chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu vaccine received at 10:30 am 11/4. By 5 pm she felt itchy "hive like" bumps on chin. Rash progressed to confluent areas on face and neck. By 11/9 itching and pain so severe, no relief with BENADRYL that she went to ED for IV steroids.
Two brothers came in to get shots. Older brother (18) went first did fine. 15 year old went second said he was okay and fine. Ask him several times. He said okay walked away couple of steps fainted blood pressure, heart rate dropped low called ambulance. He was taken to ER gave steroids released. Called 8:25 fine. Called same day fine. Released. Everything was fine when released blood pressure and heart rate resolved talke to mom twice.
fever 102, myalgias;poxal rxn-onset 3 days p/vax;erythema & edema;pain @ inj site;
On the morning following the vaccine administration the mother reported that patient was experiencing a fever of 103.2 and "lethargic". Patient was given TYLENOL and brought to the office where the temperature registered 98.7. Condition is improved.
joint pain, mainly on the left side of their body; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRALGIA (joint pain, mainly on the left side of their body) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 30-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 ARTHRALGIA (joint pain, mainly on the left side of their body). At the time of the report, ARTHRALGIA (joint pain, mainly on the left side of their body) 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.   Treatment medication was not provided.
R arm redness & Swelling, moved down to forearm, tender. Had pneumo shot 2 yrs ago. Allergic reaction treated with inj. of decadron.
CHILLS; NAUSEA; VOMITING; EXCESSIVE URINATION; INCREASED HEART RATE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 16:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-MAR-2021, the subject experienced chills. On 07-MAR-2021, the subject experienced nausea. On 07-MAR-2021, the subject experienced vomiting. On 07-MAR-2021, the subject experienced excessive urination. On 07-MAR-2021, the subject experienced increased heart rate. On 07-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-MAR-2021, and nausea, vomiting, and excessive urination on 08-MAR-2021, and had not recovered from increased heart rate, and fatigue. This report was non-serious.
pt recvd vax; fever >105 per mom at 5am;to ofc in am;pt appeared happy & social;MD advised mom apap & advil;14nov mom called & states pt shaking;eyes fixed to lt & head turned rt;suspected sz activity; to hosp; exam t & eeg WNL;
elevated liver enzymes; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (elevated liver enzymes) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (elevated liver enzymes). At the time of the report, HEPATIC ENZYME INCREASED (elevated liver enzymes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test: other (High) elevated liver enzymes.         No concomitant medications were reported No treatment medications were reported Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-046164 (Patient Link).
soreness on left arm, lymph node under left arm, and dull pain in left thigh
Emergency surgery for perforated bowel on 10-26-2021 followed by T Cell Lymphoma Diagnosis post surgical path lab.
DTaP expired 04/29/2023, was administered on 05/05/2023.  Nurse did not realize error until after immunization had been adminstered.  Parent notified at 1821 on 05/05/2023.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/26/2023 PNEUMONIA
Headache within 30 minutes  Severe arm pain within 7 hours Body pain and fatigue within 24 hours  Sever coughing  tons of green n yellow mucous with 48 hours  fevers up to  102.6 within 48 hours  and continuing on day 5  since 1st dose Lots of nausea and body pain  Sever headache continues
I tested positive for Covid-19 with no severe symptoms in February of 2021. One week after the vaccine on 04/09/2021 I broke out in hives after eating a meal. The hives were mostly on the right side of my body but there were some on the left. I also had some numbness and tingling in my mouth. I used some anti itch cream, and the hives were mostly gone the next day. Twelve days after the vaccine I started to unusual vision symptoms which included wavy zig-zag lines in my vision. My doctor advised that they were Ocular Migraines. I had a headache at the same time, but I have never had Migraines before. I was also fatigued with a little dizzy and nauseous. The headache lasted for one day, but I still felt a little nauseous the next day. The feeling of fatigue and tired ness lasted for about six weeks. Two to three days after Ocular Migraines I started to notice a bright red rash on the right side of my back. It quickly spread around my side to the midline and then up my right side to my Bra line in front. I consulted my doctor on 04/19/2021 and he identified the rash as Shingles I was prescribed Acyclovir 800mg for 7 days and then an additional 5 days. I saw my Dermatologist on 05/06/2021 and he said that the Shingles were still active so I was Prescribed Valacyclovir. The Shingles lasted about six weeks total with some fatigue before I felt normal. I still have some visible signs of the rash on my back. Dr., PCP, 04/21/2021  Dr.  Dermatology. 05/06/2021 for Shingles
Migraine - lasted 48 hours, medication (naproxen - 440mg every 6-8 hours) did not help. Sore Throat-hard to swallow, sharp throat pain, still hurts 48 hours after vaccination. Tongue Pain-started on both sides towards back of tongue, 48 hours later, still hurts, can't eat/talk without being in pain. Right side feels better, left side in a lot of pain. Can't see any type of sore on tongue.
sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was selected as an adult as per the vaccine indication. The reporter stated that she works in a pharmacy and had heard that there was a husband and wife, one got sick but the other did not after 2nd dose of the Shingrix. The reporter was not sure if any these were reported, declined to provide further details. This case has been linked with the cases US2019GSK099901 and US2019098035, reported by same reporter.
30 minutes developed Subdermal Hives in upper body along arms, chest and in armpits.  No difficulty breathing, Hives were painful and itchy.  Treated with Benadryl 50 mg and they subsided.
Varivax reaction noted above injection site with in 1-2 minutes wheal, warm indurated area about 1 inch in length. Right thigh vaccine given Varivax, Ice applied to site. RX given for Benadryl elixir 3/4 tsp PO Q 6 hours. Clarinex 1mg 2.5ml given PO. Spoke with Mom 4/26/06. Rash resolved follow up appt 1 week.
Pt presented for 2nd dose on 6/28.  Pt noted that with first dose, he developed and "uncommon syndrome" that included neck pain and left arm symptoms similar to the "uncommon syndrome" he has developed previously with the flu vaccine.  No additional information available.  No information regarding PMH, Allergies, or medications available.  Pt given Janssen Left Deltoid IM Lot 206A21A on 6/28 as an alternative to Moderna for second dose due to hx of reaction.  No reaction noted after Janssen dose.
pt recv vax & went to sit w/mom;In 1-2 min said did not feel well & was slow to respond to questions;face became red, flushed, began perspiring profusely;layed down w/feet up & epi given;amb called & responded;mom took pt to hosp
She waited at the stadium for mandatory 15 minutes after the vaccine. On her drive home, she developed numbness and swelling in the back of her throat. She had difficulty swallowing. She had no difficulty breathing. She monitored the symptoms and they resolved after two hours. She then had some tachycardia and headache later that day - resolved as well.
Congestion; Headache; Felt a little lousy; Tired/fatigued; Cranky irritable; Sore throat/frog in my throat as you can hear; Body aches; ache in my right kidney; received the vaccine in my left arm and just had a little warmth; vaccine in my left arm was a little sore; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (Age: 64; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT# EL9264), via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated, "I received the pfizer covid vaccine on  Sunday night at 6pm; I am having side effects, I have a little ethnic blood in me and am affected by viruses, the vaccines tend to nock me out. If I get a flu shot, I have a couple days of being tired. My first effect was on Monday when I woke up I had congestion and headache within 24 hours, felt a little lousy, tired, cranky, irritable and fatigued. The congestion was in my nose, then I had slight headache. I went to bed early, woke up this morning with a sore throat, checked my lymph nodes and there was no swelling. I have body aches and fatigue today and I am cranky and irritable because you I'm tired. The congestion, popped, it went away, from one minute to the next, it just cleared, it's like it popped out of your sinuses. I am also experiencing sore throat, frog in my throat as you can hear. I am going to take a nap. I received the vaccine in my left arm and just had a little warmth in that area later on, next day a little sore. I had an ache in my right kidney area also." The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Pt developed edema and erythema at the site of injection 24 hrs after the vaccination which resolved within 48 hrs.
After the 1st dose of the Pfizer vaccine, about 2 days later, I started getting severe vertigo and feeling extremely tired. I called an online doctor and he attributed it to being tired from the vaccine.  2 days later, it happened again, I got vertigo and fatigue. Over the next 2 weeks, I started waking up in the middle of the night with vestibular migraine followed by extreme nausea, dizziness and vomiting. This was occurring about 1-2 times a week over 2 weeks. I had to sleep on incline which would help alleviate the symptoms, eating less salt and staying more hydrated, resting more and taking it more easy.  It really did not help improve my symptoms. I also notice that if I do not lay on my left side, I would not get vertigo. I did go ahead to get the 2nd dose of the vaccine on 5/6/2021 (lot EW0179 IM LA). I was still having ongoing issues of vertigo and nausea.  I did get flu-like symptoms with the 2nd dose which resolved after 3 days but the vertigo and nausea continued. I finally went to see my PCP on 5/20/2021 and was prescribed Meclizine  three times a day which did help manage the symptoms. I did see an ENT on 6/1/2021 and was diagnosed BPPV (benign Paroxysmal Positional Vertigo) and was advised to practice EPLEY Maneuver which is a physical therapy to help eliminate my vertigo. I was scheduled to do an MRI which came back normal. I have been doing the EPLEY which has helped to resolve the vertigo 90% of the time. I do still get it occasionally depending on my activities which can trigger it.
No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
tested positive for COVID in ED on 12/22/21; dc'd to home with Tessalon and Zofran; back to ED on 12/26/21 via EMS with worsening SOB, O2 sats 80% on RA; NRB mask; dexamethasone, baricitinib, remdesivir; experienced change in mental status, suspected CVA, unable to obtain MRI; DNR: transferred to hospice; comfort measures; pt died in hospice
(L) flank pain, leg and arm pain and weakness. Hospitalized 10/28/18 - 10/31/18. Dx with Guillain Barre Syndrome.
6/8 2013: Hives on both thighs 6/10 saw dr; Clobetasol prescribed 6/17 improving, mild discoloration 6/21 hives received to thighs and ABD - used clobetasol 6/26 improving, blotchy spots on ABD. 6/27 mild itching 7/3 increased itching, solid hive from knees to chest; BENADRYL and oatmeal baths 7/9 improving.
Case number PHEH2016US029275, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 20 years old female patient. Past medical history and concomitant medications were not reported. The nurse stated that first temperature excursion of FLUCUELVAX Quadrivalent at 52F for 1 hour occurred on 18 Oct 2016. The patient was vaccinated with FLUCELVAX QUADIRVALENT (batch number: not reported) at a dose of 0.5 ml intramuscularly on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error (incorrect product storage).
chest pain on the lower right side just under pectoralis muscle. cat scan showed blood clots. received pain medication ( hydromorphone) received a dose of eliquis at discharge
This case was reported by a consumer and described the occurrence of vomiting in a 39-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Multivitamins and other unspecified concurrent medications. On 17 November 2011 at 18:00 the subject received 1st dose of TWINRIX at 1 ml in the left arm. On 23 November 2011, 6 days after vaccination with TWINRIX, the subject became sick. She reported that she woke up on the morning of 23 November 2011 at approximately 06:00, started vomiting and had a headache. The subject described the vomiting as continuous and nonstop. She reported that she could not even keep water down and was very sick. The subject went to her physician around 11:00 or 11:30 in the morning. She reported that her physician felt it was "just a sickness". She ended up going to the emergency room at about 19:00. The subject was treated with anti-emetic in the emergency room which she reported did not stop the vomiting. The subject went home about 23:30 or 00:00 and finally stopped vomiting the next day, 24 November 2011. The headache was reported to have resolved on 23 November 2011. The outcome of feeling "sick" was not specifically stated. She noted that she suffered for 13 hours. The subject reported that she was supposed to have received the 2nd dose of TWINRIX on 17 December 2011, but was afraid to do so and had not received it at the time of reporting.
Swelling of left arm under vaccine site on 4/8. Redness and hard lump under vaccine site. Painful when touched. First noticed at 9:00am.
ADMINISTRATION OF VACCINE TO AN ELEVEN YEAR OLD PATIENT; OFF LABEL USE; This spontaneous report received from a health care professional concerned an 11 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included food allergies, and asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: 27-APR-2022) dose was not reported, administered on 14-FEB-2022 for prophylactic vaccination. Concomitant medications included montelukast sodium for asthma, and procaterol hydrochloride for asthma. On 14-FEB-2022, the patient experienced administration of vaccine to an eleven year old patient, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine to an eleven year old patient and off label use was not reported. This report was non-serious.
arm was red and blotchy and hot to touch and had a knot in it applied ice pack and took tylenol it lasted 3 to 4 days
PATIENT WAS NOT LUCID AT FRON ENTRANCE OF STOTE  CALLED 911
Experienced severe chest pain  Severe migraine  Pain in neck and back. Took ambulance to hospital  Blood pressure was extremely high
pt recv vax 30MAR98 220PM & pt was instructed to wait for 10 to 15min in the waiting room;approx 230PM noticed red spot on site of immun;MD was informed pt was asked to wait for another 15min;
This spontaneous report was received from a healthcare worker and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX injection (exact dose, lot #, expiration date and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent (MERCK) injection. The reporter stated that the administered doses of ZOSTAVAX were stored at the temperature between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 42 minutes on an unknown date. Data logger was used to detect this temperature excursion. There was no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1709USA012678: US-009507513-1709USA012903.
Began to notice skin discoloration on right thigh beginning in Early October 2021. Gave it time to heal, since I'd just given birth (9/26/2021), but it did not improve and worsened in color and size. Saw a vein specialist in April at the referral of my OBGYN and no vein issues were identified. Went to Dermatology where they biopsied by right thigh and ordered bloodwork. Bloodwork came back fine, but biopsy showed early stages of Morphea - an autoimmune disease. I am 31 years old, healthy, and have never shown any genetic markers for any long term illness, or disease.
Patient fully vaccinated with pfizer COVID vaccine on 2/5/2021 and 3/5/2021. Pt has  h/o advanced COPD and is chronically oxygen dependent, on 5L of O2 at home, multiple sclerosis, Afib, GERD, CHF. Required admission to hospital for COVID pneumonia on 8/29/2021, requiring mechanical ventilation, and ultimately patient expired on 9/18/2021.
2hrs after vaccine: Itchy throat, itchy finger, unable to open Lt jaw, Lt ear fluid accumulation Resolved over 4 days, seen at urgent care where labs, imaging were done. Seen by allergist 3/25/21 who recommended epipen   Benadryl was not helpful
Dizzines; Fever like simptoms; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
lt thigh (where vax was given) became swollen & hard w/in a few hrs p/vax was given; APAP q 4 hrs & cool compresses to area was prescribed;
March 31 - received vaccine and immediately within 2-3 minutes experience moderate anaphylaxis: Throat constricted, rapid heartbeat, hot flash, tingly face. But breathing was normal throughout. Within minutes was given EpiPen, followed by intravenous Benadryl. Then taken to ER to later receive steroids. Was observed in ER for 4 hours, with no reoccurrence  of symptoms.  Prescription for Prednazone (3 day course) and Benadryl (as needed). Epi Pen if needed.  April 1 - Next day, felt totally normal. Slight soreness in arm, and very minor fatigue. was able to work, drive, and go about normal activities.
Muscle pain left hip; This is a spontaneous report from a contactable consumer (patient). An 80-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 15Feb2021 at 01:00 PM as single dose for covid-19 immunisation at doctor's office/urgent care. The patient had penicillin allergy and other relevant medical history was reported as none. Concomitant medications included budesonide, omeprazole, hydrocodone bitartrate, paracetamol (NORCO), lovastatin and metoclopramide (METROPRASIL) all received within two weeks of vaccination. The patient did not have covid prior to vaccination and was not tested for covid-19 post vaccination. Patient did not receive any other vaccine in four weeks. On 15Feb2021, at 05:00 PM, the patient experienced muscle pain left hip. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain left hip included chiropractor adjustment. The outcome of the event muscle pain left hip was recovering.  Follow-up attempts completed. No further information expected.
PT RECIEVED VACCINE, WALKED TO RECOVERY AND SAT DOWN. ABOUT 3 MINUTES AFTER PT'S VACCINE SHE BEGAN TO COMPLAIN OF DIZZINESS. HER HUSBAND WAS WITH HER AND CAUGHT HER AS SHE PASSED OUT. A VOLUNTEER WENT OVER TO ASSIST. PT'S HEAD PUT IN BETWEEN HER KNEES. EMS OVER TO EVALUATE. PT PUT ON SCRETCHER AND WHEELED TO A PRIVATE AREA FOR EVALUATION. VITALS STABLE. PT GIVEN GATORATE AND CRACKERS. PT AMBULATED AND LEFT WITH HUSBAND.
Approximately 12 hrs post severe stomach cramps followed by vomiting and diarrhea. Extreme tiredness, some dizziness and chills (at 18 hrs post vaccination). Pt reports symptoms lessening (18 hr post vaccine).
No adverse events. Child was identified as her sister so given 2 vaccinations intended for her sister.  Follow up received states adverse event onset date/time: 6/15/10 6:00 PM.