chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Impaired work ability, Musculoskeletal pain, Pain in extremity
Clinical narrative: very tired --sleepy--- had to leave work.  later in evening arm pain-- relief taking tylenol--every 5 hs - 2nd day--- back pain-- under shoulder blades == better 24 hrs later.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: very tired --sleepy--- had to leave work.  later in evening arm pain-- relief taking tylenol--every 5 hs - 2nd day--- back pain-- under shoulder blades == better 24 hrs later.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Peripheral swelling, Swelling, Ultrasound scan
Clinical narrative: Swelling in Bicep, Extended to entire arm, shoulder and swollen clavical.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I broke out with a rash on my legs following all 3 vaccination doses. Clears up in a week. Still have the current rash from the shot I received 9/30/21
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling hot, Hot flush, Somnolence
Clinical narrative: Shortness of breath, hot flashes, feeling hot from the inside, having to breath fast, tired, sleepy
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Impaired work ability, Injection site pain
Clinical narrative: By approximately 4pm the day I received the vaccine, I felt very tired. My arm the injection site was very sore, but there was no redness there. The next day, 9/2921, the fatigue was overwhelming-I felt like I had been hit by a bus. The pain in my arm was not just at the injection site, but went down my entire arm. I had chills (but no fever), no appetite, and palpitations off and on. I was not able to work on 9/29/21. On 9/30/21, I returned to work and all symptoms had resolved except for the soreness in my arm. By 10/2/21 the soreness in my arm resolved, however, I had developed an ulcer? in my mouth, inside of my upper lip. By 10/3/21, I had that ulcer as well as 3 places on the inside of my lower lip that weren't ulcerated, but had circular areas of skin peeling off -on the inside of my lower lip, not on the lip itself. As of 10/4/21, these areas are still present and are tender.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Pain in extremity, Palpitations, Tenderness
Clinical narrative: By approximately 4pm the day I received the vaccine, I felt very tired. My arm the injection site was very sore, but there was no redness there. The next day, 9/2921, the fatigue was overwhelming-I felt like I had been hit by a bus. The pain in my arm was not just at the injection site, but went down my entire arm. I had chills (but no fever), no appetite, and palpitations off and on. I was not able to work on 9/29/21. On 9/30/21, I returned to work and all symptoms had resolved except for the soreness in my arm. By 10/2/21 the soreness in my arm resolved, however, I had developed an ulcer? in my mouth, inside of my upper lip. By 10/3/21, I had that ulcer as well as 3 places on the inside of my lower lip that weren't ulcerated, but had circular areas of skin peeling off -on the inside of my lower lip, not on the lip itself. As of 10/4/21, these areas are still present and are tender.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunosuppression, SARS-CoV-2 test positive
Clinical narrative: Patient received first vaccine 4/8/2021 and second vaccine 5/6/2021. He is now COVID positive requiring high flow nasal cannula 100% FiO2 and 50Lpm. He is immunosuppressed for his prior liver transplant.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Bacteraemia, Biopsy prostate abnormal, Dysuria, Escherichia infection
Clinical narrative: Patient presented to hospital on 9/29/2021 for frequent urination and burning with urination. He was found to have a fever. He was recently in the emergency room on 9/11/2021 and from 9/12/2021 to 9/15/2021 for E. coli urinary tract infection and bacteremia following a biopsy of the prostate. He remained asymptomatic for COVID-19 during admission.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Pyrexia, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Patient presented to hospital on 9/29/2021 for frequent urination and burning with urination. He was found to have a fever. He was recently in the emergency room on 9/11/2021 and from 9/12/2021 to 9/15/2021 for E. coli urinary tract infection and bacteremia following a biopsy of the prostate. He remained asymptomatic for COVID-19 during admission.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Sciatic nerve got damaged, it was very severe; Sweating a lot now; has a lot of pain that is very severe; his blood pressure is very high; His sugar is very unbalanced; Nausea; vomits, stomach problems; vomits, stomach problems; muscular pain very severe; Dizziness; feels a lot of like chills in his body; urinary problems, he no longer has control of bladder; Not able to sleep; sometimes feels like his heart wants to get out, not able to breathe; sometimes feels like his heart wants to get out, not able to breathe; Fatigue; he did receive effects very, very bad.; cramps in his stomach very severe.; The second vaccine, the rash is more bigger in the chest.; headache; shaking; but they got worse after the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination 60-years-old), as a single dose for COVID-19 immunization. The patient medical history included Depression, Panic attack, Blood pressure high, Diabetes mellitus, Blood sugar problems, Chronic insomnia, and Thyroid problems. The patient concomitant medication included Synthroid taken for thyroid problems. Patient previously received first dose of BNT162B2 vaccine, via an unspecified route of administration on an unspecified date (age at the time of vaccination 60-years-old), as a single dose for COVID-19 immunization and experienced little fatigue and little rash. On an unspecified date, the patient experienced Sciatic nerve got damaged, it was very severe; Sweating a lot now; has a lot of pain that is very severe; his blood pressure is very high; His sugar is very unbalanced; Nausea; vomits, stomach problems; muscular pain very severe; Dizziness; feels a lot of like chills