chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; temperature excursion on 30-APR-2024/ Vaccine administered on 19-JUN-2024; This spontaneous report has been received from a health care professional (Medical assistant), referring to 06-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, and concomitant therapies were not reported.  On 30-APR-2024, storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) suffered a temperature excursion according to the digital data logger. Caller stated that the health care professional (HCP) who originally monitored excursions left the office, and they did not discover this excursion until much later. The temperature excursion of 74.4 degrees Fahrenheit (also reported as minimum: 39.02 degrees Fahrenheit/ maximum: 74.84 degrees Fahrenheit) was for 3 days and 23 hours. There was no previous temperature excursion.   On 19-JUN-2024, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot number X015245 that was verified to be a valid lot number (expiration date reported and validated as 22-NOV-2024) for prophylaxis (strength, exact dose, route of administration and scheme frequency were not reported) (product storage error). No symptomatic adverse events were confirmed. No additional adverse event was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2407USA009835:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: covid; covid; This is a spontaneous report received from a Pharmacist from product quality group.  An elderly patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing), notes: they were diabetic and COPD; "COPD" (unspecified if ongoing), notes: they were diabetic and COPD. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid". The pharmacist had a patient who was over 65 years old who had covid and they wanted to know how long they needed to wait to get the booster since they were diabetic and COPD. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMI XBB.1.5 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID Positive; COVID Positive; Pfizer COVID-19 vaccine on last fall (2023) and Moderna vaccine 2 weeks prior to infection; This is a spontaneous report received from a Consumer or other non HCP.  A 63-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Jun2024 as dose 2, single) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jun2024, outcome "recovering", described as "Pfizer COVID-19 vaccine on last fall (2023) and Moderna vaccine 2 weeks prior to infection"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2024, outcome "recovering" and all described as "COVID Positive". The clinical course was reported as follows: The patient reported that she had every vaccine available in a timely manner. The patient received Pfizer COVID-19 vaccine last fall (2023) and received a Moderna vaccine 2 weeks prior to infection. This was the first time the patient tested COVID-19 positive. On 29Jun2024 (day 1 as reported), the patient tested positive with symptoms and began treatment with nirmatrelvir, ritonavir (PAXLOVID) orally 2 times daily (2x/day). On 03Jul2024 (day 5 as reported), the patient had no symptoms, and had 2 negative tests. The patient also took ibuprofen (ADVIL) only during infection, for inflammation 2 per day. The patient underwent the following laboratory tests and procedures as aforementioned. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: patient received COVID-19 vaccine and asking if the  Paxlovid she got is still usable; patient received COVID-19 vaccine and asking if the  Paxlovid she got is still usable; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "patient received COVID-19 vaccine and asking if the  Paxlovid she got is still usable".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Muscular weakness, Pain in extremity
Clinical narrative: Debilitating muscle weakness; aching in both arms/aching in both hands; aching in both shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness 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, immediately after receiving Shingrix, the patient experienced muscle weakness (Verbatim: Debilitating muscle weakness), pain in arm (Verbatim: aching in both arms/aching in both hands) and shoulder pain (Verbatim: aching in both shoulder). The outcome of the muscle weakness, pain in arm and shoulder pain were not resolved.   It was unknown if the reporter considered the muscle weakness, pain in arm and shoulder pain to be related to Shingrix.     It was unknown if the company considered the muscle weakness, pain in arm and shoulder pain to be related to Shingrix.   Additional Information: GSK Receipt date: 16-JUL-2024 The patient self-reported. The patient received the first dose of Shingrix 7 weeks ago, almost immediately after, the patient had been experiencing debilitating muscle weakness, and aching in both shoulders, arms and hands which was getting worse and worse.  The patient was to see a neurologist and have an EMG done.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Alopecia, Antiphospholipid antibodies positive, Protein urine absent, Systemic lupus erythematosus
Clinical narrative: Hair loss led to testing for autoimmune. Tested low positive for Lupus. Sent to rheumatologist to confirm, which tested the same, however no protein in urine to confirm the blood work. Still having hair loss to this day.
