chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 6-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: experiencing again only soreness at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 13th January 2020, refer case US2020056770).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the concerned patient. The patient again experienced only soreness at injection site after 2nd dose of Shingrix.  The reporter consented to follow up. This case has been linked to US2020056774 and US2020AMR057294, reported by the same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 9th January 2020, refer case US2020078681.).   On 15th March 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm and it has lasted for months and yet not recovered. The reporter consented to follow up.  This case linked with US2020078683, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in an unspecified number of 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 unknown.   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 applicable for this report. The patient received Shingrix and experienced a sore arm and it has lasted for months. The reporter consented to follow up.  For tolerances of 2nd dose, refer case US2020078683, reported by same reporter for the same patient. This case linked with US2020078681, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on both sides of his face within days of receiving the first dose of Shingrix; This case was reported by a nurse via sales rep and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient developed shingles on both sides of his face within days of receiving vaccine. The patient reported adverse event to pharmacy as well. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) (batch number 7AN44, expiry date 24th April 2022) for prophylaxis.   On 19th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months 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 information was provided as follows: The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020079540.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt a little bad; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a adult male 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 feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient felt bad but was otherwise asymptomatic. For tolerance of 2nd dose, refer case US2020079532. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: could not sleep; second dose hurt / arm hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date. For tolerance of 1st dose of Shingrix, refer linked case US2020080768).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and difficulty sleeping. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the pain in arm and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in her left arm. The patient reported that, after receiving 2nd dose of Shingrix, the patient's arm hurt but it did not hurt as bad as first dose and also she could not sleep on her side . The reporter was consented to follow up. This case was linked with case US2020080768, reported by the same reporter for same patient. This case was 1 of the 4 cases, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 100.8 fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th May 2020, the patient received the 2nd dose of Shingles vaccine. In May 2020, less than a day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. The patient received Shingles vacation shot yesterday morning from the day of reporting and last night developed a 100.8 fever. The reporter wanted to know was s this something he/she should be concerned about. The reporter reported that he/she would contact doctor.
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Chills / Shivers; This case was reported by a pharmacist via sales rep and described the occurrence of chills in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingix in the end of February 2020 and experienced chills and shivers in the evening of the day the patient received the vacine. The reporter was not consented to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 9th January 2020, the dose was an unknown dose. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced a sore arm and it has lasted for months and yet not recovered. The reporter consented to follow up.  For tolerances of 2nd dose, refer case US2020AMR079295, reported by same reporter for the same patient. This case linked with US2020078683, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2020AMR079298.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   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 applicable for this report. The patient received Shingrix and experienced a sore arm and it has lasted for months. The reporter consented to follow up.  This case linked with US2020078681, reported by same reporter.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Coronavirus infection, Coronavirus test positive
Clinical narrative: Covid 19 / tested positive; This case was reported by a consumer via call center representative and described the occurrence of coronavirus infection in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer case US2020AMR080136).   On 2nd May 2020, the patient received the 2nd dose of Shingrix. On 7th May 2020, 5 days after receiving Shingrix, the patient experienced coronavirus infection (serious criteria GSK medically significant). On an unknown date, the outcome of the coronavirus infection was unknown.   It was unknown if the reporter considered the coronavirus infection to be related to Shingrix.  Additional information was provided as follows: The reporter was patient's wife. The patient did not have any symptoms. The reporter said that in her city they were offering Covid 19 testing. The patient and her wife were tested for Covid 19, the patient tested positive and his wife tested negative The reporter said, she thought it may be that the Shingrix vaccine interfered with the results.  Caller said husband did not currently have a doctor that he sees. The reporter did not consent to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Tenderness, Vaccine positive rechallenge
Clinical narrative: Sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number CD9MZ, expiry date 4th September 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 19th January 2020, refer case US2020AMR080036).   On 15th April 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details provided as follows: The sore arm still not resolved at the time of reporting. Patient was also having trouble laying down on that arm. Pain with second dose was lot more than the pain with first dose. No other details were provided.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Skin warm
Clinical narrative: Feeling of warm and burning sensation in the forearm; Feeling of warm and burning sensation in the forearm; This case was reported by a consumer via call center representative and described the occurrence of skin warm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. In April 2020, between 1 and 3 months after receiving Shingrix, the patient experienced skin warm and burning sensation. On an unknown date, the outcome of the skin warm and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the skin warm and burning sensation to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. In April 2020, the patient started noticing a feeling of warm and burning sensation in the forearm, It was on the same arm where patient received the vaccine but not exactly at the injection site, but more on her forearm. The patient said that the feelings are intermittent. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: many patients have reported flu like symptoms after getting the second dose of Shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in an unspecified number of  patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: Many patients have reported flu like symptoms after getting the second dose of Shingrix vaccine. No other details were provided. This case has been linked with US2020079554, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity
Clinical narrative: arm hurt; difficulty sleeping on side; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and difficulty sleeping. On an unknown date, the outcome of the pain in arm and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the pain in arm and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix on her left arm. After receiving Shingrix, the patient's arm hurt for a week or two weeks and she could not sleep on her side. The reporter consented to follow up. This case was linked with case US2020AMR081357, reported by the same reporter for the same patient. This was 1 of 4 linked cases reported by the same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Social problem
Clinical narrative: the first dose on 9/11/2019, and that the 2nd dose was delayed due to COVID; received the first dose of Shingrlx and developed shingles 2 weeks ago; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 7 months 18 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and social problem. The action taken with Shingrix was unknown. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles and social problem were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows:  The age at vaccination was not reported. The pharmacist stated that a patient received the first dose of Shingrlx and developed shingles 2 weeks prior to the reporting date.  Asked what were the recommendations for the 2nd dose. The 2nd dose was delayed due to COVID. The reporter consented to follow up.  This was a medication error without harm.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Failure to thrive, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: patient began with generalized hive-like pruritic macular red rash to chest and back and upper shoulders/arms; patient complaining of fatigues without joint pain or fever
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: patient began with generalized hive-like pruritic macular red rash to chest and back and upper shoulders/arms; patient complaining of fatigues without joint pain or fever
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patients were given expired Ipol on 06may2020, no AE; Initial information received on 11-May-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA124091 (same reporter).  This case involves a 4 years old male patient who was vaccinated with 0.5 ml fifth dose of IPV (VERO) [IPOL] (lot: P1A461M and expiry date: 03-May-2020) via an intramuscular route in the right arm for prophylactic vaccination.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation.  It was an actual medication error due to expired vaccine used.  At the time of reporting, the patient did not experience any adverse event. No specific symptoms were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: fish hook" little bit in skin and then she took it out; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 60 years old female patient who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot number not reported via unknown route in unknown administration site for prophylactic vaccination in 2019. It was reported that while administration of Adacel in 2019 nurse given the dose as a "fish hook" little bit in skin and then she took it out and mixed with something. She then said she thinks it was mixed arsenic and then she said it was a sedative but she knows it could not have been a sedative.  The patient's past vaccination(s) included TETANUS VACCINE with 14 year ago, TD VACCINE in JUN-2005 with 14 year ago, TDAP in JUN-2006 with 14 year ago, TD VACCINE in JUN-2013 with 14 year ago and TD VACCINE in JUN-2017 with 14 year ago. The patient's past medical history, medical treatment(s) and family history were not provided.   It was an actual medication error due to wrong injection technique.  At the time of reporting, the patient did not experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 4 year old recieved an expired Ipol expired by 9 days was given , no AE; Initial information received on 12-May-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 4 years old female patient who was vaccinated with an expired 0.5 ml third dose of suspect IPV (VERO) lot number not reported via subcutaneous route in the right arm on 11-May-2020 as prophylactic vaccination during an injury visit and reported that ipol was expired by 9 days.  Medical history included- Injury, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) all for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used.  There were no side effects  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Client learned she was pregnant 4 days after receiving Varivax vaccination, EDD January 09, 2021, presence of adverse effects unknown at this time.
Age: 30.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Client learned she was pregnant 4 days after receiving Varivax vaccination, EDD January 09, 2021, presence of adverse effects unknown at this time.
Age: 2.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Body temperature increased, Discomfort, Influenza virus test negative, SARS-CoV-2 test negative, Skin warm
Clinical narrative: Over 24 hours after getting the vaccines, 11:30AM on May 1, 2020, Patient's temperature spiked to 102.6 degrees, gave her Motrin, but she was acting normal. We continued to monitor her, at 12:30PM she was eating a peanut butter jelly sandwich and ended up vomiting that up right after. Patient then took a nap. She woke up at 5:15PM, crying, like she was uncomfortable and she was hot to the touch. We took her temperature at that time and it was 104.6 degrees, we immediately got in the car and went to Urgent Care. The urgent care took her temperature and it was 103 degrees. While at the urgent care patient vomited the Up & Up brand of Pedialyte that she was drinking, we let them know that she did have a well visit yesterday at her PCP and was given the routine vaccines for the two and half year old appointment, the doctor came in and informed me that there are no routine vaccines at two and half years old. The urgent care did a flu, step & COVID-19 test. The flu and strep test came back negative, the doctor there did want to send the strep test off to do a culture test on it also. We left the urgent care with no answers but to give her Tylenol every six hours for the fever, do our best to keep her hydrated and if any new symptoms arise to go to Hospital. We continued to monitor her and last took her temperature that day at 9:45PM and it was 101 degrees.  May 2, 2020 patient's fever continued, we gave her Tylenol throughout the day to help with the fever. She vomited about five times throughout the day. We did luke warm bath?s to help her fever. Kept working on getting her to drink Up & Up brand Pedialyte. For the second day patient was unable to keep anything in her stomach. No word from the urgent care yet about her test results.  May 3, 2020 patient's fever continued, it did start to stay down for longer periods of time, we did continue with Tylenol. She was able to keep liquids down today and she ate some crackers. Heard from the urgent care office today that the strep culture test was negative.  May 4, 2020 patient had a high fever twice throughout the day. We gave her Tylenol to control, she was drinking and eating more than yesterday. I called and left a message for patient's PCP asking them why they gave her a Dtap & Polio shot on Thursday April 30, 2020 when it wasn?t needed. A medical assistant called me back and explained to me that her transferred shot records from over a year ago were imputed into their system properly and they thought she had missed those two vaccines. I let her know that I was not informed they were ?catch up? vaccines or I would have questioned before she got them. The medical assistant did apologize and let me know there shouldn?t be any long term damage.  May 5, 2020 Urgent Care called in the evening letting us know that the COVID-19 test was negative. Patient was 90% back to her normal self.
Age: 2.0
Sex: F
Vaccine: DTAP, UNK
Symptoms: Streptococcus test negative, Vomiting
Clinical narrative: Over 24 hours after getting the vaccines, 11:30AM on May 1, 2020, Patient's temperature spiked to 102.6 degrees, gave her Motrin, but she was acting normal. We continued to monitor her, at 12:30PM she was eating a peanut butter jelly sandwich and ended up vomiting that up right after. Patient then took a nap. She woke up at 5:15PM, crying, like she was uncomfortable and she was hot to the touch. We took her temperature at that time and it was 104.6 degrees, we immediately got in the car and went to Urgent Care. The urgent care took her temperature and it was 103 degrees. While at the urgent care patient vomited the Up & Up brand of Pedialyte that she was drinking, we let them know that she did have a well visit yesterday at her PCP and was given the routine vaccines for the two and half year old appointment, the doctor came in and informed me that there are no routine vaccines at two and half years old. The urgent care did a flu, step & COVID-19 test. The flu and strep test came back negative, the doctor there did want to send the strep test off to do a culture test on it also. We left the urgent care with no answers but to give her Tylenol every six hours for the fever, do our best to keep her hydrated and if any new symptoms arise to go to Hospital. We continued to monitor her and last took her temperature that day at 9:45PM and it was 101 degrees.  May 2, 2020 patient's fever continued, we gave her Tylenol throughout the day to help with the fever. She vomited about five times throughout the day. We did luke warm bath?s to help her fever. Kept working on getting her to drink Up & Up brand Pedialyte. For the second day patient was unable to keep anything in her stomach. No word from the urgent care yet about her test results.  May 3, 2020 patient's fever continued, it did start to stay down for longer periods of time, we did continue with Tylenol. She was able to keep liquids down today and she ate some crackers. Heard from the urgent care office today that the strep culture test was negative.  May 4, 2020 patient had a high fever twice throughout the day. We gave her Tylenol to control, she was drinking and eating more than yesterday. I called and left a message for patient's PCP asking them why they gave her a Dtap & Polio shot on Thursday April 30, 2020 when it wasn?t needed. A medical assistant called me back and explained to me that her transferred shot records from over a year ago were imputed into their system properly and they thought she had missed those two vaccines. I let her know that I was not informed they were ?catch up? vaccines or I would have questioned before she got them. The medical assistant did apologize and let me know there shouldn?t be any long term damage.  May 5, 2020 Urgent Care called in the evening letting us know that the COVID-19 test was negative. Patient was 90% back to her normal self.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Hypersomnia, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: At 6:15AM wife stood up from toilet and passed out and fell to floor.  Husband heard the fall and immediately rushed in to help.  He reports that wife  was unresponsive for several minutes before  he was able to lift her to an upright position and move her into the bedroom and bed.  She subsequently slept the entire day until dinner at 4:30 PM.   This appears to be  directly related to the vaccination since she has never fainted in her entire life.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Product stroage error; This spontaneous report was received from medical assistant refers to a 4 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 05-MAY-2020, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (therapy type: Digital data logger) (PROQUAD) lot # S021324, expiry date reported as 05-JAN- 2021 via subcutaneous route for immunisation for measles, mumps, rubella and varicella (strength and dose were not reported). The reporter stated that the administered vaccine had a temperature excursion of 12.2 Fahrenheit for a time frame of 26 minutes as recorded by a data logger (product storage error). The vaccines had no previous temperature excursion. No product quality complaint was reported. The outcome of product storage error was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; a patient received a dose of VARIVAX and a dose of PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's past medical history, concurrent conditions, drug reactions/ allergies and concomitant medications were not reported. On 05-MAY-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot number S017240 and expiry date 01-DEC-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot number S010296 and expiry date 03-APR-2021 (strength, exact dose, anatomical location were not reported for both the suspects) for prophylaxis (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown. No known adverse effects were reported. No product quality complaint (PQC) was reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was administered a dose of improperly stored MMR II, ROTATEQ or PEDVAX HIB; This spontaneous report as received from a medical assistant refers to a 9 week old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 07-NOV-2019, the patient was vaccinated with a dose (1 dosage form) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot #R033252, expiration date 29-JUN-2020 (anatomical location was unknown) for prophylaxis (product storage error). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003275: US-009507513-2005USA003277: US-009507513-2005USA003150: US-009507513-1911USA003851:
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was administered a dose of improperly stored ROTATEQ; patient was administered a dose of improperly stored ROTATEQ; This spontaneous report as received from a medical assistant refers to a 9 week old male patient. The patient's pertinent medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 07-NOV-2019, the patient was vaccinated with a dose (1 dosage form) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot #R033252, expiration date 29-JUN-2020 (anatomical location was unknown) for prophylaxis (product storage error). On 11-MAR-2020, the patient was vaccinated second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). The vaccine was exposed to above 47 Fahrenheit scale (52F) for the time frame of 1 hour 15 minutes. There was previous temperature excursion. Data logger was involved. No adverse effects were reported. No product quality complaint was filed.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA003851: US-009507513-2005USA003275: US-009507513-2005USA003150: US-009507513-2005USA003276: US-009507513-1911USA003851: