chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Fainting; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 09Sep2024, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 84-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Moderna shot (several years back), for COVID-19 immunisation, reaction(s): "fainted"; Bnt162b2 nos, for COVID-19 immunisation. The following information was reported: SYNCOPE (medically significant) with onset 04Sep2024, outcome "unknown", described as "Fainting". Clinical courses is as follows: patient stated, "The side effects was fainting the next day, I was getting dressed, I woke up feeling so good I thought Pfizer has solved my problem because I had fainted with the Moderna shot (Unspecified vaccine) several years back. Shifted to Pfizer thinking that, that might be better and it was for one or two times but this time I fainted again and it would have been so easy for somebody feeling as good as I did on awakening to get in the car and try to start the normal day and they could have killed themselves or other people, thinking does not give you any warning. You just find yourself out, I mean you find yourself waking up from heaven only knows how you got to where you are." The patient was not taking any other medication. The patient had a similar response to the Moderna vaccine (Unspecified vaccine) that was several years ago and she came to Pfizer at that point hoping it would not have the same reaction on her and she had two Pfizer shots where she did not think but this time she fainted again. Patient did not take any other vaccine that day.  When probed for details for previous doses, patient stated, "Let me get where I have it. The first Pfizer Pfizer shot that I got was, it looks like 03Sep2024, this is the last one. The one before that was 10-10, they are out of water here. The one before that was 23 and that was 7-10 and 22 was another Pfizer, 10-10." Patient has no other treatment from a very long time, probably since the last shot, the shot before this one.  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dry throat, Haemorrhoidal haemorrhage, Nausea
Clinical narrative: Nausea, vomiting 2 times about 4:00 AM SEP 6.  Diarrhea at same time, rapidly  turned into liquid emptying of bowel, then turned into bloody liquid by  6:00 AM.  SEP 6 during the day and into night uncontrolled, sporadic, gushes of soft bloody intestinal discharge.   Talked to my primary care doctor's nurse, who advised going to urgent care for evaluation, which I did about 7:00 PM SEP 6. Nurse practitioner took vitals, asked questions about my condition, recommended blood work but could not do blood draw at that clinic.  I decided not to go to emergency room at night by myself. She also recommended bland diet and drinking lots of water.  Saturday, SEP 7, bloody discharge less in volume and frequency.  No fever,  drinking lot of water and eating carefully, About 3:00 PM, called the pharmacy where I got the Comirnaty vaccine, left a message for the pharmacist to call me about the extreme reaction.  Never got a return call. Sunday, SEP 8, bloody discharge seems to have stopped. Continued eating carefully and drinking lots of water.  Will contact primary care physician's office on Monday morning.  Monday, SEP 9, primary care physician ordered CBC test, which I got, see results below.  As of today, SEP 13, except for gassiness, symptoms have subsided.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Vaccination site haemorrhage, Vaccination site pain, Vomiting, Weight
Clinical narrative: Nausea, vomiting 2 times about 4:00 AM SEP 6.  Diarrhea at same time, rapidly  turned into liquid emptying of bowel, then turned into bloody liquid by  6:00 AM.  SEP 6 during the day and into night uncontrolled, sporadic, gushes of soft bloody intestinal discharge.   Talked to my primary care doctor's nurse, who advised going to urgent care for evaluation, which I did about 7:00 PM SEP 6. Nurse practitioner took vitals, asked questions about my condition, recommended blood work but could not do blood draw at that clinic.  I decided not to go to emergency room at night by myself. She also recommended bland diet and drinking lots of water.  Saturday, SEP 7, bloody discharge less in volume and frequency.  No fever,  drinking lot of water and eating carefully, About 3:00 PM, called the pharmacy where I got the Comirnaty vaccine, left a message for the pharmacist to call me about the extreme reaction.  Never got a return call. Sunday, SEP 8, bloody discharge seems to have stopped. Continued eating carefully and drinking lots of water.  Will contact primary care physician's office on Monday morning.  Monday, SEP 9, primary care physician ordered CBC test, which I got, see results below.  As of today, SEP 13, except for gassiness, symptoms have subsided.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Flatulence, Full blood count normal, Nausea
Clinical narrative: Nausea, vomiting 2 times about 4:00 AM SEP 6.  Diarrhea at same time, rapidly  turned into liquid emptying of bowel, then turned into bloody liquid by  6:00 AM.  SEP 6 during the day and into night uncontrolled, sporadic, gushes of soft bloody intestinal discharge.   Talked to my primary care doctor's nurse, who advised going to urgent care for evaluation, which I did about 7:00 PM SEP 6. Nurse practitioner took vitals, asked questions about my condition, recommended blood work but could not do blood draw at that clinic.  I decided not to go to emergency room at night by myself. She also recommended bland diet and drinking lots of water.  Saturday, SEP 7, bloody discharge less in volume and frequency.  No fever,  drinking lot of water and eating carefully, About 3:00 PM, called the pharmacy where I got the Comirnaty vaccine, left a message for the pharmacist to call me about the extreme reaction.  Never got a return call. Sunday, SEP 8, bloody discharge seems to have stopped. Continued eating carefully and drinking lots of water.  Will contact primary care physician's office on Monday morning.  Monday, SEP 9, primary care physician ordered CBC test, which I got, see results below.  As of today, SEP 13, except for gassiness, symptoms have subsided.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting 2 times about 4:00 AM SEP 6.  Diarrhea at same time, rapidly  turned into liquid emptying of bowel, then turned into bloody liquid by  6:00 AM.  SEP 6 during the day and into night uncontrolled, sporadic, gushes of soft bloody intestinal discharge.   Talked to my primary care doctor's nurse, who advised going to urgent care for evaluation, which I did about 7:00 PM SEP 6. Nurse practitioner took vitals, asked questions about my condition, recommended blood work but could not do blood draw at that clinic.  I decided not to go to emergency room at night by myself. She also recommended bland diet and drinking lots of water.  Saturday, SEP 7, bloody discharge less in volume and frequency.  No fever,  drinking lot of water and eating carefully, About 3:00 PM, called the pharmacy where I got the Comirnaty vaccine, left a message for the pharmacist to call me about the extreme reaction.  Never got a return call. Sunday, SEP 8, bloody discharge seems to have stopped. Continued eating carefully and drinking lots of water.  Will contact primary care physician's office on Monday morning.  Monday, SEP 9, primary care physician ordered CBC test, which I got, see results below.  As of today, SEP 13, except for gassiness, symptoms have subsided.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Haematochezia, Vomiting
Clinical narrative: Nausea, vomiting 2 times about 4:00 AM SEP 6.  Diarrhea at same time, rapidly  turned into liquid emptying of bowel, then turned into bloody liquid by  6:00 AM.  SEP 6 during the day and into night uncontrolled, sporadic, gushes of soft bloody intestinal discharge.   Talked to my primary care doctor's nurse, who advised going to urgent care for evaluation, which I did about 7:00 PM SEP 6. Nurse practitioner took vitals, asked questions about my condition, recommended blood work but could not do blood draw at that clinic.  I decided not to go to emergency room at night by myself. She also recommended bland diet and drinking lots of water.  Saturday, SEP 7, bloody discharge less in volume and frequency.  No fever,  drinking lot of water and eating carefully, About 3:00 PM, called the pharmacy where I got the Comirnaty vaccine, left a message for the pharmacist to call me about the extreme reaction.  Never got a return call. Sunday, SEP 8, bloody discharge seems to have stopped. Continued eating carefully and drinking lots of water.  Will contact primary care physician's office on Monday morning.  Monday, SEP 9, primary care physician ordered CBC test, which I got, see results below.  As of today, SEP 13, except for gassiness, symptoms have subsided.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: hair fell out, all of it; sick with nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "type 2 Diabetes" (unspecified if ongoing); "Something in neck not functioning" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); JANUVIA [SITAGLIPTIN PHOSPHATE MONOHYDRATE] taken for type 2 diabetes mellitus (ongoing); SYNTHROID taken for musculoskeletal discomfort (ongoing). Vaccination history included: BNT162b2 (Dose 1, 0.3ml in muscle; Arm, probably asked for left arm because she is right handed), administration date: 04Feb2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "hair fell out, all of it"; NAUSEA (non-serious), outcome "unknown", described as "sick with nausea". Therapeutic measures were taken as a result of alopecia. Additional information: It took approximately for her, almost a year for hair to come back. Her hair obviously, still has not come back. Hair started falling out within a week of being ill with Covid. Each time, sickness lasted long, it was nonsense. She got really sick this time, does not even know if that was connected. She had trouble breathing, and was sick with nausea, things like that like. Treatment for hair loss included vitamins, biotin pills, well, they are capsules, not pills. Hair was still falling out. It has not gotten any better. It was still falling out because her husband reminds her, every time she is standing at sink.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400254182 same patient and drug, different dose and event;
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Nausea
Clinical narrative: hair fell out, all of it; sick with nausea; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, 0.3 ml single (Batch/Lot number: unknown) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "type 2 Diabetes" (unspecified if ongoing); "Something in neck not functioning" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure abnormal (ongoing); JANUVIA [SITAGLIPTIN PHOSPHATE MONOHYDRATE] taken for type 2 diabetes mellitus (ongoing); SYNTHROID taken for musculoskeletal discomfort (ongoing). Vaccination history included: BNT162b2 (Dose 1, 0.3ml in muscle; Arm, probably asked for left arm because she is right handed), administration date: 04Feb2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "hair fell out, all of it"; NAUSEA (non-serious), outcome "unknown", described as "sick with nausea". Therapeutic measures were taken as a result of alopecia. Additional information: It took approximately for her, almost a year for hair to come back. Her hair obviously, still has not come back. Hair started falling out within a week of being ill with Covid. Each time, sickness lasted long, it was nonsense. She got really sick this time, does not even know if that was connected. She had trouble breathing, and was sick with nausea, things like that like. Treatment for hair loss included vitamins, biotin pills, well, they are capsules, not pills. Hair was still falling out. It has not gotten any better. It was still falling out because her husband reminds her, every time she is standing at sink.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400254182 same patient and drug, different dose and event;
