chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possible light fever; Soreness at site of administration; Mild headache; nausea; Tiredness; Sensitive teeth/gums to cold; Sensitive teeth/gums to cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 12:15 (Lot number: EW0217) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: ADVAIR HFA taken for asthma (ongoing). Vaccination history included: Bnt162b2 (Dose: 2, Lot number: EP6955, Administrator route: Intramuscular, Vaccine location: Left arm), administration date: 24Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot number: EL3247, Administrator route: Intramuscular, Vaccine location: Left arm), administration date: 02Mar2021, when the patient was 43 years old, for COVID-19 immunization; Flu (Other vaccine 4 weeks vaccine location: left arm), administration date: 22Sep2021.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Oct2021 01:00, outcome "recovering", described as "Soreness at site of administration"; HEADACHE (non-serious) with onset 13Oct2021 01:00, outcome "recovered" (Oct2021), described as "Mild headache"; NAUSEA (non-serious) with onset 13Oct2021 01:00, outcome "recovered" (Oct2021), described as "nausea"; PYREXIA (non-serious) with onset 14Oct2021 01:00, outcome "recovering", described as "Possible light fever"; FATIGUE (non-serious) with onset 13Oct2021, outcome "recovered" (Oct2021), described as "Tiredness"; GINGIVAL PAIN (non-serious), HYPERAESTHESIA TEETH (non-serious) all with onset 2021, outcome "recovering" and all described as "Sensitive teeth/gums to cold". Therapeutic measures were not taken as a result of vaccination site pain, headache, nausea, pyrexia, gingival pain, hyperaesthesia teeth.  Additional information: Patient received COMINARTY vaccine at Workplace clinic. Patient had no known allergy. other medications the patient received within 2 weeks of vaccination: Asthma inhaler. Patient received Flu vaccine within 4 weeks PRIOR. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. No Relevant Tests and Specific relevant test for thromboembolic events with thrombocytopenia were reported. The events were reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Occasional dizziness, surges of pressure from neck to head, wobbly legs, weakness in leg
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-MAR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Red, Itchy rash on face & neck, skin hot to touch, burning sensation on face day after shot - also some edema under right eye - small sack of fluid - lasted a few days - took benadryl to relieve itching - dissapated after 4 days but skin was very dry & chapped for about 10 days after
Rash/Hives near injection site and on torso appearing within 30 minutes after vaccination
I had a moderate case of COVID in March 2021; my symptoms stopped about nine days before I received the vaccine.  About 24 hours after I received my first shot, I started experiencing a high-frequency sound in my head, later diagnosed as tinnitus.  I had never had tinnitus before this event.    The tinnitus is constant and has not ceased since that time.  The intensity varies from periods of moderate loudness lasting a month or two interspersed with shorter periods of increased intensity lasting 1-2 weeks.  On the advice of my doctor, I held off on getting the second shot in order to avoid making the tinnitus worse.  In December 2021, I got the second shot.  On my doctor's advice, I got the J&J vaccine instead of Moderna, in case the tinnitus was related to the Moderna vaccine specifically.  Since then my tinnitus symptoms have remained the same.  I plan to get my booster shot in the next few weeks.
UTI; Allergies; Fever; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI), HYPERSENSITIVITY (Allergies), PYREXIA (Fever) and COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), HYPERSENSITIVITY (Allergies) and PYREXIA (Fever). At the time of the report, URINARY TRACT INFECTION (UTI) had not resolved and HYPERSENSITIVITY (Allergies), PYREXIA (Fever) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 for one day after receiving her second COVID vaccine..         The patient had other concomitant therapy of unspecified antibiotics.  Action taken was reported as dose not changed for the co-suspect drug UPADACITINIB (RINVOQ) with respect to all the events.  It was reported that patient had unspecified antibiotics for Urinary tract infection. patient had started taking an unspecified inhaler and allergy medication for her allergies.   Patient did not agree to had physician contacted.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event of UTI was not provided. The reporter's causality for the events of covid-19, allergies and fever after covid vaccine with RINVOQ(UPADACITINIB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
onset fever 101 7PM 12JUL95; felt warm around MN called ofc 13JUL95 to report fever, no other sx; rx APAP q 4 hr; by 430-5PM Thursday; 13JUL shaking & sz like activity reported; vomited x 2; dx febrile sz;
Arm was quite sore for 3 days and felt like lymph nodes were swollen.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4295026-00 (RA). A 15 year-old patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jun2021 (Batch/Lot number: unknown) at the age of 15 years as dose 2, single and intramuscular, administration date 20Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free (1 in 1 wk.) and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free (1 in 2 wk.) for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of Admin: Intra-muscular), administration date: 20May2021, when the patient was 15 years old, for Covid-19 Immunization. The following information was reported: COLITIS ULCERATIVE (medically significant) with onset Dec2021, outcome "not recovered", described as "Ulcerative colitis flare up"; MALAISE (non-serious) with onset 2022, outcome "unknown", described as "Felt ill". The action taken for adalimumab was dosage not changed. Clinical course: In Dec2021, the patient experienced ulcerative colitis flare up. In 2022, the patient experienced felt ill. Pfizer BioNTech Covid-19 vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of ulcerative colitis flare up with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of felt ill with HUMIRA(ADALIMUMAB) was no reasonable possibility. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of ulcerative colitis flare up. 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.
local reaction of left deltoid, pain, redness, warmth and slight edema.  Denies fever. Advised to go to a doctor. Notified today.