Sex: M
Vaccine: COVID19, HEPA, MEN, MENB
Symptoms: Pain in extremity
Clinical narrative: soreness in arms; This spontaneous report as received from other health professional refers to a male patient of unknown age.  Concurrent conditions, medical history and concomitant medications were not reported.  On 03-MAY-2024, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unknown) intramuscular injection (lot # X2598, not valid; dose not provided), intramuscularly (IM) as prophylaxis; COVID-19 vaccine injection (lot # AU5558B) 0.25 mL IM as COVID-19 prophylaxis; meningococcal vaccine a/c/y/w conj (tet tox)(MENQUADFI) (lot # U7949AA) IM  as prophylaxis and meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (lot # 7H75N) IM as prophylaxis.  In May 2024, the patient experienced soreness in arms (pain in extremity).      The outcome of pain in extremity is unknown.  The relatedness between hepatitis A vaccine, inactivated (manufacturer unknown) and pain in extremity was not reported.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, Injection site inflammation, Injection site pain
Clinical narrative: Inappropriate schedule of vaccine administered; inflammation and tenderness at the site of GARDASIL 9 injection; inflammation and tenderness at the site of GARDASIL 9 injection; This spontaneous report was received from a medical assistant via company representative and refers to a 12-year-old female patient. The patient's medical history, drug reactions/allergies and concurrent conditions and concomitant therapies were not reported.  On 03-MAY-2023, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe lot # reported and confirmed as: 1957405, expiration date: 11-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided). On 06-MAY-2024, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, lot #1957405, expiration date: 11-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided).   On an unknown date in May 2024 (reported as "2 weeks after vaccination"), the patient experienced inflammation and tenderness at the site of GARDASIL 9 injection. The reporter stated that the Physician's assistant ordered an MRI for the injection site. The outcome of reported events was unknown.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for improperly stored and administrated VARIVAX on 08JUL2024.; This spontaneous report was received from an other health professional referring to a 12-month-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 08-JUL-2024, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered intramuscularly for prophylaxis (lot # x010535, has been verified to be a valid lot number, expiration date reported and upon internal validation both established as 11-APR-2025; strength, exact dose and anatomical location were not provided); the first dose of measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (M-M-R II) injection, administered intramuscularly for prophylaxis (lot # W029540, has been verified to be a valid lot number, expiration date reported and upon internal validation both established as 15-SEP-2024; strength, exact dose and anatomical location were not provided); the fourth dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, administered intramuscularly for prophylaxis (lot # X022475, has been verified to be a valid lot number, expiration date reported and upon internal validation both established as 23-JAN-2026; strength, exact dose and anatomical location were not provided); the first dose of hepatitis A vaccine inact (HAVRIX) administered intramuscularly for prophylaxis (Batch/lot # BX4EA, expiration date reported as 14-NOV-2025; strength, formulation, exact dose and anatomical location were not provided); and the fourth dose of hib vaccine conj (tet tox) (HIBERIX) administered intramuscularly for prophylaxis (Batch/lot # X72L7, expiration date reported as 12-NOV-2024; strength, formulation, exact dose and anatomical location were not provided).   It was reported that the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) administered to the patient underwent a temperature excursion which was -10.86 degrees Celsius (C) for 12 hours (product storage error) (also reported as out of range for almost 12 hours). It was stated that vaccines were used prior calling manufacturer to check viability of vaccines. And manufacturer confirmed OK to use vaccines if not more than 12 hours. No previous temperature excursion was reported. There was no additional adverse event (AE) or product quality complaint (PQC).
Sex: M
Vaccine: MMR, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AEs or PQC reported; Caller reports patient received MMR II on 7/20/2024.  Patient's history shows he has also received either MMRII or PRIORIX on 2/20/2020, 8/20/2020 and 4/11/2022.  Record does not specify which vaccine- whether the dose was MMR II or PRIORIX.  No oth; This spontaneous information was received from a pharmacist concerning a male patient of unknown age. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 20-FEB-2020, 20-AUG-2020 and 11-APR-2022, the patient was vaccinated either with measles vaccine live (schwartz), mumps vaccine live (rit 4385), rubella vaccine live (wistar ra 27/3) (PRIORIX) or measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On 20-JUL-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) 0.5 ml intramuscularly (IM) in the left deltoid, lot number X026219 with expiration date 06-NOV-2025, for prophylaxis (strength was not provided) (extra dose administered).  No adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms reported; Caller reported AE on behalf of a patient who was inadvertently administered expired VARIVAX on 7/19/2024 (w /no TEs) -- SUPPORTED via post-expiry memo. No symptoms reported. Obtained consent to contact HCP. Regulatory Case Filed (Case #02641352). No additional; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 19-JUL-2024 the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # W008712 and expiration date 14-MAR-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided). It was reported that Patient was inadvertently administered expired varicella virus vaccine live (oka/merck) (VARIVAX) with no temperature excursion, supported via post-expiry memo. No symptoms reported (expired product administered and no adverse event).
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Physician confirmed that the patient involved did not experienced any medical concerns or symptoms; Physician calling to report adverse event regarding a patient who inadvertently received MMR II and PROQUAD on the same visit.  Physician stated that the patient was inadvertently administered their first dose of both MMR II and PROQUAD on 5/24/2024; This spontaneous report was received from Physician and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, previous drug reactions or allergies and concomitant medications was provided  On 24-MAY-2024, the patient was vaccinated with inadvertent vaccines with same antigen measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA)(PROQUAD) injection, 0.5 milliliter, lot #X021757, expiration date: 23-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) injection, 0.5 milliliter, lot #X011431, expiration date: 19-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) (upon internal validation, both lot numbers and expiration dates were determined to be valid numbers) (accidental overdose).   Physician confirmed that the patient involved did not experience any medical concerns or symptoms (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; Diagnosed with shingles today; painful; 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 19-JUL-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Diagnosed with shingles today) and pain (Verbatim: painful). The outcome of the vaccination failure, shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUL-2024 This case was reported by patient via (Facebook) interactive digital media. He/she got the vaccine, diagnosed with shingles today, so painful. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination 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 is considered related to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Sensory loss
Clinical narrative: Guillain Barre syndrome; permanent loss of feeling in both feet, up to knee; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: Guillain Barre syndrome) (serious criteria hospitalization and GSK medically significant) and loss of sensation (Verbatim: permanent loss of feeling in both feet, up to knee) (serious criteria hospitalization and disability). The outcome of the guillain barre syndrome was not reported and the outcome of the loss of sensation was not resolved.   It was unknown if the reporter considered the guillain barre syndrome and loss of sensation to be related to Shingles vaccine.     The company considered the guillain barre syndrome and loss of sensation to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUL-2024 This case was reported by a patient via interactive digital media. The patient got the two shots, then came down with Guillain Barre Syndrome and was 2 weeks in Hospital ward. The patient took 9 months physical therapy and had permanent loss of feeling in both feet up to knees. The patient if had it to do over,  would had found out about side effects and probability due to medical history, whether to take it. The patient's parents or grands never had it. The follow-up could not be possible as no contact details were available.; Sender's Comments: Guillain Barre syndrome and sensory loss are unlisted events which are considered unrelated to GSK's Shingles vaccine.
