chrisvoncsefalvay/vaers-outcomes huggingface dataset:
March 5, 2021: 1st dose of Pfizer vaccine. Severe site pain.  March 23, 2021: 2nd dose of Pfizer vaccine. Felt very restless and sick during night, by the next morning symptoms really sat in.  March 24, 2021: Went to Urgent Care due to fever. Had COVID-19 test (negative). Very close to passing out there (put head between knees and did not). Was sent to emergency room immediately due to heart rate (high 140s-150s. Highest known was 152 BPM). ER performed following: portable chest x-ray, blood tests, urine tests, EKG. Was told results were all normal with the exception of EKG (not told anything about it, form listed as abnormal). Passed out 2x at hospital. Was given one IV rehydration solution and released that night. Symptoms below lasted for several days: Headache Aches Nausea Aggressive shakes Shortness of breath Confusion Dizziness Site pain (also developed bump under arm) Fever - 103.8 (after 2 Advil, 2 Tylenol, 3 ice packs and eating frozen grapes) Heavy sweats Racing heart Restless  March 30, 2021: Still having frequent heart palpitations (they come and go but happen several times during the day. Keep having very high heart rates). Went to doctor. While there, nurse noted irregular heartbeat that sounded like it was ?skipping a beat? and heart rate was also jumping all over the place (high pace, low pace, high, etc.). It was clear something was abnormal. Doctor gave EKG approximately 20 minutes later, EKG looked normal. Was told to come back next morning for blood work and to cut out caffeine.  March 31, 2021: Came in for blood work to check thyroid.  April 6, 2021: Thyroid results were normal. Still having palpitations among other symptoms (see April 12 for more info) so was told to come in. Was given ?work from home? note and referred to cardiologist.  April 12, 2021: Appointment at cardiologist. Still having severe palpitations, occasional dizziness/ lightheadedness, nausea, shortness of breath, exhaustion and chest pain. Heart rate was recorded this day to have gotten up to 139 BPM-- was very high majority of the day. EKG was normal (with exception of high heart rate) but 30 mins later doctor observed high heart rate and abnormal rhythm. Was told to come back in a week and one day for a heart ultrasound and heart monitoring for three days. Still no caffeine intake since 3/30/21. Previous heart rates taken at doctor's visits over the years for comparison below. Never had any prior heart problems whatsoever:  8/29/18: 70 BPM 9/17/18: 88 BPM 10/17/18: 64 BPM 10/31/18: 73 BPM 1/21/19: 78 BPM Note: At this point, I have missed over a  week and a half of work, and worked from home for over a week. I'm not any better heart wise at all over the course of three weeks post vaccine.
Pt developed itchy rash 5 days after PREVNAR vaccine. Red blotches on arm vaccine was given.
ACHY; STRUGGLING TO DO THINGS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced achy, and struggling to do things. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the achy and struggling to do things was not reported. This report was non-serious.
pfizer covid vaccine  eua      red rash like on legs, arms and back. no pain or body itch.  reddness comes and goes.
Autoimmune disease; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A male patient of an unspecified age received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), 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 autoimmune disease on an unspecified date. The patient died on an unspecified date due to autoimmune disease. It was unknown if an autopsy was performed.  The information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. The company cannot completely exclude a causal relationship between the fatal autoimmune disease and suspect vaccine BNT162B2. Additional information regarding therapy duration, relevant medical history, underlying conditions, concomitant medications and detailed clinical course around the event onset will aid in comprehensive assessment of the case. 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.; Reported Cause(s) of Death: Autoimmune disease
Left arm was swollen from shoulder down to elbow, golf ball sized, red, hard knot at injection site + itching.
Pain during injection of the flu vaccine and extreme pain immediately after injection at the injection site (upper 1/3 of deltoid muscle).  The pain has never gone away. Decreased range of motion. Can not perform simple activities of daily living without help.
Left deltoid redness, hot to touch, soreness to touch, c/o fever. Treated with OTC Benadryl/Ice packs.
07/02/2022 in the morning I started feeling warm. On 07/05/2022 I tested positive for COVID-19. On the same day I did a tele heath with my doctor who then prescribed me with PAXLOVID for 5 days. After few days of the medication I started feeling better.
This spontaneous report as received from a other health professional refers to a 76 year old female patient. On 18-SEP-2017 the patient was vaccinated with VAQTA lot # N012324 for prophylaxis. On 18-SEP-2017, 1 day after onset of therapy the patient experienced incorrect dose administered and drug administered to patient of inappropriate age. On an unknown date the patient experienced no adverse event. The outcome of incorrect dose administered, no adverse event and drug administered to patient of inappropriate age is unknown.
Infant with tactile fever, severe vomitting, diarrhea and irritability x 5 days. Diarrhea and irritability persists. Improving but not resolved.
Patient reports Nausea, dizziness, extreme fatigue, and hot/cold sweats that began same day as vaccination. No treatment given. Symptoms improving but still persistent after 4 days post vaccination given. On 7/25/2017 Patient received GARDASIL 9 first dose in series and MENACTRA and reported same side effects however severity was lower at this time. No reported symptoms with second dose of GARDASIL. During the first dose of the vaccination the symptoms only persisted for 3 days and then resolved on their own.
I was doing well until the evening when I had some leg weakness. I used a case that night and the following morning I woke up and fell out of bed due to weakness in my right leg. I contacted my PCP and I was seen the next day. I had a nonfocal neurological exam, although I had difficulties ambulating even with a cane. I was hypertensive at 158/102 and recommended to go the ED to rule out acute stroke. My son drove me with initial head CT negative for acute infarct or bleed. Head and neck CTA demonstrated at least moderate stenosis of the left ACA A2 segment and moderately severe in the right PCA P2 segment. Follow-up brain MRI demonstrated an acute lacunar infarct of the left corona radiata without hemerrhage. I was outside the window for IV TPA. I was given asprin 324 mg and started on atorvastatin as my LDL was elevated at 110. I was boarding in the EC until I was able to transfer the next day when a telemetry bed was available. During this time, my deficits worsened to include a new right arm weakness. With my evolving stroke symptoms, I underwent repeat head and neck CTA which demonstrated evolution of this stroke. The stroke etiology was felt to be small vessel disease per neurology and I was recommended Plavix 300 mg load, then DAPT x21 days with Plavix and asprin 81 mg daily, then asprin alone. I then went into the recommended intensive inpatient rehabilitation.
7YO received Pediarix; This case was reported by a consumer via sales rep and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (On 24th March 2021, patient received 1st dose).   On 27th August 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 27th August 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-Jan-2023. Reporter's Comments: The reporter consented to follow- up. No report of adverse effects. Additional Supportive Information: Patient received 2nd dose at 7 years of age, which led to inappropriate age at vaccine administration.
Mom stated that approx 20 mins p/vax pt turned blue, profuse sweating, & clammy;
Information has been received from a physician concerning a 6 month old female patient with no drug reaction/allergies and with no medical history, who in approximately February 2007 (at 2 months of age) and in approximately April 2007 (at 4 months of age) was vaccinated with the first and second doses of ROTATEQ respectively (dose and lot # not provided). Concomitant therapy included ganciclovir for the treatment of CMV in the GI tract, and steroids (unspecified). In approximately June 2008, (at 6 months of age), the patient experienced chronic diarrhea 1 to 1 1/2 months since the first dose. The patient was thought to be well prior to the first vaccination. The patient's stool sample came back positive for rotavirus. A duodenal biopsy was positive for cytomegalovirus (CMV). The patient has been hospitalized two other times and was currently in the intensive care unit due to dehydration. The child has marked failure to thrive. She went back down in weight from 13 lbs to 5 lbs and is being treated with ganciclovir, unspecified steroid, IV fluids, and IV nutrients. The patient was losing proteins from the diarrhea. The patient had not recovered at the time of reporting. The reporter felt that weight loss, gastroenteritis rotavirus, duodenal biopsy positive for CMV, failure to thrive and dehydration were considered to be disabling, life threatening and were other important medical events. Additional information has been requested.
he told me on of his patient his cerebral palsy came back/he flared up with cerebral palsy; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer or other non-health care professional reported for another patient. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: Unknown), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. Medical history included cerebral palsy when patient was in 20 from an unknown date and unknown if ongoing. Patient went on mission for 30 years. The patient's concomitant medications were not reported. The patient's cerebral palsy came back on an unspecified date. The patient got the pfizer shot and within the week flared up with cerebral palsy. The outcome of event was unknown.  Follow-Up (06Jul2021): Follow-up attempts are completed. No further information is expected.
Started to feel muscle aches and sore arm about 7 hours after shot. That progressed over the next 2 hours into a mild fever (99 degrees) with aches and body chills. Fever grade 100 by middle of night 12 hours after vaccination. 400MG of advil consumed, Fever went away for 3 hours and then came back (101 degrees). Fever, aches, and chills persisted until I was 28 hours post vaccination. The following night (Hours 32-42) patient experienced hot flashes woke up Sunday morning (42 post vaccination) with headache and sweats. The sweating persisted throughout the day and into the whole night where patient experienced profuse sweating enough to soak the mattress. At the time of submission, it is unclear whether the night sweats have resolved.
Subsequent to receiving second dose of Engerix B, the pt developed a rash at the injection site. The reporter noted that Engerix B was administered to six pts, all of whom developed a rash.  In some cases, the rash extended to include the arm only, or the arm, face and trunk, or the whole body. The most recent information received reports the outcome of the event as resolved after one to two weeks.
This case was reported by a nurse via call center representative and described the occurrence of local swelling in a 55-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced local swelling and induration. On an unknown date, the outcome of the local swelling and induration were unknown. It was unknown if the reporter considered the local swelling and induration to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient who himself was a nurse. The age at vaccination was not reported. The patient experienced red hard lump after receiving 1st dose of SHINGRIX vaccine. The reporter wanted to know if he could take the 2nd dose of SHINGRIX when it was due or not. The patient agreed to be followed up, however he said if he is with patients he could not answer, but if the safety department leaves a message for him, he could call back.
Pt c/o flushed feeling 15 mins after receiving the 2nd dose of the vaccine, had no reaction to the 1st dose. She reported that she has Hx of HTN, DM II, hyperlipidemia, allergy to dust mites and pollen and that she ate Cheetos last night and Saltine crackers this morning. She was assessed and monitored by NP, EMT and paramedic. She denied headache, dizziness, numbness, tingling, weakness, chest pain, SOB and visual changes. BP readings from initial to last: 193/115, 180/110, 191/107, 170/90, 164/88. HR- 108, went down to 98, O2 sat 99%. She noted that she was nervous because her daughter is in the hospital. She kept at site until she felt better and no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/ SEs to call 911 and go to the ED, follow up with her PCP, register with V-safe. Also instructed to take her BP med when she gets home and BP parameters to call 911/her PCP, instructed on low salt diet and therapeutic lifestyle changes. She verbalized understanding and willingness to comply. She left site in no acute distress, had no complaints, she was awake, alert, oriented to person, place, time and situation.
Vasovagal response.  Passed out immediately after the vaccine.  Had dry heaving.  Caught by father.
I was deployed from Nov 2002 through May 2003.  I developed type II diabetes, and severe joint pain in both wrists, left index finger and thumb, right pinkie and middle finger, right knee and left big toe.  I received the last anthrax vaccination Jan 2003 and was hospitalized in June 2003 for the diabetes.  The lot number on the anthrax is FAV064.  The received the vaccinations on the following dates:  3 Dec 2002, 18 Dec 2002, and 2 Jan 2003.
DTaP was ordered by Dr. on 8-1-17. Patient was given PENTACEL. Error found 8-4-17. Called Guardian - and she reports no symptoms. Sanofi was notified and left message with County Health Dept.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 (lot # M011840, expiry date 01-FEB-2018, dose, strength, dose number, vaccination site, route not provided). The temperature excursions were reported as 1.6 c for 39 minutes on 09-AUG-2016, C for 1 hour 40 minutes on 10-AUG-2016, 1.5 C for 55 minutes on 11-AUG-2016, 1.5 C for 1 hour 7 minutes on 28-AUG-2016. No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L029631, expiration date 14-AUG-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Covid monitoring documentation. PT admitted 1/18/22 documented to have positive covid. PT received Moderna 03/16/21 Lot 006B21A for dose 1. Dose 2 was Moderna given on 4/13/21 Lot 036B21A.
90 seconds p/vax pt found sitting on the floor, pale, clammy, & weak;pt stated head was pounding;pt was fully oriented & never lost consciousness;BP & p check twice;@ 20min there were no signs of allerg rxn;
01/01/04: Left knee swelling-better by 01/04/04. 01/06/04: Right knee swelling-size of grapefruit (Aleve and Ibuprofen). 01/08/04: Saw PCP-aching back and shoulders, PCP ordered CBC: WNL, Rh factor: negative sed rate, 4 gave Celebrex prescription. 01/09/04: Severe pain in hands with swelling. 01/13/04: PCP ordered Medrol dose pack. 01/13/04: PCP ordered Percocet. 01/14/04: Pain decreased-continue on dose pack.  Presently having symptoms.
From the initial information received on 11/06/2004 from the patient regarding an adverse event occurring in the USA, it was reported that this 49 year old female received a dose of Tetanus Toxoid ADS on 06/19/2004.  The lot number and site of administration were not reported.  During the week of 07/04/2004, the patient noticed some nodules which progressively developed into very painful, purplish nodules under the skin on her shins and lower legs.  This was accompanied by swollen legs and ankles.  In August 2004, she was diagnosed with erythema nodosum.  At the time of this report, the symptoms were persisting and the patient had not recovered from the events.
On 4/22/08 Client received both Pentacel (DTaP, IPV, HIB) and Pediarix (DTaP, IPV, Hep B) at the same visit.
States approximately two hours after receiving flu vaccine noted "fever, chills, seizing chest pain, horrible sore throat, headache, conjunctivitis, muscle aches, nausea and conjunctivitis. Went to clinic for eval. Symptoms subsided within 12 hours except conjunctivitis.
Left Arm/hands was numb and  felt tingling sensation in ~20 mins from time of vaccine shot. Left Arm was also bit cold. These conditions prolonged until 3 hours from vaccine and then recovered.
This spontaneous report as received from a physician via company representative refers to a 13 year old female patient. On 30-JUN-2014 the patient was vaccinated with GARDASIL (lot # J010668, 0.5 ml, intramuscular in the right arm). Other suspect therapies included VAQTA (lot # J014584, dose unknown, in the right arm). Concomitant therapies included PROZAC and amoxicillin for ear infection. No known allergies were reported. On 30-JUN-2014, the patient experienced headache and dizziness. No treatment was given for the events. The outcome of the event was reported as not recovered/not resolved. The patient was being monitored by the physician's office. The causality was unknown. No further details provided. Additional information has been requested.
Dtap given in left arm. Child developed a red, hot, raised area in left deltoid the size of a golf ball. Child complains of tenderness in the arm.
Low heart rate. Passed out. Monitored and tested in hospital for 30 hours.
On 3/11/16 pt presented to urgent care with mother reporting redness, heat and tightness at vaccine site no pain or fever. Dx: cellulitis Dr prescribed cephalexin. Pt presented to Dr for follow up on 3/18/16 with complete resolution.
Received a 7th dose that was taken from a single reconstituted vial of Pfizer-BioNTech COVID19 vaccine. At the time of vaccine, it was not identified as a 7th dose. Did not have an adverse reaction. Report submitted to document 7th dose given states is not considered a valid dose of the vaccine.
This is a report of a vaccine error by RN. Patient denies having any adverse event from the injection.
pt recv vax; exp generalized rash on hairline & trunk;pt cont to exp eruptions & was seen by MD;
Patient became lethargic but responsive after injection of Pfizer.  Patient stating she had a tingling sensation throughout her body.  Had nausea and vomiting and diaphoretic.  Was taken to cot to lay down and vital signs taken, noticed to be hypotensive.
Patient stated that she developed severe arm pain that is still on-going. Attempted treatment with ibuprofen and hot compresses, ultimately going to physician who diagnosed infection at injection site after ordering an MRI. Patient proceeding to see an orthopedist for further treatment.
Sudden onset of cough -> chest pain and feeling of throat constriction -some relief with BENADRYL - sxs continued throughout night. Seen at health services following morning. Currently chief complaint malaise/achy joints - chest pain. Pt is otherwise healthy without meds/med hx.
PAIN AROUND MY TESTICLES; INNER FEVER/FEVER BECAME SEVER AND WORSE AFTER 48HOURS; SICK; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced sick. On 20-JUL-2021, the subject experienced inner fever/fever became sever and worse after 48hours. On an unspecified date, the subject experienced pain around my testicles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, inner fever/fever became sever and worse after 48hours, and pain around my testicles. This report was non-serious.
Awoke at 05:00 on 12/13/00 with a stuffy nose and throat felt tight and coughed up phlegm. By 13:30, after swimming in community pool, had a rash over chest, face and arms. The rash is spreading today. No fever noted. Slight itch. Rash is spreading down legs.
After 45 minutes mother brought patient back. The patient is wheel chair bound. Mother showed me that patient had a raised bump and a rash about the size of a half dollar. No other symptoms. Patient used benadryl which helped. A few days later she went to her physician that said the vaccine just needed to run it course. However patient still has rash that goes to elbow and chest and then leaves and is not noticible. This reaction has been going on since the vaccine was given.
Headache for a few hours until I took Aleve, and then about 12 hours after my dose, I began experiencing diffuse body aches that lasted for about 24 hours.