chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 17yo previously healthy male that presented to the ED due to a 3-day hx of chest pain in the setting of acutemyopericarditis secondary to the second dose of Pfizer COVID vaccine. On Friday, patient was vaccinated with the second dose of Pfizer COVID vaccine. On Saturday night, he started presenting with headaches, myalgia, a temperature of 100.0F, and chest pain. Such pain is sharp, mid-sternal, non-radiating, a 7/10 at it's worse, and worsened by lying down. For the chest pain he has been taken Tylenol 500mg and Ibuprofen 400mg as needed, with minimal improvement. The next day, his headache, myalgia, and high temperature resolved but he persisted with the chest pain. Today, he took Tylenol 500mg at 7:20am with minimal improvement. Due to persistent chest pain, he presented to our ED. Overall, he denies any UR sxs, trauma, SOB, emesis, diarrhea, abdominal pain, sick contacts at home, and known COVID-19 exposure. Denied any family history for sudden cardiac death, congenital heart disease, or arrhythmia. Currently not taking any medications. No known allergies. VUTD.   In the ED, CXR normal. Troponins elevated to 2.8. EKG with sinus rhythm, ST elevation with normally inflected T wave, and normal axis, intervals, and voltages. COVID ID now negative. He was given one dose of Ibuprofen at 11:30am with chest pain improvement to 2/10.   In CICU, the patient arrived at RA, hemodynamically stable, with good pulses, cap refill less than 2 secs, and chest pain 2/10.   During his hospital course, troponin uptrended to a maximum of 5.09. Repeat level in the afternoon with consistent downtrend at 2.86. EKG with ST elevations consistent with pericarditis but hemodynamically stable, with good pulses, cap refill less than 2 secs, and no chest pain. Echo with no structural abnormalities, no significant valvar dysfunction, and normal LV systolic function. CXR on 06/14 normal and in no respiratory distress. Pain management controlled with ibuprofen 600mg q8hrs and Tylenol PRN. Currently with no chest pain. Mycoplasma IgM and IgM and RPP pending and will be followed as an outpatient. Physical exam unremarkable. Will follow up with Dr. on 06/25/2021. Advised patient and family to refrain from strenous exercise for 2 weeks and no sports for 3-6 months.
Pt received shot at approximately 8:00 pm. Pt call on 10/27/14 to report the next morning (10/25/14) awakened at 1:00 AM with cheek swollen. Took aspirin at 3:00 AM.
Headache, CoughWheeze, CHILLS Narrative:  headache chills and cough for 2 days, was advised prn tylenol, increased fluids ,rest
Symptom; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Symptom) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Symptom). At the time of the report, ADVERSE EVENT (Symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
9/24/14 felt generally unwell. 9/28/14 began having morning fevers. 9/29/14 appt. with PCP, labs, xray and CT ordered. 10/1/2014 hot and cold sweats all day, felt awful, still having morning fevers to 101.8. 10/5/14 additionally started having drenching night sweats. Feeling very weak in his legs and little stamina (unusual) neck and shoulders hurt (different in quality, but such pain not unusual). Anemic; mass found on apex of left lung (benign, fiberous on removal via thoracotomy 11/21/14.) 12/2/14 PCP, repeat labs, still anemic, high PLT. 12/9/15 added visual distrubances that worsened with pixilation and dimming. 12/15/14 seen by eye doctor. 12/16/14 negative hemocult, still anemic. Increased BP. Jaw claudication. Hair pain. 12/18 vision problems continue, not able to drive at night, has lost 15#. STAT MRI, normal. 12/21/14 lost vision. 12/22 dx with Giant Cell Arteritis in ER. Prednisone started. Referred to ophthamologist who confirmed dx. 12/24? Left temporal artery biopsy, negative. No vision has returned.
The pt experienced a 3 x 2 cm area of erythema noted at injection site. No pain was experienced.
4th Dose Moderna Given Date of 3rd Dose 8/20/21 Full dose 0.5ml Given No adverse events
Sharp upper leg pain for 2 hrs then lessened. Then, 11/29/2013 PM, stomach pain, nausea & chills along with tiredness and not feeling well for more than 48 hrs. Gave Advil for pain and discomfort.
This spontaneous report as received from a health professional refers to mutiple patients of unknown ages. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004798 for prophylaxis. No adverse events were reported.; Sender's Comments: US-009507513-1709USA000508: US-009507513-1709USA000507:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021 at 2:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 80.74. No concomitant medications were reported. On 12-Feb-2021, Excursion time was 09:00 AM, temperature was 29, total doses given for the day was 55, condition of vaccine prior to administration was not frozen, The vial was initially moved to the fridge on 09-Feb-2021 and beyond use date was 10-Mar-2021. Product moved to clinic on 12-Feb-2021.The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. No treatment medications were reported.
One day following administration of first dose of Engerix B, the pt experienced a 4 X 6 inch bruised area, which resolved. Subsequent to receiving the third dose of Engerix B the pt experienced injection site pain. Three days later she experienced radiating pain from the injection site down her arm (like carpal tunnel) which was treated with Motrin. On 01/03/2000 she experienced front shoulder swelling. She was seen at Occupational Health where she was continued on Motrin. On 01/07/2000 she was seen by a physician. She was experiencing pain in the arm, shoulder and collar bone. She was treated with Motrin 800 mg. On 01/21/2000 she was seen in the ER by a neurologist with migraine, terrible neck pain, eye droop and lower lip droop. She was diagnosed with Bell's Palsy and treated with prednisone and an anti-viral drug (NOS). The most recent information received reports the condition of the pt as ongoing.
This spontaneous report was received from an office manager refers to a patient of unknown age and gender. The patient's concurrent condition included asthma. The patient's medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (MRK INJ) which was used for the reconstitution of VARIVAX. On an unknown date the patient was vaccinated with one dose of improperly stored VARIVAX (dose, units, frequency and route not reported) (lot # N020013 and expiration date: 17-JUL-2019) at a temperature from 6 Fahrenheit (F) to 14 F for 45 minutes. There was no previous excursion for the VARIVAX. No adverse effects reported. Data logger was involved. No product quality complaint was involved.
Approximately 72 hours after 2nd dose of Covid-19 vaccine, began experiencing rapid palpitations of heart that have continued on for a week after vaccination date.
after 7 days of received the 1 dose irritation start to show up at up left arm, pain in joints and itching
Patient hospitalized for Arthrosis of left acromioclavicular joint within 6 weeks of receiving COVID vaccination, then patient presented to the ED and hospitalized again for rapid atrial fibrillation.
sore arm; fever; chills; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 11:15 (Lot number: EW0217) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; PPI; LIPITOR. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Feb2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 26Jan2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (2021), described as "sore arm"; PYREXIA (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (2021), described as "fever"; CHILLS (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (2021), described as "chills"; HEADACHE (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (2021), described as "headache". Therapeutic measures were taken as a result of pain in extremity, pyrexia, chills, headache.  Additional information: The patient receive no other vaccines within 4 weeks prior to the COVID vaccine. Treatment included tylenol and advil to manage fever and headache.  Patient was not covid prior vaccination and did not test post vaccination.   No follow-up attempts are possible. No further information is expected.
Hiberix in freezer, then administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 21-APR-2022  Reporter's Comments: Health care professional reported that a nurse from the facility stored a Hiberix box in the freezer and then administered one of these doses to a patient. The professional did not had any information about the lowest temperature the vaccine was exposed at, or any sort of information about lot number and expiration date, or any information about the patient The reporter consented to follow up.
Got very dizzy next day while standing; felt like I was going to pass out/woozy feeling; Then I would get fluttering heart; sweaty; This is a spontaneous report from a contactable consumer. The reporter is the patient. A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) Pfizer BioNTech, administered in arm left, administration date 24MAR2021 08:45 (Lot number: EN6207) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Graves Disease" (unspecified if ongoing), "Laytex allergy" (unspecified if ongoing). Concomitant medications included: LEVOXYL; ATORVASTATIN CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; YUVAFEM.  Past drug history included: Synthroid reaction: "Allergy". The following information was reported: DIZZINESS POSTURAL (hospitalization) with onset 25Mar2021, outcome "recovered", described as "Got very dizzy next day while standing"; DIZZINESS (hospitalization) with onset 25Mar2021, outcome "recovered", described as "felt like I was going to pass out"/ "woozy feeling"; CARDIAC FLUTTER (hospitalization) with onset 25Mar2021, outcome "recovered", described as "Then I would get fluttering heart"; HYPERHIDROSIS (hospitalization) with onset 25Mar2021, outcome "recovered", described as "sweaty". Clinical course was the patient was very dizzy next day while standing and felt like she was going to pass out. Then she would get fluttering heart, sweaty, and woozy feeling that would just wash over her while sitting at her desk. She went to the doctor. Blookwork was normal, sugar level normal, EKG was affected. Sent her to Cardiologist.  The patient was hospitalized for dizziness postural, dizziness, cardiac flutter, hyperhidrosis, dizziness (hospitalization duration: 1 day(s)). The events "got very dizzy next day while standing", "felt like i was going to pass out", "then i would get fluttering heart", "sweaty" and "woozy feeling" were evaluated at the emergency room visit.  The patient underwent the following laboratory tests and procedures: Nasal Swab sars-cov-2 test: (Oct2021) negative; blood test: (unspecified date) normal; blood glucose: (unspecified date) normal; electrocardiogram: (unspecified date) affected. Therapeutic measures were taken as a result of dizziness postural, dizziness, cardiac flutter, hyperhidrosis, dizziness.  Treatment included nitroglycerin and cardiac catheterization. The patient received the second dose of bnt162b2, brand Pfizer BioNTech, lot number=EWz158, administration date was 14Apr2021, administration time was 09:15 AM, vaccine location was left arm.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient briefly fainted after getting the vaccine.  She was sweating and had nausea.  After monitoring, she was feeling better.
Medical Assistant removed vaccine from RN table without RN knowledge and Medical Asssistant administered Pfizer Booster Vaccine to patient before eligible booster date of 6 months without RN knowledge.  Instructions given at the start of site to not remove vaccines without RN knowledge.  Medical assistant removed and administered vaccine without RN confirmation of dates and eligibility and knowledge.  Patients second dose of Pfizer was administered 07/04/2021 and the Pfizer Booster was administered 12/14/2021. Patient was informed and date of Pfizer Booster dose documented on card for patient records and patient informed of early dose given.  Patient observed for adequate amount of time and no adverse reactions observed by RN.  Patient reported no adverse reactions or complaints to RN.
After I received the vaccine, I was asked to wait for 15 minutes, which I did, later I went to do chores, though it was rainy and cold a bit. When I came back around 4pm I was feeling okay, no sore on the injection site, unlike my regularly flu vaccines that I mostly feel sore at injection site which lasts about few hours immediately after the flu shot, so it was sort of surprising to see that but later that night, my body starts feeling weak, aches and a tangling on my feet, as the night progresses up to the early morning, I was unusually fatigued and lightheaded with the regression of the muscle aches and subsequently other symptoms started disappearing, notably, I started feeling soreness on the injection site, which lingered to the next day.
Developed symptomatic (mild) COVID 19 disease confirmed with RT-PCR oral swab and Nasopharyngeal swab
Patient felt light headed  and stated felt like fainting. She stated she was nervous about getting shots.  Monitored patient blood pressure 125/75 pulse 76 and five minutes later 123/81 pulse 80.  Patient waited 15 minutes after vaccination and stated was fine  and  did not want further intervention then left with family.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733(CLUSTER) and 2023SA057309(CLUSTER).  This case involves Child of unknown gender patient and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).   It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Patient was to receive Moderna Booster 0.25ml but was given Moderna 0.5ml. Patient notified and no adverse reaction noted
Approx 2 weeks after the vaccine I developed Tinnitus in my right ear.  Tinnitus is loud and continues.   Treatment is rehabitation with hearing aids prescriptions for anti depressants and sleeping aids In the beginning issues with dizziness.  Eustachian tube issues, ear not pressurizing correctly, ear pain continue sporadically
2nd shot was rough. Took my body about a week to regain strength. Pain was at injection site, with a heavy aweful sensation moving down my left arm, while moving up the left side of my neck into my left jaw bone, and left ear, at the same time, the same sensation moved across both shoulder blades and went into my right arm and down the right arm. Pain set in, and this intense heavy feeling stayed in both my arms for about 2 weeks. I could not lift my arms very well and had a hard time holding on to things. The heavy feeling started leaving left arm, but the right arm took longer. Once the heavy feeling left,  this horrible pain set in to my right arm, at different spots. Some days it's more intense than others. It it hard to lift things like a milk jug and pour a cup of milk, or lift laundry out of washing machine. I still have intense right arm pain and just last week the heavy feeling returned to both arms, almost like I have done a million push ups and can't lift them up. I saw my doctor and she asked me to report this.
4/23/21 received her vaccine today at 9AM. In the afternoon 3PM, she began to have wheezing, coughing and rash formation on her ears and face. She reports these are the same symptoms she has with her peanut allergy. She self-administered her home Epi-pen at directed by the 911 operator, with improvement in there symptoms. She was taken by ambulance to
the DTaP/IPV portion only of Pentacel vaccine was given to a 4 month old child; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a four months old patient who was vaccinated with a DTaP/IPV portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTaP- lot: UJ067AAA, expiry date: 13-Jun-2020, ActHIB- lot: UJ067AA, expiry date: 13-Jun-2020) via intramuscular route in right thigh on 29-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It is an actual medication error case due to inappropriate reconstitution technique. It was reported that the reported that the DTaP/IPV portion only of Pentacel vaccine was given to a 4 month old child.  It was unknown whether the patient had any adverse event or not or the patient will be re-vaccinated.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Headaches ongoing 4-5 days a week, waking up with headaches several days a week. All started occurring after vaccine administration. Under MD advisement, blood work orders, high levels of prolactin indicated. Following-up with endocrinologist as per MD recommendation. NEVER had headaches this frequent in my lifetime. Nothing was different except the experimental vaccine which I was forced to take in order to work. This week 12/7/2021, headache intensified into a full blown migraine last a couple hours. Received vaccine on October 16,2021.
Erythematous macular patch over trunk, flanks, thighs.  Pruritic with scale, blister, pustule, ulcerator. Lasted 5-7 days.