chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About nine hours after the injection, I started getting body aches and low grade fever. By midnight my temperature was 100.1 with chills and sweating. Intense body aches in whole body, especially back  and vey painful injection site. I halos had a headache and trouble sleeping. I too Tylenol at 5:00 a.m. and was able to sleep three hours. I took Tylenol/ibuprofen every 4 hours until evening. I was fatigued all day and spent the day sleeping/resting, which is very unusual. By 4:00 p.m.  I was mostly feeling normal. Other than arm pain, I am fine today.
Alcoholic cirrhosis with ascites, Hepatic encephalopathy, Spontaneous bacterial peritonitis. She underwent paracentesis that day but unfortunately no labs were sent.  She was treated with an insulin drip and her blood sugars were controlled.  She was switched over to a basal bolus regimen.  She had a repeat paracentesis just 2 days after the first due to reaccumulation of ascites.  This fluid was sent off to the lab and identified a spontaneous bacterial peritonitis.  Cultures grew Lactobacillus jensenii.  Patient was treated with antibiotics and continued to improve. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
C/O hives on her face after the second vaccination. Patient went home after symptoms was resolved.
Pt became light-headed 5min after recieving vaccine. A witnessed syncopal episode occurred with LOC for 3sec. Pt was AOx4 after the event. Vitals WNL. Evaluated and monitored by Medical staff and EMS. Pt fully recovered after 20min of observation and released.
Pfizer-BioNTech COVID-19 Vaccine EUA Headache, lasted around 2 days. Sore throat and post-nasal drip, 2 days fever cough
This case was reported by a consumer via call center representative and described the occurrence of erythematous rash in a 55-year-old female patient who received SHINGRIX for prophylaxis.  Concomitant products included SHINGRIX. On 20th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 20th June 2018, immediately after receiving SHINGRIX, the patient experienced erythematous rash. On 6th August 2018, the patient experienced itchy upper limbs and rash. On 7th August 2018, the patient experienced blister. In June 2018, the outcome of the erythematous rash was recovered/resolved. On an unknown date, the outcome of the itchy upper limbs, rash and blister were not recovered/not resolved. It was unknown if the reporter considered the erythematous rash, itchy upper limbs, rash and blister to be related to SHINGRIX. Additional details were provided as follows: The patient did not have lot numbers or expiration dates. On 2nd April 2018, the patient received 1st dose of SHINGRIX (refer linked case US2018143071). The patient received 2nd dose of SHINGRIX on left deltoid. The patient experienced large rash that was super red about the diameter of a grapefruit after the second  dose of the SHINGRIX series, which lasted for 4 days. Forty seven days after receiving SHINGRIX, the patient experienced spot on the thigh, itching and a rash in the opposite arm. Forty eight days after receiving SHINGRIX, the patient experienced few blisters on the thigh.
a shroud was lifted; She continues to have tinnitus at this time.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (a shroud was lifted) and TINNITUS (She continues to have tinnitus at this time.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Long haulers COVID-19) in April 2020. Concomitant products included VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (a shroud was lifted) and TINNITUS (She continues to have tinnitus at this time.). At the time of the report, FEELING ABNORMAL (a shroud was lifted) was resolving and TINNITUS (She continues to have tinnitus at this time.) had not resolved.            Patient had reported that in April 2020, she had experienced headache, tinnitus really loud, cough, fever, exhaustion, brain fog, and respiratory distress. These got worse for 29 days before improving but never went away. She felt as if something had entered her body for 29 days.  Patient also thinks she had a cytokine storm for 5 weeks sometime in 2020. In February 2021 she had another respiratory thing, felt horrible, could not walk more than a few miles, and continued to have fevers, tinnitus, brain fog, and exhaustion. She had covid-19 tests within 48 hours and 60 days of first experiencing symptoms.   Patient reported of taking CoQ 10, zinc, vitamin D, Claritin, and ecstasy for her symptoms. The only thing that seemed to have helped was electrolytes, which would seem to help the next day which she liked to consume through a coconut water protein drink. .She started to exercise but without repercussions.    This case was linked to MOD-2021-376668 (Patient Link).
Itching at site about 24 hours after receiving. Friday 1/11/14 went to sore/painful/burning itch/redness started 1/11/14 red getting worse. Area 1/2 dollar size; red; warm to touch, sore to touch left arm. 1/11/14 nausea (15 mino) dizziness) later pressure behind eye; hot flashes.
Uti subsequent to both shots...also had fever and nausea after second one.  Was fine after first.  Did have Covid in February
pt recv vax APR96 & pt dx w/hepatic hemangiomas;A nuclear scan revealed that hemangiomas were non-cancerous;
This spontaneous report was received from a physician and a medical assistant concerning a 13 year old patient of an unknown gender. Concurrent conditions, medical history and allergies were not reported. On 26-MAR-2015, the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, route and anatomical location were not reported) (lot # K006124, expiration date: 02-FEB-2017) that was improperly stored. No adverse effects were reported. This is  one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning an adult dialysis patient between the age of 60-80 years who was vaccinated with a three dose series of RECOMBIVAX HB. It was reported that the patient had antibody titer that was less than 10 mIU/ml. A product quality complaint was not involved. Additional information has been requested. This is one of the several reports received from the same source.
