chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Time of shot/noon until 7:30 pm or so, mostly fine, just tired (napped), arm pain, headache. But around 8 maybe? sudden chills-freezing, shivering, teeth-chattering lasting maybe 30 to 45 min? then chills stopped, sudden switch to fever that kept going up despite tylenol last temp taken was 102.8 (my normal temp is about 97 and I never get fevers). Skin felt like it was burning on legs and arms, felt like rug burn. Sore throat, terrible headache...the worst of this tapered off within two hours or I would have gone to Emergency Room. Was sick for another 48+ hours but by then more mild flu symptoms not crazy horrible sickness that first night.
(Starting at about 12 hours post vaccine) Developed severe headache (turned into Migraine) that lasted about 4 days, Fever (100.8) x 24 hours (medicated with Tylenol Q 4 hours),  joint pain and fatigue. Developed moderate amount of swelling at the injection site day 2 and a large red area (about the size of an orange) that lasted over a week. The red area burned and itched.   January 1, became very ill with Upper Respiratory symtoms. Shortness of breath, wheezing, fatigue, fever. Saw PCP who tested for Covid 19 (negative) and flu (negative).  Returned to PCP on January 3 with worsening symptoms of shortness of breath. Another Covid 19 test run (negative) and presc. for Steriods given. Took 1 week to recover.
COLD SYMPTOMS (A LITTLE BIT SORE THROAT, SNEEZING); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had fever. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 24-SEP-2021, the patient experienced cold symptoms (a little bit sore throat, sneezing). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cold symptoms (a little bit sore throat, sneezing) was not reported. This report was non-serious.
My husband and I drove 65 miles to get the vaccine and I was fine at the facility and left after the mandatory 15 minutes.  At around the 25 minute mark after the shot, I got dizzy, I was hot and sweaty, had anxiety and it was hard to swallow.  I had my husband drive me to the hospital where we stayed in our car in the ER parking lot in case my reaction became life threatening.  We stayed there about an hour and when my heart rate decreased and I could sip  water again (and my anxiety subsided), then we left for home.  However when we got several blocks away from the ER, my anxiety kicked back in because we had to drive over an hour on the highway to get home so back to the ER parking lot we went. After another hour, we were able to drive home.
Rash, itching, pain at joints, headaches.  The symptoms last about 3 days and occurs weekly.
pt was only 15 when dose was given - family though it was ok since she was 15 years 11 months old
Broke out in hives on chest and arm she received vaccine.  Blisters on chest and welt on arm.  Very itchy.
pt recv vax 2NOV95 & 28APR96 pt devel 20-30 vesicles on trunk, face, arms & legs which was dx as varicella;there was no assoc fever;
Throat was blistery; Right arm was sore; Throat was red; Throat was sore; Throat was raw; Had a low grade fever; Had a low grade fever for 3 days and stayed in bed; Fatigue; Headache; Shivering; Myalgia; This case was reported by a consumer via call center representative and described the occurrence of throat blister in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included peanut allergy.   In October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than an hour after receiving Shingrix, the patient experienced throat blister (serious criteria GSK medically significant), pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia. On an unknown date, the outcome of the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia were recovered/resolved.   It was unknown if the reporter considered the throat blister, pain in arm, red throat, sore throat, raw throat, low grade fever, activities of daily living impaired, fatigue, headache, shivering and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm and her right arm was sore.  Within half hour, her throat was red, sore, blistery and raw and she had a low grade fever for 3 days and stayed in bed.  The patient's symptoms were so bad that she almost went to the hospital.  After three days, patient's symptoms resolved and she was back at work.  When reviewing the common side effects for Shingrix in the package insert, the patient stated that she had all of the following including, fatigue, headache, shivering and myalgia.  The reporter consented to follow up.
effects from this virus. He has been wearing a mask and gloves; sore arm; getting really bad; shivers; This case was reported by a consumer via other manufacturer and described the occurrence of coronavirus infection in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (refer case US2020AMR159338  for 1st dose). Concurrent medical conditions included neuropathy and blood pressure high. Concomitant products included pregabalin (Lyrica), minerals nos + vitamins nos (Centrum) and losartan.   In July 2020, the patient received the 2nd dose of Shingrix. On 9th August 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, malaise and shivers. In August 2020, the patient experienced coronavirus infection (serious criteria hospitalization). On an unknown date, the outcome of the coronavirus infection, pain in arm, malaise and shivers were unknown.   It was unknown if the reporter considered the coronavirus infection, pain in arm, malaise and shivers to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was in the hospital. he had shingles shot and had a bad reaction.  The reporter clarified that the patient was prescribed and taking Lyrica for Neuropathy.  The patient got first shingles shot on unknown date and just had a sore arm for a few days. The patient was fine before he got 2nd shot, he goes to the gym every morning. Then he got a second shingles shot, a booster, maybe 1 and half weeks ago from reporting date  and had a bad reaction to that vaccine. He had the shivers. He experienced just a sore arm initially, but a day or two later he started to feel the effects of the shot. He was not been admitted to the hospital, but had been kept in the emergency room  under observation since evening of 9th August 2020. The symptoms of patient looked more like the effects from virus hence he was kept under observation for another day. They have done all kinds of tests with unknown result. The Lot number and expiry date was unknown.; Sender's Comments:  US-Pfizer-2020307288: US-GLAXOSMITHKLINE-US2020AMR159338:same reporter
This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Having an UTI), MALAISE (Just did not feel well), HEADACHE (Slight headache), CHILLS (Developed chills so bad she was shivering) and PYREXIA (Developed a fever of 99.0) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A210A and 016M2UA or OA) for COVID-19 vaccination.     Concurrent medical conditions included UTI.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (Just did not feel well), HEADACHE (Slight headache) and CHILLS (Developed chills so bad she was shivering). On 18-Mar-2021, the patient experienced URINARY TRACT INFECTION (Having an UTI) and PYREXIA (Developed a fever of 99.0). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (Having an UTI), MALAISE (Just did not feel well) and HEADACHE (Slight headache) outcome was unknown and CHILLS (Developed chills so bad she was shivering) and PYREXIA (Developed a fever of 99.0) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 99.0 (High) Through out, the day her fever ranges from 102.8-103. On 19-Mar-2021, Body temperature: 102 (High) Around 102.         No concomitant medication details was reported. Treatment medications included acetaminophen, unspecified antibiotics, and AZO. Action taken with mRNA-1273 in response to the events was not applicable.
RSV GIVEN WITH THE HIGH DOSE FLU VACCINE 22 hours later fever, nausea and one episode of vomiting, anorexia
This spontaneous report was received from a 64 year old female patient concerning herself. Pertinent medical history: tumor in the ear. Drug reactions/allergies: allergy to codeine and allergy to muscle relaxants. Approximately on an unknown date in January 2014 (also reported as end of January) the patient was vaccinated with M-M-R II (dosing regimen unspecified) (also reported as it was suggested by CDC since patient was going out of the country). Concomitant therapies included steroids (CORTICOSTEROID (UNSPECIFIED)). Approximately on 19-FEB-2014 (also reported as about a week ago) the patient experienced joint pain in both arms (left arm), joint pain in both arms (right arm), tingling in the right fingertips, numbness in the fingertips and pain in the right arm. The consumer reported that the joint pain in the left arm was almost completely gone (approximately on an unknown date in February 2014) but all the other symptoms were still there (not resolved). Causality assessment for the events was not provided. Additional information is not expected.
Per Dr. who saw the patient,  severe diffused arthralgia in the hips and spine, headache and nauseated. Dr. advised patient to go to ER
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX for prophylaxis.  Previously administered products included flu shot (Given in October). Concomitant products included cetirizine hydrochloride (Zyrtec), acetylsalicylic acid (Aspirin (Baby)) and fish oil. On 1st June 2018, the patient received SHINGRIX. On 1st June 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. In June 2018, the patient experienced injection site erythema, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site pain and injection site warmth were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown. The reporter considered the injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The nurse calling from physician office concerned that the vaccine they ordered which was administered by the pharmacy was administered at Inappropriate Site and possibly inappropriate route (subcutaneous vs intramuscular).  The nurse states that patient received SHINGRIX vaccine on Friday 1st June, 2018 and returned to office today 4th June 2018 presenting with a red (five inches in diameter), hot, painful spot on the back of the arm in the location where a subcutaneous administration would have occurred, not at deltoid.  These events have not resolved. The nurse did not know the lot number, name of pharmacist, etc.
Patient describes redness surrounding injection site in a 6 inch ring around site. No pain or itching; no other adverse effects at this time. No treatment applied. Reported Friday morning. Injection given Wed. (time unknown).
chills; headache; muscle aches; both arms hurt; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "both arms hurt"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site ".  Additional information: Patient got her 1st dose of the vaccine on April 7,2021 and scheduled to get her 2nd dose on April 28, 2021. She wants to know if she still needs to make a reservation for her 2nd dose. She also asked if she can take a pain medication like Tylenol before and after the 2nd dose. She said she's asking for future reference only because according to her sister, the 2nd dose has many side effects. She also said she experienced pain at the injection site when she got the 1st dose that's why she's asking if she can take pain medication before and after the 2nd dose a precautionary.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Since July patient has been exhibiting extreme fatigue, headaches, dizziness, tingling in arms, hair loss, and weight gain despite no appetite
AFTER RECEIVING THE FLU SHOT, I HAVE HAD PAIN AT THE INJECTION SITE FOR OVER 5 MONTHS. IT HURTS THE MOST WHEN I LIE ON MY LEFT SIDE. I HAVE BEEN UNABLE TO SLEEP ON THAT SIDE.
I developed ringing in both ears. I had never had this condition before and it does not go away. There are days where the ringing is louder than others. It's hard to function like this.
Information has been received from a physician and a healthcare professional concerning a 14 year old female who on approximately 01-JAN-2008 was vaccinated with a second dose of Gardasil (659439/1267U).  On approximately 01-JAN-2008 following vaccination the patient experienced fainting.  Unspecified medical attention was sought.  Outcome unknown.  There was no product quality complaint.  This is one of several reports received from the same source.  Additional information has been requested. Initial and follow-up information has been received froma physician and a healthcare profesional concerning a 14 year old female who on 27-DEC-2007 was vaccinated with a third dose of HPV vaccine. (659439/1267U). At 12:15 on 27-DEC-2007 following vaccination the patient experienced fainting. In follow-up it was reported that she passed out as she was walking out the exam door. She was aware that she was fainting because she felt hot, cold, then fell to the floor. Post incident she was oriented x3 and stated "didn't know why she fainted." Unspecified medical attention was sought. Outcome unknown. There was no product quality complaint. This is one of several reports received from the same source. Additional information is not expected.
This is a spontaneous report from a Pfizer-sponsored program, PFIZER RXPATHWAYS. A contactable nurse reported that a 68-year-old female patient started to receive pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported), with route of administration and therapy dates unspecified at a single dose, for immunization; and sulfamethoxazole, with route of administration, therapy dates, dose, frequency and indication unspecified. Medical history included allergy to Iodide-containing products. The patient's concomitant medications were not reported. On an unspecified date, the patient had allergies with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and sulfamethoxazole. The action taken in response to the event was not applicable for pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein); and was unknown for sulfamethoxazole. The outcome of the event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
MMR & HEP A given 11/8/11. Mom reported on 11/15/11 that child had hives and itching surrounding the sites on both thighs ever since.
4 large bumps on legs. 2 went away after 2 month. Two remain. Had mucusy stools for two months. Went from one bowel movement a day to 6. Bright butt rash. Began having allergic reactions to multiple foods in my diet through breastmilk.
Fever,chills and uncontrollable shaking. Lymph nodes enlarged. Under layers of bedding and couldn't get warm. Fever got up to 102.5 on that Saturday about 25 hours after vaccine. Also, felt weak and very tired. Early Sunday morning about 2am, I woke up to my gown dripping wet from sweating. I changed went back to sleep and woke up again about 7am to the same thing. I did take Tylenol and Ibuprofen for the fever. I spent all Sunday in bed, no more shaking but chills and Fever persisted through out the day. Monday, I felt better initially until about 8 pm and symptoms started all over but harsher because know my Lymphedema flared up
first dose on 2020,not received any additional doses; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 9th March 2020 with batch number 9355D and expiration date 14 March 2022.).   On an unknown date, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose of Twinrix series and then forgot to come back in for next dosing. Till the time of reporting, the patient had not received any additional dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
warm, red, swollen @ inj site, poss cellulitis; 4MAY94 f/u rtn'd to clinic 2FEB94 w/large red circle; hot, itchy, 8cm; given Cortaid to apply;returned 4FEB94 w/spreading rash on lt arm; hot, red, swollen; Rogephin & Cipro;
Mom says that after shots pt had stiff joints (wouldn't move arms and legs well) and had a vacant stare for 2 weeks. Also she says that she and brother got gastro 2 weeks after rotavirus. At time of shot now 21 weeks
blood clots; his arm felt sore, almost like he had just received the vaccine; doctor thinks it has something to do with the heart; low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced THROMBOSIS (blood clots) (seriousness criterion hospitalization), PAIN IN EXTREMITY (his arm felt sore, almost like he had just received the vaccine), CARDIAC DISORDER (doctor thinks it has something to do with the heart) and HYPOTENSION (low blood pressure). The patient was hospitalized on 08-Apr-2021 due to THROMBOSIS. At the time of the report, THROMBOSIS (blood clots), PAIN IN EXTREMITY (his arm felt sore, almost like he had just received the vaccine) and CARDIAC DISORDER (doctor thinks it has something to do with the heart) had not resolved and HYPOTENSION (low blood pressure) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. On 08 Apr 2021, the patient's arm felt sore, "almost like he had just received the vaccine".  He went to urgent care, and they sent him to the hospital and he was admitted.  The patient said his doctor thinks the blood clots had something to do with the heart.  The patient thought it had to do with the vaccine because he has "always been healthy" and never had any heart problems.  The patient was still in the hospital at the time of this report. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Doctor thinks "thrombosis" has something to do with the heart
Drug ineffective; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26May2023 at 10:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2 NOS), on 03Oct2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had no known allergies. The following information was reported: COVID-19 (medically significant) with onset Sep2023, outcome "recovered" (Sep2023), described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset Sep2023, outcome "recovered" (Sep2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 18Sep2023 to 23Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314716 same patient, different drug/AE;