chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 58 years old female patient with rheumatoid arthritis. The patient's medical history included chickenpox in her childhood. The patient's relevant past drug history was unknown. The patient was vaccinated with a dose of VARIVAX (reported lot number 0048AE; expiry date 20-DEC-2013) on 29-OCT-2012. Route was unknown. No other co-suspects were reported. Concomitant medications included acid and methotrexate. On 29-OCT-2012 the patient was accidentally administered VARIVAX (merck) instead of the prescribed ZOSTAVAX (Merck). The status of the patient after accidental administration of VARIVAX (merck) was unknown. Additional information has been requested.
11/02/2021, 2 days post vaccine, I started to feel like I was getting a bladder infection, UTI. My asthma kicked in. I got a bad asthma flare up. That could have been weather related. I feel run down and tired. That could be from the infection and the asthma. I went to Urgent Care 11/12/2021 to do a urine culture.  The doctor called in generic for Macrobid antibiotics. I am still being treated for both the UTI and the asthma.
Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 001A20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021 at 11:00 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine). On 02-Nov-2021, OFF LABEL USE (Not immunocompromised was administered a third full dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.  Till the time of reporting patient did not experience any adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up received on 08 Nov 2021 contains reporter details and route  and time of administration of second dose updated.
I have started to feel symptoms of intense shivers and a headache that has gotten progressively worse through the night.
Dizziness, Headache, Sedation, Fever & NauseaVomiting Narrative: Initial dose received 1/5/21 and felt stiff afterwards. On 1/6/21 felt fatigued but was able to work. That evening developed a fever (up to 103). On 1/7/21 had a fever, nausea, vertigo and a headache. Symptoms persisted for several days, improving 1/6/21and resolving by 1/10/21. History of symptomatic COVID inection 11/30/2020
During the interview, the nurse ask to the patient which previous dose she had administered and she indicates that she has been administered the COVID 19 Moderna vaccine. After a consult with the medical director of the facility, from which dose correspond to the patient due to her medical history either a 0.25 ml or a 0.50 ml dose, Dr. indicates that the corresponding dose is 0.50 ml. After administration of the vaccine, when the form was in the quality area, the employee notice that the previous dose was 0.50 ml of COVID19 Janssen vaccine. After this event, a consult was made with Dr. due to that there was an erroneous administration of the vaccine due that the corresponding dose should have been 0.25 ml since it is considered a booster, as it has been established in the CDC guidelines.
COVID SYMPTOMS/SICK/RUNNY NOSE/BREATHING ISSUE/SORE THROAT; LEG PAIN; CHEST PAIN; CHEST CONGESTION; 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: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest pain. On APR-2021, the subject experienced chest congestion. Laboratory data included: X-ray (NR: not provided) X-ray was good. On 12-APR-2021, the subject experienced leg pain. On 20-APR-2021, the subject experienced covid symptoms/sick/runny nose/breathing issue/sore throat. On 05-MAY-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Tested negative for covid test, Lab test (NR: not provided) Tested negative for bronchitis, Tested negative for flu, Tested negative for pneumonia, and Streptococcus test (NR: not provided) Negative. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative, Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the leg pain, covid symptoms/sick/runny nose/breathing issue/sore throat, chest pain and chest congestion was not reported. This report was non-serious.
projectile vomiting  and dry heaves , severe abdominal pain  ,exhaustion  started at  8am   lasted for 18 hours 2pm it was done..the last   of it then it stopped as fast as it started
A nurse reported the occurrence of a macular rash in a 23 year old female who was vaccinated with hep b vaccine recombinant (Engerix B) for prophylaxis. The subject had no relevant medical history, no known drug allergies, and no concurrent medications. The subject experienced no adverse events following the first injection of Engerix B, or other previous immunizations. On 2/20/, the subject received her second injection of Engerix B (5338B6). One day later, on 2/21/03, she develo9ped an erythematous pruritic macular rash scattered "all over body" including the trunk, forearm, and legs. The subject was seen by a physician. The reporting nurse considered the events to be possibly related to Engerix B administration. As of 2/24/03, the rash persisted.
Vaccine administered 1/8/15 7:15pm I.M. Earlier in the day pt c/o sore throat. Afebrile. CEPASTAT lozenges ordered. 1/9/15 pt c/o soreness in left arm at vaccination site and continued sore throat. Afebrile. Left forearm with localized swelling at injection site. Sore throat improved with SUDAFED and lozenges 1/10/15. Left arm tender and mild redness. Cellulitis. Started on KELFEX, MOTRIN and warm compress for comfort. Afebrile. 1/11/15 feeling dizzy. No headache. No chest pain. No S.O.B. No significant EKG findings. Sent to E.D. for eval. Returned from hosp with script for meclizine. 1/12/15 cellulitis resolving no erythema on left upper arm. Complete antibiotic. Afebrile. On 1/15/15 pt became febrile 8:34 AM 101.2 - 127 - 20 131/65 O2 Sat 96%. C/O body aches, headache, congestion, malaise, lungs clear, loose cough non-productive. Rest, fluids, sx control. 1/15/15 12:53 pm PO dropping. Continues tachy and body aches. Give Azithromycin 500mg PO x 1. Start O2 2L via N.C. TORADOL 30mg IM x 1. Encourage PO fluids. IV NS 125ml/hr x 3 bags. I and O. Private room. 1/15/15 1:33 pm now has loose stools, diaphoretic, labored breathing. Transfer pt to ED for closer monitoring. Was admitted with dx of pneumonia.
Pt complains of numbness extending from shoulder to elbow. Pt says progressively worse.
Injection of PREVNAR given (L) deltoid on 3/25/16, developed erythema, warmth, evaluated 4/1/16 at Dr's office. Normal CBC. Started cephalexin since no resolving after 1 wk.
52 y/o adult / 2nd dose of 10mcg; 52 y/o adult / 2nd dose of 10mcg; 1st dose / on 05/25/2021 and 2nd dose / on 06/02/2021; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 52-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HBV (Engerix B adult).   On 2nd June 2021, the patient received the 2nd dose of Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 2nd June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, adult product administered to child and drug dose administration interval too short. On an unknown date, the outcome of the underdose, adult product administered to child and drug dose administration interval too short were unknown.   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 patient previously received 1st dose of Engerix 20 ug dose on 25th of May 2021. The pharmacist reported that, the adult patient received dose of Engerix 10 ug earlier than the recommended interval, which led to underdose, adult use of child product and shortening of the vaccine schedule. No further information was reported. The reporter consented to follow up. This case is linked US2021134490 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021134490:same reporter
This report is from a nurse referring to a 49 year old male pt and follow-up from his personal physician. The pt has an allergy to poison ivy. The pt has a medical history of left shoulder impingement, type II diabetes, high blood pressure, obesity and restless legs. At the time of the event, he was taking Glucophage, Univasc, Sinemet, Serzone, Amaryl, Novocaine and cortisone. On 2/18/00, the pt received his 1st injection with Havrix 1440 Elisa units for prophylaxis. Approx. 1.5 hours later, the pt experienced a rash over his whole body with erythema, flatness and flushed face, without itchiness. The rash was treated with Benadryl 25mg 2X/day and resolved but reappeared later. Also, within 24 hours of the injection, the pt experienced pharyngitis with a severe sore throat and difficulty swallowing. On 2/21/00, during an office visit, it was noted the pt had 2 pustules on his tonsils. Penicillin VK 250mg every 6 hours for 10 days was begun. The pt saw a dermatologist and had a biopsy performed. The dermatologist dx'd an allergic reaction to Havrix. The pt was treated with an unspecified medication. The information received on 3/29/00 reports the pharyngitis improved, and the rash is not well dissipated after treatment.
Very sore arm. Cold sweets. Elevated temp for 2 days reaching 101.5 degrees. Sick stomach. Nearly passed out one evening when I got up out of bed. Nearly didn't make it back to bed. Body aches.  Used cold compresses and took extra strength Tylnol and Aspirin. Lots of water and Ensure. Dressed in layers to stay warm. My wife and I are sick at the same time from vaccine injection. Missed 2 days of work. Also had skjn hypersensitivity in my upper back. Had fatuque, but not as bad as my wife.
A patient came in and immunizations were pulled in from system, but did not show that she had a pneumococcal vaccine to date, so after confirming with the patient that she didn't have it yet, one was administered in clinic that day, X/X/22. At the end of the day, when the provider got back into her chart, the XXXXX administration date showed up. Pfizer was called and they confirmed that they do not see that there will be any adverse effects to the patient.
Missed window for second dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed window for second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed window for second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed window for second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included gabapentin (Neurontin), simvastatin, estrogens conjugated (Premarin) and levothyroxine sodium (Synthroid). On 21st May 2018, the patient received SHINGRIX. On 22nd May 2018, 1 days after receiving SHINGRIX, the patient experienced headache and insomnia. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the insomnia was not recovered/not resolved. The reporter considered the headache and insomnia to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient reported that she experienced headache the day after a SHINGRIX injection. The headache lasted a few days and then resolved. The patient also reported that beginning the day after the injection, she had experienced insomnia which was unresolved. The patient had denied permission to contact their physician.
Mother stated patient could not move left leg, non-stop crying which resolved later in the evening after applying warm compress.
a bruise on his left arm after the vaccine shot on his right arm; This is a spontaneous report from a contactable consumer or other non hcp (patient's son) from a Pfizer-sponsored program. A male patient (father of reporter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that reporter called on behalf of his father and stated that on an unspecified date the patient experienced a bruise on his left arm after the vaccine shot on his right arm and reporter wanted to know if it's fine. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Started with extremely sore arm hard to move. And started getting a massive headache. And uncontrollable vomiting and diarrhea. Extremely weak and tired.
7/24/02 7:30pm my husband fed pt and then was burping him. I left the room, at around 7:45pm. I came back into the room and he was lying on my husband's chest. He had turned pale, like gray pale. I immediately called the doctor's office. When the doctor called me back 7:50pm and asked me if he was breathing. I said yes, the doctor then asked me to wake him up. I had some trouble waking him up, I finally got him awake by moving him around continually, by this time his color starting coming back. I told he doctor but she told me 8pm to go to the hospital to make sure he did not have a mini seizure. At 8:20pm we arrived at the hospital. They ran different test and all the tests came back okay. I had to follow-up the next day with the doctor. When I saw the doctor on 7/25/02 it was a different doctor. I explained to the new doctor what had happened. She told me on three different occasions that  it was not a reaction and she was not going to report. She said in so many words without saying it that it was SIDS. (Quote: she said "I'm gland you caught it in time, that the way he was laying we had cut off his air supply, but I said he was breathing, she made no comment. She more or less implied that it was SIDS). I do not believe that it has anything to do with SIDS for the simple fact he was breathing and was not blue and we had just got done feeding him.
Fever 103 x 48 hrs. Erythema and induration at injection site.
Patient developed a headache on 10/22/14. On 10/29/14 he called to say that the headache got progressively worse, it was now severe, his neck was stiff and sore. When I returned the call, he was at an E.D. On 10/30/14 he reported feeling better.
Patient received FLUZONE shot - about 15 minutes later, patient & her mother returned to pharmacy because patient felt dizzy.  Patient turned pale and was cold and clammy.  She passed out for about 30 seconds.  She came to when I was ready to give EPI-PEN shot & informed me at that time of Tachycardia & shunt.  Patient said tongue was swelling and metallic taste.  Ambulance was called immediately when patient felt like she was going to pass out (patient gave permission for ambulance to be called.  She passed passed out while I was on the telephone calling 911.  No medicine was given.
Muscle pain; Joint pain; Diarrhoea; Continued injection arm symptoms; Bad aches in both arms; Arm of injection really hurts; Arm of injection feels heavy; Palpitations in chest (resolved now); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bad aches in both arms), PAIN IN EXTREMITY (Arm of injection really hurts), LIMB DISCOMFORT (Arm of injection feels heavy), PALPITATIONS (Palpitations in chest (resolved now)) and MYALGIA (Muscle pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TRAMADOL, IRON and VITAMINS WITH MINERALS for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Bad aches in both arms), PAIN IN EXTREMITY (Arm of injection really hurts), LIMB DISCOMFORT (Arm of injection feels heavy) and PALPITATIONS (Palpitations in chest (resolved now)). On 09-Apr-2021, the patient experienced MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), DIARRHOEA (Diarrhoea) and VACCINATION SITE REACTION (Continued injection arm symptoms). At the time of the report, PAIN IN EXTREMITY (Bad aches in both arms), PAIN IN EXTREMITY (Arm of injection really hurts), LIMB DISCOMFORT (Arm of injection feels heavy), PALPITATIONS (Palpitations in chest (resolved now)), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), DIARRHOEA (Diarrhoea) and VACCINATION SITE REACTION (Continued injection arm symptoms) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-072819 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072819:First dose case
Fever; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable Other health care professional (patient). A 47-Year-old female patient (non-pregnant) received second dose BNT162B2 (Solution for injection, lot number: EN5318) via intramuscular at right arm on 26Jan2021 at 16: 15 at single dose for covid-19 immunization. Patient medical history included Known allergies. Concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (Pfizer, Lot number: EL3246) Via Intramuscular at Right arm on 04Jan2021 at 05:30 PM for covid-19 immunization. On 27Jan2021 at 12:15 PM, patient had Fever, nausea, vomiting and diarrhea. No treatment for AE. No Covid prior vaccination. Covid tested post vaccination. Outcome of events was recovered on an unspecified date in 2021.
No adverse effects reported.; Patient received unspecified dose of ROTATEQ on 9/5/2019 after temperature excursion on 8/30/2019.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was reported.  On 05-SEP-2019, the patient received an unspecified dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R026541, expiration date: 11-JUL-2020, orally for prophylaxis after temperature excursion on 30-AUG-2019. The vaccine was exposed to the temperature of 34.1 degrees Fahrenheit (F) for 20 minutes and 47.6 F for 40 minutes. There was no previous temperature excursion reported. Digital data logger was involved to capture the temperature excursion. No adverse effect was reported.
2 weeks after 1st round of vaccine vision in Left Eye began to form a sparkling, dark blob in the center of my vision.  I assumed it was an ocular migraine or something but after it did not change for 24 hrs, I scheduled an appointment for a check. After many tests, the Dr. diagnosed the issue as Paracentral Acute Middle Maculopathy (PAMM) and informed me that there was an event that had caused a lack of blood flow to the center of my macula and that it is permanently damaged.  The visual field effects are that I am permanently and essentially legally blind in the better part of the center of my left eye.
Periodic Tingling sensation like electric impulses shooting from injection area in a line up arm, across shoulder and up neck about ear level;  Low back/ hip pain I haven?t had before, especially at night turning over in bed. Self-massage, change position
patient started having swelling of her tongue approximately 1 hours after the 3rd dose of Pfizer vaccine. Patient was treated with Benadryl, prednisone and epipen. Patient did not require hospitalization and patient recovered fully next day. Patient did report that she bit her tongue.
I got the vaccine shot 3/25. The next morning 3/26 @ 6:34 I woke up with a massive migraine. I took some meds for the migraine with very little relief. I decided to go to the emergency room Saturday night at the hospital. Hours later I was released still in pain because they found nothing wrong from my labs. Monday 3/29 I went to hospital for help in the out patient clinic because my bottom lip was numb and the right side of my face was swollen and throbbing. I was prescribed clindamycin and naproxen in hopes that whatever the issue was would go away because they still don't know why all of a sudden this has happened. I have been taking my prescriptions since prescribed and there is no difference or relief. My mouth is so swollen I can't really eat. I wasn't feeling any of this ever before until the next morning after receiving the covid vaccine.
At 4:30 pm the pt received immunizations. At 7pm mom took the pt to ER with hives covering body except none on legs.
Generalized pruritus for several yrs with an onset following vaccination with the anthrax vaccine (AVA) # 3 in 04 and # 4 in 08. Per allergy note, SM has a hx of allergic rhinitis, eczema, and positive skin test for formaldehyde, nickel, and chromium. Her initial onset of  pruritus was 2 mos pos AVA #3, persisted for approx 1.5 yrs then resolved. Pruritus reoccurred approx 2 mos post AVA # 4 in 08, persisted, and is worse than the previous episode.
PT REPORTED ITCHING, TINGLING AROUD HER MOUTH, AND LIGHTHEADEDNESS.  SHE WAS PLACED IN A LOUNGE CHAIR AND VITALS WERE TAKEN.  ALLERGIST CONTACTED AND ADVISED THE PT TO TAKE ZYRTEC NOW AND BID FOR THE NEXT 3 DAYS,.  PT TOOK THE DOSE AND UNDERSTOOD THE INSTRUCTIONS.  VITALS IMPROVED AND HER ITCHING SUBSIDED. HER ONLY REMAINING SYMPTOM WAS A HEADACHE THAT DEVELOPED AFTER TAKING THE ZYRTEC.  SHE WAS GIVEN ICE PACK FOR HER HEAD AND ENCOURAGED TO DRINK FLUIDS. PT STATED SHE FELT FINE AND WANTED TO LEAVE TO RETURN TO HER UNIT SO SHE LEFT OBSERVATION AT 1:31PM.