Patient fainted two minutes after receiving vaccine. Loss of consciousness was not total. Patient was pale, clammy, and lethargic. Patient's mother and myself held patient is place while she recovered in chair. Resolution was within 15 minutes from start of episode. Followed up with mother two and one-half hours post incident and mother said patient was completely recovered.
Covid19 breakthrough.  1st vaccine 01/12/2021.  Pt expired.  86 y/o PMH HTN, Afib, CVA, Right ICA with stent, Hepatitis A, ischemic bowel/ileostomy and chronic mandibular osteomylitis presented to ED.  Per pt's daughter, pt with cough, generalized weakness, hyperkalemia and large volume output from ileostomy.  1st Covid test on 1/1/2022 negative.  Pt started on IV AbX.
This case was reported by a pharmacist and described the occurrence of muscle soreness in a subject of unspecified age and gender following vaccination with Fluarix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On or before 10 November 2006, the subject was vaccinated with Fluarix. At an unspecified time after vaccination with Fluarix, the subject experienced extreme muscle soreness that lasted four days or more with swelling from the shoulder to the elbow. Further information was unknown.
Lips and tongue became numb, throat felt itchy, severe nausea, headache, chest tightness, rash - first neck and face then rash progressed to a diffuse rash over entire body. I was on my way home and drove to Er and was seen. I was given Zolfran, Pepcid Solumedrol, Benadryl and Epinephrin.
sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information regarding treatment was provided. Action taken with the drug in response to the event(s) was not applicable
Allergic to Prevnar 13 due to tetanus in it; This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable physician reported that a 78-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was allergic to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) due to tetanus in it. She could not have pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) due to Diptheria and Tetanus Toxoid In injection. The outcome of event was unknown.  Information on the batch number has been requested.
Numbness of tongue on 4/15/21 Right facial droop on 4/16/21 Went to ER on 4/16/21
Large bruise on patients left shoulder. She says she noticed yesterday (10/30) around noon.
Redness and swelling with warmth at injection site, approximately 6 x 8 cm.  No fluctuance or drainage
developed pericarditis after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERICARDITIS (medically significant), outcome "unknown", described as "developed pericarditis after receiving the vaccine".  Clinical course: Reporters wife developed pericarditis after receiving the vaccine. This adverse event was reported within the 24 hour time frame. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "pericarditis" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available.   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.
PT rcvd vax; pt exp cervix disorder & spotting during pregnancy; pt had labor abnormality & menstruation disorder;
1 of 4 pts vaxed from the same lot# (a total of 90 patients vaxed from this lot) during month MAY95 who exp fever & inj site rxn w/in 224-48hrs following vax;recovered;
Low-grade fever, chills, aches, nauseous, fatigue, headache , tender and painful at injection site
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient of an unknown demographics who received vaccines FLUZONE QUADRIVALENT (lot number, expiry date, dose, expiry date, route and site of administration were not reported) but was supposed to receive FLUZONE HIGH DOSE (lot number, expiry date, dose, expiry date, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to wrong vaccine administered. It was reported that administered FLUZONE QUAD to a patient but was supposed to be FLUZONE HD. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
This spontaneous report as received from a physician via a company representative and a nurse refers to a 11 year old female patient with asthma, common season allergies and cephalexin allergy. On 18-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number# not provided). Concomitant therapy included unspecified allergy and asthma medication. The patient immediately started feeling tingling in her face as well as pressure in her face on 18-AUG-2014. The patient was kept in the physician's office for 30 minutes after the GARDASIL was administered for observation. The patient experienced "paralysis on the side of her body and was unable to walk, dragging her one leg." The patient was taken to an unspecified emergency room and was released, without admission to the hospital, with a diagnosis of anxiety. Patient was fully recovered on an unspecified date in August 2014. Upon internal review, "feeling tingling in her face as well as pressure in her face, paralysis on one side of her body and was unable to walk, dragging her one leg, diagnosis of anxiety" was considered to be medically significant. Additional information has been requested.
1st shot, fever of 104.5 for 4 days, body aches and chills. 2nd shot, high fever for 5 days with highest of 105.1
UNEXPLAINED SEVERE, CUTTING, HOT, DEEP, INTERNAL-TORNADO LIKE PAIN TO LEFT SHOULDER; EXTREME FATIGUE AND UNABLE TO CARE FOR MYSELF/3 VERY STRANGE EPISODES WHICH LEFT HER VERY DRAINED; FEEL WEAK; DIZZY/OFF BALANCE; HURT ALL OVER/INCREASE IN NECK AND BACK PAIN; TEETH CHATTERING; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight was 220 pounds, and height was 67 inches. The patient's past medical history included right shoulder arthroscopy, and weakness, and concurrent conditions included chronic pain homebound patient with scoliosis, bone spurs, spine curvature /abnormalities, abnormal muscles, degenerative disc disease, penicillin allergy, non alcoholic, non smoker, and sick w/ scoliosis at age 16, and other pre-existing medical conditions included the patient had allergies and no drug abuse or illicit drug usage.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. Concomitant medications included hydromorphone hydrochloride, and oxycodone. On 11-JUN-2021, the subject experienced dizzy/off balance. On 11-JUN-2021, the subject experienced hurt all over/increase in neck and back pain. On 11-JUN-2021, the subject experienced teeth chattering. On 11-JUN-2021, the subject experienced feel weak. On 13-JUN-2021, the subject experienced unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder. On 13-JUN-2021, the subject experienced extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from feel weak, teeth chattering, dizzy/off balance, hurt all over/increase in neck and back pain, unexplained severe, cutting, hot, deep, internal-tornado like pain to left shoulder, and extreme fatigue and unable to care for myself/3 very strange episodes which left her very drained. This report was non-serious.
Moderna vial was placed in fridge on 01/01/22. The Moderna vial with lot number of 041J21A has not undergone a temperature excursion. Moderna booster (0.25ML) was administered to the patient on 02/07/22 at 8:15AM. Patient has not reported to the Medical Clinic with symptoms at this time.
Swelling, warmth 2 days after injection, then swollen lymph node 3 days after injection.
redness on his right eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (redness on his right eye) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007MD0A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 26-Feb-2021, the patient experienced OCULAR HYPERAEMIA (redness on his right eye). At the time of the report, OCULAR HYPERAEMIA (redness on his right eye) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Has been vaccinated with Pfizer back in December-January 2021. Developed symptoms of headache and cough after getting exposed to her coworker.
10 minutes following injection patient became lethargic and slow to respond to verbal stimulus. She reported nausea and stated that it was "hard to breathe". 911 was called for transport to ER, EPIPEN 0.3mg was administered, patient was transported to ER via EMS.
Post vaccine day 8 localized redness, warmth, swelling and firmness at vaccination site for 1 day
Pt recvd vax & exp nausea, vomiting & diarrhea; treatment Phenergan for nausea & Imodium for diarrhea;
Patient fainted while waiting  in the chair after the dose was administered. The pharmacy technician ran to the patient and put him in the ground on his back. Technician had him inhale alcohol swab and patient regained consciousness within 30 seconds. EMS and code was called at the meantime. EMS was cancelled when patient gained consciousness. We observed the patient for 15 more minutes and he walked out without any other issues.
Patient C/O of Left arm feeling like a burning sensation and broke out in a rash around injection site starting on 02/19/2018 around 12:48 PM.
Unrelenting chills for nearly 24 hours, extreme weakness, literally couldn't get off the couch - when I did, felt as if I was going to faint, pass out. Unable to eat - absolutely no appetite only had a little clear soup and 1/2 a piece of toast the entire day. I didn't have this reaction after the first shot in January - just a very sore arm - which I also have this time. I know these symptoms can be expected in some patients, but I am reporting this because of the severity - I felt so very sick and weak, unable to walk but a few steps without feeling I was going to pass out. The shot was Tuesday afternoon, it is Thursday - no more chills, but still so weak that I have not gone out of the house and cancelled two appointments.
Genital herpes outbreak on the day after receiving the vaccine, which otherwise is quite rare for me.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 31Mar2021 at 09:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. Concomitant medications were not reported. The patient had known allergies to alendronate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 17:00 (also reported as on the day after receiving the vaccine), the patient experienced genital herpes outbreak, which was quite rare for the patient. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event genital herpes was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
LOCALIZED REACTION: SWELLING AND REDNESS AT SITE. SMALL RED BUMP AT INJECTION SITE.
random  itchy bumps now near armpit and on stomach; This is a spontaneous report from a contactable consumer (patient).  A 55-years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 13:15 (Batch/Lot Number: ER8T35), age at vaccination of 56-years-old, as single dose,for covid-19 immunisation. Medical history included overweight from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOXYL) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID AC) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; cyclobendazole (CYCLOBENDAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin for drug hypersensitivity, BNT162B2 dose 1, administered in Arm Left on 26Mar2021 13:15 (Batch/Lot Number: ER8727) for covid-19 immunisation and experienced rash pruritic and herpes zoster.  On 08May2021 (3 weeks after the 2nd dose) the patient kept getting these random itchy bumps now near armpit and on stomach. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 19Apr2021 Nasal Swab. The patient had not recovered from the event.  No follow-up attempts are needed. No further information is expected
Pt has localized pain at site of injection, had vomiting, and fever.  He is unable to move arm.
p/vax pt exp a mild ataxic gait & had repeated falls;pt was eval by neuro;f/u indicated MD was unaware of any post vax ataxia;MD indicated pt exp vesicular rash;ataxia & vesicular rash were considered other medical events;