chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; Product storage error; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  Since an unknown date, the following lot# of varicella virus vaccine live (Oka/Merck) (VARIVAX) were improperly stored between 15 degrees Fahrenheit and 46 degrees Fahrenheit (mainly at 39.7 degrees Fahrenheit) for 2 hours and 20 minutes. Lot# R034391 (expiration date: 27-NOV-2020), lot# S005082 (has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 28-FEB-2021, but upon internal validation established as 19-FEB-2021) and lot# S000132 (expiration date: 02-JAN-2021). On 05-JUL-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency and route not reported) for prophylaxis. The nurse was not sure with which of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers was administered to the patient. No previous temperature of excursion was reported. A digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA004327: US-009507513-1907USA004329: US-009507513-1907USA004242:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; Product storage error; This spontaneous report was received from a nurse referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  Since an unknown date, the following lot# of varicella virus vaccine live (Oka/Merck) (VARIVAX) were improperly stored between 15 degrees Fahrenheit and 46 degrees Fahrenheit (mainly at 39.7 degrees Fahrenheit) for 2 hours and 20 minutes. Lot# R034391 (expiration date: 27-NOV-2020), lot# S005082 (has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date reported as 28-FEB-2021, but upon internal validation established as 19-FEB-2021) and lot# S000132 (expiration date: 02-JAN-2021). On 05-JUL-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, frequency and route not reported) for prophylaxis. The nurse was not sure with which of the improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) lot numbers was administered to the patient. No previous temperature of excursion was reported. A digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA004327: US-009507513-1907USA004328: US-009507513-1907USA004242:
Sex: U
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received a first dose of GARDASIL 9 and the patient has not received a second dose.; no adverse event; This spontaneous report was received from a pharmacist concerning a 24 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-JAN-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The patient had not received a second dose (inappropriate schedule of product administration).   No adverse effects reported. The outcome of inappropriate schedule of product administration was not reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; improperly stored PROQUAD; This spontaneous report was received from a registered nurse concerning to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not provided.  On 02-JUL-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number R024015 with expiration date on 19-FEB-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion between 6 up to 14 degrees Fahrenheit (12 F) degrees Fahrenheit for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004719: US-009507513-1907USA004800:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: one 16 month old patient received improperly stored VARIVAX; No adverse effects  reported; This spontaneous report was received from a registered nurse concerning to a 16 months child patient of an unknown race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were unknown by the reporter.  On 26-JUN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R017640 with expiration date on 20-JUN-2020 (exact dose, and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 (12 F) degrees Fahrenheit for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004715: US-009507513-1907USA004800:
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; the patient was administered one dose ofMMR II (lot number N026273, expiration date 9/21/2019) on 6/12/2019 and then was inadvertently administered the second dose of MMR-II (lot number N026273, expiration date 9/21/2019) two-weeks after the first do; This spontaneous report was received from a nurse and concerned to a 46 year old patient of unknown gender.  The patient's historical condition, concomitant medications and drug reactions or allergies were not reported   On 12-JUN-2019, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # N026273 and expiration date 21-SEP-2019, subdermal for prophylaxis (dosage schedule, route, and anatomical location were not reported) .         On 01-JUL-2019 (reported as two weeks after the first dose), the patient was inadvertently administered with a the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (inappropriate schedule of product administration) lot # N026273 and expiration date 21-SEP-2019, subdermal for prophylaxis (dosage schedule, route, and anatomical location were not reported) .   The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: improperly stored PROQUAD was administered to one patient on an unspecified date.; No adverse effect reported.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information provided regarding the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On an unspecified date, one dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot number R030794 and expiration date 22-APR-2020, dose and route were unknown by the reporter) was administered to the patient for prophylaxis. it was reported that the sterile diluent (DILUENT MRK INJ) used to reconstitute the vaccine was stored properly. The temperature excursion was of 6 Fahrenheit degrees to 14 Fahrenheit degrees (11 Fahrenheit) during a time frame of 8 hours. There was a previous temperature excursion of 6 Fahrenheit degrees to 14 Fahrenheit degrees (6.7 Fahrenheit) during a time frame of 4 hours. The call was because of a data logger. There was no adverse events reported.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; patient received improperly stored VARIVAX; This spontaneous report was received from a registered nurse concerning to a 15 months child patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 25-JUN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R017640, with expiration date on 20-JUN-2020 (dosage schedule, route and anatomical location were not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent.  Administered doses of vaccine experienced temperature excursion between 6 to 14 degrees Fahrenheit (12 F) for 4 hours. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004715: US-009507513-1907USA004719:
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 08-MAY-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-009507513-1907USA004890: 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-009507513-1907USA004870: 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:
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 08-MAY-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-009507513-1907USA004854: 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-009507513-1907USA004870: 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  09-MAY-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-009507513-1907USA004855: 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-009507513-1907USA004870: 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 14-MAY-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-009507513-1907USA004856: 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-009507513-1907USA004870: 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: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   The reporter considered the influenza-like symptoms to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced heavy flu like symptoms after 1st dose of Shingrix.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Pyrexia
Clinical narrative: fever; weakness; feeling bad; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for 1st dose refer case US2019118455).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, weakness and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, weakness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the fever, weakness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller was husband of the patient who received dose of Shingrix. The patient experienced fever, weakness, feeling bad that resolved after a few days. It was reported that these events were about half as bad with the second dose.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Headache
Clinical narrative: Body aches; Flu-like symptoms; Headache; Stomach hurts; Weakness; Tired; Shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in March 2019, refer case US2019AMR120858).   On 20th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced general body pain. On 20th June 2019, the patient experienced influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering. Rechallenge with Shingrix was positive. In June 2019, the outcome of the general body pain was resolved with sequelae. On an unknown date, the outcome of the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, stomach pain, weakness, tiredness, shivering and general body pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in the left arm. In the evening, less than a week after vaccination, the patient experienced flu-like symptoms, including headache, general weakness, tired, stomach hurt, nausea and fainted later the same day after vaccination. The patient experienced shivering but more severe than 1st dose. In June 2019, all of these symptoms resolved within four days. The reporter did not consent to follow-up. The outcome of the reported events was discrepantly reported in the structured field of source document as recovered/resolved with sequelae and while, it was reported as recovered/resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Pain, Vaccine positive rechallenge
Clinical narrative: Body aches; Flu-like symptoms; Headache; Stomach hurts; Weakness; Tired; Shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in March 2019, refer case US2019AMR120858).   On 20th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced general body pain. On 20th June 2019, the patient experienced influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering. Rechallenge with Shingrix was positive. In June 2019, the outcome of the general body pain was resolved with sequelae. On an unknown date, the outcome of the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, stomach pain, weakness, tiredness, shivering and general body pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in the left arm. In the evening, less than a week after vaccination, the patient experienced flu-like symptoms, including headache, general weakness, tired, stomach hurt, nausea and fainted later the same day after vaccination. The patient experienced shivering but more severe than 1st dose. In June 2019, all of these symptoms resolved within four days. The reporter did not consent to follow-up. The outcome of the reported events was discrepantly reported in the structured field of source document as recovered/resolved with sequelae and while, it was reported as recovered/resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: Body aches; Flu-like symptoms; Headache; Stomach hurts; Weakness; Tired; Shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in March 2019, refer case US2019AMR120858).   On 20th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced general body pain. On 20th June 2019, the patient experienced influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering. Rechallenge with Shingrix was positive. In June 2019, the outcome of the general body pain was resolved with sequelae. On an unknown date, the outcome of the influenza-like symptoms, headache, stomach pain, weakness, tiredness and shivering were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, stomach pain, weakness, tiredness, shivering and general body pain to be related to Shingrix.  Additional details were received as follows: The patient received Shingrix in the left arm. In the evening, less than a week after vaccination, the patient experienced flu-like symptoms, including headache, general weakness, tired, stomach hurt, nausea and fainted later the same day after vaccination. The patient experienced shivering but more severe than 1st dose. In June 2019, all of these symptoms resolved within four days. The reporter did not consent to follow-up. The outcome of the reported events was discrepantly reported in the structured field of source document as recovered/resolved with sequelae and while, it was reported as recovered/resolved.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash generalised
Clinical narrative: rash around torso/ under arms/ upper arms/ thighs; This case was reported by a physician via call center representative and described the occurrence of generalized rash in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number T73K2, expiry date 9th June 2021) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The caller was the patient and physician himself. The patient experienced rash around torso, under arms, upper arms, and thighs. The patient still had the rash that was present. The patient went to his internist and was then referred to dermatologist. The reporter did not give consent to follow up. No further details were provided.
Age: 86.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: rash around torso/ under arms/ upper arms/ thighs; This case was reported by a physician via call center representative and described the occurrence of generalized rash in a 86-year-old male patient who received Herpes zoster (Shingrix) (batch number T73K2, expiry date 9th June 2021) for prophylaxis.   On 22nd March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left arm. The caller was the patient and physician himself. The patient experienced rash around torso, under arms, upper arms, and thighs. The patient still had the rash that was present. The patient went to his internist and was then referred to dermatologist. The reporter did not give consent to follow up. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Pyrexia
Clinical narrative: fever; weakness; feeling bad; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced fever, weakness and feeling bad. On an unknown date, the outcome of the fever, weakness and feeling bad were recovered/resolved.   It was unknown if the reporter considered the fever, weakness and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller was husband of the patient who received dose of Shingrix. The caller reported that the patient experienced fever, weakness, feeling bad that resolved after a few days. For tolerance to next dose, refer case US2019AMR122601.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Dizziness, Nausea, Pain
Clinical narrative: dizziness; aches; nausea; been in bed; This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number T9KE4, expiry date 25th September 2021) for prophylaxis.   On 23rd June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd June 2019, less than a day after receiving Shingrix, the patient experienced dizziness, pain, nausea and bedridden. On an unknown date, the outcome of the dizziness, pain, nausea and bedridden were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, pain, nausea and bedridden to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in his left arm. Ever since then, the patient had been in bed.   The patient was experiencing dizziness, aches and nausea which started within 24 hours after the injection. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: excruciating arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 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 1st dose of Shingrix and experienced excruciating arm pain that lasted for 8 days and resolved. The reporter did not consent to follow up. The reporter declined to provide any contact information. There is a discrepancy between the outcome reported in the structured field (recovered) and the outcome reported in the source document (recovered/resolved with sequel).
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Soreness at injection site, muscle aches throughout body, headache, fatigue, mild nausea  Injection site less sore on the following day, other symptoms resolved.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site cellulitis
Clinical narrative: Developed Cellulitis of left upper extremity at location of injection within 24 hours. Patient evaluated at urgent care and discharged with Rx for  Bactrim. Followed up with resolution of cellulitis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Muscle spasms
Clinical narrative: Mom reports that after pt's last of vaccines that she developed a spasm type reaction with her arms. Mom concerned that it may be like a seizure.   Mom reports that when pt was a baby and received her first round of vaccines that she noticed pt would hold her hand to her chest and her arms would tremor. The tremor faded away, then returned with her next round of vaccines. At first mom suspected she was purposefully doing it to be playful. Mom reports after the second round of vaccines that the tremor became more jerky and it seemed to be painful and uncontrollable. Mom was concerned and did not vaccinate her for the next year. She reports the tremors/spasms resolved.    After her latest round of vaccines on 06/14/2019, the spasms returned. The latest episode was about 2 days ago.
Age: 0.25
Sex: M
Vaccine: RV1
Symptoms: Mucous stools
Clinical narrative: I noticed within 24 hours that my child started to have mucus in his poop. This lasted approximately two months. I thought it was part of the vaccination clearing out of his system. I took him to the doctor in late September 2018. Our doctor confirmed that his entire stool was mucus, not just mucus strains in his poop. She looked back at his newborn screening to see if he was testing for Cystic Fibrosis which he was cleared. We linked it back to his Rotavirus vaccination from when the symptoms started.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella virus test positive
Clinical narrative: Shingles right leg developed one week after Shingrix vaccination
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Gait disturbance, Injection site pain, Malaise
Clinical narrative: 1245AM - woke with severe chills/rigors (ambulation difficult), temp taken temporally at 100.3, 1g Tylenol taken.  1:00AM - Chills subside, fever spikes to unknown lever but very high by touch/feel. + headache,  +body ache 7:00AM - 400mg Advil taken All day with + malaise, + body ache, +high pain at injection site 1:00PM - 500mg Tylenol taken 6:00PM - Fever = 101 + headache and all other SX remain 10:00PM - 1g Tylenol taken 7/11/19 12:45AM - awoken with cold sweat multiple times throughout night 8:00AM - Woke up with only site injection pain. No other SX present, not further medication taken.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: 1245AM - woke with severe chills/rigors (ambulation difficult), temp taken temporally at 100.3, 1g Tylenol taken.  1:00AM - Chills subside, fever spikes to unknown lever but very high by touch/feel. + headache,  +body ache 7:00AM - 400mg Advil taken All day with + malaise, + body ache, +high pain at injection site 1:00PM - 500mg Tylenol taken 6:00PM - Fever = 101 + headache and all other SX remain 10:00PM - 1g Tylenol taken 7/11/19 12:45AM - awoken with cold sweat multiple times throughout night 8:00AM - Woke up with only site injection pain. No other SX present, not further medication taken.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient had vaccines around 12:00PM on 07/10/19 from Pediatrics. At around 4:15PM on 07/10/19 he started breaking out in hives on his thighs. The hives then spread to his stomach, back, and chest. Patient was seen at Urgent Care on 07/10/19 and instructed to give Benadryl 4mL every 4 to 6 hours as needed until hives are gone. Patient seen at Pediatrics again on 07/11/2019 and hives have improved but are not completely gone. Advised again to continue with Benadryl until hives are completely gone.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Herpes zoster
Clinical narrative: Patient developed shingles for the first time about 18 days after the vaccine was given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Dizziness, Erythema, Feeling abnormal, Headache
Clinical narrative: Started feeling bad around 2:30pm the day of the shot.: Dizzy and loss of appetite. I just rested the rest of the day and was feeling better by the next morning. I went to work and started feeling bad again around 11:00am so I went home at 1:00pm with a major headache and nausea. I took some Tylenol and rested again. Today I woke up with some pain and swelling in my arm. Also some redness. Hopefully I will be back to normal by tomorrow.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Started feeling bad around 2:30pm the day of the shot.: Dizzy and loss of appetite. I just rested the rest of the day and was feeling better by the next morning. I went to work and started feeling bad again around 11:00am so I went home at 1:00pm with a major headache and nausea. I took some Tylenol and rested again. Today I woke up with some pain and swelling in my arm. Also some redness. Hopefully I will be back to normal by tomorrow.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood test, Gait disturbance, Pain in extremity
Clinical narrative: strong pain in thighs, hips, interfering with walking, 8 out of 10 pain, lasting several weeks, not resolved.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever 101.5 F  Body ache  Tited
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. No details regarding the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were provided. On 20-JUN-2019, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # R018142, expiration date 25-JUN-2020 (exact dose, dose number, route and site of administration were not provided) for prophylaxis. The reported vaccine was exposed to the temperatures of 15 to 46 degrees Fahrenheit (39 degrees Fahrenheit) for 19 hours and 15 minutes. No previous temperature excursions were reported. A digital data logger was not involved. No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 07-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000929: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000862: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-0095075131907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937:
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Musculoskeletal chest pain, Myalgia intercostal, Pain in extremity, Rash
Clinical narrative: Hip Rash; blisters; tender rash; Rib Cage Soreness; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th June 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th June 2019, the patient experienced intercostal myalgia. On 1st July 2019, the patient experienced red rash, blister and painful rash. On an unknown date, the outcome of the pain in arm, red rash, blister and painful rash were not recovered/not resolved and the outcome of the intercostal myalgia was unknown.   It was unknown if the reporter considered the pain in arm, intercostal myalgia, red rash, blister and painful rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in left arm and reported a sore arm following vaccine that was still currently sore on the day of reporting. In the night after vaccination caller reported during the middle of the night soreness in the muscles surrounding rib cage (left and right rib cages). In the morning of day of reporting, caller reported waking up with a tender red rash on her hip with three blisters in the middle. Rash was roughly the size of a quarter. The reporter gave consent to follow up. Caller mentioned having a picture of the rash. No protocol was available concerning how to obtain picture from consumer to include in letter to healthcare professional. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 11:55 AM-Non-contiguous erythema around dual injection site on left thigh and left ankle/foot, sparing left distal thigh, knee and upper lower leg. Area warm to the touch with raised area noted beneath injection site. Raised area approximately 4 cm x 6 cm. 11:55 AM-Ice pack applied to injection site. Benadryl 2.5 ml and Tylenol 2.5 ml given orally. 12:30 PM-Redness had resolved everywhere, but quarter sized diameter around injection site. 4:30 PM-Phone call to mom who stated all redness and swelling improved, except at injection site.  7-11-19 @ 10:30 AM-f/u in office, doing well, all swelling and redness resolved except for minimal redness surrounding injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pain, Pruritus, Skin warm, Swelling
Clinical narrative: Hot, red, swollen, painful, itching
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Influenza like illness
Clinical narrative: Two days of severe flu-like symptoms: headache, muscular and joint pain, weakness, exhaustion, feeling ill. No treatment beyond analgesics. Better after second day.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: Two days of severe flu-like symptoms: headache, muscular and joint pain, weakness, exhaustion, feeling ill. No treatment beyond analgesics. Better after second day.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Headache
Clinical narrative: headache that started the same day after vaccination.  received vaccine early afternoon and  had onset headache in the evening. child might go to ER for headache relief as she has tried multiple  options without relief.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000862: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000937: