chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Nov2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Nov2023, outcome "unknown", described as "flu like symptoms".  Additional information: the patient received yesterday Pfizer's Comirnaty vaccine and he is now experiencing flu like symptoms, he wanted to know if he can he take tylenol.  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 hospitalized for perforated diverticulitis 1/17/22-1/26/22. Tested positive for COVID 1/17/22. No evidence of respiratory failure.
Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Severe
1st dose: no side effects, temporary headache in frontal lobe area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Apr2021 12:00 (Lot number: EW0173) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Clinical depression" (unspecified if ongoing); "recovering alcoholic (last drink was Jan. 31)" (unspecified if ongoing), notes: recovering alcoholic (last drink was 31Jan). Concomitant medication(s) included: ZOLOFT; NEXPLANON. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "1st dose: no side effects, temporary headache in frontal lobe area".  Additional information- it was reported that patient did not suffer drom covid prior to vaccination and did not undergo covid test.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a consumer refers to a 83 year old male patient. Patient medical history and drug reactions/allergies were none. Approximately on an unknown date in July 2013 (reported as 4-5 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). Concomitant therapies included PRILOSEC. Approximately on an unknown date in 2013, the patient developed bump that started as itching on the back and changed to pain going up the shoulder and the neck. The patient sought no medical attention. No lab Diagnostics Studies was performed. No treatment was given for the events. The outcome of the reported events was not recovered/not resolved. Additional information is not expected.
Shortness of breath, difficulty breathing, fast heart beat, pressure neck (all events happened shortly after administration of covid vaccine)
Within 24hours of injection in left thigh, swollen, mild red measles rash. Not red, warm.  Fluctuent.
Intense pain in the upper arm within two hours radiating into the shoulder causing immobility of the arm.  Within 12 hours she complained of chills, weakness, general malaise, dizziness,  low grade fever, headache, ear ache, and a sore throat.  This lasted 24 - 48 hours.  The sore arm still persists four days later to the point that she cannot raise it horizontal to the ground.  Vaccine was Tdap but I do NOT know the manufacturer as listed below.
Received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-358735, MOD-2021-358800, MOD-2021-359032, MOD-2021-358753, MOD-2021-358773, MOD-2021-358799, MOD-2021-358841, MOD-2021-358865, MOD-2021-359183, MOD-2021-359764 (Patient Link).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 24-JAN-2017 at 13:59, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000473: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456.
Pt developed 1cm erythematous macular exanthem, non pruritic at injection site L arm. No fever,No previous reaction to flu vaccine. No flu or cold symptoms 2 wks prior to receiving vaccine. No allergies to eggs.
chest tightness; shortness of breath; This case was reported by a pharmacist via call center representative and described the occurrence of chest tightness in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received the 1st dose of Shingrix .5 ml. In October 2019, 24 hrs after receiving Shingrix, the patient experienced chest tightness and shortness of breath. On an unknown date, the outcome of the chest tightness and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the chest tightness and shortness of breath to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and 24 hours after developed chest tightness and shortness of breath.  These symptoms lasted for 24 hours before going away.  The patient had to sleep sitting up with four pillows because of the breathing problems that she was experiencing.
Pt was accidentally given a combination of DTaP- IPV when Doctor ordered DTaP vaccine alone.
Symptoms started on 06/23/2022 with sniffles, cough from a tickle in the throat. This led into a runny/stuffy nose and my throat became scratchier. I took an at home test on 06/24/2022 which was negative. The symptoms escalated the next day with chills, sneezing, a headache for about 24 hours and a very mildly elevated temp of 99, muscle aches and pains, and chills. On 06/25/2022, I took an at home COVID-19 test which came back positive. I scheduled a PCR test on 06/25/2022 and that came back positive on 06/26/2022. I scheduled a telehealth visit with the ER doctor and I was told that the Paxlovid would interfere with 2 of the medicines I take on a daily basis so it was recommended that I get the monoclonal antibodies. I was scheduled for the infusion on 06/28/2022 which was kind of far away. However, due to restrictions, I was unable to get the treatment any closer. So, I drove out and received the treatment. I remained isolated from my husband after that and on 07/02/2022 i tested myself again and I was positive. However, on 07/04/2022 I tested negative and I have a PCR test scheduled on 07/07/2022. At this point, my nose is slightly runny/stuffy and I'm slightly more fatigued than normal. I have a mild cough throughout the day that is much better than when this event started.
Headache, Myalgia, NauseaVomiting, congestion fatigue Narrative:
Lethargy and debilitating pain throughout my entire body. Starting at my head where my brain throbbed like I was concussed, down my spine as though I had been in a car accident. The joints throughout my body throbbed with an arthritic type pain. I could not get out of bed was in a fetal position. It was also very painful when anyone touched my skin.
Narrative: 03/12 COVID vaccine dose #1 04/09 COVID vaccine dose #2 05/06 Pt seen by PCP, c/o Rt upper arm pain for 2wks, states pain located right upper arm where he had the covid shot. no radiation pain. c/o feeling weakness. Pain started the day after 2nd shot, went away in 2days but came back on 4/19. denies any prob after 1st shot. states pain keeps hi, up at night; has tried to treat with diclofenac 75mg bid, ibuprofen pm at bedtime, 2 different menthol creams, biofreeze, OTC foam for muscle cramps (all ineffective); prescribed naproxen, topical lidocaine/capsaicin
Increasing redness, swelling and tenderness that began as dime sized area of redness 24 hours following vaccination and has increased to 7 cm area erythema 4 days following vaccination.
acute systolic congestive heart failure; endocarditis; transient ischemic attack; bacteremia; acute kidney injury; mental status changes; metabolic encephalopathy secondary to endocarditis; Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In or around 18-JUL-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, anatomical location, lot number and expiration date were not provided). On an unknown date, the patient presented left sided weakness, shortness of breath, discoordination and zoster like rash. Then, the patient was diagnosed with acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury, mental status changes, metabolic encephalopathy secondary to endocarditis and herpes zoster (shingles). On an unknown date, the patient was hospitalized due to the events. As a direct and proximate result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events was considered as not recovered. The reporter considered all the events to be related to zoster Vaccine Live (ZOSTAVAX).  Upon internal review, the events of acute systolic heart failure, endocarditis, transient ischemic attack, bacteremia, acute kidney injury and metabolic encephalopathy secondary to endocarditis were determined to be medically significant. All the events were considered to be disabling.
10/17/02, had pneumovax, tender that day. 10/18/02 swollen, red, inflamed 2x2 inches. Saw family MD-apply ice, cortizone cream, Advil, Benadryl-fever, chills, nausea, vomiting. 10/19/02 fever and chills 3 x 4 inches. 10/20/02 4 x 6 inches. 0/21/02 6 x 6 1/2 inches, extreme achiness shoulder to wrist.
4/13/04- Crying, fussy, rash which turned to hives on bilateral legs and most of the body, decreased appetitie, not sleepong. Fever - 102 (rectally) Treatment- see back page.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL (route and lot # unknown). The physician heard from one of his patients that a girl developed a bone tumor after receiving GARDASIL. At the time of this report the patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Dizzy at first and flushed, then a red rash about the size of a silver dollar came up at the injection site with raised bumps.
The morning after DTaP, HIB, IPV, Prevnar #1 pt's whole body was swollen per parents. No other symptoms. Resolved next AM. Not seen by MD.
PATIENT RECIEVED A JANSSEN VACCINE AND WAS NOT OVER THE AGE OF 18.  PATIENT IS FINE AND AWARE. ALSO FAMILY GUARDIAN ARE AWARE.
Soreness at injection site, slight headache, no energy, tired and sleepy, no appetite, body aches. I am diabetic and without eating my blood sugar reading went up to a reading over 400. Still feel tired on todays date 26 Jul 21 (2 days after vaccination) Still have soreness at injection site.
Case received from a healthcare professional through the VIS Sanofi Pasteur on 27 April 2010 under the reference number BR2010-101.  An 83-year-old male patient with a medical history of hypertension and cardiopathy had received his injection of PANDEMIC INFLUENZA VACCINE from a non-reported manufacturer on 23 April 2010 in the left arm (batch number, number in series, route of vaccination not reported).  On 27 April 2010, i.e. 4 days after the vaccination, the patient experienced pain on the cervical area (neck) and upper right member, paresthesia on the right leg and arm and tingling on the right "tumb" of the foot and hand.  According to the reporter the patient had no previous neurologic illness.  The patient was not hospitalized.  He did not receive any corrective treatment.  The patient had not recovered at the time of the report.
patchy erythematous vesicular papular rash on calf LLE several cm's greatest  dimensions, few tiny scattered similar lesions no more than few mm in size some  in linear appearance of UE's  Onset 7 days after vaccine
Few minutes after vaccine - hot and sweaty, very dizzy and nauseous. Went away after about 20 minutes
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients' concurrent conditions and medical history were unspecified. On an unspecified dates, the patients were vaccinated with improperly stored dose of RECOMBIVAX HB (strength, route and anatomical location unspecified) with lot # M003658 and expiration date 02-JUN-2018. Number of doses administered was unspecified. The vaccine was exposed to temperature of 33.6F, for a time frame of 2 hours 30 minutes. No previous temperature excursion was reported. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Small red bumps appeared the evening two days after reviving the vaccine. They do not itch and they have seemed to calm down 24 hours after they appeared. They are semi swollen and they are scattered across my arms
TD given in left deltoid on 10/11/00 at 08:00. Client called clinic stating that Wednesday the area was non-reactive and then Thursday, noticed swelling, redness and tenderness at site and continues to enlarge. Office measurement was 12cm X 10cm of induration and erythema.
My child immediately had an adverse effect to the vaccine and continues. Immediately she had fever, chills and now constant stomach pain.
Fever of 103, shaking chills alternating with soaking sweats, body aches, headache
Swollen Lump under my left armpit. It showed up few hours after my Booster shot and has been there for the past 36 hours. It is slightly painful when touched. I have not gone to the Physician yet. Will wait for another 24 hours before visiting my physician
Rash and slight swelling around injection site. Was tender to the touch and warm to the touch. Tenderness radiated up through shoulder and to the collar bone.
On Saturday, 11/17, pt experienced acute onset of erythema extending to the elbow on the left arm, erythematous/pruritic papules across chest, back, neck, and right shoulder, nausea, significant malaise, fever to 101. Did not seek medical care. Upon follow-up on Monday, 11/19, arm erythema was resolved, energy was returning, pt was afebrile, nausea resolved. Papules remain across chest, upper back, neck, and right shoulder in addition to Smallpox inoculation site on the left shoulder.
in the injection site it was swollen; arm in the injection site it was red; left arm and it was a little sore afterwards; she had Covid; Aspontaneous case report from a consumer on 15-FEB-2021, which refers to a Female aged 78 Years experienced the events,a little sore,COVID arm in the injection site it was red,in the injection site it was swollen.  Concomitant medications included: ESOMEPRAZOLE[] ,LISINOPRIL[] ,ATENOLOL[] ,ROSUVASTATIN[] ,EZETIMIBE[] ,MONTELUKAST[] ,HYDROCHLOROTHIAZIDE[]  .  Relevant medical history was not provided.  On   the patient started taking Moderna COVID-19 Vaccine for COVID-19 vaccination. Some  11 days later,  the patient developed pain in arm. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed COVID-19,injection site swelling,injection site redness. Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Pain in extremity . .  The patient was treated for the event with TYLENOL .    On 05FEB201 Outcome of Covid was Recovered/Resolved,and on 16FEB2021 left arm and it was a little sore afterwards Recovered/Resolved.
8 days of intermittent fevers 101-106 (ongoing), rigors, chills and fatigue. Started 24 hours after COVID vaccine. This is ongoing, day 8 and fever still 101+ without ibuprofen. Seen twice at PCP's office listed above (seen by Dr.  and Dr.  this week but Dr.  is normal pediatrician. Labs abnormal as below. No other URI, bladder, GI or infectious symptoms other than fever, rigors and fatigue.  Negative COVID test 3 days into symptoms and no exposures.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05May2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 68 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: Other medical history: HTN. Concomitant medication(s) included: LEVOTHYROXINE; BISOPROLOL; SIMVASTATIN; PAROXETINE; ASA; OMEPRAZOLE. The following information was reported: DRUG INEFFECTIVE (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: Negative, notes: positive test after testing negative after Paxlovid treatment; Positive, notes: positive test after testing negative after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective and covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.
body chills; Headache; Shot 2 - left arm ached 2 days; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration in left arm on 18Feb2021 as a single dose for COVID-19 immunization. The patient's medical history included osteoporosis, sleep apnea and reflux. The patient had no known allergies. The patient's concomitant medications included multivitamin, ergocalciferol (Vit D) and omeprazole (PRILOSEC [OMEPRAZOLE]). The patient previously received the dose of bnt162b2, in left arm on 28Jan2021 at 13:15 as a single dose for COVID-19 immunization and experienced left arm ached 2 days and 5 days later diarrhea for a few days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced left arm ached for 2 days. On 19Feb2021, on the 2nd day, the patient experienced body chills and headache for which she slept it off. On day 3, the patient was back to baseline. The patient did not received treatment for the events. The patient did not undergo COVID test post vaccination. The outcome of the events was resolved.  Information on the lot batch number has been requested.
IN ER VISIT: history from patient and mother: Immediate onset lightheadedness, dry throat, intermittent neck and leg pain, then blurred vision.  In ER rapid twitching of eyelids and rapid eye movements, not consistent with nystagmus.  Exam otherwise normal, except lying in chair with eyes closed, answers appropriate but brief.  Abated with ativan and zofran. Seen at 1912 PM in ER, came by private vehicle with mother.  Discharged from ER at 2300 alert ambulatory and improved.
approx 3mos p/vax pt ;ab tests revealed that pt exp lack of seroconversion