chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 y.o. male with non contributory PMHx presents with chest pain. Patient began not feeling well on Monday May 3rd with muscle aches, sore throat, dry cough, and headache. Received COVID vaccine on Apr 30. He woke up Friday May 7 he developed a fever to 102F. Went to urgent care yesterday was diagnosed with strep based on suspicion (negative rapid, culture pending) and started on amoxicillin. Rapid covid was negative at that time as well. Now presents for chest pain. He has woken up that last two mornings with chest pain (worse when laying flat), pain is substernal, sharp/throbbing, radiates to the left arm. Belching a lot. Palpitations and one episode of emesis prior to arrival. Suspected symptoms were from gas so took charcoal tablets prior to arrival without relief of symptoms. Has been taking ibuprofen for discomfort (400 mg every 4-6 hours for > 7 days). No shortness of breath. No abdominal pain.  No diarrhea. No hematuria or dysuria. No family history of sudden cardiac death or significant for CAD.  No known tick bite. Of note, received Pfizer dose 2 3d prior to symptoms starting.   Presented to ED earlier tonight where exam was notable for: Low-grade temp, mildly hypertensive with otherwise stable vitals, appears uncomfortable, belching, neck is supple without meningismus, bilateral tonsils 1+ with exudate, oropharynx is erythematous, uvula midline, no trismus, no swelling,  lungs clear, regular rhythm mild bradycardia, no murmurs rubs or gallops, abdomen is soft and nondistended with mild tenderness in epigastrium and right upper quadrant they did  ECG, bedside Echo, Strep PCR, zofran, maalox, pepcid, IVF, tylenol, and labs which were notable for elevated troponin -> 13.58 d/w YSC Ped ED and tx   Assessment:   Patient is a 17 y.o. male previously healthy who presents with 1 week of malaise, and 3 days of intermittent substernal chest pain (now resolved), found to have elevated troponin and ST segment elevations in I and lateral leads c/f myopericarditis. Etiology is unclear at this time, likely viral vs post-vaccine. Exam notable for exudative pharyngitis, however Strep and CMV neg. EBV serology with positive EBNA only. Labs otherwise notable for elevated CRP 180, ESR 38, some transaminitis, ferritin/D-dimer wnl. COVID RNA neg, spike Ab positive c/w recent COVID vaccination. Normal function on ECHO. CRP continues to downtrend. Troponin has started downtrending again and pt remains asymptomatic.        Plan   Plan:   #Myopericarditis - Repeat echo today  - q8 troponin, AM CBC, CRP, ferritin - Motrin 400mg prn - steroid taper per Rheumatology recs             30mg PO BID for 7 days             30mg PO qday for 7 days             15mg PO qday for 7 days             7.5mg PO qday for 7 days             2.5mg PO qday for 7 days             Off - f/u ID and rheum labs - continuous telemetry: patient at high risk of arrhythmia   #FEN/GI - Regular diet - strict I/O - Pepcid 20mg BID   #dispo - steroid taper sent for delivery to bedside - upon d/c start ASA - f/u cardiology - If echo today reassuring and troponin continuing to downtrend will plan for discharge this afternoon
Started feeling a little weird and dizzy about 4 pm on 08/04/07.At 6:30pm I felt nauseated and cold with chills.Around 9pm I was having severe body aches and flu like symptoms with fever and limited range of motion to my RT.arm .I took Ibuprofen and went to bed.Woke up 08/05/07 with continued symptoms and lost of appetite that lasted until 08/07/07. I continued to take Ibuprofen around the clock with little relief. Too nauseated to drink or eat much at all.On 08/06/07 I went to work and reported this to several staff members and Chief Nurse. Noted continued swelling to Rt.deltoid and warmthness to the touch. On 08/07/07 I reported and showed RN and CMA the noticable swelling of my arm through my shirt sleeve that appears to be cellulitis. Also reported to Rn,Chief nurse per tc.Today I continue with swelling and stiffnes with limited range of motion to arm, tenderness and warmthness to the touch,loss of appetite,dehydration, dizziness and queasiness with alternating hot and cold flashes.
Redness/itching//swelling at injection site, headache, numbness and tingling in hands and feet, joint pain and stiffness in hands, metallic taste in mouth, parts of legs and arms have episodes or shooting pain and a warm feeling, some toes are separated on each feet
This spontaneous report as received from a consumer refers to her friends daughter of unknown age. On an unknown date, the patient was vaccinated with GARDASIL (lot #, dose and route not provided). On an unknown date, the patient experienced uterine cancer. At the time of the report the outcome of the event was unknown. Upon internal review, uterine cancer was considered as medically significant. This is one of two reports received from the same source. Additional information has been requested.
Patient came in with swollen left thigh and knee and was hot to the touch. The whole thigh was swollen. No fever.
Rash; 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 RASH (Rash) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter   Reporter did not allow further contact
Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, chills/ fatigue Narrative:
son-law are also tested positive for Covid last week; son-law are also tested positive for Covid last week; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient experienced tested positive for covid last week The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on unknown date    .  The clinical course was reported as follows: Caller mentioned they were all in quarantine right now for Covid because her grandkids had Covid. So, her daughter and son-law were also tested positive for Covid last week and they were vaccinated, except for the kids. The kids can't be vaccinated yet and hopefully this will get approved pretty quickly for the kids.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Skin rash Client took COVID-19 (Moderna) vaccine on 1/27/21. 9:15 am. At 6:00 pm, started itching. Reported it today 1/28/21.  Has mild rash to both arms. No other symptoms.  Has not sought any treatment.
I had both doses of the Moderna vaccine and my only adverse event would be a COVID arm after the 2nd shot. It took 1 week for the covid arm to resolve. On 8/1/2021, I started to come down with cold like symptoms. I had a runny nose, no cough. The next day, 8/2/2021, I had runny nose, cough started and chills. On 8/3/2021, I was still not feeling well and I went to get a rapid COVID test nasal swab, which came back negative. On 8/4/2021, a low grade fever came on. On 8/5/2021, I notice blood in my urine and my doctor recommended me to go to the urgent care. I went to urgent care and was positive for UTI and I was prescribed Cipro for infection. On 8/7/2021,  my fever was high at 101 and I had pain in my abdomen and back pain.  My oncologist recommended  I go to the mini ER. They did a COVID PCR test, which was positive for COVID. They also did urinalysis (normal). My kidney functions were abnormal and I am on chemo so I had to be admitted to the hospital. I was transferred from the mini ER to another facility for 2 nights. I was monitored  and once my levels and functions were back to normal, I was discharged to go home and quarantine.  I do not know how I caught COVID. I always wear a mask and I have not been around anyone who had COVID.
immunocompetent patient was administered of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old female patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   On 22-JUN-2023, the patient received Shingrix. On 22-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: immunocompetent patient was administered of Shingrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter reported that a 19 years old immunocompetent patient was administered of Shingrix. The reporter consented to follow up. The patient received Shingrix below than the recommended age schedule, which led to inappropriate age at vaccine administration.
The patient is a recalled reservist preparing to deploy over seas.  The pt received AVA #1 on 9/18/09.  He had no local reaction.  On 9/20/09 the pt noted generalized body achiness (7/10).  That evening he noted chills and a minor sore throat.  He denied: fever, cough, sneezing, rhinorrhea, or congestion.  The pt took MOTRIN and on 9/21/09 am his muscle achiness was improved but he had a decreased appetite, no N, no V, no diarrhea, no abd pain.  He continued with a "minor" sore throat until 9/22/09.  When the pt awoke on 9/22/09 he noted difficulty opening the MOTRIN bottle.  He also had difficulty with tying his shoe laces and buttoning his shirt.  Later on the 22nd he received the SMALLPOX, TDAP and FLUMIST vaccinations.  On 9/23/09 the pt's symptoms of bilateral hand weakness were worse so he went to hospital for evaluation.  The pt was referred to the health center and Neurology.  When evaluated on 9/24/09 he stated that he was slightly better in that he could tie his shoes more easily.  He also noted that for the last 12 hours he had some intermittent tingling in his index and middle fingers (bilaterally).  The pt denied lower extremity symptoms or issues with swallowing, speech, ocular symptoms, or visual changes.  The exam revealed hand weakness, no shoulder, arm or neck weakness.  No sensory deficits.  The pt was also evaluated by Neurology on 9/24/09.  See ahlta note for details.  MRI of C Spine and labs were ordered (see results below).  On reevaluation by neurology on 9/28/09 it was noted that the "symptoms have dramatically improved.  The exact etiology of his transient weakness is unclear-given the mild elevated CK along with mild generalized myalgias and weakness without sensory symptoms or reflex changes, would consider a postvaccinial myositis.  GBS seems unlikely and there is no evidence to suggest a central etiology."  The pt was released to full duty without deployment restrictions from a neurological standpoint.  The pt was referred to Hematology for evaluation of an elevated PTT X 2.
Patient requested flu vaccine on his paperwork. Computer did not flag that he had already received one a month prior. Patient did not have any adverse events
inadvertently given an expired Menveo vaccine; This case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date February 2020) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient received the vaccine which was already expired in February 2020.
Information has been received from a RN concerning a 72 yr old male who on 23Nov05 was vaccinated IM in the arm with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot unspecified). Secondary suspect vaccinations included a dose of influenza virus vaccine (unspecified) given in the same arm as the pneumococcal 23v polysaccharide vaccine. On 23Nov05 the pt developed swelling and itching at the injection site. Unspecified medical attention was sought and the pt was given over the counter medications to calm his symptoms and he recovered (date unspecified). No product quality complaint was involved. Additional information has been requested.
Arm was red, swollen after immunization. Patient had continued pain of entire arm 1 month after immunization. Given steroid course.
She woke this am with raised, red, itchy rash on trunk, back, thighs, and scalp. No fever. No respiratory symptoms. She states her glands may feel slightly swollen, like she has a sore throat.
numbness/tingling in arms and legs; migraine; fever; chills; Extreme fatigue; SOB; numbness/tingling in arms and legs; This is a spontaneous report from a contactable other hcp. A 28-year-old non pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 intramuscular, administered in the left arm on 28Jan2021 18:30 (at the age of 28 years old) dose 1, single for COVID-19 immunisation at public health clinic/veterans. Patient was not pregnant at the time of vaccination. The patient's medical history included anxiety, and migraine. Patient had no known allergies. Concomitant medications included bupropion. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 18Feb2021 at 12:00, the patient experienced extreme fatigue, SOB, numbness/tingling in arms and legs, migraine, fever, chills. No treatment was given. The clinical outcome of the events was reported as recovered on an unspecified date of 2021.  No follow-up attempts are possible. No further information is expected.
Received shot Monday night, awoke yesterday with swollen lips and tingling in mouth, had some bumps around site, as better today without swelling but states she was itchy around lips. Denies any new foods, denies latex allergy, denies reaction to any prior vaccine.
That night, around 9 pm - from the time I got the shot until then I was fine. At 9 pm, I came to my dorm and I got hot and woozy. My friend told me that my forehead was puffy (swollen). I laid down and I realized I was really really cold but skin was hot to touch. I think I had a fever.  I was shaky and shivery and trembling. I tried to take a nap. Fell asleep for an hour - don't remember that time at all - but my friend told me I went to sleep. My smart watch was telling me my heart rate was 120s and 130s while I was sleeping. I debated whether I should go to the Dr. and I called the school police and they took me to the ER   - at 03:00 am on the 8th - and they told me to rest for  day and wait it out. I still feel like I have a lot of adrenaline - my watch says that my heart rate is way to high for what I'm doing. It's usually in 70's and 80's but it's in the 120's and 130's every day and I am really shaky with adrenaline. I have had a headache since Wednesday night and it hasn't gone away. If it goes past Wednesday, I will go to my primary care doctor but otherwise no treatment at this time.
Radiating pain from shot location down into elbow-started within 4-5 hrs.
Patient developed an abscess that was warm to the touch, red, and painful to the child, we did an I&D and cultured, culture came back as a sterile abscess, it accumulated again and we did another I&D with culture and it also came back as sterile.
Patient with limp, normal reflexes, able to bear weight after dtap and hib were given in left leg one day ago. Likely local vaccine reaction and no signs of joint disease or more severe vaccine reaction at this time. Gave motrin in office and discussed using ice and motrin for next 24 hours around the clock, then as needed. If persisting in 2 days, please return or call.  If unable to bear weight or any other concerning changes, call/go to ED.
rednessat the injection site; swelling at the injection site; This spontaneous report was received from a safety clinical coordinator and a nurse referring to a 4 years old female patient. Her concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not provided.  On 14-AUG-2019 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) ; 1 dose subcutaneously for prophylaxis.  (strength, anatomical location were not reported); Lot  number S006833  has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date as reported  02-SEP-2020 , and upon internal validation established as the same. Other suspect therapies included sterile diluent, with Lot number: N030845 and expiration date: 12-JUN-2020 lot number: N028091 and expiration date:10-MAR-2020; lot number: N028744 and expiration date: 11-MAR-2020; and lot number: N028746  and expiration date: 17-MAR-2020; which the lot check  for all numbers was requested by the reporter and upon internal review all number were verified.   On 14-AUG-2019,  the patient experienced "redness and swelling at the injection site".  The events were treated with Benadryl and ice; Laboratory diagnostic or studies were not reported. The outcome of injection site erythema and injection site swelling was reported as resolved on the same day.  The casualty assessment between measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), the sterile diluent and the occurred events was not reported. This is one of several same reporter cases.; Sender's Comments:  US-009507513-1908USA007079: US-009507513-1908USA007529:
Left Temple Sunken in after the vaccination.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 12:45 (Lot number: EW0182) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "thyroid slower" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]; PROGYLUTON; EUTIROX; OLLY ACTIVE JOINTS; PROTEINS. Past drug history included: Salmon, reaction(s): "Allergies salmon". Vaccination history included: Bnt162b2 (Product: COVID 19, Brand: Pfizer BioNTech COVID-19, Lot number: EW0153, Lot unknown: False, Administration date: 16Apr2021, Administration time: 07:15 PM, Dose number: 1, Vaccine location: Right arm), administration date: 16Apr2021, for COVID-19 immunisation. The following information was reported: ADVERSE EVENT (non-serious) with onset 07May2021 13:00, outcome "not recovered", described as "Left Temple Sunken in after the vaccination.". The event "left temple sunken in after the vaccination." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of adverse event. Additional Information: Vaccine Facility Type reported as, Pharmacy or Drug Store. No other vaccine in four weeks. Patient had taken Other medications in two weeks: Prelosec, Progyluton, Eutirox, Olly, Proteins. No treatment AE. No COVID prior vaccination. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Full body joint aches starting approx 10 hours after injection. lasting strongly until 27 hours after injection. Minor joint aches continuing at least 32 hours past injection. Treated with regular doses of acetaminophen or ibuprofen. Severe full body chills, starting approximately 11 hours after injection.  Treated with multiple heavy blankets and heating pad while attempting to sleep.
pt seen w/several papules lesions on 10JUN97;By 11JUN97 they became vesicular (20-30 lesions);
Received MMR and chicken pox on 2-11-02. On 3-3-02, pt had petchial hemophagus throughtout body. Hospitalized with thrombocytopenia surpura with decreased platelets and bruising, IVIG given Transferred from one hospital to another on 3-5-02
30 hours after injection, she had diffuse redness and itching in her left upper arm and forearm(ipsilateral arm of injection) that was also on her chest and abdomen. She has photos on her phone. Right hand felt numb. Interestingly, the symptoms spared approximately 10 cm around the injection site. She had mild joint diffusely. No fever but had chills. She took 25 mg of Benadryl and her symptoms significantly improved after about an hour.
infection; Abnormal nose bleed with blood cloths the first day; Abnormal nose bleed with blood cloths the first day/6 more nose bleed that it was taking me to control up to 30 min; This is a spontaneous report from a contactable other HCP (patient). A 75-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), via an unspecified route of administration on 15Mar2021 10:45 (at 75 years old, not pregnant), single dose for covid-19 immunisation. Medical history included Type II diabetes, Hypertension, GERD and hypercholesterilymia, sulfa allergy, all from an unknown date. Concomitant medications included verapamil; rosuvastatin calcium (CRESTOR); metformin; omeprazole, unspecified blood thinners. The patient previously took tetracycline for known allergies: Tethracycline. Patient experienced abnormal nose bleed with blood cloths the first day (reported as 30Mar2021 0130). Five days later in two days had 6 more nose bleed that it was taking me to control up to 30 min. She went to ER in the morning and had a CBC having results normal with normal levels of platelets. She was referred to PCP. She saw a NP next day and gave me referral to ENT specialist. Using an scope could not find anything and ordered to have CT Scan. Results show negative for polips, tumors and show only a shadow by eye socket which MD believe it was an infection that was leading to the bleed. Prescribe a very small amount of Amoxicilline 125 mg, twice a day for 7 days plus a saline gel. Patient had the last nose bleed at midnight. For 3 days did not have any bleeding until today, at 10:15 am, with heavy bleeding which took me 15 min. to control. She has no history of nose bleed, taking blood thinners, no head traumas either. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The outcome of the event infection was unknown, other events was not recovered.; Sender's Comments: Information provided was so limited to prevent a meaningful and definite medical assessment for the events. A causal relationship cannot be completely excluded for BNT162B2 injection and development of Thrombosis and Epistaxis, only based on a plausible chronological sequence. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.