chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEIZURE; This is a spontaneous report received from a contactable reporter(s) (Physician). Other Case identifier(s): EC-2022-106820.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; perampanel (FYCOMPA), first regimen since Dec2021 (Batch/Lot number: unknown) for 2 weeks at 2 mg 1x/day (2 mg, 1x1d, approx 2 weeks) and second regimen (Batch/Lot number: unknown) at 4 mg 1x/day (4 mg, 1x1d) for seizure. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "SEIZURE". The action taken for perampanel was unknown. The patient started Fycompa approximately 4 weeks ago at 2 mg/day, which was then increased to 4 mg/day and the patient became seizure free. The patient recently received a COVID-19 vaccine (unspecified) after which the patient had a seizure. Physician plans to increase Fycompa to 6 mg/day to stabilize the seizure.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event SEIZURE  and the suspect drug BNT162B2 cannot be excluded. 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.
Initial headache, body aches, chills, vertigo, nausea, vomiting. Subsided 36 hours after injection. Returned two weeks later with headaches, vertigo, malaise, tinnitus and diplopia. Symptoms gradually lessened over time but still remain four months later.
got first dose on 15/May/2021 and didn't get second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got first dose on 15/May/2021 and didn't get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got first dose on 15/May/2021 and didn't get second dose).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Reporter devel a fever (103F), arthralgia, myalgia, chills, & shaking 3 days p/receiving Influenza vax; tx consisted of aspirin every four hrs & rest; rxn resolved in 24 hrs;
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (0.5 ml, subcutaneous) (lot# and exp date unknown) which had been exposed to temperature as high as 8.5 F. No adverse effects were reported. This is one of several reports from the same source. 1405USA008131. Additional information has been requested.
The reaction began as a small (1 inch diameter), raised, red, hard, hot, patch at the site of the injection on the upper right arm.  The patch has grown to be at least 4 inches in diameter and is very hot to the touch.  He complains that it is somewhat sore but does not seem to have reduced his movement and use of the arm.
had very heavy legs; a sharp and constant pain in my chest; my arms, legs and mouth have gone numb; my arms, legs and mouth have gone numb; had a very bad headache; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0196 and expiration date: not reported), via an unspecified route of administration,  in Left arm, on 28Jun2021 at 11:30 (at the age of 26-year-old), as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store. Medical history included penicillin allergy. The patient's concomitant medications were not reported however it reported that the patient received an unspecified antibiotic within 2 weeks of vaccination. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination patient has not been tested for COVID-19. On 08Jul2021, the patient had very heavy legs, a sharp and constant pain in chest, her arms, legs and mouth have gone numb and have had a very bad headache. No treatment was taken as a result of events. It was reported that events result in doctor or other healthcare professional office/clinic visit.  The outcome of the events was not recovered at time of report.
2/23/12 pt had pain & inflammation, area 4 cm x 4 cm red & raised, pt went to PCP 2/24/12, antibiotic KEFLEX 500 mg QID & BROLENE ointment. 2/24/12 itching noted.
Thankful to Pfizer for the COVID vaccines and boosters/He received all of his Pfizer COVID vaccines, and still got COVID; Thankful to Pfizer for the COVID vaccines and boosters/He received all of his Pfizer COVID vaccines, and still got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Thankful to Pfizer for the COVID vaccines and boosters/He received all of his Pfizer COVID vaccines, and still got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: He was only positive for COVID for 5 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received. Clinical course: he was only positive for COVID for 5 days. Caller declined report for her husband. She was very thankful to Pfizer for the COVID vaccines and boosters. Her and her husband did all of the Pfizer COVID vaccines. He received all of his Pfizer COVID vaccines, and still got COVID and had to take Paxlovid.
tooth infection; This spontaneous case was reported by a pharmacist and describes the occurrence of TOOTH INFECTION (tooth infection) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTH INFECTION (tooth infection). At the time of the report, TOOTH INFECTION (tooth infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not provided. the Treatment information was not provided.
patient due for Rotavirus vaccine but was only given sterile diluent. pt did not get live virus. attempting to notify parents, will schedule for a nurse visit so patient can get dose that was missed . Unit manager and PCP notified.
Bloody diarrhea after ROTATEQ 05/14/13 patient came into clinic mom reports no blood in stool but still having diarrhea return or call clinic 05/16/13.
On 4/12/00 pt received vaccine, on 4/13/00, the pt experienced pain, fever, localized reaction, complained of chills. Fever was 100.2 in the AM and 104.8 in PM. Pt experienced swelling moving to lower arm. On 4/17/00 continues to have low grade fever, swelling decreased but still moving around area.
Immediately after vax given - child stopped crying. Starting with ??? ???? Last about 1 min with stable HR and RR.
Severe tinnitus in left ear began several days after second vaccine.  Is non stop and only in the left ear.
Began overnight after injection. Bodily fatigue, flu like symptoms, soreness and pain at injection site, headache, loss of focus, inflammation and red filled circle about 1inch diameter at injection site. Have been taking ibuprofen 600mg as treatment.
knocked her out; 101 degree fever; This is a spontaneous report from a non-contactable consume. An adult female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced her second dose 'knocked her out' and she had 101 degree fever on an unspecified date. Outcome of events was unknown.    No follow-up attempts are possible. No further information is expected
Voice lowered; bronchioles are pretty swollen; Cough; horrible headache; Queasy; fire red at inner and upper thigh; Rash peripheral; red rash at injection site; Rash on leg; Rash trunk; fever 101.2; Pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Voice lowered), PAIN (Pain), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg) and COUGH (Cough) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.   On 05-Feb-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) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (Pain). On 06-Feb-2021, the patient experienced RASH (Rash trunk) and PYREXIA (fever 101.2). On 07-Feb-2021, the patient experienced ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), RASH (Rash peripheral) and INJECTION SITE RASH (red rash at injection site). On 08-Feb-2021, the patient experienced DYSPHONIA (Voice lowered), COUGH (Cough), BRONCHITIS (bronchioles are pretty swollen), HEADACHE (horrible headache) and NAUSEA (Queasy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg once daily; FAMOTIDINE at a dose of twice daily; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL) at a dose of 50 mg every 4 hours and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, PAIN (Pain) had resolved. On 08-Feb-2021, NAUSEA (Queasy) had resolved. At the time of the report, DYSPHONIA (Voice lowered), ERYTHEMA (fire red at inner and upper thigh), RASH (Rash on leg), COUGH (Cough), RASH (Rash trunk), RASH (Rash peripheral), BRONCHITIS (bronchioles are pretty swollen), INJECTION SITE RASH (red rash at injection site), HEADACHE (horrible headache) and PYREXIA (fever 101.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin M: Low. On an unknown date, Body temperature: 101.2 (Inconclusive) 101.2.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was taking antihistamines. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Follow up received on 08/02/2021. included patient demographic information. Second dose information, concomitant medication, Additional events are included On 07-May-2021: Patient given permission to contact the mentioned healthcare professional
the patient experienced took vaccine already and tested positive for covid vaccine; COVID-19 virus test positive; This is spontaneous report received via Social Media report from by a consumer. A patient of unspecified age and gender was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via intramuscular route of administration as a single dose for COVID-19 immunization. Patient was also administered with Creon (Pancreatin, Formulation and Lot number: were not provided) via an Intramuscular route of administration (with unknown daily dosage and Therapy dates) for Exocrine Pancreatic insufficiency(EPI) not associated with cystic fibrosis. Medical history and concomitant medication was not reported. Patient took vaccine already and tested positive for covid vaccine did not protect from getting covid with creon (pancreatin). On an unknown date, the patient experienced took vaccine already and tested positive for covid vaccine did not protect from getting covid on 21Mar2021, the patient experienced took vaccine already and tested positive for covid vaccine did not protect from getting covid. Outcome of the events was unknown.  Causality for Creon (pancreotin): The reporter's causality for the event(s) of Took vaccine already and tested positive for covid vaccine did not protect from getting covid unknown onset and took vaccine already and tested positive for covid vaccine did not protect from getting covid onset 21Mar2021 was not provided.  Information about lot/batch has been request.
Patient received her Covid19 vaccine  at 2:35 pm .  She returned to the observation area at 3:25 with complaint of nausea and severe stomach ache.  She said she had just been in the restroom and tried to have a bowel movement but had severe rectal pain without a bowel movement.  Vital signs were:  BP=118/82; P=84, regular, R= 20, Temp= 98.3.  She was alert and oriented.  She vomited a moderate amount 10 minutes later (2:37pm) and stated she felt  much better.  No complaint of any pain.  Vital signs at 3:47 pm were:  BP=112/82; P= 86 regular, R=18, regular and Temp= 98.2F.  She declined to call her doctor/clinic.  She called her mother who came to pick her up and went home.   3/02/21 - Talked with her this morning - she had an uneventful night with no more reactions or pain.  Slept well.  She returned to work today.  She did not call her doctor/clinic.
Sore arm; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot Number: EL3247), via an unspecified route of administration, administered in left arm on 23Feb2021 at 09:30, (at the age of 42-years-old) as dose number unknown, single dose for covid-19 immunization. Patient was non pregnant at the time of vaccination. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID) (daily prescribed medicine) taken for an unspecified indication from an unspecified start date and ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with covid 19 prior to vaccination and patient not tested for covid 19 since the vaccination. On 23Feb2021 at 09:30, the patient experienced sore arm. No treatment received for adverse event. The outcome of the event was recovering.   No follow-up attempts are needed. No further information is expected.
Day of Prevnar shot, pt started with tingling of hand, pain & fatigue. By 9/3/20, Thursday, the injection site now red/swollen & itching. She called our store to report adverse reaction on 9/6. She ended up going to the clinic. She was given Kefex for cellulitis. Her injection site was swollen about 4x6 in size on 9/6/20. She was told by the NP that her shot may be given too low on her deltoid. She also post a picture to her family doctor & concerned with NP assessment. When I spoke to her on 9/7, she said her injection site has increased to about 5x6 inches but no fever. She'll take the Keflex & follow-up with her family doctor. I asked her to keep me posted in her progress.
After receiving the shot I started have chest pains and couldn't hardly move. The pain started moving towards my back side and got worse.
Vasovagal response; This is a spontaneous report from a contactable consumer.  A 45-year-old female patient reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3247) into the left arm on 01Feb2021 08:15 AM at single dose for COVID-19 immunization. Age at vaccination 45 years. Concomitant drugs included multi-vitamin, D3, AERids eye vitamins. The patient had not history of allergies to medications, food, or other products. On 01Feb2021 at 08:30 AM the patient experienced a vasovagal response.Occupational Health/Wellness nurse checked blood pressure and had her lay down with legs up. After 10 minutes she went away and felt back to normal. No treatment was received. The outcome was recovered.
numbness if injection arm and face; 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 HYPOAESTHESIA (numbness if injection arm and face) 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 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 HYPOAESTHESIA (numbness if injection arm and face). At the time of the report, HYPOAESTHESIA (numbness if injection arm and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Swelling of arm, neck, and cheek. Ongoing and prolonged eye twitching, droopy eye and eye watering
Given vaccines on 10-26-11. Mom called 10-28-11 & said sites were red, swollen & warm. Looked at it at 1:00 PM. Red area size of baseball on both arms. Slightly raised & warm. Has no fever. Mom said getting much better.
patient has not reported any symptoms; Caller stated on 6/9 18-year-old patient received adult dose of vaccine. on 8/1 patient then received adolescent dose of VAQTA; Caller stated on 6/9 18-year-old patient received adult dose of vaccine. on 8/1 patient then received adolescent dose of VAQTA; This spontaneous report was received from a nurse and refers to an 18-year-old patient. he patient's medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUN-2023, the patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, first dose, administered for prophylaxis (anatomical location, lot #, expiry date, and route of administration were not provided).  On 01-AUG-2023, the patient was vaccinated with adolescent dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, second dose, lot #W028824, expiration date: 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age, inappropriate dose of vaccine administered).  The patient has not reported any symptoms (no adverse event).
Client complained of lightheadedness and nausea. He then complained of tingling all over his body. Client reported that he did not eat breakfast or lunch.
pt recvd vax & felt lightheaded, woozy had 3-5 sec sz involving all extremities; No injury resulted; no recall of episode; alert & oriented following sx; states has hx of sx related to hypoglycemia; Blood sugar 98; BP 120/70, pulse 60 regu;
shot administered 20NOV92 by 21NOV92 pt was nauseated, had vomiting; 23NOV92 pt advised to see pvt MD if sx persist to r/o vax rxn;
Fever up to 102F; headache; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8737) via an unspecified route of administration in the left arm on 30Mar2021 at 11:15 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome(POTS) and mental disorder. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN), ferrous sulfate (IRON) and prenatal vitamin (MANUFACTURER UNKNOWN), all from unknown dates and for unknown indications. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208)via an unspecified route of administration in the left arm on 09Mar2021 at 14:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had allergies to fentanyl and miconazole. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 30Mar2021 at 17:00, the patient experienced fever up to 102F, headache and diarrhea. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event fever, headache and diarrhea was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
A report has been received from a Health Professional concerning a 4 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 20-Dec-2013. The office manager reported that they gave expired FLUMIST QUADRIVALENT (preferred term: expired drug administered) which started on 20-Dec-2013. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a community health center for the onset of a severe vesicular rash which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.