chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At ~24 hours post immunization, child developed large local reaction with significant swelling and pain.  Circumference at that time ~6-8 inches.  To emergency department, recommended local care and benadryl.  By 48 hours post immunization, right thigh circumference noticeably larger than left, erythema/swelling area at least 12 inches in diameter.  To emergency department again, Rx w/ oral antibiotic in case of bacterial cellulitis.  By ~60 hours post immunization, pain and warmth improved and less brightly erythematous, but erythema now ~15x15 inches and ~3/4 circumference of right thigh.  Full range of motion, good distal circulation and sensation.  Recommended ongoing local care with cool packs, acetaminophen as needed for discomfort.
Pt received a Tetanus and Diphtheria Toxoids Adsorbed Purogenated for management of a lacerated finger and developed an injection site reaction characterized by induration, inflammation and warmth. The symptoms persisted six days post vax and the physician prescribed Duracef.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. The patient's medical history included chicken pox as a child. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX on 26-DEC-2011. No other co-suspects were reported. No concomitant medications were reported. In March or April of 2012, the patient developed a spot of shingles, and a mild case of shingles in November 2012. The patient sought unspecified medical attention. The outcome of a spot of shingles and a mild case of shingles was unknown. Additional information has been requested.
Large arm rash. Not treatment.  Pernio of toes on/off for few weeks. No known covid exposure. Negative for COVID.
Information has been received from an administrative assistant and a medical assistant concerning multiple unspecified patients of unknown age and gender. On unknown dates these patients received ROTATEQ (lot#, dose not reported, oral) that were improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient fainted X 5 minutes after receiving vaccine, immediately assessed by FNP, V/S stable, O2 applied, Patient monitored in lying position X 15 mins, sitting X 15 mins. Left in stable condition.
2 hrs after vax began having hot & cold flashes, mild stomach discomfort & nausea, fatigue & full feeling in throat.
10 minutes after pt received both injections pt presented with c/o lightheadedness, weakness, and increased heart rate.  HR: 131, RA O2: 99%.  Pt reports she ate toast and coffee, didn't really have an appetite this am, has crohns disease.  Pt states she usually eats yogurt, encouraged food intake.   1011- HR: 87, RA O2: 99%.
pt recv vax 5JAN96 & 7JAN96 pt devel a fever of 100-101 & a small number of lesions;the lesions were present for approx 1wk;no further info was provided;
This spontaneous report was received from a medical assistant concerning a 3 month old male patient. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 05-DEC-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ dose 1, lot # L029617, orally, as prophylaxis (Strength, dose and expiration date were not reported), which experienced a temperature excursion (temperature and timeframe were no reported). It was not reported if there were previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same reporter. CORRECTION FOR E2B PURPOSES ONLY (20APR2017): This safety report was previously submitted with incorrect E2B WWID: US-009507513-1701USA005974. The WWID US-009507513- 1701USA005974 refers to the linked report (and therefore not being nullified). The correct WWID is now referenced in this safety report (US-009507513-1704USA007665). Additional information has been requested.; Sender's Comments: US-009507513-1704USA006956: US-009507513-1704USA006957: US-009507513-1704USA006958: US-009507513-1704USA007655: US-009507513-1701USA005974: US-009507513-1704USA007664: US-009507513-1704USA007666: US-009507513-1704USA007667: US-009507513-1704USA007668: US-009507513-1704USA007669: US-009507513-1704USA007670: US-009507513-1704USA007671: US-009507513-1704USA007672: US-009507513-1704USA007673:
Approx 6:30 pm headache  7:05 pm headache immediately subsided, right arm grew numb 7:09 pm speech became difficult.  Trouble stringing words together. 7:15 difficulty spelling/texting 7:25 pm numbness speed to lower right quadrant of face.  Speech became more labored.  7:40 arrived in ER, numbness in face resolved  Approx 8:00 speech improved, arm numbness resolved  CT scans, MRI/MRV, echocardiogram, blood work including platelets and d-dimer, all normal. Kept in hospital under observation until approx 6:30 4/14. Discharged with diagnosis of suspected TIA. Followup scheduled with primary physician and neurology consult.
Vaginal bleeding - constant for nearly 4 weeks.  Stopped bleeding after eliminating Pradaxa. Pelvic biopsy completed. Hysteroscopy scheduled
This spontaneous report as received from a pharmacist refers to a 25 years old female patient. Drug reactions/allergies included allergy to hydrocodone which caused vomiting and an allergy to an unspecified pneumococcal vaccine (Manufacturer unknown) on an unknown date, there was none additional pertinent medical history reported by the pharmacist. On 29-AUG-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M006922, expiration date: 21-JUN-2017, via subcutaneous. Patient's concomitant therapies included KEFLEX. On 31-AUG-2016, the patient was admitted at the hospital due to an adverse effect described as "fever, right arm pain at injection site and dizziness" experienced in approximately August 2016. The pharmacist reported that a treatment was prescribed during the admission by an unspecified provider of TYLENOL, ceftriaxone and KEFLEX, the patient was discharged on 03-SEP-2016. In addition, lab tests were performed in the hospital described as "Methicillin Resistant Staphylococcus aureus (MRSA) PCR twice and were negative". The pharmacist requested a lot check for PNEUMOVAX 23 lot # M006922, expiration date: 21-JUN-2017. The outcome of pyrexia, injection site pain and dizziness was reported as recovered on an unknown date in 2016. The outcome of allergy to an unspecified pneumococcal vaccine (Manufacturer unknown) was unknown. The relationship between the events and PNEUMOVAX 23 was not provided. A product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
DIARRHEA 3 TIMES IN 5 HOURS AND NAUSEA, EYES BURNING,  HEADACHE, TIREDNESS, VACCINATION SITE VERY SORE WHICH LASTED 2-3 DAYS.  THE TIREDNESS AND GENERAL NOT FEELING WELL RETURNED SEVERAL TIMES DURING THE NEXT 3 WEEKS. AFTER THE SECOND SHOT ON 3/31/21 AT A VACCINATION SITE. THE SIDE EFFECTS STARTED AFTER 20 HOURS AS FOLLOWS: ACHY ALL OVER, HEADACHE, CHILLS, BURNING EYES,  HOT FLASHES, TIREDNESS WHICH HAS BEEN HAPPENING OFF AND ON SINCE 3/31/21.  FEEL I MAY NEED BLOOD WORK TO SEE WHAT IS GOING ON.  I HAVE HAD EPSTEIN BARR VIRUS AND WONDER IF THIS HAS BEEN REACTIVATED.
AFTER THE VACCINE WAS ADMINISTERED ABOUT 20 MINUTES LATER PATIENT SAID SHE HAD A HEADACHE AND ASKED FOR WATER. I GAVE HER WATER. SHE DENIED SEEKING MEDICAL TREATMENT. SHE SAT LONGER AND THEN GOT UP AND SAID SHE WAS FEELING OKAY AND WAS GOING TO WALK AROUND AND SHE SAID SHE WAS OKAY TO DRIVE. 2 HOURS LATER I CALLED HER AND SHE SAID SHE WAS OKAY AND JUST A LITTLE HEADACHE. SHE CALLED BACK AN HOUR LATER AND SAID HER LIPS FELT NUMB AND THROAT FELT A LITTLE TIGHT, BUT THAT SHE WAS BREATHING OKAY AND NO TROUBLE BREATHING. SHE SAID HER THROAT WAS NOT CLOSING UP AND SHE COULD BREATHE AND TALK AND I ASKED HER IF SHE HAD BENADRYL AND SHE SAID NO, I TOLD HER TO CALL 911 AND SHE SAID SHE WAS GOING TO THE HOSPITAL AND SAID BYE AND HUNG UP.
Immediate swelling after 4 months WB immunizations: DTaP, HIB, IPV, Hep B, PCV.
outbreak of HSV - genital herpes ; typical signs including flaky screen followed by sores. typiical episode is very mild, lasting 7-10 days. Treated will application of Propolis if needed. This episode continued for four weeks.  Started Valacyclovir on 4/13/21 (1 gram twice daily for 5 days), then 500 mg once daily, continuing as of 4/23/21; first sign of improvement on 4/22/21
The evening that she took the vaccine she started having chills all night and a headache. The next day she realized she had blotches on her arm which where painful.
Red itchy small bumps in a straight line which appears on the arms, back, stomach, and legs. The rash can be provoked with contact, hot showers.  Occurred 9 days after vaccination and continues to this day. Improves with Zyrtec,  Benadryl.
Began one hour after immunization, felt ill with fatigue, leg weakness, back ache, headache, double vision dys coordination for four days.
I ended up with a miscarriage; fetus I was pregnant with stopped growing at 5.5 weeks; I was pregnant with stopped growing at 5.5 weeks which happens to be the same time I had the vaccine.; This is a spontaneous report from a contactable consumer. This consumer (mother) reported similar events for self and the foetus. This report for foetus included that:  A fetus received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, via transplacental route, on 17Mar2021 13:30 as 1 st dose, single dose for covid-19 immunization. Also received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, via transplacental route, on 07Apr2021 13:30 as 2 nd dose, single dose for covid-19 immunization. The patient medical history was not reported. The concomitant drugs included Prenatal Vitamin, Iron Supplement, Zoloft which patient had received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was the workplace clinic. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 and had no allergies. The patient reported that on 07Apr2021 the foetus she was pregnant with stopped growing at 5.5 weeks which happened to be the same time she had the vaccine. She ended up with a miscarriage which resulted in doctor or other healthcare professional office/clinic visit. The patient had received the treatment. The outcome of the event was fatal.  Follow-up attempts are needed. Further information is expected  Follow-up (07Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021536223 fetal case and maternal case; Reported Cause(s) of Death: Fetal death
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non-HCP (reporting for daughter friend). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. Patient tested positive for COVID-19 yesterday, 30Aug2021 after reportedly having had the Pfizer Covid-19 vaccine. Reporter believed she was vaccinated shortly after the emergency use was granted. The only information reporter had was that her name and address. The outcome of COVID-19 was unknown.   Information on the Lot/batch number has been requested.
Information has been received from a physician concerning a patient (age and gender unknown), who, on an unspecified date was vaccinated with a dose of Gardasil. Subsequently, the patient fainted a few minutes after receiving the vaccination. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Initial and follow-up information has been received from a physician and a nurse concerning a patient  a 17 year old, who, on an unspecified date was vaccinated with GARDASIL (lot # 857622/0388U). Susequently, the patient fainted a few minutes after receiving the vaccination. At the time of the report, the patient's outocme was unknown. No product quality complaint was involved. Additional informatoin has been requested.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age. No information about patient's medical history, concurrent condition and concomitant medications. On an unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB from lot # N000237 with expiry: 25-OCT-2019 (dosing details not reported) for prophylaxis. No adverse effects reported. The vaccine lot exposed to a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit for 2 hours 25 minutes. It also had previous temperature excursion of 47 degree Fahrenheit to 77 degree Fahrenheit for 7 hours 45 minutes. The call was due to data logger. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA012148.
a bad case of shingles; Information has been received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information regarding the pt's medical history, concurrent conditions and concomitant medications was reported. On or about 12-APR-2012, the pt was inoculated with zoster vaccine live(ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered a bad case of shingles. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to using the Company's product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her 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 the Company's wrongful conduct, 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 Company's conduct, the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The causality was related.  The event of bad case of shingles was considered to be disabling.
Fever 104.4 R 3-4 days (t103 1 hr p/shot) p/shot; Taken to ER-had "swollen parotids" & rash on face, sore throat; MD called it "virus;
Red, three (3) inch raised, hot welt at injection site and enlarged lymphnode near the clavicle bone on same side as vaccine site.
Patient reported not feeling well then lost consciousness.  Hands and jaw were clenched and body was shaking.  Patient was none responsive. Epipen given and patient regained consciousness and asked what happened.  Since pharmacy is in the hospital patient was taken to the emergency room for further evaluation.
pt recvd vax;devel severe back pain;to er;dx w/ disc problem;devel szs & uncontrolled hypertension;in ICU,lost consciousness & became obtunded;remained confused;now weakness & absence of reflexes bilaterally; pt had atypical GBS;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 19-MAR-2014, the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB lot # reported as J005672, expiration date reported on 05-DEC-2015 (dose and route were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever; chills; body aches; headache; This is a spontaneous report from a contactable Physician via a sales srepresentative. This Physician reported similar events for 3 patients. This is report 2 of 3.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches and headache for about 24 hours. Events took place after receiving BNT162B2. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034918 Same drug and event, Different patient;US-PFIZER INC-2021034920 Same drug, Different patient and event
I had a stuffy nose and a sore throat. My husband was diagnosed with COVID-19 5 days prior. I did a COVID-19 at home test and I tested positive.
get a headache from neck surgery once in a while; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (get a headache from neck surgery once in a while) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neck surgery.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (get a headache from neck surgery once in a while). At the time of the report, HEADACHE (get a headache from neck surgery once in a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Contracted COVID; Contracted COVID; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269730-00 (Company).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) at the age of 63 years as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovered" and all described as "Contracted COVID". The action taken for adalimumab was unknown.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of CONTRACTED COVID was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event CONTRACTED COVID-19 (COVID-19), Causality as per reporter (Drug/Vaccine): Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available reported information, the causal association between the events drug ineffective and covid-19 and the suspect drug BNT162B2 cannot be excluded.
getting a tickle down at the bottom of our throat to our chest; coughing our heads off; This is a spontaneous report received from a contactable consumer (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0172) via an unspecified route of administration in arm right on 27Apr2021 14:00 (age at time of vaccination 66-year-old), as single dose for COVID-19 immunization. Medical history included diabetic. The patient's concomitant medications were not reported. The patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EW0150) via an unspecified route of administration in right shoulder on 06Apr2021 (age at time of vaccination 66-year-old), as single dose for COVID-19 immunization. On 27Apr2021 at 15:00, the patient experienced getting a tickle down at the bottom of our throat to chest and coughing our heads off. The seriousness of the events was unspecified. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515082 same reporter/drug/event, different patient
Approx 15-20min post vax pt went limp in father arms & color became ashen; was responsive but weak, face pallid; BP 100/50; Taken to ER;
tremors and generalized weakness Narrative:  Patient presented to local ER within 1 day of moderna #2 vaccination after waking up to arms/leg shaking on and off along with generalized weakness and inability to walk/sit up independently. Impression: myoclonus/coarse tremors was given IV lorazepam with an excellent response. Unclear etiology...though timing is consistent with COVID vaccine administration. Patient did not report AE/SE to first moderna shot.
Fever 99.5-101 degrees for 12 hours, body aches, chills, severe headaches
Hives on neck and stomach; This is a spontaneous report from a contactable consumer (Patient). A 24-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: not reported), dose 1 via an unspecified route of administration, in Arm Left on 23Feb2021 at 16:30  as single for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took benzalkonium chloride and experienced drug allergies. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient did not take other vaccine in four weeks and other medications in two weeks. On 23Feb2021 18:00, the patient had experienced hives on neck and stomach. Treatment medication was Benadryl. The outcome of event was unknown.  No follow-up attempts are possible. Information about the lot/batch number cannot be obtained. No further information is expected.
I tested positive for Covid-19. My symptoms included congestion, coughing, and I felt really tired.
facial edema, rash approx 20 mins p/vax; pt was in MD office @ time of reaction & mom reports the MD gave pt a shot;
ZOSTAVAX shot was administered Friday (9/23/16) after 5 pm. Patient complained of injection site redness, tingling and itching. Area is very warm, swollen and sore to the touch. Recommended cold compress with ice and Hydrocortisone cream for itch.
Head and hair follicles are tingling and my face is getting numb. Headache. Pin pricking sensation is getting worse.
Left deltoid with softball sized erythematous area warm to the touch. no skin breakdown present. cellulitis, No anaphylaxis.
Two hours after the vaccine was given, I developed a headache and the injection site was sore. I treated it with ibuprofen. Approximately 48 hours after the vaccine was given, I experienced a sore throat and fatigue that has lasted for two days and counting.
About one week after the vaccine, body aches, chills and shortness of breath began to occur. Overall fatigue and general malaise also persistent.