chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 23-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 05-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 06-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-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 08-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-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-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 12-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 14-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 15-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 18-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 19-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:
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; One improperly stored dose of VAQTA was administered to on patient on 3/24/2020; This spontaneous report was received from a medical assistant referring to a 13-month-old patient. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.       On 24-MAR-2020, the patient was vaccinated with an improperly stored dose (product storage error) of hepatitis a vaccine, inactivated (VAQTA) lot # S025993, expiration date on 17-OCT-2020 as prophylaxis (formulation, strength, dose, frequency, route of administration, and anatomical location were not reported).  No additional adverse effects were reported.    The previous temperature excursion was 46.1 (units not reported) for 7 minutes. The temperature was 68.58 Fahrenheit degrees, for a time frame of 9 hours and 41 minutes. No data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 1.08
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: NO ADVERSE EFFECT; one improperly stored dose of V AQTA was administered; This spontaneous report was received from a medical assistant and refers to a 13 month old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 11-MAY-2020, the patient was vaccinated with one improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # S025993, expiration date 17-OCT-2020 (upon internal validation) for prophylaxis.  The administered vaccine experimented temperature o  68.58 degrees Fahrenheit for 9 hours 41 minutes with previous temperature excursión of 46.1 degrees Fahrenheit for 7 minutes. Digital data logger was not involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received improperly stored PROQUAD; No additional adverse effect reported; This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions y concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis, lot number S021732 and expiration date 10-JAN-2021 (strength, dose, frequency and route of administration were not reported). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)  vaccine was diluted with a properly stored sterile diluent No additional adverse effect reported.   The temperature excursion was from -9°C to 8°C - 8.56C, during a time frame of 1 hour. No previous temperature excursion was reported.   It was reported that the call was made because a digital data logger.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: His daugther may have received a total of 4 doses ofGARDASIL-9; His daugther may have received a total of 4 doses ofGARDASIL-9; His daugther may have received a total of 4 doses ofGARDASIL-9; This spontaneous report was received from a physician referring to his daughter, a female patient of unknown age. The patien's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown dates, the patient may had received a total of 4 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown). No additional adverse effects were reported in the patient.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered
Clinical narrative: The patient only received 1/2 of Gardasil 9; The vaccine spilled; This spontaneous report was received from a medical assistant reporting about a patient of unknown age and gender. Information about the patient's medical istory, concurrent conditions or concomitant medications was not reported.      On an unknown date, the patient was vaccinated with only half of a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (underdose, incorrect dose administered) for prophylaxis (route, dose number, lot number and expiration date were not reported) because the vaccine "spilled".
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: imporoperly stored vaccine was administered to a patient; This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were unknown.   On 16-MAR-2020 the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (route and dosage information were unknown; lot # s025993 expiration date 17-OCT-2020) for prophylaxis.  The medical assistant reported that the vaccine was improperly stored at 68.58 F for 9 hours and 41 minutes.  The previous temperature excursion was at 46.1 F for 7 minutes.  It was not due to a data logger issue. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S025993; expirationdate: 17-OCT-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 0.33
Sex: M
Vaccine: HEP, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Rectal temp of 101.2 day after immunizations. No other symptoms
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Pain
Clinical narrative: Body aches; Chills; headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, immediately after receiving Shingrix, the patient experienced general body pain, chills and headache. On an unknown date, the outcome of the general body pain, chills and headache were not recovered/not resolved.   It was unknown if the reporter considered the general body pain, chills and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient just received the shingrix vaccine and had body aches, chills and headache. The reporter asked how long the symptoms last.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Adverse event; This case was reported by a consumer via call center representative and described the occurrence of adverse event in a 62-year-old 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 adverse event. On an unknown date, the outcome of the adverse event was not recovered/not resolved.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had adverse reaction. The reporter wanted to know long do the symptoms from getting the shot lasts.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise
Clinical narrative: felt "bed sick"; Pain at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a 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 feeling unwell and injection site pain. On an unknown date, the outcome of the feeling unwell and injection site pain were unknown.   It was unknown if the reporter considered the feeling unwell and injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age group was not reported but was selected as per the vaccine indication. The pharmacist reported that several patients had experienced pain at the injection site of felt bed sick after receiving the 1st dose of Shingrix or 2nd dose of Shingrix. The reporter did not mention specific patient, no vaccines data, no patients data. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: Arm Sores; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number 453S4, expiry date 19th March 2022) and (batch number 2325S, expiry date 3rd July 2022) for prophylaxis.   On 28th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 28th May 2020, less than a day after receiving Shingrix, the patient experienced fever. On 29th May 2020, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and at the time of reporting  his arm sores and also had fever. She mentioned that the patient was taking antibiotics because he was constantly urinating. The reporter confirmed that the patient had not started the antibiotics at the time he received Shingrix.  He was picking up the prescription for the antibiotic and received Shingrix while there. The reporter consented to follow up.
