chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nerve pain/it continued to get worse with the second dose/three weeks later, still having pain; serious insomnia; This is a spontaneous report from a contactable consumer (patient). A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN28730), dose 2 via an unspecified route of administration, administered in arm left on 28Mar2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation at other facility. Medical history included old nerve condition (it appeared to exacerbate an old nerve condition that occurred after having a large tumor removed from a nerve in her back), a large tumor removed from a nerve in her back and known allergies of steroid sensitivity. There were no concomitant medications. Previously, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administration in left arm on 09Mar2021, 04:00 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and experienced nerve pain (it appeared to exacerbate an old nerve condition that occurred after having a large tumor removed from a nerve in her back). No other vaccine in four weeks and no other medications in two weeks. No covid tested post vaccination. On unknown date in 2021, the patient experienced nerve pain/it continued to get worse with the second dose. On unknown date in 2021 (three weeks later), the patient was still having pain, and experienced serious insomnia. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment for adverse event included temporary pains meds as therapeutic measure for nerve pain/it continued to get worse with the second dose/three weeks later, still having pain. Outcome of events not recovered.  No follow-up attempts are possible. No further information is expected.
REC'D HEP A AND VARICELLA AT NURSE VISIT 8/11/2010 ABOUT 1:30PM.  HAD VISIT ON 8/13/2010 48 HOURS LATER SECOND TO SWELLING AND ERYTHEMA AT SITE.  9 1/2 X 9 CM OF EDEMA CIRCULAR AND CENTRAL ERYTHEMA AREA 4 CM. NO FEVER. DX: LOCAL REACTION.  ON 8/14 REDNESS SPREAD.  GIVEN CLINDAMYCIN 150 MG ONE PO TID X 10 DAYS.  PHONE 8/15 BETTER.
pt began having severe GI sx shortly p/vax;mom was under the impression this was toddler tummy;p/ daughter dx w/autism began to question this;problem started p/vax p/MD study;mom asked MD to do measles titer;it was elevated;devel measles;
Pt recvd 3 doses of Engerix-B on 12NOV90, 13DEC90 & 13MAY91; in APR92 titer lab check neg;
Recent COVID exposure in his house. Yesterday started feeling weak. He has had intermittent diarrhea and poor p.o. intake.
Redness 13 cm X 10 cm.  Warm to touch.  Tender to touch.  Swelling.  BACTRIM DS 200 mg - 40 mg/ 5 ml 10 ml po BID X 10 days - for possible cellulitis.  Pt. to F/U prn.
Duplicate Dose of Flu Shot.  Patient Received INCORRECT flu shot on 10/06/22, Fluzone Quadrivalent, and was given then a Fluzone High Dose Quad (based on his being over 65 years old) on 10/18/22
Information has been received from a 24 year old female consumer with penicillin allergy who on 07-JAN-2010 was vaccinated with a first dose of GARDASIL. On 08-JAN-2010 the patient experienced dizziness, nausea, rash between her breast, tenderness and pain at injection site and headache. Therapy with GARDASIL was discontinued. The patient did not seek medical attention. At the time of this report the patient had not recovered. Attempts to obtain additional follow up information have been unsuccessful. Additional information is not expected.
Mother reported rash beginning on face and swelling of lips approximately 7 hours after immunizations were administered.  Rash spread to entire body and extremities. Mother states child felt hot to touch, but did not check his temperature.  He did not have any difficulty breathing, continued to play, eat, and drink as usual.  Mother brought the child to clinic 9/15/08 to be checked.  Appears well, fading rash noted.
Dizziness upon standing, loss of balance, near fainting episodes, shooting pains in head and face, constant ache and pressure in head and back of skull/neck area, extreme fatigue and exhaustion causing inability to work, brain fog, cognitive difficulty, forgetting words, difficulty telling time, difficulty focusing, difficulty spelling, easily overwhelmed with stimuli, muscle pain and weakness, mood swings, memory loss, low body temperature, low blood pressure, cold hands and feet, irritability, lack of patience, tingling in body, spots in vision, lack of appetite, nausea, constipation, Bell's Palsy, occular migraines, sensitivity to light and sound, chemical sensitivity, irregular periods, increased urination, night sweats, stiff joints, swollen eyes and lips, rib soreness, occasional facial numbness, lack of energy, heart palpitations, ringing in ears, increased affect from alcohol.
Pfizer vial expiration date is 08/31/2022 but a dose was given on 09/07/2022.
On 03-28-03, day 8 post vaccination, this primary vaccinee reported oral ulcer on inner aspect of cheek. Vaccinee was afrebrile and no pain or tenderness reported.  On day 9, vaccinee reported ulcer resolved approximately 24 hours after onset.  Reports prior history of similar type of oral lesions.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Since 04-MAY-2015 the patients were vaccinated with doses of improperly stored (Merck) PROQUAD, (lot# reported as L005293 with expiration date: 17-AUG-2016; strength, dosage, frequency and route unspecified). No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt exp arm soreness in inj arm;/throbbing arm;chills, T100.6;sx continued 4/4 & T102.2;just below inj site 3 red blotches appeared;arm swollen from shoulder to elbow;h/a w/fever;red spot sore to touch;pt threw up;loose stools. This is in follow-up to report(s) previously submitted on 7/12/99. Information has been received from a registered nurse concerning a 23-year-old Caucasian female patient with multiple sclerosis and gastrointestinal sensitivity to erythromycin who on 02-APR-1999 was vaccinated with a first dose of PNEUMOVAX 23 in the left deltoid. That evening, the patient experienced arm soreness in the vaccinated arm. On 01-APR-1999 the patient experienced a sore and throbbing arm, chills, and a low grade temperature of 100.4 degrees F. On 04-APR-1999 the patient's temperature was 102.2 degrees F. and the arm was very sore, achy, and throbbing. Early that afternoon, in the area 1 1/2 to 2 inches below the injection site there appeared three red blotches. The arm was swollen from the shoulder to above the elbow. The patient also experienced mild headache with fever. That eveving, the three red patches connected together. The low grade temperature persisted at that time. The red spot was sore to the touch. The patient experienced loose stools that evening. At 2:00 AM on 04-APR-1999, the patient threw up. On 05-APR-1999, the patient presented to a physician and was diagnosed with "febrile reaction to PNEUMOVAX 23. All symptoms except red patch area dissipated throughout the day 05-APR-1999. Some redness on arm was still present on 12-APR-1999." Another patient was reported with adverse experiences following vaccination with PNEUMOVAX 23 (WAES98040468). Additional information has been requested.
Pt reported nausea and dizziness and feeling as if she could faint after administration of vaccine
pt recvd vax;to md w/ lesion inside mouth;otitis med;dx w/ impetigo & stomatitis;dx w/ herpes whitlow w/ a possible staphylococcal superinfection;tx w/ augmentin;20 vesicular lesions on lt thumb,a cluster of 3 vesicles @ inject site;herpes
CONFIRMED COVID-19 INFECTION; DECREASED OXYGENATION; This spontaneous report received from a consumer 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 on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On MAR-2021, the patient experienced confirmed Covid-19 infection. On MAR-2021, the patient experienced decreased oxygenation. On 11-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient started exhibiting Covid-19 symptoms decreased appetite, shivers, sweats and muscle aches. On Thursday 3/11/2021 father in law was taken to emergency room and was admitted, tested positive to Covid-19 on /March/2021. Since then father in law was discharged, but had to be readmitted some time later due to decreased oxygenation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and decreased oxygenation was not reported. This report was serious (Hospitalization Caused / Prolonged). The case is associated with a product quality complaint number: 90000173361 This case is a duplicate of 20210335533.; Sender's Comments: V0: 20210334839-Covid-19 vaccine ad26.cov2.s-Covid-19 infection. This event is considered not related. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. 20210334839-Covid-19 vaccine ad26.cov2.s-decreased oxygenation. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt. took 25mg of Benadryl at 12 noon prior to coming to clinic.  She recvd her vaccine at 12:27.  At 12:44 she started having itching on her upper chest and neck,  denied any SOB.  at 12:45 she was given additional 25mg of Benadryl.  She was monitored for additional 20 min , symptoms resolved and pt was discharged with a driver.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. No Medical History information was reported. On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, SARS-CoV-2 antibody test: equal to 189.0 Result: SARS-COV2 antibody level equal to 189.0 U/ml. On 22-Nov-2021, SARS-CoV-2 antibody test: greater than 2500 Result: SARS-COV2 antibody greater than 2500 U/ml. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter.  No treatment information provided. This case was linked to MOD-2021-404656 (Patient Link).
Vaccine 5/23/17. Started with 102 degree fever, cough, wheezing on 5/24/17.
it seems like ever since I have been kind of short-winded and I have emphysema anyways but I am usually not this short-winded; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included ongoing emphysema and short-winded. The patient's concomitant medications were not reported. The patient had a shot of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and ever since that the patient has been kind of short winded. The patient has emphysema but reported not usually that short-winded. The outcome of the event was unknown.   Information on the batch number has been requested.
rt upper arm started to swell & ache w/in 2-4 hrs;kept pt awake w/pain next day inflammed, indurated & warmth-tender above elbow to shoulder;poss herpes simple
Cold; Psoriasis flare-up; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), PSORIASIS (Psoriasis flare-up) and PAIN IN EXTREMITY (Pain in arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and PSORIASIS (Psoriasis flare-up). At the time of the report, NASOPHARYNGITIS (Cold) and PAIN IN EXTREMITY (Pain in arm) outcome was unknown and PSORIASIS (Psoriasis flare-up) had not resolved.            The patient experienced sore arm after second moderna vaccine shot. Skyrizi lost strength after six weeks and patient had break out on various places on the body. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Swelling at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling at the site of injection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swelling at the site of injection). At the time of the report, INJECTION SITE SWELLING (Swelling at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and Concomitant medicines were not included  Action taken with mRNA-1273 in response to the event was unknown
Shortness of breathe; Oxygen saturation at 96 since vaccine; Drops in blood pressure; Severe stomach pain; Loss of appetite; Intermittent fevers of 100-101 F; Chills; Severe body and muscular ache; Severe body and muscular ache; Persistent headache; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 30Mar2021 at 10:00 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included congenital heart disease, PCOS, hemiplegic migraine, undiagnosed autoimmune disease (similar to Lupus/Hashimotos) and endometriosis. Concomitant medications included atomoxetine hydrochloride (STRATTERA), metoprolol (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), probiotics (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all from unknown date for unspecified indication. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 10Mar2021(at the age of 32-year-old) as a single dose for COVID-19 immunisation and Iodine on unknown date for unspecified indication and experienced iodine allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 11:00 the patient experienced Shortness of breathe and oxygen saturation at 96, drops in blood pressure, severe stomach pain, loss of appetite, intermittent fevers of 100-101 F, chills, severe body and muscular ache, persistent headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events shortness of breathe and oxygen saturation at 96, drops in blood pressure, severe stomach pain, loss of appetite, intermittent fevers of 100-101 F, chills, severe body and muscular ache, persistent headache were not resolved.   No follow-up attempts are needed. No further information is expected.
rash at injection site, much milder than reaction to first vaccine but still noticeable. I saw Dr following the first injection but not this one.
A 3 month old with sudden onset of afebrile seizure, lasting 10 minutes. Dx: generalized seizures.
FEW MINUTES AFTER VACCINE GIVEN, LAST 3 FINGERS IN VACCINATED ARM HAD INCREASED STIFFNESS, PATIENT REPORTS RA HISTORY AND ALREADY HAS STIFFNESS/JOINT PAIN. RESOLVED WITHIN MINUTES OF BEING TAKEN TO OBS VIA WHEELCHAIR. PATIENT AND SPOUSE ESCORTED TO EXIT WITHOUT ISSUES AT 1030. 1010 INITIAL BP 143/105 HR 75 RR 22 SATS 98%; PATIENT STATES BP INCREASES AT TIMES WITH ANXIETY AT TIMES 1020 BP 143/84 HR 72 RR 20 SATS 99%
mild headache since day after vaccine to present-helped some with tylenol  mild increase in usual seasonal allergies- sinus congestion
Initial symptoms after administration was low level soreness, localized to injection site on right arm and dissipated after 2 days. Delayed onset rash appeared 7 days after injection. Rash began about 2 inches in diameter, characterized with redness, itchiness and warmth. Area was slightly raised/swollen and firm to the touch. Over the next two days (8-9 days after injection) rash grew to about 4 inches in diameter, redness and itch was present but dissipating slowly. Appears likely to resolve within the next couple days. Treatment included OTC hydrocortisone cream, applied once the first day rash appeared. No other treatments were used.
COVID-19. First symptoms probably 2/28/22. Headache, tired. On 3/1 sore throat, cough, fever about 100 degrees, exhaustion, chills, sweats. Tested positive with antigen test 3/2 (I believe). Spoke to my internist on 3/1 as my spouse had tested positive. Discussed medicating with Paxlovid if I did have C)VID-19. Spoke to doctor's nurse on 3/4 (?) and was notified of prescription which I began taking on 3/4. Symptoms started to improve after three or 4 days. Note,
first dose more than six months ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  Previously administered products included Shingrix (received 1st dose on 17th October 2019, batch no 5k99).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. This case was for few patients who received their first dose of Shingrix more than six months ago. Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow-up for the other patient. This case had been linked with case US2021208838, reported by the same reporter.
Chills; Headache; Sore arm pain; This is a spontaneous report from a contactable pharmacist. An adult non-pregnant female patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Feb2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On an unknown date in Feb2021, the patient experienced chills, headache and sore arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of the events chills, headache and sore arm pain were recovered on an unknown date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Was administered w/out patient's knowledge or prior consent the "Fluzone High Dose" seasonal flu vaccine instead of a regular flu vaccine, resulting in: -High fever w/ extreme perspiring -Severe vomiting -Diarrhea -Some "shakiness" -Inability to get into any comfortable position.
Patient has not suffered any reaction form vaccine. Patient is going to come back for pediatric doses of Hep A and Hep B.
Developed intractable apnea and bradycardia; poor color and lethargy; patient required intubation for respiratory support; evaluated for sepsis and started on antibiotics; cultures including blood, urine and CSF all negative.
07Nov96 pt recv 1 dose vax. 20Feb98 pt devel approx 20-25 small papule-like lesions. 50 percent had vesicles or crusts.
Light-headedness, dizziness, nausea, chills in extremities, feverishness, hot spots on arms and other body areas, later on under the blanket sweating.
Tdap administered in left deltoid at 5:10 pm. 20 minutes after injection patient complained of mild lightheaded and mild tingling to volar aspect of left hand.
approx 3 mins p/vax pt turned very pale & limp; VS remained stable & maintained consciousness; legs were elevated & p/approx 3-5 mins some color returned; circumoral cyanosis noted approx 15 mins p/inject;
Injection site soreness starting approximately 2 hours after injection. Still happening now  Moderate Fatigue the following morning still happening now.    Moderate Headache starting  the next morning still happening now   Severe Joint pain over entire body started approximately  24 hours after vaccination, lasting until now.   Moderate chills/feeling feverish started approximately  24 hours after vaccination. Still happening now.   Moderate Left arm weakness, grip weakness left hand
Numbness on entire right side of face/head for three days. No drooping of face. No stroke symptoms. Went away spontaneously after 3 days. Was going to go to a doctors appointment but symptoms resolved the day before I was going to go.
pt recv 1st vax; 48 hr later,exp sore arm & devel hives & rash;to MD;recv 2nd dose;p/ 3rd dose,exp stomach cramps;lab eval 20jan94 revealed anti HBs less than 10;recovered by dec94 but cont to verbalize inaccurate vax incidents;