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No symptoms reported; Per the medical assistant, a pediatric dose of VAQTA was administered to an adult on 05/15/2024; This spontaneous report was received from a medical assistant and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAY-2024, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, once, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided). No symptoms reported. No further information was reported.  Additional information is not expected.
Sex: F
Vaccine: HPV9
Symptoms: Device defective, Device leakage, No adverse event, Underdose, Wrong technique in product usage process
Clinical narrative: Patient was administered her HPV vaccine and half of the contents did not go in to her arm; The nurse who administered the vaccine stated that it was a defect with the product/exact defect observed? DURING ADMINISTRATION WHEN PUSHING THE PLUNGER, THE LIQUID LEAKED OUT OF THE LUER LOCK AREA WHERE THE NEEDLE ATTACHES TO THE SYRINGE.; LIQUID LEAKED OUT OF THE LUER LOCK AREA WHERE THE NEEDLE ATTACHES TO THE SYRINGE; No adverse event; This spontaneous report was received from a certified nurse practitioner and a consumer regarding her daughter (age not reported.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On an unknown date, while was a her yearly physical, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y003462, expiration date: 23-APR-2026, administered for prophylaxis (strength, and route of administration were not provided), the nurse shoved the needle into her arm so fast and hard, and she pushed down fast and hard; when pushing the plunger, the liquid leaked out of the luer lock area where the needle attaches to the syringe and half of the vaccine came out all over the table next to the patient (also reported as half of the vaccine content did not go into the patient's arm). It was noted that no cracks or broken components, no damages to the carton or syringen were noticed, no difficulty in pushing the plunger nor pressure was observed and there were no issues attaching the needle to the syringe before use.  The nurse who administered it stated that it was a defect with the product .  The consumer indicated that she need to understand what would be the next steps for the patient since she did not receive a full dose. No adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Injection site pain
Clinical narrative: mild injection site pain which she knew to expect; she felt faint; This spontaneous report has been received from a nurse referring to a currently 20-year-old female. The patient's medical history included Syncope. Concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, in the right deltoid, lot number W009893 which has been verified to be valid, expiration date reported as 31-SEP-2024 (conflicting information: date does not exist), but upon internal validation established as 30-SEP-2024 (strength, dose, scheme and route of administration were not provided).  On an unknown date, after vaccination, the patient had mild injection site pain which she knew to expect (Vaccination site pain). However, approximately 5 minutes after, she felt faint (Dizziness). The patient laid down, drank water, and reported she felt better after approximately 10 minutes. At the reporting time, the outcome of mild injection site pain was unknown.  Causality assessment between the suspect vaccine and the events was not provided.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Experienced a fever after receiving the second dose of GARDASIL 9; Feeling bad; This spontaneous report was received from a nurse via company representative referring to her daughter a 15-year-old female patient.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  In approximately 2016, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported).   In approximately 2016, the next day after she received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient experienced fever (Pyrexia), and she was feeling bad (Feeling abnormal). It was unknown if the patient sought medical attention, received any treatment, or if she had laboratory diagnostics or studies performed for these adverse events. Currently, at the time of the report in 2024, the patient was 23 years old and since then, recovered from the events.  The causal relationship between the events occurrence and the suspect vaccine was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: more than one year to get her second shingrix vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in January 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: more than one year to get her second shingrix vaccine). The outcome of the incomplete course of vaccination was not reported.   Additional Information: GSK Receipt Date: 04-SEP-2024 The physician reported that the patient got her 1st Shingrix and does she had to restart series since more than one year to get her second shingrix vaccine. No additional information available. Till the time of reporting the patient did not received the 2nd dose of Shingrix which led to incomplete course of vaccination.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Bexsero when she was 18 years old on February 22nd 2023, but patient received the second dose until August 30th 2024/late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose on 22-FEB-2023).   On 30-AUG-2024, the patient received the 2nd dose of Bexsero. On 30-AUG-2024, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: received the first dose of Bexsero when she was 18 years old on February 22nd 2023, but patient received the second dose until August 30th 2024/late second dose). The outcome of the drug dose administration interval too long 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: 04-SEP-2024 The pharmacist reported that a patient had received 1st dose of Bexsero vaccine on 22nd February 2023 but, the patient received 2nd dose of Bexsero vaccine until 30th August 2024. The patient received 2nd dose of Bexsero, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter mentioned that patient was considered high risk because she was sexually active. The reporter did not had initials of the patient or lot number or expiration date of the 2 Bexsero vaccines. The reporter consented to the follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Anal haemorrhage, Asthenia, Chills, Contusion, Disorientation
Clinical narrative: I took Acetominophen the night of the vaccination and again the following day. I woke up in the middle of the night, 36 hours after the vaccination, thinking I needed to have a bowel movement. Walking in the dark to the bathroom, I became dizzy, disoriented, and felt faint. I fell in the dark on the bathroom floor and a bloody flux came out of my anus: After I showered, I had brief chills, I continue to feel weak, experience general malaise, and suffered a bruise from the fall. I am adhering to a BRAT diet since the incident.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Malaise, Sleep disorder
Clinical narrative: I took Acetominophen the night of the vaccination and again the following day. I woke up in the middle of the night, 36 hours after the vaccination, thinking I needed to have a bowel movement. Walking in the dark to the bathroom, I became dizzy, disoriented, and felt faint. I fell in the dark on the bathroom floor and a bloody flux came out of my anus: After I showered, I had brief chills, I continue to feel weak, experience general malaise, and suffered a bruise from the fall. I am adhering to a BRAT diet since the incident.
Age: 35.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy
Clinical narrative: N/A - vaccine was given too early in pregnany was only 24w 3d
Age: 8.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient has not reported any symptoms. No additional AE; Medical Assistant calling to report inadvertently administering GARDASIL 9 to an 8-year-old patient. Caller stated patient has not reported any symptoms. Permission to contact HCP was granted. No additional information provided. No additional AE/PQC; This spontaneous report was received from a medical assistant concerning to an 8-year-old patient of unspecified gender.  The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.  On 26-AUG-2024, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #X024650, expiration date 31-MAY-2026 (exact dose, dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product administered to patient of inappropriate age.)  It was also informed that patient did not report any symptoms (no adverse event). No additional information was provided.
Age: 24.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AE/PQC reported; person, transferred Caller to Agency to report AE on behalf of a 24-year-old patient who was accidentally administered PROQUAD instead of MMR-II and VARIVAX separately on 8/2/2024 after identifying that the patient who is going to nursing school h; This spontaneous report was received from consumer referred to a 24-year-old patient. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported. However, it was reported that the patient was going to Nursing school and had no immunity to varicella, mumps, or rubella via titers.     On 02-AUG-2024, the patient was accidentally vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, lot #X011982, expiration date: 22-OCT-2024, Albumin status rHA (recombinant Human albumin), administered for prophylaxis (strength, frequency, scheme, dose number, route of administration and anatomical location were not provided), instead of a separated dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection plus varicella virus vaccine live (oka/merck) (VARIVAX) injection (wrong vaccine administered); no adverse event was reported.  Lot numbers of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection plus varicella virus vaccine live (oka/merck) (VARIVAX) injection is being requested and will be submitted if received.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; PROQUAD inadvertently administered to a 16-year-old; This spontaneous report was received from a nurse and refers to a 16-year-old patient of unknown gender. The reporter was unable to provide patient demographics.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 26-AUG-2024, the patient was inadvertently administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (exact dose, lot #, expiry date, and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). No side effects or symptoms were reported. No further information was reported. No additional adverse event (AE) and no product quality complaint (PQC) was noted (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: TE for GARDASIL 9; No symptoms reported; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender, who was currently 12 years old. The patient's medical history, concurrent conditions concomitant therapies and drug reactions/allergies were not reported.  On an unknown date, the vaccine hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1965046 has been verified to be a valid lot number, expiration date reported and also upon internal validation established as 22-JAN-2026) had temperature excursion of 8.6C for 10 minutes. There was no previous temperature excursion.     On an unknown date, the patient was vaccinated with above hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, for prophylaxis (strength, and route of administration were not provided) (product storage error). No symptoms were reported (no adverse event).  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2409USA004145: US-009507513-2409USA003916: US-009507513-2409USA003853: US-009507513-2409USA004156: US-009507513-2409USA004203:
Age: 1.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist called to ask if there was any safety information on administering ROTATEQ to a patient that is 16 months of age. Upon further probing, caller stated that a 16 month old patient was inadvertently administered ROTATEQ. No symptoms reported.; No additional AE; This spontaneous report was received from a Registered Pharmacist (R.Ph.) and refers to a 16-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.  On an unknown date, the patient was inadvertently vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, administered orally as prophylaxis (lot#, expiration date, strength, dose number, exact dose quantity volume, and vaccination scheme frequency were not provided) (product administered to patient of inappropriate age). Additionally, the reporter asked if there was any safety information on administering the previous mentioned vaccine to a patient of 16 months of age. No symptoms reported. No additional adverse event AE/PQC (no adverse event).  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 06-SEP-2024 This case was reported by a patient via interactive digital media. The reporter reported that his/her husband both had the vaccine a few years ago. The reporter mentioned that the patient was diagnosed with shingles and reported that the vaccine was not 100% effective. Hopefully had the vaccine will mean his shingles would not be too bad. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles.
Sex: U
Vaccine: RVX
Symptoms: Illness, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; but got it anyway; never been so sick; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: but got it anyway) and sickness (Verbatim: never been so sick). The outcome of the vaccination failure, respiratory syncytial virus infection and sickness were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection and sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 05-SEP-2024 The case was received from the patient via interactive digital media. The reporter reported that had the vaccine but got it anyway never been so sick. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: giving adult patients the pediatrics dose for the Engerix-B; giving adult patients the pediatrics dose for the Engerix-B; due the package insert advising it covers all ages.; This non-serious case was reported by a consumer via patient support programs and described the occurrence of underdose in a patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: giving adult patients the pediatrics dose for the Engerix-B), adult use of a child product (Verbatim: giving adult patients the pediatrics dose for the Engerix-B) and product package insert issue (Verbatim: due the package insert advising it covers all ages.). The outcome of the underdose and adult use of a child product were unknown and the outcome of the product package insert issue was not reported.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-SEP-2024 The other health professional reported that the provider's office had been giving adult patients the pediatrics dose for the Engerix-B Vaccine due the package insert advising it covers all ages which led to underdose, adult use of a child product and product package insert issue.  The other health professional did not wanted to complete the report.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Social problem
Clinical narrative: Its been 5 years since my first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: Its been 5 years since my first dose). The outcome of the social problem was not reported.   Additional Information: GSK Receipt Date: 03-SEP-2024 The patient reported it's been 5 years since first dose (covid intervened), which led social problem. The centers for disease control has provided guidance that if it has been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients did not need to restart the vaccine series However, the efficacy of alternative dosing regimens has not been evaluated.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache; muscle pain; fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's father) and neuropathic pain (patient's father).   On 28-AUG-2024, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headache), muscle pain (Verbatim: muscle pain) and fever (Verbatim: fever). The outcome of the headache, muscle pain and fever were not reported.   It was unknown if the reporter considered the headache, muscle pain and fever to be related to Shingles vaccine.     It was unknown if the company considered the headache, muscle pain and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-SEP-2024 The patient received 1st dose and the side effects were brutal including headache, muscle pain and fever among others, regardless the patient would not miss the second dose. The patient never been a cry baby until got the vaccine. It was worst that the covid 19.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Most horrible pain ever; This non-serious 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, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Most horrible pain ever). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date 4th Sep 2024: This case was reported by a consumer via interactive digital media.  The patient stated that it was most horrible pain ever and the patient had the shot too.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Muscle discomfort
Clinical narrative: muscular discomfort; discomfort in arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced muscle discomfort (Verbatim: muscular discomfort) and arm discomfort (Verbatim: discomfort in arm). The outcome of the muscle discomfort and arm discomfort were not reported.   It was unknown if the reporter considered the muscle discomfort and arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the muscle discomfort and arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-SEP-2024 The case was received from the patient via (social media) interactive digital media. The reporter had muscular discomfort in arm The reporter reported let's say it doesn't last forever like shingles does.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pharmacist wants to know what´s the advise to complete the schedule/give the second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose at two and a half years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Pharmacist wants to know what´s the advise to complete the schedule/give the second dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-SEP-2024 Pharmacist called to report a patient that was administered a first dose of Shingrix two and a half years ago.  Pharmacist wanted to know what was the advise to complete the schedule/give the second dose, which led to incomplete course of vaccination. The case is link with US2024109567, by same reporter.; Sender's Comments:  US-GSK-US2024109567:Same reporter
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: stored at 33.3F x 14.33 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number JT347, expiry date 30-SEP-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number 4799G, expiry date 12-OCT-2026) for prophylaxis.   On 15-AUG-2024, the patient received Menveo and Boostrix. On 15-AUG-2024, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: stored at 33.3F x 14.33 hours.). 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: 04-SEP-2024 The other health professional requested stability data Menveo and Boostrix stored at 33.3 Fahrenheit for 14.33 hours.  No prior excursions.  The other health professional reported that excursion started on 13th August 2024 and vaccine was used in patient since the excursion occurred which led to incorrect storage of drug. This was 1 of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024110235:Same reporter US-GSK-US2024110225:Same reporter US-GSK-US2024110224:SAME REPORTER US-GSK-US2024110237:SAME REPORTER
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: stored at 33.3F x 14.33 hours.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 42G27, expiry date 22-SEP-2026) for prophylaxis.   On 15-AUG-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: stored at 33.3F x 14.33 hours.). 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: 04-SEP-2024 The other health professional requested stability data Boostrix stored at 33.3 Fahrenheit for 14.33 hours.  No prior excursions.  The other health professional reported that excursion started on 13th August 2024 and vaccine was used in patient since the excursion occurred which led to incorrect storage of drug. This was 1 of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024110224:Same reporter US-GSK-US2024110235:Same reporter US-GSK-US2024110237:Same reporter US-GSK-US2024110258:Same reporter
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Product storage error
Clinical narrative: Excursion started on August 13, 2024 and multiple vaccines were used in greater than 10 pts since the excursion occurred.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-month-old male patient who received HAV (Havrix) (batch number TFQ7T, expiry date 05-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) (batch number 5H773, expiry date 13-JUL-2025) for prophylaxis.   On 16-AUG-2024, the patient received Havrix and Infanrix. On 16-AUG-2024, an unknown time after receiving Havrix and Infanrix, the patient experienced incorrect storage of drug (Verbatim: Excursion started on August 13, 2024 and multiple vaccines were used in greater than 10 pts since the excursion occurred.). 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: 04-SEP-2024 The health care professional (HCP) requested stability data for Menveo (1-vial), Havrix, Boostrix, Infanrix, Engerix-B stored at 33.3F x 14.33 hours, no prior excursions.  The excursion started on August 13, 2024 and multiple vaccines were used in greater than 10 pts since the excursion occurred., which led to incorrect storage of drug. Consented to follow up. This is 1 of 4 link cases.; Sender's Comments:  US-GSK-US2024110258:SAME REPORTER US-GSK-US2024110235:Same reporter US-GSK-US2024110225:Same reporter
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: stored at 33.3F x 14.33 hours; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number JT347, expiry date 30-SEP-2025) for prophylaxis.   On 16-AUG-2024, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: stored at 33.3F x 14.33 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 04-SEP-2024 The other health professional requested stability data Menveo (1-vial) stored at 33.3 Fahrenheit for 14.33 hours.  No prior excursions.  The other health professional reported that excursion started on 13th August 2024 and vaccine was used in patient since the excursion occurred which led to incorrect storage of drug. This was 1 of 5 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024110225:Same reporter US-GSK-US2024110224:Same reporter US-GSK-US2024110237:Same reporter US-GSK-US2024110258:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Inappropriate reconstitution technique; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2024, the patient received Shingrix. In AUG-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-SEP-2024 The nurse reported that the had an extra antigen vial of Shingrix, and so they believed that a patient must had been administered a dose of the liquid AS01B adjuvant alone, without reconstituting with the lyophilized antigen vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The extra vial was noted the morning of 15th August 2024.  They had narrowed down the date that the dose would had been given to between 9th August 2024 and 14th August 2024. The site was unsure which patient it was, they had it narrowed down to 11 possible patients.  The reporter did not had lot number information. The vaccine administration facility was the same as primary reporter.