chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 06-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to three temperature excursions (dates unspecified): the first lasting for 80 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius), the second lasting for 144 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit(-1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Hives on injection site, itchy and red. About 2 inches wide and 3 inches tall. Started April 30 around 12:00am and is persisting until May 1 around 2:30pm
24 hours after HPV9 given pt. had a HA and vertigo, was fine the next 24 hours, then rash head to toe x 7d, faint itchy rash today and better after 2 doses of prednisone. Angioedema 3 days after immunizations.
Extreme arm pain in left arm beginning within 4 hours of getting vaccine. Extreme total body pain beginning within 24 hours of vaccine. Intensified menstrual cramps beginning within 30 hours of getting vaccine
Patient felt dizzy and light headed.  History of same with injections in the past.  VS WNL  O2 Sat 98%.  Patient brought to medical observation tent and observed for 20 mins.  Has not eaten since breakfast. Wife is taking him to lunch post injection.  All symptoms resolved and no transport indicated.
Patient was given HPV vaccine inadvertently. NP notified, patient examined upon discovery, no adverse signs or symptoms.
administration of ROTATEQ after temperature excursion; This spontaneous report was received from a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.  On 11-JAN-2021, the patient was vaccinated with improperly stored (after temperature excursion) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742457, expiration date was reported as 16-FEB-2022, but upon internal review was determined as 06-JAN-2022, 2 milliliter, administered orally for prophylaxis. Temperature was 1.3 Celsius degree (C) for 19 minutes. There was no previous temperature excursion. Data logger was involved.  This is one of several reports received from the same reporter.
Treatment of COVID-19; Treatment of COVID-19; Moderna, Date: 11Mar2021 / Pfizer, Date: 17Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Mar2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The patient had no known allergy.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Dec2021, outcome "unknown", described as "Moderna, Date: 11Mar2021 / Pfizer, Date: 17Dec2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 07Aug2023 to 11Aug2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a little headache; a little fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a little headache), PYREXIA (a little fever) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (a little headache), PYREXIA (a little fever) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (a little headache), PYREXIA (a little fever) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided
Fever 102.  Body aches.  Fevers, chills, nausea and vomiting.
pt got 2nd bivalent shot in less than 2 months and they shouldn't get more than 1
pt recvd vax on 28OCT93 & started breaking out in a rash on the following Sunday; rash became worse; broke out in hives on 1NOV93; went to ER;
10/30/07 8:30 pm Fluzone 0.5ml/IM administered. 10/31/07 0130 - Progressive headache, sniffles, sore throat and burning of eyes. Sclera and conjunctiva very red, moist with mild eyelid edema observed at 0645 am. Denies SOB or rash.
Breakthrough COVID-19 case with symptom onset 8/23/2021: Runny Nose/Congestion, Cough. Hospitalized on unknown date for unknown duration. Death 8/29/2021. From Vital Records COD = ACUTE RESPIRATORY ARREST, COVID 19 PNEUMONITIS. per vital records (09/08/2021) other significant conditions: (none listed). place of death: HOSPITAL-INPATIENT PRONOUNCING AND CERTIFYING PHYSICIAN;
pt recvd vax & devel nausea, vomiting, & diarrhea;
3 days after receiving flu and pneumonia shots same arm, inch apart per pt request, redness/swollen/warm in left arm. Diagnosis: Cellulitis per Dr. Treatment: BACTRIAM and levofloxacin
The injection site was high on the deltoid; nearly to the apex of the shoulder. Within a few hours, I begin to experience some discomfort and a limited range of motion.  By the next morning, the right side of my neck was stiff. This may have been a result of me unable to sleep comfortably on my right side. I have also been having some slight headaches. Headaches are very rare for me, and these particular episodes do not tend to subside with over-the-counter relief. The oddest thing is my inability to focus visually. I wear corrective eye wear, but mostly for close work and reading. This Saturday, 4/24/2021, I had difficulty reading the subtitles on the television, with or without my glasses.
Menstrual cycle came 2 weeks early following COVID vaccine. Menstrual cycle previously was very consistent but came 2 weeks early following vaccine.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 73 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received first booster dose with covid-19 vaccine ad26. cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first booster dose of covid-19 vaccine ad26. cov2.s (dose number in series 2).  The patient received second booster dose with covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination which was off label use and inappropriate schedule of vaccine administered (dose number in series 3). Age at time of vaccination 73 years old. The batch number was not reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. No concomitant medications were reported. The patient was fine after third dose of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Information has been received from a pharmacist concerning a male patient of unknown age. There was no pertinent medical history or drug reactions/allergies reported. On 04-SEP-2015 the patient was vaccinated with ZOSTAVAX (dose, frequency, lot# and expiration date unspecified). After vaccination the patient experienced an active case of shingles "with open sores on the lower back and the front of his body". VALTREX was given for the adverse events at the time of report. Dates of onset of shingles and therapy of VALTREX were unspecified by the reporter. The reporter also stated that the patient was experiencing a worsening of pain on an unspecified date following the administration of ZOSTAVAX. The patient sought medical attention by making an appointment with a physician. At the time of reporting, the outcome and causality between the events and ZOSTAVAX were not provided. Additional information has been requested.
I got a rash raised welts in a couple of place that were warm to the touch just a little bit they lasted a few days about 3 to five day she has a low grade fever. No medications but was told to monitor her condition.
08/01/22 that morning I felt so out of sorts. I had no energy and unusually tired. I had a little bit of a runny nose. I went to my doctor. They checked me out and felt like I had a heart murmur and told me I needed to see my cardiologist. A few days later I went to my cardiologist who diagnosed me with AFIB. I had AFIB about 20 years ago that was corrected, and I have had no issues until this. My doctor gave me amiodarone which I started taking that day. This helped. I continue to monitor it with doctor visits. If it acts up again, he will shock my heart. I have recovered.
Approximately 10 minutes after 3rd COVID vaccine was administered, patient complained of dizziness and felt faint. Patient was given apple juice. BP 129/91. EMS was contacted and patient was transported to the ED after EMS evaluation. Patient does have a history of vasovagal syncope.   Patient stated she felt pre syncopal but no true syncope. While in the ED, patient also complained that she had 2-3 days of N/V/D with cramping abdominal pain. While in the ED, patient then began having left side chest pain. No hx of CAD. Chest pain, dizziness, N/V/D have all resolved but it has now triggered a migraine headache which she has a history of. Denies f/c, cp, soa, abdominal pain, urinary symptoms.    Patient was given anti-emetic and fluids. Patient and MD discussed that the booster vaccine caused a vasovagal dizziness and presyncope feeling. Patient had symptom relief and was discharged from the ED.
T103 @ MD's office 101, fine rash on abdomen, vomiting approx 2 hrs p/immun;  MD gave meds for allergic rxn & congestion & pain;
Immediately after getting the first dose I started to notice a change in my hair. My hair started becoming brittle in texture and when I would shower it would fall out in clumps. This has continued for two years and there are even some bald patches. Now, about a month after getting the second dose I started to notice alot of abdominal bloating , more pain than usual and even pain during times not associated with an upcoming period or during a period, then my periods were significantly delayed and there would be occasions I would miss one or two months altogether which is not normal for me at all.
pt has hx of dementia; brought to ED with increasing lethargy x 1wk, non-productive cough, rhinorrhea, diarrhea, decreased UOP; started on supplemental oxygen; diagnosed positive for COVID;  started on decadron and remdisivir; antibiotics for suspected UTI; DNR/DNI; respiratory status decreased despite being on Vapotherm 40 L 100% and supplemental NRB mask @ 15 LPM; O2 sats in 60 - 70s; full comfort measures instituted; pt expired in the hospital; acute hypoxic respiratory failure due to COVID pneumonia
This spontaneous report as received from  a nurse, referring to a female patient of unknown age. The patient's historical drugs, medical history,concomitant therapies and concurrent conditions were not reported. On 14-SEP-2017 the patient was vaccinated with PNEUMOVAX 23 lot # N019348 and expiration date 08-feb-2019, intramuscular, for prevention of pneumonia (strength, dose and frequency were not reported). Late, on the same date, the patient experienced  pain in arm  that vaccine was administered in that was shooting into fingers (pain in extremity), fever, shaking, and hives", so the patient began to applying ice to the affected area. The patient sought medical attention by calling nurse, but no intervention to prevent serious criteria was performed. The outcome of pain in extremity, fever, shaking, and hives were reported as recovered/resolved in September 2017 (also reported as recovery date unspecified; conflicting information). The assessment causality between pain in extremity,fever, shaking, and hives with PNEUMOVAX 23 was not reported.; Sender's Comments:  US-009507513-1710USA000626: US-009507513-1709USA015022:
body aches, nasal congestion, loss of taste & smell, diarrhea, shortness of breath, tested 01/04/2021 for COVID-19 and results are Positive
Shortly after my second dose of Moderna, I started experiencing pain in my upper left thigh, while sleeping and upon waking.  This pain caused me to have to alter my sleep habit of laying on my left side.  As soon as I stepped on my leg, I felt a shooting pain.  This leg/thigh continues today.  I've been able to relieve this pressure with over the counter pain pills and a heating pad.  I've started using a walking cane, in the mornings.  The first appointment I was able to secure is June 8, 2021.
approx 9 days after dose 2 of Pfizer pt developed urticaria involving bilateral upper extremities, throat swelling, lip swelling which worsened at night and early in the morning. He has no known food allergies but notes it worsened after eating pecans. Denies any of these symptoms immediately after either covid vaccine dose. does have history of anaphylaxis to amoxicillin but has not been on any medications or supplements recently. He is currently being treated with benadryl, steroids, and is being referred to an allergist for further evaluation.
menstrual bleeding in post-menopausal female, mostly spotting but sometimes heavy with cramping
Adverse event reported by patient's mother. Patient with severe autism disorder and partial complex epilepsy disorder. Patient had a breakthrough seizure about 3 hours after first moderna vaccination. Seizure lasted approximately 3 minutes per mother, who is his caretaker. Patient recovered to baseline after the seizure. Unknown if any medications were given. Mother did not have the patient evaluated in a clinic or ER after the event. Adverse event was not known until patient presented for the second vaccination, at which point, second vaccination was delayed.
0.5ml Moderna Covid vaccine was given as a booster shot instead of the CDC recommended 0.25ml
After receiving vaccine, patient complained of nausea, vomiting,. Urticaria, tightening of throat, pruritis. EMS and MD responded, patient was given IM Benedryl by EMS, IV access was obtained, Albuterol was given via EMS and patient was transferred tou Hospital. Symptoms started at 12:05, left for transfer at 12:30 pm
Tested positive for COVID on 12Aug2021 after receiving last vax dose; Tested positive for COVID on 12Aug2021 after receiving last vax dose; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single and on 21Apr2021 (Lot Number: ER2613) (at the age of 23-years-old) as dose 2, single for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD). Concomitant medication included pantoprazole taken daily for gastrooesophageal reflux disease. The patient tested positive for COVID on 12Aug2021 after receiving last vaccine dose. The patient experienced loss of taste and smell, headache, stuffy nose, sore throat and fatigue. The outcome of the events was unknown.
About 1 hour I started getting muscle aches and headache, today severe nausea muscle and headache, temp of 102.4, sometimes I cant see straight, I get hot and sweaty between being cold.
Sudden onset nausea, headache, dizziness, paleness, diaphoresis.
During the administration of the vaccine, the needle was not tightly screwed onto the syringe, causing the vaccine to explode from the syringe when the plunger was depressed.  The needle separated from the syringe and remained in the patient's arm while the vaccine ran down her arm.  Patient didn't experience any symptoms of distress and the full dose of vaccine was administered in the opposite arm.  She was observed for the full 15 minutes and left without any adverse reactions.
I woke up to the worst migraine in my right eye the day after my 2nd COVID shot. The next day, I had what looked like blinds (white/black) lines in my vision, then half moon shape in my vision in my right eye for days. Dizziness (I felt like I was on a boat dock), confusion, tiredness and pain the back of the eye for two weeks, numbness of the eyes.   I went to the Opthalmologist who stated that I was having an ocular migraine. My Neurologist also said I was having an Ocular Migraine, but I?m stuck in the Postdrome Stage. Gave me Topiramate daily and told me stay away from screens and reading (that means no working and no TV). With the meds, I?m 70% back to my old self, I can drive again, run errands, do yard work, but I can?t work. We increased the dose, still can?t use screens and side effects pushed us to find another drug. Started new drug  Amitriptyline on May 30, and symptoms are not disappearing.   I have had symptoms (mostly eye numbness, vision issues, dizziness) continuously all day, everyday for 3 39 days and counting
Patient received second dose of Moderna vaccine on 3/23/2021. Patient's wife called pharmacy on 4/16 to report that patient experienced "full body rash" about a week after vaccination which has not improved. She later described the rash as just on his back, with itching as biggest complaint. Patient went to doctor since the rash started, but stated that he didn't mention this to his doctor. Patient reports taking Benadryl orally since and plans to apply topical hydrocortisone. Patient denies any bouts of trouble breathing, throat swelling, or other signs of serious adverse events.
Recurrent headache (frontal); local tightening of the muscles deltoids and triceps of the left arm; This is a spontaneous report from a contactable Other HCP. A 33-year-old male patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EL3247), via unspecified route in left arm on 23Jan2021 01:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. No known allergies reported. Patient previously took first dose of BNT162B2 (BNT162B2, Solution for injection, batch/Lot number Ek9231 and expiration date was not reported), via unspecified route in left arm on 02Jan2021 10:00 as single dose for COVID-19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not take other medication in 2 weeks. On 24Jan2021 at 18:00 the patient experienced Recurrent headache (frontal), and local tightening of the muscles deltoids and triceps of the left arm. The patient was not taking any treatment medications. The outcome of both event was not recovered.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Patient reported his muscles felt "twitchy" and he felt like he needed to stretch.  Then after he was uncomfortable while sitting in a meeting from feeling in leg muscles.  By 3 days post-vaccination all symptoms resolved per T.U. to patient.
Patient was BIB her sister, states she had similar symptoms after receiving her 1st Pfizer vaccine later in the evening. She received the vaccine approximately around 4:15 PM. She started to complain of weakness and numbness in her entire body. Denies F/C, dizziness, HA?s, CP, SOB, abdominal pain, N/V. We obtained vitals which were stable; Pt felt more comfortable sitting upright on exam table. We obtained vitals again which were WNL. Pt states her symptoms were improving. Kept her for observation for almost 1 hr, gave her water, pt was doing better, and pt?s sister took her home approximate time 4:50 PM. Strict ER precautions were given to them both as well as possible side effects of the vaccine. Pt verbalized understanding.   PMH: Pt denied any significant medical hx Meds: Denies Allergies: Pt reports allergies to an antibiotic (unknown name); she also states having sensitivity to Morphine, or other strong pain medications, where she has had similar symptoms.   Vitals-  4:17 PM                    BP: 126/79 HR: 83 bpm O2%: 100%  4:33 PM: BP: 131/80 HR: 81 bpm  PE:  General: Pt in mild distress, sitting upright on exam table, A&O x 3 Heart: RRR, no murmurs, rubs or gallops Lungs: CTA in all lung fields, no wheezing, rhonchi or rales Neuro: No motor deficit, muscle strength in B UE 5/5. Sensation intact in bilateral upper and lower extremities.
R09.02 HYPOXIA 4/24/2023 ASTHMA, UNSPECIFIED
14:15 client C/O feeling nauseated, flushed, and head was swimming. BP 158/97 P 98 R 20 alert and oriented x 3. Face was flushed, hives on cheeks and forehead. BP repeated 173/103. Declined transport to emergency room.
Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Medium, Additional Details: patient was given the flu shot first, followed by the moderna vaccine.  She told me she was just "nervous" and then turned very white and passed out.  I was able to stand beside her immediately so she did not fall out of chair or hit her head on anything.  Her father was with her at hte time of vaccination as well my intern pharmacist.  The two helped me move her gently to the floor and bend her legs.  She was responsive within about 15 seconds.  She was then able to tell me her name, etc.
outbreak of shingles involving ophthalmic division CN5, 1st symptom occurred 48 hours after immunization, mild burning, HA. Rash started 2/7/08, 6 days after immun. Rx acyclovir on 2/11/08