chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Has dropped some weight over the last few days; Fever; Hot cold sweats; dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 57 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single; Lot Number: ER8734), administration date: 06Apr2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "tested positive for COVID"; BNT162b2 (Dose 2, Single; Lot Number: ER8734), administration date: 27Apr2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "tested positive for COVID". The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Has dropped some weight over the last few days"; PYREXIA (non-serious), outcome "recovering", described as "Fever"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "Hot cold sweats"; DIZZINESS (non-serious), outcome "recovering"; ASTHENIA (non-serious), outcome "not recovered", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He got the original first 2 shots of COVID vaccine and got the booster shot in December and after a month tested positive for COVID this Tuesday. Reporter asked what was the process of getting another booster shot. Patient has dropped some weight over the last few days. His fever has broken somewhat but he was still going through hot cold sweats, weakness, and dizziness. He has improved from the first day but still feels a lot of weakness. Patient did not visit emergency room or physician office. Family history was reported as none. Relevant lab test was reported as none. The patient did not receive any other vaccines on the same date of Pfizer vaccination. Since the vaccination, the patient had been tested for COVID-19 on 26Jul2022. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with any other AE.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Pyrexia, Weight
Clinical narrative: Has dropped some weight over the last few days; Fever; Hot cold sweats; dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 57 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single; Lot Number: ER8734), administration date: 06Apr2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "tested positive for COVID"; BNT162b2 (Dose 2, Single; Lot Number: ER8734), administration date: 27Apr2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "tested positive for COVID". The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Has dropped some weight over the last few days"; PYREXIA (non-serious), outcome "recovering", described as "Fever"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "Hot cold sweats"; DIZZINESS (non-serious), outcome "recovering"; ASTHENIA (non-serious), outcome "not recovered", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He got the original first 2 shots of COVID vaccine and got the booster shot in December and after a month tested positive for COVID this Tuesday. Reporter asked what was the process of getting another booster shot. Patient has dropped some weight over the last few days. His fever has broken somewhat but he was still going through hot cold sweats, weakness, and dizziness. He has improved from the first day but still feels a lot of weakness. Patient did not visit emergency room or physician office. Family history was reported as none. Relevant lab test was reported as none. The patient did not receive any other vaccines on the same date of Pfizer vaccination. Since the vaccination, the patient had been tested for COVID-19 on 26Jul2022. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with any other AE.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Has dropped some weight over the last few days; Fever; Hot cold sweats; dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 57 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single; Lot Number: ER8734), administration date: 06Apr2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "tested positive for COVID"; BNT162b2 (Dose 2, Single; Lot Number: ER8734), administration date: 27Apr2021, when the patient was 56-year-old, for COVID-19 immunization, reaction(s): "tested positive for COVID". The following information was reported: WEIGHT DECREASED (non-serious), outcome "unknown", described as "Has dropped some weight over the last few days"; PYREXIA (non-serious), outcome "recovering", described as "Fever"; HYPERHIDROSIS (non-serious), outcome "recovering", described as "Hot cold sweats"; DIZZINESS (non-serious), outcome "recovering"; ASTHENIA (non-serious), outcome "not recovered", described as "weakness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He got the original first 2 shots of COVID vaccine and got the booster shot in December and after a month tested positive for COVID this Tuesday. Reporter asked what was the process of getting another booster shot. Patient has dropped some weight over the last few days. His fever has broken somewhat but he was still going through hot cold sweats, weakness, and dizziness. He has improved from the first day but still feels a lot of weakness. Patient did not visit emergency room or physician office. Family history was reported as none. Relevant lab test was reported as none. The patient did not receive any other vaccines on the same date of Pfizer vaccination. Since the vaccination, the patient had been tested for COVID-19 on 26Jul2022. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with any other AE.
Age: 5.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AEs were reported.; Medical assistant reported that a patient received a dose of VARIVAX which was reconstituted with polio vaccine (IPOL).; This spontaneous report was received from a medical assistant regarding a 5-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-JUL-2022, the patient was vaccinated with a second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose of 0.5 mL, lot #U022320, upon internal review the expiration date was established as 15-JUL-2023 (route of administration, and anatomical location were not provided) as prophylaxis, which was reconstituted with polio vaccine inactivated (reported as "IPOL") (4th dose, batch/lot #VIA021M) 0.5 mL (route of administration, expiration date and anatomical location were not provided) (Product preparation error). No additional adverse events were reported. The nurse mixed wrong vaccines instead of diluent, she did not pay attention to workflow. The vaccines had no experience temperature excursion reading from a digital data logger.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not reported.  On 07-JUL-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (0.5 mL, subcutaneously (SQ), lot number T020638 and expiration date was reported as 01-FEB-2022, but upon internal validation established as 26-FEB-2022; strength, anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; The patient inadvertently received a dose of PROQUAD instead of MMR II and/or VARIVAX; This spontaneous report as received from a medical assistant refers to a 15 year old patient. The patient received his/her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck) (VARIVAX) in May of 2022 (exact date was unknown). The medical assistant stated the patient was receiving "catch up vaccinations". The patient inadvertently received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot # W004030 exp date 02-AUG-2023) on 08-JUL-2022.and did not receive a second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and/or varicella virus vaccine live (oka/merck) (VARIVAX) wrong product administered). The patient had never received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) in the past. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; Caller reports that a patient was scheduled to receive a dose of RECOMBIVAX HB but was inadvertently administered a dose of VAQTA instead on 15-JUL-2022; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  The nurse stated that on 15-JUL-2022, the patient was scheduled to receive a dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (strength, dose/route/frequency of administration, lot number, and expiration date not reported) for prophylaxis but was inadvertently administered a dose of hepatitis A vaccine, inactivated (VAQTA) (wrong product administered) at a dose of 0.5 mL (strength, route/frequency of administration not reported) (lot number U012007 with expiration date on 18-JAN-2023) for prophylaxis.  The nurse denied that this was related to a product confusion and stated that the nurse simply grabbed the wrong vaccine to administer. No additional adverse events (AE) were reported (not adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Patient was administered expired GARDASIL 9; This spontaneous report was received from a medical assistant, concerning a female patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 14-JUL-2022, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number 1637651, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 09-JUN-2022) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (expired product administered). No additional adverse event reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Hypoacusis, Visual impairment
Clinical narrative: vision problems; hearing problems; balance problems; This spontaneous report was received from a lawyer and a currently 69 year old female patient regarding a case in litigation. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 09-MAR-2013, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose, route of administration, anatomical location not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, she was treated by providers for the following injuries resulting from patient's ZOSTAVAX use: vision problems, hearing problems and balance problems. At the reporting time, the outcome of the events was unknown.  The reporters considered vision problems, hearing problems and balance problems to be related to ZOSTAVAX.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP reported an adverse event. Caller explained GARDASIL 9 was administered to a 4 year old patient. No additional AE or PQC reported. No additional information provided.; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 02-AUG-2022, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot number: 775811 (strength, expiration date and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported (No adverse event).  Lot number 775811 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HBP reporting a patient was inadvertently administered a dose of MMR II after the labeled expiration date.; This spontaneous report has been received from a office manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 02-AUG-2022, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (recombinant human albumin (rHA) 0.5 milliliters (ml) as prophylaxis (lot number: T013727, which was determined to be valid, with an expiration date on 21-APR-2022) (scheme, route and anatomical location of administration was not reported) (Expired product administered). Caller confirmed the vaccine had no temperature excursions. No additional adverse event was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No Additonasl AE's a; improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 01-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot #U031561, expiration date: 06-APR-2023 (strength, exact dose and route of administration were not provided) for prophylaxis (Product storage error). No details regarding the storage conditions were provided. No adverse events were reported (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Caller reports no additional adverse reactions; Patient was administered 4th dose of GARDASIL 9 on 7/28/2022; This spontaneous report has been received from a prescriber nurse, concerning a female patient of unknown age.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date (reported as 0 months), 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) injection. On an unspecified date in 2016 (reported as 2 months) and in August 2016 (also reported as 6 months), the patient was vaccinated with the second and third doses, respectively, of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. The three doses were administered at a dose of 0.5 ml as prophylaxis (lot numbers, expiration dates, routes of administration, and anatomical locations were not provided).   On 28-JUL-2022, the patient was administered with a 4th dose of rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) as prophylaxis (Extra dose administered).  No additional adverse reactions were reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Malaise, Pain
Clinical narrative: interfere with daily activites for 2 days; body aches/ pain for a week; general malaise; This case was reported by a physician via sales rep and described the occurrence of activities of daily living impaired in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced activities of daily living impaired, general body pain and malaise. On an unknown date, the outcome of the activities of daily living impaired, general body pain and malaise were recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired, general body pain and malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's comments: The patient reported that she had general malaise, body aches and pain for a week after the vaccination. It was not debilitating but strong enough to interfere with daily activities for the first two days. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first dose 9/21 but didn't get second dose; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (8 times prior to this reporting).   In September 2021, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. In July 2022, less than a year after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the patient experienced 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 Shingles vaccine.     Additional Information: GSK receipt date: 1-Aug-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The patient received 1st dose of the vaccine in September 2021 but did not get the second dose. The patient broke out with shingles this week. The patient wanted to ask how long patient should wait before getting the vaccine. Also wanted to ask patient would need 2 doses or just one. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow up would not possible since contact details were not provided.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: dose administered after expiration date; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a male patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-AUG-2022 Reporter's comment: The Healthcare Professional (HCP) reported that a patient had received Bexsero dose, which was already expired on 31st July 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: temperature excursion for PEDIARIX, administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th July 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 4-Aug-2022 Reporter comment: The reporter stated that the temperature excursion for Pediarix that was administered to the patient.  The temperature excursion with a lowest temperature of 35.9 Fahrenheit was for 40 minutes on 18th July 2022. Additional Supportive Information: Pediarix was at lowest temperature of 35.9 Fahrenheit  for 40 minutes, which lead to Incorrect storage of drug. This case was linked with case US2022AMR115318, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR115318:Same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Incorrect route of product administration, Pain, Pain in extremity
Clinical narrative: pain in left arm; pain in her left arm that radiates up to her shoulder; pain up shoulder; got vaccine subQ versus intramuscular; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2021, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. On 14th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm, radiating pain, shoulder pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the pain in arm, radiating pain and shoulder pain were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the pain in arm, radiating pain and shoulder pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: Caller was a nurse stating that she got the first dose of Shingrix vaccine subcutaneous versus intramuscular in left arm.  Since getting the vaccine subcutaneous, she has had pain in her left arm that radiated up to her shoulder. In November 2021, patient received second dose of 0.5 ml Shingrix via intramuscular route in right arm. The consent to follow up was not granted. Additional Supportive Information: As patient received Shingrix via subcutaneous route instead of intramuscular route, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to infant less than 1 YO; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix 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 Information: GSK Receipt Date: 29-Jul-2022 Reporter's Comments: The pharmacist reported a Kinrix might had been administered to an infant less than one year of age. Healthcare professional unsure if this happened but they were investigating, he was anonymous in the original case but agreed to follow up via email. Additional Supportive Information: The infant patient was administered with Kinrix vaccine, which led to inappropriate age at vaccine administration.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: rash in the injection site; rash in the abdomen area/Rash could be a herpes zoster rash; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 7bc47, expiry date 9th June 2023) for prophylaxis.   On 14th July 2022, the patient received the 1st dose of Shingrix. On 19th July 2022, 5 days after receiving Shingrix, the patient experienced injection site rash and vesicular rash. On 19th July 2022, the outcome of the injection site rash and vesicular rash were recovered/resolved.   It was unknown if the reporter considered the injection site rash and vesicular rash to be related to Shingrix.     Additional Information: GSK receipt date:01-Aug- 2022 Reporters comment:  The patient developed rash in the abdomen area and in the injection site. The reporter consented for follow-up. Rash could be a herpes zoster rash. Additional Supportive information: The HCP mentioned that he was not sure if the rash was herpes zoster, herpes zoster was not considered.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose (2022-July-4) of the Engerix-B vaccine on 2022-July-15) inadvertently; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HBV (Engerix B) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 15th July 2022, the patient received Engerix B. On 15th July 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-AUG-2022 Reporter's comment: The Healthcare Professional (HCP) reported that a patient had received an expired dose of 4th July 2022 of the Engerix-B vaccine on 15th July 2022 inadvertently. The reporter consented to follow-up.  Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used. The case was linked with case US2022AMR114215, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR114215:Same reporter
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Bexsero had expired the day before; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 2022, unknown after receiving Bexsero and an unknown time after starting Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-AUG-2022 Reporter's comments: The Healthcare Professional (HCP) office manager reported that a medical assistant had given a dose of Bexsero that had expired the day before. The vaccine administration facility is the same as primary reporter. The reporter did not consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Product prescribing error
Clinical narrative: prescription to start a 2nd series of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of product prescribing error in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included organ transplant (had organ transplant on an unknown date). Previously administered products included Shingrix (completed the series in 2018).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.   Additional Information: GSK Receipt Date: 1-Aug-2022 Reporter's Comments: The patient had completed the Shingrix series in 2018 and had a organ transplant. The patient had a prescription to start a 2nd series of Shingrix. The reporter did not know what type of transplant and the patient had not yet received any repeat doses. The reporter consented to follow up. Additional Supportive Information: The patient had a prescription to start a 2nd series of Shingrix, which led to Product prescribing error.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-Aug-2022 Reporter's comment: A nurse reported that a patient received an expired dose of Infanrix. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Infanrix, which led to expired vaccine used.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received Bexsero and Meningococcal B Vaccine Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Bexsero and Meningococcal B Vaccine Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:02-Aug- 2022 Reporters comment: The reporter consent for follow-up. Additional Supportive information: The patient received an expired (31-July-2022) dose of the bexsero vaccine on 2-August-2022 which led Expired vaccine used. .
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea; Pimples on face; Tiredness; Fever; Nausea; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of pimples in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2022, 5 hrs after receiving Shingrix, the patient experienced headache and chills. On 30th July 2022, the patient experienced tiredness, fever and nausea. On 31st July 2022, the patient experienced pimples. On 1st August 2022, the patient experienced diarrhea. On 1st August 2022, the outcome of the fever, nausea and chills were recovered/resolved. On an unknown date, the outcome of the pimples, tiredness and headache were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the pimples, diarrhea, tiredness, fever, nausea, headache and chills to be related to Shingrix.     Additional Information: GSK receipt date: 02-Aug-2022 Reporter comment: This case was self-reported by the patient. The patient received Shingrix vaccine on the left arm. The patient received the Shingrix vaccine after 5 hours and patient developed a headache and chills. One day after receiving vaccination, the patient experienced a fever, nausea and feeling very tired. The fever and nausea resolved, but the tiredness persisted. Two day after receiving vaccination, reported small yellowish puss filled pimples on her face including the forehead, chin and between the eyebrows and cheeks.  Last night 3 days after receiving vaccination, the patient experienced diarrhea not yet resolved but was better.  The reporter does not give permission to contact health care professional, but does give permission to contact her.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Diarrhea; Pimples on face; Tiredness; Fever; Nausea; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of pimples in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2022, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2022, 5 hrs after receiving Shingrix, the patient experienced headache and chills. On 30th July 2022, the patient experienced tiredness, fever and nausea. On 31st July 2022, the patient experienced pimples. On 1st August 2022, the patient experienced diarrhea. On 1st August 2022, the outcome of the fever, nausea and chills were recovered/resolved. On an unknown date, the outcome of the pimples, tiredness and headache were not recovered/not resolved and the outcome of the diarrhea was recovering/resolving.   It was unknown if the reporter considered the pimples, diarrhea, tiredness, fever, nausea, headache and chills to be related to Shingrix.     Additional Information: GSK receipt date: 02-Aug-2022 Reporter comment: This case was self-reported by the patient. The patient received Shingrix vaccine on the left arm. The patient received the Shingrix vaccine after 5 hours and patient developed a headache and chills. One day after receiving vaccination, the patient experienced a fever, nausea and feeling very tired. The fever and nausea resolved, but the tiredness persisted. Two day after receiving vaccination, reported small yellowish puss filled pimples on her face including the forehead, chin and between the eyebrows and cheeks.  Last night 3 days after receiving vaccination, the patient experienced diarrhea not yet resolved but was better.  The reporter does not give permission to contact health care professional, but does give permission to contact her.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had not received dose 2 yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on 7th January 2022).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  GSK receipt date: 02-Aug-2022 Reporter comment: Nobody every reminded patient to take second dose before 6 months.  The patient had not received second dose yet.  Education was provided. Referred to health care professional. Medical information phone number was given. 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.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB835AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: The office manager called in to report an expired Bexsero dose was inadvertently administered to a patient. No other details provided. The reporter consented to follow up. Additional Supportive Information: The administration of expired dose of Bexsero to the patient, dose was expired since 31st July 2022, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA576A, expiry date 31st July 2022) for prophylaxis.   On 3rd August 2022, the patient received Menveo. On 3rd August 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022114880   Additional Information: GSK Receipt Date: 03-AUG-2022. Reporter's Comments: The licensed practical nurse (LPN) reported that they administered today on the day of reporting an expired dose of Menveo to a patient.  The consent to follow up was granted. Additional Supportive Information: As patient received Menveo beyond expiry date, which led to expired vaccine used. This case was linked with US2022114880 reported by same reporter for same patient for Bexsero dose.; Sender's Comments:  US-GSK-US2022114880:Same reporter
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired dose to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022114879   Additional Information: GSK Receipt Date: 03-AUG-2022 Reporter's Comments: The nurse reported that they administered an expired dose of Bexsero to a patient. The reporter consented to follow up. Additional Supportive Information:  The administration of expired dose of Bexsero to the patient, dose was expired since 31st July 2022 which led to expired vaccine used. This case was linked with US2022114879 reported by same reporter for different suspect vaccine.; Sender's Comments:  US-GSK-US2022114879:Same reporter
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd August 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter comment: The nurse reported that the patient was administered a dose of Bexsero on 02th Aug 2022 , which had an expiration date of 31th Jul 2022.   This was the patient's second dose in the series.  At the time of reporting, the dose has not been repeated. Did not consent to follow-up. Additional supportive Information: The patient received vaccine which was already expired which lead to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: was administer with a two days expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The pharmacist reported that a patient was administered with a two days expired dose of Bexsero. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: was given an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABxb35aa, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The medical assistant stated that a patient was given an expired dose of Bexsero in left arm on the day of reporting. No side effects were reported. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.