chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives; Itching; Bumps; Thinks it indicates this is an allergic reaction; This is a spontaneous report from a contactable consumer. This 22-year-old female consumer reported for her mother stating that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced hives, itching, bumps, thinks it indicates this is an allergic reaction. Caller received her first dose of the Pfizer covid on 12Mar2021. Caller stated that her reaction happened the day of, not sure if it was a reaction. My mother had reactions to the vaccine also and called earlier this morning and reported to Pfizer, she had hives and I want to make sure she was okay with what I was experiencing. Caller states 13 minutes into the 15 waiting she was fine and she am fine now, she had severe nausea, felt like she was going to throw up, my heart beat started racing, she felt disoriented, she had difficulty breathing, for only a short time. She thought these because she was panicking because she thought she was going to throw up. She had chills and my hearing went muffled for ten seconds, then I was fine. At the vaccination site she was sitting in the middle of the room, when it happened, I panicked for 60 seconds and then it went away, I think a minute to a minute and a half, She had nothing since then. The caller received her first dose on Friday and she went with her mother. The caller's mother developed hives and itching and bumps which the caller thought it indicated this is an allergic reaction. The clinical outcome of events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Left arm - swelling around shot sight - swelling in hand couldn;t make a fist - red and hot around injection. Lips and hand tingles. Relieved with antihistamine. Scary side effects for person.
Day after vaccine (about 18 hours after) body aches, chills, headache. Lasted for about 24 hours. About 12 hours later, nausea and lightheaded.
Fever; Weakness; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and weakness. On an unknown date, the outcome of the fever and weakness were unknown.   It was unknown if the reporter considered the fever and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had fever and weakness. The reporter asked how long did the fever and weakness last after the 2nd Shingrix shots.
Atrial fibrillation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (COMIRNATY), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, Single, Moderna), for covid-19 immunization, reaction(s): "Atrial fibrillation"; Moderna covid-19 vaccine (DOSE 2, Single, Moderna), for covid-19 immunization, reaction(s): "Atrial fibrillation". The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown". Therapeutic measures were taken as a result of atrial fibrillation. Clinical Information: Information was received from a Consumer/other non health professional concerning a Female patient, enrolled in the post marketing study A non-solicited program in which a patient received a product. : NON-SOLICITED-OTHER STUDIES who received Suspect product APIXABAN for atrial fibrillation (from 2022), lot number:Unknown. On an unknown date, the patient experienced hypoacusis(hard of hearing) which was considered not serious. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN medication is unknown. Concomitant medications were not reported. The reporter did not provide a causal assessment for event hypoacusis to product APIXABAN. Reporter stated that after the first two COVID-19 shots and the 1st booster shot, she started having atrial fibrillation and that is when she started taking Eliquis. First two shots were the Moderna COVID-19 vaccine and only her booster shot, which was caller's 3rd dose, was the Pfizer COVID-19 vaccine. Follow-up was not performed as the reporter denied consent for further contact. Tracking of Changes: 10-May-2022: Initial information was received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Diffuse hives-like rash beginning day 6 post 1st booster shot of Pfizer COVID vaccine. Mildly itchy and mostly noted on trunk, flanks, thighs, inner upper arms and wrists. No particular reaction noted at the injection site.
C/o throat itchy/scratchy, blurry visiton, "not feeling right".
This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 59-year-old female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date 30th June 2016). On 2nd October 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 2nd October 2015, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site induration. On 3rd October 2015, the patient experienced injection site erythema and injection site tenderness. On an unknown date, the outcome of the injection site induration, injection site erythema and injection site tenderness were not recovered/not resolved. The reporter considered the injection site induration, injection site erythema and injection site tenderness to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor and a health department. The patient herself was a healthcare professional. The patient experienced induration of 4 x 3 cm at the injection site (left deltoid). On 3rd October 2015, 1 day after receiving the vaccine, the patient experienced erythema and tenderness (pain) at the injection site along with arm pain. No other details were provided at the time of the reporting. This case has been linked to other two patients for experiencing induration after receiving the vaccine from the same vial (see cases US2015142208 and US2015142209).
pt recv vax 6AUG97 & pt became pregnant between 29OCT97 & 2NOV97;LMP 15OCT97;8JAN98 it was reported that pt had a spontaneous abortion & was dx w/an empty sac/blighted ovum @ 12 wk gestation;
Pepper spray feeling in mouth; Numbness around lips; Slight tightness of throat; Headache; Jaw pain; Ear pain; Chills; Neck stiffness; Arm pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Er8733), via an unspecified route of administration in the right arm on 30Mar2021 at 09:00 (at an age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient had an allergic reaction to ocrelizumab (OCREVUS). The patient did not receive any other vaccines within four weeks prior to COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 30Mar2021, about 5 to 10 min after vaccine, the patient experienced pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain and ear pain. 12 hrs later, the patient still felt the same, but experienced chills, neck stiffness, arm pain. The events resulted in emergency room/department or urgent care visit. The patient did not receive any treatment for reported events. The clinical outcome of events pepper spray feeling in mouth, numbness around lips, slight tightness of throat, headache, jaw pain, ear pain, chills, neck stiffness, pain in arm were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
My lymph nodes were very swollen on my right arm. I also developed headaches, fatigue and body aches. Consulted with my PCP who suggested a mammogram and an ultrasound. Both done at Hospital. It shows lymph nodes are swollen and a follow up appointment has been schedule for 3 months. If they are still swollen a biopsy will be made.
fever; the back of my neck and chest felt warm; nausea; chills; tiredness in the neck; very intense heaviness in the nape.; had general tiredness; This is a spontaneous report from a contactable consumer or other non hcp. Received from Pfizer Colleague. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot Number: AW0198)), dose 2 unknown, administered in the left arm on 23Jul2021 at 15:15 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Jul2021 at 15:35, the patient experienced tiredness, very intense heaviness in the nape. On 23Jul2021, the patient had general tiredness. On 23Jul2021 at 20:00, the patient had, chills, fever. On 24Jul2021 at 11:00, the patient had fever, the back of my neck and chest felt warm. About 20 minutes later I started to feel very heavy / tired on the back of my neck. The sensation disappeared 20 minutes later. In the late evening the patient had general tiredness and around 20:00 the patient had nausea and chills. The next day, at 11 a.m. The patient started to feel a fever, the patient did not measure my temperature, but my neck and chest felt warm, so the patient took a 500 mg Tylenol tablet. The fever sensation disappeared at about 13:30 pm. Therapeutic measures were taken as a result of, fever (pyrexia), the back of my neck and chest felt warm (feeling hot). The outcome of the events tiredness, very intense heaviness in the nape recovered on 23Jul2021 at 15:55, had general tiredness, nausea, chills, was unknown, fever and the back of my neck and chest felt warm was recovered on 24Jul2021 at 13:30. Additional information: My second dose of Comirnaty was administered to my left arm on July 23, 2021 at 3:15 PM. About 20 minutes later I started to feel very heavy / tired on the back of my neck. The sensation disappeared 20 minutes later. In the late evening I had general tiredness and around 8 I had nausea and chills. The next day (July 24), at 11 a.m. I started to feel a fever, I did not measure my temperature but my neck and chest felt hot, so I took a 500 mg Tylenol tablet. The fever sensation disappeared at about 1:30 pm.  Follow-up attempts are possible; information about batch number will be obtained.  Follow-up (25Oct2021) new information received from same contactable consumer via email included: Lot and clinical information was updated.  Follow-up attempts completed and no further information is expected.
Arm pain began roughly 2 hours after injection. By 8 hours the arm was a 7/10. The following day the pain was 9/10 for the majority of the day. Today the pain has significantly diminished to 2/10. No other symptoms.
This spontaneous report was received from a registered nurse refers to a 0 month old male patient. On 22-JUN-2014 at 10:40 am (same date that the patient was born) the patient was vaccinated improperly stored dose of RECOMBIVAX HB intramuscular, dose 1, Lot # J012520, Expiration date: 30-JAN-2016 (dose was not reported). No adverse symptoms reported. It was reported that the vaccine storage temperature dropped to 0-1 degrees (units not reported) for 18 different episodes according to minimum/maximum. All recorded temperatures were within 2-8 degrees (units were not reported). Additional information is not expected due to all follow ups requested to complete the case were received.
This spontaneous report was received from a nurse and refers to a 2 female patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB injection, (lot number N002202, expiration date: 04-NOV-2019) (exact dose, route of administration were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested.
17 YO PATIENT.  2 PFIZER PRIMARY.  TEAR PAD, TEAR STRIP, VACCINE CARD, AND VACCINE LABELED MODERNA BOOSTER #1.  CONSENT RECEIVED BY MOTHER FOR  CONSENT.  MODERNA BOOSTER ADMINISTERED LEFT DELTOID.  NO COMPLICATIONS.   OBSERVATION FOR 15 MIN WITHOUT INCIDENT.
noted a rash at the base of his spine and had nerve pain radiating from his spine to his crotch.  The skin area is very sensitive to touch and clothing. Immediately started taking his famvir
I began to experience tinnitus in my left ear within days of receiving my second shot of Pfizer. It is pulsating, low buzz tinnitus. I have never experienced tinnitus in my life. It is terrible. I saw an ENT who confirmed that I have no hearing loss, but spoke to me about tinnitus and what I can do to "get used to it" basically.
(3/21) Generalized aching & fatigue at first then neck & shoulder pain. (3/26) Missed day of work & pain increased & started having weakness in the left arm. Was seen by provider on 4-2-2012 without intense pain over left shoulder extending to cervical spine with weakness & loss of motion. Dx: Arthus reaction to Tetanus prophylaxis.
productive cough of yellow-green sputum and low grade fevers. starting 9/4/21
Seizure occurring at 0700 in dining room, 1 episode, unresponsive for 2 minutes, after episode experienced general weakness then shortly was able to walk after, vitals stable after
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not reported. On 28-JUL-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (dose and route were unknown, lot # L044694, expiratory date 04-FEB-2018), which was exposed to temperature excursion of 49 degrees Fahrenheit (F) for 64 hours. There was no previous temperature excursion. Data logger was not involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hypotension and diaphoretic, pale. Epinephrine 0.3 ML once.
Apparent Genital Herpes on penis. Rash and small blisters. 10 days  used Preparation H. Also Back pains started several days later.
Dehydration; Fever; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of DEHYDRATION (Dehydration), PYREXIA (Fever) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DEHYDRATION (Dehydration), PYREXIA (Fever) and HEADACHE (Headache). In February 2021, DEHYDRATION (Dehydration), PYREXIA (Fever) and HEADACHE (Headache) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was provided. No treatment information was provided  Action taken with mRNA-1273 in response to the events was not applicable.
I had no reaction to first shingrix shot 2 months ago. This second shot,  experiencing muscle soreness around shot site, fatigue, fever 99.8, chills within 12 hours of vaccination. Restless sleep that night. In morning,  nausea and dry heaves until pain relieved by several BMs, Slept all day, no appetite. Fatigue next day but no fever.  I have no reason to think this is COVID; however, Iwill be tested today (to protect family I live with)
pt devel fever, cellulitis & upper arm swelling p/vax;pt was treated w/DPH & has recovered;addtl recv 30JUL96 & pt was also treated w/ATB & advil q 6hr;
77 yo male pt s/p Pfizer COVID vaccination: dose 1 on 2/18 and dose 2 on 3/11. Past medical history of CLL on acalabrutinib, atrial fibrillation, type 2 diabetes, and hypothyroidism who presented to the ED on 8/26. His presenting symptoms were cough, weakness, rhinorrhea, clear sputum, and diarrhea. While in the ED he was found to be positive for COVID-19 with fevers of 101.1 He was started on Remdesivir on the evening of 8/26. Sputum cultures were collected and Initial chest X ray was negative for any acute processes. He had new hypoxia on 8/28 requiring supplemental oxygen. Given his new hypoxia and positive COVID test, he was started on a 10 day course of dexamethasone. Repeat Chest Xray on 8/28 showed multifocal hazy airspace opacities consistent with covid pneumonia. He was empirically started on ceftriaxone 8/28. On 8/29 his sputum cultures were positive for Klebsiella Pneumonia that was susceptible to ceftriaxone. His supplemental oxygen was titrated to a maximum of 6L on 9/2 and eventually weaned off until he was back to his baseline of room air on 9/8. Patient completed a total of two courses of Remdesivir on 8/26-8/31 and 9/2-9/5. His Ceftriaxone was completed on 9/4 for a total duration of 8 days. At his time of discharge, patient was maintaining his saturations on room air. Additionally he was started on 2.5mg Eliquis BID for 30 days given his increased risk of hypercoagulability post-covid infection.
Adverse reaction apparent significant gastrointestinal discomfort for one week, beginning approximately 2-3 days after vaccination date, and diarrhea for 2.5 weeks, also beginning 2-3 days after vaccination date.  Diarrhea was dark green and mucousy, 8-12X per day, child still had plenty of wet diapers and did not require hospitalization.
Immediately after the injection I had numbness and tingling in my left hand.  12 hours after the injection I had severe chills,  a severe headache, hand tremors and nausea  which lasted for several hours.  The headache (less severe) and hand tremors lasted for several days.
Parents report late at night child became very fussy, felt hot to touch, gave infant Tylenol according to dosing on bottle, and noted child had a rash and question of swelling to feet bilat. Child is acting and playing normal other than being clingy.
L/leg swollen due to injections. Rash in face. Sent child to ER. Dx:L/leg cellulitis.
Varivax and Proquad was administered to the same patient at the same visit. The Medical Assistant who administered the immunizations did not know varicella was part of proquad. The parents of the patient was contacted and the patient had no adverse signs or symptoms. The Medical Assistant who administered the immunization received education on immunizations, was counseled on reading all labels, and participated in creating a label making it easy to identify between the MMRV and MMR to prevent this from happening in the future. The office will be educated on this.
Severe hyper-allergenic reaction at the injection site. Eventally blistered and scabbed. Still have a scar.
dizziness; he couldn't stand up; he laid down the bed would float; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry: Apr2021), via an unspecified route of administration on 09Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included retired, he became allergic to penicillin when he was 17 year old and hasn't taken it since, lost his taste and smell, potassium is high sometimes - the doctor recommend he cut down on banana and potatoes, extra heart beat, stomach acid, and thyroid disorder. Ongoing concomitant medications included levothyroxine sodium - has been taking it for a year and a half to two years for thyroid, metoprolol succinate - has been on it about a year and half because an EKG showed he had an extra heart beat, and omeprazole capsule - been on it two or three years for stomach acid. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and experienced allergy. After having a Pfizer shot on Saturday, he had a reaction - dizziness. His wife also received the COVID vaccine but did not have any reaction. He sat in the office for 15 minutes like he was supposed to. He drove home and was fine. Two hours later he was so dizzy he couldn't stand up. He was holding onto things to walk through the house. That was two hours after he took the vaccine. After that he thought it would go away in a day. All day yesterday, which was the second day, he was still dizzy. If he laid down the bed would float. It was an awful experience. He received the vaccine at 11:45am on 09Jan2021. Two hours later is when it started. He had to hold onto the rail to get up there. If he gets up quick it is still there. He just had blood work and was due back in Apr for check up. He hasn't had taste and smell for four years or better. He lost his taste and smell and never got it back. He doesn't know what caused that. He hasn't been sick. Outcome of the event dizziness was recovering, for the other events was unknown.
Swelling, erythematous, tender induration down right arm 2 1/2 inches, surrounded by erythema about 2 inches. Warm to touch. Dx localized cellulitis. Tx with Cephalexin 500mg tid x 7 days.
This report was received from the investigator on 07 June 2010. A 20 year-old male subject with no significant medical history received the following vaccines on 27 January 2010: ACAM2000 (lot number not reported); TYPHIM Vi (lot number not reported; H1N1 (manufacturer unknown and lot number not reported); and ANTHRAX (other manufacturer and lot number not reported). Twenty-five days after vaccination, the subject was diagnosed with acute idiopathic pericarditis. On day 25 (21 February 2010), the subject had a Troponin I of 6.44 (abnormal); an abnormal electrocardiogram; and a normal echocardiogram. The outcome was not reported. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
fever started the morning p/DTP & the site was red & hot; fever was 103 x 3 days & the thigh devel red streaks to the groin; pt seen by MD dx cellulitis; swelling lasted 6 days;