chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 04-FEB-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J008433 and expiry date: 11-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall support ranged of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
My arm - in the area below the injection side has become red, and warm. It has been consistent now for at least 24 hours. A large red circle approx. 4 inches across.
Covid infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Lot number: FK5618) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 26Nov2021, outcome "not recovered", described as "Covid infection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19. Additional information: Facility where the most recent COVID-19 vaccine was administered: School or Student Health Clinic. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. AE resulted in: None of the above. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:Yes.
Systemic: other-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Additional Details: pt presents to the pharmacy around 12pm for the second dose of pfizer ,I asked pt if he is feeling ok today and any side effect from the 1 st dose, pt said he is fine and no symptoms from the previous shot, but pt presents a little pale and anxious. After giving the shot, I told the pt to stay on seat for 15 minutes, recommend him to take acetominophen after lunch if he starts to feel headache or flu like symptoms . After 10 minutes , pt starts to have nausea and vomit , no other sympt
Shot 1 - arm pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 24Mar2021 16:45 (Lot number: ER8732) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Shot 1 - arm pain at injection site".  Additional information: Patient has not been administered any other vaccines prior to 4 weeks and  patient has not been tested for COVID in post vaccination and patient took other medications in two weeks included Clopidogrel, Amlodipine, Simvastatin, Alprazolam.  No follow-up attempts are possible. No further information is expected.
experiencing pain in her back where kidneys; fatigued/extreme fatigue; dry cough; diarrhea; aches/pains/aches and pains around her body; severe pain in injection arm; injection site very painful; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. She reported that the evening of her first dose, she experienced severe pain in injection arm on 06Jan2021. She stated that night injection site very painful. She had to take Tylenol Extra Strength overnight. She stated that she woke up and she was fine. On 09Jan2021, she reported feeling fatigued, dry cough, extreme fatigue, diarrhea, aches/pains, and aches and pains around her body, but no fever. She woke up this morning on 11Jan2021, experiencing pain in her back where kidneys, still fatigued but no fever. She has taken the Covid test and does not have the results. She wanted to know if these are side effects of the vaccine or is this potentially the Covid virus. The events were assessed non-serious. The outcome of severe pain in injection arm, injection site very painful was recovered, of fatigued was not recovered, of other events were unknown.  Information on the lot/batch number has been requested.
This spontaneous report was received from a doctor of pharmacy and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 04-OCT-2015, the patient was inadvertently administered with two doses of ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
No additional AE/PQC.; HCP calling to report a child was inadvertently given an expired dose of PROQUAD.; This spontaneous report was received from a medical assistant and refers to a child patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with an expired dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) diluted in sterile diluent (STERILE DILUENT) solution for injection/infusion, 0.5 milliliter (strength, lot #, expiry date, route of administration, and indication were not provided). The vaccine had no previous temperature excursion. No additional information or adverse events were reported.
fever, pain, swellling, warm not hard abscess rt deltoid, abscess formation, drained spontaneously, BP measured, surgery on rt arm 2MAR92 & 4JUN92;
3/30/2021 8:45 PM - fever 99.7, chills, body aches 3/31/2021 1:00 AM - fever 100, chills, body aches, headache, sore throat, parched 3/31/2021 7:30 AM - fever 99, chills, body aches, headache, sore throat, parched, pain in all joints.  Severe right knee pain - could not put pressure on it.  Had to use a cane to walk.  Chills and headache throughout the day. 4/1/2021 AM - woke up with headache and sore throat.  After treatment, relief by 8:30 AM.  Can now walk without cane. April 2021 - on an off symptoms throughout month of joint pain and fatigued by early evening. May 2021 - on and off joint pain continues.  Labs done on May 3 had unusual results, especially with A1C.  Doctor says they are seeing odd labs recently, so not concerned.  Will repeat in 4 months.  Wondering if inflammation response from vaccine is causing unusual labs. May 20, 2021 - had labs done 2 weeks later for an insurance exam, and my numbers were better, including A1C. June - August 2021 - continue to have on an off joint pain and fatigue.
I was told by the pharmacist that whatever side effects I had from my second shot would likely be the same for my booster, so that?s what I was expecting: extreme fatigue, chills and body aches. The majority of my symptoms began 24 hours after the booster. I wasn?t feeling well when I woke up the morning after but still went to work. By 10a I was feeling unwell enough that I had to leave and come home. I was very fatigued, achy, and my eyes burned like when you have the flu. By 5p I was exponentially worse. I had nausea and could barely get my evening pills down. The lymph nodes in my armpits, neck and inguinal region were very tender, nothing like I?ve ever experienced before in past illnesses. I ached from my toenails to the hair on my head. I took my temperature and it was 98.3, normal by medical standards though I usually run 96-97. By 8p I was vomiting and kept that up until I went to bed about 11p. I was so miserable I didn?t even have the energy to cry about it. At 2p I woke up with heart palpitations, I think, brought on by dehydration. I had completely soaked the sheets and pillow with sweat. I contemplated going to the ER to get rehydrated (I avoid hospitals and doctors so to even entertain this idea is a testament to my misery), but remembered it would cost me my deductible, so I laid back in bed, chilling in the sweat-soaked sheets waiting for the grim reaper. By 3a I suddenly turned the corner and felt maybe I might survive this. I didn?t ache as bad and could hold down sips of water. By 8a (Saturday) I was eating toast and by 7p collecting my sister from the airport. Back to 85% on Sunday and 100% on Tuesday. What a ride that was, but can?t say I regret getting the booster. I?m convinced now I?d die for sure if I caught Covid.
A legal complaint was received from an attorney regarding an adult male. The plaintiff's history includes exposure to asbestos and asbestos-containing products. According to the legal complaint, sometime in the 1950's or 1960's, the plaintiff was administered OPV or IPV. In October 2001, the plaintiff was reportedly diagnosed with mesothelioma. The legal complaint states that the plaintiff's exposure to asbestos, asbestos-containing products, and the SV40 virus caused severe and permanent injury to the plaintiff including, but not limited to breathing difficulties, asbestosis, lung and/or other cancer, mesothelioma, and/or other lung damage. The legal complaint states that the plaintiff stopped working on 11/23/01 due to his mesothelioma.
Second dose has not be received; blisters on their gums, inside their top and bottom lip, and on the inside of both cheeks; Blisters were very painful; Blisters were red; This case was reported by a consumer via call center representative and described the occurrence of blistering of mouth in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2021, several hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced blistering of mouth, pain and erythema. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the blistering of mouth, pain and erythema were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the blistering of mouth, pain and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and few hours later experienced blisters in mouth, on gums, in upper and lower lips and inside both cheeks which were very painful and red. Blisters were recovered in 2 days. The patient did not receive second dose yet, which led to incomplete course of vaccination. Consent to follow up was granted.
Same day post vax, pt developed inconsolable, high-pitched crying lasting for 3 days.
NOT FEELING LIKE MYSELF; BACK ACHES; CONSTANT HEADACHE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. On an unspecified date, the patient experienced not feeling like myself, constant headache, and back aches (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. 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 patient experienced not feeling like myself, constant headache, and back aches (Dose number in series 2). As per reporter "From I took the COVID shots I'm not  feeling like myself. I have this constant headache and back aches." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the not feeling like myself, constant headache and back aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20220932895.
BODY TWITCHING; HEADACHE; CHILLS; BODY ACHE; UPSET STOMACH; This spontaneous report received from a patient concerned a 65 year old female. 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 the patient had no known drug or non drug allergy. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and 1805018 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced chills. On 12-MAR-2021, the subject experienced body ache. On 12-MAR-2021, the subject experienced upset stomach. On 13-MAR-2021, the subject experienced body twitching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and upset stomach on 13-MAR-2021, and had not recovered from headache, body ache, and body twitching. This report was non-serious.
This spontaneous report as received from a medical assistant refers to a 12 year old patient of unknown gender. On 13-FEB-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L027282 with expiration date 21-SEP-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
2 wks p/inj pt exp periodic joint discomfort in knees, elbows, ankles-described as aching pain; this cont to present;
I felt nausea the day of and after the shot. On May 4, 2021 I noticed a small lump in my right arm (under the skin) that was painful to the touch and firm.
tremor in her left hand; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "tremor in her left hand"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "tremor in her left hand". The following information was reported: TREMOR (non-serious), outcome "unknown", described as "tremor in her left hand".  Additional information: Patient is a Registered Nurse and also a recipient of Pfizer Covid 19 vaccine shot and booster who had been watching the news for the past week and seeing people complaining about twitching from the vaccine. She is a nurse who works for a small pharmaceutical company who does drug discovery science, so she understands the background and is a complete supporter of the vaccine. She doesn't know if it's relevant but she got two boosters and the regular two shots since then she developed a tremor in her left hand for example she cannot eat a soup without falling off the spoon, her right arm is completely fine. She doesn't know if there's a real concern about tremor with the vaccine, but because she works in drug discovery she feels like it's important to have somebody who's reputable to talk about this. She thinks people are sensationalizing it in the media. She wanted to check if there are any studies or revealing a tremor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300017881 Same patient, drug and event, different dose;
SORE ARM AT INJECTION SITE. RESOLVED IN 2 DAYS Narrative:
child devel rash on 2oct95 following exposure to sister who recvd vax;
Pt recvd Engerix-B 16JUL92 had fine, rd, raised areas on trunk & back, under arms & around abdo area w/itching; seen by MD;
Starting with just 5 hours after the vaccine, I had a slight fever which reached up to 99.6F and began to have some nausea. I was able to eat, and I took Tylenol throughout the night, then had a fever the following morning of 99.9. Took more tylenol and was fatigued. Fever reached up to 100.3 during the day, took more Tylenol.  Just over 24 hours later, I noticed a large local injection site reaction on left arm where vaccine was administered. I felt it and it was a big bump on arm at injection site, intense pain and warmth at location.  This location had much inflammation and about 7cm in diameter for the lesion. I immediately started putting ice on the location for a few hours and also took some Advil.  I alternated with that and continued to take Tylenol and woke up during the night with a fever of 100.5, had night sweats. Woke up with a fever the next day again, but no more fever throughout the day after this. The lesion continued with pain at sight, and lesion has started to itch. It is 4 days after reaction appeared, and the inflammation and swollenness has now subsided. The location remains itchy, no more fever.
ITCHINESS; BODY RASH; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hives, and brown recluse spider bite. The patient was previously treated with diphenhydramine hydrochloride for hives, and dexamethasone for hives. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced headache. On 24-MAY-2021, the subject experienced itchiness. On 24-MAY-2021, the subject experienced body rash. Treatment medications (dates unspecified) included: dexamethasone, and diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache, and was recovering from itchiness, and body rash. This report was non-serious.
Patient received Pnenomax 23 vaccine on 8/28/2020. The expiration date on consent form said 8/2021. After giving pt the vaccine, I saw expiration date on actual syringes to be 8/12/2020. The patient stayed in store for approximately 30 mins to make sure he was ok. He was immediately informed and felt no adverse effects. I immediately called the manufacturer (Merck) on 8/28/2020. The manufacturer said that there were no recommendations for the patient to get evaluated by a healthcare provider. They recommend that I just wait until Monday for them to call me back to let me know if the patient should be revaccinated or not. They informed me that the patient is not in any immediate harm. On 8/29/2020, I called the patient to make sure he was ok. He stated he was fine and that he did not have any adverse effects. On 8/31/2020, Merck called us back and informed me that the vaccine was still potent enough because the manufacturer guarantees stability of it for approximately/month past the written expiration date. The vaccine was potent enough for the patient based on this information.
Was given 2nd shot March 22 and within 12 hours     I had what I would call shooting nerve pain on the level pain of shingles except it was everywhere. Next day I hurt all over.  Wednesday some recovered, Thursday I went to work. Friday I would have said I was 100% till 3:30pm.  I had adominal pain.  Went to ER  and was diagnoised with appendicitus.  Had surgery next morning.
Received expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. No information on treatment medications was reported.
Information has been received from a physician concerning a 30 day old female patient who on 21-MAY-2010 was vaccinated with a dose of ROTATEQ (Lot number 665272/0203Z). The physician stated that the infant received the first dose of ROTATEQ suspension too soon (on 21-MAY-2010). No adverse symptoms noted. The patient sought unspecified medical attention. Additional information has been requested.
About 45 minutes after receiving the 3 vaccines, he developed shaking chills, achiness across his back and legs, an episode of sweating and nausea, after which he vomited twice.  He had a very mild headache, and a tingling feeling in the head for a few seconds which resolved as the headache appeared.  The headache was mild and he said that he would not have sought treatment for this headache.
Hep B given 3/10/04. Outdated on 1/11/04. No adverse reaction.
flu; Initial information was received on 12-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210217000689).  This case involves an adult patient who experienced flu, while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
ON THE NIGHT OF INJECTION  PT. EXPERIENCED A SLIGHT FEVER. ON THE NEXT DAY HE WAS OK ACCORDING TO PARENT.