient received improperly stored vaccine" and Vaxelis was not applicable. Further information is expected. FOLLOW-UP INFORMATION was received by MCM on 14-MAY-2025 from a healthcare professional. The case is maintained as non-serious. The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events. Due to the nature of the event, the causality between the event "patient received improperly stored vaccine" and Vaxelis was not applicable. No further information is expected
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| 2842374 | 05/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Cardiac failure
Cardiac failure
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heart failure; Safety information originally reported under manufacturer case PV202500058845 has bee...
heart failure; Safety information originally reported under manufacturer case PV202500058845 has been nullified and re-entered under this new manufacturer report number 202500104046. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for covid-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (16May2025): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. Updated information: Reporter and patient's name updated. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. Follow-up (19May2025): This is a follow-up report to notify that the cases PV202500058845 and 202500104046 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 202500104046. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2842375 | F | 05/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Arthritis, Gait disturbance, Hypotonia
Arthritis, Gait disturbance, Hypotonia
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Can't walk; hard to walk; Losing muscle tone; hard to make a fist; Arthritis; This is a spontan...
Can't walk; hard to walk; Losing muscle tone; hard to make a fist; Arthritis; This is a spontaneous report received from a consumer from medical information team, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), in 2023 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Can't walk; hard to walk"; HYPOTONIA (non-serious), outcome "unknown", described as "Losing muscle tone; hard to make a fist"; ARTHRITIS (non-serious), outcome "unknown". The events "can't walk; hard to walk", "losing muscle tone; hard to make a fist" and "arthritis" required physician office visit and emergency room visit. Additional Information: The patient would like to know the side effects to the Pfizer COVID-19 vaccine (Comirnaty 12+). After providing the side effects, the patient states she can't walk, and she is losing muscle tone. It is her whole right side; it is hard to make a fist, and it is hard to walk. The patient doesn't know if her symptoms have to do with the vaccine, but she didn't have problems before. The patient has been to her doctor, but they are telling her it is arthritis, but she had to go to the ER, and they were telling her they didn't see any arthritis. The patient got the shot 2 years ago, hopefully it is not from shot. The patient asked for the time frame that people are reporting things after getting the Pfizer COVID-19 vaccine, if they report having side effects that start a year or two later. The patient was also asking if there are any reports or studies on what she is experiencing. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2842376 | F | 05/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Therapeutic response unexpected
Therapeutic response unexpected
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She also stated that she has gastroenterology problems and whenever she has had the Pfizer vaccine b...
She also stated that she has gastroenterology problems and whenever she has had the Pfizer vaccine booster it always fixed her gastroenterology flares.; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing); "gastroenterology problems" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation; Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "She also stated that she has gastroenterology problems and whenever she has had the Pfizer vaccine booster it always fixed her gastroenterology flares.". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2842377 | 05/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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The Pfizer one made me sicker than COVID; This is a spontaneous report received from a Consumer or o...
The Pfizer one made me sicker than COVID; 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: ILLNESS (non-serious), outcome "unknown", described as "The Pfizer one made me sicker than COVID". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2842378 | 05/22/2025 |
COVID19 |
PFIZER\BIONTECH |
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Illness
Illness
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It made me less sick afterwards then the Pfizer; This is a spontaneous report received from a Consum...
It made me less sick afterwards then the Pfizer; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna COVID-19 vaccine (Dose number unknown, lot number unknown), for COVID-19 immunisation, reaction(s): "sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "It made me less sick afterwards then the Pfizer". Additional information: the patient specified that he/she prefers to receive Moderna because it made him/her less sick afterwards then the Pfizer. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
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| 2842379 | 4 | F | OR | 05/22/2025 |
DTAP |
GLAXOSMITHKLINE BIOLOGICALS |
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Bell's palsy, Facial paralysis
Bell's palsy, Facial paralysis
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left facial paralysis (bells palsey)
left facial paralysis (bells palsey)
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| 2842380 | 11 | M | NJ | 05/22/2025 |
HPV9 MNQ |
MERCK & CO. INC. SANOFI PASTEUR |
U8494AA |
Unevaluable event; Unevaluable event
Unevaluable event; Unevaluable event
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none
none
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| 2842381 | 4 | F | NM | 05/22/2025 |
DTAPIPV MMRV |
GLAXOSMITHKLINE BIOLOGICALS MERCK & CO. INC. |
4L454 Y019465 |
Injection site cellulitis, Injection site erythema, Injection site induration, I...
Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
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Redness to Left upper thigh measures 12.5cm x 13.75cm, firm and warm to palpation. cellulitis also ...
Redness to Left upper thigh measures 12.5cm x 13.75cm, firm and warm to palpation. cellulitis also noticed. no fever noted the onset started the evening the vaccine was received. patient started on clindamycin 75mg/5ml solution take 18mls po every 8 hrs x 7 days. Tylenol or ibuprofen recommended if needed.
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| 2842382 | 46 | F | AZ | 05/22/2025 |
HPV9 |
MERCK & CO. INC. |
X014788 |
Product administered to patient of inappropriate age
Product administered to patient of inappropriate age
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Patient was administered an HPV vaccine after at age 46 years old and the cut off for this vaccine i...
Patient was administered an HPV vaccine after at age 46 years old and the cut off for this vaccine is 45 years of age. Patient left office prior to realizing this nurse administered it by mistake so I was unable to monitor for any adverse reactions.
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| 2842383 | 77 | F | FL | 05/22/2025 |
TDAP |
GLAXOSMITHKLINE BIOLOGICALS |
L5229 |
Unevaluable event
Unevaluable event
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NONE
NONE
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