chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed a hive type rash in several areas of my body. It seemed bilateral, large red areas with welt like bumps. Places included my neck...front  and back, front of my chest near my armpits, under my armpits, both sides all over my ribs, my waistband my groin area , several areas of my back, by buttocks, the back of my legs, and the back of my knees.   The rash wa extremely itchy and cortisone cream did not help. It kept me up most of the night. It went away in the morning but started up again at about 5pm the next day. That second day was worse covering more areas of my body
a four months old male patient was received the liquid DTaP and IPV of the Pentacel vaccine with out Lyophilizing ActHIB powder/No AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a four months old male patient who received the liquid DTAP and IPV of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] vaccine without lyophilizing ACT-HIB powder dose (Product preparation issue): 0.5ml, lot UJ014AAA, expiry date: 10-OCT-2020 via intramuscular route in the right thigh on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was an actual medication error due to inappropriate reconstitution technique (Product preparation issue).  It was unknown if adverse event occurred or not.  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 and Module VI of the 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.  List of documents held by sender: none.
vertigo 8 a.m. I was so dizzy I could not dress myself or drive; stayed in bed the whole day was less dizzy the second day but did not go to work I feel small repercussions of slight dizziness since then
After immunizing for Hep A, child developed strep throat.  1st dose Dx 4 days later.  2nd dose Dx 3 days later.
Aphthous Ulcer; This is a spontaneous report from a contactable physician for himself. A 29-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC4248), via an unspecified route of administration on left arm on 19Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history reported as none.  The patient's concomitant medications were not reported.  The patient previously took aspirin [acetylsalicylic acid] and experienced drug hypersensitivity. The patient took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 29Dec2020 02:45 PM at single dose for covid-19 immunisation. The patient experienced aphthous ulcer on 21Jan2021 12:00 with outcome of not recovered. No treatment received. No Covid prior vaccination. No Covid tested post vaccination.
12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. PAIN ON INJECTION SITE. TOOK TYLENOL.
This is a spontaneous report from a contactable consumer (patient) reported in response to non-HCP follow-up letter sent in cross reference case. A 79-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9809, expiration date: Jun 2021), at the age of 79, intramuscularly, in right arm, on Feb 17, 2021, at 15:00, single dose, for COVID-19 immunization, at a hospital. Historical vaccine included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EL8982, expiration date: May 2021), intramuscularly, in right arm, on Jan 27, 2021, at 15:00, single dose, for COVID-19 immunization and experienced projectile vomit, projectile diarrhea, high temperature, muscle fatigue and extreme tiredness. The patient's medical history and concomitant medications not reported. Prior vaccination within 4 weeks was none. The patient experienced high fever, headache, chills and arm pain on Feb 17, 2021, at 01:00. Reported serious (important medical event). The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on Feb 10, 2021, with all the symptoms of COVID-19 except lost of taste and smell. Patient wanted to make sure she did not have COVID-19 for the sake of her husband. The patient did not received treatment for the events. The outcome of the events was recovered on an unspecified date. No follow-up attempts possible. No further information expected.
About 8 hours after receiving the vaccine, I had a 103 degree fever, body aches, and hot/cold flashes lasting for 3-4 hours. I took some ibuprofen (2 400 mg pills) and the fever eventually subsided. If the fever hadn't subsided sooner, I was considering going to the hospital.
administered STERILE DILUENT Reconstituted PROQUAD to Patient with Corresponding Patient having moved (See AE Case# 02371099) and with some of the Corresponding PROQUAD having sprayed into Physician's eyes; dministered STERILE DILUENT Reconstituted PROQUAD to Patient with Corresponding Patient having moved (See AE Case# 02371099) and with some of the Corresponding PROQUAD having sprayed into Physician's eyes; No additional AE reported.; This spontaneous report was received from a healthcare business professional referring to a 32-year-old male patient . Information regarding his medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-APR-2023, the patient administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (dose, strength, vaccination scheme, frequency, lot#, expiration date, route of administration and anatomical site of injection, were not reported), which had been diluted  with sterile diluent solution for injection/infusion (dose, lot#, expiration date, frequency, anatomical location, and route of administration were not provided), for prophylaxis; nonetheless, it was reported that while it was being administered, the patient who he was administering the product to, moved and therefore, some of the product sprayed into the his eyes (accidental exposure to product, occupational exposure to produce). Moreover, following this event, the patient had flushed his eyes with water as confirmed by the reporter . It was unknown if any laboratory or diagnostics were performed due to the event; furthermore, the patient did not sought medical attention for this event. No additional adverse events were reported (no adverse event).
This spontaneous report as received form a nurse refers to a patient of unknown age and gender. On 27-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA: expiration date: 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48 F for 35 minutes, 52F for 95 minutes, 48 F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Red rash, very warm to touch, vertigo, throat felt like it was closing up, cotton mouth.
arm pain, redness at injection site, swelling at injection site, warmth at injection site, headache, dizziness, nausea, fatigue
Swollen Lymph Nodes, chills, headache, nauseous stomach, pain radiating in left boob & left back, and tireness
Information has been received from a physician concerning a 13 year old male who on 13-AUG-1996, was vaccinated with the first dose of MMR II (route, site, dose and lot number not reported).  On 03-SEP-1997 the patient was vaccinated with the second dose of MMR II (route, site, dose and lot number not reported).  On 03-JAN-2010, the patient experienced mumps.  The patient was afebrile and had parotitis.  The outcome for mumps was not reported.  No further information is available.
blood blister; red spots in my mouth; red blotch on my left hand that later turned brown; The brown skin on my hand pealed off; The brown skin on my hand pealed off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 02Apr2021 14:50 (Lot number: ERE730) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "hypertension" (ongoing); "known allergies: some foods" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for hypertension (ongoing); CHLORTHALIDON taken for hypertension (ongoing); LOSARTAN taken for hypertension (ongoing); POTASSIUM; PULMICORT taken for asthma (ongoing); VENTOLIN [SALBUTAMOL] taken for asthma (ongoing). Past drug history included: Amoxicillin, reaction(s): "drug allergy: Amoxicillin"; Iodine, reaction(s): "known allergies:iodine internal". Vaccination history included: Bnt162b2 (lot number=EL9266, lot unknown=False, administration date=04Mar2021, administration time=14:40, dose number=1, vaccine location=Left arm , route of administration=intramuscular), administration date: 04Mar2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: BLOOD BLISTER (non-serious) with onset 06Aug2021, outcome "recovered" (Aug2021), described as "blood blister"; ORAL MUCOSAL BLISTERING (non-serious) with onset 06Aug2021, outcome "recovered" (Aug2021), described as "red spots in my mouth"; RASH MACULAR (non-serious) with onset 06Aug2021, outcome "recovered" (Aug2021), described as "red blotch on my left hand that later turned brown"; SKIN EXFOLIATION (non-serious), SKIN DISCOLOURATION (non-serious) all with onset 06Aug2021, outcome "recovered" (Aug2021) and all described as "The brown skin on my hand pealed off". The events "blood blister", "red spots in my mouth", "red blotch on my left hand that later turned brown" and "the brown skin on my hand pealed off" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood blister, oral mucosal blistering, rash macular, skin exfoliation.  Additional information : It was reported that, 4 months after the second shot, she got a blood blister and many red spots in my mouth. She also got a red blotch on my left hand that later turned brown. No other vaccine in four weeks. She experienced an event that caused several blisters and many red spots in the roof of my mouth. she also have a red circle on my wrist (left) that later turned brown, and then the skin pealed off and new skin appeared under this location. These symptoms lasted for a week. By the time she was able to see her doctor. The symptoms were gone and he could not explain the event.  Follow-up attempts are completed. No further information is expected.
Nerve pain in feet and restless legs preventing me from sleeping for weeks.  Had episodes of tachycardia and aFib diagnosed by cardiologist beginning July 4, 2022.  Had 2nd booster on 8/9/22, this time Moderna, and another episode of Afib on 8/31/22.
This case was reported by a physician via sales rep and described the occurrence of seizure in a 19-year-old male patient who received BEXSERO. Previously administered products included MENACTRA. Concurrent medical conditions included cerebral palsy. On 30th August 2017, the patient received the 1st dose of BEXSERO .5 ml. On 30th August 2017, less than a day after receiving BEXSERO, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to BEXSERO. Additional details were provided as follows: The patient previously received all of his vaccines, including his MENACTRA. The age at vaccination was not reported. On 30th August 2017, in the late evening, the patient had a seizure. The patient was hospitalized for a few days and was released on Saturday or Sunday (the one just before the date of reporting) and everything appeared to be fine.
3 days later developed rash on left thigh/leg with burning sensation and pain from groin to foot. Also general weakness and malaise.
Vaccine administered beyond Expiration date. However, per Moderna- all vaccines met viability requirements.  Completing VAERS per agency requirements.
Patients mother called office to report pain/swelling at injection site. States golf ball size area of redness. Instructed to ice 20 min. on/20 min. off 6-8 times a day and take Ibuprofen as directed on bottle. If no improvement in 24hrs to call family doctor.
Severe muscle/nerve pain in neck, back, gluts, hamstrings while in bed from 3 am to 6 am.  It has occured for four nights five days after the vaccine shot.  Daytime okay. Taking Tylenol 625.  Did not affect it.  Need  advice if this is a reaction or I should see a doctor.
I got COVID after Dose 3 started experiencing mild fever, chest congestion, felt flu like symptoms, no body pains, energy level low. Mostly had chest congestion took Mucinex and ran humidifier in my room. The symptoms lasted a week still experienced stuffiness in my nose. I followed up with my doctor on March 14, 2022 to check my lungs he stated everything looked clear.
High Blood Pressure (144/105), dizziness, nausea, severe headache.
Patient reported two weeks prior to vaccination, she had a concussion with symptoms of headaches and nausea, Vicodin prescribed at the time of diagnosis of concussion, but never taken medication. On August 4, 2007, Tetanus-Diphtheria administered, patient called the unit from her place of employment on 6 Aug 07 that she was having a reaction from the vaccine with nausea and redness warm bump at the injection site. Began the evening of the vaccination. Patient instructed to seek medical attention immediately.
LIGHT HEADEDNESS; VOMITING; EXTREME HEADACHE; PROLONGED FATIGUE/EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headedness. On 09-APR-2021, the subject experienced vomiting. On 09-APR-2021, the subject experienced extreme headache. On 09-APR-2021, the subject experienced prolonged fatigue/extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and extreme headache on APR-2021, and had not recovered from prolonged fatigue/extreme fatigue, and light headedness. This report was non-serious.
Pt. was given flu shot at approximately 10:30 AM. Pt was ambulatory and showed no problem after vaccination. Pt did not complain at any problem at the flu shot. I received a call from facility that at approximately at 11:45 after exercising the patient fell and was taken to hospital. I do not believe that the flu shot vaccination had anything to do with the patient's fall.
suffering severe headaches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a 13-year-old patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, immediately after receiving Meningococcal B vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 dose vaccination and experienced horrible severe headaches lately.
Bells palsy, muscle uncontrollable on right side of face. For 3 days.
Ischemic stroke; Cancer; 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 78-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 5 (booster), single (Lot number: GH9694) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL9267), as dose 2, single (Lot number: EN6203), as dose 3 (booster), single (Lot number: EW0164) and as dose 4 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ISCHAEMIC STROKE (medically significant), outcome "unknown", described as "Ischemic stroke"; NEOPLASM MALIGNANT (medically significant), outcome "unknown", described as "Cancer". The patient was asking whether it was okay to receive the Pfizer COVID vaccine if you have had a ischemic stroke. She heard there was a second booster dose out and wanted to know if it was okay to get it. She stated she asked her primary care doctor and she could not give her an answer and went to the health department where she got the "last 3 shots." The "3 prior" shots she got at where she had her cancer taken care of. None of them could give her any advice. She had all the Pfizer COVID vaccines and had no reaction from them (as reported). Read on the net about a warning on taking Pfizer COVID 19 shot if had a certain stroke, the stroke the patient had called ischemic stroke.  No follow-up attempts are possible. No further information is expected.
inadvertently given Dtap-IVP portion of Pentacel and not the HIB portion/no AE; Initial information received on 16-Apr-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 months old male patient who inadvertently given DTAP-IVP portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and not the HIB portion(product preparation issue) On 16-APR-2020 for prophylactic vaccination at the left thigh via intramuscularly [batch number U66AB and expiry date 30-APR-2021]. Batch number and expiry date of DTAP and HIB was reported as U66AB,UJ207ABA and 30-APR-2021, 30-APR-2021 respectively.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to Inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
burning in arm with injection and for 1 hour after fatigue and sweating started 3 hours after injection and lasted for 3 days
Soreness in neck, sore at injection site, fatigue, low grade fever (99.2)
has a scratchy sore throat; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (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: THROAT IRRITATION (non-serious), outcome "unknown", described as "has a scratchy sore throat". Additional Information: The patient was wondering if this was due to the vaccine or coincidentally showing symptoms of the virus.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very adverse affect; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis.   On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to DTP (A or W not known).  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that after vaccination, the patient had very bad adverse effects and was scary stuff. This case has been linked with case US2019AMR234290, reported by same reporter.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received 4 month before 2nd shot). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than an hour after receiving SHINGRIX, the patient experienced injection site swelling, pruritus, burn, erythema and pain. The patient was treated with ZYRTEC. On an unknown date, the outcome of the injection site swelling, pruritus, burn and erythema were unknown and the outcome of the pain was recovered/resolved. The reporter considered the injection site swelling, pruritus, burn, erythema and pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The side effects including swelling at injection site within 10 to 15 mins, on fire, itched, burned, bright red. The patient started ZYRTEC immediately after shot. The patient experienced Intense pain less than week after vaccination. Intense pain subsided within 2 days, full week before totally pain free. The second dose received 4 months initial shot. The patient and health care professional certain adverse event directly related to receiving shot. The reporter did not agreed to follow up with GlaxoSmithKline.