chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose number=3; Pericarditis; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female non-pregnant patient received bnt162b2 (BNT162B2), third single dose intramuscularly, administered in arm left on 09Oct2021 (Batch/Lot Number: FF2587) for covid-19 immunisation at age of 26-year-old. The patient was not pregnancy at time of vaccination. There was no medical history and no known allergies. Concomitant medications included influenza vaccine (FLU) third single dose at right arm for an unspecified indication from 09Oct2021 to 09Oct2021 and birth control medication within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 (Batch/Lot No: EH9899) on 20Dec2020 intramuscularly at left arm and second dose of bnt162b2 (Batch/Lot No: EL3248) on 10Jan2021 intramuscularly at left arm for covid-19 immunisation, both at age of 25-year-old. Prior to vaccination, the patient didn't diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced pericarditis on 09Oct2021. The event resulted in doctor or other healthcare professional office/clinic visit. Patient received EKG, chest X-rays, NSAIDS, echo, lab work as treatment for the event. Outcome of the event was not recovered.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of events Pericarditis and immunization cannot be totally 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.
fast and racing heartbeat, chest pain, dizzy and weak, shortness of breath only lasted 2 days after vaccine was given and then stopped.
Pt had dizziness and palpitations several hours post H1N1 and Seasonal Flu vaccination. Was admitted to ICU for atrial flutter.
rash started on face 24MAR93; by 27MAR93 had spread all over, t98.9 ax; fever up for 2 days up to 102.9; when checked had mild pharyngitis; full blown erythema multiforme like rash; over entire body;
c/o pain in lt arm feels like pins sticking in arm; denies numbness or tingling sensation in extremities; afebrile; does c/o h/a; no vertigo;
Symptoms occurred 8-12 hours after injection and were mostly gone within 24 hours.  mild rash on abdomen, swelling of right breast, shallow breathing No treatment.
patient was very anxious before getting vaccine. after vaccine administration patient felt dizzy right away and could n t answer questions . patient was feeling very dizzy and was about to faint  911 called patient felt better after and was able to go home
Soreness around the shot area.   The Majority of the soreness went away in 2 days.
15July97 Pt recv 1 dose vax. 01Feb98 Pt devel breakthrough varicella. 50 lesions, some crusted. Vesicles on chest, legs & face. Low grade fever
On 10/22/2021, I had abdominal, pelvic, and perineal pain. I went to the ER, and I was told that I was having Braxton-Hicks contractions. I was then sent home. On 11/12/2021, I had upper abdominal pain. Suddenly, the vision in both my eyes became blurry for a few seconds, and I felt faint. I decided to take my blood pressure, which was 160/100. I then went to the ER. At the ER, I underwent nine blood tests, a PCR test for COVID-19, and a urine test. I was diagnosed with chest pains, dizziness, and giddiness. I was also diagnosed with anemia with resulting complications to pregnancy and supervision elderly multigravida, third trimester. I was not given any medications on account of my pregnancy, and they told me they would monitor my blood pressure and overall situation. Prior to my pregnancy, I had never had high blood pressure. I was then sent home. On 11/15/2021, I noticed that I wasn't feeling my baby move as much as before, so I went to the ER. At the ER, I underwent a urinalysis, a fetal biophysical profile with non-stress testing, and a limited obstetrical ultrasound. I was told that the baby's vitals looked fine and that there were no anomalies. On 11/2021, I went to hospital, where labor was induced. I was tested for COVID-19, and the result was positive. I gave birth to my daughter, who was 19.5 inches long and weighed 7 lbs., 2 oz. After I had the baby, I experienced chest pains, and I was examined by both a cardiologist and a neurologist. The cardiologist thought that the pains may have been caused by the COVID-19. I underwent an MRI with contrast dye; the neurologist thought that they had spotted a possible aneurysm, but fortunately, that turned out not to be the case. During my labor, I was given an epidural. After the birth, I was given pain pills, such as Motrin. I was given no medication for the COVID-19, though. I was discharged on the morning of 11/25/2021. I was admitted to the hospital on 12/7/2021, because my blood pressure was 200/180. I was given magnesium to lower my blood pressure. I underwent an echocardiogram and an EKG. I was released on 12/10/2021. I was prescribed Labetalol (100 mg), which was instructed to take every morning. On 12/21/2021, I had another episode in which my blood pressure was dangerously high. I went back to the ER.
Patient had a seizure like reaction versus a diptonic reaction after receiving the shot. She recovered within 15 minutes and after 1/2 hour, she completely recovered.
Vaccine given 10/8/15. Patient's husband states patient had sore arm and neck within 2 days. Dr visit on 10/30/15. Paralysis from neck down.
Vaccine was given about 1 hour past the 6 hour expiration time frame for the Pfizer COVID vaccine once diluted. There were no apparent adverse side effects noted to patient. Expiration time was noted shortly after dose was administered.
Chills in arm started within an hour after shot.  Later spread to whole body experiencing chills.  About 7 am  the next day experienced nausea, but that turned to diarrhea and lasted until about 7 or 8 pm.  Not constant, but when I would eat would pass through quickly.
Follow up received from the physician on 5/28/03 provided information regarding the patient's medical history. A physician reported via a company representative that a 23 month old male received his third dose of Prevnar on 1/16/02 at 9 months of age. The physician indicated that the child had no illness at time of vaccination and no pre-existing medical conditions at the time of the event. On 3/11/03, the child developed  pneumococcal meningitis and was subsequently hospitalized. Treatment medications included unspecified IV antibiotics. Serotyping revealed one of the pneumococcal serotypes found in Prevnar; however, the specific serotype was not reported. The child recovered.
After receiving MCV4, pt noted pain & swelling in her (R) upper arm that night. On the next day, 12/21/11 she noted some numbness too on her (R) shoulder and at the side of her (R) breast. She states she did not do any treatment or see a Dr. She called the Health Dept on 12/27/11 with this complaint and was advised to see a Dr. Several attempts were made to follow up with her by phone. On 12/28/11 with no answer, 12/29/11 LMOM, 1/3/12 - no answer and, 1/19/12 - LMOM (left message on machine). Pt was finally able to be reached on 2/9/12, states problem resolved but did not see a Dr.
37 yo male s/p full Pfizer COVID vaccination: dose 1 on 4/8 and dose 2 on 4/29. Pt is an employee at this institution. Reports new onset cough, fatigue, muscle/body aches, headache, congestion/runny nose on 8/9. Denies known exposure to COVID positive person. PCR test results back positive on 8/9.
KNOCKED DOWN A BIT, IT FELT ROUGH; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. 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 in left arm on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced knocked down a bit, it felt rough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of knocked down a bit, it felt rough was not reported. This report was non-serious.
Patient has multiple sclerosis. He received the vaccine Monday morning (6/27/22), said he was completely fine the rest of the day until bedtime. He said he could barely get into bed, had very limited mobility in bed throughout the night (rolling over), and he could barely get out of bed in the morning and needed assistance. All of this he described as abnormal. During the day on Tuesday (6/28), his symptoms improved, however, that evening, he experienced the same symptoms, and slept in his recliner rather than his bed. Since Wednesday morning, he said he has been feeling normal again. He described this event as an "MS exacerbation." He also said he did not change anything in his medication routine, and had no reaction to his first J&J COVID-19 vaccine.
Mild difficulty swallowing 15 minutes after shot administered. Mild muscle tension in the throat as well. Went to the ER, was given adrenaline, benadryl, and pregnazone. Symptoms went away after these treatments.
Narrative:  COVID vaccinated patient presented to the hospital with abdominal pain/shortness of breath found to be COVID positive.
approx 24 hrs p/vax pt mom stated not pt was pale, limp, lethargic; sx lasted for approx 18 hrs; (until evening of 4NOV93); no treatment;
1136 Pt c/o tightness in throat. EPIPEN 0.3mg to (R) thigh. 50 mg BENADRYL. Pt denies any other s/s. 1240 Pt discharged to home with husband.
fever; chills; This is a spontaneous report from a contactable consumer (Patient). A 15-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that 14 hours post second dose the patient experienced fever and chills approximately 15 years old. Event took place after use of product. The outcome of the events were unknown.  Information about batch/lot number has been requested
pt recv vax; to clinic w/ c/o redness at inject site;to see MD; also applies warm soaks to site; red area lateral & below inject approx 4" long x 2 1/2"; apap given;MD prescribed ATB;recovered
Swollen left testicle, and on 04/16/2021 headache and sinus pain and slight breathing issues and chest pain
Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ vaccine live (human-bovine) on the schedule of 4, 6, and 8 months of age. A product quality complaint was not reported. No other information was available. Additional information has been requested.
Headache; Loss of taste and smell; Loss of taste and smell; Nausea; Dizziness; General body aches; This is a spontaneous report from a contactable nurse reported for herself. A 58-year-old female patient 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 medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Headache, loss of taste and smell, nausea, dizziness, general body aches. Outcome of events was unknown.   Information on the lot/batch number has been requested.
pt recvd vax;approx 1 wk later,devel pain leg;adm to hosp for blood clot; at home in 7days w/ coumadin;
Child had a swollen left cheek and fever of 102. The parotid was not swollen. Child was irritable for about 3 days with fever.
Patient developed rash about 12 days after administration of Fluzone -HD vaccine and was diagnosed as shingles by her doctor She is currently taking antiviral medication for the condition.
Other side effects; Anaphylaxis; Anaphylaxis; A spontaneous report was received from a nurse, concerning a 32-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 2 episodes of anaphylaxis (onset: 28 Jan 2021 and 29 Jan 2021) and other unspecified side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date patient took her first of two planned doses. On 28 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced the event of anaphylaxis (life threatening), within 30minutes after the second dose of vaccine. Hence, she received epinephrine and her condition did not improve so received a second dose of the same, also was treated with diphenhydramine and oxygen and sent home. Next day, on 29 Jan 2021, the patient again went into anaphylaxis, hence, received another epinephrine and was also given with prednisone due to which patient got better and was stable today. But, however, she still having other side effects but not anaphylaxis. The patient's clinical history says that on Sunday night she continued to be symptomatic with vaccine side effects. The patient was confirmed to be not pregnant. Treatment for event other side effects were unknwon.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of events anaphylaxis (onset: 28 Jan 2021) and anaphylaxis (onset date: 29 Jan 2021) was resolved on 29 Jan 2021. The outcome of event other side effects was considered unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Janssen COVID-19 Vaccine EUA  Chills starting at 8pm, began having a fever around 9:30 of about 99.5.  Fever worsened during the night to 101. Chills continued through night.   Following day fever subsided and no chills but had a horrible headache. Took ibuprofen which helped.
red, blotchy, hard, swollen around the injection site. 4-inch diameter around the injection site. Localized
MOC called & reports child crying since getting home (3 pm) from dr's appt. Also with redness, swelling left thigh instructed to come to office. Arrived 3:15 pm,  Motrin 3cc/ice pack to left thigh, Observed  X 1 hr, Babe fell asleep, Minor swelling noted on arrival subsided.
Two days after receiving seasonal influenza vaccine at work hospital employee returned to health department with hives on arms, head, waist and bra line. Had take Loratadine with little relief, so was given Diphenhydramine.
Induration; Redness; Pain after injection; This case was reported by a physician via call center representative and described the occurrence of induration in an unspecified number of patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than a year after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced induration, erythema and pain. On an unknown date, the outcome of the induration, erythema and pain were unknown.   It was unknown if the reporter considered the induration, erythema and pain to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced induration, redness and pain during three days after receiving Fluarix vaccine. The reporter denied consent to follow-up.
7/2/19 Local red area around injection site later in the evening of injection.  7/3/19 Next morning larger red area, mid day-nausea, vomiting, fever, chills, body aches all over, fatigue, weakness.  7/4/19 larger area of redness 2.25" across by 3.5" long, now hot to the touch and hard under redness, painful. Nausea has subsided, muscle pain is now only on effected arm and shoulder. Dr. was called and pictures sent to him, he has prescribed Keflex 500 MG TID x 10 days, May use Benadryl 25 mg 1 tablet am, and 1 tablet pm.
12sep90 pt vax 3rd hepta b. pt ex arthralgia, h/a, n, diarrhea, and weakness.  sx resolved
Foot pain. Bottom of the feet were painful to touch and walking became very painful for 2 days. Reaction occurred on 3rd day after receiving vaccination.  Pain has subsided but took 2 days to stop.
This spontaneous report was received from a pharmacist referring to multiple unspecified patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates the patients were vaccinated with improperly stored ZOSTAVAX 19400 plaque-forming unit (PFU), lot # M037655 and expiration date on 29-NOV-2017 (dose and route of administration were not reported) for prophylaxis; which was reconstituted with properly stored sterile diluent (DILUENT MRK). The doses of stored zoster vaccine live (ZOSTAVAX) were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46°F during a time frame of 17 hours, which was detected by the data logger. Previous temperature excursion was reported as 6°F to 14°F for 7 hours 30 minutes. No adverse events were reported and no product quality complaints were present.
Blood Vessels in Right Eye; Eye is extremely red/eye is blood red; had a little soreness to injection site; This is a spontaneous report from a contactable consumer. A 61-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Mar2021 09:40 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included amlodipine besylate taken for hypertension from an unspecified start date (Started years ago) and ongoing. Patient states he took his Pfizer covid19 vaccine on Sunday morning. When he woke up on Monday morning there were some blood vessels in his right eye and his eye was extremely red. States that while he is uncertain of the exact time that this happened to his eye as he was sleeping; he noticed it Monday morning around 0700 when he woke up and looked in the mirror. States he had a little soreness to injection site, but nothing serious. Outcome of event eye red was not recovered, of others was unknown.
Patient developed baseball-sized knot on arm about 30 minutes after receiving the vaccine.  Her arm was very sore, and she developed red streaks down her arm.  She then developed chest pains and shortness of breath.  She went to the ER where they administered medications and sent her home with a prescription of Prednisone.
Pt presents to the emergency room on Sat 1/31/09 complaining of painful, itchy rash on torso.  During review of systems and physical exam, pt noted to have the following: + erythematous maculopapular rash  over (L) ant abd and (L) paraspinal area in dermatomal distribution. No vescicles; no bullae. Pt had previously received the vaccination on 1/22/09
pt recvd vax & following the vax pt possibly devel core antibody; No further details were provided
05/17/2022 I did start to come down with COVID-19 Symptoms that seemed like allergy issues. On the 20th I went and got tested for COVID-19 and it did come out positive. The symptoms that came down with were runny nose, congestion, cough, no fever or anything else. I tried an Allegra and it did not help the symptoms at all. I am still to this day having the cough and I am still having GI issues that became apparent after my infection and my doctor believes that it may be COVID-19 related. I had been told that many patients coming in with COVID-19 have shown issues with their GI. Bloodwork that was done came back normal and a CT scan that came back completely normal. I was given an IV and then was sent home after going to the ER.
therapy non responder; This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B and the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B and Engerix B, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   It was unknown if the reporter considered the therapeutic response decreased to be related to Engerix B, Engerix B and Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient was receiving full 4 dose series of Engerix B if titers testing immunity were low, which led to decreased therapeutic response.      Lab Comments: On an unknown date, the patient's lab test was low.
Patient presents 2 days after vaccinations with widespread hives that began more than 24 hrs after he received his menquadfi, trumenba, and flucelvax. Symptoms partially resolved with use of some benadryl
Patient got Moderna booster on Wednesday.   Severe arm pain started appox 3 hours later.  Patient concernd that the needle may have nick/hit the nerve.  Patient expected arm to be sore but this was much more severe.    she described an episode of frozen shoulder where she was unable to move it for a period of time.   Also had pain shooting from the area to elbow down to wrist and sometime to fingertips of pointer and thumb.   The episode started  3 hours after injection and lasted 12 hours.   She was still having some trouble doing some movement  5days later.
pt recvd vax 230PM & was cranky, t103, crying high pitched & leg very tender w/very swollen thigh;pt had episode approx 7PM becoming limp & shaking especially hands & arms & had goose bumps all over body-episode lasted about 1/2 min
Presenting symptoms included: mental status changes; regression of developmental milestones; ataxic gait; incoordination; seizures; loss of speech; inability to eat; meningial signs; tremor; irritability. Above mentioned symptoms appeared acutely on 12/1/05. Pt. is still in the hospital, already two weeks. A clear diagnosis has not been established, working diagnosis is post-infection/post-vaccine encephilitis.Treatments included: empiric antibiotics started and discontinued, acyclovir continued for 14 days, IVIG. Patient is improving. Discharge summary states viral infection. msv
Injection site red, warm to touch, swollen, pain 3/10, headache.
tingling in lips and sinuses 10 min. after vaccine -dizziness /lower lip slightly swollen /bp 124/84 pulse 82 -c/o tightness in throat -swallowing -no respiratory issues
My left upper arm (non-dominant arm) hurts.  The problem is that I cannot lift it above my head freely.  I must do it very slowly and carefully