in his body; urinary problems, he no longer has control of bladder; Not able to sleep; sometimes feels like his heart wants to get out, not able to breathe; Fatigue; he did receive effects very, very bad; cramps in his stomach very severe; The second vaccine, the rash is more bigger in the chest; headache; shaking; and but they got worse after the vaccine. On an unspecified date, the patient underwent lab tests and procedures which included Blood glucose: Unbalanced, Sugar is very unbalanced; and Blood pressure measurement: very high, blood pressure is very high. Patient clarifies he has taken everything for panic attacks, Ibuprofen, and it's not working. Patient went to pharmacy where they gave him some Benadryl cream, he put the cream on his chest and the rash disappeared. The outcome of the event the second vaccine, the rash is more bigger in the chest was recovered on an unspecified date; and all other events was unknown.  The lot number for [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101171811 same reporter/patient/product, different dose/event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Headache, Pyrexia, Somnolence
Clinical narrative: Fever; severe headache; dizziness; sleepiness; red skin face; This is a spontaneous report from a contactable other healthcare professional (patient). A 58-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on 18Mar2021 12:00 (at the age of 58-years-old), at dose 1, single for covid-19 immunization. Medical history included atrial fibrillation, supraventricular tachycardia, known allergies to garlic, lactose intolerant. Concomitant medications included metoprolol succinate; flecainide acetate (FLECAINIDE). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. The patient experienced fever, severe headache, dizziness, sleepiness, red skin face on 18Mar2021 20:00. No treatment was received for the events. The outcome of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Product temperature excursion issue
Clinical narrative: No additional adverse effect; PNEUMOVAX 23(syringe) that underwent a temperature excursion was administered; This spontaneous report was received from an other reporter and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 27-SEP-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, lot # T040202, expiration date: 11-SEP-2022 (exact dose, injection site and route of administration were not provided) for prophylaxis.  On an unknown date, the administered dose experienced a temperature excursion of above 47 degrees Fahrenheit (47.5 degrees Fahrenheit) for 2 hours 32 minutes and 0 seconds. No previous temperature excursion had occurred. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse events reported; improperly stored MMR II were administered; This spontaneous report was received from a registered medical assistant (RMA) and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 28-SEP-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 1 dose, lot # T016197, expiration date 11-MAY-2022 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 10.5 degrees Celsius for 6 hours and 46 minutes and 8.5 degrees Celsius for 1 hour and 24 minutes. There was no previous temperature excursion. No other adverse events were reported.  This is one of two reports received from the same reporter (cross-referenced with US-009507513-2109USA007552).; Sender's Comments:  US-009507513-2109USA007552:
Sex: F
Vaccine: FLUX, HPV9, MNQ, TDAP
Symptoms: Fall, Skin laceration, Syncope
Clinical narrative: patient fainted after the vaccinations; cut her chin; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.  On an unknown date, reported as recently, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, exact dose, dose #, route, anatomical location, lot # and expiration date was not provided). On the same day, she was also vaccinated with meningococcal vaccine a/c/y/w conj (dip tox)(MENACTRA), influenza vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (strengths, exact doses, dose #, routes, anatomical locations, lot # and expiration dates were not provided). The vaccines were given all together and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered at the very last. After the vaccinations, the patient fainted, fell off the table and cut her chin. She sought medical attention. She recovered from fainting while in the office. The patient had a follow up appointment to address the chin cut resulted form the fainting event. The outcome of the event of chin cut was reported as recovering.  The causality assessment was not provided.   Upon internal review, the event of syncope was determined to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported.; temperature excursion / temperature 30.4 F; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 21-SEP-2021, the patient was vaccinated with an improperly stored dose of hepatitis B vaccine (recombinant), thimerosal free (RECOMBIVAX HB) lot # T025374, expiration date 25-JAN-2023 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 30.4 degrees Fahrenheit (F) for 76 hours 20 minutes. No previous temperature excursion nor adverse effect were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Pruritus, Skin reaction
Clinical narrative: little icky; This case was reported by a consumer and described the occurrence of feeling unwell 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, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The patient's wife reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt little icky for a couple of days. The patient thought he had shingles again after the Pfizer shot, but they had learned that it was a common reaction and not shingles although it looked just like them but were bilateral and extremely itchy and therefore the patient would not be getting any booster. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurt; This case was reported by a consumer and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt a hurt. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Gastric disorder, Injection site pain, Pyrexia
Clinical narrative: hurt; just like covid/ chills; just like covid /exhausted; just like covid/ temp; just like covid/ stomach; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain, chills, exhaustion, fever and gastric disorder. On an unknown date, the outcome of the injection site pain, chills, exhaustion, fever and gastric disorder were unknown.   It was unknown if the reporter considered the injection site pain, chills, exhaustion, fever and gastric disorder to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2nd shot of Shingles vaccines and stated short truly hurt and also symptoms from 2nd shot was just like Covid. The patient also experienced chills, exhausted, temperature and stomach issue. The patient was glad that both the shots were done. The patient stated that then others said they had nothing, only she had symptoms. The follow-up could not be possible as no contact details were available. The case was linked with case US2021AMR203450 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203450:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Mobility decreased
Clinical narrative: sick; couldn't move for 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced mobility decreased and sickness. On an unknown date, the outcome of the mobility decreased was recovered/resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the mobility decreased and sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a shot of Shingles vaccine and got so sick and could not move for 4 days. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Nasal polyps
Clinical narrative: nasal polyps; This case was reported by a consumer and described the occurrence of nasal polyp in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Nucala, the patient experienced nasal polyp. The patient was treated with mepolizumab (Nucala). On an unknown date, the outcome of the nasal polyp was unknown.   It was unknown if the reporter considered the nasal polyp to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient received a dose of Shingrix and experienced nasal polyps. The patient stated that she was prescribed Nucala for nasal polyps. She reported that she was supposed to start her first dose of Nucala on 7th September 2021 but she did not start it until 21st September 2021 because she got the Shingles vaccine and her dose had to be pushed back. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021191013:same reporter US-GLAXOSMITHKLINE-US2021AMR203624:same reporter, same patient
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: areas on skin that look like shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced several areas on his/her skin that look like they could be shingles. The patient asked this was a possible side effect. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Malaise
Clinical narrative: sick with second dose; still don't feel well; This case was reported by a consumer via (Shingrix) interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than a month after receiving Shingrix, the patient experienced sickness and feeling unwell. On an unknown date, the outcome of the sickness and feeling unwell were not recovered/not resolved.   The reporter considered the sickness to be related to Shingrix. It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows. This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got the Shingrix vaccine on Friday which made her/him sick. The patient stated that she/he still did not feel well and asked how long did it last. The follow-up would not possible as contact information was not available.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Nervous system disorder, Pain in extremity, Tremor
Clinical narrative: neurological issues; Arm pain; Joint pain throughout body; night tremors, similar to GBS but not GBS; This case was reported by a other health professional via sales rep and described the occurrence of neurological disorder nos in a 56-year-old 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, less than a day after receiving Shingrix, the patient experienced neurological disorder nos, pain in arm, joint pain and tremor. On an unknown date, the outcome of the neurological disorder nos, pain in arm, joint pain and tremor were recovered/resolved.   It was unknown if the reporter considered the neurological disorder nos, pain in arm, joint pain and tremor to be related to Shingrix.  Additional details were reported as follows: The reporter was an office manager. The age at vaccination was not reported. The reporter stated that the patient received Shingrix vaccine and experienced neurological issues, arm pain, by evening joint pain throughout the body and that night tremors, similar to GBS (Guillain-Barre syndrome) but not diagnosed as GBS,  issues continued for 6 weeks reported to pharmacy and was advised to not get 2nd dose. The reporter agreed to follow-up from GlaxoSmithKline.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Product administered to patient of inappropriate age, Vaccination failure
Clinical narrative: have shingles at 8yo. He had been vaccinated / suspected vaccination failure; shingles; have shingles at 8yo. He had been vaccinated; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 8-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's parent.. The age at vaccination was not reported. The patient was tied for the youngest person to have shingles at 8 years old. He had been vaccinated and reporter never knew he actually had chickenpox, until he got shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has bene linked with US2021AMR205252 repored by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205252:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: passed out; Head ache; nausea; chills; fever; This case was reported by a consumer and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), headache, nausea, chills and fever. On an unknown date, the outcome of the passed out, headache, nausea, chills and fever were recovered/resolved.   The reporter considered the passed out, headache, nausea, chills and fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had a terrible reaction to the 1st of the second dose shingles vaccination.  