chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.   On 14-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 18-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 19-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 25-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 25-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 26-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 13-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 18-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pyrexia
Clinical narrative: felt achy; fever 100F; This case was reported by a consumer and described the occurrence of fever in a 59-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   On 2nd October 2020, the patient received Fluarix Quadrivalent 2020-2021 season. On 2nd October 2020, 6 hrs after receiving Fluarix Quadrivalent 2020-2021 season, the patient experienced fever. In October 2020, the patient experienced general body pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the general body pain was unknown.   It was unknown if the reporter considered the fever and general body pain to be related to Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows:  The case reported by patient himself. The developed a fever 100 degree F about 6 hours later which lasted overnight and into the next day. Less than a week, the patient felt achy.  Fever subsided 24 hours after injection. The patient saw only a small percentage of those in the trials had fever (less than 5 percentage). The patient would like to know the differences between the Fluvarix Quadrivalent vaccine administered to 2020- 2021 and the Fluvarix Quadrivalent vaccine that finished clinical trials around the 2017-2018 timeframe.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza, Vaccination failure
Clinical narrative: flu /suspected vaccination failure; flu; sick / it was the aluminum and the mercury and other contaminants, that where in the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Flu vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. When patient took the vaccine, it was the aluminum and the mercury and other contaminants, that where in the vaccine that made the patient sick right away. Because of that patient did not take nay vaccine. It has been a long time since patient had the flu. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Last time I had the flu was about 12 years ago after getting the shot / never again / suspected vaccination failure; Last time I had the flu was about 12 years ago after getting the shot / never again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine.  Additional case details were reported as follows: The reporter was the patient. The age at vaccination was not reported. The patient had flu shot 12 years before day of reporting and after getting the shot had flu. The patient did not want this again. This case was considered as suspected vaccination failure as details regarding laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The follow up was not required.
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test, Influenza like illness, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: At injection site, swollen, red warm lump moved down my arm / above the elbow; At injection site / red warm lump moved down my arm / above the elbow; At injection site / warm lump moved down my arm / above the elbow; At injection site / lump moved down my arm / above the elbow; I had flu like symptoms; Low fever for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth, injection site lump, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site lump were unknown and the outcome of the influenza-like symptoms and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site lump, influenza-like symptoms and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was due for her 2nd Shingrix shot but had an adverse reaction so did not know if should go ahead. Adverse reaction was at the injection site. Swollen, red warm lump moved down her arm until it was just above the elbowby day 4. The patient also had flu like symptoms and low fever for a couple of days but her arm reaction seemed worrying. The patient had an antibodies test the other day to see if another shot was needed and it was more than 8.0 but did not know how to interpret. The reporter consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: At injection site, swollen, red warm lump moved down my arm / above the elbow; At injection site / red warm lump moved down my arm / above the elbow; At injection site / warm lump moved down my arm / above the elbow; At injection site / lump moved down my arm / above the elbow; I had flu like symptoms; Low fever for a couple of days; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema, injection site warmth, injection site lump, influenza-like symptoms and fever. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth and injection site lump were unknown and the outcome of the influenza-like symptoms and fever were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site lump, influenza-like symptoms and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was due for her 2nd Shingrix shot but had an adverse reaction so did not know if should go ahead. Adverse reaction was at the injection site. Swollen, red warm lump moved down her arm until it was just above the elbowby day 4. The patient also had flu like symptoms and low fever for a couple of days but her arm reaction seemed worrying. The patient had an antibodies test the other day to see if another shot was needed and it was more than 8.0 but did not know how to interpret. The reporter consented to follow up
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Diarrhoea haemorrhagic, Gastrointestinal disorder
Clinical narrative: Bloody Diarrhea; gastrointestinal issues; This case was reported by a physician via call center representative and described the occurrence of bloody diarrhea in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number FX2TZ, expiry date 5th September 2021) for prophylaxis.   On 16th September 2020, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 30th September 2020, 14 days after receiving Rotarix lyophilized formulation, the patient experienced bloody diarrhea (serious criteria GSK medically significant) and gastrointestinal disorder. On an unknown date, the outcome of the bloody diarrhea and gastrointestinal disorder were recovering/resolving.   It was unknown if the reporter considered the bloody diarrhea and gastrointestinal disorder to be related to Rotarix lyophilized formulation.  Additional case details were reported as follows: The reporter inquired about the incidence of bloody diarrhea in a two month old patient that was given an oral dose of Rotarix. Two weeks later on 30th September 2020, patient started with gastrointestinal issues that on 1st October 2020, developed to bloody diarrhea. No other symptom was confirmed for the patient. The reporter consented to follow up. As per sales data sheet reported batch number was changed from  FX2TZ9521 to FX2TZ.. The gastrointestinal issues was considered as sign and symptoms of bloody diarrhea, and therefore accordingly event onset date was captured as 30 Sep 2020.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: experienced reoccurring shingles infections after receiving an older shingles vaccine/ suspected vaccination failure; experienced reoccurring shingles infections after receiving an older shingles vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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 was provided as follows: The case was reported by patient's husband. The age at vaccination was not reported. The patient experienced reoccurring shingles infections after receiving an older shingles vaccine. No additional information provided. The reporter did not consent to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Age: 6.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vision blurred
