chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; 4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported.   On 31-Aug-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022).    No concomitant medication was reported.    No treatment information was reported.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19 on 02/13/2023. I had insomnia for 2 nights and felt like I was getting a head cold. I contacted my Physician and was prescribed a 5 day course of PAXLOVID, I was feeling better by 03/18/2023. On 03/19/2023 I tested positive for COVID-19 again. My symptoms were mild  this time.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19-2, FLU4
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 on 02/13/2023. I had insomnia for 2 nights and felt like I was getting a head cold. I contacted my Physician and was prescribed a 5 day course of PAXLOVID, I was feeling better by 03/18/2023. On 03/19/2023 I tested positive for COVID-19 again. My symptoms were mild  this time.
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Caller states patient started GARDASIL 9 series on 12/12/2022.  Patient received 2nd dose on 1/16/2023 and third dose on 2/15/2023.   GARDASIL 9 lot W000244  Expiration date 8/9/2024 for dose 1 and 2.  GARDASIL 9  Lot 1775827   Exp. 6/27/2024  for do; no advserse event; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-DEC-2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W000244, expiration date: 09-AUG-2024, administered intramuscularly (strength, and indication were not provided). On 16-JAN-2023 and on 15-FEB-2023, the patient received the second and third doses of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775827, expiration date: 27-JUN-2024, administered intramuscularly (strength, and indication were not provided) (Inappropriate schedule of product administration). No additional AEs reported.
Sex: U
Vaccine: HPV9, HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller states patient started GARDASIL 9 series on 12/12/2022.  Patient received 2nd dose on 1/16/2023 and third dose on 2/15/2023.   GARDASIL 9 lot W000244  Expiration date 8/9/2024 for dose 1 and 2.  GARDASIL 9  Lot 1775827   Exp. 6/27/2024  for do; no advserse event; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-DEC-2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W000244, expiration date: 09-AUG-2024, administered intramuscularly (strength, and indication were not provided). On 16-JAN-2023 and on 15-FEB-2023, the patient received the second and third doses of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775827, expiration date: 27-JUN-2024, administered intramuscularly (strength, and indication were not provided) (Inappropriate schedule of product administration). No additional AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: continue allergic reaction with Pfizer COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "continue allergic reaction with Pfizer COVID vaccine".  Additional Information: It was reported that the adverse event took place after the use of Pfizer product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: MMR, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; RN calling to report that expired STERILE DILUENT was administered along with MMR II (not expired). STERILE DILUENT expired on 12/24/2022 and was administered on 12/27/2022 to 1 year old patient.; This spontaneous report has been received from a registered nurse and refers to a 1 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 27-DEC-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)(strength, lot #, expiration date, dose, route and frequency were not reported) for prophylaxis; that was diluted with an expired sterile diluent 0.5 milliliter once (strength, lot # and route were not reported) for prophylaxis; which expiration date was 24-DEC-2022. It was mentioned that the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)was not expired. No adverse events were reported.
Sex: F
Vaccine: PNC15
Symptoms: Injury associated with device, Occupational exposure to product, Skin laceration, Syringe issue, Wound
Clinical narrative: VAXNEUVANCE syringe breaking in nurses hand and cutting her finger; VAXNEUVANCE syringe breaking in nurses hand and cutting her finger; VAXNEUVANCE syringe breaking in nurses hand and cutting her finger; two VAXNEUVANCE syringes were dropped and the necks of the syringe broke in half; This spontaneous report was received from a registered nurse via a company employee and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were unknown by reporter.   On an unknown date, two pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (indication: prophylaxis; strength, dose, lot #, expiry date and route of administration were not provided) syringes were dropped and the necks of the syringe broke in half (syringe issue). Nurse was concerned about the quality of the glass pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringes since this was the second time this happened. Nurse stated the last time this happened, the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringe broke in a nurse's hand and cut her finger (skin laceration, occupational exposure to product, injury associated with device). It was unknown whether the patient sought medical attention or any treatment was given. Information about lab diagnostics/studies was unknown by the reporter. The outcome of all events was unknown. The causal relationship between all events and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not provided.
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Adverse event
Clinical narrative: #AB659 is a legacy vote and legislators should know what Merck knows but is hiding from the public in their sealed documents; This spontaneous report was received from a consumer on a social media via Agency, regarding a case in litigation, referring to a patient of unknown age and gender. Information about the patient medical history, concomitant medications, drug allergies or reactions was not provided.  On an unspecified date, the patient was vaccinated with either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strengths, dosages, dose numbers, vaccination scheme frequencies, routes of administration, anatomical sites of applications, lot numbers and expiration dates were not provided) as prophylaxis (reported as "Help protect against certain HPV-related cancers and diseases").  On an unspecified date, the patient experience unspecified adverse event and the legislators wanted more information from the manufacturer.  At the reporting time, the outcome of the event was not reported. The causality assessment between the event and the company unidentified HPV vaccine administered was assessed as related.
Age: 33.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; HCP reported that a dose of PROQUAD was administered to a adult patient. No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from a medical assistant, referring to a 33-year-old female patient. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 24-MAR-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), at a dose of 0.5 millilite (ml) (stength, vaccination scheme, anatomical site of vaccination and route of administration was not reported; lot number W004694, expiration date was reported and validated as 08-AUG-2023) as prophylaxis (product administered to patient of inappropriate age). No additional adverse event reported.
Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: portion of the vaccine came out of her arm; No Adverse Event; This spontaneous report was received from a nurse refers herself a 32-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On unknown date, the patient was vaccinated with the three doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.   On unknown date (reported as: reporter did not know the exact date of the event sometime 2 years), reporter referred that when she received her 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) during the time of injection 2 years ago, portion of the vaccine came out of her arm. It was stated by nurse, that she always wondered if she was fully vaccinated (incorrect dose administered). She has completed all her 3 doses of vaccination. No additional adverse event reported (no adverse event).
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Pharmacist called in to report that a female patient was inadvertently administered one dose of MMR II on 03/29/2023 and one dose of MMR II today 03/30/2023.  The lot and expiration that is documented represents the dose that was administered on toda; This spontaneous report has been received from a pharmacist, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 29-MAR-2023, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided). Consequently, on 30-MAR-2023, the patient received another dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection as prophylaxis (lot number W034592 has been verified to be valid; expiration date reported and established as 10-MAY-2024) (strength, dose, route of administration, and anatomical location were not provided) (inappropriate schedule of product administration). No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Got shot, have it right now/ Suspected vaccination failure; Shingles in eye; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, have it right now/ Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in eye) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or She received Shingles vaccine and right now have wonder of shingles and even in his or her eye. The patient stated that he or she nothing like it and good luck. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient did receive a second dose for Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patient swho received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too long (Verbatim: patients did receive a second dose for Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The pharmacist called to report a late second dose of Shingrix The reporter stated that in pharmacy they receive various patients for a late second dose of Shingrix but did not had specific information to report. The reporter consented to follow up via email. This case was linked with US2023AMR043623 reported by the same reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2023043217:Same reporter
Sex: U
Vaccine: TDAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Boostrix given in less than the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received first dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Boostrix given in less than the recommended interval). The outcome of the extra dose administered 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: 21-MAR-2023 The reporter reported that multiple patients received Boostrix in less than the recommended interval.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. At the time of reporting, the patient received Boostrix in less than the recommended interval, which led to inappropriate schedule of vaccine administered. The reason why other patient's received 2 doses in less than recommended interval was not clarified. This case was linked with US2023043196 reported by the same reporter.; Sender's Comments:  US-GSK-US2023043196:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Viral infection, Weight decreased
Clinical narrative: Weight loss; Viral like syndrome, does not go away; This non-serious case was reported by a physician via call center representative and described the occurrence of weight loss in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included smoker (patient is a smoker) and chronic obstructive pulmonary disease (has COPD).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weight loss (Verbatim: Weight loss) and viral syndrome (Verbatim: Viral like syndrome, does not go away). The outcome of the weight loss and viral syndrome were not reported.   It was unknown if the reporter considered the weight loss and viral syndrome to be related to Shingrix.     It was unknown if the company considered the weight loss and viral syndrome to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAR-2023 The reporter reported that she has a patient who claimed he had a Shingrix vaccine given in 2019 and since that time he has had weight loss, viral like syndrome that last for several months and did not go away.  The symptoms occurred year after year after year in the spring. The reporter reported she had not seen the patient very long and did not have him when he received Shingrix and developed these symptoms.
Sex: U
Vaccine: DTAP
Symptoms: Atrial fibrillation
Clinical narrative: vaccine-associated atrial fibrillation; This serious case was reported in a literature article and described the occurrence of atrial fibrillation in a patient who received DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis.  On an unknown date, the patient received Diphtheria tetanus acellular pertussis. On an unknown date, an unknown time after receiving Diphtheria tetanus acellular pertussis, the patient experienced atrial fibrillation (Verbatim: vaccine-associated atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was not reported.   The reporter considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.    The company considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case refers to the patient from age group 0-17 years who received DTPa vaccine and had atrial fibrillation. The patient was a part of study which aimed to shed the light on the reported incidence of atrial fibrillation (AF) with different widely used vaccines. The Vaccine Adverse Event Reporting System (VAERS) was used between 1990 and 2021 to search for AF. In this study, the comprehensive evaluation of the incidence of AF in association with all vaccines (COVID, zoster, influenza, pneumococcal, hepatitis B, tetanus, diphtheria, and pertussis (TDAP), tetanus and diphtheria (TD), tetanus toxoid (TTOX), smallpox, anthrax, typhoid, meningococcal, hepatitis A, Lyme, measles, mumps, rubella (MMR), yellow fever, human papillomavirus (HPV), Japanese encephalitis virus, poliovirus, and varicella) was done. The association between the use of vaccines with arrhythmia adverse events was assessed by disproportionality signal detection analysis using the reporting odds ratio (ROR). Total 2341 cases of AF were reported. The patient received tetanus, diphtheria an acellular pertussis vaccine and experienced Vaccine-associated atrial fibrillation.; Sender's Comments:  US-GSK-US2023GSK048793:Same author US-GSK-US2023GSK048858:Same author
Sex: U
Vaccine: DTAP
Symptoms: Atrial fibrillation
Clinical narrative: vaccine-associated atrial fibrillation; This serious case was reported in a literature article and described the occurrence of atrial fibrillation in a patient who received DTPa (Diphtheria tetanus acellular pertussis) for prophylaxis.    On an unknown date, the patient received Diphtheria tetanus acellular pertussis. On an unknown date, an unknown time after receiving Diphtheria tetanus acellular pertussis, the patient experienced atrial fibrillation (Verbatim: vaccine-associated atrial fibrillation) (serious criteria GSK medically significant). The outcome of the atrial fibrillation was not reported.   The reporter considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.    The company considered the atrial fibrillation to be related to Diphtheria tetanus acellular pertussis.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case refers to the patient without age group reported who received DTPa vaccine and had atrial fibrillation. The patient was a part of study which aimed to shed the light on the reported incidence of atrial fibrillation (AF) with different widely used vaccines. The Vaccine Adverse Event Reporting System (VAERS) was used between 1990 and 2021 to search for AF. In this study, the comprehensive evaluation of the incidence of AF in association with all vaccines (COVID, zoster, influenza, pneumococcal, hepatitis B, tetanus, diphtheria, and pertussis (TDAP), tetanus and diphtheria (TD), tetanus toxoid (TTOX), smallpox, anthrax, typhoid, meningococcal, hepatitis A, Lyme, measles, mumps, rubella (MMR), yellow fever, human papillomavirus (HPV), Japanese encephalitis virus, poliovirus, and varicella) was done. The association between the use of vaccines with arrhythmia adverse events was assessed by disproportionality signal detection analysis using the reporting odds ratio (ROR). Total 2341 cases of AF were reported. The patient received tetanus, diphtheria an acellular pertussis vaccine and experienced Vaccine-associated atrial fibrillation.; Sender's Comments:  US-GSK-US2023GSK048793:Same author US-GSK-US2023GSK048184:Same author
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: 2nd dose administered/Boostrix + Administration in less than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3GX9E, expiry date 18-MAR-2024) for prophylaxis.   Previously administered products included Boostrix (received 1 dose of boostrix on 31st Mar 2022).   On 06-JUL-2022, the patient received Boostrix. On 06-JUL-2022, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: 2nd dose administered/Boostrix + Administration in less than recommended interval). The outcome of the extra dose administered 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 21-Mar-2023 The pharmacist reported that multiple patients received Boostrix in less than the recommended interval. The reporter could  only provide information for one of the patients who received one dose of boostrix on 31st March 2022 and the second dose was administered on 6th July 2022. It was mentioned that the reason of the 2nd dose was that the patient forgot about having the first dose. The Vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received boostrix on 31st March 2022 and the second dose was administered on 6th July 2022 which led to extra dose administered.; Sender's Comments:  US-GSK-US2023AMR043739:Same reporter
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose at almost 6 months old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number K33EZ, expiry date 15-JUL-2023) for prophylaxis.   On 08-FEB-2023, the patient received Rotarix lyophilized formulation. On 08-FEB-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: 1st dose at almost 6 months old). 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: 21-Mar-2023 Practice Manager called to inquire how to proceed with the Rotarix. Manager reported a patient received Rotarix first dose at almost 6 months of age administered. The patient only received Hep B at Birth. Did not consent to follow-up. The patient received Rotarix vaccine at almost 6 months of age, which led to inappropriate age at vaccine administration.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site nodule, Injection site pruritus
Clinical narrative: Nodule at injection site; Bruising at injection site; nodule is itchy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site nodule in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Shingrix. In MAR-2023, less than 2 weeks after receiving Shingrix, the patient experienced injection site nodule (Verbatim: Nodule at injection site), injection site bruising (Verbatim: Bruising at injection site) and injection site itching (Verbatim: nodule is itchy). The outcome of the injection site nodule, injection site bruising and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site nodule, injection site bruising and injection site itching to be related to Shingrix.     It was unknown if the company considered the injection site nodule, injection site bruising and injection site itching to be related to Shingrix.   Additional Information: GSK receipt date 21 Mar 2023 The reporter was patient.  The reporter stated that receiving first dose of Shingrix, in the right arm. The reporter noticed nodule at injection site approximately one week ago. The nodule was itchy.  The reported there was also bruising at the injection site. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired Bexsero dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number 7HH92, expiry date 28-FEB-2023) for prophylaxis.   On 16-MAR-2023, the patient received Bexsero. On 16-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired Bexsero dose administered). 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: 21 Mar 2023 The Nurse reported a medical assistant administered an expired vaccine of Bexsero. The Vaccine Administration Facility was the same as Primary Reporter.  The reporter consented to follow up via email. The patient received expired vaccine of Bexsero which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receive a second dose for shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st September 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: receive a second dose for shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The pharmacist called to report a late second dose of Shingrix The health care professional (HCP) firstly reported patient had not received a second dose, later on in the same call reported, that this patient did receive a second dose for Shingrix but date for the second dose was unknown. Information about lot number and expiration date was asked and hcp look in their system but it was not registered, so it was declined. The reporter consented to follow up via email. This case was linked with US2023043217 reported by the same reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.; Sender's Comments:  US-GSK-US2023AMR043623:Same reporter
Sex: U
Vaccine: DTAPIPV, TDAP
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Kinrix and Boostrix. On an unknown date, an unknown time after receiving Kinrix and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). 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: 21 Mar 2023 A medical assistant reported that Boostrix and Kinrix vaccines were exposed to 47.4 degree F and 30.2 degree F.The health care professional mentioned that the temperature probe was placed too close to the cooler. The some of these vaccines were administered, and asked if patients had to be re-vaccinated. The reporter did not share information about patients who received these doses nor information about Boostrix and Kinrix vaccines (lot number, date of administration, expiry date). Permission for follow up was not requested.
Age: 24.0
Sex: U
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: 24 YO received pediatric dose; 24 YO received pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 24-year-old patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: 24 YO received pediatric dose) and inappropriate age at vaccine administration (Verbatim: 24 YO received pediatric dose). The outcome of the accidental underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt date: 21-Mar-2023 The nurse accidentally gave pediatric or adolescent Havrix 0.5 mL to a 24-year-old adult.  This office had a nurse accidentally give pediatric or adolescent Havrix 0.5 mL to a 24-year-old adult.  The question was should the patient restart the 2 doses series at 1 mL, or could the office complete the series using 1 mL when patient was due for their second dose. The patient had 0.5 mL Havrix to a 24-year-old adult, which led to accidental underdose and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year ago, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over a year ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose a year ago, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The pharmacist called to enquire, if patient should start Shingrix series again or get the second dose. The reporter (RPH) reported that a patient had not received the second dose. The RPH inquired any information available because they were talking about what the guidance would be to provide patient. The RPH was unable to provide any patient nor vaccine details. The reporter did not consent to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2019, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The pharmacist asked if patient could receive the second dose or if the patient had to restart the vaccine series. The reporter did not had information about first dose of Shingrix (lot number, expiration date, date of administration). The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion used; Only liquid portion used; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA771A, expiry date 31-JAN-2024) for prophylaxis.   On 20-MAR-2023, the patient received Menveo. On 20-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion used) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion used). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The nurse informed that a patient accidentally received only the liquid portion of Menveo. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the liquid portion; Received only the liquid portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Received only the liquid portion) and inappropriate dose of vaccine administered (Verbatim: Received only the liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-MAR-2023 The patient's age was 12 years and 5 months old. The nurse reported that a patient received the liquid portion of Menveo. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Small blisters that resemble chicken pox; This non-serious case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-MAR-2023, the patient received the 2nd dose of Shingrix (left arm). On 21-MAR-2023, 1 days after receiving Shingrix, the patient experienced blister (Verbatim: Small blisters that resemble chicken pox). The outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.     It was unknown if the company considered the blister to be related to Shingrix.   Additional Information: GSK Receipt date: 21-MAR-2023 The consumer was the reporter. The patient had her 2nd Shingrix vaccination administered in her left arm and she has small blisters on her left arm that resemble chicken pox. The patient declined to provide any other information, including consent, MD name and phone number and consumer address.  No further information was known. The reporter did not consent to follow up.
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received Kinrixinstead of 4th DTap; 3 YO received Kinrix; Received Kinrixinstead of 4th DTap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 04-AUG-2022, the patient received Kinrix. On 04-AUG-2022, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: Received Kinrixinstead of 4th DTap), inappropriate age at vaccine administration (Verbatim: 3 YO received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Received Kinrixinstead of 4th DTap). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 21-Mar-2023 The nurse called to inform that 3-year-old patient had to receive the 4th dose of the DTap series but received a dose of Kinrix. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received kinrix instead of 4th dose of DTap at 3 years of age, which led to Wrong vaccine administered, Inappropriate schedule of vaccine administered and inappropriate age at vaccine administration.
Age: 34.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix adminsitered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 34-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 20-MAR-2023, the patient received Havrix. On 20-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix adminsitered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 The reporter was a retired nurse. The reporter did consent to follow up. The patient received a Havrix vccine which was already expired, which led to expired vaccine used.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Shingrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number FZ7Z4, expiry date 27-JAN-2023) for prophylaxis.   On 23-MAR-2023, the patient received Shingrix. On 23-MAR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Shingrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-MAR-2023 The reporter was a physician assistant. The reporter reported that the patient received expired Shingrix vaccine and wanted to know how to proceed with the patient. The reporter did consent to follow up. The patient received a Shingrix vaccine which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Blisters on hands and chest (ER); Pain from shingles; Had both doses in 2018, diagnosed with shingles in 2023/Suspected vaccination failure; Diagnosed with shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11-SEP-2018, the patient received the 2nd dose of Shingrix. On 08-MAY-2018, the patient received the 1st dose of Shingrix. On 29-MAR-2023, 1660 days after receiving Shingrix and 1786 days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Had both doses in 2018, diagnosed with shingles in 2023/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Diagnosed with shingles). On an unknown date, the patient experienced blister (Verbatim: Blisters on hands and chest (ER)) and pain (Verbatim: Pain from shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved and the outcome of the blister was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, blister and pain to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure, shingles, blister and pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 29-MAR-2023 The case was reported by the patient. The patient did not wish to provide his date of birth but provided current age. At 7 am morning on the day of reporting, the patient went to the emergency room because he had blisters on his hands and chest.  The patient was diagnosed with shingles and was given Valacyclovir for shingles treatment. The patient also experienced pain from the shingles.  The patient gave consent to follow up with healthcare professional (pharmacy). This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.