chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Persitent lower Back Pain; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 14Apr2021 at 12:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 25Mar2021 (at age of 49-years-old) at 12:00 as a single dose for COVID-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 16:00, the patient experienced persistent lower back pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the event persistent lower back pain was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling, Urticaria
Clinical narrative: Swelling; Rash all over body with lots of itching; Hives; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 09Apr2021 (at the age of 63-years-old), as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Apr2021 at 10:30 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included heart condition, high blood pressure, bronchial asthma, penicillin allergy, shellfish allergy (crab allergy) and mycotic allergy (mushroom allergy), all since unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included cetirizine hydrochloride (ZYRTEC) on an unknown date for unknown indication and unknown if ongoing. The patient previously took Benadryl (MANUFACTURER UNKNOWN) and aspirin (MANUFACTURER UNKNOWN)and experienced drug allergy, on an unknown date. On 12Apr2021, ever since the patient was vaccinated, the patient had a bad rash all over body with lots of itching, hives and swelling.  The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of a bad rash all over body with lots of itching, hives and swelling and included treatment with unspecified creams, prednisone, zyrtec (MANUFACTURER UNKNOWN) , and atarax (MANUFACTURER UNKNOWN) . The clinical outcome of the events a bad rash all over body with lots of itching, hives and swelling were not recovered at the time of this report.   The lot number for the vaccine, [PFIZER-BIONTECH COVID-19 mRNA VACCINE], was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain in left arm/arm joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain in left arm/arm joint pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced ARTHRALGIA (Joint pain in left arm/arm joint pain). At the time of the report, ARTHRALGIA (Joint pain in left arm/arm joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Ear discomfort, Feeling abnormal, Head discomfort
Clinical narrative: Memory loss; Pressure in my head and right ear (not painful); Pressure in my head and right ear (not painful); Ringing in both ears; Constant lightheadedness with dizzy spells; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Constant lightheadedness with dizzy spells), FEELING ABNORMAL (Brain fog), AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)) and EAR DISCOMFORT (Pressure in my head and right ear (not painful)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Lisinopril) and Blood pressure high (Under control with medication).   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 100 microgram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced DIZZINESS (Constant lightheadedness with dizzy spells) and FEELING ABNORMAL (Brain fog). On an unknown date, the patient experienced AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)) and TINNITUS (Ringing in both ears). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Sensation of pressure in ear and Ringing in ears, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Ear discomfort and Ringing in ears, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Constant lightheadedness with dizzy spells) and FEELING ABNORMAL (Brain fog) had not resolved and AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)) and TINNITUS (Ringing in both ears) outcome was unknown.            No concomitant medications were provided by the reporter. The patient did not get relief after treatment. Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Memory loss; Pressure in my head and right ear (not painful); Pressure in my head and right ear (not painful); Ringing in both ears; Constant lightheadedness with dizzy spells; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Constant lightheadedness with dizzy spells), FEELING ABNORMAL (Brain fog), AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)) and EAR DISCOMFORT (Pressure in my head and right ear (not painful)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Lisinopril) and Blood pressure high (Under control with medication).   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 100 microgram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced DIZZINESS (Constant lightheadedness with dizzy spells) and FEELING ABNORMAL (Brain fog). On an unknown date, the patient experienced AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)) and TINNITUS (Ringing in both ears). The patient was treated with MECLIZINE HCL ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Sensation of pressure in ear and Ringing in ears, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Lightheadedness, Dizzy spells, Head pressure, Ear discomfort and Ringing in ears, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Constant lightheadedness with dizzy spells) and FEELING ABNORMAL (Brain fog) had not resolved and AMNESIA (Memory loss), HEAD DISCOMFORT (Pressure in my head and right ear (not painful)), EAR DISCOMFORT (Pressure in my head and right ear (not painful)) and TINNITUS (Ringing in both ears) outcome was unknown.            No concomitant medications were provided by the reporter. The patient did not get relief after treatment. Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen limp nodes in neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen limp nodes in neck) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced LYMPHADENOPATHY (Swollen limp nodes in neck). At the time of the report, LYMPHADENOPATHY (Swollen limp nodes in neck) had not resolved.            Concomitant medication not provided. Treatment medication not provided  Patient took X-rays and ultrasound to ensure no cancer.
Age: 1.25
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse reactions reported; Patient inadvertently given PROQUAD and V ARlV AX on the same day; PROQUAD 0.5ml IM; This spontaneous report was received from a registered nurse referring to a 1-year-old  unreported gender patient. The patient's pertinent medical history, concomitant therapies, drug reactions, or allergies were not reported.     On 19-JUL-2021, "about a half hour ago", the patient was inadvertently given Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) 0.5 milliliters (ml)  intramuscular (lot number T036565 with expiration date 26-APR-2022) (incorrect route of product administration) and varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml subcutaneous (lot number T036561 with expiration date 28-OCT-2022) as prophylaxis (incorrect route of administration and inappropriate schedule of product administration) (doses number, vaccination scheme frequencies and anatomical locations of administration were not reported).  No additional adverse reactions were reported.
Age: 2.0
Sex: F
Vaccine: MMRV
Symptoms: Adverse event, Injection site erythema, Injection site rash
Clinical narrative: slight injection site red rash; This spontaneous report has been received from a physician referring to a 2 year old female patient. No concomitant medication, pertinent medical history or drug reactions/allergies was reported.     On 19-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), injection, 0.5 milliliter, subcutaneously for prophylaxis (lot#, expiration date and strength were not reported, indication reported as "Measles, Mumps, Rubella and Varicella Virus Vaccine").  Other suspect therapies included sterile diluent (STERILE DILUENT) subcutaneously (lot#, expiration date, strength, dose, frequency and indication were not reported).      On 20-JUL-2021, the patient developed a very slight injection site red rash. The patient sought medical attention via unspecified way. Lab diagnostics/studies was not performed.  No treatment was given for the adverse event.  The outcome of the event was unknown. Causality was not reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired GARDASIL 9 was administered to a patient.; This spontaneous report was received from a medical assistant concerning a 12-year-old patient. No concurrent condition, medical history, or concomitant therapy was reported.      On 19-JUL-2021, the patient was vaccinated with a expired dose (expired product administered) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (lot # R029515, has been verified to be a valid lot number, expiration date reported as 08-JUL-2021; strength, route of administration and anatomical location were not provided)  for prophylaxis. The vaccine did not experience any temperature excursions. No additional 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: R029515; expirationdate: 08-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
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No PQC or additional AEs reported; Caller states she has a 17 yo that received 1st dose of GARDASIL 9 about one year ago, received the second dose on 6/28/2021.; This spontaneous report as received from a pharmacist refers to a 17-year-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  Approximately in July 2020 (reported as about one year 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, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 28-JUN-2021, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, intramuscularly, lot # T028582, expiration date 04-MAR-2023 (anatomical location was not reported) for prophylaxis. There was no adverse event 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: T028582; expirationdate: 04-MAR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 46.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ PQC reported; Improperly stored and administered; This spontaneous report was received from a physician (also reported as health care professor (HCP)) referring to a 46-year-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On 15-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T012807 with expiration date of 14-APR-2022 or lot # T013724 with expiration date of 21-APR-2022; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The storage temperatures were -50 Celsius degrees to 8 Celsius degrees (7.4 Celsius degrees) for 1 hour 0 minutes and 0 seconds. Previous temperature excursion was above 9 Celsius degrees (9.1 Celsius degrees) for 6 hours 15 minutes and 0 seconds. Data logger was not involved. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Eye movement disorder, Tremor
Clinical narrative: shaking of hands; fluttering eyes; This spontaneous report was received from a registered nurse via company representative, referring to an adult patient of unspecified age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On an unspecified date in 2021, reported as in the past 4 to 6 months, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter injection, intramuscularly for prophylaxis (site of administration, lot number and expiration date were not reported).         While the patient was in the clinic following the vaccination, the patient experienced fluttering eyes (eye movement disorder) and shaking of hands (tremor).   The patient was then sent to the emergency room, received an unspecified treatment, recovered and was sent home. The outcome of tremor and eye movement disorder was reported as recovered. The reporter did not assess the causal relationship between therapy with  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pain in extremity, Product storage error
Clinical narrative: Arm pain; temperature excursion that occurred on 17 /JUL/2021, 18/JUL/2021, and 19/JUL/2021. PROQUAD and V ARlV AX were both administered to the patient on 19/JUL/2021.; This spontaneous report as received from a certified medical assistant refers to a 4-year-old female patient. The patient's concurrent condition, concomitant medication and medical history were not provided.      On 19-JUL-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) "1 time dose", lot # T035399 was confirmed to be valid, expiration date 16-OCT-2022 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) "1 time dose", lot # T010650 was confirmed to be valid, expiration date 26-MAR-2022 (dose, route of administration, vaccination site were not specified for any of them); both for prophylaxis. On the same date, she received diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) lot # reported as 5RM39, expiration date 25-NOV-2022 in the right arm and polio vaccine inact (IPV) lot # reported as TID448IM, expiration date 22-JUL-2022 in the left arm (dose, route of administration were not specified for any of them); both for prophylaxis. The administered doses underwent a temperature excursion of 55.4 degrees Fahrenheit for 33 hours. There were no previous temperature excursions. Digital data logger was involved. On 19-JUL-2021 the patient experienced pain in arm. The outcome of the event was unknown.  The relatedness between the event and the suspect vaccines was not provided.
Age: 2.0
Sex: U
Vaccine: PPV
Symptoms: Wrong product administered
Clinical narrative: A 2-year-old was inadvertently given the PNUEMOVAX 23 shot; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of an unknown gender. There was no information about the patient's concurrent condition, concomitant medication and medical history provided.  On 23-JUL-2021, the patient was inadvertently given pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) shot for prophylaxis (exact dose, route of administration, lot number and expiration date were not provided) (wrong vaccine administered).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration
Clinical narrative: Patient is not having any adverse events at this time other than the medication error.; she inadvertently gave a patient a dose of PROQU AD and a dose of V ARlV AX.; Proquad administered IM; Varivax administered IM; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. Information regarding the patient's pertinent medical history, concomitant therapies, drug reactions, or allergies was not reported.     On 26-JUL-2021 the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (recombinant human albumin)(PROQUAD) (lot number: T028297, which has been verified to be a valid lot number, and expiration date reported and established as: 16-FEB-2022) that was administered intramuscularly (IM) on the left thigh (incorrect route of product administration) (dose and vaccination scheme frequency were not reported) as prophylaxis. On the same day the patient also was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: T025945, which has been verified to be a valid lot number, and expiration date reported and established as: 30-JUL-2022) that was administered IM on the left thigh (incorrect route of product administration) (dose and vaccination scheme frequency were not reported) as prophylaxis (inappropriate schedule of product administration). In addition on the same date the patient was vaccinated with diphteria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3V (MRC 5), tetanus vaccine toxoid (QUADRACEL) (lot number: C5851AA, expiration date: 25-MAR-2023) administered IM on the right thigh (dose and vaccination scheme frequency were not reported) as prophylaxis. It was reported that the vaccines were administered at the private doctor's office/hospital, purchased with private funds and no digital data logger was involved. The patient did not experience any additional reaction.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No additional AE reported; The patient was administired a dose of PNEUMOVAX23 that experienced a temperature excursion; This spontaneous report has been received from a nurse, concerning a patient of unspecified age and gender patient. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported.  On 26-JUL-2021, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliters (ml) (route pf administration, anatomical location, and vaccine scheme were not reported; lot number T035379, expiration date was not reported but upon internal validation established as: 31-MAY-2022) as prophylaxis.   The involved vaccine was exposed to a temperature excursion of 8.2 degrees Celsius (C) for 1 hour and 15 minutes, as recorded by a data logger (product storage error). There was not a previous temperature excursion. No additional adverse event (AE) reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T035379; expirationdate: 31-MAY-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: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events reported; Caller reported that the currently 21-month-old received the first dose of VAQTA ON 19-APR-21, and the second on 28-JUL21; it was administered before the recommended interval due to the lack of immunization record at the time of administation; This spontaneous report has been received from a registered nurse, concerning a currently 21-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions and previous drug reactions or allergies.  On 19-APR-2021, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (strength, vaccination scheme frequency, route and anatomical location of administration, lot number and expiration date were not reported); and on 28-JUL-2021, the patient received the second dose, 0.5 milliliters (ml) (lot number T035721, expiration date 15-APR-2022, which were determined to be valid) (route and anatomical location of administration were not reported); both as prophylaxis. The nurse stated that the second dose was administered before the recommended interval due to the lack of immunization records at the time of administration (inappropriate schedule of product administration). No additional adverse events were reported  nor product quality complain involved. . combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T035721; expirationdate: 15-APR-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: 16.0
Sex: U
Vaccine: HPV9, HPV9, UNK
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No signs or symptms have been reported; temperature excursion / Gardasil 9 was administered to a patient on 29/JUL/2021; This spontaneous report has been received from a registered nurse concerning a 16-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 29-JUL-2021, the patient was vaccinated with the second dose, of 1 time dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) on the patient's left arm (dose, route of administration and vaccine scheme were not provided; lot number T028929 has been verified to be a valid lot number, expiration date reported and established as 08-MAR-2023), as prophylaxis, and which was improperly stored.   The vaccine was improperly stored at minus 0.5 Centigrade degrees during a time frame of 1 hour 30 minutes; 13.6 Celsius degrees during a time frame of 1 hour 40 minutes. The cumulative time frame was 2 hours 10 minutes (product storage error), which was detected by digital data logger. It was reported that the temperature excursion occurred due to power outage and a storm. There was a miscommunication when reporting high and low readings of temperature. Initially received a clearance to use vaccines on 28-JUL-2021.  There was no previous temperature excursion. No signs of symptoms were 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: T028929; expirationdate: 08-MAR-2023; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse experiences were reported as a result of the vaccine administration; the product was improperly stored and administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-JUL-2021 at 08:00, the patient was vaccinated with an improperly stored single dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) lot # T021643, expiration date 21-DEC-2021 (route of administration and anatomical location were not reported) for prophylaxis (product storage error). No additional adverse experiences were reported as a result of the vaccine administration. Administered dose of vaccine experienced the temperature excursion of 5 degrees Celsius for 92 hours. Data logger was not involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AEs reported.; an expired dose of VARlVAX was administered to a patient; This spontaneous report as received from a vaccine coordinator referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.         On 26-JUL-2021, the patient was vaccinated with expired varicella virus vaccine live (oka/merck)(VARIVAX) 1 injection (dose, strength, route of administration and anatomical site of vaccination were not reported, lot # S022757, expiration date reported as 22-JUL-2021) for prophylaxis (expired product administered). The outcome of expired product administered was unknown. No other adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; MMR II was administered by the intramuscular route and not the subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 30-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 time dose, lot# T020656, expiration date 16-JUN-2022) via intramuscular instead of subcutaneous route for prophylaxis (incorrect route of product administration). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: a temperature excursion states that doses have been administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On 10-JUN-2021, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, lot number T010298, and expiration date 24-MAR-2022 (route were not provided) for prophylaxis (product storage error). The vaccines were exposed to temperature excursion of -7.2 degree Celsius for 2 hours 21 minutes. The vaccines were exposed to previous temperature excursion of -5.9 degree Celsius for 2 hours 31 minutes. Data logger was involved.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Vaccination error, Wrong product administered
Clinical narrative: No other adverse events reported; MMR II was inadvertently administered with PROQUAD; This spontaneous report was received from a registered nurse and refers to a 12-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 30-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD), dose reported as 1 dose, lot # T036563 (Lot No. T036563 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and upon internal validation established as 26-APR-2022) for prophylaxis (dose number, exact dose and route of administration were not provided).  On the same day, the patient was inadvertently administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), dose reported as 1 dose, lot # T003384, expiration date: 28-JAN-2022 (dose number, exact dose and route of administration were not reported) also for prophylaxis (vaccination error).  No adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; inadvertently administered an expired dose of MMR II; This spontaneous report as received from a customer referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, current condition, drug reactions/allergies and concomitant medication were not provided.         On 02-AUG-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 1 time dose (dose, strength, route of administration and anatomical site of vaccination were not reported, lot # S023656, expiration date reported as 30-JUL-2021) for prophylaxis administered by a medical assistant inadvertently (expired product administered). There was no temperature excursions for this vaccine. The outcome of expired product administered was unknown. No other adverse events reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE's reported/no symptoms were reported; Proquad administered since the excursion occured on 22-JUL-2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection, lot # T037955, expiration date 09-MAY-2022, dose 1 (unit not provided) (injection site and route of administration were not provided) for prophylaxis.   On 22-JUL-2021, the administered dose experienced a temperature excursion of 13.02 degrees Fahrenheit for 1 hour and 30 minutes The digital data logger was involved in recording the temperature excursion details. Previously the dose experienced a temperature excursions of 6 degrees Fahrenheit to 14 degrees Fahrenheit (14 degrees Fahrenheit) for 6 hours, 14 degrees Fahrenheit to 46 degrees Fahrenheit (46 degrees Fahrenheit) for 14 hours and 47 degrees Fahrenheit to 77 degrees Fahrenheit (48.9 degrees Fahrenheit) for 30 minutes. The vaccine was given a new expiry date of unknown date in September 2021. No additional adverse events were reported.   This is one of 5 reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA004806: US-009507513-2108USA004804: US-009507513-2108USA004805: US-009507513-2108USA000973:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no additional AE reported; vaccine administered intramuscular instead subcutaneous; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 02-AUG-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, intramuscularly (injection site, albumin status, lot # and expiration date were not provided) for prophylaxis (incorrect route of product administration). No additional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; the vaccine administered today (8/4/2021) was expired.; This spontaneous report has been received from a nurse prescriber, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On 04-AUG-2021 (reported as today), the patient was vaccinated with an expired dose of Hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination and vaccine scheme was not reported; lot number S037574 has been verified to be a valid lot number, expiration date reported and established as 10-APR-2021) (expired product administered) as prophylaxis The caller reported no symptoms from injection. No additional adverse events (AEs) were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: S037574; expirationdate: 10-APR-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: 1.0
Sex: U
Vaccine: MMR
Symptoms: Cyst, Injection site erythema, Injection site swelling, Soft tissue swelling
Clinical narrative: after the vaccine was given the injection site was red, and swollen.; after the vaccine was given the injection site was red, and swollen.; soft tissue swelling; multiple cystic growths with no need to drain the left thigh.; This spontaneous report has been received from a physician, via company representative, referring to a 12-months-old patient of unspecified gender. Information regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was unknown by the reporter.  On 25-JUN-2021, the patient was vaccinated with a one (1) time dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) that was administered on the left tight (exact dose and route of administration were not provided; lot number T013728 that has been verified to be valid with an expiration date reported and established as 21-APR-2022) as active immunization for the prevention of measles, mumps, and rubella (prophylaxis). On that same date, right after the vaccine was given the injection site was red and swollen (vaccination site erythema and vaccination site swelling).   On an unspecified date in 2021, the patient developed soft tissue swelling with multiple cystic growths (cyst) that were noted on a visit to emergency room (ER) on 09-JUL-2021 (reported as "2 weeks after the injection"). It was reported that it was no needed to drain the left thigh. It was stated that patient has been followed up by a pediatric surgeon.  It was reported that no treatment was given for the events. It was unknown by the reporter if any lab diagnostics or studies were performed. It was stated that this patient experienced the same effects as another baby patient who also was vaccinated with a Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (M-M-R II) that had the same lot number (reported in case #2108USA001689).   The outcome of the events at the time of this report was reported as unknown. The causality assessment between the suspect vaccine with all the events was not provided.  This is one of two reports reported by the same reporter.; Sender's Comments:  US-009507513-2108USA001689:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Bacterial infection, Culture tissue specimen positive, Diagnostic aspiration, Injection site erythema, Injection site induration
Clinical narrative: a needle aspiration which showed microbial growth; the injection site was red, and hard; the injection site was red, and hard/ the injection site "lump" was bigger; the injection site "lump" was bigger, painful; This spontaneous report was received from a physician and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were unknown.  On 12-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), in the left thigh, at a dose reported as 1 time dose, lot # T013728, expiration date: 21-APR-2022 (dose number, exact dose and route of adminstration were not provided) for active immunization for the prevention of measles, mumps, and rubella.  Right after the vaccine was given, the injection site was red and hard (vaccination site erythema; vaccination site mass). 2 weeks later on 26-JUN-2021, a patient's mother reported to the physician that the injection site "lump" was bigger, painful, but there was no fever (vaccination site pain). On 28-JUN-2021, the mom took the patient to the emergency room (ER). In the ER they did an ultrasound and a needle aspiration which showed a microbial growth (culture tissue specimen positive). The infectious disease doctor gave the baby antibiotics (no details).  At the time of the report, the outcome of the events was unknown.  The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) was not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001414:
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Injection site mass, Injection site pain, Ultrasound scan abnormal
Clinical narrative: a needle aspiration which showed microbial growth; the injection site was red, and hard; the injection site was red, and hard/ the injection site "lump" was bigger; the injection site "lump" was bigger, painful; This spontaneous report was received from a physician and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were unknown.  On 12-JUN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II), in the left thigh, at a dose reported as 1 time dose, lot # T013728, expiration date: 21-APR-2022 (dose number, exact dose and route of adminstration were not provided) for active immunization for the prevention of measles, mumps, and rubella.  Right after the vaccine was given, the injection site was red and hard (vaccination site erythema; vaccination site mass). 2 weeks later on 26-JUN-2021, a patient's mother reported to the physician that the injection site "lump" was bigger, painful, but there was no fever (vaccination site pain). On 28-JUN-2021, the mom took the patient to the emergency room (ER). In the ER they did an ultrasound and a needle aspiration which showed a microbial growth (culture tissue specimen positive). The infectious disease doctor gave the baby antibiotics (no details).  At the time of the report, the outcome of the events was unknown.  The causality assessment between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) was not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001414:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; VARIVAX was administered yesterday to one patient / Names of vaccines involved (...) VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 04-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # T032321, expiration date 22-SEP-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported). Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 7.7 degrees of Fahrenheit for 1 hour and 18 minutes. There was no previous temperature excursion reported. No additional adverse events reported.  On 13-AUG-2021, an inbound call was received from the medical assistant. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: post herpetic neuralgia; herpes zoster; painful rash; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender who at the time of vaccination with zoster vaccine live (ZOSTAVAX) was at least 59 years old. No information was provided regarding the pt's medical history, concurrent conditions or concomitant medications. On or about 07-APR-2016, the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by healthcare providers for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: painful rash, herpes zoster, and post herpetic neuralgia. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired MMRII was administered to a patient; This spontaneous report was received from a pharmacist referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication or drug reactions/allergies was provided.  On 02-AUG-2021, an expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (rHA) (lot number R031679 has been verified to be valid, expiration date reported and validated as 01-NOV-2020) was administered to the patient as prophylaxis (administered dose, vaccination scheme, route of administration and anatomical location of vaccination were not reported) (expired product administered). The vaccine was reconstituted using the sterile diluent (STERILE DILUENT) (lot number S002624 and expiration 05-NOV-2021, both verified as valid). No additional adverse event (AE) reported.