Clinical narrative: experienced blurry vision after receiving Bexsero and Menveo on the same day; This case was reported by a physician via call center representative and described the occurrence of blurred vision in a 6-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 25th September 2020, the patient received the 1st dose of Bexsero and the 1st dose of Menveo. On 26th September 2020, 1 days after receiving Bexsero and Menveo, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was recovered/resolved.   It was unknown if the reporter considered the blurred vision to be related to Bexsero and Menveo.  Additional details were reported as follows: The patient received Bexsero and Menveo vaccines on the same day and experienced blurry vision. Physician stated that the symptom started the following day and the last week the vision improved, and the patient was recovering. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Atrial fibrillation
Clinical narrative: AFib; This is a spontaneous report from a contactable physician via Pfizer Sales Representative. A 68-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) intramuscular in the left deltoid muscle on his left arm on 07Oct2019 at 0.5 mg single dose for pneumonia and invasive pneumococcal disease. Medical history included chronic coronary artery disease, Gastrooesophageal reflux disease (GERD), anxiety, and bleeding hemorrhoids.  Concomitant drugs when the patient was on at the time he received the pneumococcal 13-val conj vac (dipht crm197 protein) included amlodipine 5 mg once daily orally, acetylsalicylic acid (ASPIRIN 81) at 81 mg once daily orally, atenolol 55mg once a day by mouth, atorvastatin 40mg once a day by mouth, apixaban (ELIQUIS) 5mg twice a day by mouth, losartan 50mg once a day by mouth, sildenafil citrate (VIAGRA) 100 mg, sertraline hydrochloride (ZOLOFT) 150mg once a day by mouth.  Serious adverse event was reported as A-fib with onset date of 07Oct2019and seriousness criterion of hospitalization. The event clinical course was as follows: The patient went into A-fib on 07Oct2019. It was unknown exactly when A-fib began, but the patient went right to the hospital when it did begin. Patient was not in the provider's office when it began, it was sometime later that day, and the patient never told the provider until recent visit this year in Sep. It was unknown if the patient was admitted when he went to the hospital that day.  Outcome of the event was resolved.    Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently provided, A-fib occurrence most likely is associated with the patient underlying cardiovascular condition unlikely related to PREVNAR 13 use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: I need to get all my immunizations again since having that transplant; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization.  Medical history included stem cell transplant. The patient's concomitant medications were not reported.  The patient needed to get her/his all immunizations again since having that transplant on an unspecified date.  Outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: rash took place after use of product  that covered patient bicep; This is a spontaneous report from a contactable Pharmacist via sales representative. This Pharmacist reported similar events for 2 patients. This is first of 2 reports.   A female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The relevant medical history and concomitant medications were not reported. The Pharmacist had questions about reactions to pneumococcal 13-val conj vac (dipht crm197 protein) that included a rash that covered patient bicep. The pharmacist wanted to know if this had been happening more lately or if something was different because something similar occurred to another patient of hers. Event took place after use of product. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020399755 same reporter/drug, similar event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: rash took place after use of vaccine that covered patient bicep; This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported similar events for 2 patients. This is second of 2 reports. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash that took place after use of vaccine  and covered patient bicep on an unspecified date. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020399735 same reporter/drug, similar event, different patient.
Sex: U
Vaccine: FLUX
Symptoms: Gastroenteritis viral, Illness, Impaired work ability, Pharyngitis streptococcal
Clinical narrative: stomach viruses; strep throat; Initial information received on 07-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer through social media.  This case involves patient (unknown demographics) who experienced stomach viruses and strep throat, while he/she received vaccine INFLUENZA VACCINE.  The patient's past vaccination(s) included INFLUENZA VACCINE and experienced sick (patient worked with toddlers-adorable little germ factories that like to sneeze directly into your eyeballs after they lick the window and eat a cheerio they found on the playgeound. hadn't missed work in over 4 years).  Medical history, medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious stomach viruses four times and strep throat two times, (unknown latency) following the administration of INFLUENZA VACCINE. It was reported that patient missed 15 days of work in that time.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events was reported as unknown (not reported).  There will be no information available on the batch number for this case.
Age: 52.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Employee states her Right upper arm became swollen, tender, itchy with redness at the injection site and down her arm about 6 inches. Notified Employee Health and was referred to be seen in Urgent Care.   UC provider instructed employee to use ice, take Ibuprofen, Tylenol and to try Benadryl and Pepcid to relieve symptoms.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Eye movement disorder, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Few moments after shots he turned pale and faint followed by eye rolling and jerking for 2 seconds.
Age: 92.0
Sex: M
Vaccine: FLUA4
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Swelling and pain at site, extreme pain and unable to raise left arm. Still have same symptoms now 11 days after injection. Using muscle cream, but not much help.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: I don't have the lot number
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Malaise, Skin warm
Clinical narrative: left arm warm, red.  Patient has some malaise symptoms.  currently has symptoms, but not severe
Age: 79.0
Sex: M
Vaccine: UNK
Symptoms: Gait disturbance, Headache, Sleep disorder
Clinical narrative: Severe headache, unstable walking, dissupted sleep
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Urticaria
Clinical narrative: Round erythematous rash over left side of chest, scattered hives over his back
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Influenza, Pain, Pyrexia
Clinical narrative: Fever and severe chills and body aches. Definitely flu symptoms. Lasted 24 hours, then I gradually started feeling better. By the third day I feel normal, but a little tired.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Patient verbally reports she received both vaccines on 9/23/20. The week of October 4-10 (unclear which specific day), she developed symptoms of Bells Palsy. She was diagnosed with Bells Palsy on 10/13/20 by her Primary Care Provider. Patient has had Bells Palsy in the past. She reports her symptoms are worse on the left side, which is where she received the Shingles vaccine dose. She reports that she Is stable and being followed by her Primary Care Provider, however she was not evaluated or managed at this facility for the adverse event.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Computerised tomogram, Facial paralysis
Clinical narrative: Patient verbally reports she received both vaccines on 9/23/20. The week of October 4-10 (unclear which specific day), she developed symptoms of Bells Palsy. She was diagnosed with Bells Palsy on 10/13/20 by her Primary Care Provider. Patient has had Bells Palsy in the past. She reports her symptoms are worse on the left side, which is where she received the Shingles vaccine dose. She reports that she Is stable and being followed by her Primary Care Provider, however she was not evaluated or managed at this facility for the adverse event.
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: bells palsy
Age: 60.0
Sex: F
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Computerised tomogram, Facial paralysis
Clinical narrative: bells palsy
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Lethargy, Mobility decreased, Pain, Pyrexia
Clinical narrative: Around 2:00 am woke up with chills.  Woke up at 7:30am with fever of 102.0.   Achy, lethargic.  Couldn't get out of bed.  Slept till 3:00pm at which time fever was gone and I felt fine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Cranial nerve paralysis, Eye movement disorder
Clinical narrative: i received a phone call from mom who transfered out of our office to another state. while in this state, mom noticed that his eye was turning inward. mom stated that could not  get into a pediatric doctor so took him to see a doctor at clinic. per mom was told by that doctor that his eye turning inward was a result of his 4 yr. shots and that was common and told grow out of it or not. per mom that doctor called it cranial nerve palsy. mom then stated  went to eye doctor who told them that he needed glasses. per mom the doctor at clinic is suggesting that he get an MRI of the brain done.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Strabismus, Vaccination complication
Clinical narrative: i received a phone call from mom who transfered out of our office to another state. while in this state, mom noticed that his eye was turning inward. mom stated that could not  get into a pediatric doctor so took him to see a doctor at clinic. per mom was told by that doctor that his eye turning inward was a result of his 4 yr. shots and that was common and told grow out of it or not. per mom that doctor called it cranial nerve palsy. mom then stated  went to eye doctor who told them that he needed glasses. per mom the doctor at clinic is suggesting that he get an MRI of the brain done.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Corrective lens user, Eye movement disorder, Magnetic resonance imaging brain abnormal, Ophthalmological examination abnormal, Strabismus
Clinical narrative: i received a phone call from mom who transfered out of our office to another state. while in this state, mom noticed that his eye was turning inward. mom stated that could not  get into a pediatric doctor so took him to see a doctor at clinic. per mom was told by that doctor that his eye turning inward was a result of his 4 yr. shots and that was common and told grow out of it or not. per mom that doctor called it cranial nerve palsy. mom then stated  went to eye doctor who told them that he needed glasses. per mom the doctor at clinic is suggesting that he get an MRI of the brain done.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: VIth nerve paralysis
Clinical narrative: i received a phone call from mom who transfered out of our office to another state. while in this state, mom noticed that his eye was turning inward. mom stated that could not  get into a pediatric doctor so took him to see a doctor at clinic. per mom was told by that doctor that his eye turning inward was a result of his 4 yr. shots and that was common and told grow out of it or not. per mom that doctor called it cranial nerve palsy. mom then stated  went to eye doctor who told them that he needed glasses. per mom the doctor at clinic is suggesting that he get an MRI of the brain done.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, MMRV, DTAPIPV, MMRV, DTAPIPV
Symptoms: Strabismus
Clinical narrative: i received a phone call from mom who transfered out of our office to another state. while in this state, mom noticed that his eye was turning inward. mom stated that could not  get into a pediatric doctor so took him to see a doctor at clinic. per mom was told by that doctor that his eye turning inward was a result of his 4 yr. shots and that was common and told grow out of it or not. per mom that doctor called it cranial nerve palsy. mom then stated  went to eye doctor who told them that he needed glasses. per mom the doctor at clinic is suggesting that he get an MRI of the brain done.
Sex: M
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 19-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate: manufacturercountry: devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 20-AUG-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter