chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days post-vaccination developed rash, muscle aches, nausea, diarrhea,  vomiting and fever. 10 days post-vaccination admitted to hospital with acute kidney injury and hypotension.  Released on oral steroids for presumed hypersensitivity reaction.  Admitted second time 36 days post-vaccination rapid worsening of rash, nausea, vomiting, diarrhea, fever and hypotension.  Discharged to community on oral steroids
Vasovagal Syncope- fainting about 15 hours after the 2nd dose vaccine was administered. Contacted PCP for consult.   Brain fog, headache, nausea, body aches.
Pt. reported very sick to stomach, nausea, dizziness, sweating.  Sudden onset lasted about 1 hour and then he felt fine.
Case number PHEH2013US024849, is an initial spontaneous report received from a pharmacist on 25 NOV 2013. This report refers to a 76-year-old male patient. Past medical history and concomitant medication were not reported. He was inadvertently vaccinated with MENVEO (batch number: A11077 and expiry date: APR 2014), at a dose of 0.5 ml intramuscularly on 24 NOV 2013. No adverse event was reported following this administration error.
Pt reports a full body rash appearing on 10/22/11. She did not report this to our office until 10/31/11. Stated she is on a MEDROL dose pak & still has a rash on her neck. Her physician is unsure if it is related to the flu shot.
Pt had a sz @ home, stopped breathing & turned blue; pts dad revived him & took him to hosp ER; had t102.4 R dx febrile seizure not related to vax;
9 days after receiving vaccination developed red itchy rash at and around injection site. And vaginal yeast infection with no other known cause.
HIGH FEVER (1O3 DEGREES); NAUSEA; VOMITING; CHILLS; ACHES; FATIGUE; SHAKING.  SYMPTOMS STARTED THE EVENING OF THE VACCINATION AND CONTINUED SEVERAL DAYS.  PATIENT IS STILL RUNNING FEVER (100.2) AND VOMITING 5 DAYS LATER ALTHOUGH SHE IS FEELING SOMEWHAT BETTER
Pt received vaccines on 12/8/15. Returned on 12/11/15 due to localized swelling, erythema, induration, and pain. Reaction started on 12/9/15.
A few days later I was having headache and pain on my left knee, I was told it was going away and now I started Therapy due to the pain. It has helped me some but I'm still not completely recovered.
No adverse effect reported; unknown doses of improperly stored GARDASIL 9 were administered; This spontaneous report as received from a nurse refers to a 11-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.  On 01-JUL-2019, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R027577, expiration date 23-JUN-2021 (dose and route of administration were not provided) for prophylaxis. The vaccine was stored in the lowest registered temperature below 36 Fahrenheit degrees (30.60 F) for total 59 minutes and the highest registered temperature above 47 Fahrenheit degrees (49.10 F) for total 30 minutes. Previous temperature excursion was registered when the vaccine was stored in the temperature between 36 and 46 (45.5) Fahrenheit degrees for 1 hour. The digital data logger was involved.  No adverse effects were reported.; Sender's Comments:  US-009507513-1907USA012222: US-009507513-1907USA012231: US-009507513-1907USA012224: US-009507513-1907USA012225: US-009507513-1907USA012226: US-009507513-1907USA012227: US-009507513-1907USA012228: US-009507513-1907USA012229: US-009507513-1907USA012230: US-009507513-1907USA002267: US-009507513-1907USA012220: US-009507513-1907USA012219: US-009507513-1907USA012223:
Narrative: The patient had a mild fever the day after injection then developed a few vesicles on his back. Symptoms:. 1. Mild fever and a few vesicles Suspect Drug # 1 Dosing: Merck Lot # 1551X. Treatment Drugs Used. 1. Valacyclovir Dose: 1 Units. GM Freq: TID Route. PO.
w/in 5 hr of vax pt devel t104 ax temp lasting 4 days; very irritable & fussy; mom gave APAP prior to vax q 4 hr; saw MD morning of 3rd day post vax who prescribed ibuprofen
pt recv vax 13JUN96 & 23MAY97 pt devel approx 75 pox in clusters & a sl fever;
fever (102°F); Fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (102°F)), FATIGUE (Fatigue) and HEADACHE (headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for Adverse event.    On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced PYREXIA (fever (102°F)), FATIGUE (Fatigue) and HEADACHE (headache). At the time of the report, PYREXIA (fever (102°F)), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2021, Body temperature: 102 (High) (102°F)High.         No treatment information were reported.   Reporter did not allow further contact
Cluster headaches that was in remission for the last three years have returned with a vengeance; Bad taste in my mouth; Head feels foggy; ringing in my right ear; This is a spontaneous report from a contactable consumer (Patient). A male patient (age: 67 unit: not given) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 30Jan2021 at 03:15 PM as single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249) via unspecified route of administration in right arm on 09Jan2021 at 03:15 PM as single dose for COVID-19 immunization. Medical history included cluster headaches. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and verapamil hydrochloride. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Feb2021, patient head feels foggy, developed ringing in my right ear. Cluster headaches that was in remission for the last three years have returned with a vengeance, bad taste in my mouth. No treatment was received. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.
severe tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (severe tinnitus) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067f21a, 017b21a and 027a21a) for COVID-19 vaccination.     Patient not had COVID + test or diagnosis. No medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (severe tinnitus). At the time of the report, TINNITUS (severe tinnitus) had not resolved.            It was reported that vaccination about 2-3 weeks after the first booster patient started to experience severe tinnitus. No similar event was experienced by the patient in the past. The patient symptoms had worsened. No treatment medication details was reported.
5 minutes after receiving vaccines (Pentacel, PCV-13, MMR-V, Influenza), patient stood up and put coat on, then reported that she didnt feel well and lied down on the ground. No LOC. C/o belly pain. BP 60/30 (pre-vaccine 92/56); improved over 30 minutes with juice and rest. Attributed to vasovagal response.
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Diarrhea-Medium, Systemic: Fever-Mild
Significant painful axillary and supraclavicular lymphadenopathy lasting 96 hours
Nausea and vomiting in a six year old female. Nausea throughout the day the next day. Vomiting started at approximately 7pm the next evening. She vomited twice within one hour. Symptoms are currently being monitored.
Rheumatoid arthritis pain has worsened; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain has worsened) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain has worsened) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain has worsened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt had sudden shortness of breath and passed out 11/01/19. Called 911 and was taken to hospital for treatment
red, itchy hives all over my body; This is a spontaneous report from a contactable other health care professional.  A 25-year-old female (non-pregnant) patient received bnt162b2 (Pfizer-BIONTECH COVID-19 Vaccine, Solution for injection, Batch/lot number and expiry date: not reported) 2ND DOSE via an unspecified route of administration, administered in Arm Left on 19Feb2021 08:15 as 2ND SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient Historical vaccine includes first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported)  via an unspecified route of administration, administered in Arm Left on 29JAN2021 at 08:30AM  as SINGLE DOSE for covid-19 immunisation. Other vaccine administered in 4 weeks was reported as no. The patient was not tested for COVID prior to vaccination. Any known history of allergies was reported as no. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), fish oil, colecalciferol (VITAMIN D [COLECALCIFEROL]), vitamin b complex (VITAMIN B), magnesium. On 06FEB2021 the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Approximately three days after the vaccine, on 22FEB2021 at 06:00, the patient experienced red, itchy hives all over my body. The outcome of the event was reported as not recovered.  Information about lot/ batch number has been requested. No follow up attempts possible. No further information is expected.
My heart rate and b/p  increased evening after injection.  My heart rate and b/p have been maintained at  normal ranges for years!  B/P usually 122/76 and heart rate 76-80. Since I got that vaccine, each evening my heart rate has been 97, 87, 94, 90.  B/P 133/85, 145/84. I had flu-like symptoms, headache, injection site pain  and joint pain.  They subsided.
Narrative:  COVID infection following COVID vaccine series 04/30, Pfizer, dose #1 05/21, Pfizer, dose #2 09/24 COVID swab, result: detected 09/24 pt cc: exposure: unknown 09/24 COVID swab, result: detected 09/26 COVID swab, result: detected 09/26 SARS-COV-2 Variant Sequencing result: pending 09/26 SARS-CO-COV-2 IgG: 4.05 09/27 DDIMER: 0.44 10/22 clinically resolved 10/12 BinaxNOW COVID-19 Ag: not detected 10/14 BinaxNOW COVID-19 Ag: not detected 10/15 BinaxNOW COVID-19 Ag: not detected 11/02 BinaxNOW COVID-19 Ag: not detected 10/26 BinaxNOW COVID-19 Ag: not detected 10/29 BinaxNOW COVID-19 Ag: not detected 11/02 BinaxNOW COVID-19 Ag: not detected 11/05 BinaxNOW COVID-19 Ag: not detected
2nd dose of moderna vaccine given IM in the R arm at 0800 on 1/26/21. I had severe chills, severe body aches, a mild fever, and extreme redness and swelling at the injection site. The side effects kept me out of work for one shift. The chills, body aches, and fever subsided within 36 hours, the severe redness and swelling at the injection site has continued to persist. I took Tylenol 1g q8hr for the side effects.
Patient given influenza vaccine (listed below) 0.5ml dose at 1524 and mom noted "bumps" on his face (1535). Child brought back to exam room and assessed by Dr.. Hives to bilateral cheeks but no respiratory distress or complaint of chest pain or tightness. mild itching sensation to face. Treated with 2.5ml Zyrtec by mouth with Benadryl 1 tsp by mouth to be given before bed. Hives completely gone by 11/8/07 morning.
Gave patient flu dose of 0.5 ml instead of 0.25 ml.
Narrative: COVID infections following completion of COVID vaccine series 03/05/21 COVID vaccine dose #1 03/29/2021 COVID vaccine dose #2 07/19/21 Pt reports no symptoms, pre-op COVID test performed for laryngoscopy ENT scheduled for 7/21/21; COVID POSITIVE
Arm swelling, increased warmth, erythema, and mild pain ongoing x4 days and not improving
Approximately 48 hours after first and only dose of Janssen vaccine, I experienced several accute, intense brief pains in my right foot (arch area) that lasted for only seconds. It repeated every few minutes or so, for hours. Upon sleep and a muscle relaxant, it did not re-occur. However approximately 4 days later, (today) I experienced very similar "spasms" in my left rib cage area, just below my breast. They feel like a muscle spasm, lasting only seconds, but repeat within minutes for hours.
Immediately after administration of the flu shot, patient developed full tonic clinic seizure lasting 10 minutes. Recovered well.  Call neurology and told to dc home with return precautions and outpatient follow up.
Too weak to lift himself out of bed into the wheelchair or from wheelchair onto toilet.  Fell twice on two consecutive days when trying to get from the bed into his wheelchair.  911 was called each time to help him get off the floor and into his chair.
Itching and rash that would develop and last for a few hours then disappear, it would be in different places on my body but mostly my chest, back , neck and arms, also at times even my genitalia. The itching would be intense enough for me to take antihistamines and put steroid creams on it. At first I thought it may be other bug bites, or skin allergies but the way it kept moving and disappearing made me suspicious. The dr thought it was eczema after seeing pictures of it, but a few days after seeing her the incidences suddenly stopped , that was also about 3 weeks or soafter my second covid shot.
Very high blood pressure; Feeling tired; Other effect: Was gluten intolerant - rash and hives disappeared after vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2  (lot number: ER8737) via an unspecified route of administration in right arm on 01Apr2021 02:00 PM at 2nd dose single for COVID-19 immunization. The patient was not pregnant. The patient had known allergies gluten intolerance (rash and hives disappeared after vaccine). The historic vaccine was bnt162b2 (lot number: EN6199) via an unspecified route of administration in right arm on 11Mar2021 01:00 PM at 63 years old at 1st dose single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination included: levothyroxine and liothyronine, all for an unknown indication, start/stop date not reported. The patient experienced feeling tired, very high blood pressure, and gluten intolerant: rash and hives disappeared after vaccine on 25May2021 10:45 AM. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included blood pressure high on 25May2021. Therapeutic measures were taken as a result of very high blood pressure and included treatment with blood pressure medications. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
15 minutes after injection c/o itching/tingling in entire left arm and body. Vital signs stable, no other symptoms. Given dexamethasone IM with near immediate resolution of symptoms, remained stable under additional observation.
Coughing, fever, body aches, swelling of hands and feet, the roof of your mouth is torn. Crowded lines continue to swell, short of breath.
Had red, macular rash on upper arm (L) since Td on 9/7/04.
a pregnant nurse was accidentally exposed to a spray of varicella vax in her face prior to vaccinating a child;the nurse felt that the exposure to the vaccine was probably very small;no further details were provided;
Congestion; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 17:30 (Lot Number: 18) at the age of 40 years old as single dose for covid-19 immunisation. The patient's medical history included No known allergies. Concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug store. No other vaccine in four weeks. The patient experienced congestion on 27Feb2021 06:00. No treatment received. No covid prior vaccination and no covid tested post vaccination. The outcome of the event was recovering.    No follow-up attempts are possible. No further information is expected.
ALLERGIC REACTION, INIT 4/20/2022 &  4/30/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a physician concerning an 11 year old who on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (unknown lot number). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports from the same source.
Information has been received on 30-NOV-2016 from a medical assistant referring to a 46 year old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 22-SEP-2016, the patient was vaccinated with vaccinated with RECOMBIVAX HB (lot number and expiration not reported) dose 1 for prophylaxis. On 02-NOV-2016, the patient was vaccinated with vaccinated with RECOMBIVAX HB (lot number and expiration not reported) dose 2 for prophylaxis. On 30-NOV-2016, the patient was vaccinated with an earlier than scheduled dose 3 of RECOMBIVAX HB (lot number and expiration not reported) for prophylaxis. No adverse effects reported. No further information is available. Additional information has been requested.
I noticed a rash on my lower-right side on 09/12/2021.  By 09/14/2021, the rash spanned from my lower-right side to the middle of my back.  I visited urgent care on 09/14/2021. I was diagnosed with Shingles and was prescribed Valtrex (1,000 MG x3 daily).  I had an appointment with primary care on 09/22/2021 to address the nerve pain, and I was prescribed Neurontin (300 MG capsule).
Dose was administered outside of the recommended time window after first vial puncture. Dose determined invalid.
Pt recvd vax 11MAR92 approx 915AM-slept from 930AM-1015AM awakened w/"shaking" all over; sitter state pt then vomited-taken to MD 1045AM t101.6 AX; t102 that PM;
Arm swelling and redness. Hoarseness. Hives and pruritus.
during administration, the needle on the syringe wasn't tight; during administration, some of the vaccine leaked out/No AE; Initial information received on 10-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient with unknown demographic who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. During administration some of the vaccine leaked out (underdose), and the needle on the syringe wasn't tight (syringe issue).  Medical history, medical treatment, vaccination and family history were not provided.   On 09-Dec-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was actual medication error case due to vaccine leaked out (underdose).  It was also the case of Syringe issue.  It was unknown whether the vaccines were administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Information on the batch number was requested.
Initial unsolicited report received from a physician on 10-MAR-2017. This case involves a female patient (onset age unknown) who was vaccinated with an unknown dose injection of PENTACEL (batch number: C5251AA and expiry date, route and dose in series were not reported) and a dose of PREVNAR (batch number, expiry date, route and dose in series were not reported) in the leg (reported as one vaccine per leg) on an unknown date. The patients' medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed bilateral swelling, redness, and knot at injection site. The patients Lab data and corrective treatment was reported as unknown. The patient's outcome was reported as unknown. List of documents held by sender: none.
Information has been received from a licensed practical nurse concerning a 45 year old female with asthma, rhinitis allergic, sulfonamide allergy, penicillin allergy and drug hypersensitivity to CEFZIL and aspirin, and a history of pneumonia 2 years ago who on 11-AUG-2006 was vaccinated with Pneumovax 23 (lot number 651328/1046P) in the left arm.  Concomitant therapy included CLARITIN and FLONASE.  Between 11-AUG-2006 and 13-AUG-2006, the patient experienced cellulitis at injection site, with erythema and pain that extended to the entire upper arm.  The patient was treated with oral CIPRO and subsequently, the patient improved rapidly (also reported as recovered) from cellulitis at injection site, with erythema and pain that extended to the entire upper arm.  Additional information has been requested.