1. Morning after, temperature was 1-1.2 degrees above normal; by afternoon, back to normal.  2. On Day 6, 6 red splotches on right arm below site.  Over next two days, spread into a 4" x 7? uniformly reddish area.  Some itchiness; some burning.  Used warm compresses, switched to cool.  By Day 10, spread on arm halted.  Itchiness elsewhere, left side of torso, small patch.  Red bumps on left leg above knee. Day 11, some fading, receding on arm. Day 12, better, but still pink, uncomfortable.  Left torso still small itchy area, tiny white bumps.  Note:  Same arm as 1st vaccine, which had no adverse effects.
sz like shaking, staring, heart beating extremely fast, breathing stop;p/mouth to mouth cries, vomit, then seems to be fine
back especially in one area started to be very uncomfortable. And then it became painful and this is still happening; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  An 83-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 30Sep2023 at 03:00 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "shingles" (unspecified if ongoing), notes: many years ago she had shingles, even before she had her first vaccine. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunisation, reaction(s): "feeling a little achy for 24 hours". The following information was reported: BACK PAIN (non-serious) with onset 30Sep2023, outcome "not recovered", described as "back especially in one area started to be very uncomfortable. And then it became painful and this is still happening". Therapeutic measures were taken as a result of back pain. Additional information: Caller had her Covid vaccine at 3 in the afternoon yesterday, several hours later she was having pain on a familiar area on her back, she had Shingles before, it is the same area where she had that back pain, she had that sensation, as she believes that will feel the sensation years after. The rest of the day and last night, she felt it, she is asking if there is anything in the vaccine that could cause these reactions because she had Shingles before. She had no issue with the previous covid shot except of feeling a little achy for 24 hours. She had this shot at 3pm and within several hours her back especially in one area started to be very uncomfortable. And then it became painful, and this is still happening. Caller added that many years ago she had shingles, even before she had her first vaccine. She knew that even years later she can still get residual symptoms from shingles. You don't breakout from a rash, but you still have pain and various things happening. She had some issues with that for years but are very mild. A few hours after having had the vaccination it became very exaggerated. She takes pain pills all the time for back issue and she stepped up the dosage time and she is still feels very uncomfortable.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Patient stated she felt funny immediately after vaccination. She desribed it as a cold feeling and could feel the shot flowing through her body, like a slight buzz.   Onsite EMS was called no abnormal vitals. By 12:23pm she stated she felt fine and went home.
On 3/17/21 patient returned to clinic complaining of sudden onset of dizziness, weakness, shaking, some SOB and anxiety. Patient reports this started suddenly at noon. She reports associated lightheadedness and difficulty with focusing her vision. She reports "feeling like I am going to pass out and not wake up". Denies nausea, vomiting, head injury, fall, slurred speech, confusion, or chest pain.  Last meal was previous night, has not eaten that day. She denies recent alcohol use, did admit to smoking marijuana prior to episode starting. She did have the Johnson&Johnson Covid vaccine on 3/12/21, only has had a sore left arm, denies other side effects. Patient was sent to the emergency department via ambulance for further evaluation. Work up at the emergency department showed bilateral pulmonary embolisms.
Immediate migraine and arm pain. 7 hours after shot, severe fever and chills, nausea. Migraine and arm pain continued into next day. Fever broke but came back, not as severely, next day.
Developed a lump and rash at site of vaccination with reddness as well as rash under (L) eye.
This case was reported by a consumer and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. On 8th July 2018, the patient received the 1st dose of SHINGRIX. On 8th July 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain, muscle pain and pain in arm. In July 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema, shoulder pain and muscle pain were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, shoulder pain, muscle pain and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received the SHINGRIX vaccine shot 4 days ago. Less than a week after receiving vaccination, the patient had experienced some of the common side effects which included redness around the site. The patient had shoulder and muscle pain and a very sore arm that is even tender to light touch. The patient felt pretty achy for the first two days and her arm soreness was still quite painful even now. The patient was concerned about the second shot in 6 months and wanted to know do people have less of a reaction with the second shot. The patient really dread the thought of this painful arm again and  do not know yet how long this pain would last and wanted any information or suggestions that would be very helpful.
