chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AE reported.; The patient was supposed to receive an unspecified meningitis vaccine, but instead, the medical assistant administered GARDASIL 9; The patient was supposed to receive an unspecified meningitis vaccine, but instead, the medical assistant administered GARDASIL 9; This spontaneous report was received from a registered nurse and refers to a male patient of unknown age. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 21-APR-2016, the patient was vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (exact dose, lot #, expiry date, site and route of administration were not provided) for prophylaxis. The patient was supposed to receive an unspecified meningitis vaccine, but instead, the medical assistant administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Wrong product administered, Extra dose administered). Per the patients immunization record, he had already received doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 21-APR-2016, 23-JUN-2016, and 08-NOV-2016. The 4th dose was administered 29-AUG-2022 during a visit for a physical examination. No additional adverse event was reported.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-AUG-2022, the patient was vaccinated with improperly stored one dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis orally (strength, and route of administration were not provided) lot #w004504, expiration date: 16-JUN-2023 or lot# W002562 which has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) expiration date reported as 12-OCT-2023, the same as internal validation (product storage error). The healthcare worker did not specify which actual lot the patient received. Administrated vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 11.3 Celsius degrees for 34 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse events).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE were reported; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report as received from a healthcare worker refers to a 4-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 29-AUG-2022, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # W002562 with expiration date 12-OCT-2023 or lot # W004504 with expiration date 16-JUN-2023 (the patient received only one dose but the healthcare worker did not specify which actual lot number the patient received) (exact dose was not reported) as prophylaxis (product storage error). The vaccine was stored in the temperature of 11.3 degrees Celsius for 34 minutes. There was no previous temperature excursion. No additional adverse events were reported (no adverse event).
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report was received from a healthcare worker and refers to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-AUG-2022, the patient was vaccinated with improperly stored 1 dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, for prophylaxis (strength, and route of administration were not provided) lot # w004504, expiration date: 16-JUN-2023 or lot# W002562 which has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) expiration date reported as 12-OCT-2023, the same as internal validation (product storage error). The healthcare worker did not specify which actual lot the patient received. Administrated vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was stored at 11.3 Celsius degrees for 34 minutes, no previous temperature excursion were reported.  There were no adverse events reported (no adverse events).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Occupational exposure to product
Clinical narrative: No additional AE reported.; Caller was Physician. Caller reported AE for Nurse. At same call time, Caller reported Separate AE for Patient (See AE Case# 02242794).   Patient was administered a partial PROQUAD dose on 09/08/2022 (See AE Case# 02242794); corresponding Patient was; This spontaneous report was received from a physician and refers to a nurse of unknown gender and age. The nurse's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-SEP-2022, while the nurse was administering measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, for prophylaxis (dose, strength, lot number, expiration date, and route of administration were not provided) to an unspecified patient, it was reported that the patient was "wiggling" and the nurse's eye was exposed to the vaccine (occupational exposure to product). No additional adverse event was reported (no adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2209USA003013:Same Reporter Link
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; healthcare professional in charge of vaccine storage calling for evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. Healthcare professional provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare professional and refers to a patient of unknown age and gender. Concomitant therapies included sterile diluent. There was no information about the patient's concurrent conditions, drug reactions, allergies or medical history provided.  On 06-SEP-2022, the patient was administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot # U031360 was confirmed to be valid, with expiration date 07-OCT-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).; Sender's Comments:  US-009507513-2209USA002722:02242097 US-009507513-2209USA002779:02242131 US-009507513-2209USA003055:02242082 US-009507513-2209USA002510:02242136 US-009507513-2209USA002557:02242137 US-009507513-2209USA002540:02242138 US-009507513-2209USA002566:02242139 US-009507513-2209USA002746:02242132 US-009507513-2209USA002481:02242135 US-009507513-2209USA002745:02242092 US-009507513-2209USA002570:02242096 US-009507513-2209USA002574:02242099 US-009507513-2209USA002469:02242101 US-009507513-2209USA002559:02242113 US-009507513-2209USA002573:02242103 US-009507513-2209USA002606:02242106 US-009507513-2209USA002532:02242109
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details available; HBP in charge of vaccine storage calling for TE evaluation on refrigerated products that occurred 9/5/2022. Products were administered to multiple patients. HBP provides initials for all patients involved.  Names of vaccines involved (including lot/e; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. Concomitant therapies included sterile diluent. There was no information about the patient's concurrent conditions, drug reactions, allergies or medical history provided.  On 07-SEP-2022, the patient was administered a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection, lot # U031360 was confirmed to be valid, with expiration date 07-OCT-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). It was unknown if data logger was used to capture the temperature excursion. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).; Sender's Comments:  US-009507513-2209USA002722:02242097 US-009507513-2209USA002779:02242131 US-009507513-2209USA003021:02242077 US-009507513-2209USA002510:02242136 US-009507513-2209USA002557:02242137 US-009507513-2209USA002540:02242138 US-009507513-2209USA002566:02242139 US-009507513-2209USA002746:02242132 US-009507513-2209USA002481:02242135 US-009507513-2209USA002745:02242092 US-009507513-2209USA002570:02242096 US-009507513-2209USA002574:02242099 US-009507513-2209USA002469:02242101 US-009507513-2209USA002559:02242113 US-009507513-2209USA002573:02242103 US-009507513-2209USA002606:02242106 US-009507513-2209USA002532:02242109
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other adverse event occurred; Customer reported an AE for VARIVAX and MMRII. The caller said these products were administered to the patient after two temperature excursions occurred. Confirmed with caller no other AE occurred. Caller did not specify if she could be contacted. AE; This spontaneous report was received from a consumer concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-SEP-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U019291, expiration date: 18-JUN-2023, (strength, and route of administration were not provided); and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164, expiration date: 09-SEP-2023, (strength, and route of administration were not provided), both administered as prophylaxis.  The reporter stated that the vaccines were administered to the patient after two temperature excursions at a temperature of 5.9 Celsius degrees (C) for 10 hours, and 8.8C for 8 hours (product storage error). There were no previous temperature excursions and no other adverse events reported.   This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2209USA004041:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported. No PQC reported.    ?    Names of vaccines involved (including lot/exp) PROQUAD (W0; This spontaneous report has been received from a physician, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 29-AUG-2022, the patient was vaccinated with an improperly stored dose of with improperly storage dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, for prophylaxis (lot number: W017570, which was determined to be valid, with an expiration date on 29-NOV-2023) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 5.7 degrees Fahrenheit (F), during a time frame of 30 minutes (product storage error). There was a previous temperature excursion reported of 6 F up to 14 F (9.1 F) for 1 hour and 6 minutes.The administered doses of the vaccines had additional prior excursion on 18-JUL-2022, at a temperature of 6 F up to 14 F (10 F) during a time frame of 1 hour and 8 minutes.   No additional adverse events were reported in the patient.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; PROQUAD was administered after a temperature excursion; This spontaneous report has been received from an "HBP" responsible for vaccines concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 18-JUL-2022, the vaccine of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) had a previous temperature excursion of 6 degrees Fahrenheit (F) up to 14 F (10F) for 1 hour and 8 minutes and 0 seconds, and another temperature excursion on an unspecified date of 6 F up to 14 F (9.1 F) for 1 hour and 6 minutes and 0 seconds.    On 07-SEP-2022, the patient was vaccinated with an improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) administered as prophylaxis, lot number W017570 with expiration date 29-NOV-2023 (dosage frequency and route of administration were not provided). The previously mentioned vaccine underwent a temperature excursion of 5.7 F for 30 minutes and 0 seconds. No additional adverse event were reported (No adverse event).
Age: 0.08
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Inbound call from HCP reporting a 1 month old was inadvertently administered a VAQTA instead of a hepatitis B vaccine.; No additional AE details or PQC.; This spontaneous report was received from a registered nurse and refers to an 1-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 13-SEP-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, 0.5 milliliter, lot #W015191, expiration date: 27-OCT-2023 (route of administration were not provided) instead of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) reported as hepatitis B vaccine (strength, dose, lot #, expiration date and route of administration were not provided) for prophylaxis (Wrong product administered). No adverse events were reported (No adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Blood immunoglobulin G, Fibrin D dimer increased, Heparin-induced thrombocytopenia test positive, Immunoglobulin therapy, Immunology test
Clinical narrative: Vaccine-induced immune thrombotic thrombocytopenia; Literature Article:   Information has been received from the authors of a published literature article, titled as stated above, regarding a 25-year-old female patient without a history of heparin exposure. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, route, lot #, expiry date, and anatomical location of administration were not provided).  On an unknown date, 10 days after vaccination, the patient developed vaccine-induced immune thrombotic thrombocytopenia (VITT), thrombosis sites included the right internal iliac vein and bilateral pulmonary emboli.   On an unknown date, she underwent several laboratory tests including D-dimer which levels were elevated, the reactivity of patient's sample to activated platelet factor 4 (PF4)polyanion complexes evaluated in a heparin-induced thrombocytopenia (HIT) enzyme-linked immunosorbent assay (ELISA) showed that patient 's antibodies strongly recognized polyanion-complexed PF4 and assay's positive cutoff was 0.4 optical density (OD). Additionally, patient's serum in the un-complexed PF4 ELISA (which was considered a vaccine-induced immune thrombotic thrombocytopenia (VITT) specific assay) showed that her antibodies strongly recognized un-complexed PF4 and assay's positive cutoff was 1.0 optical density.    The patient was treated with intravenous immunoglobulin G (IVIg), to which she responded promptly. Subsequently, her levels of immunoglobulin G (IgG) were quantified and showed 7.88 mg/mL.   Then, on an unknown date, 12 months after acute presentation, a sample was obtained and continued to test strongly positive (greater than >1.0 OD) in both PF4polyanion and un-complexed PF4 ELISAs.   At the time of follow-up, the patient's platelet count sampling was 246000/micro-L considered as normal and she was clinically stable with no thrombosis/thrombocytopenia (recovered).   The author considered vaccine-induced immune thrombotic thrombocytopenia to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was specified that this vaccine is based on virus-like particle technology and does not utilize adenoviral vectors where patient antibodies strongly recognized uncomplexed PF4.    Upon internal review, the event vaccine-induced immune thrombotic thrombocytopenia was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: HPV9
Symptoms: Pelvic venous thrombosis, Platelet count, Platelet factor 4 increased, Pulmonary embolism, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Vaccine-induced immune thrombotic thrombocytopenia; Literature Article:   Information has been received from the authors of a published literature article, titled as stated above, regarding a 25-year-old female patient without a history of heparin exposure. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (dose, route, lot #, expiry date, and anatomical location of administration were not provided).  On an unknown date, 10 days after vaccination, the patient developed vaccine-induced immune thrombotic thrombocytopenia (VITT), thrombosis sites included the right internal iliac vein and bilateral pulmonary emboli.   On an unknown date, she underwent several laboratory tests including D-dimer which levels were elevated, the reactivity of patient's sample to activated platelet factor 4 (PF4)polyanion complexes evaluated in a heparin-induced thrombocytopenia (HIT) enzyme-linked immunosorbent assay (ELISA) showed that patient 's antibodies strongly recognized polyanion-complexed PF4 and assay's positive cutoff was 0.4 optical density (OD). Additionally, patient's serum in the un-complexed PF4 ELISA (which was considered a vaccine-induced immune thrombotic thrombocytopenia (VITT) specific assay) showed that her antibodies strongly recognized un-complexed PF4 and assay's positive cutoff was 1.0 optical density.    The patient was treated with intravenous immunoglobulin G (IVIg), to which she responded promptly. Subsequently, her levels of immunoglobulin G (IgG) were quantified and showed 7.88 mg/mL.   Then, on an unknown date, 12 months after acute presentation, a sample was obtained and continued to test strongly positive (greater than >1.0 OD) in both PF4polyanion and un-complexed PF4 ELISAs.   At the time of follow-up, the patient's platelet count sampling was 246000/micro-L considered as normal and she was clinically stable with no thrombosis/thrombocytopenia (recovered).   The author considered vaccine-induced immune thrombotic thrombocytopenia to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). It was specified that this vaccine is based on virus-like particle technology and does not utilize adenoviral vectors where patient antibodies strongly recognized uncomplexed PF4.    Upon internal review, the event vaccine-induced immune thrombotic thrombocytopenia was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: low rubella titer; This spontaneous report was received from a female healthcare professional of unknown age who was referring to herself. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date, the was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot #, expiration date and route of administration were not provided) for immunization. The patient received dose when she was small and has no record of vaccination.  On an unknown date, the had low rubella titer (Rubella antibody negative). The outcome of the event was unknown. Action taken was not applicable.  The causal relationship between low rubella titer and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Pyrexia
Clinical narrative: The patient developed a fever of 102F; Caller explained a patient was inadvertently administered PROQUAD and VARIVAX at the same time.; This spontaneous report was received from  a nurse regarding a male patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-SEP-2022, the patient was inadvertently vaccinated at the same time with measles, mumps, rubella and varicella (rHA) (oka-merck) virus vaccine live (PROQUAD) lot #W016355, expiration date: 29-OCT-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002596, expiration date: 24-JAN-2024, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Accidental overdose). On the same day, he developed fever of 102 Fahrenheit (F). It was unknown whether the patient received treatment. At the time of reporting, the outcome of fever was not provided.  The causal relationship between fever and measles, mumps, rubella, varicella (oka-merck) virus vaccine live (PROQUAD), and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Hand-foot-and-mouth disease, Nasopharyngitis, Pyrexia, Rash, Secondary transmission
Clinical narrative: The patient developed a fever of 102F; Caller explained a patient was inadvertently administered PROQUAD and VARIVAX at the same time.; This spontaneous report was received from  a nurse regarding a male patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-SEP-2022, the patient was inadvertently vaccinated at the same time with measles, mumps, rubella and varicella (rHA) (oka-merck) virus vaccine live (PROQUAD) lot #W016355, expiration date: 29-OCT-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002596, expiration date: 24-JAN-2024, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Accidental overdose). On the same day, he developed fever of 102 Fahrenheit (F). It was unknown whether the patient received treatment. At the time of reporting, the outcome of fever was not provided.  The causal relationship between fever and measles, mumps, rubella, varicella (oka-merck) virus vaccine live (PROQUAD), and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Cough, Decreased appetite, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: The patient developed a fever of 102F; Caller explained a patient was inadvertently administered PROQUAD and VARIVAX at the same time.; This spontaneous report was received from  a nurse regarding a male patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-SEP-2022, the patient was inadvertently vaccinated at the same time with measles, mumps, rubella and varicella (rHA) (oka-merck) virus vaccine live (PROQUAD) lot #W016355, expiration date: 29-OCT-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002596, expiration date: 24-JAN-2024, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Accidental overdose). On the same day, he developed fever of 102 Fahrenheit (F). It was unknown whether the patient received treatment. At the time of reporting, the outcome of fever was not provided.  The causal relationship between fever and measles, mumps, rubella, varicella (oka-merck) virus vaccine live (PROQUAD), and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: M
Vaccine: MMRV, VARCEL, VARCEL, HEPA, MMRV, VARCEL
Symptoms: Secretion discharge, Vomiting, Wrong product administered
Clinical narrative: The patient developed a fever of 102F; Caller explained a patient was inadvertently administered PROQUAD and VARIVAX at the same time.; This spontaneous report was received from  a nurse regarding a male patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-SEP-2022, the patient was inadvertently vaccinated at the same time with measles, mumps, rubella and varicella (rHA) (oka-merck) virus vaccine live (PROQUAD) lot #W016355, expiration date: 29-OCT-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; and  varicella virus vaccine live (oka/merck) (VARIVAX) lot #W002596, expiration date: 24-JAN-2024, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Accidental overdose). On the same day, he developed fever of 102 Fahrenheit (F). It was unknown whether the patient received treatment. At the time of reporting, the outcome of fever was not provided.  The causal relationship between fever and measles, mumps, rubella, varicella (oka-merck) virus vaccine live (PROQUAD), and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: Vaccinated and boosted for shingles 3 years ago, got shingles now/suspected vaccination failure; Shingles on face (awful); Covid-19; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis, COVID-19 VACCINE for prophylaxis, COVID-19 VACCINE for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine, the 3rd dose of COVID-19 VACCINE, the 2nd dose of COVID-19 VACCINE and the 1st dose of COVID-19 VACCINE. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine.     Additional Information: Receipt Date: 12-SEP-2022. Reporter's Comment: This case was reported by a patient via  interactive digital media. The patient was vaccinated with shingles vaccine and boosted for shingles three years ago and he/she got shingles now in his/her right side of face, awful. The patient stated that, was also vaccinated twice and boosted once for covid-19 and experienced covid. On an unknown date, unknown after receiving covid-19 vaccination the patient experienced shingles and covid-19.  The patient asked if the vaccines really work? The patient was not so sure about it now. It was unknown if the reporter considered the shingles and covid 19 to be related to covid 19 vaccine.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The event covid 19 and suspect covid 19 vaccine was coded conservatively. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingles shot but still got shingles/Suspected vaccination failure; Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient got the shingles shot but still got shingles.  The reporter wanted to know how long did the shot last. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had them even I had a shot/Suspected vaccination failure; I had them, not so good; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 13-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, he/she had the shingles even though he/she had a shingles shot already. The reporter stated that, it was not so good. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got 2 shots, then shingles/Suspected vaccination failure; still got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's comment: This case was reported by a patient's cousin via interactive digital media. The patient got two shots of Shingles vaccine and still got Shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Loss of personal independence in daily activities, Muscle strain, Pain in extremity
Clinical narrative: severe pain in right hand; Couldn't brush teeth, hold coffee cup,  brush hair/ thought it strained; got the same pain in every joint in my body; patient could not brush his/her teeth, hold a coffee cup or brush his/her hair; This case was reported by a consumer via interactive digital media and described the occurrence of pain in hand in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced pain in hand, muscle strain, joint pain and activities of daily living impaired. The patient was treated with steroids nos (Steroid Pack (Nos)). On an unknown date, the outcome of the pain in hand and joint pain were recovered/resolved and the outcome of the muscle strain and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain in hand, muscle strain, joint pain and activities of daily living impaired to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR130567   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: This case was reported by a patient via  interactive digital media. The reporter stated that, when he/she was of 63 years, he/she decided to get Shingles vaccine.  Five days after the first shot he/she started getting severe pain in my right hand.  The patient could not brush his/her teeth, hold a coffee cup or brush his/her hair.  The patient thought that he/she had strained it. After three weeks he/she went to the doctor who could not find anything wrong. He gave him/her a steroid pack and the pain was gone.  The patient had pain in every joint in his/her body. The patient stated that if you have any strange symptom after the first shot please do not get the second. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR130567 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR130567:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Myalgia
Clinical narrative: Still have sore muscles (side effects); Bad head ache (side effects); This case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness and headache. On an unknown date, the outcome of the muscle soreness and headache were not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Sep-2022 Reporter's comment: This case was reported by a patient via interactive digital media. Reporter stated that patient was at 4 days and still had sore muscles and bad headache. The reporter wanted to know how long would it last. Additional supportive information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got first dose on 8/23, on 9/9 had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd August 2022, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   The reporter considered the shingles to be possibly related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Sep-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient got the patient first dose of the shingles shot on 23 August 2022 and on 9th September 2022 went to physician and they said patient  had shingles. The pharmacist told to patient it was a possibility that the patient got it from the shot. Additional supportive information: The follow up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the vaccine, five days later got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-SEP-2022 Reporter's comment: The patient's relative reported this case via interactive digital media. The patient received dose of Shingles vaccine and five days later he got shingles. The reporter stated that he/she had almost over shingles (no shot) on his/her right hip area and they hadn't been bad at all. The reporter also stated that he/she must be lucky because everybody that has had them states how bad they hurt. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: arm was quite sore; headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date : 11-SEP-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received shingrix vaccine and experienced quite sore arm and headache for 24 hrs Additional Supportive information:The duration of the headache was 24 hrs hence outcome captured as recovered/resolved
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Did not receive 2nd dose due to Covid locked down; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2020).   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 social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter husband had the first dose of Shingrix. When the patient was due for the second does, everything was locked down due to Covid.  The patient never got the second dose.  No one seems to be able to tell us if he should now get the vaccine. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Engerix B series was incomplete; 1st Havrix 13jul2018, Twinrix Aug2022 / 2nd Engerix B Aug 2018, Twinrix Aug 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) (batch number j477y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and HBV (Engerix B) for prophylaxis.   Previously administered products included Havrix (received a dose of Havrix on 13th July 2018 with lot number 4h37y expiration date of 8th November 2020), Engerix B (received 1st dose on 13th July 2018 with lot number of 94s22 and expiration date of 4th September 2020 ) and Engerix B  (received 2nd dose in August 2018 ).   In August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 3rd dose of Engerix B. In August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose Twinrix (booster dose was late for Hepatitis A) later than the recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting the patient did not receive 3rd dose of Engerix-B, which led to incomplete course of vaccination. In situations where a booster dose of both hepatitis A and hepatitis B are desired, Twinrix can be given. Alternatively, subjects primed with Twinrix may be administered a booster dose of either of the monovalent vaccines. Therefore Twinrix coded with lengthening of vaccine schedule event was coded considering Twinrix as a booster for Havrix.
Sex: F
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: administered dose that was not reconstituted; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 7-week-old female patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th September 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 9th September 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication 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:09-SEP-2022 Reporter's Comment: The reporter declined to provide patient information aside from age and gender. The reporter reported that, a patient was administered a dose of Rotarix that was not reconstituted, so the patient only received the liquid diluent portion.  The reporter did not have the lot number / expiration date information at the time of call.  The patient had not been redosed at the time of reporting. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The reporter reported that, a patient was administered a dose of Rotarix that was not reconstituted, so the patient only received the liquid diluent portion, which led to inappropriate preparation of medication.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash, Urticaria
Clinical narrative: rash; hives-like rash; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 17-year-old female 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 and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 15th August 2022, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device and Menveo. In August 2022, 1 week after receiving Bexsero, Bexsero Pre-Filled Syringe Device and Menveo, the patient experienced rash and hives. On an unknown date, the outcome of the rash and hives were recovered/resolved.   It was unknown if the reporter considered the rash and hives to be related to Bexsero, Bexsero Pre-Filled Syringe Device and Menveo.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: 09-SEP-2022 and 12- SEP-2022 Reporter's Comments: The patient received her first dose of Bexsero and dose of Menveo. A week later she developed a rash that looked like hives all over her body. The health care professional was not sure if it was related to the Bexsero and Menveo. She had nothing else to report. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.