chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia, Urticaria
Clinical narrative: chills; body aches; hives/hives on my back, my front under my breasts, around armpits, and in groin area. The hives lasted 2 days; fever/ran a fever for 2 days; fatigue for a week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2022 at 14:00 as dose 4 (booster), single (Lot number: FM7553) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dry eyes" (unspecified if ongoing); "salzman's Nodular degeneration in right eye" (unspecified if ongoing). Concomitant medication(s) included: RESTASIS. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: EL1284, Administration time: 12:00 PM, Vaccine location: Left arm), administration date: 14Jan2021, when the patient was 76-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2, Single, Lot number: EL9265, Administration time: 12:00 PM, Vaccine location: Left arm), administration date: 05Feb2021, when the patient was 77-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Single, Lot number: IC3183, Administration time: 12:00 PM, Vaccine location: Left arm), administration date: 26Aug2021, when the patient was 77-year-old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 03May2022 at 12:00, outcome "recovered" (May2022), described as "body aches"; CHILLS (non-serious) with onset 03May2022 at 12:00, outcome "recovered" (May2022); FATIGUE (non-serious) with onset 03May2022 at 12:00, outcome "recovered" (May2022), described as "fatigue for a week"; PYREXIA (non-serious) with onset 03May2022 at 12:00, outcome "recovered" (May2022), described as "fever/ran a fever for 2 days"; URTICARIA (non-serious) with onset 03May2022 at 12:00, outcome "recovered" (May2022), described as "hives/hives on my back, my front under my breasts, around armpits, and in groin area. The hives lasted 2 days". The events "chills", "body aches", "hives/hives on my back, my front under my breasts, around armpits, and in groin area. the hives lasted 2 days", "fever/ran a fever for 2 days" and "fatigue for a week" required emergency room visit. Therapeutic measures were taken as a result of chills, pain, urticaria, pyrexia, fatigue.  Additional information: If other vaccine in four weeks: No. Other medications in two weeks: Multivitamin. If Covid prior vaccination: No. If Covid tested post vaccination: No. The night of the day, the patient got the shot and had chills, body aches. The next morning, the patient had hives on her back, her front under her breasts, around armpits, and in groin area. The hives lasted 2 days. The patient took Benadryl to combat them. The patient ran a fever for 2 days and experienced fatigue for a week. Advice about what she could take.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Heart attack; Cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 at 14:30 as dose 3 (booster) , single (Lot number: EW0186) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: Well controlled hypertension. Concomitant medication(s) included: NORVASC. Vaccination history included: BNT162b2 (Dose:1, Vaccine lot number= EL3248,, Vaccine lot unknown=False, Vaccine dose number unknown=False, Vaccine location=Left arm), administration date: 12Jan2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (Dose:2, Vaccine lot number=EN5318,, Vaccine lot unknown=False, Vaccine dose number unknown=False, Vaccine location=Left arm), administration date: 12Feb2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: CARDIAC ARREST (hospitalization, medically significant, life threatening) with onset 18Apr2022 at 07:45, outcome "recovered with sequelae" (01May2022); MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 18Apr2022 at 07:45, outcome "recovered with sequelae" (01May2022), described as "Heart attack". The patient was hospitalized for myocardial infarction, cardiac arrest (hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) positive. Therapeutic measures were taken as a result of myocardial infarction, cardiac arrest.  Clinical course: Antiviral details was reported as for product COVID 19 treatment Paxlovid and treatment start date 28Apr2022 and stop date 03May2022 for the indication of treatment of COVID-19. Patient reported that Adverse event COVID related heart attack on 18Apr2022 after testing positive for COVID on 08Apr2022 with cardiac arrest x2 stent occlusion 2 hours after placement CCU stay with intubation, defribillation and temporary pacemaker. AE resulted in Hospitalization, Life threatening illness (immediate risk of death from the event) and patient was hospitalized for 5 days. AE treatment was received as catherization, stent, defibrillation, intubation. No known allergies was reported.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: Heart attack; Cardiac arrest; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 at 14:30 as dose 3 (booster) , single (Lot number: EW0186) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: Well controlled hypertension. Concomitant medication(s) included: NORVASC. Vaccination history included: BNT162b2 (Dose:1, Vaccine lot number= EL3248,, Vaccine lot unknown=False, Vaccine dose number unknown=False, Vaccine location=Left arm), administration date: 12Jan2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (Dose:2, Vaccine lot number=EN5318,, Vaccine lot unknown=False, Vaccine dose number unknown=False, Vaccine location=Left arm), administration date: 12Feb2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: CARDIAC ARREST (hospitalization, medically significant, life threatening) with onset 18Apr2022 at 07:45, outcome "recovered with sequelae" (01May2022); MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 18Apr2022 at 07:45, outcome "recovered with sequelae" (01May2022), described as "Heart attack". The patient was hospitalized for myocardial infarction, cardiac arrest (hospitalization duration: 5 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) positive. Therapeutic measures were taken as a result of myocardial infarction, cardiac arrest.  Clinical course: Antiviral details was reported as for product COVID 19 treatment Paxlovid and treatment start date 28Apr2022 and stop date 03May2022 for the indication of treatment of COVID-19. Patient reported that Adverse event COVID related heart attack on 18Apr2022 after testing positive for COVID on 08Apr2022 with cardiac arrest x2 stent occlusion 2 hours after placement CCU stay with intubation, defribillation and temporary pacemaker. AE resulted in Hospitalization, Life threatening illness (immediate risk of death from the event) and patient was hospitalized for 5 days. AE treatment was received as catherization, stent, defibrillation, intubation. No known allergies was reported.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mitral valve disease, Nasal congestion, Nasopharyngitis, Pyrexia
Clinical narrative: have Covid now; have Covid now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Nov2020 (unspecified if ongoing), notes: Covid; "open heart surgery", start date: Nov2020 (unspecified if ongoing), notes: to repair a mitral valve. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "have Covid now". Clinical Course: Patient had the Pfizer Covid 19 vaccine back in Apr2021 of last year (confirmed 2021) and had her second dose 5 weeks later. She got her booster in Nov2021 (confirmed 2021). She had COVID now. She had read time and time again. She had COVID in Nov2020 (confirmed 2020) before vaccines were available. Is having the booster in Nov led to a lesser degree of Covid? she had it really bad last year. Patient thought it was congenital but she had to have open heart surgery in Nov to repair a mitral valve. She was not dying over here. She called her doctor and they were going to put her on Paxlovid which she was hesitant to take with the side effects and her history. She took cholesterol medicine. She made it through ok last time. Her fever was not as high as before, she was a just really congested like a bad cold. It doesn't seem as bad. She do not want to take that pill. Is it going to be shorter lived? Is COVID shorter lived after 3 doses?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: have Covid now; have Covid now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Nov2020 (unspecified if ongoing), notes: Covid; "open heart surgery", start date: Nov2020 (unspecified if ongoing), notes: to repair a mitral valve. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "have Covid now". Clinical Course: Patient had the Pfizer Covid 19 vaccine back in Apr2021 of last year (confirmed 2021) and had her second dose 5 weeks later. She got her booster in Nov2021 (confirmed 2021). She had COVID now. She had read time and time again. She had COVID in Nov2020 (confirmed 2020) before vaccines were available. Is having the booster in Nov led to a lesser degree of Covid? she had it really bad last year. Patient thought it was congenital but she had to have open heart surgery in Nov to repair a mitral valve. She was not dying over here. She called her doctor and they were going to put her on Paxlovid which she was hesitant to take with the side effects and her history. She took cholesterol medicine. She made it through ok last time. Her fever was not as high as before, she was a just really congested like a bad cold. It doesn't seem as bad. She do not want to take that pill. Is it going to be shorter lived? Is COVID shorter lived after 3 doses?  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Corneal abrasion, Eye movement disorder, Magnetic resonance imaging abnormal
Clinical narrative: Developed Bells Palsy on right side of face & corneal abrasions in both eyes as a result of not being able to close eye.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Corneal abrasion, SARS-CoV-2 test negative
Clinical narrative: Developed Bells Palsy on right side of face & corneal abrasions in both eyes as a result of not being able to close eye.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: Entire right side hurts. Neck, arm, head.  My arm is swollen .  My lymph nodes are extremely swollen and painful.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Entire right side hurts. Neck, arm, head.  My arm is swollen .  My lymph nodes are extremely swollen and painful.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Insomnia, Nausea
Clinical narrative: Flu like symptoms including fatigue, Body aches and headache started after 3 hours and stayed for 2 days.  Insomnia, Low fever and nausea were experienced periodically over two days.  Tylenol helped with headache and body aches and took it every 6 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Flu like symptoms including fatigue, Body aches and headache started after 3 hours and stayed for 2 days.  Insomnia, Low fever and nausea were experienced periodically over two days.  Tylenol helped with headache and body aches and took it every 6 hours.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Muscular weakness, Pain
Clinical narrative: Persistent electrical type pain,  persistent weakness of L upper extremity , and this is 5 weeks from injection date
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Fear, Laboratory test normal, Magnetic resonance imaging head normal, Photopsia
Clinical narrative: Four days after receiving the vaccine I started to see a star that appears and disappears  intermittently.  Next day I waited to see what happens and if this stars goes away.  On saturday I started to be afraid because the stars were more frequent and also I started to see flashes of lights so I decided to go to an eye emergency clinic very well known in my city (name of eye facility).  The symptons are still the same and even worst.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler normal, Visual impairment
Clinical narrative: Four days after receiving the vaccine I started to see a star that appears and disappears  intermittently.  Next day I waited to see what happens and if this stars goes away.  On saturday I started to be afraid because the stars were more frequent and also I started to see flashes of lights so I decided to go to an eye emergency clinic very well known in my city (name of eye facility).  The symptons are still the same and even worst.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), 4 months 27 days after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; a patient received an improperly stored vaccine today; temperature: 34F; This spontaneous report was received from a medical assistant referring to a 8-week-old male patient. Information about patient's medical history, concomitant medications, concurrent conditions and drug reactions/ allergies was not provided.  On 14-APR-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) dose of 2 mL, administered orally, lot number: 1837116, expiration date: 24-MAR-2023 (dose number and formulation was not reported) for prophylaxis (product storage error). A physician also reported that on the same day, the patent received diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (manufacturer unknown) dose of 0.5 mL, lot number: B4722, hib vaccine conj (tet tox) (ACTHIB) (manufacturer unknown) dose of 0.5 mL, lot number: UJ604AAA and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (manufacturer unknown) dose of 0.5 mL, lot number: EX1980 (dose number, formulation, route of administration, anatomical location and expiration date was not reported for all of the vaccines) for prophylaxis. No other information provided. No additional adverse events (AEs) or product quality complaint (PQC) reported (no adverse event).  The administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion of 66 degrees Fahrenheit for 15 hours and 10 minutes. It was reported that there were no previous temperature excursions. It was unknown, whether a digital data logger was involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller is a nurse who reports a dose of PROQUAD was given to a patient following temperature excursion.; This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions or allergies were not provided.   On 22-MAR-2022 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) 0.5 ml once, administered as prophylaxis, lot number U029319 was verified to be a valid lot number, expiration date: 19-MAR-2023 (route of administration and anatomical location were not reported), the vial was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot number and expiry date were not reported) (product storage error).  The measles, mumps, rubella and varicella (oka merck) virus vaccine live (PROQUAD) was stored at a temperature of -11.7 Celsius (C) for the time frame of 49 minutes. There was no previous temperature excursion.  No further adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE; Caller is a nurse who reports a dose of VARIVAX was given to a patient following temperature excursion.; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, previous drug reactions or allergies were not provided.   On 21-MAR-2022 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml once, administered as prophylaxis; there were four lots involved and it is not clear which lot was given to the patient: lot numbers U002395, U007475, U028164 and T028304 that were verified to be a valid lot numbers, expiration dates: 22-JAN-2023, 03-AUG-2023, 09-SEP-2023 and 20-AUG-2023, respectively, (strength, route of administration and anatomical location were not reported), the vials was reconstituted with sterile diluent (MERCK STERILE DILUENT) (strength, dose, lot number and expiry date were not reported) (product storage error).  The  varicella virus vaccine live (Oka/Merck) (VARIVAX) was stored at a temperature of -11.7 Celsius (C) for the time frame of 49 minutes. There was no previous temperature excursion.  No further adverse event (AE) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; An expired dose of VARIVAX was administered to a patient on April 13, 2022.; This spontaneous report was received from a registered nurse referring to an unspecified age and gender patient whose medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-APR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml), once, for prophylaxis, lot number T012552, was determined to be a valid lot number, and the expiration date was reported and upon internal verification established as 10-APR-2022 (expired vaccine used) (route of administration, anatomical location, and vaccine scheme were not reported).   No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event, Product storage error
Clinical narrative: no additional AE information provided; VARIVAX that experienced a supported temperature excursion was administered to two patients on March 19, 2022; dose 5 mL; This spontaneous report was received from physician and refers to a patient of unknown age and gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 19-MAR-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 5 mL for prophylaxis (lot #U015689, expiration date: 18-MAY-2023; strength and route were not reported) (incorrect dose administered). The vaccine had a temperature excursion at temperature -14 degree Celsius up to -10 degree Celsius (-14.5 degree Celsius) for 5 min (product storage error). No additional adverse event information was provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA006498:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No aditional AE; The nurse called to evalauate an administered expired dose of GARDASIL 9.  The GARDASIL 9 expired on 2/26/2022 and was administered to a patient on 4/15/2022.  No adiitional AE's and no PQc's were reported.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's historical conditions, past drugs reactions or allergies, concurrent conditions or concomitant therapies was not provided.  On 15-APR-2022, the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe formulation administered as prophylaxis (expire dose reported as 26-FEB-2022) (strength, dose, vaccination scheme, route of administration and anatomical location, and lot number were not provided) (expired product administered). No additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report that PROQUAD vaccine which expired on April 14, 2022 was administered to a patient today, April 21, 2022. Caller confirms the product was stored appropriately and there were no temperature excursions on the product. No additiona; This spontaneous report was received from a licensed practical nurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported.  On 21-APR-2022, the patient was vaccinated with expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot #T035409, expiration date: 14-APR-2022 (dose, site and route of administration were not provided) for prophylaxis (Expired product administered). No additional adverse event information was provided (No adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No additional AE reported; expired dose of STERILE DILUENT was used to reconstitute M-M-R II and administered to a patient on 22-APR-2022; expired dose of STERILE DILUENT was used to reconstitute M-M-R II and administered to a patient on 22-APR-2022; This spontaneous report was received from licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 22-APR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II) at a dose of 0.5 ml, lot number U023829 was found to be valid, expiration date 30-JUL-2023 (strength, route of administration and injection site were not reported) for prophylaxis. The vaccine was diluted with an expired dose sterile diluent at a dose of 0.5 ml, lot # S008565 was found to be valid, expiration date 09-AUG-2021 (expired product administered, product preparation issue). The caller confirmed that the dose of sterile diluent did not experience a temperature excursion. No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Customer calling to check stability of PROQUAD. Per caller the product has been stored in the refrigerator since April 20, 2022. Date of excursion April 20 ,2022; This spontaneous report was received from a medical assistant referring to an unknown gender and age patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  It was reported that the product (measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) had been stored in the refrigerator experienced a temperature excursion (Temperature: 45 Fahrenheit (F)) (Product storage error) since 20-APR-2022.  On 25-APR-2022, after a time frame of 120 hours of storage of the product, the patient was vaccinated with measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) (valid lot #W004694, expiration date: 08-AUG-2023) (strength, dose and route of administration were not provided) administered for prophylaxis.
Age: 1.17
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, Product use issue, Wrong product administered
Clinical narrative: Patient who was supposed to receive MMRII and VARIVAX, but received a full dose of VARIVAX and half a dose of PROQUAD.; Patient who was supposed to receive MMRII and VARIVAX, but received a full dose of VARIVAX and half a dose of PROQUAD.; Patient who was supposed to receive MMRII and VARIVAX, but received a full dose of VARIVAX and half a dose of PROQUAD.; This spontaneous report has been received form a prescriber nurse, regarding a 14-month-old patient of unknow gender. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 25-APR-2022, the patient was supposed to receive a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). Instead, the patient received a full dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) and half a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) as prophylaxis (strength, dose, route of administration, anatomical location, lot number or expiration date were not reported) (wrong product administered) (incorrect dose administered) (product use issue).
Age: 1.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects or symptoms as a result of administration. No other AE/no PQC.; dose of PNEUMOVAX23 was given to a patient who was 1 year and 11 days old; This spontaneous report was received from a licensed practical nurse and refers to an 1-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-APR-2022, the was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter, lot #T039322, expiration date: 09-SEP-2022 (strength, site and route of administration were not provided) for prophylaxis (Product administered to patient of inappropriate age). No adverse events were reported (No adverse event).
Sex: M
Vaccine: COVID19, PPV
Symptoms: Feeling abnormal, Ill-defined disorder, Vaccination site erythema, Wrong product administered
Clinical narrative: The patient went into a pharmacy to receive the PNEUMOVAX 23 vaccine about 1 week ago. One or two days later, his arm turned red. / redness on his arm where the vaccine was administered all the way down to his elbow; a doctor who looked at the patient's arm told him that he must have received the Covid vaccine instead of PNEUMOVAX 23; patient reported to her he is experiencing "something", but she couldn't remember what "something" was.; "the patient feels like he received the Covid vaccination instead of the PNEUMOVAX 23"; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On approximately 20-APR-2022, reported as about 1 week ago, the patient went into the pharmacy to receive the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, injection site, lot number and expiration date were not reported) for vaccination (prophylaxis). On approximately 21-APR-2022 (reported as one or two days later; discrepancy, also reported as 1 week ago), his arm turned red. He sought medical attention in the emergency room and the physician, who looked at his arm told him, that he must have received the coronavirus disease (COVID) vaccine (COVID-19 vaccine) (dose, route of administration, injection site, lot number, expiration date and indication were not provided) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (wrong product administered, adverse event onset date 20-APR-2022). The patient received benadryl as a treatment of the vaccination site erythema. The patient was unsure which vaccine was administered to him, but he felt like he received the COVID vaccine (feeling abnormal, adverse event onset date unknown date in April 2022). The reporter stated, the patient told her, that "he is experiencing something", but she could not remember what it was (ill-defined disorder, adverse event onset date: unknown date in April 2022). It was reported, that the events were not considered as an overdose. The outcome of vaccination site erythema was reported as recovering (discrepancy, also reported as "arm is no longer red nor swollen"- recovered). The outcome of ill-defined disorder was not recovered/ not resolved at the time of the reporting. The outcome of feeling abnormal was unknown.  The relatedness between the events and suspected therapy was unknown.
Age: 0.42
Sex: M
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; HCP reported an expired ROTATEQ was administered to a patient. She reported that ROTATEQ with an expiration date of 3/29/2022 was administered to a patient today (4/27/2022).; This spontaneous report was received from a nurse and refers to a 5-month-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions, and concomitant medications were not provided.  On 27-APR-2022, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter (ml), lot 1707496, expiration date reported as 29-MAR-2022 (strength, and route of administration were not provided) (expired vaccine used). No additional adverse event was reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD expired on 4/14/2022 and was administered on 4/22/2022; The PROQUAD did have a previous temperature excursion on 2/23/2022; This spontaneous report was received from a nurse and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 22-APR-2022, the patient was vaccinated with a dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, dose: 0.5ml, lot # T035389, expiration date: 14-APR-2022, administered subcutaneously in right arm for prophylaxis (strength was not provided) (expired product administered). Prior to being administered, on 23-FEB-2022, the vaccine underwent a temperature excursion (product storage error). Temperature and duration of excursion were not reported. No additional adverse event reported (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: her son's arm is really sore after his vaccinations were administered; This spontaneous report was received from the patient's mother and refers to a 13-year-old male patient. There was no information regarding his medical history, concurrent conditions and concomitant medications provided.  On an unknown date, the patient was vaccinated with 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 provided) for prophylaxis.  On an unspecified date, after the vaccination, the patient's arm became sore. At the time of the report, the patient had not recovered from the event.  The causality between the event and the suspect vaccine was not reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2204USA009815:
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; The nurse called to determine the stability of an expired dose of MMR II that was administered to a patient. No additional Ae's and no PQc's were reported.; This spontaneous report was received from a administrator referring to a 6-year-old patient of an unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 27-APR-2022, the patient was vaccinated with an expired vaccine (Expired product administered) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin - rHA) (M-M-R II) subcutaneous injection, lot number T001214, expiration date: reported as 17-JAN-2022 but internally confirmed as 12-JAN-2022, (strength, dose, anatomical location, and route of administration were not provided).   No additional adverse events reported.
Age: 0.5
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product use issue
Clinical narrative: No aditional AE info; Physician calling reports patient was given a 3rd dose of PEDVAX HIB. First dose was given DEC 10 2021 at 2 months, second dose given FEB 11 2022 at 4 months and third dose given APR 15 2022 at 6 months. No additional AE info. No PQC.; This spontaneous report has been  received from physician and refers to a 6-month-old female patient.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On 10-DEC-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, first dose, a second dose was received 2 months later on 11-FEB-2022, and a third dose 2 months later on 15-APR-2022 administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided) (product use issue). No additional adverse event were reported.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE info; Nurse calling for  TE evaluation of refrigerated products mentions vaccines were administered to 4 patients.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-APR-2022, the subject was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (valid lot #U032681, expiration date: 26-OCT-2023) (strength, dose, route of administration and anatomical location were not provided) as prophylaxis. A temperature evaluation of refrigerated products  was made and showed that for 4 hours 2 minutes 0 seconds, the temperature vaccine was 58.5 Fahrenheit (F) (Product storage error). No previous temperature excursion occurred. There was no adverse event reported.  This is one of for reports received from the same reporter (captured in MARRS#2205USA000274, MARRS#2205USA000454 and MARRS#2205USA000252). ; Sender's Comments:  US-009507513-2205USA000454: US-009507513-2205USA000274: US-009507513-2205USA000252:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details.; Nurse calling for TE evaluation of refrigerated products mentions vaccines were administered to 4 patients.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-APR-2022, the patient was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (valid lot #U032681, expiration date: 26-OCT-2023) (strength, dose and route of administration were not provided) as prophylaxis. A temperature evaluation of refrigerated products was made and it was reported that for 4 hours 2 minutes 0 seconds, the temperature vaccine was 58.7 Fahrenheit (F) (Product storage error). No previous temperature excursion occurred. There was no adverse event reported.  This is one of several reports received from the same reporter (captured on #2205USA000274, #2205USA000427 and #2205USA000252). ; Sender's Comments:  US-009507513-2205USA000274: US-009507513-2205USA000427: US-009507513-2205USA000252:
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; Office manager reporting that an expired dose of MMRII was given to a 6 year old patient.; This spontaneous report has been received from an office manager (also reported as a health care professional) via email concerning a 6-year-old male patient.  There was no information about the patient's medical history, concurrent conditions, or concomitant medications.  On 27-APR-2022 (also reported on 26-APR-2022 by the same reporter,conflicting information), the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (injectable) rHA,  lot #: T001214, expiration date:17-JAN-2022 for as prophylaxis (dose and route of administration were not reported) (Expired product administered).   No adverse reaction to receiving an expired Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine has been reported by the patient or his family. The practice manager would like a call back regarding follow up including what to expect due to the child having received an expired vaccine.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: NO ADVERSE EVENT; Caller reports expired dose of MMR II was administered; This spontaneous report was received from an unspecified reporter regarding to a patient of unknown age and gender.   The patient's concurrent conditions, medical history, and  historical drugs, were not reported.  On 18-APR-2022, the patient was vaccinated with a expired dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin) (M-M-R II)  0.5ml, subcutaneously (SQ)  (lot number T013003 has been verified to be valid, expiration date: 15-APR-2022), in addition with sterile diluent (manufacturer unknown) (lot number U006619 has been verified to be valid, expiration date: 06-SEP-2023) (anatomical location was not provided) as prophylaxis.   At the time of reporting, no additional information was provided, furthermore no adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; Patient was administered expired GARDASIL 9; 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 concurrent conditions, medical history and concomitant medications was provided.  On 03-MAY-2022, the patient was vaccinated with an expired dose (expired product administered) of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot #: S031287, expiration date: 08-APR-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis. There was no temperature excursions reported for the vaccine. There was no additional adverse event reported.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range; This spontaneous report was received from an administrator and refers to a 4-year-old female patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 19-APR-2022, the patient was vaccinated with an improperly store dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot # U039258, expiration date: 09-JUN-2023, in addition with sterile diluent (DILUENT MERCK) (Lot # and expiry date were not reported) solution for injection/infusion, administered for prophylaxis (strength, dose description and route of administration were not provided).  The storage temperature was 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (7.9 F) for 4 hours 8 minutes 0 seconds. There was no previous temperature excursion. The excursion was called by a digital data logger. No adverse event was reported.   This is one of seven reports received from the same source.; Sender's Comments:  US-009507513-2205USA001202: US-009507513-2205USA000973: US-009507513-2205USA001272: US-009507513-2205USA001205: US-009507513-2205USA001043: US-009507513-2205USA001271:
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: No additional AE; the doctor reported that she administered a third dose of GARDASIL 9 to a patient who was eligible for the two dose regimen.; the doctor reported that she administered a third dose of GARDASIL 9 to a patient who was eligible for the two dose regimen.; This spontaneous report was received from a physician referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 12-JUL-2017, 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) (strength, dose, lot #, expiry date, route of administration and anatomical location were not provided) to prevent human papilloma virus infection. On 12-JAN-2018, the patient received the second dose of HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Then, on 28-JAN-2022, the patient received a third dose of the vaccine (extra dose administered), however it was eligible for the two-dose regimen (Drug use for unapproved schedule). No additional adverse event or further information was reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reported that a patient received PROQUAD that had undergone temperature excursion before calling the news station/Temperature: -14.0C for 5 minutes and 50 seconds and -14.1C for 5 minutes, Time frame: 10 minutes and 50 seconds; No additional AE reported; This spontaneous report was received from a nurse and refers to a 5-year-old at the reporting time, female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) product quantity: 1, lot #: U002532, expiration date: 24-JUL-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis, that had undergone temperature excursion (product storage error) "before calling the news station". Temperature excursion information: -14 degree Celsius for 5 minutes and 50 seconds and -14.1 degree Celsius for 5 minutes; previous temperature excursion: yes. There was no additional adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: incorrect product storage; no adverse event; This spontaneous report was received from a healthcare worker, concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.     On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number T028583, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 04-MAR-2023) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis. The administered vaccine experienced a temperature excursion of 49.6F during a time frame of 32 minutes (product storage error). No additional adverse events were reported.