chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU4, FLUA4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain in arm when turning arm in one certain inward direction; This spontaneous case retrieved on 09-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2488238-1), reported by other healthcare professional and concerned a 65-year-old, male patient.  The patient's medical history included high blood pressure, and gastrooesophageal reflux disease (reported as GERD). The patient's concurred medication included bystolic (nebivolol hydrochloride), Telmisartan (reported as telmisarten), esomeprazole, and atorvastatin, all used for unreported indication.  On 10-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (Influenza vaccine inact split 4v, dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), and indication: not reported). The batch number reported was 346346. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On 11-Oct-2022, one day after receiving Fluad Quadrivalent. The patient experienced pain in arm when turning arm in one certain inward direction.  At the time of initial reporting, the patient had not recovered from the event of 'pain in arm'. It was reported that two weeks after injection, it was still hurting.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: The event of pain in arm is considered as possible related to Fluad Quadrivalent due to temporal relationship.; Sender's Comments: The event of pain in arm is considered as possible related to Fluad Quadrivalent due to temporal relationship.
Age: 26.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Chest discomfort, Pharyngeal swelling, Pruritus, Swollen tongue, Vomiting
Clinical narrative: *****NOTE this is COVID19 BOOSTER - not option above 26 yo F with depression and insomnia was at clinic visit when offered Covid19 G (Pfizer product). Patient had previously tolerated 3 vaccinations with Covid19 Moderna vaccine.  Pfizer product Lot # GH9702 Bivalent Covid vaccine was given in right deltoid at 0839 11/3 by the CMA.  Approximately 5 minutes later, patient began feeling hot, tightness in chest, swelling of the throat and tongue, itchiness from hives, and vomiting. Patient has allergy history that includes tree nuts, cherry, peas, cetirizine, and clindamycin.  Patient also takes Allegra (fexfenadine)180mg po daily and has an Epipen.  Per chart, epinephrine IM injection was given while in clinic. Called EMS ~0858.  On arrival, patient's hives were dissipated but patient was still reporting tightness in chest and was vomiting. IV access obtained.  As EMS was about to push IV diphenhydramine 50mg (~0919), pt had a rapid onset on SOB, throat swelling, and chest tightness. Pt became tachycardic and struggling to breathe. IM EPI was given at 0921.  Famotidine 20mg IV given at 0926.  Methyllpred 125mg IV given at 0945.  Pt returned to baseline. Pt reports her allergic reactions are rapid onset
Age: 26.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Chest discomfort, Dyspnoea, Feeling hot, Hypersensitivity, Pharyngeal swelling
Clinical narrative: *****NOTE this is COVID19 BOOSTER - not option above 26 yo F with depression and insomnia was at clinic visit when offered Covid19 G (Pfizer product). Patient had previously tolerated 3 vaccinations with Covid19 Moderna vaccine.  Pfizer product Lot # GH9702 Bivalent Covid vaccine was given in right deltoid at 0839 11/3 by the CMA.  Approximately 5 minutes later, patient began feeling hot, tightness in chest, swelling of the throat and tongue, itchiness from hives, and vomiting. Patient has allergy history that includes tree nuts, cherry, peas, cetirizine, and clindamycin.  Patient also takes Allegra (fexfenadine)180mg po daily and has an Epipen.  Per chart, epinephrine IM injection was given while in clinic. Called EMS ~0858.  On arrival, patient's hives were dissipated but patient was still reporting tightness in chest and was vomiting. IV access obtained.  As EMS was about to push IV diphenhydramine 50mg (~0919), pt had a rapid onset on SOB, throat swelling, and chest tightness. Pt became tachycardic and struggling to breathe. IM EPI was given at 0921.  Famotidine 20mg IV given at 0926.  Methyllpred 125mg IV given at 0945.  Pt returned to baseline. Pt reports her allergic reactions are rapid onset
Age: 26.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Pruritus, Swollen tongue, Tachycardia, Urticaria, Vomiting
