chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recieved the 1st Dose of the Moderna Vaccine 48 Days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recieved the 1st Dose of the Moderna Vaccine 48 Days ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recieved the 1st Dose of the Moderna Vaccine 48 Days ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Recieved the 1st Dose of the Moderna Vaccine 48 Days ago) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient reported that no AEs experienced after 2nd dose.
Itchy hives in scalp five hours after vaccines administered. Next 3-4 days hive welts appeared as isolated welts on upper back, rib cage and inner thigh.
Information has been received from a 16 year old female who on approximately 20-SEP-2007 was vaccinated IM with the third dose of GARDASIL (Lot#not reported). On approximately 20-SEP-2007 the patient stated that it was a little painful in my legs, but that might have to do with the fact I swim everyday for 3 hours". At the time of this report it was not known if the patient had recovered. Additional information has been requested.
Low Fever 99.0-101.7 on going at 99.0 Chills/headache Arm Rash on the same arm others of where shot was injected  Fatigue on going. Racing Heart.
Fever most likely due to infection - less likely due to immunization - seen at ER - possible infection per ER.
a persistent head ache that will not go away with Tylenol or other headache meds; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  AA 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 15:45 (Lot number: fh8028) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gurd" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "known allergies: Peppers" (unspecified if ongoing), notes: known allergies: Peppers. The patient took concomitant medications. The following information was reported: HEADACHE (medically significant) with onset 02Dec2021, outcome "not recovered", described as "a persistent head ache that will not go away with Tylenol or other headache meds". Therapeutic measures were taken as a result of headache. Facility type Vaccine: Doctor's office/urgent care. No other vaccine in four weeks. Patient had a persistent head ache that will not go away with Tylenol or other headache meds. No Covid prior vaccination.Not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
I developed nausea the night of the vaccine, the next morning I woke up with a headache behind my eyes, and fainted while getting ready for work that morning. I then had a really bad headache and slept the entire day. I was unable to go to work or care for my house or children.
Patient had heart attack and died at 10:15 PM following dose at 3:00 PM
Wife reports client stated he had light headed and needed to lie down.  He also complained of some nausea and mild diarrhea.  Started taking his oral typhoid vaccine 6-5-11.
11 days after the vaccine, I experience excruciating neck pain that went from the right side of my neck to the left side and back to the middle.  I had a small fever 100.8   I could not sleep for four nights due to pain
This spontaneous report was received from an other health professional regarding seven unspecified patients. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of improperly stored (Merck) PROQUAD (lot# K025766, expiry date: 08-JUN-2016 (dose and route were unknown). No adverse events were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Diagnosed with shingles last week. Although several months after getting second dose of vaccine, still find it odd to get shingles ar such a young age. No precipitating factors. No change in meds, no change in lifestyle, no known exposures.
No adverse effects were reported; Multiple unspecified patients were vaccinated with improperly stored PROQUAD and VARIVAX; This non-valid spontaneous report was received from the office manager and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On an multiple unspecified dates since September 2018, the patients were mostly vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number N027000 with expiration date of 28-SEP-2019 or lot number N022979 with expiration date of  23-AUG-2019) or doses of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number R017628 with expiration date of 18-DEC-2019 or lot number N025929 with expiration date of 18-MAR-2019) (dose and route of administration) for prophylaxis. The vaccines were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for an unknown time frame. There were previous temperature excursions, however the details were unknown. It was reported that no doses of the and varicella (oka-merck) virus vaccine live(PROQUAD) (Lot number N025929 with expiration date 18-MAR-2019) were given after it expired; however doses were given after the first and subsequent temperature excursions, dating back to an unknown date in September 2018.   Digital data logger was involved.  Follow up information has been received from the office manager on 22-APR-2019. No dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) was administered to the patient. Sterile diluent was properly stored. No adverse effects were reported. On 25-SEP-2018, the patient was vaccinated with dose of improperly stored rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) (lot number N025929 with expiration date of 18-MAR-2019). The vaccine was stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (13.9 Fahrenheit degrees) for 69 hours and 11 minutes (multiple excursions). No prior excursion was confirmed. Digital data logger was involved.  This case was previously considered non-valid but upon receipt of follow-up with patient identifiers, it was determined that the case is valid now.  This one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA012655: US-009507513-1904USA012656: US-009507513-1904USA012657: US-009507513-1904USA012658: US-009507513-1904USA012659: US-009507513-1904USA012660: US-009507513-1904USA012653: US-009507513-1904USA009929: US-009507513-1904USA012652:
I received my shot at 1:15pm this afternoon. The arm that I got the shot in was immediately sore, and has continued to be a bit tender to touch and stiff when I move the arm. By 5pm I was feeling very fatigued. Around 7pm I began feeling cold and achy, and it has continued to progress to full body aches and chills. I have no appetite, but I?m not feeling nauseous.
This spontaneous report was received from a health professional (medical assistant) and refers to a 4 year old female patient who had a cleft palate at birth. No pertinent medical history and drug allergies were reported. On 28-MAY-2015, the patient was vaccinated with her first dose of PROQUAD (Merck) lot #K019102 expiry 15-APR-2016, 0.5 ml, subcutaneously. No concomitant medications were reported. On 28-MAY-2015, minutes after vaccination, the patient experienced sneezing and gagging, followed by vomiting, shortness of breath, redness and hives covering the entire body all of which took place while the patient was still in the physician's office. The physician treated the patient with BENADRYL, DEPO MEDROL and epinephrine. The patient remained in the physician's office for two hours and her symptoms had improved well enough to be sent home with treatment medications EPIPEN and prednisone. On 29-MAY-2015, next day, the patient returned to the office and was examined by physician who noted that the patient had redness at the injection site and on her cheeks. The outcome of the events sneezing, gagging, vomiting, shortness of breath, redness and hives covering the entire body was reported as recovered on 29-MAY-2015. The outcome injection site redness and redness of cheeks was reported as unknown. The reporter did not assess the causality of all the events with PROQUAD (Merck). Additional information has been requested.
This spontaneous report was received from a doctor of pharmacy refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of live ZOSTAVAX (lot # H011048, expiration date 05-SEP-2013, route not reported) which was placed in refrigerator for 6 days. No adverse effects reported. Additional information has been requested.
Left arm sore on did 3/24 sustained fatigue sore joints headache nausea and fever of 101 to 102
Erythema, induration, itching, and local swelling. Majority of symptoms improved after second day.
Hospitalization for acute hypercapni/hypoxic respiratory failure and COVID-19 pneumonia on dates  9/18/22- 9/30/22. Treated with dexamethasone, baricitinib, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
This spontaneous report was received from a nurse refers to a 21 week old patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date, the 4 month and 28 day old infant was vaccinated with first dose of ROTATEQ (dose, route and lot # were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse symptoms reported.
painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Mar2021 10:30 (Lot number: EN6204) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibroids/recon surgery uterus", start date: 1995, stop date: 19Jan1995, notes: Fibroids/recon surgery uterus, Uterine-fibroid removal reconstruction. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "painful". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that, patient had the Pfizer booster 03Nov2021. The injection was more painful that the 2 previous injections he received. Patient do yoga and extremely healthy, run, lift weights, exercise 6 days per week, have excellent weight low/norm BMI, he was vegan with a normal resting HR of 52. He takes no medications and was in very good health before this.  No follow-up attempts are possible. No further information is expected.
reported headache, low-grade fever, and chills began 02/05/2021 evening. Pt temp spiked at 99.1F and most recent temp is 98.2F. Pt took pseudoephedrine along with Tylenol 02/05/2021 evening. Low-grade fever and chills subsided 02/06/2021 morning, headache still persists  Date and time of vaccination: (list both if they received both shots):  1st Dose-  01/07/2021 @ 11:30      Moderna 1st Dose-  Lot# 0112L0A  2nd Dose- 02/05/2021 @ 09:30     2nd Dose- Lot# 012M20A
Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: TCR received on 22-Apr-2021. Event outcome was updated.
flu-like symptoms; hives/ welts; itching; chills; This is a spontaneous report from a contactable other HCP (nurse). A 65-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration on 17Mar2021 (at the age of 65 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced welts, hives, itching a day after receiving the vaccine, chills, and flu-like symptoms on 17Mar2021 a few hours after receiving the vaccine. The outcome of the events was not resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment medication provided.   This case was linked to MOD-2021-395985 (Patient Link).
No adverse event reported. Only administration of Rotateq to infant at 15 weeks and 5 days of age.
Scheduling second vaccine appointment, more than 36 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Scheduling second vaccine appointment, more than 36 days after first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scheduling second vaccine appointment, more than 36 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Scheduling second vaccine appointment, more than 36 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided by reporter. No treatment information provided by reporter.
received 2nd dose today and approximately 2 minutes after receiving vaccine,  became unresponsive.  I was present and carried behind the curtain and placed the on the floor.  began to posture and have tonic clonic movement.  Pupils were fixed and dilated.  This lasted nearly 3 minutes during which time his airway and C spine was protected and an ambulance was called.   regained consciousness and stated that he has passed out from vaccines several years ago.   does not have a history of seizure.  A complete neuro exam was performed: intact as tested, cerebellar exam is intact, speech is of a regular and steady cadence, transported to ED
10 days after MMR #1 was given, patient had temperature up to 105.1 degrees F. Irritable, fussy and rash on skin. Treatment: Observation.
diarrhea for 2days , nausea day after vaccine, stomach cramps day after vaccine
Pt received COVID19 Vaccine (Moderna) on 1/8/2021 at 1:52PM.   -Pt felt fine immediately after the vaccine. -10 min later was reporting dizziness and that her tongue felt numb for 1 minute.  -Also reported dry (but not itchy) throat.  -I evaluated patient. -Denies itchy/sore throat, itchy/watery eyes, rash, difficulty breathing, shortness of breath, N/V, chest pain, numbness/tingling, swelling.  -Pt's symptoms subsided within 10 minutes after she rested and was given water.  -She was observed for ~30 minutes total and discharged.
Narrative:  12/08 COVID vaccine dose #3 01/02 pt presents to ED c/o generalized weakness x 3 weeks with SOB with exertion, acute on chronic "passing out" episodes, states multiple w/u in the past for recurrent syncope with no dx given Has had increase in amount of episodes - states 3-4 in the past week, per patient he passed out in the car on the way to ED, admitted to hospital; per med H&P note: PMHx of vasovagal syncopes, Sarcoidosis, CKD3, HTN and dyslipidemia presented with generalized weakness and multiple syncopal episodes during this week. Pt has been very tired and fatigued x 6 weeks per wife. He stated that he has been very debilitated since getting J&J booster on 12/08/21. Pt endorses fatigue and said that last Sunday he became lightheaded while sitting at church and passed out. He was carried to the floor until he regained consciousness. Pt had bladder incontinence which had never happened before. He spent the day sleeping yesterday. Today he was sitting having breakfast and became lightheaded when he stood up, sat down on the floor and lost consciousness. Per wife, he lost control of his bowel and bladder and rolled his eyes to the back of his head. Pt woke up and c/o L sided discomfort prior to passing out again per wife, but pt denied CP, SOB , n/v prior to the episodes and only stated feeling lightheaded before syncopizing. In the car on his way to the hospital pt had another syncopal episode. Denied fever, chill, sob, recent URI, headache or palpitations. Endorses good appetite and denied been outside in sun/being dehydrated. Of note, pt was diagnosed with vasovagal syncope s/p extensive cardiac and neurologic work-up done in home. Had a loop recorder implanted and subsequently removed. 01/05 Discharged from hospital, no abnormal findings during admission, returned home for follow up
This spontaneous report was received from a nurse and refers to an 8 week old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 13-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
MENOPAUSAL SYMPTOMS; DELAYED CRAMPS; COULD NOT BEND DOWN IN A SQUAT; DIZZINESS; BACK ISSUE; ACHY LIKE FLU SYMPTOMS; TINGLING IN LEGS; This spontaneous report received from a female patient of an unspecified age. Race and ethnicity not reported. Local reference number EZR20210104013. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. It was reported that the patient works and has children and is a busy person. The patient has a new puppy in house.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  At some timepoint after vaccination, the patient experienced dizziness. About 6-8 weeks after vaccination in late MAY-2021, the patient began to experience tingling in her legs. She initially proceeded with an urgent care visit and then primary care provider to have blood work done. The primary care provider attributed the tingling in her legs to restless leg syndromes. Later the patient saw a neurologist who advised her that she did not have restless leg syndrome but attributed her events to an issue with her back because she could not bend down and squat when at work without holding onto something to get back up. The patient returned back to her primary care provider who attributed her events to menopause as she reported delayed cramping. The patient reported that she must grab a hold of something to go over the puppy gate. The patient reported that affected areas were back and hands but not arms. As of 13-JUL-2021, the patient felt achy-like flu symptoms which she feels are related to to her immune system being affected from vaccine and that she may have Guillain-Barre since her events are in time with potential onset of Guillain-Barre. The patient wants to reach out to her care provided and get tested for Guillain-Barre and/or for Covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from achy like flu symptoms, and the outcome of tingling in legs, back issue, menopausal symptoms, delayed cramps, could not bend down in a squat and dizziness was not reported. This report was non-serious.
Runny nose within 48 hours - no infection 5/14 (9 days post injection) - patient got sick enough to not get out of bed, could not walk, loss of muscle strength, and 104 degree fever, vomiting that continued for 7 days. Patient went to doctor and got promethazine after this but did not feel any better. Stopped vomiting though. Couldn't walk more than 10 stairs in patient's home for 3 weeks.
PT had a local reation that spread across the Tricep of the course or 24hrs and covered the greater area of the bicep. Spreading down to the Forearm. Symptoms to include: Redness, swelling, warm accompanied with itching sensation.