chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergies: Naproxen May cause hives". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 24Aug2023 till 28Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300291281 same patient, different product and event;
DIED; This spontaneous report received from a consumer via company representative via social media, concerned multiple patients(two male patients under 30 years old) of unspecified race and ethnicity. No past medical histories or concurrent conditions were reported. The patient's pre-existing medical conditions included: patients were healthy under 30 years old. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the multiple patients died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated, "Two friends died within several days after the vaccine. Both were healthy males under 30 years old I would rather be shamed for not getting the vaccine by shameful people than play the perverbial game of roulette". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220322018-COVID-19 VACCINE AD26.COV2.S-died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
patient called medical practice reporting a "rash and swelling at the injection site"; patient called medical practice reporting a "rash and swelling at the injection site"; This spontaneous report was received from an office manager, referring to a 43-year-old female patient. The patient's pertinent medical history, concomitant medication, concurrent conditions, previous drug reactions or allergies were unknown by the reporter.  On 25-SEP-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection for immunization, lot # S013490 expiration date not reported but upon internal validation established as 06-MAR-2021 (strength, frequency and route of administration were unknown by the reporter; anatomical injection site was not reported).   Afterwards, on an unspecified date in September 2019, the patient experienced rash and swelling at the injection site (injection site rash and injection site swelling). The patient sought medical attention, and an unspecified physician prescribed antibiotic cream (unspecified) and loratadine (CLARITIN) as treatment. It was unknown by the reporter if any laboratory diagnostics or studies were performed to the patient.   At the time of this report, the outcome of injection site rash and injection site swelling was unknown.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
approx 3 days post first injection, began experiencing constant hard heartbeats. Could hear and feel heart constantly. Additionally, I would experience random bouts of rapid heart beats. Would experience feeling tired simply by walking 20 feet.
Extreme pain, tightness and weakness all over, especially in arms, legs, back and face. Tingling sensation like goose bumps, headache, fever, chills, sore throat w/ painful swallowing, fatigue. Taking Ibuprofen and TYLENOL, warm bath, heating pad, rest. Have not seen doctor and symptoms persisting through 10/15/16 (today).
Intense brain fog started two hours after injection and lasted through bedtime; less intense brain fog has persisted; Lower back muscle pain started upon awakening five days after vaccination (Monday 3/8/21); today (Tuesday 3/9/21) lower back pain has practically immobilized me; I have no history of back pain and there was no other event that would be a likely cause
Took probiotic and experienced a drop in blood pressure; negative for COVID-19; Drop in blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (Drop in blood pressure), DRUG INTERACTION (Took probiotic and experienced a drop in blood pressure) and SARS-COV-2 TEST NEGATIVE (negative for COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced BLOOD PRESSURE DECREASED (Drop in blood pressure). On an unknown date, the patient experienced DRUG INTERACTION (Took probiotic and experienced a drop in blood pressure) and SARS-COV-2 TEST NEGATIVE (negative for COVID-19). At the time of the report, BLOOD PRESSURE DECREASED (Drop in blood pressure), DRUG INTERACTION (Took probiotic and experienced a drop in blood pressure) and SARS-COV-2 TEST NEGATIVE (negative for COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter  Treatment for the event included probiotics.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow-up information received on 08 JUN2021 contains Information:- even tab updated by changing event coding; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information is requested.
this past Saturday, she tested positive; This is a spontaneous report from a patient reported for herself. An 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202) via unknown route first dose on 10Mar2021, at an unknown dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the 1st dose covid vaccine on 10Mar2021. She has tested negative for covid infection every Saturday since then. However, this past Saturday (Mar2021), she tested positive. She is scheduled to receive the 2nd dose of the covid vaccine on 31Mar2021. Patient would like to know whether she can get the 2nd dose of the covid vaccine although she has tested positive for covid after the 1st dose. Patient would like to know if she still has to wait the isolation period (10 days) before returning for her second dose if she tests negative tomorrow. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Oct-2021 at 5:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter. Treatment information was not provided.
Initial - cough -> low grade fever and maculopapular rash (trunk and extremities). Tx - sxs watched and used APAP.
C/O NAUSEA. VOMITED ONCE. REMAINED NAUSEATED THROUGH 12/25/2010 AND DID NOT FEEL BETTER UNTIL 12/26/2010 UPON WAKING IN THE A.M.
Description: 19 year old male developed multiple symptoms after vaccination with SPV, JEV, and Flumist. Symptom: Epistaxis start: 11/07/2006. Comment: Reports an episode of 1.5hrs of bleeding on last week. One episode of 10 minutes on yesterday. Reports a problem of 'chronic nosebleeds' in the past and prior to vaccination. Symptom: Pain start: 11/07/2006. Comment: Reported pain in his neck and back since last week, helped by Tylenol. Symptom: Lymphadenopathy, axillary. Start: 11/07/2006. Comment: Very painful left axilla on last week; resolved now. Symptom: Fever. Start: 11/08/2006. Comment: Patient has felt feverish but his measured temps have been normal. Temp yesterday was 98-98.7F. Symptom: Chills. Start: 11/08/2006. Comment: Alternating with the previous fever. Symptom: Vomiting. Start:11/13/2006. Comment: X 1 episode with 'streaks' of blood. Symptom: Anorexia. Start: 11/07/2006. Comment: patient reports his appetite had been decreased by half for the past few days.
Injection done in bursa area of right arm, via drive through clinic. 4/8/21  Developed a dime size bump and then increased in size to quarter size and larger, red, large, hot inflamed area to the right of injection site.  Weakness in right arm, pain radiating to finger, constant throbbing pain, red inflamed hot area on right arm increased 3 days after injection. Family dr stated covid arm- prescribed prednisone dose 4/14/21, tapered, after completion arm weakness, pain, constant, radiating.
Initial and follow up information has been received from a pharmacist, concerning a 16 year old female patient with no pertinent medical history, who on 13-APR-2007, approximately 9:30am, was vaccinated IM in the right deltoid, with the first dose, 0.5ml, of GARDASIL (Lot #654885/1424F). There was no concomitant medication. It was unknown if there was any illness at the time of vaccination. On 15-APR-2007 the patient developed a full body rash. The pharmacist described the rash as not itchy but red, and noted it was located on the patient's chest, legs, arms and back. Treatment included BENADRYL, with a MEDROL DOSE PAK also prescribed. At the time of this report, the pharmacist confirmed the patient was recovering from the rash. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. At the time of this report, the pharmacyst confirmed the patient had recovered (date an duration not specified). No further information is expected.
INJECTION SITE REACTION. PT HAS SLIGHT REDNESS AND SWELLING AROUND INJECTION SITE. SAYS IT FEELS LIKE HER ENTIRE ARM IS "LUMPY". PT HAS NOT ICED AREA OR TAKEN ANY PAIN MEDICATION SO ADVISED PT TO DO SO. PT DOES NOT WANT TO CALL DOCTOR
Information regarding Prevnar was received from a consumer regarding a 15 month old male patient who inadvertently received a fifth dose of Prevnar instead of MMR vaccine along with the fourth dose of DTap (manufacturer unknown) on 26 Jan 2007 and experienced mild fever and diarrhea. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 26 Jan 2007. Additional suspect vaccine included Dtap. Concomitant medications were not reported. Event Details: on 26 Jan 2007, the patient inadvertently received a fifth dose of Prevnar (accidental overdose) (incorrect dose administered) instead of MMR vaccine (wrong drug administered) along with another childhood vaccine. On 27 2007, the child developed a mild fever (pyrexia). It was unknown if the patient recovered from the pyrexia. On 28 Jan 2007, the patient experienced diarrhea. As of 31 Jan 2007, the patient had not recovered from the diarrhea. The consumer noted that the physician informed her that the diarrhea is "not but to the Prevnar." No additional information was available at the time of this report. Information regarding PREVNAR was received from a consumer regarding a 15-monthold male patient who inadvertently received a fifth dose of PREVNAR instead of MMR vaccine along with the fourth dose of DTAP vaccine (manufacturer unknown) and experienced mild fever and diarrhea. On 26-Jan-2007, the patient inadvertently received a fifth dose of PREVNAR instead of MMR vaccine along with another childhood vaccine. On 27-Jan-7, the child developed a mild fever. It was unknown if the patient recovered from the pyresia. On 28-Jan-2007, the patient experienced diarrhea. As of 31-Jan-2007, the patient had not recovered from the diarrhea. The consumer noted that the physician informed her that the diarrhea is "not due to the PREVNAR". No additional information was available at the time of this report.
Tinkling, like being pricked with needles, under my left ear, jawbone area.  Felt a lump & swelling at this location.  Very tender to touch. Swelling & lump went down in size the following day, Sunday  (first notice Saturday night).
Slight fever within hours of shot.  On day 2 I was unable to move my back and could not stand up like my back and legs seized and on day 3 my neck was stiff and could not move it. Visit to my GP who immediately put me on muscle relaxers and is keeping me out on short term disability until symptoms go away.
Received first Pfizer dose on august 13th, 2021. Three days later my tongue started to feel numb and tingly. The next day my calves and left forearm became numb and tingly. The sensation has improved but it is still there.
The last 7 days I have had muscle cramp in lower leg.  (calf muscle/shin) mostly right leg but at least once in middle of night , every night 7 days straight. So started 16 days  after shot. I want to know how to stop it or if I should not get a 2nd shot. Not low on Potassium. Never had  more than one night  and not recently before shot.  Is this related?? I don't know. --Did have injection in both knees for joint arthritis less than a week before it started.
Dizziness tingling and subjective throat swelling Narrative:  only taken to ER on account of employee health closed
infection on the injection site; redness on the injection site; sometimes painful; inflamed; annoying; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFECTION (infection on the injection site), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE PAIN (sometimes painful), VACCINATION SITE INFLAMMATION (inflamed) and ADMINISTRATION SITE IRRITATION (annoying) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure and Gout.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFECTION (infection on the injection site), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE PAIN (sometimes painful), VACCINATION SITE INFLAMMATION (inflamed) and ADMINISTRATION SITE IRRITATION (annoying). At the time of the report, VACCINATION SITE INFECTION (infection on the injection site), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE PAIN (sometimes painful), VACCINATION SITE INFLAMMATION (inflamed) and ADMINISTRATION SITE IRRITATION (annoying) outcome was unknown. Not Provided      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.; Sender'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.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: PT INFORMED ME THAT SHE HAD BEEN TAKEN TO ER AFTER BOTH DOSES BUT THEY ONLY GAVE HER IV FLUIDS. I TIRED TO TALK TO THE PT OUT OF GETTING THE VACCINE BECAUSE OF PREVIOUS ISSUES WITH VACCINE BUT SHE INSISTED. 911 WAS CALLED AND SHE REFUSED TO GO TO THE HOSPITAL, HER VITALS WERE NORMAL. HER DAUGHTER IRISE TOOK HER HOME.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on 30-JUN-2014 (administration between "yesterday and today") unspecified number of patients might have received an unspecified number of doses of PNEUMOVAX23 single dose vial (SDV) 0.5 ml once (route, lot number and expiration date not reported that were improperly stored at 31F for 24 hours. No adverse effects reported. Additional information has been requested.
Pt. complains of pain/soreness in left arm in area below site of injection. There is some swelling and redness. Pt. states swelling and redness only began today. Area of redness is approx. 1" x 2".
Within 4 hours I started spotting (vaginal) and by the next morning, my period came (6 days early) incredibly intense. Severe cramping, heavy bleeding, back aches. Also, both breasts are very sore/tender and swollen.
A report has been received from a Health Professional concerning a 3 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. Medical assistant reported that they inadvertently gave expired FLUMIST QUADRIVALENT on 15-Jan-2014. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Headache last night, body aches and chills this morning - reviewed online sources and indicates not a "typical" reaction.  Not really concerned but thought I should report
Red circle about 3 inches wide and 3 inches long bruising itching, swelling, dizzy headache
Severe headache like an ice pick into the side of my head, starting the day after second injection.  Lasting ever day for 8 days, duration 3-8 seconds of severe pain, then gone.  After 8 days the headaches were not as severe, normally occurring every other day, some times daily.  Still occurring.  Normally lasting 3-8 seconds. One day I had 15 headaches with a 3 minute period. Not high intensity, but enough to stop me walking across the room.
SICK; FEEL LIKE HIT BY A TRUCK; This spontaneous report received from the reporter via news article concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sick, and feel like hit by a truck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feel like hit by a truck and sick was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
3 days p/vax severe h/a occurred;h/a cont w/dizziness, confusion & disorientation;p/approx 8 days pt unable to walk for 2hr;pt was able to walk w/severe balance problems & falling;all of these sx lasted for 2 1/2mo;
Joint pain in both shoulders and elbows (arthralgia) muscle aches (myalgia) 26 year old female described joint pain in both shoulders and both elbows, left greater than right and mucscle aches on left side only. Noted to begin on 01/07/2004. She was seen by a physician on 01/16/2004, Upon exam at Occupational Health Clinic 01/16/2004, chest clear, BP 120/80, Heart RR, ext, no edema, small induration to left arm, 1-2cm in diameter, mild discomfort to bicipital tendons at both shoulder, NL exams of elbows, NL liver and spleen. As of 02/03/2004 all symptoms have resolved. Occupational Health Service on 01/23/2004 recommended Zyrtec or Claritin prior to next Anthrax vaccination. Patient had point tenderness to both shoulders over deltoid bursa-more on the left than the right, NL ROM, NL neuro exam.
Two weeks after receiving second does of Moderna I got hives on my elbows which started itching. Hydrocortisone cream dud not help. They then started spreading all over my upper arms, hands, back, legs, thighs, stomach, neck, pelvic and chest. I now have scars from scratching and I still get hive flare ups and itching. It's now Feb 22, 2022
5:00 am Woke after NIGHTMARE 8:00 am URGE TO VOMIT while driving  10:20 am TEARS-a couple episodes(reminded me of pre-menstrual emotions I had before hysterectomy)
Monday tried to get out of the bed and kept falling back.  I couldn't keep myself upright.  Went back to sleep.  Then  tried again and landed on the floor.  Couldn't get up by my hands so started crawling.  Finally was able to get up.  Then today I felt much better but if I got ahead of myself, I get exhausted.  Have had to cancel several activities.
Patient received vaccine Thursday, 09/23/21. Was able to go to work the next day on Friday 09/24/21 even though experiencing adverse reactions of headache, fatigue, dry mouth and a sore right arm. Later in day, during the evening hours, patient started to experience tingling or "pins and needles" in both feet. This has continued intermittently since the evening of 09/24/21 until present, when patient called vaccine provider,  Tingling sensation in feet  does not seem to the  patient to be worse or better if at rest or walking.
Patient got booster dose vs first dose (0.25mL vs 0.5mL).
Incorrect vaccine was given. PNEUMOVAX 23 was ordered, but PREVNAR 13 (second dose) was given in error.
Sudden onset approximately one hour after injection; shortness or breath.  12/2/08 Reviewed hospital medica records of 10/9-10/10/2008. FINAL DX: SOB w/emphysema Records consist of labs & only partial d/c notes but hospital medical records states this is all that is available.
Generalized maculo-papular rash. Temperature at MD's office 99.2, rectally.
Joint pain 10/10/19 6:00 pm Ankle swelling and pain 10/12/19 5:00 am
Systemic: Fainting / Unresponsive-Severe, Systemic: Hypotension-Medium, Additional Details: received at 12:15. advised to sit in chair or bench near pharmacy. he was up walking and fainted at 12:22. unresponsive for 15sec. bp 96/75 and pulse 75 after awake and sitting upright. ems called immediately and he left with them at 12:35.
Client received AstraZeneca COVID vaccine, no reaction. AstraZeneca vaccine unavailable in the , Janssen given as an alternative on 09/15/21.
At the site w/injection, patient noticed mild itchiness, some soreness, redness and swelling. It started 7 days after vaccine administration.