chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive with COVID PCR tests; tested positive with COVID PCR tests; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient (pharmacist colleague) received the first does of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EJ1685, Expiration Date: Mar2021), via an unspecified route of administration at site of left arm at 11:45 on 27Dec2020 at single dose for covid-19 immunization. Medical history included was none. There were no concomitant medications. There were no other vaccinations given recently, or no new medications. The patient experienced tested positive with COVID PCR tests on 28Dec2020 (also reported 24 hours - 48 hours after getting the vaccine). Clinical: After the first dose of vaccination, the patient had no symptoms, she had been routinely screened prior and was negative, then tested positive 24 hours after receiving vaccination on 29Dec2020. they did another one on 29Dec2020 and on 30Dec2020 that were negative. Event was assessed as non-serious since patient had no symptoms. After the second dose, the patient did not test positive, and after the second one they did a little study. The patient underwent another lab tests and procedures which included CT value: 24 on 28Dec2020.; Sender's Comments: Based on the current available information, Drug ineffective and COVID-19 PCR test positive are unlikely related to BNT162B2 vaccine.  The event occurred two day after vaccination, when vaccine was not expected to achieve the effect.   The case will be reassessed if additional information becomes available.
Fatigue, extremely painful arm where shot was given,  and significant muscle aches and pains throughout body,
2 weeks after covid 19 vaccine pt presented with right sided facial droop which started on 11/5  treated for bels palsy Prior to that patient reporting non-painful pruritic rash over her mid chest (noted on 11/3) and two day later pruritic lesion over her nose. On the 11/7 patient took part in a local marathon and as she reach the 18th mile she noticed HA, dizziness and pressure like chest pain which appeared to resolved with rest.
Chills, fever (100.4), fatigue, headache, slight stomach queasiness, body aches, swollen fingers, decreased appetite Took anti-paretics (three doses) t/o next day. Symptoms resolved in just over 24 hours.
Hives/itch on whole body, swelling in hands, feet, lips.  Began ~10 days after injection.  Treatment was two 6-day courses of Prednisone, zyrtec, allegra, benadryl.  Hives mostly resolved at 8 weeks, continued dermatographia.
RN administered expired Typhoid vaccine - vaccine expiration date: 11/2/2023; vaccine administration date 11/6/2023; No adverse effect noted by patient as of 11/7/2023; Patient informed via phone call regarding need to revaccinate patient for Typhoid
Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning an approximately 20 weeks months of gestation fetus, whose mother was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported) on approximately 12-OCT-2010, one month prior to conception (Previously reported in WAES#: 1104USA02227). Physician reported that on an unknown date a serum alpha-fetoprotein test (AFP) screening was performed and it was abnormal, and that on 15-APR-2011, an ultrasound of the fetus showed hypoplastic right heart and open neural tube encephalophy. At the time of the report, the patient's outcome was unknown. Hypoplastic right heart and open neural tube encephalophy were considered to be congenital anomalies by the physician. This is one of several reports from the same source. Additional information has been requested.
Large local reaction to flu vaccine left deltoid - slight warm to touch - scant elevated pink swelling to elbow - swelling to axilla and upper chest pink blotchy rash along (L) clavicle.
Right upper outer thigh with hot 3-4 cm hard lump with two visible near papules.
Patient given a 12+ years Pfizer COVID-19 vaccine instead of the authorized 5-11 years Pfizer COVID-19 vaccine.  Parents notified via letter 3/23/2023.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 19Oct2021 as dose number unknown,single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had been testing negative on antigen tests since day 4 on Paxlovid; Positive, notes: testing positive 3 days after finishing the Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a patient who was administered their first ROTATEQ dose at 16 weeks; This spontaneous report was received from a registered nurse and refers to a 16-week-old infant patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-MAR-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (product administered to patient of inappropriate age).
dizzy; had a headache; his arm and legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), HEADACHE (had a headache) and PAIN IN EXTREMITY (his arm and legs hurt) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 06-Apr-2021, the patient experienced DIZZINESS (dizzy), HEADACHE (had a headache) and PAIN IN EXTREMITY (his arm and legs hurt). At the time of the report, DIZZINESS (dizzy) and HEADACHE (had a headache) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NO concomitant medications provided No treatment information provided   Reporter did not allow further contact
Felt fine for the first week. Exactly one week after receiving my first Pfizer vaccine I suffered from brain fog most of the day. Then I began to notice some very mild chest pain, a mild ache. The ache comes and goes but I am now constantly short of breath and fatigued. My arms ache also and feel tingly (pins and needles) as if they don't have enough blood flow throughout the day.  I also occasionally feel like my heart is pounding and my breathing is purposeful or forced. I have a dry cough but it is rarely noticeable. I made an effort to get plenty of sleep and stay hydrated with no resolve. I cannot take long walks, read aloud for a long period or do much of anything without wanting to sit down and rest.  Since the symptoms have not gone away and seem to even be getting worse, I decided to seek treatment. I went to the Urgent Care on Thursday, Oct. 21. I had blood work and EKG and a chest x-ray. the chest x-ray showed cloudy/ inflammation looking according to the doctor. He prescribed prednisone for the inflammation. Tomorrow is my last dose of prednisone and I can only feel minimal improvement. I plan to go back to the Urgent Care for follow up. I still need to get my 2nd vaccine and have been trying to clear this up and finish medication first.   My persisting symptoms are those of possibly pericarditis or myocarditis. The doctor told me I could get the vaccine even if I tested positive ( I did test negative at the Urgent Care visit). Or even while on Prednisone. I am still waiting to get my second vaccine as prednisone can compromise the immune system and I understand the second vaccine is stronger.
Itching to trunk and all 4 extremities 3 hours after flu shot administration. No angioedema, no visible rash, lung clean pulse ox 98%.
This spontaneous report as received from a registered nurse refers to a 5 year old patient (gender was not reported). On 31-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Severe pain after injection.  Few minutes later severly dizzy and disoriented.  Blurred, splotchy vision.  Still have pain in arm to which it was administered
Hives; Itchy; Redness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L2019) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not reported).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness). The patient was treated with HYDROCORTISONE (topical) for Itchy, at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives), PRURITUS (Itchy) and ERYTHEMA (Redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: Follow-up received on 12-FEB-2021.Patient demographics, Vaccine information which includes date of first dose, batch number, Route of administration were added.Treatment information and new events which includes Itchiness, Redness were added.
Patient felt light headed and was assisted to the floor by the staff with elevated legs. EMS was called and patient taken to Hospital.
Mom noticed a cluster of hives greater than size of 1/2 of deck of cards on inner thigh, opposite leg from where Rec'd injection. When child became warm noticed hives on face greater than the size of a quarter. Also small hive by eye. Hive on leg gone when noticed face.
Moderna COVID-19 Baccine EUA  Unable to fall asleep from 9PM-12PM, slept for 3 hours, awake for rest of night and all of the following day. Second night was normal. No pain but felt wide awake and alert. Almost like I had a small dose of adrenaline. No high or nervousness. Quite normal except for the fact that it wasn't daytime! Check online and saw that Pfizer had sleeplessness as a side effect but not Moderna. It was not an "adverse" event for me...rather fascinating since I've never had anything like that before.
No additional AEs; Caller reported expired dose of vaccine administered; This spontaneous report as received from a nurse refers to an unspecified patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-JAN-2022, the patient was vaccinated with a dose of expired varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 ml subcutaneously, lot # T002848, expiration date 23-JAN-2022 (site of vaccination was not provided) for prophylaxis (Expired product administered). No additional adverse events reported (No adverse event).
Muscle pain, shoulders, arms, hips, totally debilitating, started right after immunization and gotten progressively worse, diagnosed with PMR on 11/9/18.
NECK PAIN; RIGHT ARM PAIN; This spontaneous report received from a parent concerned a 31 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included patient have no known allergies, the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced neck pain. On 11-APR-2021, the subject experienced right arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neck pain, and right arm pain. This report was non-serious.
MMR given 2/27/07 child developed rash 3/7/07 on feet and legs, then hands. Examined in our clinic 3/8/07 with rash on erythema multiform.
is currently pregnant; This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number LZ4N2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Fluarix Quadrivalent 2020-2021 season at an unknown time during the pregnancy. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The case was reported by patient herself who was also the physician. The patient received a dose of Fluarix during pregnancy, which led to vaccine exposure during pregnancy. The patient was not sure whether the dose given was expired or not and wanted to confirm for the season of the dose she received. The dose was confirmed as 2020-2021 and the patient was currently pregnant wanted to know if she could receive a second dose. Since no information was available patient did not confirm she would get another dose of the Fluarix vaccine.
Injection site erythema; tested positive for COVID-19; COVID-19 symptoms; A spontaneous report was received from a physician who was a 67 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Covid-19 symptoms, injection site erythema, and tested positive for Covid-19.    The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 039K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   The physician called to report that he received his first dose of Moderna Covid-19 vaccine on 26 Dec 2020. On 31 Dec 2020, he developed Covid-19 symptoms (unspecified) and tested positive for Covid-19 on 04 Jan 2021. He stated that after developed Covid-19 symptoms, he also developed a 3-5cm ring of erythema at the injection site. The patient provided that he did not have any reaction or tenderness at the injection site on the day of vaccination. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not provided/unknown.   The outcome of the events, Covid-19 symptoms, injection site erythema, and tested positive for Covid-19 were unknown/not reported.  The reporter did not provide causality for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the events of COVID-19 and SAR-COV-2  test positive. The event of COVID-19 and SAR-COV-2 test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
This spontaneous report as received from a pharmacist via publicist representative refers to a female patient in her 60's. On an unknown date, the patient was vaccinated with ZOSTAVAX 0.65 ml, one time, subcutaneous. On an unknown date, the patient experienced redness and swelling at the injection site in an unspecified arm shortly after receiving ZOSTAVAX. The redness lasted more than a few days. The outcome of injection site redness and injection site swelling was reported as not recovered/not resolved. Additional information has been requested.
pt recv vax; exp ear infection which resulted in a loss of equilibrium or inner ear disturbance; at time of rpt,sx persisted;pt did not feel exp was disabling;
Pts mom states that child has fluid filled blisters appearing all over body. Confirmed by hospital staff. Started 10/30/06.
Patient was out of the age range for the Moderna Emergency use vaccine. She is 12 years old.
1st time shortness of breath , maybe related to medication and after a week , my chest felt heavy and got steroid inhaler and 25 and 27AUG2021 for covid testing. that was negative and take the inhaler. Went to ER on 30 AUG2021. 8 weeks for healing for my lung to come back to normal. I missed 10 days of work.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. Patient's pertinent medical history was not known. It was reported that the patient had no drug reactions or allergies. On 17-OCT-2016, the patient was vaccinated with ZOSTAVAX (lot # M003486, expiry date: 27-MAR-2017), subcutaneously (dosing regimen unspecified). Concomitant therapies included gabapentin (manufacturer unknown), baclofen (manufacturer unknown), morphine sulfate (manufacturer unknown), oxycodone (manufacturer unknown) and AMBIEN. On 17-OCT-2016, the patient experienced redness at the injection site following vaccination with ZOSTAVAX. It was reported that the redness extended "high up on the arm". On 18-OCT-2016, the patient developed "blisters in a cluster in an area that was about 3 inches round". On an unknown date, the patient reported that her arm was "hot to the touch". The pharmacist requested for a lot check for the lot number provided. At the time of this report, the patient did not recover from the events of injection site erythema, skin warm and injection site vesicles. Causality assessment was not provided by the reporter. Additional information has been requested.
Pt phoned on 10/2/2017 to state she had a hard lump and a 2 x 3 inch itchy red spot on her arm. She hadn't noticed it until this day and that is why she called.
pt c/o itchy eye & ears, throat; pt has had hx of this problems;
Vomiting  around 8am 6/3 and 3am 6/4
Symptoms on my right arm big rash around the injection site and hot and itchiness is still occurring
Two days after immunization left deltoid area became red, hot and swollen. (12/19/02)
- Injection site pain (burning, stinging) immediately after shot that dissipated within a few minutes, followed by arm soreness that lasted approx. 3 days. -Fatigue late afternoon followed by chills beginning 6-7 hours after injection. Chills became more severe (uncontrollable) as the night progressed and affected the whole body.  Layered clothing and blankets, and was still shaking. -Approx. 8 hours after injection, developed a low grade fever (99.9) which progressed into a high grade fever (101.2) by late night. Fever continued overnight, breaking at about 11 am the following day. No medication was taken for the fever. -Overnight experienced join pain and muscle aches, and developed a migraine headache with nausea. Experienced heart racing/rapid pulse and could feel /hear pulsing and whooshing noise in my ears. Was unable to sleep. Muscle and join pain continued and was noticeable for about two days post vaccine. Migraine became a mild headache by mid morning. About 6 pm took a Bayer Back and Body for the lingering joint/muscle/headache issue (24+ after vaccine).  -Loss of appetite first few days post vaccine. -Feeling of brain fog, difficulty concentrating, very noticeable during first two weeks. -For two and half weeks following the vaccine, felt bouts of fatigue, muscle aches and joint pain, and occasional whooshing noise in my ears.
Face swelling; Face red; Face itchy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swelling), ERYTHEMA (Face red) and PRURITUS (Face itchy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Face swelling), ERYTHEMA (Face red) and PRURITUS (Face itchy). At the time of the report, SWELLING FACE (Face swelling), ERYTHEMA (Face red) and PRURITUS (Face itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.
Experience severe tachycardia with lethargy, weight loss, intractable nausea and vomiting. Spent a total of 10 day in the hospital. Admitted twice each time was a 5 day stay. Also, had 2 ER visits.  Multiple tests were run. I ultimately ended up with an NG tube to supply nutrition as I was malnourished and lost 12 lbs resulting in me weighing only 102 lbs. I still have the NG tube and am on my 3rd month of sickness. I developed a positive ANA lab test and my IGE was elevated.
In about  less than 1 week after 2nd shot I developed palpitations. I never had a single one before. Now it happens everyday and sometimes several times a day. some are so severe that I have to immediately lay down because otherwise I will  fall. Some days it is more related when I walk but some days even when I quietly sit and read.
Was seen approx. 1 hour after initial injection. States approximately 20 minutes after injection began feeling "funny" sensation in throat, generalized itching to entire body. No redness or hives noted, no redness, irritation or hives at injection site. Was able to speak clear complete sentences, no change in LOC. Denies allergies or issues with flu shots in the past. Was sent immediately to ED for further eval. States received oral BENADRYL and symptoms resolved. No lasting symptoms since then.
Initial information received on 18-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years old patient who was vaccinated with a 0.25 ml dose of vaccine FLUZONE QUADRIVALENT (lot UT6259LA and Exp. Date 30-JUN-2019) via unknown route in the left thigh on 17-Dec-2018. The patient's medical history not reported. No other vaccines were given to patient. It was an actual medication error case due to vaccine underdose. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.