Sex: U
Vaccine: RVX
Symptoms: Malaise, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; rsv; very sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, 1 month after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: rsv) and sickness (Verbatim: very sick). The outcome of the vaccination failure, respiratory syncytial virus infection and sickness were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine.     The company considered the vaccination failure to be related to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2024 The patient got the vaccine and a month later got respiratory syncytial virus. The patient was very sick. This case was considered as suspected vaccination failure as details regarding laboratory confirmation were unknown for respiratory syncytial virus infection at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK's RSV vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got 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: got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2024 The patient self-reported this case. The patient got vaccinated with Shingles vaccine and got shingles. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination 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 is considered related to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: RVX
Symptoms: Death
Clinical narrative: mother passed away in nursing home shortly after vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, immediately after receiving RSV vaccine, the patient experienced unknown cause of death (Verbatim: mother passed away in nursing home shortly after vaccine) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to RSV vaccine.     The company considered the unknown cause of death to be unrelated to RSV vaccine.   Additional Information: GSK Receipt date: 23-JUL-2024 This case was reported by the patient's children via (social media) interactive digital media. A reporter reported that his/her mother (patient) passed away in nursing home shortly after vaccine.; Sender's Comments: Death  is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.; Reported Cause(s) of Death: Unknown cause of death
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Insomnia, Myalgia
Clinical narrative: Intense headache; muscle aches over night; was unable to get any deep sleep but 6 minutes; This non-serious case was reported by a consumer and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number NDC 58160-0823-11) for prophylaxis.   Concurrent medical conditions included endometrial hyperplasia. Concomitant products included losartan.   On 15-JUL-2024, the patient received Shingrix. On 15-JUL-2024, less than a day after receiving Shingrix, the patient experienced headache (Verbatim: Intense headache), muscle pain (Verbatim: muscle aches over night) and difficulty sleeping (Verbatim: was unable to get any deep sleep but 6 minutes). The outcome of the headache, muscle pain and difficulty sleeping were resolving.   It was unknown if the reporter considered the headache, muscle pain and difficulty sleeping to be related to Shingrix.     It was unknown if the company considered the headache, muscle pain and difficulty sleeping to be related to Shingrix.   Additional Information: GSK Receipt date: 16-JUL-2024 A reporter reported that he/she inquiring about the expected duration of this reaction (intense headache and muscle aches overnight, was unable to get any deep sleep but 6 minutes). The symptoms were treated.
Age: 0.17
Sex: M
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a two month, a (premature) an MMR, a priorix; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received MMR (Priorix) (batch number 7T3HD) for prophylaxis.   On 19-JUL-2024, the patient received the 1st dose of Priorix (unknown thigh). On 19-JUL-2024, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave a two month, a (premature) an MMR, a priorix). The outcome of the inappropriate age at vaccine administration was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2024 The nurse called and informed that one of their medical assistants (MAs) gave a 2 month old premature patient the first dose of MMR (Priorix) vaccine. The reporter also mentioned that the patient also got other vaccines that day but didn't specify which ones. The patient received 1st dose of Priorix at an inappropriate age, which led to inappropriate age at vaccine administration.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; diagnosis with Shingles; This serious case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had Shingles 4 years ago). Concomitant products included hydrochlorothiazide, atracurium besilate (Atracurium Besylate), nebivolol and atorvastatin.   On 05-JAN-2024, the patient received the 2nd dose of Shingrix. In OCT-2023, the patient received the 1st dose of Shingrix. On 12-JUL-2024, 189 days after receiving Shingrix and between 8 and 10 months after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: diagnosis with Shingles) (serious criteria clinically significant/intervention required). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   The company considered the vaccination failure and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-JUL-2024 The patient received both Shingrix Vaccine and was diagnosed . with Shingles. The patient went to Urgent Care for treatment and diagnosis of Shingles. The patient was prescribed Valacyclovir (manufacturer not specified). The patient believes she had Shingles 4 years ago, because what she developed recently looks the same as it did 4 years ago, and it is in the same spot. This case was considered as suspected vaccination failure as details 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 (Long TTO.) is considered unrelated to GSK  vaccine Shingrix 1st and Shingrix2nd dose.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix 1st and Shingrix2nd dose..
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: We had Shingrix outside of temperature range at about 52 degrees for roughly 12 hours; 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 80-year-old male patient who received Herpes zoster (Shingrix) (batch number 559T9, expiry date 09-JUN-2026) and (batch number PH353) for prophylaxis.   On 14-JUL-2024, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: We had Shingrix outside of temperature range at about 52 degrees for roughly 12 hours). The outcome of the incorrect storage of drug was not reported.   Additional Information: GSK Receipt Date: 16-JUL-2024 The reporter had Shingrix outside of temperature range at about 52 degrees for roughly 12 hours. The reporter looking for information regarding if the product was still usable or if it needs to be replaced.  The reporter reported, 1 dose was administered and wondering if dose needs to be redone. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Chills, Headache
Clinical narrative: Reports chest pain; back pain; chills; headache; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of chest pain in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced chest pain (Verbatim: Reports chest pain), back pain (Verbatim: back pain), chills (Verbatim: chills) and headache (Verbatim: headache). The outcome of the chest pain, back pain, chills and headache were not reported.   It was unknown if the reporter considered the chest pain, back pain, chills and headache to be related to Shingles vaccine.     It was unknown if the company considered the chest pain, back pain, chills and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUL-2024 This case was reported by patient itself. The patient experienced chest pain, back pain, chills, headache following the vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site pain, X-ray normal
Clinical narrative: Joint pain which resolved on its own within 3 days. Pain at the injection site that did not resolve on its own - given medrol and sent to physical therapy. Improved significantly after completion of 5 days of medrol. Resolved completely after 2 weeks of physical therapy.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Adhesiolysis, Arthralgia, Back pain, Nerve block, Pain in extremity
Clinical narrative: Continual pain in back, hips, legs and arms.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral nerve destruction
Clinical narrative: Continual pain in back, hips, legs and arms.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Presyncope
Clinical narrative: Vasovagal reaction and dizziness
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site warmth, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient stated that after she received her 2nd Shingrix vaccine, she developed some small bumps below the injection site that were red, raised, itchy, painful, and warm to the touch.  She went to her doctor to have it looked at and she told me her doctor believes the vaccine was not administered deep enough and it infiltrated.  She stated that after about a week, it resolved.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC20
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Child came to Walk-in clinic 24 hours after vaccines with Hives on legs and torso, no breathing distress, no fever
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Syringe issue, Underdose
Clinical narrative: Pt was seen in the office 7/25/24 and was to receive a Prevnar 20 vaccine. When the injection was administered into the patient's left deltoid an unknown amount of the solution sprayed out of the side of the syringe. It is unknown how much of the solution was administered into the pt's arm.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Patient reporting joint pain that continuing
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Urticaria
Clinical narrative: Hives started 24 hours after vaccines given. Hives started to appear in diaper area and spread over the next few hours to all over her body.
Age: 65.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: PT EXPERINCING REDNESS/SWOLLENING ON LEFT ARM WHICH IS THE SITE OF SHINGRIX VACCINE. IT STARTED ON THE NIGHT OF 07/23/24. PT STATES WARM TO TOUCH AND HARD/STIFF AND IT HAS GOTTEN  BIG OVER THE LAST DAYS.  PT STATES SHE DID NOT EXPERIENCE ANY SIDE EFFECTS WITH THE FIRST SHINGRIX VACCINE. PT STATES SHE HAS BEEN PUTTING WARM COMPRESSORS ON SWELLING.
Sex: U
Vaccine: MENB
Symptoms: Intercepted product storage error
Clinical narrative: stored in the fridge at 46.9 F for 15 minutes and whether or not it would still be safe to use; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of intercepted product storage error in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient did not receive Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted product storage error (Verbatim: stored in the fridge at 46.9 F for 15 minutes and whether or not it would still be safe to use). The outcome of the intercepted product storage error was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2024 The healthcare professional called in for additional information on Bexsero.  The reporter reported that they had Meningococcal Group B Vaccines stored in the fridge at 46.9 Fahrenheit for 15 minutes and wanted to know the temperature excursion of the product and whether or not it would still be safe to use the samples of Bexsero, which led to intercepted product storage error.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came to our clinic for his 15 year well visit. Had not been seen at our clinic in 7 years. We asked mom if he had been seen anywhere else in the last 7 years and mom initially said no. Before administering vaccines patient remembered that he had been seen at an urgent care for a visit and thought he had received his Tdap. We called that urgent care to see if he had received any vaccines while there. Urgent care told us that they did administer Tdap but family had refused the Menactra. Urgent care stated they were going to fax over records right away. Did not receive records in a timely manner and Menquadfi was administered to patient while in our office. Patient had no reactions to vaccine and left the office with his mother. About an hour after the patient had left our office we received the vaccine records from the urgent care and on the record is showed he received Menactra at the urgent care at the same time as the Tdap. Patient inadvertently received an extra dose of Meningitis ACWY and will need to receive another dose when he is 16 years old. Family notified and patient still doing well. Urgent care notified of the misinformation given.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: INJECTION SITE WAS SWOLLEN, RED AND HOT.
Age: 62.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: 62 YO patient was given pediatric dose instead of adult dose of Energix B (0.5mL)
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given an expired vaccine. No reaction or negative outcome
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: The injection site became red, swollen, and hot with a knot in the place of the injection site.  It started about the size of a golf ball.  I called the pharmacist on Monday morning, July 22, and she said that it is common.  On Tuesday, July 23, the redness and swelling got worse.  It was now the size of the palm of my hand.  I went to see the pharmacist and spoke with a different pharmacist.  I showed him the site of the injection and he said that it is probably an allergic reaction, and I should not get the second vaccine.  He recommended taking advil and benadryl to help.  I have been taking advil and benadryl, and applying cold compresses to alleviate the heat and swelling.  It is now Friday, July 26th and it is still red, swollen and hot.  The size of the redness is still the size of my palm.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Site swollen, firm and warm to touch for a few days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Immediate post-injection reaction, Injection site swelling, Neck pain, Pain
Clinical narrative: Patient reported having a bump right after administration and started to experience pain the next day. 5 days later he started having shortness of breath but it subsided after 2 days. now as of 07/26/2024 he says he has neck pain
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Blood creatine phosphokinase decreased, C-reactive protein increased, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Moderna Spikevax administered on 5/4/24 and started having back pain and stiffness on 5/17/24. Initially diagnosed as musculoskeletal back pain, but symptoms persisted and worsened. Ultimately diagnosed with polymyalgia rheumatica and has been started on prednisone therapy.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Moderna Spikevax administered on 5/4/24 and started having back pain and stiffness on 5/17/24. Initially diagnosed as musculoskeletal back pain, but symptoms persisted and worsened. Ultimately diagnosed with polymyalgia rheumatica and has been started on prednisone therapy.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: CLIENT WAS INADVERTENTLY GIVEN PROQUAD WITH EXPIRATION DATE OF 07//19/2024 SUBCUTANEOUSLY IN LEFT THIGH. CLIENT GUARDIAN NOTIFIED OF ADVERSE EVENT IN CLINIC. CLIENT DID NOT EXHIBIT ANY ADVERSE SYMPTOMS POST VACCINATION. MONITORED CLIENT IN OFFICE FOR FIFTEEN MINUTES.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Magnetic resonance imaging, Mobility decreased, Pain
Clinical narrative: Started hurting within 48 hrs after getting shot, couldn't lay on that side, then severe pain lasting for months, unable to move my arm ,horrific severe pain , couldn't sleep, dressmyself ,work, do daily activities, at all for 6 mo. Still have pain .
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Started hurting within 48 hrs after getting shot, couldn't lay on that side, then severe pain lasting for months, unable to move my arm ,horrific severe pain , couldn't sleep, dressmyself ,work, do daily activities, at all for 6 mo. Still have pain .
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Patient starting to develop couple of red spot on his left hand later that day.  He stated he only feel itchy not pain.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Blisters
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Nurse stated patient has 2/3 of upper arm all red and swollen. Resident let the nurse know of this today.
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: ARM REDNESS AROUND INJECTION SITE, SLIGHTLY SORE BUT STILL ABLE TO MOVE WITH NO RESTRICTIONS
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Blood test abnormal, Groin pain, Injection site pain, Laboratory test
Clinical narrative: I received the flu vaccine at the left Ventro gluteal and have been having hip, groin and buttock pain on the left side. I knew that I would have some pain at the injection site, but the pain never left and gotten much worse to where after sitting for longer than 10 mins its very painful after getting up and very painful when laying on that side, and I can no longer sit in any other position without pain.  I have gone to a nerve Dr, Rheumatologist due to high numbers in blood for Arthritis. and received shots in my hip area from an orthopedic Dr. I am still seeing and orthopedic to try and find the reason behind the constant pain.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Magnetic resonance imaging, Musculoskeletal pain, Nerve conduction studies, Pain, Product administered at inappropriate site
Clinical narrative: I received the flu vaccine at the left Ventro gluteal and have been having hip, groin and buttock pain on the left side. I knew that I would have some pain at the injection site, but the pain never left and gotten much worse to where after sitting for longer than 10 mins its very painful after getting up and very painful when laying on that side, and I can no longer sit in any other position without pain.  I have gone to a nerve Dr, Rheumatologist due to high numbers in blood for Arthritis. and received shots in my hip area from an orthopedic Dr. I am still seeing and orthopedic to try and find the reason behind the constant pain.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: I received the flu vaccine at the left Ventro gluteal and have been having hip, groin and buttock pain on the left side. I knew that I would have some pain at the injection site, but the pain never left and gotten much worse to where after sitting for longer than 10 mins its very painful after getting up and very painful when laying on that side, and I can no longer sit in any other position without pain.  I have gone to a nerve Dr, Rheumatologist due to high numbers in blood for Arthritis. and received shots in my hip area from an orthopedic Dr. I am still seeing and orthopedic to try and find the reason behind the constant pain.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events noted. Patient only received extra vaccine to equal 3 instead of 2
Age: 17.0
Sex: M
Vaccine: MMRV, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no signs of symptoms
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac ablation, Dizziness, Dyspnoea, Impaired work ability, Laboratory test
Clinical narrative: I began having heart palpitations shortly after my  booster, which occurred 6 months after the initial injections (03/04/2021 and  03/25/2021). It was determined that I was having premature valve contractions; the condition continued to worsen. I saw doctors to determine the issue - I was having horrifying palpitations, shortness of breath, dizziness. Of most concern to me was that there is no history of heart issues or disease in my family. It was finally determined that I needed cardiac ablation to address severe fibrillations in my right ventricle; currently, I am having atrial contractions.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Ventricular extrasystoles
Clinical narrative: I began having heart palpitations shortly after my  booster, which occurred 6 months after the initial injections (03/04/2021 and  03/25/2021). It was determined that I was having premature valve contractions; the condition continued to worsen. I saw doctors to determine the issue - I was having horrifying palpitations, shortness of breath, dizziness. Of most concern to me was that there is no history of heart issues or disease in my family. It was finally determined that I needed cardiac ablation to address severe fibrillations in my right ventricle; currently, I am having atrial contractions.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Baby developed blood in her stool 2-3 days after her 2 month check up with vaccines.  There was no irritability or vomiting.  Mother had no bleeding or cracked nipples.  Baby was exclusively breast feeding.  Hemoccult test of stool was positive.  Baby was changed to hypoallergenic formula.  Blood in stool subsequently resolved.  Mother at first gave breast milk after stopping dairy but eventually return to consuming dairy and breast-feeding baby with no subsequent blood in diaper, no rash, and no vomiting.
Age: 35.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Blister, Headache, Injection site erythema, Injection site pain, Injection site vesicles
Clinical narrative: Injections administered 7/12/24; Next day arm injection sites red/sore, muscle aches, headache. These symptoms continued through 7/25/24 when she woke up at approx 1200 with a fever of 101F and blisters near injection site of L deltoid. Throughout day blisters multiplied & reported on legs, back, face, neck, left arm; painful with muscle aches.
Age: 35.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Injections administered 7/12/24; Next day arm injection sites red/sore, muscle aches, headache. These symptoms continued through 7/25/24 when she woke up at approx 1200 with a fever of 101F and blisters near injection site of L deltoid. Throughout day blisters multiplied & reported on legs, back, face, neck, left arm; painful with muscle aches.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Localized left thigh redness, swelling purpleish discoloration as well as over the anterior thigh, no sign of deep infection, swollen lymph nodes in groin area, patient walking well.  Recommended icing area, ibuprofen 1-2 days, follow up increasing pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPVHIB, MMRV
Symptoms: Dermatitis acneiform, Injection site erythema, Injection site mass, Injection site reaction
Clinical narrative: Temp ~ 101 on 7/16/24 at night.  Developed raised red lump on left arm about 4 inches in diameter with no streaking.  On right arm, pimply rash.  Recommended cool compresses and Tylenol/Motrin.  Improved after 7/17/24 with no further treatment