chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; Improperly stored dose of PROQUAD was administered to the patient on 03-JUN-2020; 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.   On 03-JUN-2020, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously, lot # S031705 and expiration date 06-APR-2021 (dose and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 17.2°F in a timeframe of 14 hours and 2 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ HH) was administered to the patient.   It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001657: US-009507513-2006USA001639: US-009507513-2006USA001624:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms; Improperly stored dose of PROQUAD was administered to the patient on 03-JUN-2020; 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.   On 03-JUN-2020, dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) subcutaneously, lot # S031705 and expiration date 06-APR-2021 (dose and frequency were not reported) as prophylaxis, which was improperly stored in a temperature of 17.2°F in a timeframe of 14 hours and 2 minutes and reconstituted with a properly stored sterile diluent (STERILE DILUENT MRK INJ HH) was administered to the patient.   It was reported that the call was made due to data logger and no previous temperature excursion occurred.  No adverse symptoms were reported for the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001624: US-009507513-2006USA001639: US-009507513-2006USA001645:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Constipation, Dehydration, Laboratory test, Migraine
Clinical narrative: the patient did not urinate for entire day/urine retention; dehydrated/dehydration; migraine; constipation; This spontaneous report was received from the patient's mother referring to a 13 years female patient. The patient was not pregnant. The patient had no medical history. The patient was allergy to azithromycin and cefdinir (OMNICEF). Concomitant medications included other unspecified medications.  On 07-JUN-2016, 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) (route was reported as injection; dose detail, strength, lot# and expiration were not provided) for prophylaxis. On 30-SEP-2016, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route was reported as injection, lot # L038503, expiration date 18-DEC-2017; dose detail and strength were not provided) for prophylaxis.         In October 2016, the patient did not urinate for entire day, was dehydrated, and was experiencing a migraine. The patient went to emergency room with a length of stay of one to two days. The patient was hospitalized the second time in January 2017 with symptoms of migraine, dehydration, urine retention and constipation, for two days. The patient was then hospitalized once each in February and March 2017 again for migraine, dehydration, urine retention and constipation for two to three days per incident visit. The patient received many unspecified medications for treatment. On unspecified dates, many unspecified lab tests and blood work were performed. The outcome of the events was reported as not recovered.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, urine retention was determined to be medically significant.  AEQIR routine was initiated since the patient was requesting lot check.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urinary retention, Urine output decreased
Clinical narrative: the patient did not urinate for entire day/urine retention; dehydrated/dehydration; migraine; constipation; This spontaneous report was received from the patient's mother referring to a 13 years female patient. The patient was not pregnant. The patient had no medical history. The patient was allergy to azithromycin and cefdinir (OMNICEF). Concomitant medications included other unspecified medications.  On 07-JUN-2016, 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) (route was reported as injection; dose detail, strength, lot# and expiration were not provided) for prophylaxis. On 30-SEP-2016, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route was reported as injection, lot # L038503, expiration date 18-DEC-2017; dose detail and strength were not provided) for prophylaxis.         In October 2016, the patient did not urinate for entire day, was dehydrated, and was experiencing a migraine. The patient went to emergency room with a length of stay of one to two days. The patient was hospitalized the second time in January 2017 with symptoms of migraine, dehydration, urine retention and constipation, for two days. The patient was then hospitalized once each in February and March 2017 again for migraine, dehydration, urine retention and constipation for two to three days per incident visit. The patient received many unspecified medications for treatment. On unspecified dates, many unspecified lab tests and blood work were performed. The outcome of the events was reported as not recovered.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, urine retention was determined to be medically significant.  AEQIR routine was initiated since the patient was requesting lot check.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced symptoms.; Impropertly stored doses of varivax were administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), subcutaneous (dose and frequency were not provided; Lot number reported as S036637 has been verified to be valid; expiration date reported and validated as 14-NOV-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).  The vaccine underwent a temperature excursion of 17.2 Fahrenheit for a period of 14 hours and 2 minutes. The vaccine did not undergo a previous temperature excursion. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any symptom.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2006USA001819: US-009507513-2006USA001641: US-009507513-2006USA001815: US-009507513-2006USA001818: US-009507513-2006USA001817:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Impropertly stored doses of varivax were administered; No patients experienced symptoms.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 01-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX), subcutaneous (dose and frequency were not provided; Lot number reported as S036637 has been verified to be valid; expiration date reported and validated as 14-NOV-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).  The vaccine underwent a temperature excursion of 17.2 Fahrenheit for a period of 14 hours and 2 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any symptom.  This is one of several reports received form the same source.; Sender's Comments:  US-009507513-2006USA001819: US-009507513-2006USA001816: US-009507513-2006USA001818: US-009507513-2006USA001641: US-009507513-2006USA001815:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No patients experienced symptoms.; Impropertly stored doses of varivax were administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX), subcutaneous (dose and frequency were not provided; Lot number reported as S036637 has been verified to be valid; expiration date reported and validated as 14-NOV-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).  The vaccine underwent a temperature excursion of 17.2 Fahrenheit for a period of 14 hours and 2 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any symptom.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2006USA001815: US-009507513-2006USA001819: US-009507513-2006USA001641: US-009507513-2006USA001816: US-009507513-2006USA001817:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 27-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 28-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 04-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 11-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 07-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 08-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 09-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 13-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events.; on 02-JUN-2020 a patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, referring to a 18-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions/allergies and concomitant medications were not reported.  On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection (lot number S022913, which has been verified to be valid, expiration date reported and validated as 19-JAN-2021) (dose, route of administration, vaccination scheme frequency and anatomical injection site were not reported) administered as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The administered dose of the vaccine experienced a temperature excursion from 15 degrees Fahrenheit (F) to 46 F (36.86 F) for a time frame of 9 hours 49 minutes. There was a previous temperature excursion reported from 15 F to 46 F (19.13 F) for a time frame of 1 hour 30 minutes. There were no additional adverse events reported. There was not a product quality complaint (PQC) involved.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: fever; Pain in his left arm at the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient Shingrix in the left arm. The patient experienced fever that lasted for about 1.5 days and had pain in his left arm at the injection site.   For tolerances of 2nd dose, refer case US2020094353. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020094353:same reporter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: tenderness; heat at the site of injection; swelling; Extreme fatigue still persist; This case was reported by a physician via call center representative and described the occurrence of injection site tenderness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received Shingrix. In May 2020, less than a week after receiving Shingrix, the patient experienced injection site tenderness, injection site warmth, injection site swelling and fatigue. On an unknown date, the outcome of the injection site tenderness, injection site warmth, injection site swelling and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site tenderness, injection site warmth, injection site swelling and fatigue to be related to Shingrix.  Additional details were provided as follows: The physician reported they had a patient who on day 4 after the vaccination still had significant swelling, tenderness and heat at the site of injection. The patient also still had extreme fatigue. The reporter did not consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Difficulty breathing; Palpitations; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 73E59, expiry date 19th November 2021) for prophylaxis.   On 13th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, less than a week after receiving Shingrix, the patient experienced difficulty breathing and palpitation. On an unknown date, the outcome of the difficulty breathing and palpitation were not recovered/not resolved.   It was unknown if the reporter considered the difficulty breathing and palpitation to be related to Shingrix.  Additional details were provided as follows: About 2 to 3 days after getting the vaccination, one morning, the patient experienced difficulty breathing and palpitations due to which she had to go to the emergency room. The patient was sent back home the same day and was still experiencing the adverse reactions, but not as intense. No other details were provided. This case linked with US2020091749, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020091749:same reporter
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Malaise
Clinical narrative: didn't feel well / felt sick; Sick & Unable to work; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th January 2020, less than a day after receiving Shingrix, the patient experienced feeling unwell and inability to work. On 21st January 2020, the outcome of the feeling unwell and inability to work were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and inability to work to be related to Shingrix.  Additional details were provided as follows: The patient was didn't feel well after getting the 1st dose of Shingrix. On 18th January 2020 the patient feeling sick and was unable to work until 21st January 2020. The reporter did consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: fever; felt a little bit off/didn't feel right until; upper left arm became red; Arm hurt/ upper left arm doesn't hurt as much as when he received the first injection; This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in March 2020, refer case US2020AMR095093).   On 1st June 2020, the patient received the 2nd dose of Shingrix. On 1st June 2020, less than a day after receiving Shingrix, the patient experienced fever. In June 2020, the patient experienced feeling abnormal, injection site erythema and injection site pain. Rechallenge with Shingrix was positive. On 3rd June 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the feeling abnormal, injection site erythema and injection site pain were unknown.   It was unknown if the reporter considered the fever, feeling abnormal, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in upper left arm and that evening he experienced a fever. The reporter claims that he felt a little bit off and just did not feel right until date of reporting and upper left arm became red now but it did not hurt as much as when he received the first injection. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR095093:same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu Like Symptoms; Chills; Body ache; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, general body pain, headache and fever. In January 2020, the outcome of the influenza-like symptoms, chills, general body pain, headache and fever were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, chills, general body pain, headache and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. In the night of vaccination, the patient started experiencing flu like symptoms, chills, body ache, headache and fever that lasted for total of 3 days.  The reporter consented to follow up. No other details were provided.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: Shivering; feeling cold; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 7th January 2020, the patient received the 2nd dose of Shingrix. On 7th January 2020, less than a day after receiving Shingrix, the patient experienced shivering and feeling cold. On 8th January 2020, the outcome of the shivering and feeling cold were recovered/resolved.   It was unknown if the reporter considered the shivering and feeling cold to be related to Shingrix.  Additional details were provided as follows: On 23rd October 2019, the patient received 1st dose of Shingrix and had no side effects. In the afternoon the patient received 2nd dose, and in the evening started feeling cold and shivering. The reporter did not consent to follow up.
Age: 1.58
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB was administered with sterile water to the patient / No AE; Initial information was received on 28-May-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 19 months old male patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] with sterile water (product preparation error).  Medical history, medical treatment, vaccination and family history were not provided.   Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.   On 21-May-2020, the patient received a 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE (for powder: lot UJ185AA and expiry date 27-Apr-2021 and for diluent lot number U6723AA and expiry date 17-Sep-2021) via unknown route in an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: product was reconstituted sterile saline and not the diluent that comes in the package/no AE; Initial information received on 29-May-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a male patient(age not specified) who received HIB (PRP/T) VACCINE [ACT-HIB] which was reconstituted with sterile saline and not the diluent that comes in the package(product preparation error) via unknown route at an unknown administration site on an unknown date for prophylactic vaccination(batch number and expiry date not reported).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient explained she had puffiness, redness, warm to touch at site of injection.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: Patient Experienced a rash shortly after vaccine was given.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Bursa disorder, Injection site pain
Clinical narrative: The patient stated that she has " a lot of pain" in her bursa of the same shoulder she received the injection. She states that she has had shoulder pain previous to the injection but not as severe as it is now. The site of the pain is not where the injection was administered. She stated that she received the vaccine around noon on 6/9/20 and states that it really began to hurt around 6:00 pm that same day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Confusional state, Feeling hot, Muscle spasms, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Pt was asleep and started to have uncontrolable spasms, became stiff and was not responding to mom's voice.  Mom reports this lasted a 'few minutes'.  Then became responsive but confused, was able to drink water.  Pt felt hot but mom didn't have a thermometer.  No urinary or stool accident.  Slept fine afterwards and was acting fine the next morning when he was in our office.  No fever or signs of illness.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: contracted herpes zoster
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: redness, swelling spreading to below the knee, warm to touch.  Prescribed prednisolone and benadryl.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Chest X-ray, Hand-foot-and-mouth disease, Pyrexia, Rash erythematous
Clinical narrative: She started running fever and violently throwing up the weekend of the shots. We took her back in  to pediatrician the following Monday to get her checked out. He said it was not a reaction to the shots and she should be fine. The following weekend, 8 days after her shots, she started running fever again (104.3) and we took her to ER. She had a slight rash across her forehead at the time, they tried to get fever broken, it was unsuccessful. So they sent us home and told us to give her meds around the clock and try to break the fever ourselves. The next night her fever shot back up to 104.3, we took her to a different Urgent Care, they tested her for Covid and refused to test her for any other viral infection, not only was her fever back up at this time, the rash had spread from her head all the way down her stomach and back and was now bright red. The doctor wouldn't look at her spots or do any other testing on her. We wound up back at ER the next night because the rash was spreading like wildfire and she was keeping a low temp (101) that we could not get broken. They told us she had hand-foot-mouth and sent us home. We went to her Pediatrician the following morning. He told us she did not have hand-foot-mouth, but that she had Roseola. I kept being told that nothing was wrong with her and it was viral and needed to just run its course. That afternoon I finally got some answers as to what was going on with patient and found out that she did not have hand-foot-mouth, she did not have Roseola, but she was actually having an adverse reaction to her shots and wound up with a strand of measles. At this point her rash had spread down her arms and legs. We are keeping her inside, no direct contact with sunlight, giving her vitamin A for 3 days, and bathing her in oatmeal for the irritation.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Respiratory viral panel, Roseola, Urine analysis
Clinical narrative: She started running fever and violently throwing up the weekend of the shots. We took her back in  to pediatrician the following Monday to get her checked out. He said it was not a reaction to the shots and she should be fine. The following weekend, 8 days after her shots, she started running fever again (104.3) and we took her to ER. She had a slight rash across her forehead at the time, they tried to get fever broken, it was unsuccessful. So they sent us home and told us to give her meds around the clock and try to break the fever ourselves. The next night her fever shot back up to 104.3, we took her to a different Urgent Care, they tested her for Covid and refused to test her for any other viral infection, not only was her fever back up at this time, the rash had spread from her head all the way down her stomach and back and was now bright red. The doctor wouldn't look at her spots or do any other testing on her. We wound up back at ER the next night because the rash was spreading like wildfire and she was keeping a low temp (101) that we could not get broken. They told us she had hand-foot-mouth and sent us home. We went to her Pediatrician the following morning. He told us she did not have hand-foot-mouth, but that she had Roseola. I kept being told that nothing was wrong with her and it was viral and needed to just run its course. That afternoon I finally got some answers as to what was going on with patient and found out that she did not have hand-foot-mouth, she did not have Roseola, but she was actually having an adverse reaction to her shots and wound up with a strand of measles. At this point her rash had spread down her arms and legs. We are keeping her inside, no direct contact with sunlight, giving her vitamin A for 3 days, and bathing her in oatmeal for the irritation.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash vesicular
Clinical narrative: painful blistering rash, which was diagnosed as herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 years-old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 04-DEC-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy for the long-term prevention of shingles and zoster-related conditions (dose, route, and lot # not provided). Subsequently, on an unknown date, the patient was treated by a provider for the following injuries resulting form patient's zoster vaccine live (ZOSTAVAX) use: painful blistering rash, which was diagnosed as herpes zoster. The outcome of the event was unknown. The event herpes zoster was related to suspected vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: headache; Chills; very tired; very swollen lymph node; This case was reported by a consumer and described the occurrence of enlargement of lymph nodes in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2020, the patient received the 2nd dose of Shingrix. On 3rd June 2020, 2 days after receiving Shingrix, the patient experienced headache, chills and tiredness. In June 2020, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes, headache, chills and tiredness were unknown.   It was unknown if the reporter considered the enlargement of lymph nodes, headache, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had very swollen lymph node on my underarm on the same side as the injection.  The patient felt very tired, headache and chills. The reporter asked could this be a side effect of the injection.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Raised rash; HEADACHE; PAIN; FATIGUE; CHILLS; FEVERISH; The rash is present around the knees and ankles and the back of the arms; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shellfish allergy (had shrimp allergy).   On 3rd June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced raised rash, headache, pain, fatigue, chills, fever and rash. On an unknown date, the outcome of the raised rash, headache, pain, fatigue, chills, fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the raised rash, headache, pain, fatigue, chills, fever and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing the common side effects in addition to a rash described as raised rash like she gets from her shrimp allergy.   The rash was present around the knees and ankles and the back of the arms. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: Raised rash; HEADACHE; PAIN; FATIGUE; CHILLS; FEVERISH; The rash is present around the knees and ankles and the back of the arms; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shellfish allergy (had shrimp allergy).   On 3rd June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced raised rash, headache, pain, fatigue, chills, fever and rash. On an unknown date, the outcome of the raised rash, headache, pain, fatigue, chills, fever and rash were not recovered/not resolved.   It was unknown if the reporter considered the raised rash, headache, pain, fatigue, chills, fever and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing the common side effects in addition to a rash described as raised rash like she gets from her shrimp allergy.   The rash was present around the knees and ankles and the back of the arms. The reporter did not consent to follow up.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain
Clinical narrative: Extreme body aches in middle of night after injection, fatigue and feeling sick x 1-2 days. Considered going to ER.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea, Pain
Clinical narrative: fatigue, body aches, chills, slight nausea
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Chills, Dizziness postural, Feeling cold, Headache, Pallor
Clinical narrative: About 15 minutes after patient had the vaccine, around 1015 in the morning, he started to feel cold. He then went on to have shivering and shaking, he had paleness to his lips and face. he vomited one time and then developed a headache. he was having shaking throughout the episode. he also felt dizzy with standing, greater then his baseline dizziness with standing.  The vomiting started after he had eaten fast food-hamburger, fries. patient had no eaten prior to vaccine being administered.
Age: 18.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Tremor, Vomiting
Clinical narrative: About 15 minutes after patient had the vaccine, around 1015 in the morning, he started to feel cold. He then went on to have shivering and shaking, he had paleness to his lips and face. he vomited one time and then developed a headache. he was having shaking throughout the episode. he also felt dizzy with standing, greater then his baseline dizziness with standing.  The vomiting started after he had eaten fast food-hamburger, fries. patient had no eaten prior to vaccine being administered.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Fever 102-105 starting the morning of 6/9 . Alternating Motrin and Tylenol every three hours until 6/10. Two episodes of vomiting around 11am on 6/9. Mild swelling noted left upper arm on 6/9. Site appeared normal on 6/10 per mom.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or adverse effects reported; 3 patients received unspecified dose of ROTATEQ that was improperly stored.; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 20-MAY-2020, the patient was vaccinated with dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1660958, expiration date 23-MAR-2021 (strength and dose not provided) for prophylaxis. Administered dose of vaccine was stored in temperature of 46.9 degrees Fahrenheit (F) for 1 hour. Data logger was involved. There were no previous excursions reported. No symptoms or adverse effects reported.; Sender's Comments:  US-009507513-2006USA003741: