chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast normal
Clinical narrative: Headache. Mild headache post vaccine for 2 days. Then post vaccine about 6-7 days severe headache lasting for over 30 days. Headaches now come and go multiple times per day but never quite go away.  Historically I have very rarely had headaches. My first Covid Vaccines were Pfizer and no reaction whatsoever. The Vaccine on June 15, 2023 was Moderna. OTC meds like aspirin, ibuprofen or tylenol do not help. No other symptoms.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain, Peripheral swelling, Pyrexia
Clinical narrative: swelling on arm, fever,body aches,diziness
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Syncope
Clinical narrative: patient waiting 15 minutes to see if no reactions with vaccines, after 5 minutes after administering vaccines, patient fainted in room, ambulance was called per Provider and patient was taken via ambulance to Hospital. Patient followed up in office today 07/19/2023  with our provider.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, HEPA, PNC15
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: When client woke up 7/18/2023 he R thigh hurt and had a penny size red, hard , warm spot. By this morning 7/19/2023 it was the size of a silver dolloar. Still hurting mother says she does not want anyone to touch her leg.  Mother states she will take her to doctor today and call back with what doctor tells her.  client did not call back, not sure if she di take her to the doctor.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Baseball size red area on right arm.  Hot to the touch.  Itching all started the day after the vaccine.   Cold compresses to arm, antihistamines, if does not decrease to return for an appointment.
Age: 1.25
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Irritability, No adverse event, Pyrexia, Wrong product administered
Clinical narrative: MMRV was given instead of MMR at the same time Varicella was given by mistake.   No adverse reaction noted at this time. Mother states Patient has been fussy with low grade fever. She has given tylenol and motrin as need.
Age: 1.25
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, Incorrect dose administered, No adverse event
Clinical narrative: No side effects; PROQUAD and VARIVAX were inadvertently administered at the same time to a patient; This spontaneous report was received from a nurse practitioner and refers to a 15-month-old female patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.  On 20-JUN-2023, the patient was inadvertently vaccinated at the same time with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status: recombinant Human albumin (rHA)) (PROQUAD) subcutaneous injection, at a dose of 0.5 ml, lot # W036939, expiration date 19-MAY-2024, subcutaneously and varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection, at a dose of 0.5 ml, subcutaneously, lot # W018837, expiration date reported as 14-MAR-2024, but upon internal validation it was established as 14-JUN-2024 both as routine immunization (accidental overdose). No side effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: HCP calling to report temperature excursion for VARIVAX after being administered to a patient. Temperature 28.9F, Time frame 13 hours 59 minutes 54 seconds; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 29-JUN-2023, the patient was vaccinated with an improper storage varicella virus vaccine live (oka/merck) (VARIVAX) injection, one dose, lot #X001000, expiration date reported as 09-JAN-2024, but upon internal validation established as 09-JAN-2025, for prophylaxis (route of administration and anatomical location were not provided). The vaccine had a temperature excursion at a temperature of 28.9 Fahrenheit (F) for a time frame of 13 hours, 59 minutes and 54 seconds. Temperature excursion assessment was supported.
Age: 0.17
Sex: F
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported with the administration of the vaccine.; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) and ROTATEQ (Lot #1968385; Expiration; This spontaneous report was received from an other health professional and referred to a 12-week-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-JUN-2023, the patient was vaccinated with improperly storage pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection through right thigh, strength: 0.5 milliliter, dose: 0.5 milliliter, lot #W039033, expiration date: 01-OCT-2024, administered once for prophylaxis (route of administration was not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered once orally for prophylaxis (strength was not provided). It was reported that a temperature excursion (TE) for pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) with current excursion (49.1F) for 34 minutes, with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (same excursion details) (Product storage error). No adverse side effects were reported with the administration of both vaccines. User of the device was an HCP and product was not available to obtain.  ; Sender's Comments:  US-009507513-2307USA004472:
Age: 0.5
Sex: F
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported with the administration of the vaccine.; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) and ROTATEQ (Lot #1968385; Expiration; This spontaneous report was received from an other health professional and referred to a 6-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2023, the patient was vaccinated with improperly storage pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection through right thigh, strength: 0.5 milliliter, dose: 0.5 milliliter, lot #W039033, expiration date: 01-OCT-2024, administered once for prophylaxis (route of administration was not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered once orally for prophylaxis (strength was not provided). It was reported that a temperature excursion (TE) for pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) with current excursion (49.1F) for 34 minutes, with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (same excursion details) (Product storage error). No adverse side effects were reported with the administration of both vaccines. User of the device was an HCP and product was not available to obtain. ; Sender's Comments:  US-009507513-2307USA004472:
Age: 0.5
Sex: M
Vaccine: PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse side effect; TE; This spontaneous report was received from a medical assistant referring to a 6-month-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 mL, administered for prophylaxis (lot #W039033, expiration date: 01-OCT-2024; strength and route of administration were not provided) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 mL, administered orally for prophylaxis (lot #1968385, expiration date: 22-MAY-2024; strength was not provided). Both vaccines had a current excursion at 49.1 F for 34 minutes, with two previous excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes (Product storage error). No adverse side effects were reported with the administration of the vaccines.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2307USA004472:
Age: 1.0
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) which was also administered to a patie; This spontaneous report has been received from a medical assistant referring to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 12-JUN-2023, the patient was vaccinated with improperly stored pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 milliliter (mL) injection (0.5mL, once, lot# W039033, expiry date 01-OCT-2024) via injection in left thigh for prophylaxis. It was reported that the suspect vaccine was underwent a current temperature excursion at 49.1 degree Fahrenheit (F) for 34 minutes. The suspect vaccine also underwent two previous temperature excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes (product storage error). User of the device was a health care professional (HCP) and product was not available to obtain. No adverse side effects were reported with the administration of the vaccine. No additional adverse event information and no product quality complaint (PQC) were provided.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2307USA004472:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP calling to report that a patient was administered a improperly stored vaccine.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, lot #W035460, expiration date: 06-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine were improperly stored before administration (Product storage error). No additional adverse event was reported.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Vaccination site mass, Vaccination site pain
Clinical narrative: he had some pain; her son noticed a lump under his skin where the vaccine had been administered; Vaccination site pain; This spontaneous report was received from the patient mother refers her son  a 13-year-old male patient.     The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-JUN-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.         On unknown day in July 2023, the patient experienced pain. It was reported that the patient had some pain initially with the vaccination, but that it went away (discrepant information, the patient status was reported as: not recovered). On unknown day in July 2023 (a few days ago), the patient experienced vaccination site pain and vaccination site mass. It was reported that the patient noticed a lump under his skin where the vaccine had been administered. The reporter stated that it was a decent sized lump and painful to the touch. The outcome of pain, vaccination site pain and vaccination site mass was reported as not recovered/not resolved.        The causality assessment was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Chest pain, Dyspnoea, Herpes zoster, Vaccination failure
Clinical narrative: can not breath; Jabbing pain in my back; Chest really hurt; Suspected vaccination failure; I got it about three weeks ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got it about three weeks ago). On an unknown date, the patient experienced difficulty breathing (Verbatim: can not breath), back pain (Verbatim: Jabbing pain in my back) and chest pain (Verbatim: Chest really hurt). The patient was treated with morphine. The outcome of the vaccination failure was unknown and the outcome of the shingles, difficulty breathing, back pain and chest pain were resolving.   It was unknown if the reporter considered the vaccination failure, shingles, difficulty breathing, back pain and chest pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, difficulty breathing, back pain and chest pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt date: 09-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she got it about three weeks ago, and he/she still have jabbing pain in his/her back, the pain is really intense, it's unbearable.  The patient states that he/she went to twice, they gave his/her morphine, and it did nothing for his/her. The patient states that his/her chest really hurt, and he/she couldn't breathe. Get the vaccine people, Even though he/she got two vaccines, it hit he/she really hard, thank goodness he/she had been slowly getting better since. Follow up was not possible, as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 12-Jul-2023 This case was reported the patient via interactive digital media. The patient received a pf or jab and now (at the time of reporting) the patient had shingles. The patient was really struggled with it. The reporter stated it was miserable, as awful jab injury. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Headache, Neuropathy peripheral
Clinical narrative: Neuropathy in his lower extremities and hands; Confusion; Intense headaches; This serious case was reported by a physician via sales rep and described the occurrence of neuropathy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced neuropathy (Verbatim: Neuropathy in his lower extremities and hands) (serious criteria GSK medically significant), confusion (Verbatim: Confusion) and headache (Verbatim: Intense headaches). The outcome of the neuropathy, confusion and headache were resolved (duration 24 hrs).   It was unknown if the reporter considered the neuropathy, confusion and headache to be related to Shingrix.     It was unknown if the company considered the neuropathy, confusion and headache to be related to Shingrix.   Additional Information: GSK receipt date: 17-JUL-2023 The patient, who is an Internal Medicine physician, received his first dose of Shingrix in mid-June 2023 and experienced more than the usual and expected adverse events including severe neuropathy in his lower extremities and hands which lasted for approximately 24 hours.  In addition, patient also experienced confusion where, for example, patient could not add 15 plus 2.  The patient also experienced intense headaches and confusion all over a 24 hour duration, when these symptoms resolved itself. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Housebound
Clinical narrative: Extreme weakness; Diarrhea has been house bound; This non-serious case was reported by a other health professional via patient support programs and described the occurrence of weakness in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included covid-19 (since December 2021). Concomitant products included amlodipine besilate.   On 17-MAR-2023, the patient received Shingrix. On 18-MAR-2023, 1 days after receiving Shingrix, the patient experienced weakness (Verbatim: Extreme weakness) and chronic diarrhea (Verbatim: Diarrhea has been house bound). The outcome of the weakness and chronic diarrhea were not resolved.   It was unknown if the reporter considered the weakness and chronic diarrhea to be related to Shingrix.     It was unknown if the company considered the weakness and chronic diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUL-2023 The reporter reported that the patient administered Shingrix vaccine and had extreme weakness and chronic diarrhea. The reporter thought intervention required of seriousness for extreme weakness and chronic diarrhea. The reporter reported that the patient took amlodipine besilate for hypertension. The reporter reported that patient also suffered from long Covid. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: First shot made me very ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced illness (Verbatim: First shot made me very ill). The outcome of the illness was not reported.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.     It was unknown if the company considered the illness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-Jul-2023 This case was reported the patient via interactive digital media. The patient had 1st shot and made the patient very ill. The patient was not able to get the second one. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Last year I had 3 shots of Shingrix - do I need another booster this year?; This non-serious case was reported by a consumer and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2022 the patient received 1st dose) and Shingrix (In 2022 the patient received 2nd dose).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Last year I had 3 shots of Shingrix - do I need another booster this year?). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 13-JUL-2023 The patient received three shots of Shingrix last year (2022). The patient wanted to know if he/she need another booster this year. The patient received 3rd shot of Shingrix which led to extra dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingrix.     It was unknown if the company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter reported that her husband experienced fever after received Shingrix vaccine. The reporter did not consent to follow up. This case had been linked with US2018GSK077003 by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2018GSK077003:same reporter wife case
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel lousy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-JUL-2023, the patient received the 2nd dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: feel lousy). The outcome of the feeling bad was not resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-JUL-2023 This case was reported by a patient via interactive digital media. The patient got 2nd vaccination the day before reporting and made the patient feel lousy. But the patient stated that he/she would be ok in few days. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: SICK; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: SICK). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 12-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she got sick from the shingles vaccine but he/she guess he/she won't get shingles. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient who received one dose of shingrix in the fall of 2021 but has not received 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received in fall of 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: a patient who received one dose of shingrix in the fall of 2021 but has not received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-JUL-2023 The patient had not received the second dose of Shingrix.  He wanted to know if he had to start the two dose series over again or if he only needs the second shot.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th April 2022).   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: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-Jul-2023 and 18-Jul-2023 The nurse stating that one of her residents (patient) did not receive his second Shingrix vaccination. The reporter asked that the guidance was for someone who did not receive a second dose of Shingrix or the series need to be restarted. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 49.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Expired product administered
Clinical narrative: received 2 pediatric doses to complete an adult dose; both vaccine administered were expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 49-year-old male patient who received HBV (Engerix B pediatric) (batch number LP724, expiry date 18-MAY-2023) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number LP724, expiry date 18-MAY-2023) for prophylaxis.   On 07-JUL-2023, the patient received the 2nd dose of Engerix B pediatric and the 1st dose of Engerix B pediatric. On 07-JUL-2023, an unknown time after receiving Engerix B pediatric and Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: received 2 pediatric doses to complete an adult dose) and expired vaccine used (Verbatim: both vaccine administered were expired). The outcome of the adult use of a child product and expired vaccine used were 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: 11-JUL-2023 It was reported that a patient received 2 pediatric doses of Engerix B to complete an adult dose but both were expired and wished to know how to proceed which led to adult use of a child product and expired vaccine used. The reporter did not wish to receive follow up and gave partial information about vaccine, event and patient.  The reporter did not consent to follow up. The vaccine administration facility is the same as primary reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Rash
Clinical narrative: painful twinge on left thigh; shingles; rash on his left buttock and left thigh; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included back pain, pain in thigh and spinal disorder (lesion on spinal column).   On 16-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 22-JUN-2023, 6 days after receiving Shingrix, the patient experienced shingles (Verbatim: shingles) and rash (Verbatim: rash on his left buttock and left thigh). On 23-JUN-2023, the patient experienced pain in thigh (Verbatim: painful twinge on left thigh). The patient was treated with valaciclovir hydrochloride (Valtrex), lidocaine (Lidocaine Patch) and calamine (nos) (Calamine Lotion). The outcome of the shingles and pain in thigh were not resolved and the outcome of the rash was resolving.   It was unknown if the reporter considered the shingles, rash and pain in thigh to be related to Shingrix.     It was unknown if the company considered the shingles, rash and pain in thigh to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUL-2023 The patient received his first dose of Shingrix and next day he had his usual physical therapy session for pre-existing back and thigh pain (due to a spinal lesion).  The patient noticed a rash on his left buttock. He had been outdoors the day before and thought the rash was due to bug bites. On 23 June 2023 he had a painful twinge on left thigh and noticed a rash there also. On 25 June 2023 he saw a physician at urgent care and the rash was diagnosed as shingles. He took Valtrex for 7 days and is using lidocaine patches and calamine lotion. The rash was fading, and the pain came and went.  Some days he had more pain than other days. He saw his primary physician on day of reporting and the shingles diagnosis was confirmed. Nothing else was reported. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient inadvertently received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 3N743, expiry date 20-AUG-2024) for prophylaxis.   Previously administered products included Shingrix (on 30th October 2020 received 1st dose.) and Shingrix (on 31th December 2020 received 2nd dose.).   On 13-JUL-2023, the patient received the 3rd dose of Shingrix (left deltoid). On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient inadvertently received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 13-JUL-2023 The pharmacist reported that a patient inadvertently received a third dose of Shingrix on 13 July 2023. The reporter states that the patient had 2 doses of vaccine before, did not remember at time of injection and received a 3rd dose which led to extra dose administered.  The reporter did not consent to follow up.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 18 year old patient administered an adult dose of Engerix B; 18 year old patient administered an adult dose of Engerix B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HBV (Engerix B) (batch number 79S54) for prophylaxis.   On 13-JUL-2023, the patient received Engerix B. On 13-JUL-2023, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: 18 year old patient administered an adult dose of Engerix B) and inappropriate age at vaccine administration (Verbatim: 18 year old patient administered an adult dose of Engerix B). The outcome of the overdose and inappropriate age at vaccine administration were 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: 13-JUL-2023 The pharmacy intern stated that an 18 year old patient was administered an adult dose of Engerix B which led to overdose and inappropriate age at vaccine administration. The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got the first dose of the vaccine but missed the second dose; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: got the first dose of the vaccine but missed the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-JUL-2023 The reporter enquired that if you got the first dose of the vaccine but missed the second dose (window of 2 to 6 months), do you had to repeat the series? MI did not spoke with the Health Care Provider, so please follow up with the Sales Representative for more information.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 73.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix was administered on march 18, 2020; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 73-year-old female patient who received HAB (Twinrix) (batch number LG325, expiry date 15-MAR-2020) for prophylaxis.   On 18-MAR-2020, the patient received Twinrix. On 18-MAR-2020, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix was administered on march 18, 2020). 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: 13-JUL-2023 The reporter did not reported any reaction. The patient received a Twinrix which was already expired, which led to expired vaccine used. The reporter did consent to follow up via email
Sex: M
Vaccine: HEP, HEP, HEP, HEP, HEP, HEP
Symptoms: Blood test normal, Hepatitis B surface antibody negative, Therapy non-responder
Clinical narrative: negative immunity and later in 2013 patient had a titer that came back negative; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 36-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 1st dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 3rd dose of Hepatitis B vaccine, the 4th dose of Hepatitis B vaccine, the 5th dose of Hepatitis B vaccine and the 6th dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: negative immunity and later in 2013 patient had a titer that came back negative). The outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 17-Jul-2023 The medical assistant reported that a patient who was an emergency medical services had 2 full series of Hepatitis B vaccination over several years, 1st series was as baby series then the 2nd series around 7th grade after testing showed negative immunity and later in 2013 patient had a titer that came back negative and bloodwork came back negative again, no immunity to it. The reporter was calling and asking how to proceed and their office currently stocks Engerix-B that's why they were calling GlaxoSmithKline. The reporter did not know the brand name or manufacturer of the Hepatitis vaccines that the patient received. Another adverse event would be reported for other similar situations. The reporter consented to follow-up. The case was linked with case US2023098117, reported by same reporter for different patients. The patient received 2 full series of Hepatitis B and had negative immunity, which led to therapy non-responder.; Sender's Comments:  US-GSK-US2023098117:Same reporter
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Injection site erythema, Product administered at inappropriate site
Clinical narrative: 4X4 sized red area; Wrong Route of Administration/ given SQ instead of IM; Vaccine Administered at Inappropriate Site/vaccine was administered lower than the deltoid area; This non-serious case was reported by a nurse via call center representative and described the occurrence of erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (On 12th June 2021). Previously administered products included Shingles vaccine (In 2016 received shingles vaccine).   On 04-FEB-2023, the patient received the 1st dose of Shingrix (subcutaneous, left arm). On 04-FEB-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong Route of Administration/ given SQ instead of IM) and vaccine administered at inappropriate site (Verbatim: Vaccine Administered at Inappropriate Site/vaccine was administered lower than the deltoid area). On an unknown date, the patient experienced erythema (Verbatim: 4X4 sized red area). The outcome of the erythema was resolved and the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the erythema to be related to Shingrix.   It was unknown if the company considered the erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JUL-2023 The case was reported by the patient. The reporter reported that she received Shingrix and she believed that a pharmacy technician might had administered her vaccine and because the patient was a nurse herself, she thought that the vaccine was administered lower than the deltoid area (Vaccine administered at inappropriate site) and probably given SQ instead of IM (Wrong route of administration).  The patient also reported that a couple of days after the injection (no specific date provided), she had a 4X4 sized red area below the injection site that lasted a week to ten days.  The patient also reported that she received another shingles vaccine (unknown vaccine) prior to Shingrix in 2016.  The patient also reported that she had shingles (preexisting Shingrix). The patient did have photos of the red area adverse event and could send them, if needed. The reporter consented to follow up. The patient thought that the vaccine was administered lower than the deltoid area and probably given SQ instead of IM, which led to Intramuscular formulation administered by other route and vaccine administered at inappropriate site.
Sex: F
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: she developed COVID; This non-serious case was reported by a consumer via call center representative and described the occurrence of covid-19 in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced covid-19 (Verbatim: she developed COVID). The outcome of the covid-19 was resolved.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     It was unknown if the company considered the covid-19 to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR099052   Additional Information: GSK Receipt Date: 17-JUL-2023 The reporter was the patient.  The patient received her first Shingrix dose about 2 years ago. The patient didn't receive the second dose within six months because she didn't know she needed a second dose and because she developed COVID. The reporter consented to follow up. This case had been linked with US2023AMR099052 due to same patient and reporter.; Sender's Comments:  US-GSK-US2023AMR099052:Same reporter, different dose
Sex: M
Vaccine: FLUX
Symptoms: Disability, Wheelchair user
Clinical narrative: now wheelchair bound for life; This serious case was reported by a other health professional via interactive digital media and described the occurrence of wheelchair user in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced wheelchair user (Verbatim: now wheelchair bound for life) (serious criteria disability). The outcome of the wheelchair user was not resolved.   It was unknown if the reporter considered the wheelchair user to be related to Flu vaccine.     It was unknown if the company considered the wheelchair user to be related to Flu vaccine.   Additional Information: GSK Receipt Date: 12-JUL-2023 The case was reported by patient's wife via interactive digital media. The reporter stated the patient was now wheelchair bound for life, compliments of a mere Flu vaccine in 2009.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    Patient was over 18 years of age. No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 27 Jun 2023, 2 doses were administered at administration site 1. No treatment medication reported.   This case was for the 4th patient out of 47 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case (Patient 01)
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Swelling and soreness of infraricular lymphnode; Moderate soreness at injection site; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (Swelling and soreness of infraricular lymphnode) and VACCINATION SITE PAIN (Moderate soreness at injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 immunization.     Previously administered products included for COVID-19 immunisation: pfizer COVID-19 VACCINE (Dose 1, Batch no: EL9262) on 28-Jan-2021, pfizer COVID-19 VACCINE (Dose 1, Batch no: EL9262) on 28-Jan-2021, pfizer COVID-19 VACCINE (Dose 2, Batch no: EN6200) on 17-Feb-2021, pfizer COVID-19 VACCINE (Dose 2, Batch no: EN6200) on 17-Feb-2021, pfizer COVID-19 VACCINE (Dose 3, Batch no: FC3181) on 21-Aug-2021, pfizer COVID-19 VACCINE (Dose 3 and Batch no: FC3181) on 21-Aug-2021. Past adverse reactions to the above products included Painful lymphadenopathy with pfizer COVID-19 VACCINE, pfizer COVID-19 VACCINE and pfizer COVID-19 VACCINE; and Vaccination site pain with pfizer COVID-19 VACCINE, pfizer COVID-19 VACCINE and pfizer COVID-19 VACCINE.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced LYMPHADENOPATHY (Swelling and soreness of infraricular lymphnode) and VACCINATION SITE PAIN (Moderate soreness at injection site). At the time of the report, LYMPHADENOPATHY (Swelling and soreness of infraricular lymphnode) and VACCINATION SITE PAIN (Moderate soreness at injection site) outcome was unknown.            No concomitant medication was reported. On 09-Sep-2022, Merck vaccine (Dose 5 and Batch no: GH9694) was administered. On 22-Apr-2023, Pfizer COVID-19 VACCINE BIVALENT (Dose 6 and Batch no: GL0087) was administered. It was reported that the product was prescribed by a healthcare professional.  Patient experienced Moderate soreness at injection site, Swelling and soreness of infraricular lymph node with each COVID-19 vaccine. After 24hrs of last injection patient had low grade fever(101 degree), Joint aching which resolved with out treatment. Patient tested with covid positive on 17-May-2023. Treatment with Paxlovid. Patient experienced fever, lethargy, aching for 24hrs  then symptoms resolved. Negative test of COVID on 22-May-2023.