chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hives; shingles; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 40 year old adult female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives causing urticaria and shingles leading to herpes zoster on an unspecified date with outcome of unknown. The adverse events led to physician office visit. Therapeutic measures were taken as a result of this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I am going on day 7 of random and inconsistent: Dizziness Body aches Chills Fever Sweats Blurred Vision Nausea Extreme Arm Pain (In the injected arm)  Head Ache I went to my Dr. on 11-07-07. My Dr. gave me Tamadol for the pain and MethylPREDSNISolone for the infection.   I have also been treating with IBProfen, heat, and cold packs.
Child presented pain on (R) leg, unable to bear wt. on affected extremity since imm. adm. 3/18/2011.
Nausea; Experienced diarrhea later that afternoon; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Experienced diarrhea later that afternoon) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced DIARRHOEA (Experienced diarrhea later that afternoon). On 09-Mar-2021, the patient experienced NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 09-Mar-2021, DIARRHOEA (Experienced diarrhea later that afternoon) had resolved. At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Concomitant products included vitamins and eye drops for glaucoma.
Sick; This case was reported by a consumer via(Facebook) interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported the patient for himself/herself. The age at vaccination was not reported. The reporter reported that patient received both shingles vaccines but after second dose felt sick. Also stated that glad to receive Shingles vaccine as shingles were bad.
Red welps from knees up to neck; Rash all over body; Body itch/ mild itching; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Body itch/ mild itching), ERYTHEMA (Red welps from knees up to neck) and RASH (Rash all over body) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included METFORMIN, LISINOPRIL, SIMVASTATIN, CYANOCOBALAMIN (VIT B12), INSULIN GLARGINE, LIXISENATIDE (SOLIQUA), TOCOPHEROL (VIT E [TOCOPHEROL]) and INSULIN for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Body itch/ mild itching). On 13-Mar-2021 at 10:00 AM, the patient experienced RASH (Rash all over body). On 15-Mar-2021, the patient experienced ERYTHEMA (Red welps from knees up to neck). The patient was treated with PREDNISONE ongoing from 15-Mar-2021 at a dose of 2 dosage form once a day; PREDNISONE from 07-Apr-2021 to 02-May-2021 at a dose of 3 dosage form once a day and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Body itch/ mild itching) and RASH (Rash all over body) had not resolved and ERYTHEMA (Red welps from knees up to neck) outcome was unknown.            Treatment for the events included diphenhydramine (Benadryl), Benadryl IV, Prednisone. Action taken with mRNA-1273 in response to the events was not applicable. On 14-Mar-2021, the patient went to urgent care and was given Benadryl  IV and tablet. The itching still did not stop. On 15-Mar-2021, she again went to urgent care. She was completely covered in red welps from knees up to neck. Prednisone 2 tablets once daily was started and was referred to an Allergy Specialist and was ordered a blood test.On 29-Apr-2021 she was sent to see a Urologist. She still continued to have mild itching and body sores.   This case was linked to MOD-2021-135137, MOD-2021-135137 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-May-2021 and Added HCP details, patient demographics, relevant medical history (Allergy: Tetracycline, Current condition: Diabetic). New concomitant medications (Insulin, Prednisone) added. New events Body itch and Red whelps from knees up to neck added. The outcome of the event Full body rash changed (from Resolved to Not resolved).
Had shoulder pain following day after second dose. Pain has not subsided at all over 2 months later and has gotten worse.   Dr has diagnosed me with Sirva based on MRI results.
Patient reported pain at injection site following vaccine admin. Completed flu visit with PCP. Advised to use NSAIDS, ice, mild exercise.
a patient received improperly stored vaccine on 15-APR-2019; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 15-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R021078, expiration date 12-JUN-2021 (strength, route and anatomical location were not provided) for prophylaxis. The vaccine was exposed to a temperature of 52.5 degree Fahrenheit, for 4 hours and 40 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved.
Patient came in to report to pharmacy that she developed some bumps on her skin that were itchy that happened about a month after receiving her 1st Shingrix. She didn't associate it with the vaccine until she went online and read that something like this might be possible. It has come down from it's peak. She also did ask her doctor about it when she went for a routine visit. The doctor was unsure of the cause. I informed the patient that it could be due to another cause that may be unrelated to the vaccine.
Broke out into severe hives all over the body including face arms legs, back, stomach, heart  Palpitations high blood pressure, nausea
Patient states felt sweaty, flushed after receiving the vaccine.  Noted hives on patient back and torso . Benadryl administered via intramuscular. Patient monitored for 30 minutes  and patient states feeling better . Patient advised to call 911 if symptoms return or worsen .   Blood pressure : 130/ 66 Pulse Rate : 100 Blood Glucose : 90 mg/dl
Chronic spontaneous urticaria and dermatographia starting about two weeks after my Moderna booster. I must take Zyrtec daily, and it?s been an entire year of this. If I stop taking Zyrtec, the urticaria and dermatographia return within two days.
Patient did not receive vaccine at health clinic, but called for medical consult.  Patient started feeling a malaise, nausea, fever at 3pm same day of vaccine, on/off congestion for days 3-5, tired and nauseous days 5-9.   On day 9 developed erythema/edema at site of injection.
Information has been received from an RN concerning a 58 year old female who, post vax, experienced nausea, diarrhea, vomiting, aches, fatigue, dizziness, fever, abdominal pain and cramps. The pt sought unspecified medical treatment and subsequently, recovered from diarrhea, vomiting, aches and fatigue. The pt's nausea persisted. For the past 2 years, the pt has experienced bouts of nausea that she did not have prior to vaccination. The nausea
I was reading online and it is called Covid arm; Around 4 inches across and 3 inches wide; Very itchy; Red area around the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (I was reading online and it is called Covid arm), RASH (Around 4 inches across and 3 inches wide), VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (Red area around the injection site) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE REACTION (I was reading online and it is called Covid arm), RASH (Around 4 inches across and 3 inches wide), VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (Red area around the injection site) and PYREXIA (Fever). At the time of the report, VACCINATION SITE REACTION (I was reading online and it is called Covid arm), RASH (Around 4 inches across and 3 inches wide), VACCINATION SITE PRURITUS (Very itchy), VACCINATION SITE ERYTHEMA (Red area around the injection site) and PYREXIA (Fever) outcome was unknown.            No concomitant medication provided.  No treatment information mentioned.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
I had a slightly sore arm after receiving the vaccine. On 12/18/2022, I started not feeling well with a dry throat, one eye was red and a runny nose. I tested positive for COVID-19 on 12/19/2022 with a home test. I had PCR test on 12/20/2022 which confirmed I was COVID-19 positive.  I received a prescription for Paxlovid and tolerated it very well.
This spontaneous report was received from a nurse and refers to a 15 month old patient of an unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 03-NOV-2017, the patient was subcutaneously vaccinated with a dose of PROQUAD lot # N016994, expiry date 29-NOV-2018, therapy type: rHa (exact dose was not reported) for prophylaxis. On the same day, the patient was vaccinated with a dose of VARIVAX (exact dose, route of administration, lot# and expiry date were not reported) for prophylaxis. The lot # and expiration date for the sterile diluent used to reconstitute the vaccines was not provided. No adverse effects were reported.
This spontaneous report as received from a nurse refers to 2 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On 25-MAR-2015, the patients were vaccinated with improperly stored VAQTA (dose, frequency and indicatrion were not provided). No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. No further information provided. Additional information has been requested.
Patient had pain radiating from vaccine site towards her neck and fingers. There was significant swelling, heat, and redness that spread from injection site and around her arm over the next two days. Patient came to pharmacy last night and asked if she should get it looked at by a doctor, I advised as it looked somehwhat like cellulitis. She went to urgent care 8/24/2017 and recieved and antibiotic injection and brought me a prescription for oral antibiotics and oral steroids 8/25/2017. Patient declined to take steroids but picked up antibiotics and stated that she had significant improvement in swelling, redness and heat in arm since antibiotic injection. Dr. at the urgent care diagnosed her as having cellulitis.
INDIVIDUAL STATED HAD A REACTION AT SITE OF INJECTION.  CONSULTED DERMATOLOGIST WHO DIAGNOSED IT AS AS AN ALLERGIC REACTION TO BANDAID WHICH PT. WAS NOT CONVINCED. EVENTUALLY INDUVIDIAL STATED THE  AREA AT THE SITE OF INJECTION NOW AS DARK SPOTS  IS INCREASING. PHARMACIST SUGGESTED TO APPLY HYDROCORTISONE AND REVISIT THE DERMATOLOGIST. DUE TO THE REACTION. INDIVIDUAL IS AFRAID OF GETTING THE 2ND DOSE.
110907-Pain/Level 05/left eye socket To Back of Head Discomfort his left side of Body/Dizziness/More loss of BU of left side of Body; 111007 - Headache and Body Soreness
Patient developed small lump at site of injection which persisted unchanged for 2-3 mo. Then during the month of June. Lump elevated in size. Pt was seen 6/30/2009 - diagnosed with 2 cm abscess. Pt was seen 7/1/09 by surgeon and taken to OR for drainage of abscess. Culture negative. Suggestive of sterile abscess.
I have lupus of the connective tissues and had just come out of my flare 4 weeks ago. 2 days ago I'm waiting till another flare; terrible terrible muscle weakness and it's really bad; This is a spontaneous report from a contactable consumer (patient).  A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration  in Arm Right on 23Jul2021 10:00 (Batch/Lot Number: Ew0198) (at the age of 65-years-old) as single dose for covid-19 immunisation.  Medical history included chronic obstructive pulmonary disease, mitral valve disease, cardiac failure congestive, renal cancer stage III, pulmonary embolism from 06May2021, antiphospholipid syndrome from 2003, fibromyalgia from 2007, Sjogren's syndrome from 2007 , Lupus connective tissues 2007 from 2007 and drug allergy to Morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient was not pregnant. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE) taken for an unspecified indication.  The patient  reported she had lupus of the connective tissues and had just come out of her flare 4 weeks before reporting. On 31Jul2021 02:00 she was waiting till another flare and she was having terrible terrible muscle weakness and it was really bad. The patient was treated with Muscle relaxant. Since the vaccination,  the patient has been tested for COVID-19. The outcome of the events was not recovered.
