chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea/vomiting, fever, body aches, headaches, chills; Nausea/vomiting, fever, body aches, headaches, chills; Nausea/vomiting, fever, body aches, headaches, chills; Nausea/vomiting, fever, body aches, headaches, chills; Nausea/vomiting, fever, body aches, headaches, chills; Nausea/vomiting, fever, body aches, headaches, chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Nausea/vomiting, fever, body aches, headaches, chills), NAUSEA (Nausea/vomiting, fever, body aches, headaches, chills), VOMITING (Nausea/vomiting, fever, body aches, headaches, chills), PYREXIA (Nausea/vomiting, fever, body aches, headaches, chills) and HEADACHE (Nausea/vomiting, fever, body aches, headaches, chills) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN (Nausea/vomiting, fever, body aches, headaches, chills), NAUSEA (Nausea/vomiting, fever, body aches, headaches, chills), VOMITING (Nausea/vomiting, fever, body aches, headaches, chills), PYREXIA (Nausea/vomiting, fever, body aches, headaches, chills), HEADACHE (Nausea/vomiting, fever, body aches, headaches, chills) and CHILLS (Nausea/vomiting, fever, body aches, headaches, chills). At the time of the report, PAIN (Nausea/vomiting, fever, body aches, headaches, chills), NAUSEA (Nausea/vomiting, fever, body aches, headaches, chills), VOMITING (Nausea/vomiting, fever, body aches, headaches, chills), PYREXIA (Nausea/vomiting, fever, body aches, headaches, chills), HEADACHE (Nausea/vomiting, fever, body aches, headaches, chills) and CHILLS (Nausea/vomiting, fever, body aches, headaches, chills) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       concomitant medication was not reported  treatment medication was reported by patient.
Sex: M
Vaccine: HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: did not complete the series; No additional AE reported.; This spontaneous report was received from a pharmacist, referring to a male patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date in 2018 (also reported as three years ago), 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) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis but did not complete the series (inappropriate schedule of product administration). No additional adverse event reported.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No other AEs; received 2 doses of vaccine on same day; This spontaneous report was received from an office manager referring to a 10 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 03-AUG-2021, the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (0.5 milliliter, lot # T025370, expiration date 01-DEC-2022) via unknown route for prophylaxis (extra dose administered). This was patient's second vaccine in a series of 2. No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T025370; expirationdate: 01-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 4.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product preparation error, Wrong product administered
Clinical narrative: No further information is available.; Nurse is reporting that today a patient received PROQUAD that was reconstituted with V AQTA due to human error; Nurse is reporting that today a patient received PROQUAD that was reconstituted with VAQTA due to human error; This spontaneous report was received from a registered nurse referring to a 4-year-old male patient. The patient's pertinent medical history, concomitant therapies, previous drug reactions, or allergies were not reported.     On 16-AUG-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHa)(PROQUAD) (dose, route of administration, vaccine scheme and anatomical location were not provided; lot number T035410 has been verified to be a valid lot number, expiration date reported and established as 14-ABR-2022), as prophylaxis, and that was reconstituted with Hepatitis A Vaccine, Inactivated (VAQTA) due to a human error, 0.5 milliliters (ml) (route of administration, vaccine scheme and anatomical location were not provided; lot number T022333 has been verified to be a valid lot number and expiration date reported and established as 11-DEC-2021) as prophylaxis (product preparation error and wrong product administered). No further information is available (no adverse event).
Age: 63.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: The caller reported being unaware of any adverse experience following administration of the vaccine; The caller reported a supported temperature excursion overnight (11AUG2021-12AUG2021) for VAQTA with subsequent administration (12AUG2021 "around lpm") to a consumer; This spontaneous report was received from a nurse and refers to a 63-year-old female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 12-AUG-2021 around 13:00, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection in prefilled syringe, lot # T034003 (lot number was verified to be valid), expiration date: 28-MAR-2022, 1 milliliter (injection site and route of administration were not provided) for prophylaxis.  The administered dose experienced a temperature excursion of 75.7 degrees Fahrenheit for 1 hour and 3 minutes overnight (11-AUG-2021-12-AUG-2021). No previous temperature excursion had occurred. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T034003; expirationdate: 28-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; PROQUAD was inadvertently administered to an 18 year old patient; This spontaneous report was received from a certified medical assistant and refers to an 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 13-AUG-2021, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot # U002538, expiration date: 24-JUL-2022, 1 dose (injection site and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). The reporter stated that the patient was due for measles, mumps and rubella (reported as MMR) and varicella so she thought it would be easier to give one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) not thinking about the labeled age range. No additional adverse events were reported.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; the patient was administered the first dose of GARDASIL in the series 2 years ago at age 16 (date unspecified). The patient is now returning to complete the series at age 18; the patient was administered the first dose of GARDASIL in the series 2 years ago at age 16 (date unspecified). The patient is now returning to complete the series at age 18; This spontaneous report was received from a physician, referring to an 18-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified date in 2019 (also reported as 2 years ago at age 16), the patient was vaccinated with the first dose in the series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml) (strength, frequency, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unspecified date in 2021 (also reported as now), the patient was returning to complete the series at age 18 (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). No additional adverse effect (AE).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: patient received an expired MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 20-AUG-2021, the patient received 1 dose of an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rha) (M-M-R II) lot # S025155 for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The vaccine had expired on 13-AUG-2021.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No additional AE reported; 15 year old patient was administered with a dose of PROQUAD; This spontaneous report was received from a nurse referring to a 15-year-old patient of unknown gender. The patient's pertinent medicalñ history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 20-AUG-2021, the 15-year-old patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin) 0.5 ml, lot # U009259 with expiration date 17-SEP-2022, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; an expired adult dose of VAQTA was administered today; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 26-AUG-2021, the patient was vaccinated with an expired adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # T033517, expiration date 11-JUL-2021, 1 dosage form) for prophylaxis (expired product administered). The dose was properly stored up through administration. No adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Expired dose of vaccine administered to patient.; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 26-AUG-2021, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # R030453 was confirmed to be valid, expiration date 23-JUL-2021, for prophylaxis (dose, route and site of administration were not reported). No additional adverse event was provided. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030453; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No additional AE reported. No PQC.; the 50 year old male received a pediatric dose instead of an adult dose; This spontaneous report has been received from a nurse, referring to a 50-year-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 27-AUG-2021, the patient was vaccinated with a pediatric dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) 0.5 ml (incorrect dose administered) (route of administration, vaccine scheme, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis.  No additional adverse event (AE) reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No other adverse event reported; First dose of Hepatitis A vaccine administered in 2015 and received a dose of  VAQTA today 8/27/2021; This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.  On unknow date in 2015, the patient was vaccinated with a first dose of  hepatitis a vaccine, inactivated(VAQTA) (dose, lot #, expiration date and route were not reported).    On 27-AUG-2021, the patient was vaccinated with a second dose of hepatitis a vaccine, inactivated(VAQTA), intramuscularly, 1 ml, lot # T036739, expiration date 22-APR-2022 for prophylaxis. No other adverse event or product quality complaint were reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events or product quality complaints were reported.; the excursion occurred 26AUG2021 and the administration occurred 27AUG2021; This spontaneous report has been received from a nurse referring to a 4-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 27-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, route of administration, anatomical site of vaccination, dose number, and vaccination scheme were not reported; lot number U006313 has been verified to be valid, expiration date reported and established as 24-AUG-2022) as prophylaxis.   The vaccine exposed to a temperature excursion of 38.8 degrees Fahrenheit (°F) during a time frame of 8 hours. There was not a previous temperature excursion, and no additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001031: US-009507513-2108USA008076: US-009507513-2108USA008073:
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional AE; inadvertently administered a 4th GARDASIL 9; This Spontaneous report has been received from a nurse via company representative regarding a 28-year-old female patient. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 31-AUG-2021, the patient was inadvertently vaccinated with a forth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) as prophylaxis. No additional adverse event.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs; A expired dose was inadvertently administered to a patient; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 31-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 1 time dose, for prophylaxis (lot number S025157 was determined to be vlaid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 13-AUG-2021) (strength, route of administration and anatomical location were not provided).         No adverse event reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Improperly stored PROQUAD had been administered to a patient; This spontaneous report was received from an administrator referring to a 4-year-old patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 30-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number T034826, expiration date 11-APR-2022 (dose, route of administration not provided) for prophylaxis. No adverse event was reported.  The temperature excursion was between -14 degrees Celsius (°C) and -10°C with an average of -14°C for 30 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 31-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000593: US-009507513-2109USA000594: US-009507513-2109USA000595: US-009507513-2109USA000596: US-009507513-2109USA000591: US-009507513-2109USA000590: US-009507513-2109USA000589: US-009507513-2109USA000588: US-009507513-2109USA000592: US-009507513-2109USA000674: US-009507513-2109USA000675: US-009507513-2109USA000673: US-009507513-2109USA000672: US-009507513-2109USA000671:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 26-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000652: US-009507513-2109USA000653: US-009507513-2109USA000654: US-009507513-2109USA000655: US-009507513-2109USA000656: US-009507513-2109USA000651: US-009507513-2109USA000649: US-009507513-2109USA000648: US-009507513-2109USA000647: US-009507513-2109USA000650:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 20-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 23-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 19-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 30-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 25-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis.  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U006313, was verified to be a valid lot number with an expiration date reported and established as 24-AUG-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 23-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis.  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 16-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 17-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 13-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 24-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 20-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 18-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U002539, was verified to be a valid lot number with an expiration date reported and established as 24-JUL-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 12-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number U002539, was verified to be a valid lot number with an expiration date reported and established as 24-JUL-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 13-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (lot number T030760, was verified to be a valid lot number with an expiration date reported and established as 08-MAR-2022) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 17-AUG-2021, the patient was vaccinated with this improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that there was a previous temperature excursion reported of 24.8 degrees Fahrenheit (F) with a time frame of 2 hours and 41 minutes. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000271:
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: allergic to the vaccine; This case was reported by a consumer via Interactive digital media and described the occurrence of allergy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergy. On an unknown date, the outcome of the allergy was unknown.   It was unknown if the reporter considered the allergy to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient reported that he/she was allergic to the vaccine.