The patient had head ache, passed out the next morning, nausea, chills & fever for a few days.  The reactions to the second dose were not quite as severe. For tolerance of second dose refer US2021AMR205343, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205343:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, had shingles / Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient was ex husband of reporter. The patient got the vaccine and then had singles months later. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case was linked with US2021AMR205467 and US2021AMR205468, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205467:Same reporter US-GLAXOSMITHKLINE-US2021AMR205468:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, had shingles / Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the vaccine and then had singles months later. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR205456 and US2021AMR205468 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205456:Same reporter US-GLAXOSMITHKLINE-US2021AMR205468:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, had shingles / Suspected vaccination failure; Shingles; This case was reported by a consumer and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the vaccine and then had singles months later.  This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. THis case has been linked with US2021AMR205456 and US2021AMR205467 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205456:Same reporter US-GLAXOSMITHKLINE-US2021AMR205467:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received diluent only; received diluent only; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th September 2021, the patient received Shingrix. On 30th September 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On 30th September 2021, the outcome of the inappropriate preparation of medication was unknown. On an unknown date, the outcome of the inappropriate dose of vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that the patient received only diluent portion, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No additional details were provided. The reported consented to follow up. This case was linked with the case US2021205510, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021205510:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Social problem
Clinical narrative: COVID hit/ Can I get second shot now; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not applicable for this report. The patient did not received the 2nd dose till the time of reporting due to covid which led to social problem. The patient enquired if he/she could get the 2nd dose now or have to start over again. Follow-up would not be possible as no contact details available.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Erythema, Nausea, Peripheral swelling, Vomiting
Clinical narrative: Significant arm  swelling; Significant arm  redness; Nausea; Vomiting; This case was reported by a nurse via sales rep and described the occurrence of swelling arm in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a day after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced swelling arm, erythema of extremities, nausea and vomiting. On an unknown date, the outcome of the swelling arm was unknown and the outcome of the erythema of extremities was not recovered/not resolved and the outcome of the nausea and vomiting were recovered/resolved.   It was unknown if the reporter considered the swelling arm, erythema of extremities, nausea and vomiting to be related to Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo and Bexsero at the same visit in the same arm and experienced significant arm swelling and redness. On the following day after vaccination, the patient developed nausea and vomiting.  The nausea and vomiting had resolved at the time of reporting but the patient's arm was still red. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: dose 1 month apart; This case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 12th July 2021, the patient received the 2nd dose of Shingrix. On 12th July 2021, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist asked for further instructions for a patient who received a Shingrix dose 1 month apart, which led to shortening of the vaccine schedule. The reporter agreed for follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Illness, Malaise, Pyrexia
Clinical narrative: sick (malaise); fever; chills; couldn't get out of bed (Weakness); This case was reported by a consumer via call center representative and described the occurrence of malaise in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (13 years ago). Previously administered products included Zostavax (received the approximately 13 years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, fever, chills and weakness. On an unknown date, the outcome of the malaise, fever, chills and weakness were recovered/resolved.   It was unknown if the reporter considered the malaise, fever, chills and weakness to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient was diagnosed with Shingles 13 years ago and when the rash went away, she received the Zostavax vaccine (approximately 13 years ago). The concomitant medication includes blood pressure lowering medicine and cholesterol lowering medicine. The patient received 1st dose of Shingrix vaccine and was sick (malaise), fever and chills and couldn't get out of bed (weakness) and it lasted 2 days (malaise, fever, chills, weakness are resolved). The call center representative referred her to speak with her doctor about her medical concerns. The patient said she might seek legal representation. The reporter consented to follow up. For tolerance to 2nd dose, refer case US2021AMR202920, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202920:Same reporter
Age: 56.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: received her first dose on 10/3/2019; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number X9GM4, expiry date unknown) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received the 2nd dose of Shingrix. In June 2021, less than 2 years after receiving Shingrix and Influenza vaccine Quadrivalent unspecified season and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.   Additional details were reported as follows: The case was reported by the patient. The reporter stated she received her 1st dose of Shingrix and not received 2nd dose till the time of reporting which led to incomplete course of vaccination.  The patient had shingles after 1st dose of Shingrix and Flu vaccine. The reporter inquired about how close one could receive the Shingrix vaccine after having shingles.   The reporter consented to follow up.  Note: Shingles reported as current condition but occurred after received Shingles and Flu vaccine, so captured as an event.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Immunodeficiency, Underdose
Clinical narrative: immunocompromised ./did not receive 40 mcg; This case was reported by a consumer via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Concurrent medical conditions included transplant (patient had an unknown transplantation). Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 23rd September 2021, the patient received the 1st dose of Engerix B (intramuscular) 20 µg and hepatitis B vaccine pre-filled syringe device. On 23rd September 2021, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced underdose. On an unknown date, the outcome of the underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The immunocompromised patient received 20 mcg of Engerix B instead of 40 mcg, which led to underdose. The patient also received a dose of Havrix on same day in the right deltoid. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Lumbar puncture
Clinical narrative: have a spinal tap done, because makes you feel so bad.; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included infection.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The physician said there had been people that had actually gone to the hospital and infectious disease doctors looked at them and they had a spinal tap done and could only come up with it was the shingles vaccine that had that made the patient feel so shitty, so bad. This case linked with US2021203774 and US2021203777, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203774:same reporter US-GLAXOSMITHKLINE-US2021203777:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number J3TE5, expiry date 20th January 2023) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not reported. The pharmacist called to report the patient was administered the Shingrix and during administration link between the syringe and needle started leaking, so the patient received approximately half the dose of vaccine, which led to accidental underdose. The reporter consented to follow-up by email. No further information was reported at time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: Passed out; Felt hot; felt dizzy; felt weak; Sore arm; did not really eat for dinner; stressing out; This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced stress. On 21st September 2021, the patient experienced feelings of weakness, pain in arm and appetite absent. On 22nd September 2021 11:00, the patient experienced passed out (serious criteria GSK medically significant), feeling hot and dizziness. On an unknown date, the outcome of the passed out, feeling hot, dizziness, feelings of weakness, pain in arm, appetite absent and stress were unknown.   It was unknown if the reporter considered the passed out, feeling hot, dizziness, feelings of weakness, pain in arm, appetite absent and stress to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix last Tuesday and had sore arm, felt weak, and did not really eat for dinner that day. On next day of vaccination, at about 11 am she felt dizzy and hot, and then she passed out. Less than a week after receiving Shingrix, the patient also mentioned that she would like to end the call as she was stressing out. It was unknown whether she was stressed out from the vaccine or other factors. The information regarding date of birth, email address, lot/expiry date, dose, vaccination date and route of administration, and if the symptoms were resolved or ongoing were not collected. The reporter did not give consent to follow-up with health care professional. Health care professional contact information was not collected. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Stress
Clinical narrative: Passed out; Felt hot; felt dizzy; felt weak; Sore arm; did not really eat for dinner; stressing out; This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2021, the patient received the 2nd dose of Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced stress. On 21st September 2021, the patient experienced feelings of weakness, pain in arm and appetite absent. On 22nd September 2021 11:00, the patient experienced passed out (serious criteria GSK medically significant), feeling hot and dizziness. On an unknown date, the outcome of the passed out, feeling hot, dizziness, feelings of weakness, pain in arm, appetite absent and stress were unknown.   It was unknown if the reporter considered the passed out, feeling hot, dizziness, feelings of weakness, pain in arm, appetite absent and stress to be related to Shingrix.  Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received a dose of Shingrix last Tuesday and had sore arm, felt weak, and did not really eat for dinner that day. On next day of vaccination, at about 11 am she felt dizzy and hot, and then she passed out. Less than a week after receiving Shingrix, the patient also mentioned that she would like to end the call as she was stressing out. It was unknown whether she was stressed out from the vaccine or other factors. The information regarding date of birth, email address, lot/expiry date, dose, vaccination date and route of administration, and if the symptoms were resolved or ongoing were not collected. The reporter did not give consent to follow-up with health care professional. Health care professional contact information was not collected. The reporter did not consent to follow-up.