Clinical narrative: *****NOTE this is COVID19 BOOSTER - not option above 26 yo F with depression and insomnia was at clinic visit when offered Covid19 G (Pfizer product). Patient had previously tolerated 3 vaccinations with Covid19 Moderna vaccine.  Pfizer product Lot # GH9702 Bivalent Covid vaccine was given in right deltoid at 0839 11/3 by the CMA.  Approximately 5 minutes later, patient began feeling hot, tightness in chest, swelling of the throat and tongue, itchiness from hives, and vomiting. Patient has allergy history that includes tree nuts, cherry, peas, cetirizine, and clindamycin.  Patient also takes Allegra (fexfenadine)180mg po daily and has an Epipen.  Per chart, epinephrine IM injection was given while in clinic. Called EMS ~0858.  On arrival, patient's hives were dissipated but patient was still reporting tightness in chest and was vomiting. IV access obtained.  As EMS was about to push IV diphenhydramine 50mg (~0919), pt had a rapid onset on SOB, throat swelling, and chest tightness. Pt became tachycardic and struggling to breathe. IM EPI was given at 0921.  Famotidine 20mg IV given at 0926.  Methyllpred 125mg IV given at 0945.  Pt returned to baseline. Pt reports her allergic reactions are rapid onset
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Death, Renal cell carcinoma
Clinical narrative: Antibiotics were continued per recommendations 10/27 1 PRBC transfused, pt declined COVID vaccine 10/28 increased swelling and erythema proximal LLE and suprapubic area, no fever, vanc added for possible superimposed cellulitis 10/31 f/u appt, not a candidate for further cancer treatment, hospice recommended 11/3 1 PRBC   Overall patient continued to worsen with respect to mental status. His CT last week was most c/w progressive CNS metastatic disease. He was not eating much at all and became unable to take PO medications now. He was clear with NP last week that he did not want a feeding tube. Hospice care was offered but his wife was not ready yet.   He died peacefully 11/14/22, his 41st wedding anniversary. I spoke with the wife this afternoon. She expressed gratitude for the care he received throughout this illness. Cause of death: Renal cell carcinoma Other contributing factors: Left hip, gluteal, and thigh abscesses and osteomyelitis Severe protein calorie malnutrition
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abscess limb, Blood albumin decreased, Blood creatine phosphokinase decreased, Blood creatinine increased, Blood gases
Clinical narrative: Antibiotics were continued per recommendations 10/27 1 PRBC transfused, pt declined COVID vaccine 10/28 increased swelling and erythema proximal LLE and suprapubic area, no fever, vanc added for possible superimposed cellulitis 10/31 f/u appt, not a candidate for further cancer treatment, hospice recommended 11/3 1 PRBC   Overall patient continued to worsen with respect to mental status. His CT last week was most c/w progressive CNS metastatic disease. He was not eating much at all and became unable to take PO medications now. He was clear with NP last week that he did not want a feeding tube. Hospice care was offered but his wife was not ready yet.   He died peacefully 11/14/22, his 41st wedding anniversary. I spoke with the wife this afternoon. She expressed gratitude for the care he received throughout this illness. Cause of death: Renal cell carcinoma Other contributing factors: Left hip, gluteal, and thigh abscesses and osteomyelitis Severe protein calorie malnutrition
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid, Blood potassium decreased, Blood potassium increased, Blood sodium increased, Blood urea increased
Clinical narrative: Antibiotics were continued per recommendations 10/27 1 PRBC transfused, pt declined COVID vaccine 10/28 increased swelling and erythema proximal LLE and suprapubic area, no fever, vanc added for possible superimposed cellulitis 10/31 f/u appt, not a candidate for further cancer treatment, hospice recommended 11/3 1 PRBC   Overall patient continued to worsen with respect to mental status. His CT last week was most c/w progressive CNS metastatic disease. He was not eating much at all and became unable to take PO medications now. He was clear with NP last week that he did not want a feeding tube. Hospice care was offered but his wife was not ready yet.   He died peacefully 11/14/22, his 41st wedding anniversary. I spoke with the wife this afternoon. She expressed gratitude for the care he received throughout this illness. Cause of death: Renal cell carcinoma Other contributing factors: Left hip, gluteal, and thigh abscesses and osteomyelitis Severe protein calorie malnutrition
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carbon dioxide decreased, Computerised tomogram abnormal, Death, Eating disorder, Erythema
Clinical narrative: Antibiotics were continued per recommendations 10/27 1 PRBC transfused, pt declined COVID vaccine 10/28 increased swelling and erythema proximal LLE and suprapubic area, no fever, vanc added for possible superimposed cellulitis 10/31 f/u appt, not a candidate for further cancer treatment, hospice recommended 11/3 1 PRBC   Overall patient continued to worsen with respect to mental status. His CT last week was most c/w progressive CNS metastatic disease. He was not eating much at all and became unable to take PO medications now. He was clear with NP last week that he did not want a feeding tube. Hospice care was offered but his wife was not ready yet.   He died peacefully 11/14/22, his 41st wedding anniversary. I spoke with the wife this afternoon. She expressed gratitude for the care he received throughout this illness. Cause of death: Renal cell carcinoma Other contributing factors: Left hip, gluteal, and thigh abscesses and osteomyelitis Severe protein calorie malnutrition
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Glycosylated haemoglobin normal, Haemoglobin decreased, Liver function test normal, Malnutrition, Mental status changes
Clinical narrative: Antibiotics were continued per recommendations 10/27 1 PRBC transfused, pt declined COVID vaccine 10/28 increased swelling and erythema proximal LLE and suprapubic area, no fever, vanc added for possible superimposed cellulitis 10/31 f/u appt, not a candidate for further cancer treatment, hospice recommended 11/3 1 PRBC   Overall patient continued to worsen with respect to mental status. His CT last week was most c/w progressive CNS metastatic disease. He was not eating much at all and became unable to take PO medications now. He was clear with NP last week that he did not want a feeding tube. Hospice care was offered but his wife was not ready yet.   He died peacefully 11/14/22, his 41st wedding anniversary. I spoke with the wife this afternoon. She expressed gratitude for the care he received throughout this illness. Cause of death: Renal cell carcinoma Other contributing factors: Left hip, gluteal, and thigh abscesses and osteomyelitis Severe protein calorie malnutrition
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Metastases to central nervous system, Osteomyelitis, Peripheral swelling, Platelet count increased, Red blood cell transfusion
Clinical narrative: Antibiotics were continued per recommendations 10/27 1 PRBC transfused, pt declined COVID vaccine 10/28 increased swelling and erythema proximal LLE and suprapubic area, no fever, vanc added for possible superimposed cellulitis 10/31 f/u appt, not a candidate for further cancer treatment, hospice recommended 11/3 1 PRBC   Overall patient continued to worsen with respect to mental status. His CT last week was most c/w progressive CNS metastatic disease. He was not eating much at all and became unable to take PO medications now. He was clear with NP last week that he did not want a feeding tube. Hospice care was offered but his wife was not ready yet.   He died peacefully 11/14/22, his 41st wedding anniversary. I spoke with the wife this afternoon. She expressed gratitude for the care he received throughout this illness. Cause of death: Renal cell carcinoma Other contributing factors: Left hip, gluteal, and thigh abscesses and osteomyelitis Severe protein calorie malnutrition
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Renal cell carcinoma, Swelling, White blood cell count decreased, White blood cell count increased
Clinical narrative: Antibiotics were continued per recommendations 10/27 1 PRBC transfused, pt declined COVID vaccine 10/28 increased swelling and erythema proximal LLE and suprapubic area, no fever, vanc added for possible superimposed cellulitis 10/31 f/u appt, not a candidate for further cancer treatment, hospice recommended 11/3 1 PRBC   Overall patient continued to worsen with respect to mental status. His CT last week was most c/w progressive CNS metastatic disease. He was not eating much at all and became unable to take PO medications now. He was clear with NP last week that he did not want a feeding tube. Hospice care was offered but his wife was not ready yet.   He died peacefully 11/14/22, his 41st wedding anniversary. I spoke with the wife this afternoon. She expressed gratitude for the care he received throughout this illness. Cause of death: Renal cell carcinoma Other contributing factors: Left hip, gluteal, and thigh abscesses and osteomyelitis Severe protein calorie malnutrition
Age: 20.0
Sex: F
Vaccine: VARCEL, COVID19, FLUX, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: nausea; vomiting; Dose of VARIVAX was accidently given to a pregnant woman at 11 weeks gestation. She was taking unspecified prenatal vitamins prior to administration and was prescribed the following the day of her appointment: ASPIRIN 81 MG, GINGER 500 MG, ONDANSETRO; VARIVAX was accidently given to a pregnant woman; This spontaneous prospective pregnancy report was received from a nurse practitioner, regarding a 20-years-old female patient. The patient's pertinent medical history included tachycardia as current condition. The patient's previous drug reactions or allergies were not reported. Concomitant medication included prenatal vitamins (not specified).  On 17-OCT-2022, at 11 weeks of gestation(last menstrual period was not reported, approximately on 01-AUG-2022), the patient was accidentally vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 milliliters subcutaneously as prophylaxis (lot number: U025205, which was determined to be valid, with an expiration date on 13-AUG-2023) (scheme and anatomical location of administration was not reported) (exposure during pregnancy) (Contraindicated product administered).  On an unspecified date, the patient was also vaccinated with a flue vaccine (not specified, manufacturer unknown) and a Covid-19 vaccine (not specified, manufacturer unknown) (strengths, doses, schemes, routes and anatomical locations of administration, lot numbers and expiration dates were not reported).  On 17-OCT-2022 (reported as after vaccination), the patient experienced nausea and vomiting. The outcome of the events was not reported.  The pregnancy outcome was not reported at the time of the report therefore, the fetal outcome was unknown. No additional adverse event was reported.  The patient was prescribed on the day of her appointment acetylsalicylic acid (ASPIRIN), ginger, ondansetron, pyridoxine and doxylamine, but by the time of the report it was unclear if she started these medications.  The causal relationship between nausea and vomiting and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Age: 20.0
Sex: F
Vaccine: VARCEL, COVID19, FLUX, VARCEL
Symptoms: Contraindicated product administered, Exposure during pregnancy, Nausea, Vomiting
Clinical narrative: nausea; vomiting; Dose of VARIVAX was accidently given to a pregnant woman at 11 weeks gestation. She was taking unspecified prenatal vitamins prior to administration and was prescribed the following the day of her appointment: ASPIRIN 81 MG, GINGER 500 MG, ONDANSETRO; VARIVAX was accidently given to a pregnant woman; This spontaneous prospective pregnancy report was received from a nurse practitioner, regarding a 20-years-old female patient. The patient's pertinent medical history included tachycardia as current condition. The patient's previous drug reactions or allergies were not reported. Concomitant medication included prenatal vitamins (not specified).  On 17-OCT-2022, at 11 weeks of gestation(last menstrual period was not reported, approximately on 01-AUG-2022), the patient was accidentally vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 0.5 milliliters subcutaneously as prophylaxis (lot number: U025205, which was determined to be valid, with an expiration date on 13-AUG-2023) (scheme and anatomical location of administration was not reported) (exposure during pregnancy) (Contraindicated product administered).  On an unspecified date, the patient was also vaccinated with a flue vaccine (not specified, manufacturer unknown) and a Covid-19 vaccine (not specified, manufacturer unknown) (strengths, doses, schemes, routes and anatomical locations of administration, lot numbers and expiration dates were not reported).  On 17-OCT-2022 (reported as after vaccination), the patient experienced nausea and vomiting. The outcome of the events was not reported.  The pregnancy outcome was not reported at the time of the report therefore, the fetal outcome was unknown. No additional adverse event was reported.  The patient was prescribed on the day of her appointment acetylsalicylic acid (ASPIRIN), ginger, ondansetron, pyridoxine and doxylamine, but by the time of the report it was unclear if she started these medications.  The causal relationship between nausea and vomiting and varicella virus vaccine live (Oka/Merck) (VARIVAX) was not provided.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error, Wrong technique in product usage process
Clinical narrative: No additional AE information provided; product was not stored at 36F-46F after reconstitution and was held in the HCP's hand for up to 65 minutes before being administered to the patient; VARIVAX was administered to a patient approximately sixty-five minutes after product was reconstituted; This spontaneous report has been received from a registered nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 14-OCT-2022, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number: W017551, which was determined to be valid, with an expiration date on 01-JUN-2024) and an improperly storage dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (albumin status rHA) Subcutaneous Injection (lot number: W009106, which was determined to be valid, with an expiration date on 04-DEC-2023), both as prophylaxis (strengths, doses, schemes, routes and anatomical locations of administration were not reported).  The reporter stated that the dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to the patient approximately sixty-five minutes after product was reconstituted (Wrong technique in product usage process). And the administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not stored at 36 to 46 degrees Fahrenheit (F) after reconstitution and was held in the HCP's hand for up to 65 minutes before being administered to the patient (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; ROTATEQ was administered to a patient after temperature excursions; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 26-SEP-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally for prophylaxis. Lot # was reported as W002561 which was valid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ), expiration date 07-OCT-2023 (exact dose, dose # and anatomical location was not provided). The reporter stated that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient after temperature excursions (product storage error). Temperature and time frame were reported as: 1 hour at 9.13 Celsius (C); 37 hours and 15 minutes at minimum of -8.45C. There was no previous temperature excursion. No additional adverse event information provided.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: a titer showing that the patient does not have antibodies; This spontaneous report was received from a pharmacist and refers to a 42-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On unknown dates in 2012, the patient was administered two doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, for prophylaxis (exact dose, route of administration, injection site, lot # and expiration date were not provided).  On an unknown date, a titer showed that the patient did not have antibodies (antibody test negative). Due to the event, the patient's doctor would like for him to receive another dose of varicella virus vaccine live (oka/merck) (VARIVAX). It was unknown if the patient was treated for the event. At the time of the report, the outcome of the event was unknown.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided by the reporter.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong technique in device usage process
Clinical narrative: No additional AE reported; Patient who was 180 pounds was administered, on 10/24/2022, GARDASIL 9 via GARDASIL 9 Prefilled Syringe with '5/8 inch' Needle Attached instead of '1 inch' Needle Attached.; This spontaneous report was received from a nurse practitioner regarding a 13-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 24-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #U031051, expiration date: 14-JUN-2024, (strength, dosage regimen, anatomical location, and route of administration were not provided) administered as prophylaxis. it was reported that the patient with 180 pounds was vaccinated with "5/8 inch" needle attached instead of "1 inch" needle attached (Wrong technique in device usage process). No adverse events were reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No other AE; The caller said the patient had a titer drawn (date unknown) and she needed a dose of MMRII, but the patient inadvertently received PROQUAD; 37-year-old patient; This spontaneous report was received from the Medical Assistant, and refers to a 37-year-old female patient.  Her medical history, concurrent conditions, and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant Human albumin, subcutaneous injection, 0.5 milliliter, lot #u039255, expiration date: 09-JUN-2023, administered for viral titre decreased (strength, and route of administration were not provided); inadvertently, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product administered to patient of inappropriate age, wrong product administered). No other adverse event occurred.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Caller is an HCP reporting an expired dose of VARIVAX (Lot: T025947, Expiration Date: 30JUL2022) was accidently administered to a patient. No additional clarifying statements or details were provided. See additional related AE case 02287159. No PQC.; This spontaneous report was received from a licensed practical nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day in August 2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX), at a dose of 0.5 milliliter (ml) (strength, anatomical site of vaccination and route of administration were not reported; lot number T025947, expiration date was reported and validated as 30-JUL-2022) as prophylaxis (expired product administered).
Sex: F
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The second dose of Jynneos administered on day 14; Case reference number US-BN-2022-002329 is a spontaneous case report initially received on 09-Sep-2022 from a nurse via agency (reference number: USBAV22-1342) and concerns a 33-year-old female patient.  The patient's current medical condition included HIV.  The patient's concomitant medication details were not provided.  On 26-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00003), at a dose 0.5 mL, administered subcutaneously, for monkeypox prophylaxis.   On 09-Sep-2022, 14 days after the first dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number: FDP00003) at dose 0.5 mL, administered subcutaneously (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received from Bavarian Nordic on 09-Sep-2022 included the local BN case ID.; Reporter's Comments: A 33-year-old female patient was vaccinated with the second dose of Jynneos vaccine, administered subcutaneously, 14 days after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's current medical condition included HIV and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 33-year-old female patient was vaccinated with the second dose of Jynneos vaccine, administered subcutaneously, 14 days after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Jynneos vaccine. The patient's current medical condition included HIV and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered Heplisav-B Two Days Past the Expiry Date; Initial Report Received on 09-SEP-2022  This is a spontaneous report received from an immunization program specialist regarding a 37-year-old patient who received HEPLISAV-B for hepatitis B immunisation.   Medical history and concomitant medications were reported as unknown.   On 19-Sep-2022, of the first dose of HEPLISAV B (Lot # 935841, expiration date 17-Sep-2022, NDC # not reported), route and site not specified, was administered for hepatitis B immunization.   It was reported that the dose was administered two days past the expiration date. The patient has not reported any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Received An Expired Dose of Heplisav-B; Initial Report Received on 23-Sep-2022  This is a spontaneous report, received from a pharmacist regarding a 32-year-old- female, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 23-Sep-2022, a dose of HEPLISAV B (Lot #934976, expiration date 30-JUL-2022, NDC #43528-003-05, S/N 520194073663), route not specified, was administered intramuscularly in the left deltoid for hepatitis B immunisation.   On 23-Sep-2022, the patient received an expired dose of HEPLISAV-B. The pharmacist was not certain if the injection was the patient's 1st or 2nd dose of the series. To the pharmacist's knowledge, the patient did not experience any adverse side effects, and the patient was going to be notified regarding the receipt of an expired dose.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received an Expired Dose of Heplisav-B; Initial Report Received on 29-SEP-2022  This is a spontaneous report, received from a patient care service regarding a female patient, aged 21 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient. The patient had no known drug allergies.   Concomitant medications were not reported.  On 27-Sep-2022, a dose of HEPLISAV B (Lot #93584, expiration date 17-SEP-2022, NDC #43528-003-05), route not specified, was administered in the right deltoid for hepatitis B immunisation.   The dose was reported as being 10 days past the expiration date. The patient did not report any adverse reactions.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient Received 1st Dose of Heplisav-B , and 2nd Dose 5 months Later; Initial Report Received on 10-OCT-2022   This is a spontaneous report received from a pharmacist regarding a patient who received HEPLISAV-B for hepatitis B immunisation.    There was no medical history reported for the patient.    Concomitant medications were not reported.   On 20-APR-2022, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # not reported), was administered for hepatitis B immunisation.     On 08-SEP-2022, 142 days after having been vaccinated with HEPLISAV B, the patient received her second dose of HEPLISAV B.   The outcome of the adverse event was not reported.   No further information was available at the time of the report.   Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness, Fall, Headache
Clinical narrative: passed out; Hit his nose, got a bleeding and open wound; chills; weakness; dizziness; started to fall again.; headache; myalgia,; swollen calf; hit the bridge of this nose; This case was reported by a consumer and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), wound bleeding (serious criteria GSK medically significant), chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury. On an unknown date, the outcome of the passed out, wound bleeding, chills, weakness, dizziness, fall and nose injury were unknown and the outcome of the headache, myalgia and calf swelling were recovered/resolved.   It was unknown if the reporter considered the passed out, wound bleeding, chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter stated that, night after the Shingrix shot, the patient had chills, weakness and dizziness. The patient got up to use restroom and passed out on the way. The patient had hit the bridge of this nose on furniture but unsure exactly how it happened. The patient proceeded to bathroom sink and started to fall again. The patient had bleeding and open wound on bridge of nose. The patient went onto had headache myalgia and swollen calf for a few more days. The reporter agreed to follow up from GlaxoSmithKline.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of consciousness, Myalgia, Nasal injury, Peripheral swelling, Wound
Clinical narrative: passed out; Hit his nose, got a bleeding and open wound; chills; weakness; dizziness; started to fall again.; headache; myalgia,; swollen calf; hit the bridge of this nose; This case was reported by a consumer and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), wound bleeding (serious criteria GSK medically significant), chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury. On an unknown date, the outcome of the passed out, wound bleeding, chills, weakness, dizziness, fall and nose injury were unknown and the outcome of the headache, myalgia and calf swelling were recovered/resolved.   It was unknown if the reporter considered the passed out, wound bleeding, chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter stated that, night after the Shingrix shot, the patient had chills, weakness and dizziness. The patient got up to use restroom and passed out on the way. The patient had hit the bridge of this nose on furniture but unsure exactly how it happened. The patient proceeded to bathroom sink and started to fall again. The patient had bleeding and open wound on bridge of nose. The patient went onto had headache myalgia and swollen calf for a few more days. The reporter agreed to follow up from GlaxoSmithKline.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Wound haemorrhage
Clinical narrative: passed out; Hit his nose, got a bleeding and open wound; chills; weakness; dizziness; started to fall again.; headache; myalgia,; swollen calf; hit the bridge of this nose; This case was reported by a consumer and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2022, the patient received Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), wound bleeding (serious criteria GSK medically significant), chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury. On an unknown date, the outcome of the passed out, wound bleeding, chills, weakness, dizziness, fall and nose injury were unknown and the outcome of the headache, myalgia and calf swelling were recovered/resolved.   It was unknown if the reporter considered the passed out, wound bleeding, chills, weakness, dizziness, fall, headache, myalgia, calf swelling and nose injury to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter stated that, night after the Shingrix shot, the patient had chills, weakness and dizziness. The patient got up to use restroom and passed out on the way. The patient had hit the bridge of this nose on furniture but unsure exactly how it happened. The patient proceeded to bathroom sink and started to fall again. The patient had bleeding and open wound on bridge of nose. The patient went onto had headache myalgia and swollen calf for a few more days. The reporter agreed to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got my shingles shot, still got shingles/Suspected vaccination failure; Still got shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the shingles shot and still got shingles. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shot, then got shingles/suspected vaccination failure; Them, Shingles/have had them for 2 weeks already; very painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had a shot for them before but he/she got shingles. The patient have had them for 2 weeks already, very painful. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite
Clinical narrative: Loss of appetite; This case was reported by a consumer via interactive digital media and described the occurrence of appetite lost in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced appetite lost. On an unknown date, the outcome of the appetite lost was unknown.   It was unknown if the reporter considered the appetite lost to be related to Shingrix.     Additional Information: GSK Receipt Date: 7-Nov-2022 Reporter's Comments: This case was received from consumer via  interactive digital media. The reporter stated that Shingrix cause loss of appetite.  Additional Supportive Information: The follow up would not possible as no contact details were available.
Age: 49.0
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Why did they give me the 1st shot being under 50; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. In September 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: The patient self-reported this case. The patient got his/her first dose of Shingrix 2 months ago from the date of reporting. The patient stated that the pharmacist refused to give him/her second Shingrix shot. The patient also stated the pharmacist said him/her that the computer told him he could not give the second dose but did not say why.  The patient assumed it was his/her age. The patient asked why they gave him/her the first shot. The patient reported that he would be turn 50 in July. Additional supportive information: The 49 years old patient received dose of Shingrix vaccine, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bedridden, Illness, Malaise
Clinical narrative: Knocked me on my butt; Knew I wasSick; Feeling pretty weak; in bed for 4 days; This case was reported by a consumer via other manufacturer and described the occurrence of feeling unwell in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, refer case US2022AMR163793). Concurrent medical conditions included immunosuppression. Concomitant products included etanercept (Enbrel).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell, bedridden, sickness and weakness. On an unknown date, the outcome of the feeling unwell, sickness and weakness were unknown and the outcome of the bedridden was recovered/resolved.   It was unknown if the reporter considered the feeling unwell, bedridden, sickness and weakness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR163793   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: The patient was taking an immunosuppressive medication (Enbrel). The patient reported that the second dose of shingrix knocked him on his butt and he was in bed for 4 days. The patient also reported that within 30 seconds after 2nd shot he knew was sick. The next week felt pretty weak. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR163793:Same Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression. Concomitant products included etanercept (Enbrel).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR163747   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: The patient was taking an immunosuppressive medication (Enbrel). The patient received dose of Shingrix vaccine and experienced just a sore arm. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2022AMR163747:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold
Clinical narrative: chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   The reporter considered the chills to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had chills from shingrix. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles from the shingles shot the next day after second dose. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Twinrix in August 2022 but hasn't yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received in August 2022, route - Intramuscular).   On an unknown date, the patient received did not receive the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 07-Nov-2022 Reporter's comment: The reporter was the patient. She received her first dose of Twinrix in August 2022 but had not yet received the second dose.  The patient did not realized that the second dose was due after 1 month.  Nothing else was reported. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.