chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On 05-NOV-2021, Hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion with temperature excursion of 47.1 Fahrenheit degrees for 36 minutes. No previous temperature excursion. On the same day, the patient was vaccinated with the improperly stored hepatitis a vaccine, inactivated (VAQTA) (1 time dose, lot # T031201, expiration date 14-JUN-2022; strength and route not reported) for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-2111USA005243: US-009507513-2112USA000877: US-009507513-2112USA000882: US-009507513-2112USA000883.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous report was received from a nurse referring to an adolescent patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medication not provided. On an unknown date in 2018, reported as when the patient was 13 years old, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route, lot number and expiration date not reported). It was reported that the patient was now 16 years of age and wanting to receive the rest of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (inappropriate schedule of product administration).
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; patient at the office today, 12/2/2021, who was scheduled to receive GARDASIL 9. The patient inadvertently received a dose of PNEUMOV AX 23 instead of GARDASIL 9.; patient at the office today, 12/2/2021, who was scheduled to receive GARDASIL 9. The patient inadvertently received a dose of PNEUMOV AX 23 instead of GARDASIL 9; patient at the office today, 12/2/2021, who was scheduled to receive GARDASIL 9. The patient inadvertently received a dose of PNEUMOV AX 23 instead of GARDASIL 9; Information has been received from the office manager, referring to a 11 years-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-DEC-2021, the patient was scheduled to receive hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), however, instead of this vaccine the patient inadvertently received a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # U018309, expiration date 08-JAN-2023 (anatomical location and administration route were not reported) for prophylaxis.  The reporter stated that the patient missed his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), but the patient did receive a flu shot (manufacturer unknown) also on 02-DEC-2021. No additional adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional Adverse event; Exprired dose of MMR II was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drug, concomitant therapies were not provided.  On 02-DEC-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live albumin status of rha (recombinant human albumin) (M-M-R II) 1 dose, (lot # S037501, Expiration date; 20-NOV-2021) (route and site of administration not reported) for prophylaxis (expired product administered). No additional adverse events was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administered a separate dose of this Case's improperly stored GARDASIL 9 to Patient; This spontaneous report as received from a physician assistant and healthcare business professional refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 19-NOV-2021, the patient was vaccinated with a separate dose of improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # T025370, expiry date 01-DEC-2022 (exact dose, route and anatomical location of administration were not reported) for prophylaxis (product storage error). Administered dose of vaccine experienced the temperature excursion above 47 degrees Fahrenheit (F) on 04-NOV-2021 (53.0 degrees F for 3 hours and 30 minutes), on 11-NOV-2021 (59.7 degrees F for 6 hours), on 15-NOV-2021 (48.2 degrees F for 1 hour and 30 minutes), and on 19-NOV-2021 (57.3 F for 3 hours and 20 minutes). No additional adverse event details were provided (no adverse event).  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2111USA009160:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; Administration of an expired MMR Il dose; This spontaneous report has been received from a medical assistant referring to a patient of unreported age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 09-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 ml one time (expired product administered) (lot number S037501 has been verified to be a valid number, expiration date reported and established as 20-NOV-2021;, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported), for prophylaxis.  The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), had no prior temperature excursion.  No additional adverse events (AE) were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Possible administration of improperly stored PROQUAD.; Possible administration of improperly stored PROQUAD.; No additional adverse events reported; This spontaneous report was received from a physician referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  The physician reported the possible administration of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) lot number U014798 and expiration date of 06-NOV-2022 for prophylaxis. The vaccine was exposed to a temperature excursion of -6.27°C with a time frame of 1 hour 15 minutes. There were previous temperature excursions: -14°C to-10°C for 0 hours 30 minutes 0 seconds; -10°C to 8°C for 0 hours 15 minutes 0 seconds; -14°C to-10°C for 0 hours 30 minutes 0 seconds; -10°C to 8°C for 0 hours 15 minutes 0 seconds. No additional adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; Patient was inadvertently administered a dose of MMR II on 12/10/2021 with a labeled expiry of 11/20/2021; This spontaneous report was received from a medical assistant referring to a patient of unreported age and gender. The patient's pertinent medical history, concomitant therapies, and previous drug reactions or allergies were not reported.  On 10-DEC-2021, the patient was inadvertently vaccinated with a labelled expiry of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 ml (milliliter) for prophylaxis (expired product administered) (lot number S037499 has been verified to be a valid lot number, the expiration date was reported and established as 20-NOV-2021; dose number, vaccination scheme, route of administration and anatomical site of vaccination were not reported).   No additional AE was reported.  No temperature excursion was reported
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired product administered; No additional adverse event reported; This spontaneous report was received from a consumer concerning to a 15-month-old female patient. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On an unspecified date, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), (lot number, expiry date, dose, anatomical location, route of administration and dose description was not reported) for prophylaxis (expired product administered). Reporter did not know exact expiration date, but she said it was expired 6 days ago. No additional adverse event reported, and no further information provided.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No other adverse event; Expired product administered; This spontaneous report was received from a medical assistant concerning to a patient of an unknown age and gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.  On 10-DEC-2021, the patient was vaccinated with an expired dose of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), lot # S039311, expiry date 04 Dec 2021, 0.5 milligram (anatomical location, route of administration was not reported) for prophylaxis (expired product administered). No other adverse event reported.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional information; patient received their first GARDASIL 9 vaccination at age 22, their second vaccine at age 24 and the patient is now 25 wanting to complete series; This spontaneous report was received from a pharmacist and refers to a 24 year-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unspecified date in 2018, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date in 2020, the patient was vaccinated (Inappropriate schedule of product administration) with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route and site of administration, lot # and expiration date were not reported) for prophylaxis.  At the time of reporting (reported as "now is 25"), the patient wanted to complete the series of vaccinations. No additional information was provided (No adverse event).
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate shcedule of Hepatitis B vaccine; This spontaneous report was received from a physician via an immunization record, from a case in litigation for zoster vaccine live (ZOSTAVAX) (Marrs # 2008USA012413), concerning a 9-week-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-OCT-2000, she was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as "Hepatitis B") dose 1 as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On 19-DEC-2000, she received the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) and on 26-FEB-2001, the third dose of the vaccine was administered (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.    This is one of several reports concerning the same patient.; Sender's Comments:  US-009507513-2008USA012413: US-009507513-2112USA004907:
Age: 0.17
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of pneumococcal vaccine; This spontaneous report was received from a physician via an immunization record, from a case in litigation for zoster vaccine live (ZOSTAVAX) (2008USA012413), concerning a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-DEC-2000, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as "pneumococcal conjugate") (manufacturer unknown) dose 1 as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). On 26-FEB-2001, she received the second dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and on 26-APR-2001, the third dose of the vaccine was administered (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.    This is one of several reports concerning the same patient.; Sender's Comments:  US-009507513-2008USA012413: US-009507513-2112USA004906:
Sex: U
Vaccine: VARCEL
Symptoms: Hand-foot-and-mouth disease, Rash macular
Clinical narrative: This initial spontaneous report as received from a nurse concerning a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were unknown per reporter. On 28-OCT-2021, another child of 6-years old was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route, Lot # and expiration date not reported) for prophylaxis. It was reported that the patient had the same babysitter as one of the other children and developed spots. The nurse stated that the 6-year-old child was suspected to have spread the illness to the patient. It was stated that after speaking with the nurses that day it was verify that the child did not seek medical attention and there was never a confirmed case of chicken pox. The nurse's supervisor stated that she did not think it was chicken pox and instead Hand-foot-mouth disease. The nurse also reported that they had spoken to the state immunization advisor about this situation and that the advisor was not considering this to be a confirmed case of varicella as there was not Polymerase Chain Reaction (PCR) testing performed. At the time of the report, the outcome of rash macular, secondary transmission and hand-foot-and-mouth disease was unknown. The causal relationship between the events and vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. This is one of several cases from the same source.; Sender's Comments: US-009507513-  2112USA005507: US-009507513-2111USA006313.
Sex: U
Vaccine: VARCEL
Symptoms: Hand-foot-and-mouth disease
Clinical narrative: Hand-Foot-Mouth disease; developed vesicles and it was diagnosed as chickenpox; the 6-year-old child was suspected to have spread the illness to the patient; This initial spontaneous report as received from a nurse concerning a child of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were unknown per reporter.       On 28-OCT-2021, another child of 6-years old was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route, Lot # and expiration date not reported) for prophylaxis.         On an unknown date in 2021, the child developed vesicles and it was diagnosed as chicken pox. The nurse stated that the 6-year-old child was suspected to have spread the illness to the patient, and it was reported that the children were in the same classroom. It was stated that after speaking with the nurses that day it was verify that the child did not seek medical attention and there was never a confirmed case of chicken pox. The nurse's supervisor stated that she did not think it was chicken pox and instead Hand-foot-mouth disease. It was unknown if treatment was given for the events.  The nurse also reported that they had spoken to the state immunization advisor about this situation and that the advisor was not considering this to be a confirmed case of varicella as there was not Polymerase Chain Reaction (PCR) testing performed.   At the time of the report, the outcome of varicella, secondary transmission and hand-foot-and-mouth disease was unknown.  The causal relationship between the events and vaccination with varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.   This is one of several cases from the same source.; Sender's Comments:  US-009507513-2112USA005506: US-009507513-2111USA006313:
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of injection site tenderness in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 23JKS, expiry date 13th April 2020) for prophylaxis. Previously administered products included Shingrix (received 1st dose on 20th April 2019, Lot:MX2LT, expiry date:21st May 2021). Concurrent medical conditions included type ii diabetes mellitus. Additional patient notes included Ethnicity-Caucasian. On 15th June 2019, the patient received the 2nd dose of Shingrix. On 15th June 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced injection site tenderness and injection site swelling. On an unknown date, the outcome of the injection site tenderness and injection site swelling were recovered/ resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the injection site tenderness and injection site swelling to be related to Shingrix. Additional details were provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix vaccine and experienced injection site tenderness and swelling.  From March 2021, patient had current conditions of high blood pressure, type 2 diabetes mellitus and abscess. The patient had Covid in March 2020 and was not able to get tested in March 2020, but he had an antibody test in July2020 that confirmed he had it. Since 8th March 2021, the patient was on concomitant products Lisinopril (Dosage may had started a little lower) and from October 2021, Ozempic (0.25mg once a week, then was increased to 0.5mg once a week). On 11th March 2021, patient received 1st dose of Pfizer BioNtech Covid 19 vaccine, Lot: EN6204. On 1st April 2021, patient received 2nd dose of Pfizer BioNtech Covid 19 vaccine, Lot: ER8737 and 3rd dose received on 2nd December 2021, Lot: 33030BD, Expiry date : 31st May 2022. The patient had a noticeably stronger immune response with the Covid and Shingrix vaccines than with any other vaccine. The patient reported that had a full on natural exposure of Covid, the side effects are better than having the illness itself.
Age: 56.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Spiked fever 101.6; Sore arm; Exhaustion, very fatigued, tired; This case was reported by a consumer via patient support programs and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 VACCINE for prophylaxis. The patient's past medical history included endometrial ablation, ulcerative colitis and hysterectomy. Concurrent medical conditions included heart disorder (may have some heart issues). On 6th December 2021, the patient received Shingrix and COVID-19 VACCINE. In December 2021, less than a week after receiving Shingrix, the patient experienced headache, fever, pain in arm and exhaustion. In December 2021, the outcome of the headache, fever, pain in arm and exhaustion were recovered/resolved. It was unknown if the reporter considered the headache, fever, pain in arm and exhaustion to be related to Shingrix. Additional details were provided are as follows: The patient has had some medical condition as, endometrial ablation, ulcerative colitis, hysterectomy and might have some heart issues (still getting some tests run to rule out with doctor, which might be inconclusive). The patient received a dose of Shingrix and less than a week, after vaccination, the patient had headache, spiked fever 101.6 degree, sore arm and very fatigue or tired. The patient stated if anyone asks then did not took Covid vaccine and Shingrix at once, she was feeling really exhausted. It was unknown if the reporter considered the headache, fever, pain in arm and exhaustion to be related to Covid-19 vaccine. The reporter consented to follow-up. Note: There is discrepancy regarding the onset date of adverse event and vaccination date, conservatively captured partial onset date for all event and tto was captured in accordance with  receipt date, dates would be clarify in upcoming follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 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 the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site erythema, injection site swelling, injection site pain and fever. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain and fever were unknown.  It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site pain to be related to Shingles vaccine. The reporter considered the fever to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got fever from the 1st shot of Shingles vaccine and had some redness, swelling and soreness on the injection site. The patient stated that the 2nd dose would be in next year. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis. On 7th December 2021, the patient received Shingrix. On 7th December 2021, less than a day after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received a dose of Shingrix vaccine yesterday and in afternoon the patient had fever 100.7 degree. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: very sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingles vaccine on an unknown date and experienced Sickness. The patient had to get monthly transfusions to counteract the damage but it did not work for her. The patient was still suffering from the adverse event. Consent to follow up was possible as contact details were not available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Illness, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, fever, chills, headache and general body pain. On an unknown date, the outcome of the sickness, fever, chills, headache and general body pain were unknown. It was unknown if the reporter considered the sickness, fever, chills, headache and general body pain to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was extremely sick with first shot. The patient had a fever, chills, headache and body ache. The patient was very hesitant to get the 2nd shot but received. The patient had luckily no side effects with that one. The patient would definitely recommend the shots over getting shingles.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR254299:same reporter (invalid case).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot, I got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. A year after the patient got the shot, he/she got shingles and that was worst than giving birth. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In December 2021, unknown after receiving Shingles vaccine, the patient experienced fever, pain and fatigue. On an unknown date, the outcome of the fever, pain and fatigue were recovered/resolved. It was unknown if the reporter considered the fever, pain and fatigue to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter reported that 2 days with low fever and aches. The patient was very tired. The patient informed that the day of reporting was day three and he/she felt fine. The patient further stated that they need 2 doses about a month apart.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and still got shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine. Additional details were provided are as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got both Shingles vaccine shots and he still got shingles on his lower back. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, burning sensation and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, burning sensation and pain were not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles, burning sensation and pain to be related to Shingles vaccine. Additional details provided were as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received the Shingles vaccine a few months ago but patient had the burning and pain of shingles right now. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Chills, Feeling hot
Clinical narrative: feel warm; chills; body is weak; stomach is upset.; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of feeling of warmth in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th December 2021, the patient received the 1st dose of Shingles vaccine. On 12th December 2021, less than a day after receiving Shingles vaccine, the patient experienced feeling of warmth, chills, weakness and upset stomach. On an unknown date, the outcome of the feeling of warmth, chills, weakness and upset stomach were unknown.   It was unknown if the reporter considered the feeling of warmth, chills, weakness and upset stomach to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she received Shingles first dose today (on the day of reporting) and felt warm, had chills, his/her body was weak and stomach was upset. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: Very sick; Flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness and influenza-like symptoms. On an unknown date, the outcome of the sickness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient just had the 1st dose of newest Shingles shot.  The day after 1st dose, the patient was very sick with flu like symptoms that lasts 24 hrs.  The patient said they did not warn the person about that when you get it. The follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2021AMR254585, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR254585:Same reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient has not received the 3rd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 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.   Previously administered products included Twinrix (received 1st dose on 01st June 2021) and Twinrix (received 2nd dose on 1st July 2021).   On an unknown date, the patient received Twinrix (injection) and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix 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 details were provided as follows: The age at vaccination was not applicable for this report. The patient was the reporter's wife. At the time of reporting, the patient wanted to know about the dosing schedule of Twinrix (if a 3rd dose was required), components in Twinrix and availability of the vaccine.  Till the time of reporting, the patient did not receive the 3rd dose of the vaccine, which led to incomplete course of vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeling hot, Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included ondansetron for migraine and promethazine for migraine. The patient's past medical history included migraine headache. Previously administered products included COVID vaccine with an associated reaction of chills (experienced headache chills, fever, nausea, vomiting and diarrhea after COVID vaccine but did not get hives). Concurrent medical conditions included adhesive tape allergy. On 6th December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, the patient started ondansetron at an unknown dose and frequency and promethazine at an unknown dose and frequency. On 6th December 2021, less than an hour after receiving Shingrix, the patient experienced migraine headache, chills, fever, nausea, vomiting and diarrhea. On 7th December 2021, the patient experienced extremities hot feeling of and itchy upper limbs. On 8th December 2021, the patient experienced hives and fatigue. The action taken with ondansetron was unknown. The action taken with promethazine was unknown. On an unknown date, the outcome of the migraine headache, chills, fever, nausea, vomiting and diarrhea were recovered/resolved and the outcome of the extremities hot feeling of, itchy upper limbs, hives and fatigue were not recovered/not resolved. It was unknown if the reporter considered the migraine headache, chills, fever, nausea, vomiting, diarrhea, extremities hot feeling of, itchy upper limbs, hives and fatigue to be related to Shingrix. Additional details were provided as follows: The patient self reported this case. The patient had a history of migraines and is allergic to band-Aid adhesive. The reporter inquired about ingredients in SHINGRIX and stated she received her first dose of Shingrix and within 1 hour after receiving the vaccine, she experienced a headache (triggered a migraine), chills, fever, nausea, vomiting and diarrhea. The patient took ondansetron and promethazine for her migraine which helped her to sleep. On 7th December 2021, the patient noticed that her right arm was hot and itchy. On 8th December 2021, the patient noticed she had hives on her right arm, and that she was very tired, and her arm was still hot and itchy. The patient stated that she called her doctors office and that they are aware of her reaction to the vaccine. The patient stated that her experience with Shingrix was similar to COVID vaccine but did not get hives. The patient did not have dosing, lot, expiration date information of the vaccine. It was unknown if the reporter considered the migraine headache, chills, fever, nausea, vomiting, diarrhea, extremities hot feeling of, itchy upper limbs, hives and fatigue to be related to ondansetron and promethazine. The reporter consented to follow up. The patient consented to contact physicians Office.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Urticaria, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of migraine headache in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included ondansetron for migraine and promethazine for migraine. The patient's past medical history included migraine headache. Previously administered products included COVID vaccine with an associated reaction of chills (experienced headache chills, fever, nausea, vomiting and diarrhea after COVID vaccine but did not get hives). Concurrent medical conditions included adhesive tape allergy. On 6th December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, the patient started ondansetron at an unknown dose and frequency and promethazine at an unknown dose and frequency. On 6th December 2021, less than an hour after receiving Shingrix, the patient experienced migraine headache, chills, fever, nausea, vomiting and diarrhea. On 7th December 2021, the patient experienced extremities hot feeling of and itchy upper limbs. On 8th December 2021, the patient experienced hives and fatigue. The action taken with ondansetron was unknown. The action taken with promethazine was unknown. On an unknown date, the outcome of the migraine headache, chills, fever, nausea, vomiting and diarrhea were recovered/resolved and the outcome of the extremities hot feeling of, itchy upper limbs, hives and fatigue were not recovered/not resolved. It was unknown if the reporter considered the migraine headache, chills, fever, nausea, vomiting, diarrhea, extremities hot feeling of, itchy upper limbs, hives and fatigue to be related to Shingrix. Additional details were provided as follows: The patient self reported this case. The patient had a history of migraines and is allergic to band-Aid adhesive. The reporter inquired about ingredients in SHINGRIX and stated she received her first dose of Shingrix and within 1 hour after receiving the vaccine, she experienced a headache (triggered a migraine), chills, fever, nausea, vomiting and diarrhea. The patient took ondansetron and promethazine for her migraine which helped her to sleep. On 7th December 2021, the patient noticed that her right arm was hot and itchy. On 8th December 2021, the patient noticed she had hives on her right arm, and that she was very tired, and her arm was still hot and itchy. The patient stated that she called her doctors office and that they are aware of her reaction to the vaccine. The patient stated that her experience with Shingrix was similar to COVID vaccine but did not get hives. The patient did not have dosing, lot, expiration date information of the vaccine. It was unknown if the reporter considered the migraine headache, chills, fever, nausea, vomiting, diarrhea, extremities hot feeling of, itchy upper limbs, hives and fatigue to be related to ondansetron and promethazine. The reporter consented to follow up. The patient consented to contact physicians Office.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Dysphagia, Urticaria
Clinical narrative: Difficulties swallowing; Product Complaint; Hives; This case was reported by a nurse via call center representative and described the occurrence of hives in a 22-year-old male patient who received HBV (Engerix B adult) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included type i diabetes mellitus.   On 23rd November 2021, the patient received the 2nd dose of Engerix B adult (intramuscular) and Engerix B Pre-Filled Syringe Device. In November 2021, less than a day after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the patient experienced swallowing difficult and pharmaceutical product complaint. The patient was treated with prednisone. On an unknown date, the outcome of the hives was not recovered/not resolved and the outcome of the swallowing difficult and pharmaceutical product complaint were unknown.   The reporter considered the hives to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device. It was unknown if the reporter considered the swallowing difficult to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Engerix-B dose and within 12 hours of vaccination, he developed hives all over his face, neck, chest and back.  The patient saw his primary physician and was prescribed prednisone. The hives resolved but return every evening.  Less than 3 weeks after vaccination, the patient also experienced difficulties swallowing. The action taken with Engerix B adult was no change. The reporter believed the hives were related to this lot number.  The reporter reported that neither she nor anyone else had previously reported this complaint to GlaxoSmithKline.  The reporter was uncomfortable using this lot number for any additional patients. The reporter stated that the Engerix-B box had 2 syringes used from it and 8 syringes remained. There was no obvious visual defect noted to the box or syringes. The reporter ordered additional Engerix-B and received four more boxes of this same suspect lot number.  The reporter would retain the vaccine in question until GlaxoSmithKline contacts her.  The reporter consented to follow up. The case had been linked to US2021252035, reported by the same reporter. Note: There was discrepancy regarding the event difficult swallowing, during clarification it was not clear which patient had this event only guess was made through the notes that the male patient had, therefore conservatively difficult swallowing was coded in both cases.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252035:Same reporter. Pt 1/2.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old 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 pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that patient had a sore arm for 10 days after receiving Shingrix. The reporter did not had any further information. This case has been linked with US2021252832, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021252832:same reporter
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: an eleven year old received a dose of Infanrix.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The medical assistant reported that an eleven year old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The health care professional declined to provide demographic details, lot number, or expiration date. The reporter did not consent to follow-up.