chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 04-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 04-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 06-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 07-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 10-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 12-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue
Clinical narrative: when it was injected it squirted toward the right from the needle hub resulting in a partial dose of medication administered to the patient; No adverse effects were reported.; patient was administered a partial dose of GARDASIL 9 in a defective pre-filled syringe /  when it was injected it squirted toward the right from the needle hub / Medical assistant reported she could feel a crack in the vial part of the syringe.; patient was administered a partial dose of GARDASIL 9 in a defective pre-filled syringe /  when it was injected it squirted toward the right from the needle hub / Medical assistant reported she could feel a crack in the vial part of the syringe.; patient was administered a partial dose of GARDASIL 9 in a defective pre-filled syringe /  when it was injected it squirted toward the right from the needle hub / Medical assistant reported she could feel a crack in the vial part of the syringe.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported about the patient's concomitant medication, pertinent medical history and drug reactions/allergies.  On 09-JUL-2019, the patient received a partial dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot number R008163 and expiration date 18-NOV-2020) intramuscularly for prophylaxis, from a defective pre-filled syringe (product quality issue, syringe issue, incorrect dose administered). It was reported that the syringe looked fine and was not leaking prior to attempted administration, but when it was injected it squirted toward the right from the needle hub resulting in a partial dose of medication administered to the patient (product container issue). The medical assistant reported she "could feel a crack" in the vial part of the syringe. No adverse effects were reported.  The outcome of the product quality issue, syringe issue and the product container issue was not reported; the reporter did not provide a causality assessment between them and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Was administered a dose of VARIVAX on 06/14/2008, which was too early to the patient; No adverse effects; 1 patient was administered a dose of improperly stored VARIVAX on 07/09/2019; "This dose of VARIVAX was also the patient's 4th dose of VARIVAX; The patient was then "administered a dose ofMMR II on 06/30/2008 and there has not enough time between the first dose of VARIVAX and the dose of M-M-R II; This spontaneous report was received from a physician concerning to patient of unknown gender who was 12 months of age at the first vaccination. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 14-JUN-2008, the patient was administered a dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported), the physician considered it was too early for the patient to received the vaccine (product administered to patient of inappropriate age).  On 30-JUN-2008, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported), and there was not enough time between the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) and the dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (inappropriate schedule of product administration). The patient received another dose of varicella virus vaccine live (oka/merck)(VARIVAX) on 30-JUN-2008, then a booster dose of the same vaccine on 23-JUN-2011.   On 09-JUL-2019, the patient was vaccinated with a dose of improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) lot. No. R022116 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported  and establish as 02-AUG-2020, it was also reported that this was the 4th varicella virus vaccine live (oka/merck)(VARIVAX) administered (extra dose administered).  The administered 4th dose of varicella virus vaccine live (oka/merck)(VARIVAX) experienced a temperature of 6 to 14 Fahrenheit for 15 minutes. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; a improperly stored dose of VARIVAX was administered on 12-JUL-2019; This spontaneous report was received from a healthcare worker, who was also the office manager, and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 12-JUL-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R018143, expiration date on 25-JUN-2020 (strength, dose, route, and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 18.9 fahrenheit, during 18 hours and 4 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: Medication burned as it went in; Initial Report Received on 26-Jun-2019 and 01-Jul-2019  A virtual sales representative reported that a pharmacy technician reported that she, a 31-year-old female (race not provided), received an injection of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced "burning as it went in."  Relevant medical history was not reported. The patient reported that she had no allergies.    Concomitant medications were reported as unknown.    On an unknown date, the patient received the first injection of HEPLISAV-B (lot #, expiration date, and NDC # not provided). The vaccine was administered by a pharmacist at the pharmacy the patient worked at.    On 26-Jun-2019, a virtual sales representative reported that a pharmacy technician reported that when she received the injection, the medication burned as it went in. No lot number or batch number was available when asked. The virtual sales representative stated that the medication might have come from another company and she was unaware if it was a vial or prefilled syringe that the patient got the medication from.   On 01-Jul-2019, the pharmacy technician reported that she told the pharmacist administering the vaccine that the event was not an adverse event but the pharmacist stated that the event needed to be reported. She reported that the burning lasted for 30 seconds and then it resolved. She could not remember if she experienced burning with other vaccines before. She experienced no other adverse events. She reported that she would be getting her second dose.    The reporter did not provide a seriousness assessment for this event.   Company comment: The company assessed the event of injection site burning as non-serious. The event of injection site burning is unlisted per HEPLISAV-B USPI.  ; Sender's Comments: The company assessed the event of injection site burning as non-serious. The event of injection site burning is unlisted per HEPLISAV-B USPI.
Sex: U
Vaccine: VARZOS
Symptoms: Fear of injection, Feeling hot, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: unable to move arme due to increase in pain; Arm was very painful at rest; my arm still throbs; Terrified of what the second one WILL DO to me.; arm swollen; Arm was hot; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision (removed lymph node from other side).   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection. The patient was treated with ibuprofen and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Shingrix, the patient had warm or hot and swollen arm at least 2 inches from injection site for 4 weeks. The patient reported that, the arm was very painful at rest and almost unable to move due to increase in pain. The patient reported that, at the time for 2nd shot, the arm was still throbs, especially after doing normal movement and would needed to had shot in same arm as, the he or she had lymph nodes removed from other side. The patient had treatment with ice and ibuprofen, which minimally hepled. The patient did not have shingles, but was terrified for what the 2nd dose would did to him or her.
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: unable to move arme due to increase in pain; Arm was very painful at rest; my arm still throbs; Terrified of what the second one WILL DO to me.; arm swollen; Arm was hot; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lymph node excision (removed lymph node from other side).   On 6th May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection. The patient was treated with ibuprofen and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection were unknown.   It was unknown if the reporter considered the injected limb mobility decreased, swelling arm, extremities hot feeling of, pain in arm, throbbing pain and fear of injection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After vaccination with Shingrix, the patient had warm or hot and swollen arm at least 2 inches from injection site for 4 weeks. The patient reported that, the arm was very painful at rest and almost unable to move due to increase in pain. The patient reported that, at the time for 2nd shot, the arm was still throbs, especially after doing normal movement and would needed to had shot in same arm as, the he or she had lymph nodes removed from other side. The patient had treatment with ice and ibuprofen, which minimally hepled. The patient did not have shingles, but was terrified for what the 2nd dose would did to him or her.
Sex: U
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: Atrial Fibrilation; This case was reported by a pharmacist via call center representative and described the occurrence of atrial fibrillation in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown.   The reporter considered the atrial fibrillation 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 was selected as adult as per vaccine indication. The patient received Shingrix and experienced atrial fibrillation after receiving Shingrix. The patient believed the atrial fibrillation was attributable to receiving the vaccine. No additional details available, The reporting pharmacist received this as hearsay and has no direct relationship to the patient.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: my right arm over a week pain increased to a point that my upper arm became immobile.  It became swollen, no range of motion, could not lift it.. could only move from the elbow down.  Tylenol was not helping, nor ice, the pain was constant.. FINALLY today 7/16/19 I have full range of motion and can lift my arm away from my body.  the pain was horrible.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling cold, Pain in extremity
Clinical narrative: Adverse events:  Arm soreness. Chills, Stomach issues.  Treatment:  Motrin Outcome: Unknown at this time. Still having problems almost 24 hours later.   WILL NOT SUPPLY THIS INFORMATION. The office manager is useless.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Mobility decreased, Pain, Pain in extremity
Clinical narrative: This is my 2nd dose of the Shingrix 50mcg vaccine. The 1st one was 4 /22/2019. Had it also in the left arm. The 1st one, about 1 hour after the shot my arm was so sore.  Later that day it got to the point I couldn?t even left my arm high enough to comb my hair. This side effect lasted for 5 days. By the 3rd day, it got gradually better. This shot 2 hours later I had the same soreness in my arm, But, also by 4 hours, I felt so exhausted and everything aches in my body. I took 2 Advil and went to bed. I was tossing and turning all night, just couldn?t get comfortable. This am, I am still aching all over, very sore arm and I have a low grade temp. I just completely feel drained.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Restlessness
Clinical narrative: This is my 2nd dose of the Shingrix 50mcg vaccine. The 1st one was 4 /22/2019. Had it also in the left arm. The 1st one, about 1 hour after the shot my arm was so sore.  Later that day it got to the point I couldn?t even left my arm high enough to comb my hair. This side effect lasted for 5 days. By the 3rd day, it got gradually better. This shot 2 hours later I had the same soreness in my arm, But, also by 4 hours, I felt so exhausted and everything aches in my body. I took 2 Advil and went to bed. I was tossing and turning all night, just couldn?t get comfortable. This am, I am still aching all over, very sore arm and I have a low grade temp. I just completely feel drained.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain
Clinical narrative: chills. body aches,
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Meningitis, Pyrexia, Respiratory arrest
Clinical narrative: Pt's mother states that pt had fever for 24hrs, stopped breathing and was rushed to Hospital, but was deceased on arrival. Coroner contacted mother and informed her that pt appeared to have had meningitis (H. Flu), but death listed as non-conclusive.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site vesicles, Irritability
Clinical narrative: Grandma called to report redness and blistering at injection site.  Child has been "crabby" also.  No fever.  Redness did not start until 4 days after injection.  Injections given on Thursday afternoon and redness started on Monday then fluid filled blisters appeared at site.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Patient had moderate to severe arm pain, swelling within hours of vaccination, sending her to ER due to pain and swelling. Very warm/hot tight skin per patient.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Paraesthesia, Pruritus