5 days later started itching and red at injection site only. Quarter size red, itchy spot. Called MD for patient.
Pt developed Varicella despite receiving Varivax. Disease diagnosed 11/13/07' tx with Acyclovir though mild; pt received Varivax 5/24/07.
My right hand went partially numb and tingled for 2 days after getting my booster.
EMS dispatched to the Vaccine Clinic for the syncopal. Found male supine in vehicle ico event paramedic. Stated male received a Johnson and Johnson vaccine. Stated he drove his car to the medical monitoring location. Stated he had a syncopal episode with muscle rigidity. IV established. Fluids administered. Vitals noted to be hypotensive. Patient-stretcher-ambulance. Patient stated he felt dizzy. Muscle rigidity present. Patient stated he feels his whole body cramping. Stated he remember events that occurred. Denies chest pain. Denies SOB. Denies ABD pain. Denies N/V. Stated he felt healthy prior to the vaccine. No incident during transport. Muscle rigidity resolved PTA at the ER. Patient received 900cc NS. Transfer of care to ER nurse w/ report.
This case was reported by a lawyer and described the occurrence of autism in a 30 month old male pt who received DTP/DTaP and hep B vaccine recombinant for prophylaxis. This report was received as a result of litigation proceedings, and a physician or other health care professional has not verified this report. The pt received vaccination with diphtheria and tetanus toxoids and pertussis vaccine adsorbed on 12/6/95, 2/16/96, 5/1/96 and 2/25/97. The pt received vaccination with hep B vaccine recombinant on 10/6/95, 12/6/95 and 5/1/96. The pt received vaccination with Haemophilus influenzae type B vaccine on 12/6/95, 2/16/96, 5/1/96 and 2/25/97. Approximately fourteen months after the fourth doses of DTP/DTaP and Haemophilus vaccines, and approximately 23 months after the third dose of hep B vaccine, in April 1998, the tp developed neurodevelopmental injuries including autism. The attorney attributed the events to mercury poisoning resulting from the thimerisol component of the DTP/ DTaP, hep B and Hib vaccines. According to the legal complaint, the pt incurred medical expenses and will continue to incur medical expenses in the future, and the pt "has suffered a significant impairment in his ability to enjoy life, he faces significant obstacles to performing the tasks and activities of everyday living, and he suffers ongoing physical an dmental distress." The events were unresolved. This case was assessed as medically serious (OMIC) by manufacturer.
Extremely sore arm for 3 days. So severe, I could not raise my arm above my head. The day after the vaccine, I felt tired, had the chills, body aches, and run down.
fever in excess of 100 degrees for about 6 hours accompanied by chills, headache
After my booster, I developed heart palpitations/fluttering a few months after; After my booster, I developed heart palpitations/fluttering a few months after; I went to the emergency room twice due to my fast heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Endometriosis" (unspecified if ongoing), notes: Other medical history: Endometriosis/ Fibroid; "Fibroid" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 2, Vaccine location: Left arm, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 08Apr2021, when the patient was 42-year-old, for COVID-19 immunization; BNT162b2 (Dose number: 1, Vaccine location: Left arm, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: 18Mar2021, when the patient was 42-year-old, for COVID-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant), PALPITATIONS (non-serious) all with onset 20Jun2022, outcome "not recovered" and all described as "After my booster, I developed heart palpitations/fluttering a few months after"; HEART RATE INCREASED (non-serious) with onset 20Jun2022, outcome "not recovered", described as "I went to the emergency room twice due to my fast heart beat". The events "after my booster, i developed heart palpitations/fluttering a few months after" and "i went to the emergency room twice due to my fast heart beat" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: Nasal swab. Therapeutic measures were not taken as a result of cardiac flutter, palpitations, heart rate increased. Clinical details: It was reported, After booster, on 20Jun2022 the patient developed heart palpitations/fluttering a few months after. She went to the emergency room twice due to fast heartbeat. The patient was Not recovered. No treatment given. COVID prior vaccination was No. COVID was tested positive post vaccination with Nasal swab PCR test on 08Oct2022. Known allergies include Penicillin. Other medical history include Endometriosis/ Fibroid. No other vaccine in four weeks. No other medications in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Second dose of the vaccine administered after day 36 from the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine administered after day 36 from the first dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine administered after day 36 from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine administered after day 36 from the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient has not received  the second dose at the scheduled time because he moved; and his second dose was within the time frame when the pharmacist was not accepting walk-ins so the patient did not try to come in.  Action taken with mRNA-1273 with respect to events was not applicable.
got the shingles shot/ still got the shingles/suspected vaccination failure; still got the shingles/ his were worse; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingles shot and experienced shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown. This case linked with US2021AMR151351, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR151351:Same reporter