chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysplasia, Glossectomy, Human papilloma virus test negative, Laboratory test normal
Clinical narrative: The patient presented for her first Moderna COVID-19 on 3/4/21, Lot# 030A21A and was administered at Medical Ggroup.  Following vaccination, she experienced significant nausea, as well as a severe headache and exhaustion for several days.  She had no oral lesions at that time.  She had 2nd Moderna COVID-19 vaccination, Lot # 038A21A date administered on 4/1/21 at Medical Center.  Following this second dose, she had no adverse effects.    The third Moderna COVID-19 vaccination was administered on 11/27/21, Lot # 013F21A.  Two weeks following the administration of the booster, she developed a white patch the size of the nickel on her tongue.  She presented to Dentistry and they diagnosed her with leuoplakia and recommended a biopsy.  A biopsy was conducted on 1/4/22 and revealed mild dysplasia.  She was referred to an oral surgeon for further evaluation at Hospital, and then was referred for a further evaluation at facility. In February, 2022, she met with the oral surgeon and on 3/14/22 she had laser surgery in which the area was burned off.  In mid April, she was diagnosed with COVID-19.  She started with a slight URI, cough, and sniffles, and then had 7 days of diarrhea as well as abdominal pain.    In June 2022, she was re-evaluated by the oral surgeon at facility and the white patch recurred.  It was the exact same location and the size of nickel.  She presented back for follow-up in October/November, 2022 as recommended for repeat biopsy which revealed squamous cell carcinoma of the tongue.  She underwent an extension surgical resection (partial glossectomy) in December 2022.  All lymph nodes were negative and final report revealed well-differentiated squamous cell carcinoma of the tongue.  It was also HPV negative.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Laser therapy, Leukoplakia oral, Oral surgery, Rhinorrhoea, Squamous cell carcinoma of the tongue
Clinical narrative: The patient presented for her first Moderna COVID-19 on 3/4/21, Lot# 030A21A and was administered at Medical Ggroup.  Following vaccination, she experienced significant nausea, as well as a severe headache and exhaustion for several days.  She had no oral lesions at that time.  She had 2nd Moderna COVID-19 vaccination, Lot # 038A21A date administered on 4/1/21 at Medical Center.  Following this second dose, she had no adverse effects.    The third Moderna COVID-19 vaccination was administered on 11/27/21, Lot # 013F21A.  Two weeks following the administration of the booster, she developed a white patch the size of the nickel on her tongue.  She presented to Dentistry and they diagnosed her with leuoplakia and recommended a biopsy.  A biopsy was conducted on 1/4/22 and revealed mild dysplasia.  She was referred to an oral surgeon for further evaluation at Hospital, and then was referred for a further evaluation at facility. In February, 2022, she met with the oral surgeon and on 3/14/22 she had laser surgery in which the area was burned off.  In mid April, she was diagnosed with COVID-19.  She started with a slight URI, cough, and sniffles, and then had 7 days of diarrhea as well as abdominal pain.    In June 2022, she was re-evaluated by the oral surgeon at facility and the white patch recurred.  It was the exact same location and the size of nickel.  She presented back for follow-up in October/November, 2022 as recommended for repeat biopsy which revealed squamous cell carcinoma of the tongue.  She underwent an extension surgical resection (partial glossectomy) in December 2022.  All lymph nodes were negative and final report revealed well-differentiated squamous cell carcinoma of the tongue.  It was also HPV negative.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discolouration, Upper respiratory tract infection
Clinical narrative: The patient presented for her first Moderna COVID-19 on 3/4/21, Lot# 030A21A and was administered at Medical Ggroup.  Following vaccination, she experienced significant nausea, as well as a severe headache and exhaustion for several days.  She had no oral lesions at that time.  She had 2nd Moderna COVID-19 vaccination, Lot # 038A21A date administered on 4/1/21 at Medical Center.  Following this second dose, she had no adverse effects.    The third Moderna COVID-19 vaccination was administered on 11/27/21, Lot # 013F21A.  Two weeks following the administration of the booster, she developed a white patch the size of the nickel on her tongue.  She presented to Dentistry and they diagnosed her with leuoplakia and recommended a biopsy.  A biopsy was conducted on 1/4/22 and revealed mild dysplasia.  She was referred to an oral surgeon for further evaluation at Hospital, and then was referred for a further evaluation at facility. In February, 2022, she met with the oral surgeon and on 3/14/22 she had laser surgery in which the area was burned off.  In mid April, she was diagnosed with COVID-19.  She started with a slight URI, cough, and sniffles, and then had 7 days of diarrhea as well as abdominal pain.    In June 2022, she was re-evaluated by the oral surgeon at facility and the white patch recurred.  It was the exact same location and the size of nickel.  She presented back for follow-up in October/November, 2022 as recommended for repeat biopsy which revealed squamous cell carcinoma of the tongue.  She underwent an extension surgical resection (partial glossectomy) in December 2022.  All lymph nodes were negative and final report revealed well-differentiated squamous cell carcinoma of the tongue.  It was also HPV negative.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exposure via skin contact, Injection site haemorrhage, Syringe issue
Clinical narrative: syringe used malfunctioned.  when administering dose (0.5mls) had to use more force than usual. Most or all of the volume came out of the hole or arm and barrier band aid.  It went down her right arm and some on the table.  She bled. The blood was contained behind the barrier. I recommended that we give her another full dose.  She was hesitant at first. Then agreed to get in her left arm.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypothyroidism, Injection site erythema, Injection site rash, Rash
Clinical narrative: Patient stated that she had rash/redness from injection site down to forearm. She also suffered from hypothyroidism
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: Hives on Rt foot up to knee & thigh area, and Rt arm. Benadryl given 11/21/22 evening time & 11/22/22 am before coming into clinic. Advise to cont Benadryl OTC liquid & get OTC Benadryl cream, vaccine added to allergy list.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: she still got covid twice after get the second shot; she still got covid twice after get the second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2011, stop date: 2011, notes: Caller claims to have had covid back in 2011, and reports that she got covid again just last year. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she still got covid twice after get the second shot".  Clinical information: The reporter reported that she still got covid twice after get the second shot. The reporter claimed to have had covid back in 2011, and reports that she got covid again just last year.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029596 Same patient and drug, same event in different time;
Sex: U
Vaccine: RV5
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AE details were provided and no additional AE's were reported; an infant was inadvertently administered ROTATEQ intramuscularly instead of orally; This spontaneous report was received from a physician and refers to an infant patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-JAN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (dose, frequency, vaccination scheme, vaccine injection site, strength, lot number, and expiration date were not provided). The vaccine was inadvertently administered intramuscularly instead of orally (incorrect route of product administration). No additional adverse event was reported.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other adverse events; GARDASIL9 first and second dose were administered 23 days apart; This spontaneous report was received from a physician via customer center representative and refers to a female patient potentially in her twenties. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.     On approximately 19- DEC-2022, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). On approximately 11-JAN-2023, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (inappropriate schedule of product administration). The physician stated that she did not have lot numbers or expiration dates of these doses, also dose quantity and route were not reported. No other adverse events or product quality complaints were reported.
Age: 15.0
Sex: F
Vaccine: FLUC3, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from a Licensed Vocational Nurse (L.V.N.), who was also an office manager/ administrator and refers to a 15-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in left deltoid for prophylaxis (strength and route of administration were not provided) and influenza vaccine inact sag 3v (FLUCELVAX), lot# 348359, expiration date: 30-JUN-2023 administered in right deltoid (strength, formulation, route of administration and indication were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports from the same reporter.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from an other health professional and refers to an 18-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1st dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in right deltoid for prophylaxis (strength and route of administration were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports from the same reporter.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from a Licensed Vocational Nurse (L.V.N.), who was also an office manager/ administrator and refers to a 12-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in right deltoid for prophylaxis (strength and route of administration were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports from the same reporter.
Age: 13.0
Sex: M
Vaccine: FLUC3, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events were reported; improperly stored Gardasil 9 and VAQTA administered on 09-SEP-2022; This spontaneous report was received from a Licensed Vocational Nurse (L.V.N.), who was also an office manager/ administrator and refers to a 13-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 09-SEP-2022, the patient was vaccinated with an improperly stored (temperature below 36 Fahrenheit [F] degrees [29.8 F] for 17 hours, 0 minutes and 0 seconds, there were no previous temperature excursions) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #1780878 was found to be valid, expiration date: 02-DEC-2023, administered in left deltoid for prophylaxis (strength and route of administration were not provided) and influenza vaccine inact sag 3v (FLUCELVAX), lot# 348359, expiration date: 30-JUN-2023, administered in right deltoid (strength, formulation, route of administration and indication were not provided) (product storage error). The patient experienced no adverse event (no adverse event).  This is one of several reports form the same reporter.
Age: 8.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE reported.; patient received an extra dose of PROQUAD today (01/18/2023). Patient received 1st dose in 2018 and 2nd dose 2019.; This spontaneous report was received from a physician regarding an 8-year-old patient of an unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown day in 2018, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis.   On an unspecified day in 2019, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) administered as prophylaxis.     On 18-JAN-2023 (reported as "today"), the patient was vaccinated with a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, product quantity 1, lot #W029543 and expiration date: 14-MAR-2024, (strength, anatomical location, and route of administration were not provided) administered as prophylaxis (Extra dose administered). No adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE. No PQC; an adult receiving a pediatric dose of VAQTA; This spontaneous report was received from  a medical assistant and refers to an adult patient.  The patient's medical history, concurrent conditions, concomitant therapies and previous drugs reaction or allergies were not reported.  On 17-JAN-2023, the patient was vaccinated with a pediatric dose of hepatitis a vaccine, inactivated (VAQTA), 0.5ml, lot #U024094 that upon internal review was found valid as vial formulation, expiration date: 10-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided (Product administered to patient of inappropriate age). No additional adverse event was reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist reported that he only received two doses of GARDASIL 9. It has been a few years and pharmacist has still not received the third dose of GARDASIL 9.; No additional AE reported.; This spontaneous report was received from a pharmacist reffering to himself, the male patient of an unknown age. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection for prophylaxis (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided). Pharmacist reported that he only received two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It had been a few years and he had still not received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Patient was administered Improperly Stored, Separate PNEUMOVAX 23; This spontaneous report has been received from an office manager and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions and concomitant medication provided.  On 27-DEC-2022, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, lot # W007035 confirmed to be valid with expiration date 23-OCT-2023 (exact dose, dose number, route of administration and anatomical location were not reported), for prophylaxis (product storage error). There was no additional adverse event reported.  On 23-DEC-2022, the administrated dose of the suspect vaccine underwent a temperature excursion of 55 Fahrenheit degrees for 153 hours. There was no previous temperature excursion.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; patient was administered improperly stored PNEUMOVAX23; This spontaneous report was received from an office manager, concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-DEC-2022, a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was improperly stored at a temperature of 55 degrees Fahrenheit for 153 hours. There were no previous temperature excursions. On 04-JAN-2023, the patient was vaccinated with the improperly stored (Product storage error) dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (Lot #W007035, expiration date reported as 23-OCT-2023, but upon internal validation stablished as 20-OCT-2023, administered for prophylaxis (strength, anatomical location and route of administration were not provided). No additional adverse events were reported.   This is one of several reports from the same reporter.  ; Sender's Comments:  US-009507513-2301USA007635: US-009507513-2301USA007605: US-009507513-2301USA007405: US-009507513-2301USA007693: US-009507513-2301USA007699:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Patient was administered Improperly Stored, Separate PNEUMOVAX 23; This spontaneous report has been received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 23-DEC-2022, pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature of 55.0 Fahrenheit degrees (°F) during 153 hours. On 03-JAN-2023, the patient was vaccinated with an improper stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot # W007035, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent [23-valent] [PNEUMOVAX23], expiration date reported as 23-OCT-2023, but upon internal validation established as 20-OCT-2023) (dose, anatomical location and route of administration were not reported) (Product storage error). The vaccine did not have previous temperature excursion.  No additional adverse event was reported.
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Product Administered; Initial Report Received on 07-DEC-2022  This is a spontaneous report, received from a registered nurse regarding a female patient, aged 42 years, who received HEPLISAV-B for hepatitis B immunisation.   Medical history at the time of vaccination was reported as shrimp allergy.  Concomitant medications were not reported.  On 07-NOV-2022, a dose of HEPLISAV B (Lot #937783, expiration date 29-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.    On 25-NOV-2022, 16 days after the patient was vaccinated with HEPLISAV B, the reporter received notice that the HEPLISAV B that the patient received underwent a temperature excursion.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Temperature Excursion Product Administered; Initial Report Received on 07-DEC-2022  This is a spontaneous report, received from a registered nurse regarding a male patient, aged 28 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 28-OCT-2022, a dose of HEPLISAV B (Lot #937783, expiration date 29-SEP-2023, NDC #43528-003-05), route and site not specified, was administered for hepatitis B immunisation.    On 25-NOV-2022, 28 days after the patient was vaccinated with HEPLISAV B, the reporter received notice that the HEPLISAV B that the patient received underwent  a temperature excursion.  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: Injection site erythema, Injection site papule, Injection site rash
Clinical narrative: Red Raised Bumps Around Injection Site; Initial Report Received on 08-DEC-2022  This is a spontaneous report, received from an "LPN"  regarding a 33-year-old female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  The patient was reportedly not pregnant.  Concomitant medications were not reported.  On 08-NOV-2022, dose 1 of HEPLISAV B (Lot #937231, expiration date 30-JAN-2023, NDC #43528-003-05), was administered intramuscularly in the left deltoid for hepatitis B immunisation.   On 08-DEC-2022, dose 2 of HEPLISAV B (Lot #937231, expiration date 30-JAN-2023, NDC #43528-003-05), was administered intramuscularly in the right deltoid for hepatitis B immunisation.   On 08-Dec-2022, the same day after having received dose 2 of HEPLISAV B, the patient reported that she developed red raised bumps around the injection site on the right deltoid and on the other arm at the deltoid area, which was the injection site for dose 1.  No other adverse reactions or medical intervention was relayed by the patient.   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: Expired Dose Administered; Initial Report Received on 13-DEC-2022, 14-DEC-2022  This is a spontaneous report, received from an office coordinator at an Internal Medicine Office regarding a 39-year-old male patient who received HEPLISAV-B for hepatitis B immunisation.   Medical history was reported as an allergy to naproxen (rash).  Concomitant medications were not reported.  On 12-DEC-2022, a dose of HEPLISAV B (Lot # 934975, expiration date 13-AUG-2022, NDC # 43528-003-05), route and site not specified, was administered for hepatitis B immunisation.    The dose of HEPLSIAV B administered was reported as expired.  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: Ear infection
Clinical narrative: Ear Infection; Initial Report Received on 14-DEC-2022  This is a spontaneous report, received from a female patient, who received HEPLISAV B for hepatitis B immunisation.  There was no medical history reported for the patient.  Concomitant medications were not reported.  On 16-NOV-2022, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # 43528-002-01), was administered in the left arm (route not specified) for hepatitis B immunisation which was administered at a pharmacy.    On 04-DEC-2022, 18 days after vaccination with HEPLISAV B, the patient experienced an ear infection.    On 14-DEC-2022, she finished a course of Augmentin (amoxicillin/clavulanic) and went back to the doctor due to fluid in the ear.  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 15-Dec-2022  A medical assistant reported that a 54-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that expired.  Medical history was reported as unknown.  No relevant concomitant medications were reported.    On 15-Dec-2022, the patient received a dose (unspecified dose number) of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, NDC # 4352800301) intramuscularly in the left deltoid.   The HEPLISAV B dose administered was 13 days past the expiration date.  The patient had no other adverse effects.   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: No adverse event, Product storage error
Clinical narrative: Low Temperature Excursion Product Administered; Initial Report Received on 23-Dec-2022  A pharmacist reported that a 55-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 01-Nov-2022, the patient received a dose of HEPLISAV-B (Lot # 937783, expiration date 29-Sep-2023 and NDC # 43528000305) intramuscularly in the left deltoid.   On an unspecified date, the reporter stated that they received information that Heplisav-B Lot #937783 had been involved in a low temperature excursion that went out of range. One of the doses from that lot had been administered to the patient.  The patient reported no additional adverse effects.  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, No adverse event
Clinical narrative: Heplisav-B and Twinrix at the Same Time; Initial Report Received on 27-Dec-2022  A pharmacist reported that a 46-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and was given Twinrix at the same time.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 27-Dec-2022, the patient received a dose of HEPLISAV-B (Lot # 940487, expiration date 14-Nov-2024 and NDC # 43528000301) intramuscularly in the right deltoid from a pharmacist. Concomitant vaccines administered included Twinrix (Lot #, route, and site not provided).   On 27-Dec-2022, on the same day he was vaccinated with HEPLISAV-B, the patient was given Twinrix at the same time. No additional adverse effects were reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Don't get it, it gave my uncle shingles/Suspected vaccination failure; Shingles; painful rash; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and painful rash. On an unknown date, the outcome of the vaccination failure, shingles and painful rash were unknown.   The reporter considered the vaccination failure, shingles and painful rash to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's Comment: This case was reported by a patient's relative viainteractive digital media. The reporter stated that did not get the vaccine because it gave my uncle (patient) shingles. The reporter stated that take action. Find out more about the risk of shingles and take steps to help prevent this painful rash. The reporter thought that the event might had been related to the drug. The reporter did not agree that the company's safety team might contact their HCP to gather further information. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/Got them after taking his shingles vaccine; Shingles truly the pits, Got them; 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.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 16-Jan-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient reported that shingles was truly the pits. The patient got them after taking the shingles vaccine. The patient stated never again. 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: M
Vaccine: VARZOS
Symptoms: Rash, Rash macular
Clinical narrative: Dry blotches on face; Dry blotches on face; This case was reported by a consumer and described the occurrence of macular rash in a 68-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th January 2023, the patient received Shingles vaccine. On 10th January 2023, 5 days after receiving Shingles vaccine, the patient experienced macular rash and rash. On an unknown date, the outcome of the macular rash and rash were unknown.   It was unknown if the reporter considered the macular rash and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingles vaccine and experienced dry blotches on face. The symptoms were not treated. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Cough, Sinusitis
Clinical narrative: Had a little cough; Bronchitis; Sinus infection; This case was reported by a consumer via call center representative and described the occurrence of bronchitis in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2022, the patient received the 1st dose of Shingrix. On 6th January 2023, 175 days after receiving Shingrix, the patient experienced bronchitis and sinus infection. On 12th January 2023, the patient experienced cough. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On 10th January 2023, the outcome of the bronchitis and sinus infection were recovered/resolved. On an unknown date, the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the bronchitis, sinus infection and cough to be related to Shingrix.     Linked case(s) involving the same patient:  US2023AMR004661   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The patient received the Shingrix vaccine and patient did not remember the location of administration. The patient had bronchitis and sinus infection over the weekend. The patient feels better but had a little cough last night. The patient was on antibiotics. The reporter did not consent to follow up. Additional supportive information: The case had been linked with US2023AMR004661 reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023AMR004661:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product complaint, Product storage error
Clinical narrative: delivery issue/Delivered with tag alert/ administered one; Delivered with tag alert/; This case was reported by a consumer and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number 5L3HB, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug and pharmaceutical product complaint. On an unknown date, the outcome of the incorrect storage of drug and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The patient was administered 1 dose of compromised Shingrix. The reporter would reach out to the customer to confirm if this had already been reported and if not, she would direct the customer to call GlaxoSmithKline. The 10 dose of Shingrix vaccine was delivered with tag alert. Additional Supportive Information: The patient was administered 1 dose of compromised Shingrix and vaccine was delivered with tag alert, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient only received the adjuvant; Patient only received the adjuvant; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-Jan-2023 Reporter's Comment: The reporter stated the patient float pool MA did not reconstitute the vaccine correctly and the patient only received the adjuvant suspension.  The reporter stated GlaxoSmithKline had a program to replace Shingrix due to a medication error. The reporter consented to follow up. Additional supportive Information: The patient only received the adjuvant suspension, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: injection site redness; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingles vaccine and had injection site redness. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shingles shot 2 years ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (1st dose received 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 19-JAN-2023 Reporter comment: The reporter stated that, was it too late to get her/his 2nd dose now. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: after reconstitution was stored overnight/pt refused vx.; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product storage error in a patient who received Herpes zoster (Shingrix) (batch number DH3SB, expiry date 20th May 2024) for prophylaxis.   On 12th January 2023, the patient did not receive Shingrix. On 12th January 2023, unknown after receiving Shingrix, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.   Additional Information: GSK Receipt date: 13-JAN-2023 Reporter Comment: The pharmacist reports that a Shingrix vaccination reconstitution and stored overnight in a syringe under refrigeration. Vaccine was drawn up for patient and then patient refused vaccine. The reporter consented to follow up. Additional supportive information: After Shingrix vaccination reconstitution vaccine was stored overnight in a syringe under refrigeration and did not receive by the patient which led to intercepted product storage error.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Oct2021, 2nd Nov2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of Shingrix in October 2021).   In November 2022, the patient received the 2nd dose of Shingrix. In November 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The case was reported by the patient. The patient provided limited information.  The reporter needed to end call as she needed to see patients (reporter was also an healthcare professional). The reporter did not consent to follow-up.  Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: HEPA, HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: 1st dose 2014, 2nd 2019; 2nd dose in 2019, 3rd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received HAB (Twinrix) 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, HAB (Twinrix) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received first dose of Havrix in 2014) and Twinrix (received first dose of Twinrix in 2014).   On an unknown date, the patient did not receive the 3rd dose of Twinrix, Twinrix Pre-Filled Syringe Device, the 2nd dose of Twinrix, Twinrix Pre-Filled Syringe Device and the 2nd dose of Havrix. On an unknown date, unknown after receiving Twinrix, Twinrix Pre-Filled Syringe Device and Havrix, the patient experienced drug dose administration interval too long and incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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-Jan-2023 Reporter's comment: The pharmacist reported that the patient received first dose of Havrix in 2014 and second dose in 2019. After 2nd line consult it was mentioned that she was not sure if it was havrix or possibly twinrix. The patient had no proof of documentation so was trying to figure all this out and what to do next. The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Havrix and Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting, the patient did not receive the third dose of Twinrix, which led to incomplete course of vaccination. As per reported information, it was not clear whether the patient had received Havrix doses or Twinrix doses therefore in worst approach, the case was kept valid with both Havrix and Twinrix considering that the patient received both the vaccines and had medication error and for further clarification query was raised.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Swelling face
Clinical narrative: red cheeks, become slightly worse; warm cheeks, become slightly worse; swollen cheeks, become slightly worse; This case was reported by a consumer via call center representative and described the occurrence of red face in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 10th January 2023, 5 days after receiving Shingrix, the patient experienced red face, feeling of warmth facial and cheek swelling. On an unknown date, the outcome of the red face, feeling of warmth facial and cheek swelling were not recovered/not resolved.   It was unknown if the reporter considered the red face, feeling of warmth facial and cheek swelling to be related to Shingrix.  Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The reporter was the patient's husband and did not want to give any further demographics.  He stated that his wife got her Shingrix vaccine and then started with red, warm, swollen cheeks.  He states that her symptoms had become slightly worse since they started.  She was still having symptoms at the time of the call.  The reporter did not consent to follow-up. No follow up with HCP.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Contracted Shingles; One dose long time ago, 2nd never received; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JAN-2023 Reporter's Comment: The reporter was a healthcare professional from vaccine facility. The reporter reported that the patient received first dose of Shingrix vaccine a long time ago and never received the second dose of Shingrix vaccine. The reporter stated that the patient experienced Shingles. The timing of the initial dose and the onset of the adverse event was not known. The reporter stated that it was not known whether the patient was planning to receive the 2nd dose of the Shingrix vaccine series. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.