Case number PHEH2011US04447, is an initial spontaneous report received from a nurse on 15 Sep 2011: This case refers to 13-year-old male patient. He received only MenCWY liquid conjugate component of MENVEO (batch number M10056), 0.5 ml, intramuscularly into his right deltoid, on 15 Sep 2011 without being reconstituted with MenA lyophilized conjugate component. Concomitantly he was also vaccinated with Hep A intramuscularly into his right deltoid, DTaP into his left deltoid and GARDASIL into his left deltoid on 15 Sep 2011. No adverse event reported. Follow up information received from the nurse on 04 Oct 2011: Updated concomitant vaccines.
pt recv vax 30SEP96 & 14OCT96 pt devel a rash which looked like a diaper rash;19OCT96 bumps devel a crusty appearance & looked like pustules;21OCT96 original rash was red & bumpy;pt had herpetic virus;MD felt was varicella rash;
1st HPV - red hot itchy arm (approx 5 cm) lasting 10 d. Started the following am. 2nd HPV - red hot, itchy arm approx 15 cm lasting 0+ days. No fever, SOB.
Pt received Pfizer vaccines on 04/24/2021 and 05/15/2021. Pt presented to the ED on 11/19/21 with complaints of AMS. Pt was found to be COVID positive and was diagnosed with COVID pneumonia. Pt was not hypoxic.
Rash on Face; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in an unspecified anatomical site on 12Mar2021 (at an unspecified age), as a first single dose for COVID-19 vaccination. The patient's medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. Concomitant medications were not reported. On 12Mar2021, the patient experienced rash on face. The patient did not receive any treatment for the adverse events. The clinical outcome of rash on face was recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
Resident given expired flu vaccine Influenza Vaccine adjuvant Fluad Quadrivalent 0.5 ml GTIN: (01): 00370461121034 SN (21): 3PWARB8CDF EXP (17): June 30, 2022 LOT (10): 312866
pt recvd flu vax 5OCT93; redness @ site of injection w/warmth;
Patient arrived 6-26 for PPD reading. C/O left arm pain and redness from MENACTRA given 2 days prior. Seen by doctor who noted +4 cm irregular shaped erythematous, tender, warm area at injection site over left deltoid. No streaking. Diagnosis cellulitis and not a local reaction. Treated with OMNICEF 300 mg BID till gone #20. Return 2 days if no better.
mom stated pt broke out in a sz 19JAN t106 to ER dx viral or pneumonia 2 days later FMD said not pneumonia viral but on ATB;
I had the vaccine on the 23rd December I was monitored for 15 mins. My throat felt scratchy and itchy, I left at 3pm by 3:15 my head started hurting, mild. at 7pm I had a pounding headache, chills, body aches on the 24th AM I could not warm up my body was shivering I went to work at 8 am I thought I had a fever and I checked it was 100.2 when I got home my temp was 101 and 102.9 and my body aches were horrible I couldn't move nausea no appetite, shortness of breath, I did a telemed and talked to my primary and she said this was all related to the vaccine, she prescribed something for the nausea was asked to get a covid test and it came back negative, I started getting better Dec 27th .
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. The patient's medical history was not reported. On 01-AUG-2017, the patient was vaccinated with VAQTA of lot # M040421 with an expiry date of 26-MAY-2017 (Strength, dose, frequency and route was not reported) for prophylaxis. On 01-AUG-2017, the patient was administered an expired dose of VAQTA (Expired product administered). No adverse effects. There was no product quality complaint involved.
8 days after the injection I got a rash at the injection site.  (COVID Arm) but I also have hives on my feet and other places on my body.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 16:00 as dose 1, single (Lot number: HH7595) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "CKD" (unspecified if ongoing), notes: CKD (post renal donation). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Jan2000; MONTELUKAST, start date: 01Jan2000; OMEPRAZOLE, start date: 01Jan2000; ADVAIR, start date: 01Jan2000. Vaccination history included: Covid-19 vaccine (Dose: 5, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 4, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown, Lot Number: Unknown), for COVID-19 Immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Oct2023) positive; (21Oct2023) negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received Paxlovid from 13Oct2023 to 18Oct2023.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 vaccine in this patient cannot be completely excluded.
Patient received MMR vaccine on 3/22/22 by LPN. He tolerated it well. On March 30, 2022 father called at 10:37am stating patient had a low grade temperature of 99.0 F that day and day before. Advised parents to monitor temperature and could give Tylenol or motrin if temp rose above 100.4. He was eating and drinking well, per dad and having wet diapers. Dad verbalized understanding and would call back as needed.  Dad called back that day at 4:12pm stating he had an unresponsive incident and some odd leg movements. It was advised at that time for him to be evaluated at ED. Parents agreed and brought him to the ED right away.  Patient was seen at ED for seizure activity, fever and rash on patient's trunk. He was evaluated and then discharged  home. Diagnosed with possible seizure activity related to fever.  Patient was seen today by Dr. for follow up appointment. Patient was happy and doing well. He is afebrile, no seizure acitivity noticed, but continues to have small pin point, raised red rash on abdomen and back. Rash believed to be related to MMR vaccine.