chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 minutes post vaccine patient was standing with parents. Felt dizzy and dropped on the floor. Blood pressure was 90/64 upon first measurement. Little sweat. Little nauseated. BP 25 minutes late 101/68. Measure blood pressure standing up 99/66. No dizziness or orthostatic hypotension  after 30 minutes. Snacks, 500 ml water and Orange juice
SEVERE PAIN BACK (BOTH SIDES-PELVIC AREA); CRAMPING ( LEFT ARM, RIGHT ARM, LEFT FINGERS, RIGHT UPER THIGHT, LEFT CAFT); BURNING EYES (SLIGHTLY); NAUSEA; FEVER; SORE ARM, INJECTION SITE; SINUS HEADACHE; ALL OVER BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included postural orthostatic tachycardia, asthma, dysautonomia, celiac, gluten allergy, wheat allergy, mould allergy, tree allergy, alcohol use, and non-smoker.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced sinus headache. On 11-MAR-2021, the subject experienced all over body aches. On 11-MAR-2021, the subject experienced fever. On 11-MAR-2021, the subject experienced sore arm, injection site. Laboratory data included: Body temperature (NR: 97.3 - 97.6) 101-103 F. On 12-MAR-2021, the subject experienced cramping ( left arm, right arm, left fingers, right uper thight, left caft). On 12-MAR-2021, the subject experienced burning eyes (slightly). On 12-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced severe pain back (both sides-pelvic area). On 16-MAR-2021, Laboratory data included: Urine culture (NR: not provided) POSITIVE (units unspecified). Laboratory data (dates unspecified) included: Blood culture (NR: not provided) Pending, and COVID-19 (NR: not provided) negative. Treatment medications (dates unspecified) included: ibuprofen, and oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning eyes (slightly), sinus headache, all over body aches, and fever on 15-MAR-2021, was recovering from sore arm, injection site, and nausea, and had not recovered from cramping ( left arm, right arm, left fingers, right uper thight, left caft), and severe pain back (both sides-pelvic area). This report was non-serious.
About an hour after my vaccine I felt like my tongue had been burned with hot liquid. It stayed that way for several hours. 2 days later my arm felt like someone was hitting it over and over with a needle. I had numbing pain in my shoulder and back. I felt nauseated. It has been over a week and I still have pain at the injection site and have body aches. I am unsure who to contact and am not sure what I should do.
inconsol crying; onset 1 hr p/vax; up all noc; APAP given q 4 hrs; t101, local reaction-min tender; shivering during fretful noc;
Main Complaint: New pruritic migratory rash; Chronology: Today's date is: 01/26. I noticed since on about  01/20, a new rash. An index lesion appears shortly after the beginning of intense pruritus, becomes dark pink, geographic, sometimes with the contour darker, about 5-25mm, very rarely with a papular feature. The pruritus disappears after 15 min and the lesion itself after max. 30 min. Most affected are the hands, then forearms and axillae, abdomen and pubic area. I do not have any pruritus over night and in the first 30 min after waking up. Areas under mild pressure (palm, under watch band, under belt) more easily triggered to get the rash. 01/13 visit local park. 01/07 visit distant park. 12/15 ~ visit local park. No visit followed by known insect bites. No change in toiletries, detergents used, clothes used, any known contact related objects. No fever, fatigue, neurological symptoms or other systemic symptoms. No other sick member of the household. No upper respiratory or digestive symptoms. No musculoskeletal / articular symptoms. Medication: as before except between 01/20-23 500mg/day Fe citrate, stopped when rash noted. Loratadine 20 mg/day since 20/23 was without effect. Solumedrol pack started on 1/27/2022. Rash largely but incompletely resolved after first 16 of treatment as specified by the manufacturer and continuing to improve. CBC of ~01/15 attached. COVID 19 antigen test (BINAX now): negative on 01/25. No COVID infection detected previously either by sequential PCR tests or suspected by symptoms. TREATMENT. The rash did not respond to Loratadine 20 mg/day since 20/23 was without effect. Solumedrol pack started on 1/27/2022. Rash largely but incompletely resolved after first 16 of treatment as specified by the manufacturer and continuing to improve.
Patient  administered an expired dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient  administered an expired dose of Moderna COVID-19 Vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient  administered an expired dose of Moderna COVID-19 Vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient  administered an expired dose of Moderna COVID-19 Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment medications were provided.   This case was linked to MOD-2021-368741, MOD-2021-369061 (Patient Link).
12/31/03: 5:05 PM mom called pt, fever 102 degrees, Tylenol was given. 1/2/04: called mom to check on pt. Still has fever, not eating well. I told her to take him to ER for check up. 1/5/04: call today, pt is OK, mom didn't take him to ER, states he is fine.
ED visit for bilateral ear congestion; treated and released. One day later Patient  was admitted with acute elevation of her liver enzymes.  Patient had been refraining from alcohol use for 1 week prior to admission.  Patient was given IV fluids as well as thiamine and folate during admission.  Ultrasound of her abdomen revealed possible cirrhosis of the liver.  It also showed some dilation of the common bile duct concerning for choledocholithiasis.  Patient had no abdominal pain, nausea, vomiting during admission.  Gastroenterology was contacted to set up patient as an outpatient for follow-up. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient was given flu vaccine and HPV at around 7:00pm, patient had a vagal response to the immunization. He dropped the paper he was holding, then slowing layed down on the exam table and made some gurgling sound, holding both arms upright. The vagal response lasted less than one minute. Patient responded when his name was called. He appeared slightly pale. Vital signs showed bradycardia with HR of 40-59. EKG showed some premture supraventricular complexes. O2 sat was 98%. Patient was given some water in clinic and responded well. He did not remember the episode.
Patient received Bexsero and upon administration felt light headed and dizzy. Then the patient fainted and started to convulse. This only lasted for less than a minute then the patient woke up.
Received pneumonia vaccine LD, flu vaccine rd around 9:30 on 10-28-02. Around 17:00 noted LD was reddened, sore and warm to touch, shoulder very sore. 10-29-02, returned to health dept erythema, edeam, induration 4in by 3in noted, skin very warmt to touch. Phoned her Dr.; was seein in his office about 10:30, was given Keflex 500mg Tid, Benadryl 25mg every 3-4 hours, cortison cream Tid. Phoned patient around 16:45 she states she feels a little better, will report further problems. Was better by 16:45 10-29-02.
ON 08/29/19 PT RECEIVED HER FIRST SHINGLES SHOT, SHE STATES THAT THE INJECTION SITE IS RED AND SWOLLEN AND INCH BELOW THE INJECTION SITE ARE 2 HIVE THAT ARE BEGINNING TO MERGE TOGETHER & rED AND SWOLLEN AT INJECTION SITE, 1 INCH BELOW DEVELOPED 2 HIVES DIPHENHYDRAMINE 25 MG AT BEDTIME
Tender red indurated area 8 by 16 cm surrounding injection site on right anterior thigh.
Just after vaccination, the pt reported felt numbness all over and then faint. No LOC, no headache, slight ambulation difficulty "feels like pricks' from mid shoulder blades to back of head. walked assisted to medical tent for further eval. A=Ox4, GCS 15, BGl 114, dry mouth, no speech impairment, Cincinnati neg at 11:07am, PERRL. ambulated w/o assist upon leaving. reports "feeling better' but still tingles present. advised to f/u with ED, PCP etc.  10:48 169/91 p95 96% 10:50 97% p 93 10:51 p 92, 96% hr 93 10:56 hr 82, 93% p 86 143/83 p 85 11:01 hr 91 95% p92  11:07 95% p 93 137/76 p 92 above information obtained from rhythm strip from EMS
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA BREATHING RELATED SLEEP DISORDER OBSTRUCTIVE SLEEP APNEA RIGHT BELLS PALSY RIGHT FACIAL MUSCLE WEAKNESS
Bulging veins in lower legs and both arms and present until approximately 05/01/2021
Info has been received from a health professional concerning a 6 year old male who at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. It was reported that the child experienced 50 or more pox and had no vesicles. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info has been requested. Additional info has been requested.
Mother called unit = 1 hr. after shots stating child is having "breathing problems"-instructed to go to ER.
No additional AE; Patient was administered Expired ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient medical history, current condition, and concomitant medication.      On 20-APR-2023 the patient was vaccinated with dose of expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # W000381 and expiration date 13-APR-2023 for prophylaxis (exact dose and route of administration were not provided) (expired product administered and no adverse event).
Patient said he started to feel really nauseous and really tired then he doesn't remember anything until we were picking him up. The dr and I were talking and patient slowly awkwardly fell to the ground by my feet and laid his head down and his eyes closed.  He started to shake and twitch for a couple seconds then started to come to when we were asking if he was okay and helping him up. At first he looked similar to sleep walking, vacant, and confused, then he started to make eye contact and get scared.  He was dazed and crying and said that he felt dizzy.  We walked him from the exam room where he just had his well check up to a station where another nurse took his blood pressure and gave him juice.  He was very tired and just wanted to come home and sleep.  The doctor said it couldn't have been a reaction to the vaccine because it happened so quickly, within 5 mins after injection.  She said he probably just passed out from pain and/or anxiety, but to watch him and call if anything changes.
Five minutes after receiving flu shot, patient felt dizzy and had elevated heart rate and blood pressure. Her symptoms continued and she was very cold, then very warm. It called an ambulance. While waiting, her condition seemed to deteriorate - she had a wave of nausea and was shaking. She complained her throat hurt and felt tight, so I administered an EPIPEN. At that point about 25 minutes had passed. Several minutes later, paramedics arrived and took her to ER. Patient received BENADRYL and steroids at ER.
Pt reported swelling/redness and "hot feeling" after injection in (L) arm was given. Was taken to local ER - tx with antihistamine, ice pack, PHENERGAN for N/V. Followed up with PCP and reports given cortisone injection and muscle relaxer.
3 hours following vaccine experienced vomiting, loss of balance and throat tightening resulting in shortness of breath.  Was seen in same day care within 20 minutes of symptom onset.  Given Kenalog 80mg intramuscular  and Zofran 4mg intramuscular with improvement of symptoms
Temporal Fever in patient up to 102. Sleeping well. Not fussy. No rash, redness, or swelling at sites. No other symptoms. seen on 10/2 and 10/6
The vial was exposed to room temperature for 73-74 hours; The vial was first punctured on 13-May-2022 and administered on 16-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022 at 9:15 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022 at 9:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 13-May-2022. It was first punctured on 13-May-2022 at 8.00 am Pacific Time and was stored at room temperature post puncture. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range 8 degree Celsius to 25 degree Celsius was 73-74 hours.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2022: Follow up received. Added reporter, expiry date and time of Spikevax administration and updated lot number.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Nov2021 as dose 3 (booster), single (Lot number: 033f21a), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). There were no concomitant medications.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022 at 07:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (unspecified date) negative, notes: Rebound case after testing negative I am positive again; (29Jun2022) positive, notes: Rebound case after testing negative I am positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Anti-viral details; product: COVID 19 Treatment, brand= Paxlovid; treatment start date: 20Jun2022; treatment stop date= 24Jun2022, Indication=Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
generalized hive like rash, not pruritic; has been treated with two courses of Prednisone without worsening or improvement in sx's.
This spontaneous report as received from a pharmacist refers to his 62 years old wife with naproxen and penicillin allergy. The patient had no pertinent medical history. On 08-MAY-2014 the reporting pharmacist administered ZOSTAVAX (subcutaneous, dose, lot # and expiry date were not reported) to his wife. Concomitant therapies included atenolol and escitalopram. On 12-MAY-2014 the patient began to experience a herpes like rash on her neck which radiated to one of her arms and then spread to the other arm. No lab diagnostics were performed. It was reported that this rash seemed to disappear, then return. The patient saw her primary physician who diagnosed her with the shingles, but her allergist said it was not the shingles, although he could not come up with a definitive diagnosis. The allergist prescribed the patient ALLEGRA and ZYRTEC, but both have not helped. The rash has spread to patient's legs, and again it seemed to disappear for some time then reemerged. It was reported that the rash was beginning to subside at the time of the report. The patient's status was reported as not recovered. The relatedness between ZOSTAVAX and herpes like rash and shingles was unknown. Additional information has been requested.
My adverse event started on 12/05/2022. I had diarrhea, fever, chills, body aches, headaches, fatigue, and  shortness of breath. I had Influenza A. I took over the counter medications. I took TYLENOL. My son tested first positive for Influenza and I had the same symptoms. I didn't see any doctor for it. My symptoms lasted 4-5 days. I am still experiencing shortness of breath.
vertigo; This is a spontaneous report from a contactable consumer (patient's daughter), from a Pfizer sponsored program COVAX US Support. A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 (at an unspecified age) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient felt dizzy. Later on, she was diagnosed with vertigo. She was hospitalized. Consumer wanted to know if it would still be safe and okay for the patient to receive the 2nd dose. Patient had already been past the 3 weeks since her 1st dose and she still has not received the 2nd dose. 12Apr2021 is her second dose. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Case became extremally fatigued and disorientated on 05/29/2022, was taken to hospital, tested positive and was admitted.
pt recvd vax;8feb96 woke up p/ cold sx;rash all over body;at noc,joint pain;
On the night of the vaccination: 102 degree fever, chills, palpitations, headache, nausea. Fever and chills continued for two days. On 3rd day following vaccination, developed pain on entire inner surface of left arm and trouble focusing eyes including double vision.  Arm pain increased on subsequent days. Arm started to swell on 7th day. Woke up on morning of 9th day with entire arm and hand swollen. Range of motion (both flexing and extending arm) became limited due to pain.  It is now 21st day. Swelling is decreasing.  Still unable to fully flex or extend arm. Vision problems continued.
Onset of blood-tinged watery stools one day after vaccine administration.  10/19/07 Reviewed vax record which provided RO dose & lot #.  Unable to read other lot numbers.  T/C to pcp to clarify.  v/m left for return call. 10/23/07 Received t/c from pcp office.  Will mail vax records.  Patient has recovered completely. 10/26/07 Received vax record w/readable info.  VAERS database updated w/same.
Narrative:  93 yo m with hx of cad s/p remote cabg, htn, hld, rheumatoid , bph/urinary retention s/p remote TURP died on 2/10/2021.Pt had received one dose of covid vaccine on 1/13/2021. Mostly likely death unrelated to vaccine. Pt died when outpatient with no notes available in database regarding pt's death.
c/o red eyes watering, itching burning, c/o scratchy throat & throat later on feeling full-order DPH
vesicular eruption; fever; This literature marketed report has been received from the authors of a published literature article, and refers to a male patient of unknown age. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date the patient was vaccinated with varicella virus vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not provided) for prophylaxis. On an unknown date, the patient experienced vesicular eruption with fever. The outcome of the events was not provided. The authors considered the events to be related to varicella virus vaccine (manufacturer unknown) as the events occurred after vaccination.   This is one of two reports derived from the same literature article and concerning the same patient (cross referenced with #1907USA003553). A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-1907USA003553:
Information has been received from a registered nurse concerning a 9 year old white female with a history of otitis who on 10-MAR-1998 was vaccinated SC in the left with a first dose of Varivax. Illness at the time of vaccination included otitis. On 17-APR-2006 the patient was seen in the office for possible strep throat. Cultures were done, which were negative for strep, and the patient was treated with amoxicillin. On 25-APR-2006 the patient presented to the office. Over the previous 16 hours she had broken out in lesions on her trunk, arms, face and ears. There were about 40 lesions. She was afebrile. She was treated with Benadryl. The health department took pictures and a swab and determined that the patient had varicella. It was reported that the patient's father was immunized with smallpox vaccine two weeks prior, he was doing a plasma study for servicemen. There was no product quality complaint involved. Follow-up information was received by the registered nurse which indicated that on 24-APR-2006 in the PM lesions began on the patient's face and hand (about 20). It was reported that the patient had exposure to varicella. On 24-APR-2006 a skin swab was taken from a vesicle and a varicella zoster DFA was performed that was questionable. A virus culture was also performed, no varicella zoster was isolated. It was reported that the patient's brother (WAES# 0605USA00024) experienced a similar reaction after vaccination with Varivax. Additional information has been requested.
Patient presents to the ED with  Covid, received a positive test from Urgent Care  Patient is experiencing weakness and shortness of breath. Patient is hospitalized for evaluation and treated with Remdesivir.
Patient was given a 1st dose Pfizer, patient stated she had not been vaccinated yet. When putting her record into the database it was noticed that she did get the J&J vaccine on March 3rd 2021
Severe swelling right arm, erythema. Fever, sweats, unwell x 3 days.