Clinical narrative: Patient developed a rash on 07/05/2019, within ~48 hours of vaccine.  Diagnosed in clinic with zoster rash on 07/08/2019. Per Dr.'s notes dated 07/08/2019: Diagnosis #1 Shingles: Reports rash, noticed on Friday, after administering Shingrix vaccination on Wednesday. States rash appeared one day later vaccination; had burning, itching and tingling sensation before rash appeared. Has pain and itching, treated with Tecnu thinking it was Poison Ivy rash, was not beneficial. Reports increase in size, blisters and discharge. States there are breakouts all over her body. Informs pain resolves occasionally. History of shingles in the past. -Crusted vesicles over right inner arm, in a nerve distribution consistent with shingles. -Cautioned to avoid contact with newborn until lesions healed ( 4 mo grandchild)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scab, Secretion discharge
Clinical narrative: Patient developed a rash on 07/05/2019, within ~48 hours of vaccine.  Diagnosed in clinic with zoster rash on 07/08/2019. Per Dr.'s notes dated 07/08/2019: Diagnosis #1 Shingles: Reports rash, noticed on Friday, after administering Shingrix vaccination on Wednesday. States rash appeared one day later vaccination; had burning, itching and tingling sensation before rash appeared. Has pain and itching, treated with Tecnu thinking it was Poison Ivy rash, was not beneficial. Reports increase in size, blisters and discharge. States there are breakouts all over her body. Informs pain resolves occasionally. History of shingles in the past. -Crusted vesicles over right inner arm, in a nerve distribution consistent with shingles. -Cautioned to avoid contact with newborn until lesions healed ( 4 mo grandchild)
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; improperly stored doses of PEDVAX HIB and ROTATEQ were administered to the patient; This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. Informaion regarding patient's medical history, concurrent conditions and concomitant medications was not provided.  On 19-JUN-2019 the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot # R033485, expiration date 24-JUN-2020, and haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R027328, expiration date 12-JUL-2021 and lot number reported as R019391 and expiration date 23-OCT-2020 (strength and dose were not reported for any of the vaccines), both for prophylaxis. No Adverse effects reported.   Regarding the temperature, the total time and highest temperature wa above 47 °F/9° C  for 1 hour and 30 minutes. There was no previous temperature excursion. The call  was done because a data logger.  This case is one of several cases received from the same reporter.  ; Sender's Comments:  US-009507513-1906USA008683: US-009507513-1906USA009093:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Allergy to vaccine
Clinical narrative: allergic reaction to vaccine; This spontaneous report was received from a company representative via physician referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug allergies were unknown. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) first dose, single dose (1 dosage form) (route of administration, anatomical location, lot number and expiry date were unknown) for prophylaxis (unable to confirm if it was quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On an unknown date, the patient had drug allergy to vaccine (drug hypersensitivity). The outcome of hypersensitivity was reported as recovered. The reporter considered hypersensitivity to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). No product quality complaints (PQC) were involved.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse reactions; 12 month old patient did not receive the full dose of MMR II; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On 12-JUL-2019, as the patient moved during injection did not receive the full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), subcutaneously for prophylaxis (dose, anatomical location, lot number and expiration date were not reported).  No adverse reactions were reported.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: arm was extremely painful/sorness at injection site; Swelling; Redness; rash from her elbow to her shoulder; skin turned a brownish color; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, swelling, erythema, rash and skin discoloration. On an unknown date, the outcome of the injection site pain and rash were recovered/resolved and the outcome of the swelling, erythema and skin discoloration were unknown.   It was unknown if the reporter considered the injection site pain, swelling, erythema, rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on her left arm. She immediately developed pain and soreness at the injection site and over the next several hours, she developed swelling, redness and a rash from her elbow to her shoulder. Over the next several days, the rash slowly resolved, but her skin turned a brownish color in the inner portion of her left arm and slowly faded over the next couple of months. The patient granted permission to contact her doctor for follow up. The caller reported her adverse reactions of both vaccines to the Food and Drug Administration. For the tolerances of 2nd dose, refer case US2019123841, reported by same reporter for the same patient.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: arm was extremely painful/sorness at injection site; Swelling; Redness; rash from her elbow to her shoulder; skin turned a brownish color; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain, swelling, erythema, rash and skin discoloration. On an unknown date, the outcome of the injection site pain and rash were recovered/resolved and the outcome of the swelling, erythema and skin discoloration were unknown.   It was unknown if the reporter considered the injection site pain, swelling, erythema, rash and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on her left arm. She immediately developed pain and soreness at the injection site and over the next several hours, she developed swelling, redness and a rash from her elbow to her shoulder. Over the next several days, the rash slowly resolved, but her skin turned a brownish color in the inner portion of her left arm and slowly faded over the next couple of months. The patient granted permission to contact her doctor for follow up. The caller reported her adverse reactions of both vaccines to the Food and Drug Administration. For the tolerances of 2nd dose, refer case US2019123841, reported by same reporter for the same patient.
Sex: U
Vaccine: MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: passed out; This case was reported by a physician via sales rep and described the occurrence of passed out in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo at an unknown dose. On an unknown date, less than an hour after receiving Menveo, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patients fainted after receiving Menveo. The reporter stated that they encourage the patients to wait for 15 minutes after vaccination but the patients did not always wait. The patient fainted at check out window. This case was 1 of the 3 cases, reported by same reporter.