chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; herpes zoster; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On 27-MAY-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster and postherpetic neuralgia was not recovered. The causality assessment was considered as related by the lawyer.  The events herpes zoster and postherpetic neuralgia were considered to be disabling by the lawyer.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: PEDVAX HIB had a temperature excursion and was administered; This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 10-FEB-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T020614 expiration date 12-MAR-2023 for prophylaxis (dose and route were not provided).         Digital Data Logger registered a temperature excursion of 35.4 Fahrennheit degrees along 15 minutes.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous report has been received from a health professional referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided.     On an unknown date, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (strength, indication, dose, route, frequency, anatomical location, lot # and expiration date were not provided) for prophylaxis.
Sex: F
Vaccine: MMR
Symptoms: Chest pain, Myocardial infarction, Near death experience, Vomiting
Clinical narrative: it nearly killed her; like a heart attack; vaccine reaction; further described as throwing up; chest pain; This spontaneous report refers to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, route, lot# and expiration date were not provided). She stated it nearly killed her (near death experience) and she further described as throwing up (vomiting), chest pain and almost like a heart attack (myocardial infarction). The outcome of near death experience, chest pain, vomiting, vaccination complication and myocardial infarction was unknown.     The reporter considered vaccination complication, myocardial infarction, chest pain, vomiting and near death experience to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown) as she considered the reaction was caused by an ingredient in the vaccine but she did not know much about that.  Upon internal review, myocardial infarction and near death experience were considered medically significant events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding her medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster, and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient 's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of herpes zoster, and postherpetic neuralgia was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 06-APR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route were not provided; lot# was T017685 and expiration date was 21-MAY-2022; lot# was T027303 and expiration date was 12-AUG-2022; lot# was T010311 and expiration date was 24-MAR-2022; lot# was T017681 and expiration date was 21-MAY-2022) involved temperature excursions for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).               The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.   This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003267: US-009507513-0503USA00121: US-009507513-2104USA003265: US-009507513-2104USA003268: US-009507513-2104USA003266: US-009507513-2104USA002475:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, 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 16-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 10 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. 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: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002451: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002491:
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, 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 31-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 10 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. 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: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002451: US-009507513-2104USA002490: US-009507513-2104USA002491:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Chills, fatigue, headache, muscle contraction, muscle soreness, weakness , nausea , lightheaded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Myalgia, Nausea
Clinical narrative: Chills, fatigue, headache, muscle contraction, muscle soreness, weakness , nausea , lightheaded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Almost immediately I felt off after the vaccine I wanted to get it to protect my son since I work in a public place not even an hour after I got it I fell asleep unable to keep my eyes open I thought it was okay but here it is Friday and I'm still having trouble staying awake ill be okay for a few hours at a time then have a uncontrollable need to sleep I never ever nap in the daytime and im a very energetic person but I can seem to wake up for more than a little at a time I have to fight it for work but fined myself dozing off standing up I just wanted to report this for it to be known I hope the feeling goes away I really wanna have high hopes for this vaccine
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea
Clinical narrative: I have shortness of breath and nausea
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: low grade fever (100), body aches, tiredness
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: low grade fever (100), body aches, tiredness
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsey
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Myalgia, Nausea
Clinical narrative: Myalgias, chills, subjective fever and diffuse nonfocal abdominal pain without acute abdomen, N/V or D.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Myalgias, chills, subjective fever and diffuse nonfocal abdominal pain without acute abdomen, N/V or D.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Skin rash in the arm of the vaccine
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Electrocardiogram normal, Fatigue, Syncope
Clinical narrative: Syncopal episode with loss of consciousness approximately 36 hours after vaccine. Unknown length of loss of consciousness as patient lives alone. Pt experienced dizziness, fatigue and decreased appetite the day of adverse event.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Impaired work ability
Clinical narrative: Extreme dizziness - like I was drunk all of the sudden - Severe Tiredness, bad Headache, Muscle pain, Chills, Fever 100 - 100.6, Nausea (dry heaving). Missed two days of work. I am going to work today but still feel like crap.   I had the same reaction, but less to the first dose.  3/23/21
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Retching, Vaccine positive rechallenge
Clinical narrative: Extreme dizziness - like I was drunk all of the sudden - Severe Tiredness, bad Headache, Muscle pain, Chills, Fever 100 - 100.6, Nausea (dry heaving). Missed two days of work. I am going to work today but still feel like crap.   I had the same reaction, but less to the first dose.  3/23/21
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Fever, chills, body aches, pain under right arm, tingling skin
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever, body pain, chills, fatigue and fever.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Herpes simplex, Myalgia
Clinical narrative: extreme fatigue, muscle pain, headache       treated with acetaminophen, resolved by 48 hours outbreak of hsv, beginning 4/8/2021, unresolved as of 4/16/2021
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Non-specific, non-pruritic rash on abdomen and lower extremities.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Thirst
Clinical narrative: Blurry while driving to OBS/nausea, sweating, woozy, dizzy, pale.  Drank water. Paramedics to VS.  Felt better.  Drove home.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Vital signs measurement
Clinical narrative: Blurry while driving to OBS/nausea, sweating, woozy, dizzy, pale.  Drank water. Paramedics to VS.  Felt better.  Drove home.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia
Clinical narrative: Pneumonia due to Covid
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope, Unresponsive to stimuli, Vital signs measurement
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Patient fainted a few minutes after receiving the vaccination-Medium, Additional Details: Patient was given Pfizer COVID-19 vaccination by RPH.  A few minutes into the observation period, I heard a loud noise that sounded like a fall.  I run outside to find Patient on the floor.  She woke up within a few seconds, 911 was called.  I kept her awake and took her vitals BP prior to EMS arrival= 118/72 mmHg. Upon Fire dept arrival BP= 148/65 mmHG. Transitioned to EMS/Fire Dept.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020109 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided). No additional adverse effect reported.   Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002701:
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted briefly, EMS contacted and vitals were ok.  He drove himself back to college
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Musculoskeletal stiffness, Rash, Vaccine positive rechallenge
Clinical narrative: The day after the shot, I had upset stomach, stiff neck and shoulders, and chills in afternoon.  2nd day after the 1st shot, I came down with a severe case of a rash (similar to shingles) across my entire back, and left side mostly.  After 2nd shot, the same symptoms as the first shot and 2 new areas of rash broke out again.  Dr. put me on steroids. ( Methylprednisolone 4 mg)
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Product administration error
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin irritation
Clinical narrative: Full body rash at exactly one week after my vaccination. Bumps that are red and irritated.  On arms, legs, stomach, chest, back and chin. Doctor prescribed an antihistamine to help with itching sensations
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site pain, Loss of consciousness
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER 5 MINUTES OF BEING VACCINATED, PATIENT WAS SEATED WAINTING FOR THE 15 MINUTES AND FAINT LOSSING CONSCIOUSNESS FOR 5 MINUTES, THEN AFTER RECOVERED HE WAS PALE, SWEATING, COLDNESS OF THE HANDS AND DIZZY. WHEN 911 ARRIVED, HE SAID THAT HAD NOT EATEN ANYTHING SINCE 5:00 AM, 10 HOURS BEFORE THE EVENT HAD PLACE, SO MAYBE HE EXPERIENCED A HYPOGLYCEMIC EVENT.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER 5 MINUTES OF BEING VACCINATED, PATIENT WAS SEATED WAINTING FOR THE 15 MINUTES AND FAINT LOSSING CONSCIOUSNESS FOR 5 MINUTES, THEN AFTER RECOVERED HE WAS PALE, SWEATING, COLDNESS OF THE HANDS AND DIZZY. WHEN 911 ARRIVED, HE SAID THAT HAD NOT EATEN ANYTHING SINCE 5:00 AM, 10 HOURS BEFORE THE EVENT HAD PLACE, SO MAYBE HE EXPERIENCED A HYPOGLYCEMIC EVENT.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest discomfort, Chest pain, Chills
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Systemic: Nausea-Medium, Systemic: Vomiting-Medium
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Unevaluable event
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020109 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided).  No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002701:
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue, beginning about 2 hours after shot, Seems to have gone away by next morning.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: After 6 hours my left arm was hurting a lot. After that I got the chills and heavy fever (102.7). A lot of headache, body aches and vomiting. I could not do anything else than staying in bed. Did not eat and was not able to take Tylenol or anything else. It last for a full 24 hours, fever and vomiting was gone, but after that I still had headaches.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: After 6 hours my left arm was hurting a lot. After that I got the chills and heavy fever (102.7). A lot of headache, body aches and vomiting. I could not do anything else than staying in bed. Did not eat and was not able to take Tylenol or anything else. It last for a full 24 hours, fever and vomiting was gone, but after that I still had headaches.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Nausea, Vomiting
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Hyperhidrosis
Clinical narrative: Patient complained of feeling weak and sweaty. No chest pain or shortness of breath or rash. Treatment- NO po water or juice given as patient is muslim and was fasting VS 203/138, HR 69, RR 12, Pulse Ox 99% EMS called for elevated BP and symptoms EMS arrived and repeated BP with manual cuff and BP was 137/86, accucheck normal and was released to go home Patient was obsed for one hour and DCed home
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020109 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002701:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020109 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided).  No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020109; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002701:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of hepatitis a vaccine, inactivated(VAQTA) lot # T020442 expiration date 26-JAN-2022 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.   Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T020442; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002701:
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039316 expiration date 04-DEC-2021 for prophylaxis (strength, dose and route were not provided).  No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S039316 expiration date 04-DEC-2021 for prophylaxis (strength, dose and route were not provided).  No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1688504 expiration date 19-NOV-2021 for prophylaxis (strength, dose and route were not provided).    No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
Sex: U
Vaccine: RV5
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1688504 expiration date 19-NOV-2021 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.     Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: incorrect product storage; No additional adverse effect reported; This spontaneous report recibed from a nurse practitioner refers to a patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unknown date, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1688504 expiration date 19-NOV-2021 for prophylaxis (strength, dose and route were not provided). No additional adverse effect was reported.  Digital Data Logger registered a temperature excursion between 47 to 77 Fahrennheit degrees (47.7) for 20 minutes.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2104USA002701:
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; The involved vaccine had a labeled expiry of 03/31/2021 and was administered on 04/08/2021.; This spontaneous report was received from a medical assistant and refers to a 18-month-old male patient. There was no information about his concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2021, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) lot # S009753, expiration date: 31-MAR-2021 (formulation, strength, dose, frequency, route of administration were not reported) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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. ; manufactureraddress: ; manufacturercity: ; manufacturerstate: ; manufacturercountry: ; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. 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. West Point; manufactureraddress: 770 Sumneytown Pike; manufacturercity: West Point; manufacturerstate: PA; manufacturercountry: UNITED STATES; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209: