chrisvoncsefalvay/vaers-outcomes huggingface dataset:
within 2 weeks she came down with Covid; within 2 weeks she came down with Covid; This is a spontaneous report received from a contactable pharmacist. A 21-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; lot number and Expiry Date was not reported) via an unspecified route of administration  on unspecified date as a single dose for COVID-19 immunization. Patient medical history and concomitant medication were reported as none. It was reported that pharmacist wanted to know when the patient would be able to get the 2nd dose of the BNT162B2. Patient tested positive for COVID after getting the 1st dose around 10-14 days after getting the 1st dose, patient developed COVID 19 symptoms and tested positive. Pharmacist stated that he/she had a patient who received the first dose of the Covid-19 vaccine, within 2 weeks she came down with Covid. Pharmacist stated that he/she did not actually administered it, so not sure for vaccine LOT number. Pharmacist was not sure regarding patient's date of birth and stated that not treated the patient, the practice Nurse try them, know what to do. Pharmacist had no idea regarding the patient's height, weight and ethnicity, Expiration date, NDC# and UPC#. Patient experienced within 2 weeks she came down with Covid as Drug ineffective and COVID-19. Product Complaint was reported. The patient under-went lab test and procedure which included COVID: positive. The patient was quarantined. The causality reported as no. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
The pt complained of neck pain one day post vax. The pt went to the ER. MD wasn't sure if reaction was related to the vaccine. No redness at the site of injection was noted.
2 days after receiving the vaccine patient started getting rashes behind neck which traveled up to the head, left side of the waist area.   2 weeks later patient started getting clear blisters and pumps on arms legs and stomach area,
I had large red  and hot welt. I had lip node enlargement. It lasted for a week.
extreme low back, pelvis pain; extreme low back, pelvis pain; bone pain; torso body rash, hot to touch non itchy; tired; night sweats; general malaise; Body aches; Joint pain; stiffness; chills; swollen left axillary soar lymph nodes; This is a spontaneous report from a contactable other health care professional (patient). A 56-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 13:00 (at the age of 56-years-old) as dose 2, single for covid-19 immunization at facility. The patient medical history included cancer, low thyroid, depression, Hx breast cancer , neuropathy, fatigue, brain fog, brain fog weight gain uncontrolled, Known allergies: Sulfa, Known allergies: bee stings, FLOXED. Patient has known allergies. Concomitant medications included levothyroxine, glutathione, levothyroxine sodium (SYNTHROID), omeprazole sodium (OMEGA [OMEPRAZOLE SODIUM]) all taken for unknown indications from an unknown date. Other medications patient received within two weeks included Synthroid, mitocore, fishoil, glutathione, Omegas VD NAD, levothyroxine. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL9267, expiration date was not reported), via an unspecified route of administration, administered on left arm on 11Feb2021 01:00 PM (at the age of 56-years-old) as dose 1, single for covid-19 immunization at facility. The patient previously took levaquin and experienced Known allergies: levaquin, morphine and experienced Known allergies: morphine, neulasta and experienced Known allergies: Neulasta, Hydrochlorothiazide and experienced Known allergies: Hydrochlorothiazide. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, on 12Mar2021 04:00 PM the patient experienced body aches, join pain, stiffness, chills, swollen left axillary soar lymph nodes. It was also reported that on 12Mar2021 06:00 PM 30hrs post 2nd vac the patient experienced, extreme low back, pelvis pain, bone pain, day 2 post, swollen lymph nodes, torso body rash, hot to touch non itchy, tired, chills, night sweats, general malaise, body ache, for a week. No treatment was received for the adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
high fever 102.5; chills; Myalgia; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever 102.5), CHILLS (chills), MYALGIA (Myalgia) and HEADACHE (Headache) 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 COVID-19 in December 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever 102.5), CHILLS (chills), MYALGIA (Myalgia) and HEADACHE (Headache). At the time of the report, PYREXIA (high fever 102.5), CHILLS (chills), MYALGIA (Myalgia) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 (High) Fever.         Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-057097 (Patient Link).   Reporter did not allow further contact
shard of metal caught in eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE INJURY (shard of metal caught in eye) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE INJURY (shard of metal caught in eye). At the time of the report, EYE INJURY (shard of metal caught in eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient on painkillers
15 minutes after injection, I felt whole body flushing with tachycardia and palpitations that lasted for 5 minutes. The symptoms resolved and then 15 minutes later, the same symptoms occurred and lasted 10 minutes.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Bradycardia-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient had not eaten all morning and felt very anxious about vaccine prior to administration.
Patient is an 89-year-old male with history of dementia, hypothyroidism and GERD presenting to the emergency department with his daughter For low oxygen saturation.  Daughter states patient lives alone and she brought him up here in hopes to place him in a facility, which she states she has been trying to work on.  She states ever since December 13 he has had more frequent falls and progressive weakness.  She states he fell yesterday and hit his head on the bathtub.  He is not on blood thinners.  She also noted today while he was eating breakfast his oxygen was 79%.  Patient denies any feeling of shortness of breath, denies chest pain.  He states the reason he fell yesterday was because he slipped.  He has been vaccinated against Covid.  He denies abdominal pain, nausea, vomiting or diarrhea. Daughter does note they had a family Christmas party on December 18, and a couple days later they were notified someone at the party was diagnosed with Covid.
PT had the J & J Covid shot on  April  10.   four days later he started having symptoms of dyspnea.  pleuritic chest pains and headaches.  HE NEVER had these symptoms before.   He wanted to tough it out to see if he would improve, but this was not happening  so he came to the emergency room and saw me on  June 1.    He was hypoxemic at triage with an 02 sat of 89% on RA.   On ABG he had a PaO2 of 50 on RA.  I performed CTA of the chest,  and venous dopplers of the legs.  No PE,  no DVT, no pneumona,  Had no fever, no elevated WBC and No infectioin,.   Pt was admitted. Inpatient work up had normal Coronary arteries, Echocardiogram had an  Systolic Ejection Fraction  70 %   ,  Had negative respiratory pannel.  No infectious agents identified.  High resolution CT scan of the Scan of the chest , Demonstrates ground Glass opacites  in the lungs.    End Result was pt diagnosed with ATYPICAL pneumona    discharged on Levaquin and two liters of oxygen by nasal Cannula
1st Dose given 2/16/2021, 2nd Dose given in error on 3/11/2021
pt recvd vax; devel some vesicular lesions;next 4-5 days devel approx 40-50 lesions;exp low grade fever,malaise & some swollen glands in neck;md felt lesions were mild type of chicken pox;
Initial case received from a health care professional, who is also the patient, on 17 April 2014. A 73-year-old female patient, with a reported medical history of allergies to BIAXIN and epinephrine and no reported concomitant therapies, had received an intramuscular dose of FLUZONE HIGH-DOSE on the left deltoid on September 2013 (batch number not reported). She had previously received yearly flu shots. She denied any illness at the time of vaccination. On 30 December 2013, the patient stated that she woke up with headache, muscle aches, general malaise and sweats. There were no records of fever. The patient went to consult at a local emergency department on 31 December 2013 and stated to the ED physician: "I have the flu and I need a prescription for TAMIFLU". No flu test was performed to confirm the diagnosis. TAMIFLU was prescribed as per patient's request along with hydrocodone for headache and muscle aches. Patient stated that symptoms resolved in 72 hours. The patient recovered from the events. She did not report this to her own physician. Documents held by sender: none.
This case was reported by a physician via call center representative and described the occurrence of hives in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX. On 21st March 2019, 4 hrs after receiving SHINGRIX, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX and experienced hives and urticaria. The patient received the dose of SHINGRIX from a pharmacy, no contact details were provided. The health care professional could not provide lot number or expiration date. The day before reporting, the adverse event hives and urticaria were persisting at the time of report.
2 days post vax pt devel fever to 101 & flu-like sx w/aches & muscle pain;sx resolved p/tx w/Advil & APAP;
I woke up the next morning with a fever (99)  and felt a little foggy.  I spent the day sleeping and taking ibuprofen  for the fever.  Later that evening I was feeling a little better so I went to do a karaoke show.  At 11:00 pm I was on my way home when I blacked out , ended up in a ditch on the side of my vehicle which was totaled.
Several hours after the vaccine I noticed abdominal pain located in my lower back, primarily on the left side. I also had a pounding headache (not a migraine), and other body aches. Over the next several days (Thursday night through Saturday, 4/1-4/3) these symptoms persisted along with mild dehydration and constipation. The aches I treated with ibuprofen, and I used a mild, natural laxative to try to poop. The constipation was relieved by pooping, but it was much less than my normal amount of stool, and it took a couple days to fully abate. I also noticed that I wasn?t sweating very much/at all until about a week after I received the vaccine, which was very worrying. I attempted to drink plenty of water during all of this, though I can?t be sure I succeeded. I think my menstrual period may have happened during this week, maybe starting on the Tuesday falling the vaccine, but cannot remember for sure. Constipation and dehydration are unusual for my period, though the pain is not. There was soreness in my arm muscles around the vaccine site, but it was consistent with what I feel from any other vaccine, and only lasted a day.  All discomfort ceased about a week after the vaccine.
This spontaneous report was received from a medical assistant refers to an unspecified patient of unknown demographics. On an unknown date, the patient had been vaccinated with improperly stored dose of one of the following vaccines: VAQTA lot # N008823, expiration date: 26-MAY-2018; ROTATEQ lot # N000172, expiration date: 10-JUN-2018, oral; RECOMBIVAX HB lot # M032649, expiration date: 11-NOV-2018 or VARIVAX lot # N008829, expiration date: 16-MAR-2019 for prophylaxis. The reporter was not sure about which vaccine the patient had received. Temperature for VARIVAX, in the range (-9 °C to 8 °C); for VAQTA, ROTATEQ, and RECOMBIVAX HB, in the range (9 °C to 25 °C). Time frame for VARIVAX, 7 hours and 20 minutes, for the VAQTA, ROTATEQ, and RECOMBIVAX HB, 5 hours and 37 minutes. No previous temperature excursion. Data logger was involved. No adverse effect reported. No product quality complaint involved. No additional information was provided.
Erythema/edema (L) anterior thigh 13cm x 11 cm in length around.
Same day, approx. 9pm, experienced extreme fatigue. Approx. 1am during that night, experienced full on flu symptoms. Including: chills, muscle aches, massive headache, so much so, I could not get up for aspirin. Fading in and out of brief periods of sleep, all night. Approx. 830am took 2 aspirins and slept about an hour. It helped and I thought it was over. My stomach started cramping and making all sorts of gurgling noises shortly after noon. Then I had very unpleasant bathroom visits (many). At one point almost passed out. Got thru that and began the chills and body aches again! My husband had his right before me and he had NO complications. I am nervous that I will go thru this again during the booster. Seems my body did not like this AT ALL!
Redness, swelling within less than a minute patient still has bumps on legs per mom on 3/19/08.
client complained of dizziness and shortness of breath post vaccine. MD and EMT onsite evaluated client. Vital signs obtained BP 128/98 oxygenation 100%. Denies any chronic medical conditions. Stayed in observation area for 30 mins. Left without incident, advised to follow up with MD or call 911 if signs or symptoms return
patient started feeling lightheaded and fainted.  Has a history of this after vaccinations. Patient remained seated was given an ice pack to comfort her and recovered.  Sat for an additional observation period and was fine.
No Adverse effects were reported; the patient was inadvertently administered 2 doses ofVAQTA; the patient was inadvertently administered 2 doses ofVAQTA; This spontaneous report was received from a nurse and refers to a 2-year-old patient of unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 12-JUL-2019, the patient was inadvertently administered with two doses of hepatitis a vaccine, inactivated (VAQTA) injection, intramuscularly (lot # S002460 has been verified to be a valid lot number, expiration date 15-MAY-2020 ). First dose was administered in the patient's left tight and the second dose of hepatitis a vaccine, inactivated (VAQTA) was administered in the patient's right tight. The reporter confirmed it was not product confusion. No adverse effects were reported.
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-449524 (Patient Link).
Flu and pneumonia vaccines given in right deltoid 1" apart. Injections went well - no bleeding. He said later that evening was red, swollen and sore - went to express care 3 days later - swollen and red about 4" below injection. Received BACTRIM DS - 2 BID. Today - swollen down to elbow. Saw Infectious Disease Dr who ran CBC - waiting for results.
Chief Complaint Patient presents with ? Psychiatric Problem     Per EMS comes from assisted living since son has stated he was on the phone with her and she sounded different and has manic episodes.  ? Fall     per patient has fallen 5 times in the past 10 days. last fall was last night around 10pm. denies thinners and denies LOC.     Patient is a 68 year old female who presents to the ED for a manic episode.  Per patient's son, she has called him multiple times and has had flight of ideas similar to previous episodes.  She was seen and evaluated in geropsych previously.  She states that she has fallen 5 times in the past 10 days and the falls have been mechanical.  She denies hitting her head.  No difficulty with ambulation.  No other complaints.            Review of Systems  Constitutional: Negative for chills and fever.  HENT: Negative for ear discharge, ear pain and hearing loss.   Eyes: Negative for photophobia.  Respiratory: Negative for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria and urgency.  Musculoskeletal: Negative for back pain, myalgias and neck pain.  Skin: Negative for rash.  Neurological: Negative for dizziness, seizures and headaches.  Psychiatric/Behavioral: The patient is hyperactive.
pt recvd vax 25AGU95 & 13SEP95 pt devel hives on abd, face, joint areas, & arms;reporter felt that the pt's hives were not related to varicella vax;no further details were provided;
Generalized macular-papular nonpruritic rash, various sized papular. Afebrile and otherwise asymptomatic.
Blisters at injection site, redness on upper arm, warm to touch, edema. Temp x 24 102-103 to ER night of vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 11Nov2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 07Jun2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received antiviral treatment for Covid-19 with Paxlovid from 11Jul2022 to 16Jul2022. Rebound COVID symptoms - bad sore throat. Patient received treatment with Methylprenisolone 4 mg.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329219 same reporter/patient/product, different dose/AE;
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 22-JUN-2017 the patient was vaccinated with VARIVAX lot # N001530 with expiration date of 13-JAN-2019, 1 DF for prophylaxis. Concomitant therapies included sterile diluent. On 22-JUN-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VARIVAX. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013239.
Pt received immunisation on 8/8/07 in the morning. Same day evening, was seen at Emergency Room for urticaria, rash - all over the body. Pt was given Benadryl and Orapred - Pt was seen at office on 8/10/07 - intermittent rash - resolved urticaria - Benadryl and Orapred continued. Recovering rash.
Herpes 2 flare-up/outbreak on lower back (belt line) within 2 hours of injection into arm. Flare-ups typically happen 6-18 months. Previous flare-up was 1-2 days after first covid vaccination on 4/21/21.
Vaccine was adminstered on 4/30/10 patient c/o pain and swelling of left arm shortly after administration and progressed over the next 3 days.  Patient was then seen in the ED and admitted to the hospital for cellulitis.
Had 3 of 3 dose series of Rabies vaccine on 10/02/08 at 10:09 AM. Called center at 8:00 PM on 10/03/08 and stated injection site is red, slightly swollen and tender. Stopped at center, area is raised and red approx 2 1/2 x 2". Donor denies any other symptoms.
Very high fever for 3 weeks; Shivers; Extreme fatigue; Lethargy; GI problems; Increased  level of traponin; Very dark and itchy red rash; Very high blood pressure
Patient presented to pharmacy < 7 days after vaccine complaining of arm pain/discomfort. Was counseled to try OTC analgesics along with heating pad and mobility to help. Also advised to seek Dr recommendation/appointment if did not resolve after treatment attempt. She reappeared about a week later stating that she still had discomfort. She was still reluctant to contact primary care.
Child's arm where vaccine administered swelled to at least twice its size from shoulder to elbow and the skin is tight. Itchy and painful. So swollen it is almost purple. Hot to the touch.
Fever 101.2(AX) 7/22/08 - none 7/23/08; very mild ery surrounding 1 injection site right leg
Throat tightness, tongue numb/swelling, fever, chills, ache/joint for 12 hours.