chrisvoncsefalvay/vaers-outcomes huggingface dataset:
R Shoulder developed 3cm pruritic, eurythmic area of vaccine w/in 10 min of administration.
Numb sensation in shoulder and neck. Lasted 1 day. Developed headache that lasted 1 1/2 weeks. Felt extremely tired but couldn't sleep. Felt like he was "on drugs". Felt like his mind was "racing". His concentration was affected while he had the headache.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tinnitus-Mild, Additional Details: patient fint for 2 minutes but recovered consciousness
MODERNA COVID VACCINE #3 GIVEN 01/06/2022, LOT # UNKNOWN; pt brought to ED with flu-like sx, non-productive cough and diarrhea; found to be positive for COVID; started on steroids; stable on RA initially, encephalopathy worsened; brain imaging was unremarkable; respiratory status worsened; O2 supplementation and ABX given; pt was DNR/DNI; given Decadron; condition continued to worsen; status changed to comfort measures and pt passed away in the hospital
Took 1st oral Typhoid capsule 6/17/11, had rash on face that resolved. Took 2nd oral Typhoid capsule 6/19/11 resulting in rash on face, arms, legs/pruritic. Took oral BENADRYL. Stopped taking oral Typhoid. Resolved in 3 more days.
Drug administration error. Cough. A non-serious spontaneous report of got two doses of FLUMIST the same day and experienced coughing has been received from a licensed practical nurse (patient's grandmother) concerning a four year old male, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications included were not reported. On 27 Oct 2009, the patient received two doses of FLUMIST. The patient was inadvertently given two doses of FLUMIST by his elementary school on 27 Oct 2009. The reporter indicated a contributing factor was there were two children with the same name. He "coughed a lot" during the night. He has no other symptoms. The outcome of the medication error was considered resolved. The outcome of the coughing was not provided. The reporter stated the cough lasted for approximately one week. On 03-Nov-2009, the event of coughing resolved. The outcome of the medication error was considered resolved. On 18-Feb-2010 additional information was received and incorporated into case: event outcome for coughing. Required follow-up attempts have been performed, requested information unable to be obtained. 18-Feb-2010.
Patient stated he did not have his vaccine record but was determined to be eligible based on the information he gave about his previous vaccinations. This was a incentive vaccination event and the patient just wanted gift cards. We found out he was given his bivalent booster a month earlier when we were at the same site.
Patient reports sudden muscle weakness on her left arm after injection. Patient reports not being able to raise her arm and having hard time to lift objects even though they are not heavy.
Horrible body aches and chills that began approximately 12-15 hours after injection and continues for 12+ hours. Fever began approximately 12 hours after vaccine was given and lasted 24+ hours. Headaches horrible and are still intermittent after 24+ hours.
Small scattered Rash on body. Low grade temp 99.6. Resolved 3 days Calamine/BENADRYL.
Screaming, Dermatitis, Coma  A male rcvd Hibtiter, DTP,  and poliomyelitits virus vac on 5/10/99.  The pt was rcving ephedrine for tx of nasal obstruct. Same day developed rash and began screaming. He was "Hypnotised" on 7/19/99.
Terrible back pains, light headed, hard at breathing, tightness in chest, weak.
I think it helps in my pain that I used to have; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. Medical history included pain from an unknown date. The patient's concomitant medications were not reported. The patient got the vaccine on 29 and just at the site where patient got the needle, that is it and right now, it actually be going away, patient put hand up on it and didn't even feel it, patient was not throwing up, have no headache, no body ache. Patient was doing fine so far it is just 2 day, patient was not in any pain. Actually, patient think it help in pain that patient used to have. The occurrence date was Dec2020. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Acquired chicken pox, low grade temp, symptoms lasted 3 days. Sym included vomitting, red sores on torso and face. Given tyl. 1st first day only.
12/05/21 presents to ED for "nausea/vomiting/diarrhea and shortness of breath with associated fevers and chills". PMHx of "hypertension, pre-diabetes, diverticulosis, OSA, HLD and depression"
THE DAY FOLLOWING THE VACCINE MILD COLD SYMPTOMS OCCURRED.  STUFFY NOSE AND SCRATCHY THROAT.  TWO DAYS AFTER THE SYMPTOMS BECAME MORE SEVERE AND FORCED ME TO STAY HOME FROM WORK.  I ALSO BEGAN TO EXPERIENCE STIFFNESS IN MY LEFT ARM WHERE THE VACCINE WAS INJECTED.  I ALSO HAVE A RASH ON MY LEFT THIGH.  I DO NOT KNOW IF IT IS RELATED
Upper left arm developed a rash, became itchy, noticeably hotter than the other arm, sore/tender, and swollen.
Large lump hard "3 inches. Does not bother unless he puts pressure.; His arm is swollen where he got the shot; This is a spontaneous report from a contactable consumer or other non-HCP (patient's wife). An 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on 05Mar2021 (age at the time of vaccination 86-years-old), as a single dose for COVID-9 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date, the patient experienced Large lump hard "3 inches. Does not bother unless he puts pressure; and His arm is swollen where he got the shot. Patient did not received treatment for adverse events. Caller stated, should he take the second dose. The outcome for all the events was unknown.  No follow-up attempts are possible. No further information is expected.
PATIENT ALERTED US ON 6-18-21 THAT EXACTLY 2 WEEKS AFTER HIS VACCINE HE WNET TO THE DOCTOR FOR SHOULDER PAIN AND HAD A SUPERFICIAL BLOOD CLOT. THEY PERFORMED AN MRI AND DETERMINED BLOOD WAS STILL FLOWING SO THEY DETERMINED NO TREATMENT WAS NECESSARY
Localized erythema surrounding pustule with lymphangitis spread to axillary lymph node.
No adverse event; Received 0.25ml instead of 0.5ml of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25ml instead of 0.5ml of Bivalent Booster).    No concomitant medications were reported.  It was reported that 20 adult patients received 0.25ml instead of 0.5ml of Bivalent Moderna COVID-19 Booster from end of August to middle of October 2022.   No treatment medications were reported.  This case contains information for the 3rd of 20 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-662871, US-MODERNATX, INC.-MOD-2022-662849, US-MODERNATX, INC.-MOD-2022-662859, US-MODERNATX, INC.-MOD-2022-662863, US-MODERNATX, INC.-MOD-2022-662865, US-MODERNATX, INC.-MOD-2022-662866, US-MODERNATX, INC.-MOD-2022-662869, US-MODERNATX, INC.-MOD-2022-662873, US-MODERNATX, INC.-MOD-2022-662876, US-MODERNATX, INC.-MOD-2022-662879, US-MODERNATX, INC.-MOD-2022-662958, US-MODERNATX, INC.-MOD-2022-662995, US-MODERNATX, INC.-MOD-2022-663011, US-MODERNATX, INC.-MOD-2022-662875, US-MODERNATX, INC.-MOD-2022-662881, US-MODERNATX, INC.-MOD-2022-663016 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662871: US-MODERNATX, INC.-MOD-2022-662849: US-MODERNATX, INC.-MOD-2022-662859: US-MODERNATX, INC.-MOD-2022-662863: US-MODERNATX, INC.-MOD-2022-662865: US-MODERNATX, INC.-MOD-2022-662866: US-MODERNATX, INC.-MOD-2022-662869: US-MODERNATX, INC.-MOD-2022-662873: US-MODERNATX, INC.-MOD-2022-662876: US-MODERNATX, INC.-MOD-2022-662879: US-MODERNATX, INC.-MOD-2022-662958: US-MODERNATX, INC.-MOD-2022-662995: US-MODERNATX, INC.-MOD-2022-663011: US-MODERNATX, INC.-MOD-2022-662875: US-MODERNATX, INC.-MOD-2022-662881:Patient 3 US-MODERNATX, INC.-MOD-2022-663016:Patient 3
Vaccinated at 8:30AM.  Abrupt onset on extreme dizziness at 11AM.  Passed out for 4 hours in a recliner at Noon.  When awoke at 4PM was unable to sit, stand, or walk.  Had to crawl to bathroom.  Symptoms largely abated by 7PM.  Was able to participate in 2 hours of outdoor vigorous racket sports the following morning.  No apparent residual effects.
Case number PHHY2013US025419, is an initial literature report received on 13 Mar 2013. The author reports a case of Evans syndrome following influenza vaccine. This report refers to a 50-year-old male patient. He was vaccinated with influenza virus vaccine (manufacturer and batch number: unknown) on an unspecified date. On unknown date, four days after vaccination he presented to an emergency department (ED) with gum-bleeding and painless discoloration of his right hand for 1 day. Upon examination, he had bilateral petechial lesions on his sclera and multiple petechial lesions on his soft palate. A purpuric rash was noted on his left forearm, and he had ecchymosis on his right thenar eminence. He had a platelet count of less than 5 k/1/4L and a WBC count of 3.6 k/1/4L. In addition, thrombocytopenia was seen with a peripheral blood smear. The patient was admitted and treated with prednisone. However, his platelet count did not improve. He was treated with immune globulin, and his platelet count increased to 70 k/1/4L. He was discharged with a prednisone taper. One week later (unspecified date), he returned to the ED with gum-bleeding. His WBC count and haemoglobin level were 20.6 k/1/4L and 8.7 g/dL, respectively. His platelet count was less than 5 k/1/4L. A peripheral blood smear revealed thrombocytopenia with occasional spherocytes, and he also had a hypercellular marrow with erythroid and megakaryocytic hyperplasia. He was treated with immune globulin and methylprednisolone. His condition improved gradually, and he was discharged on prednisone. At last follow-up, his platelet count had improved to 200 k/1/4L. Causality of the events was not reported. The outcome of the events was not reported.
Pt to ED 11/6 for cough. Pt COVID+ 11/6, pt denies feeling short of breath, chest pain, or in respiratory distress. 11/7 pt alert and oriented x4 with some anxiousness, on room air. 11/9 Reports productive cough that is worse at night, shortness of breath with exertion, and reports wheeze occasionally. Pt discharged 11/11.
Syncopy, hit my head, out for approx 5 minutes.  Went to the ER, had a head CT which showed orbital fractures from the fall.
Metal taste in my mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metal taste in my mouth) in a patient of an unknown age and gender 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 DYSGEUSIA (Metal taste in my mouth). At the time of the report, DYSGEUSIA (Metal taste in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
pt received 2 hep vaccinations at birth (6/9/2008 523am, 6/11/2008 1000am). pt developed severe constipation two days later. one er visit, barium enema, office visit with primary physician
Pain in left arm and shoulder, up and down arm 09/17/2020 @ 8:30. no redness, swelling, etc identified at any period of time.
Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient reported not having eaten since previous day in the afternoon, briefly experienced syncope and fell out of chair that he was seated in while waiting 15 min after given first dose of covid shot, patient waited full amount of time and felt fine after 15 min
States after the 1st two doses, she had little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (States after the 1st two doses, she had little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (high blood pressure) and Kidney failure (stage 3 kidney failure).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (States after the 1st two doses, she had little sore arm). At the time of the report, MYALGIA (States after the 1st two doses, she had little sore arm) outcome was unknown.            Concomitant details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-308166, MOD-2021-308184  (Patient Link).
Initial and follow-up information has been received from a physician and a health professional concerning a 17 year old female who on 08-AUG-2007 was vaccinated with a first dose of Gardasil.  Concomitant therapy included hormonal contraceptives (unspecified). On 13-AUG-2007 the patient experienced dizziness, difficulty breathing and blurred vision.  Unspecified medical attention was sought.  At the time of the report, the status of the patient was unknown.  No laboratory or diagnostic tests were performed.  In follow-up the health professional reported that the physician did not believe the patient's symptoms were related to the vaccination with an onset of at least 3 days after the vaccination and were not reported to a health professional until one week following the vaccination.  The physician reported that the patient is a "nervous" person who may have "exaggerated" the experience.  Additional information has been requested.
4/11 Sunday afternoon fatigue and tired. 4/11 Sunday night into 4/12 Monday morning woke up with severe coughing, heart racing, and a rash. The rash was present on the right side of body, chest, arm, ribs. The rash was round bumps, raised, bright red, severe itching, and warm to touch.  The rash and itching presented for 5 days. Tuesday severe headache and body aches present in addition to other symptoms. Heart racing continues still to this day 4/18.
The next morning I woke up a little after 6 a.m. to use the bathroom and started having increased a heart rate, pounding heartbeat. That that was alarming and scared me so I went to urgent care. When I checked it myself before going to ER it was up to 160 beats a minute.
Information has been received from a Registered Nurse for a GARDASIL (lot # was unknown), a pregnancy registry product, concerning a 20 years old female patient. The patient's history of previous pregnancies and live births was unknown. The patient was vaccinated intramuscularly with first dose of GARDASIL (lot # was unknown), on 27-Apr-2012, was subsequently determined to have pregnancy (LMP was on 09-APR-2012 and an EDD was on 14-JAN-2013). Nurse Practitioner reports that "a first trimester dating ultrasound performed on 4-Jun-2012 determined fetal age to be 8 weeks and 0 days". Concomitant medications included: ibuprofen, which nurse reported the patient took 2-3 times and stopped as soon as she realized she was pregnant. Initial exposure to GARDASIL was at 2 week(s). The patient was exposed to GARDASIL during trimester 1 and 2. No treatment information was reported. The patient sought medical attention in an unspecified way. No adverse event was reported. Follow-up information was received from the licensed practical nurse. On 25-MAY-2012, pregnancy test was positive. On 17-AUG-2012 fetal survey showed 18 5/7 weeks. On 17-AUG-2012, maternal serum alpha-fetoprotein (MSAFP) was unlimited (at 18 2/7 weeks of pregnancy). On 25-OCT-2012, glucose test was elevated (at 27 1/7 weeks of pregnancy). On 25-OCT-2012, GTT (glucose tolerance test) was normal and on 18-DEC-2012 Group B streptococcus (B-strep) was negative (at 36 1/7 weeks). At 39 3/7 weeks of LMP, on 10-JAN-2013, the patient delivered a male infant via vaginal delivery. The outcome of vaccine exposure during pregnancy was reported as recovered/resolved and the pregnancy outcome was live birth on 10-JAN-2013. The infant was born normal with no congential anomalies. APGAR scores were 8 in 1 minute and 9 in 5 minutes. The birth weight was 8.75 pounds and length was 141 centimeters. Additional information is not expected.
Administration error. FDA approved ZOSTAVAX vax for 60 years old persons. Patient is 54. The day after vaccination pt was feeling well for 24 hours. After 24 hours pt. was tired, malaise feeling following vaccination. Patient taled to ER Director to explain her situation. She asked the Dr if she could have the ZOSTAVAX vaccine under the age of 60 years he approved the vaccine for economic reasons. Pt. also mentioned to him that she had chicken pox as a child and exposure in health care practice.
approx 10 hr p/receiving vax, developed onset induration & inflammation @ site, reached maximum 8 cm, w/central 2 cm vesiculation, p/24 hr; rx DPH 50 mgm q 6 hr, topical 1% HC cream; faded gradually over next 5 days;
couldn't sleep; sudden hearing loss; complete hearing loss a few days later/hearing loss in right ear; constant humming in her right ear/getting hissing in my ear; arm felt tender; This is a spontaneous report from a contactable consumer (patient).   A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was either: EL1283, CL1283, or LL1283) on 11Jan2021 at 11:00 at single dose in left arm for COVID-19 immunization. Medical history was none. There were no concomitant medications. Patient previously took pneumonia shot on an unknown date and flu shot in Oct2020 for immunization. Patient got the first dose of the vaccine on 11Jan2021 at 11:00 in the morning. On 11Jan2021 her arm felt tender where the needle went in.On 12Jan2021 late afternoon, she started getting hissing in her ear that was still there and had not gone away at all and she also had a constant humming in her right ear. By 13Jan2021, she still had the humming.  She saw an ENT on 13Jan2021 and doctor didn't know if it was correlated to the vaccine or not; doctor took some wax out of her ear and she seemed to get relief from the hissing for about 15 minutes but about 15-20 minutes later the hissing/ humming continued. On 14Jan2021, woke up with complete deafness in right ear. Immediately called ENT doctor and did a hearing test. Patient could not hear and they confirmed she had sudden hearing loss in her right ear on 14Jan2021, she had nothing in her right ear (as reported). They put her on 40 mg a day of Prednisone (20mg tablets) and so far, prednisone hadn't done anything: originally taking prednisone 40mg for four days and was taking two a day;  on 16Jan2021 when she was getting no relief and couldn't sleep due to the humming in her ear, she called doctor and was advised to take the 40mg together in the morning, she will take 40mg a day. On 19Jan2021 she took 20mg for four days and then decreased by half again. She was also advised by doctor to take 25mg Benadryl (UPC: 30048284 Lot: SPS023 Exp: Jun2022) at night. They are scheduling her for an MRI in Jan2021.Patient was also scheduled for the second dose on 01Feb2021 and will be on the prednisone until 26Jan2021; she would like to know whether the prednisone will diminish the effectiveness of the vaccine. She also asked  if there was a certain amount of time she should wait to restart in case the doctor decided she should not get the second dose; she also wanted to know if she should wait on the second vaccine and maybe start over in two months.She was concerned and wanted to know if she should proceed with the second shot. The patient underwent blood work on an unspecified date to see if she can receive contrast for an MRI. She never had problem with MRI contrast before. Final outcome of the events was reported as unknown.
The day after injection, patient developed a reddened, raised area at the injection site. She took Benadryl and Vistaril, as well as apply ice and the redness decreased. She did develop a blotchy rash 5 days after injection which she described as itchy and all over her body.  She reported that she had continued Benadryl and Vistaril. She did not develop any distress with her breathing although she thought her lower lip might have been slightly swollen a few days ago. She reported this on 5/11/22 wit a call to the clinic and was seen today 5/12/22
1-3-06 seizure in mild duration seen in office 1-4-06, 1-10-06 EEG done-abnormal EEG findings potentially epileptiform
This case was reported by a pharmacist and described the occurrence of influenza in an adult subject of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). On an unspecified date in 2007, the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix, the subject experienced influenza and lack of efficacy. The pharmacist did not have all the details regarding the event, but did confirm at least two weeks or more had passed since the administration of Fluarix. Relevant test results included a "quick flu test" that diagnosed the subject with the flu. At the time of reporting the outcome of the events were unspecified.
Major swelling, numbness, bleeding externally on the skin when given, bruising under the skin on arm, yellowing of skin in area of vaccine, arm feels "funny" and soreness in area, patient needs to wiggle fingers in order to feel arm.
Patient developed rash, soreness, swelling around the injection site later on that day. Patient describes that it does not seem to be improving 48 hours after the injection.