chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: 3US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry:; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004534: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004535: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004536:
Sex: U
Vaccine: HEPA, HEPA, HEPA, UNK, UNK, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; on 3/9/2020, patient received a dose of improperly stored PROQUAD that was reconstituted with properly stored MERCK DILUENT; Information has been received from an immunization consultant in charge of vaccine, who was also a healthcare worker, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 09-MAR-2020, the patient received a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot # S009756, expiration date 27-SEP-2020; dose and strength were unknown) subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. The vaccine was exposed to temperature excursion between 6 to 14 degrees Fahrenheit (11.3 degrees Fahrenheit) for 12 hours and 30 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.   This is one of four reports received from the same reporter. ; Sender's Comments:  US-009507513-2005USA004443: US-009507513-2005USA004496: US-009507513-2005USA004621:
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal pain, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: fatigue; vomiting; nausea; fever; abdominal pain; This case was reported by a physician via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th November 2021) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   On 6th May 2020, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMOVAX 23. In May 2020, less than a week after receiving Shingrix, the patient experienced fatigue, vomiting, nausea, fever and abdominal pain. On an unknown date, the outcome of the fatigue, vomiting, nausea, fever and abdominal pain were unknown.   It was unknown if the reporter considered the fatigue, vomiting, nausea, fever and abdominal pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine on unknown site and pneumonia vaccine on the left arm and experinced fatigue, vomiting, nausea, fever and abdominal pain. The doctor was transferred to medical information for additional assistance.  He did not want to provide date of birth or other information specific to the patient due to confidentiality concerns.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Diarrhoea, Pain, Rash, Vomiting
Clinical narrative: c/o body aches, rash, vomiting and diarrhea - was prescribed prednisone by mouth x 5 days
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported.; one patient received an improperly stored dose of VARIVAX; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On 21-APR-2020, the patient received an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S022755 with expiration date: 22-JUL-2021; route, strength, frequency, dose were unknown) for prophylaxis (incorrect product storage). The sterile diluent used to reconstitute the varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. No additional adverse effects reported.  Administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under 6 degrees fahrenheit (F) to 14F (7.89F) for 90 minutes. The previous temperature excursion was under 15F to 46F (26F) for 36 hours. The digital data logger was involved to capture the temperature excursion.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 17-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 16-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; on 5/8/2020 an improperly stored VARIVAX was administered to a patient; Information has been received from a medical assistant referring a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 08-MAY-2020, the patient was administered an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S025913, expiration date 20-AUG-2021; dose, strength and route were unknown) for prophylaxis. The sterile diluent that was used to reconstitute the vaccine was properly stored. The vaccine was exposed to temperature excursion between minus 14 degrees Celsius to minus 10 degrees Celsius (minus 11.2 degrees Celsius) for 9 hours and 58 minutes and excursion between minus 9 degrees Celsius to 8 degrees Celsius (3 degrees Celsius) for 13 hours and 35 minutes (incorrect product storage). There was no previous temperature excursion. The call was not due to digital data logger. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: sores on the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In January 2020, the patient received the 2nd dose of Shingrix. On 7th May 2020, between 3 and 4 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and noticed on the injection site that had sores. The reporter was this something to be concerned about.
Age: 7.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Patient received IPOL in office on 5/12/2020 and the vaccine that was given had expired on 4/26/2020.  This was the patient's 2nd of three dose series of IPOL ( Alternative schedule ).  Patient had no negative symptoms after receiving the vaccine.  Mom was contacted to let her child received expired vaccine.  When mom returns for 6 month booster, Dr would like to do a titer to assure that child is protected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Large, red painful lump at injection site.  Raised and approximately 5" by 3".  This is day 3 and it's just beginning to lessen in pain and color.  Also itchy
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 21-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 22-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Headache, Malaise, Pyrexia
Clinical narrative: fever like symptoms; slight shortness in breath; headache; not feeling to good for about 3 days; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, shortness of breath, headache and malaise. On an unknown date, the outcome of the fever, shortness of breath, headache and malaise were recovered/resolved.   It was unknown if the reporter considered the fever, shortness of breath, headache and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received shingrix and experienced fever like symptoms and slight shortness in breath the first 24hrs. The headache and just not feeling too good for about 3 days. At the time of reporting with covid 19 on the table the patient reluctant to get the second one. The reporter asked could he/she wait till the whole covid thing was over.
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury, Pain of skin, Skin laceration
Clinical narrative: feels like my skin is tearing; Skin tear; nerve endings seem to be increasing in hyper activity; This case was reported by a consumer and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 2nd dose of Shingrix. In October 2019, immediately after receiving Shingrix, the patient experienced nerve damage. On an unknown date, the patient experienced skin pain and skin tear. On an unknown date, the outcome of the nerve damage, skin pain and skin tear were not recovered/not resolved.   It was unknown if the reporter considered the nerve damage, skin pain and skin tear to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Shingrix and had nerve endings seem to be increasing in hyper activity. It seems to be getting worse. In fact, as of the last 30 to 60days it feels like my skin was tearing or shirts feel like sandpaper to my skin.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a other health professional via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter asked can 2nd dose of vaccine cause fever.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Contusion, Headache, Injection site erythema, Malaise
Clinical narrative: the injection site was very red/the size of an orange; did not feel well for about two weeks; had headache; whole arm was significantly bruised; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 23rd January 2020, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site erythema, malaise, headache and bruising of arm. On an unknown date, the outcome of the injection site erythema and malaise were unknown and the outcome of the headache and bruising of arm were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, malaise, headache and bruising of arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm and the injection site was very red, the size of an orange and the whole arm was significantly bruised.  She also had headache and did not feel well for about two weeks.  She also stated that she got the pneumonia vaccine in the right arm on the same day. The reporter consented to follow up.
Age: 0.08
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: ithe patient was injected with only liquid component of the Pentacel vaccine, no adverse event; Initial information was received on 08-May-2020 regarding an unsolicited valid non-serious case from a non-health care professional.  This case is linked to case 2020SA121416 (same reporter).  This case involves a one month old patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number U6615AA and expiration date) via an unknown route in the right thigh on 23-Apr-2020 for prophylactic vaccination. However, the patient was injected with only the liquid component of the pentacel vaccine.  The patient medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was given expired IPOL/ No AE; Initial information received on 11-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case is linked to case 2020SA125068 (same reporter).  This case involves a four years old female patient who on 06-May-2020 received 0.5 mL fifth dose of expired vaccine IPV (VERO) (lot P1A461M and expiry date 03-May-2020) via intramuscular route in the right arm for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used.  At a time of reporting no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: a 15 months old male patient was given a 0.5 ml dose of Act-Hib vaccine which was incorrectly reconstituted with sterile water instead of the diluent provided with the vaccine/No AE; Initial information received on 11-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient was given a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] which was incorrectly reconstituted with sterile water instead of the diluent provided with the vaccine (lot UJ183AAA, expiry date: 12-FEB-2021) via unknown route in the left vastus lateralis on 11-May-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.   It was an actual medication error case due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fat necrosis, Mass
Clinical narrative: SEVERE REDNESS INITIALLY THAT TURNED INTO A FLUID FILLED MASS - 3-4 CM IN LENGHT, 2 CM IN WIDTH   - MY CLINICAL IMPRESSION WAS FAT NECROSIS.  AT TIME OF VISIT 3/4/2020 DID NOT HAVE PAIN OR REDNESS
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: On May 14 at School, patient was administered four times the correct dose of inactivated polio virus. The patient was monitored for 5 mins to check for reaction, and none were present.  I realized that the dosage was wrong while logging the vaccine into the system. Immediately  I let provider, know of the error and she spoke to, patient's mother. We told her that he was administered more of the vaccination than he should have received. She was calm and just asked us what she should watch for. They were asked to stay in order for us to watch the patient to see if he had any adverse reaction to the vaccine. They left about half an hour after. I let them know we would be calling the CDC and poison control to get any instructions from them, and also know how to guide her in his care. Provider contacted the CDC and I contacted Poison Control, we both got back the same responses. The patient should be fine, the higher dosage of polio should only increase the risk of the regular vaccine symptoms such as fever, vomiting, bruising and soreness at the site, and child irritability. After receiving the information I contacted the mother and let her know, we also gave her our on call phone number in case she had any questions or concerns. The mother verbalized understanding.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Insomnia, Peripheral swelling, Pruritus
Clinical narrative: left arm swollen, red (2"x2" area) and itchy; can't sleep
Age: 5.0
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects reported; one patient was inadvertently administered an expired dose of properly stored PROQUAD which was reconstituted with properly stored but expired STERILE DILUENT; one patient was inadvertently administered an expired dose of properly stored PROQUAD which was reconstituted with properly stored but expired STERILE DILUENT; This spontaneous report was received from a medical assistant, referring to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were not reported.  On 11-MAY-2020, the patient was inadvertently vaccinated with an expired dose of properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHa) (vaccination scheme, anatomical location of injection and route of administration were not reported; and lot number R026722, which has been verified to be valid, expiration date reported and validated as 17-MAR-2020) as prophylaxis (expired product administered), which was reconstituted with properly stored but expired sterile diluent (MERCK STERILE DILUENT) (concentration, dose, frequency, indication, and route of administration were not reported; and lot number N029636 which has been verified to be valid, expiration date reported and validated as 29-MAR-2020) (expired product administered). No additional adverse effects reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 23-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 27-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 29-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient received a dose of improperly stored PROQUAD that was reconstituted with properly stored MERCK DILUENT; Information has been received from an immunization consultant in charge of vaccine, who was also a healthcare worker, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 20-FEB-2020, the patient received a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (lot # S009756, expiration date 27-SEP-2020; dose and strength were unknown) subcutaneously for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT. The temperature excursions were from 6 to 14 degrees Fahrenheit (11.3 degrees Fahrenheit) for 12 hours and 30 minutes (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effect was reported.  This is one of four reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA004591: US-009507513-2005USA004496: US-009507513-2005USA004443:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Outside of my arm hurting pretty significantly; This case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and only reaction had pain in arm. For tolerances of 2nd dose, refer case US2020AMR078362, reported by same reporter for the same patient.
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination. Child had no ill effects thus far
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient and guardian were both with dialect different. Patient was asked to verify DOB, she reported another DOB with a document to support it. Then upon checking out after receiving vaccines, the guardian presented another document that reported a different DOB, which was finally confirmed the actual correct DOB. Patient was given extra dose of MMR and Polio vaccine not needed for her correct age and immunization record. No adverse effects from the vaccines given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Patient received shingrix vaccine 5/13/20. Later in the evening started to get redness to the site and soreness before going to bed started with flu like symptoms of body aches and low grade fever. Next day redness was the size of an orange. Took tylenol and today feeling a little better. Redness remains about the size of a fist on day 3. Denied any swelling. No fever at this time. Discussed applying warm or cool compress to area and continue with Tylenol. Advised to call office if redness gets any larger or swelling starts to develop.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 100F, tylonol 1000 mg
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient received shingrix vaccine 5/13/20. Later in the evening started to get redness to the site and soreness. Next day redness was the size of an orange and body aches. Took tylenol and today felling a little better. Redness remains about the size of a fist. Denied any swelling. No fever at this time but wife had symptoms that were worse. Discussed applying warm or cool compress to area and continue with Tylenol. Advised to call office if redness gets any larger or swelling starts to develop.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: MMRV vaccine administered on 5/7/2020. Fever tmax 102.8 noted on 5/11/2020, patient was seen in the ER, no other signs of illness noted at the time. Patient advised to monitor Fever resolved on its own. Seen yesterday, 5/14 for routine follow up, patient well on exam. This morning 5/15/20, her mother noted a rash starting along her hairline, right chest wall. She has been more fussy than usual, otherwise, no other symptoms, adequate intake and wet diapers
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Child given vaccine that may have had temperature excursion (Data Logger Failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination Child had no ill effects thus far