Sex: U
Vaccine: DTAP, HPVX, MMR
Symptoms: Flushing, Rash maculo-papular, Swelling, Swelling face, Systemic mastocytosis
Clinical narrative: ISM(Indolent systemic mastocytosis); accentuation (swelling) of lesions of MPCM; accentuation (swelling) of lesions of MPCM; facial swelling; flushing; Initial information received on 25-May-2020 regarding an unsolicited valid serious case from other healthcare professional, issued from a literature article.   This case is linked to case 2020SA136384(same literature).  This case involves a 15 years old patient who experienced facial swelling (swelling face), flushing(flushing), accentuation(swelling) of lesions of Maculopapular cutaneous mastocytosis(urticarial pigmentosa), (condition aggravated) and ISM-indolent systemic mastocytosis (systemic mastocytosis), while he/she received vaccines MMR, HPV VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer; HPV VACCINE(not produced by Sanofi Pasteur) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (not produced by Sanofi Pasteur) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed facial swelling (swelling face), flushing(flushing), accentuation (swelling) of lesions of Maculopapular cutaneous mastocytosis (urticarial pigmentosa), (condition aggravated) and ISM-indolent systemic mastocytosis (systemic mastocytosis), (Unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, (Unknown latency) following the administration of HPV VACCINE and (Unknown latency) following the administration of MMR. All the events were assessed as medically significant.  Laboratory test results included: Tryptase - On an unknown date: 62.9 Ng/mL  Final diagnosis were swelling face, flushing, urticarial pigmentosa, condition aggravated and systemic mastocytosis.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were not reported.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a 15 years old patient(unknown gender) who experienced systemic mastocytosis and condition aggravated after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, MMR and HPV VACCINE(other manufacturer). The time to onset was not known. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be  assessed.
Sex: U
Vaccine: DTAP, HPVX, MMR
Symptoms: Tryptase increased, Urticaria pigmentosa
Clinical narrative: ISM(Indolent systemic mastocytosis); accentuation (swelling) of lesions of MPCM; accentuation (swelling) of lesions of MPCM; facial swelling; flushing; Initial information received on 25-May-2020 regarding an unsolicited valid serious case from other healthcare professional, issued from a literature article.   This case is linked to case 2020SA136384(same literature).  This case involves a 15 years old patient who experienced facial swelling (swelling face), flushing(flushing), accentuation(swelling) of lesions of Maculopapular cutaneous mastocytosis(urticarial pigmentosa), (condition aggravated) and ISM-indolent systemic mastocytosis (systemic mastocytosis), while he/she received vaccines MMR, HPV VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer; HPV VACCINE(not produced by Sanofi Pasteur) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (not produced by Sanofi Pasteur) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed facial swelling (swelling face), flushing(flushing), accentuation (swelling) of lesions of Maculopapular cutaneous mastocytosis (urticarial pigmentosa), (condition aggravated) and ISM-indolent systemic mastocytosis (systemic mastocytosis), (Unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, (Unknown latency) following the administration of HPV VACCINE and (Unknown latency) following the administration of MMR. All the events were assessed as medically significant.  Laboratory test results included: Tryptase - On an unknown date: 62.9 Ng/mL  Final diagnosis were swelling face, flushing, urticarial pigmentosa, condition aggravated and systemic mastocytosis.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were not reported.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a 15 years old patient(unknown gender) who experienced systemic mastocytosis and condition aggravated after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, MMR and HPV VACCINE(other manufacturer). The time to onset was not known. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be  assessed.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: low fever at 7 hour mark = 100.4 fever at 20 hour mark for 7 hours = 102.5 severe body aches and headache fever subsided at 30 hour mark of course my arm hurt really badly, but it always hurts badly from an intramuscular shot
Age: 61.0
Sex: U
Vaccine: UNK
Symptoms: Blood test, Discomfort, Limb discomfort, Musculoskeletal discomfort, Pain
Clinical narrative: Box 17 - Shigrix (Dose 1 of 2)   Painful at beginning, but turned into discomfort over the next three days. Discomfort in left arm from shoulder blade to bicep.  Discomfort has lessened, but is still present. Seen by NP, prescribed Ibuprofen. Discomfort is still present.
Age: 61.0
Sex: U
Vaccine: UNK
Symptoms: X-ray
Clinical narrative: Box 17 - Shigrix (Dose 1 of 2)   Painful at beginning, but turned into discomfort over the next three days. Discomfort in left arm from shoulder blade to bicep.  Discomfort has lessened, but is still present. Seen by NP, prescribed Ibuprofen. Discomfort is still present.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abdominal pain upper, Decreased appetite, Emotional distress, Fatigue, Feeling abnormal
Clinical narrative: Mother, reported reaction on behalf of patient. Reported stomach hurting and nausea starting one day after the vaccination. Stomach pain continued off and on for about 1 week. Mother noted that patient did not ever vomit. Patient had a decrease in appetite, tired/fatigue, feeling out of sorts, irritability, and over emotional for that week also. Mother states that 2 days after the vaccines, that patient reported a headache and was given advil just one time, the symptom resolved and no further medication was given. Mother reports no local reaction at the site of either vaccine. Mother reports that 8 days after the vaccine patient stated that all symptoms resolved (5/29). On 5/30, patient's appetite returned to normal and he was acting like his normal self. That is when she contacted our office to let us know what had happened.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Irritability, Nausea
Clinical narrative: Mother, reported reaction on behalf of patient. Reported stomach hurting and nausea starting one day after the vaccination. Stomach pain continued off and on for about 1 week. Mother noted that patient did not ever vomit. Patient had a decrease in appetite, tired/fatigue, feeling out of sorts, irritability, and over emotional for that week also. Mother states that 2 days after the vaccines, that patient reported a headache and was given advil just one time, the symptom resolved and no further medication was given. Mother reports no local reaction at the site of either vaccine. Mother reports that 8 days after the vaccine patient stated that all symptoms resolved (5/29). On 5/30, patient's appetite returned to normal and he was acting like his normal self. That is when she contacted our office to let us know what had happened.
Age: 1.33
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Staring
Clinical narrative: Seen 4 days after vaccine with fever 101.4. Slight rash under chin for less then 24 hours that was gone by time of visit. Saw child for 18 month WCC and dad stated he saw staring spells and what he though could be seizure activity which has since resolved.
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 S032357 has been verified to be valid; expiration date reported and validated as 14-OCT-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 adverse event.  This is one of several reports received from the same source; Sender's Comments:  US-009507513-2006USA001641: US-009507513-2006USA001819: US-009507513-2006USA001817: US-009507513-2006USA001816: US-009507513-2006USA001818:
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Hip pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in hip in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in hip. On an unknown date, the outcome of the pain in hip was unknown.   It was unknown if the reporter considered the pain in hip to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The patient received Shingrix and had pain in hip. The reporter wanted to know was hip pain associated with the vaccination.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Cheilitis, Diarrhoea, Dizziness, Injection site pain
Clinical narrative: sores on upper lips; lightheadedness; Diarrhea; blurred vision; pressure in abdominal area; soreness and itching at the injection site; itching at the injection site/itching is also present around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site itching. On 28th May 2020, the patient experienced sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort. On an unknown date, the outcome of the injection site pain, injection site itching, sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site itching, sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the left arm. Since 28th May 2020, 2 days after vaccination, the patient had been experiencing sores on upper lips, lightheadedness, pressure in abdominal area, diarrhea, and blurred vision. The patient also experiencing soreness and itching at the injection site.  The itching was also present around the injection site. The reporter did not consent to follow up. No other details were provided.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Vision blurred
Clinical narrative: sores on upper lips; lightheadedness; Diarrhea; blurred vision; pressure in abdominal area; soreness and itching at the injection site; itching at the injection site/itching is also present around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th May 2020, the patient received the 2nd dose of Shingrix (intramuscular). In May 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site itching. On 28th May 2020, the patient experienced sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort. On an unknown date, the outcome of the injection site pain, injection site itching, sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site itching, sores lip, light headedness, diarrhea, blurred vision and abdominal discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the left arm. Since 28th May 2020, 2 days after vaccination, the patient had been experiencing sores on upper lips, lightheadedness, pressure in abdominal area, diarrhea, and blurred vision. The patient also experiencing soreness and itching at the injection site.  The itching was also present around the injection site. The reporter did not consent to follow up. No other details were provided.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: had outbreak of Shingles on both sides of body after the second dose; swab the blister; This case was reported by a physician via call center representative and described the occurrence of shingles in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th November 2019).   On 28th May 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles and blister were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were reported as follows: The patient had outbreak of Shingles on both sides of body after the second dose of shingrix. After transfer from first line specialist, physician stated that she was willing to swab the blister in order to test whether the shingles were caused by the vaccine. She states this can be requested via safety follow up. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Neuralgia, Radiculopathy
Clinical narrative: On 5/16/20 developed new rash on left shoulder, diagnosed with zoster and started on acyclovir and gabapentin.  On 5/21/20 acyclovir was switched to valacyclovir.  As of 6/5/20 patient reported that zoster rash improving but still experiencing nerve irritation and pain.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Injection site redness & swelling, pain with headache started 1 day after the vaccination.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling (firm to touch) at injection site, increased in size over 2-3 days, mild discomfort/tenderness and warm to touch.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Computerised tomogram, Injected limb mobility decreased, Magnetic resonance imaging, Muscular weakness
Clinical narrative: Ongoing severe left arm pain, loss of mobility, muscle weakness tendonitis, bursitis. Rule out Parsonage-Turner syndrome. Currently seeing neurology for workup and referred to another location for specialty care.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Tendonitis, X-ray
Clinical narrative: Ongoing severe left arm pain, loss of mobility, muscle weakness tendonitis, bursitis. Rule out Parsonage-Turner syndrome. Currently seeing neurology for workup and referred to another location for specialty care.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Electromyogram, Laboratory test, Magnetic resonance imaging, Mobility decreased, Pain
Clinical narrative: Ongoing severe left arm pain, loss of mobility, muscle weakness tendonitis, bursitis. Rule out Parsonage-Turner syndrome. Currently seeing neurology for workup and referred to another location for specialty care.
Age: 36.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Radiculitis brachial, Shoulder injury related to vaccine administration
Clinical narrative: Ongoing severe left arm pain, loss of mobility, muscle weakness tendonitis, bursitis. Rule out Parsonage-Turner syndrome. Currently seeing neurology for workup and referred to another location for specialty care.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Chills, Dyspnoea, Ear pain
Clinical narrative: fever; shivers/chills; headache; body aches; pain in ears; rapid heart beat so much so that it was hard to breath; chest and back pains like a heart attack; side pains; pain in the back of neck and stiff neck; throat hurt 06/08/2020 - dull headache still  remains and body pains
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Musculoskeletal stiffness, Neck pain, Oropharyngeal pain
Clinical narrative: fever; shivers/chills; headache; body aches; pain in ears; rapid heart beat so much so that it was hard to breath; chest and back pains like a heart attack; side pains; pain in the back of neck and stiff neck; throat hurt 06/08/2020 - dull headache still  remains and body pains
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever; shivers/chills; headache; body aches; pain in ears; rapid heart beat so much so that it was hard to breath; chest and back pains like a heart attack; side pains; pain in the back of neck and stiff neck; throat hurt 06/08/2020 - dull headache still  remains and body pains
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Upon wakeup next morning, patient had fever of 100.7, severe headache, body aches, occasional chills, fatigue. Symptoms lasted all day with gradual diminishing toward evening.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Tremor
Clinical narrative: Patient was given his injection for shingrix. He sat back in his chair. I asked if he would like some water. I went out to get the paient some water, and when I returned he seemed very weak. I moved the chair out a little so pt would not fall. I went to get help from Dr. As we came into the room patient started to shake and began to fall out of his chair. Dr and I placed the Paient on the floor. The paient became alert and had ask what had happen. The paients blood preasure was taken.  The paient was watched and then after some time then releast to his wife's care. Our office was in contact with the Paient a few hours later. The paient had reported that he was feeling better.
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 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 S032357 has been verified to be valid; expiration date reported and validated as 14-OCT-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 adverse event.   This is one of several reports received from the same source; Sender's Comments:  US-009507513-2006USA001819: US-009507513-2006USA001817: US-009507513-2006USA001816: US-009507513-2006USA001815: US-009507513-2006USA001818:
Sex: U
Vaccine: VARCEL
Symptoms: 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 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 S032357 has been verified to be valid; expiration date reported and validated as 14-OCT-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-009507513-2006USA001641: US-009507513-2006USA001815: US-009507513-2006USA001816: US-009507513-2006USA001817: US-009507513-2006USA001818: