chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: I have the heavy three menstrual cycle in a month; every single month for the last year and now I am not even having weekend between them I am on my 4th menstrual cycle for the month; Two months after consistent bleeding; this is not normal; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 23-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: 33130BA), in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "I have the heavy three menstrual cycle in a month; every single month for the last year and now I am not even having weekend between them I am on my 4th menstrual cycle for the month"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "Two months after consistent bleeding; this is not normal". The events required physician office visit.  Additional information: The patient wanted to report another side effects right after she got the vaccine (clarified as Pfizer COVID-19 Vaccine) last year, she called the same day. "I have the heavy three menstrual cycle in a month, every single month for the last year and now I am not even having weekend between them I am on my 4th menstrual cycle for the month and this all this Feb. I just got off my period 5 days ago and now I have it again and I don't take medicine and I don't take get vaccines the only vaccine I have had within the last 10 years of Pfizer. I don't need to take it." Consumer stated, "I went to try to get help and I have verified it's not just an symptoms of ovarian cancer. I went to an gynecologists like about two months after consistent bleeding and they are the ones that told me like that no, this is not normal. I have some documents back, because I ended up getting on birth control (Name could not be clarified hence, captured as unspecified medication) thinking it will stop the bleeding and they gave me signs of 'closure' before they gave me birth control things and I was bleeding three times a month before I even get birth control." Consumer stated, "I am not taking any other medications or I wasn't at that time either, I was perfectly healthy normal I won't even take aspirin, I don't do medicine." Consumer stated, "Yes, it is the first shot. I got was from withheld and the second vaccine was from withheld pharmacy. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300083604 same patient/drug, different dose/event;
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 5/14/21 Lot# 006C21A; Moderna 6/11/21 Lot# 040B21
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Lichenoid keratosis
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 4 (booster), single (Lot number: GH9703) for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN6198), on 20Feb2021 as dose 2, single (Lot number: EN6198) and on 15Oct2021 as dose 3 (booster), single (Lot number: 8020FH) for covid-19 immunisation. The patient's relevant medical history included: "Rash" (ongoing). Concomitant medication(s) included: CARVEDILOL, start date: 11Sep2018 (ongoing); LIOTHYRONINE, start date: 01Jan1990 (ongoing); HYDROXYCHLOROQUINE taken for rash, start date: 06Sep2022 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 09Jun2022 to 15Jun2022.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 4 (booster), single (Lot number: GH9703) for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN6198), on 20Feb2021 as dose 2, single (Lot number: EN6198) and on 15Oct2021 as dose 3 (booster), single (Lot number: 8020FH) for covid-19 immunisation. The patient's relevant medical history included: "Rash" (ongoing). Concomitant medication(s) included: CARVEDILOL, start date: 11Sep2018 (ongoing); LIOTHYRONINE, start date: 01Jan1990 (ongoing); HYDROXYCHLOROQUINE taken for rash, start date: 06Sep2022 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 09Jun2022 to 15Jun2022.
Sex: U
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Anxiety, Blood test normal, Chills, Computerised tomogram abdomen normal, Condition aggravated
Clinical narrative: fatigue; brain fog; celiacs; GI system is completely backwards. It became unbearably sensitive; whole year in pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "GI system is completely backwards. It became unbearably sensitive"; COELIAC DISEASE (medically significant) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "celiacs"; PAIN (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "whole year in pain"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: tested: negative; negative; negative; negative; negative; negative; negative; negative; negative. Therapeutic measures were taken as a result of coeliac disease, gastrointestinal disorder, pain. Clinical course: 13 months ago (Jan2022), the patient got his/her booster. 2 months after (Mar2022), the patient started to develop some very worrying symptoms. His/her gastrointestinal (GI) system is completely backwards, became unbearably sensitive. It's almost like he/she have Celiacs. The patient spent the whole year in pain and on various probiotic strains, and bought so many supplements to combat it. The patient changed his/her whole diet around and even that only works a bit. Around now (2023), brain fog and fatigue were taking over the patient's life. The patient tested 9 times and all were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Defaecation urgency, Depression, Diarrhoea, Faeces soft, Feeling abnormal
Clinical narrative: fatigue; brain fog; celiacs; GI system is completely backwards. It became unbearably sensitive; whole year in pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "GI system is completely backwards. It became unbearably sensitive"; COELIAC DISEASE (medically significant) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "celiacs"; PAIN (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "whole year in pain"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: tested: negative; negative; negative; negative; negative; negative; negative; negative; negative. Therapeutic measures were taken as a result of coeliac disease, gastrointestinal disorder, pain. Clinical course: 13 months ago (Jan2022), the patient got his/her booster. 2 months after (Mar2022), the patient started to develop some very worrying symptoms. His/her gastrointestinal (GI) system is completely backwards, became unbearably sensitive. It's almost like he/she have Celiacs. The patient spent the whole year in pain and on various probiotic strains, and bought so many supplements to combat it. The patient changed his/her whole diet around and even that only works a bit. Around now (2023), brain fog and fatigue were taking over the patient's life. The patient tested 9 times and all were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Feeling cold, Gastrointestinal disorder, Gastrointestinal pain, Headache, Hyperhidrosis
Clinical narrative: fatigue; brain fog; celiacs; GI system is completely backwards. It became unbearably sensitive; whole year in pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "GI system is completely backwards. It became unbearably sensitive"; COELIAC DISEASE (medically significant) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "celiacs"; PAIN (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "whole year in pain"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: tested: negative; negative; negative; negative; negative; negative; negative; negative; negative. Therapeutic measures were taken as a result of coeliac disease, gastrointestinal disorder, pain. Clinical course: 13 months ago (Jan2022), the patient got his/her booster. 2 months after (Mar2022), the patient started to develop some very worrying symptoms. His/her gastrointestinal (GI) system is completely backwards, became unbearably sensitive. It's almost like he/she have Celiacs. The patient spent the whole year in pain and on various probiotic strains, and bought so many supplements to combat it. The patient changed his/her whole diet around and even that only works a bit. Around now (2023), brain fog and fatigue were taking over the patient's life. The patient tested 9 times and all were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Impaired work ability, Laboratory test, Pyrexia, Tremor, Urine analysis normal
Clinical narrative: fatigue; brain fog; celiacs; GI system is completely backwards. It became unbearably sensitive; whole year in pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "GI system is completely backwards. It became unbearably sensitive"; COELIAC DISEASE (medically significant) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "celiacs"; PAIN (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "whole year in pain"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: tested: negative; negative; negative; negative; negative; negative; negative; negative; negative. Therapeutic measures were taken as a result of coeliac disease, gastrointestinal disorder, pain. Clinical course: 13 months ago (Jan2022), the patient got his/her booster. 2 months after (Mar2022), the patient started to develop some very worrying symptoms. His/her gastrointestinal (GI) system is completely backwards, became unbearably sensitive. It's almost like he/she have Celiacs. The patient spent the whole year in pain and on various probiotic strains, and bought so many supplements to combat it. The patient changed his/her whole diet around and even that only works a bit. Around now (2023), brain fog and fatigue were taking over the patient's life. The patient tested 9 times and all were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Coeliac disease, Fatigue, Feeling abnormal, Gastrointestinal disorder, Investigation
Clinical narrative: fatigue; brain fog; celiacs; GI system is completely backwards. It became unbearably sensitive; whole year in pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "GI system is completely backwards. It became unbearably sensitive"; COELIAC DISEASE (medically significant) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "celiacs"; PAIN (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "whole year in pain"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: tested: negative; negative; negative; negative; negative; negative; negative; negative; negative. Therapeutic measures were taken as a result of coeliac disease, gastrointestinal disorder, pain. Clinical course: 13 months ago (Jan2022), the patient got his/her booster. 2 months after (Mar2022), the patient started to develop some very worrying symptoms. His/her gastrointestinal (GI) system is completely backwards, became unbearably sensitive. It's almost like he/she have Celiacs. The patient spent the whole year in pain and on various probiotic strains, and bought so many supplements to combat it. The patient changed his/her whole diet around and even that only works a bit. Around now (2023), brain fog and fatigue were taking over the patient's life. The patient tested 9 times and all were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19-2, COVID19
Symptoms: Pain
Clinical narrative: fatigue; brain fog; celiacs; GI system is completely backwards. It became unbearably sensitive; whole year in pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "GI system is completely backwards. It became unbearably sensitive"; COELIAC DISEASE (medically significant) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "celiacs"; PAIN (non-serious) with onset Mar2022, 2 months after the suspect product(s) administration, outcome "unknown", described as "whole year in pain"; FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "brain fog"; FATIGUE (non-serious) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: tested: negative; negative; negative; negative; negative; negative; negative; negative; negative. Therapeutic measures were taken as a result of coeliac disease, gastrointestinal disorder, pain. Clinical course: 13 months ago (Jan2022), the patient got his/her booster. 2 months after (Mar2022), the patient started to develop some very worrying symptoms. His/her gastrointestinal (GI) system is completely backwards, became unbearably sensitive. It's almost like he/she have Celiacs. The patient spent the whole year in pain and on various probiotic strains, and bought so many supplements to combat it. The patient changed his/her whole diet around and even that only works a bit. Around now (2023), brain fog and fatigue were taking over the patient's life. The patient tested 9 times and all were negative.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Inflammatory marker test, Vaccination site pain
Clinical narrative: Inbound call from HCP who stated a patient received their second dose of GARDASIL 9 "about 6 months ago" and now has a complaint of chronic pain in her left arm where the vaccine was administered. No additional AE details or PQC.; This spontaneous report was received from a physician concerning a female patient who was 11 years old at time of vaccination. The patient's concurrent conditions included pain in knees, ankles and elbows. The patient's medical history and concomitant therapies were not reported.  On 05-JAN-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #1775808, expiration date: 20-AUG-2023), administered intramuscularly for prophylaxis (anatomical location and dose were not provided). In approximately August 2022 (reported as about 6 months ago), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  On an unknown date, the patient had complaint of chronic pain in her left arm where the vaccine was administered. The patient sought medical attention but did not receive treatment for the event. She had a negative inflammatory work up (unspecified). At the moment of this report, the patient had not recovered from the event. No causality assessment was provided.
Sex: M
Vaccine: PNC15
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient was administered two doses of VAXENUVANCE less than 6 months, second administration was accidental; No additional AE information reported; This spontaneous report has been received from a nurse practitioner via a company employee referring to a 62-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with one dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (first dose; strength, exact dose, lot #, expiration date and route of administration were not provided) for prophylaxis. On an unknown date less than 6 months apart, the patient was vaccinated with another dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (second dose; strength, exact dose, lot #, expiration date and route of administration were not provided) for prophylaxis (extra dose administered). It was reported that the second administration was accidental that provider was unaware patient had already received one dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). No additional adverse event (AE) information or product quality complaint (PQC) was reported.
Age: 49.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information; e received GARDASIL 9 on 2/24/2023 at the age of 49; This spontaneous report was received from a consumer and refers to a 49-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 24-FEB-2023, the patient was vaccinatedwith hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered for prophylaxis (strength, lot #, expiry date and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event information was provided (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No additional AEs; a pregnant patient received a GARDASIL 9 vaccine by mistake instead of the scheduled TDAP; a pregnant patient received a GARDASIL 9 vaccine by mistake instead of the scheduled TDAP; This spontaneous prospective pregnancy case has been received from  an office manager concerning to a female patient of an unknown age. The patient's pertinent medical history, concomitant therapies and drug reactions or allergies were not provided.   On 27-FEB-2023, the patient was vaccinated by mistake with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, vaccination scheme frequency, route of administration, anatomical site of application, lot number, expiration date, and route of administration were not provided)(exposure during pregnancy) for prophylaxis; instead of scheduled TDAP vaccine (wrong product administered).   No additional adverse events (AE).   By the reporting time, the outcome of the event exposure during pregnancy was unknown.  The patient's last menstrual period (LMP), expected date of delivery (EDD) (due date) and the fetal outcome were unknown. The pregnancy outcome was outcome pending.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Until got the shot, had shingles/Suspected vaccination Failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 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 Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that his ex girlfriend dad did not had the shingles until he received the Shingles vaccine. The reporter stated that the patient was cussing at the physician that told him that he should receive that vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot, now have it/Suspected vaccination failure; Now have it; This 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.   In April 2022, the patient received Shingles vaccine. In February 2023, between 10 and 11 months 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Feb-2023 Reporter's comments: The case was received from the patient via interactive digital media. The patient got his/her shot in April and now had them. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the primary schedule and laboratory confirmation of shingles were not provided. The follow-up could not be possible as no contact details were available. Vaccination date and onset date was partially captured considering that in April 2022 patient got the vaccine and in February 2023 got the shingles and accordingly time to onset was captured.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shot years ago, have them now/Suspected vaccination failure; Have them now, had them  number of time; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them a number of time).   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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Feb-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shot years ago and had them now. The patient guessed he/she will get the new shot when he/she can. The patient stated that hoped it helps. Additional supportive information: 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. The follow-up could not be possible as no contact details were available. As per narrative, dose number was not clear which patient got years ago and for which dose patient was guessing to get, therefore the case was kept valid with single dose without dose number and along with suspected vaccination failure and shingles.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rubber sensitivity
Clinical narrative: allergic reaction to rubber; allergic reaction; This case was reported by a other health professional via sales rep and described the occurrence of rubber sensitivity in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rubber sensitivity.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rubber sensitivity and allergic reaction. On an unknown date, the outcome of the rubber sensitivity and allergic reaction were unknown.   It was unknown if the reporter considered the rubber sensitivity and allergic reaction to be related to Shingrix.     Additional Information: GSK receipt date: 21-FEB-2023 Reporter's comment:  The patient received 1st dose of Shingrix and had allergic reaction, possibly from rubber. The health care professional said the allergic reaction was after the dose was administered.  The patient went to an allergist who said the patient was allergic to rubber.  Health care professional was unsure if this was related to Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only received 1 dose 2 years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, 2 years ago, ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-FEB-2023 Reporter's comment:  The reporter asked as if someone only received one dose of shingrix 2 years ago, should they restart the series. They disconnected the chat without giving additional information. Additional Supportive Information: Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Really hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day 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 Information: GSK Receipt date: 22-Feb-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. Day after getting the Shingles shot really hurts. Patient was sure that pain was not as bad as having as shingles. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25th May 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 Information: GSK Receipt Date: 16-FEB-2023 Reporter's Comment: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient. The reporter stated that below temperature excursion had happened in October. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter called to inform that a dose of Havrix that had been in a below temperature excursion and was not considered stable was administered to a patient, which led to incorrect storage of drug. This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023026693:Same reporter US-GSK-US2023026692:Same reporter US-GSK-US2023026695:Same reporter US-GSK-US2023026696:Same reporter US-GSK-US2023026698:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: received dose reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number AE234, expiry date 12th December 2023) for prophylaxis.   On 15th February 2023, the patient received Hiberix. On 15th February 2023, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 20-Feb-2023 and 21-Feb-2023 Reporter's comment: The nurse reported that a patient (did not know which one cause they did not keep records of the patients) was administered Hiberix diluted using sterile water (that was part of Varivax). The incident was discovered the next day while doing inventory and they realized that one of hiberix vaccines had not powder accompanying.  Did not refer product quality complain. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received Hiberix which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles NEAR the eye/Shingles (left side of face); blisters on face.; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2023, the patient received the 1st dose of Shingrix. In January 2023, 2 days after receiving Shingrix, the patient experienced shingles and blister. The patient was treated with valaciclovir hydrochloride (Valtrex) and ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)). On an unknown date, the outcome of the shingles and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: The reporter was the patient. The reporter called stating that he was unsure if he ever had chicken pox.  The reporter was instructed by his primary care physician to have Shingrix administered, although he did not want to have the vaccine, he complied with the request of his primary care physician. Shingrix was administered approximately one month prior to his call to GlaxoSmithKline on a Wednesday.  Then two days later, on a Friday, the blisters appeared on the left side of his face.  The patient did not have shingles prior to the vaccination. He had blisters on the left side of his face. The reporter did not consent to follow-up. The reporter declined to provide any more information pertaining to his demographics or anything else related to this case. The minimal information obtained to file adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st 28Jan2020, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-FEB-2023 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose. The patient received the vaccine at a pharmacy but the pharmacy had since closed.   The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2023028619, reported by same reporter. Details pertains to 1st dose of Shingrix in product tab; Sender's Comments:  US-GSK-US2023028619:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 28Jan2020, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th January 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-FEB-2023 Reporter's comment: The reporter was the wife of patient.  The patient had not yet received the second dose. The patient received the vaccine at a pharmacy but the pharmacy had since closed.   The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case is linked with US2023028619, reported by same reporter. Details pertains to 1st dose of Shingrix in product tab; Sender's Comments:  US-GSK-US2023028620:Same reporter
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, expiry date August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 20-FEB-2023 Reporter's comment: The information about patient and vaccine was asked but declined. The reporter consented to follow up via email. Additional supportive information: The patient was administered an expired dose of Twinrix, which led to expired vaccine used.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number CM7KN, expiry date 29th January 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 20-FEB-2023 Reporter's Comment: A healthcare professional called to inform that earlier that day a patient had received a dose of Boostrix that had expired on 29 January 2023. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient had received an expired dose of Boostrix vaccine, which had led to expired vaccine used.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the diluent; Administered only the diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5NC4N, expiry date 8th October 2023) for prophylaxis.   On 30th January 2023, the patient received the 1st dose of Shingrix. On 30th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-FEB-2023 Reporter's comment: The HCP(health care professional) reported that patient received dose of Shingrix in the series was administered with diluent only.  No side effects was reported.  The reporter consent to follow up. Additional Supportive Information: The patients received Shingrix vaccines with diluent only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 4L9E4, expiry date 7th February 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 20th February 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 20-FEB-2023 Reporter's comments: The nurse reported that a patient received an expired dose of Infanrix at the time of reporting. The reporter did not consent to follow-up. Additional information declined by HCP. Additional supportive information: At the time of reporting, the patient had received an expired dose of Infanrix vaccine, which had led to expired vaccine used.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymphoma.   On 20th February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 20th February 2023, less than a day after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt date: 21-FEB-2023 Reporter comment: The reporter was the patient. The patient received her first Shingrix dose and experienced injection site pain. Nothing else was reported. The reporter did not consent to follow up