chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days after my second Covid-19 shot, I had to inject myself with my Aimovig shot (for migraines). I take the shot in my upper left thigh, first thing in the morning. I got a migraine at about 10:00 p.m. Sometimes I get a mild headache after the shot. Not usually a migraine, though. I took my rescue drug (Butabital, which I've been taking for about a year with no negative side effects) and went to bed. Around 1:00 or 2:00 a.m. I woke up with hives all around my Aimovig injection site. I have taken Aimovig for about a year and this is the first time I've had a reaction to the shot. I didn't know if there was any connection to the timing of the Covid-19 shot two days earlier or not. I took an OTC allergy medication and went back to sleep. The hives and the headache were gone in the morning. The day after the Covid shot I had joint pain, and a 100.9 degree fever. I had a mild rash at the Covid injection site for about 2 days after the shot, which would overlap with the Aimovig injection.
1 day after vaccine, development of Lt arm skin reaction - lesions 0.5-2cm in size distributed over arm that start as small erythematous vescicles and are painful, then over days develop into evolving blisters and resolve. Last provider recommended triamcinolone cream which doesn't prevent blisters but does help them resolve and become less painful. Highest suspicion for shingles, may be other nonspecific rash vaccine reaction.
OFF LABEL USE; GOT VACCINATED WITH JNJ VACCINE AFTER HAVING TAKEN A SINGLE SHOT OF PFIZER M-RNA VACCINE; This spontaneous report received from a patient concerned a 67 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included: asthma. The patient was not pregnant at the time of vaccination. The patient previously received 1 dose of Pfizer m-RNA vaccine (tozinameran) (dose number in series 1) (forms of admin, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for prophylactic vaccination. No adverse events were reported following vaccination Pfizer m-RNA vaccine (tozinameran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which was an off label use as patient got vaccinated with JNJ vaccine after having taken a single shot of pfizer m-rna vaccine (inappropriate schedule of vaccine administered) (dose number in series 2).  The batch number was not reported and has been requested.  No concomitant medications were reported. The patient also received additional second covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry: were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second covid-19 vaccine ad26.cov2.s (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and got vaccinated with JNJ vaccine after having taken a single shot of pfizer m-RNA vaccine was not reported. This report was non-serious.
Patient complained of headache, nausea, joint pain, low grade fever, fatigue, arm pain. Instructions - Advil, Tylenol, fluids, rest, follow up FMD.
Painful lumps (multiple) in both breasts and underarms; Painful lumps (multiple) in both breasts that have still not gone away 3 months later; Painful lumps underarms that have still not gone away 3 months later; My period was 5 days late after my second dose and I spotted 2 weeks after until my period came again.; This is a spontaneous report from a contactable consumer (Patient) and other healthcare professional. A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0196, Expiry Date: Not Reported), via an unspecified route, administered in Arm Right on 03Jul2021 (at the age of 35-year-old) at 13:45 as dose 2, single for covid-19 immunization. The patient did not have any medical history. The patient was allergy to animal (cats) and pollens. There were no concomitant medications. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9269, Expiry Date: Not Reported), via an unspecified route, administered in Arm Right on 06Feb2021 (at the age of 35-year-old) at 13:15 as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 05Jul2021, the patient experienced Painful lumps (multiple) in both breasts and underarms that have still not gone away 3 months later (more prominent leading up to now consistently late periods). The patient period was 5 days late after her second dose and She spotted 2 weeks after until her period came again. Her next period came 45 days later. She has had very regular periods since the age of 12 except for when she was pregnant and nursing with her only child. It was unknown if the patient received any treatment for the reported event. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. Case was considered as non- Serious. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected
Within 10 minutes of receiving vaccine, he complained of dizziness, loss consciousness with posturing, stiffening or arms and legs and odd moaning/grunting noise.  Lasted about a minute.  Slowly recovered, then large emesis.  We left clinic, had another episode in car and again at the ER.  So 3 episodes of dizziness, vomiting and loss of consciousness within 2 hours of receiving vaccine
Temp not recorded, but believed to be over 37, chills, weakness, asthma worsened;
24 hrs post vaccination I had severe pain in the back of my skull. Burning, shooting pains, felt bumps on back of head and Left side of head. Went to Dr. on 3/30 and was diagnoised with shingles. I had chicken pox as a child, and was not vaccinated for shingles.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided. On 27-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX lot # N034558, expiration date: 05-DEC-2019 (strength, dose, route of administration and anatomical location were not reported) indicated for prophylaxis which was reconstituted with MERK STERILE DILUENT (lot# and expiration date not reported) properly stored. The administered dose of the vaccine Oka/Merck VARIVAX experienced multiple temperature excursions of 6 degrees Fahrenheit (°F) to 14 degrees Fahrenheit (°F) for 303 minutes, as recorded by a data logger. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA002034: US-009507513-1809USA002035: US-009507513-1809USA002036: US-009507513-1809USA002033: US-009507513-1809USA002037: US-009507513-1809USA001866: US-009507513-1809USA002031.
Patient wanted Shingrix and the label was printed for flu vaccine.  While she was informed at the time of vaccination she would be receiving the flu vaccine, she agreed to get the flu vaccine and would get the Shingrix at another time.  The error was presented to vaccinator after the vaccine was given.  The patient knew she was receiving the flu vaccine, but initially wanted the Shingrix first.  She later came in on another day to receive the Shingrix shot.
Right after receiving the vaccine I had racing heartbeat for 2 hours. I was short of breath over the next few days. I developed a swollen and itchy arm. I developed dark bags under my eyes that made me look like I had "black eyes". My fingers turned purple. my veins in my hands and feet enlarged and looked green to me. I feel fine, I just have these funny things happening. everything started to go away after about 3 days and are almost normal except for the veins. I felt fine. then 3 days later on 2/15 I felt like I was going to faint, I felt a rush of heat like a fever and nausea. I felt fine by the end of the day. I am sleeping a lot. I also have a strange feeling in my foot that comes and goes for a few seconds.
Almost immediately after the vaccine on May 24, 2021, weakness, fatigue and body aches occurred for approximately one week. The patient felt better for 1-1.5 days, then started to lose his balance, feel low on energy and felt achy and feverish again on May 31st. He kept thinking these symptoms may go away again, and wasn't sure if they were vaccine side effects or not.  The symptoms continued and the patient fell approximately 10 times the following 5-6 days. His speech also began to slur with a slight facial droop. He went to the ER on June 5th and had a CT, then MRI that confirmed a stroke. Looking back at the course of events, the patient believes his stroke occurred on May 31st. The patient stayed in the hospital for 3 days, then rehabilitation hospital for 14 day receiving inpatient therapy.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 08-JUL-2014 the patient was vaccinated with improperly stored GARDASIL lot # J015378, expiration date: 09-APR-2016. Dose and route of administration were not reported. No adverse effect reported. Additional information has been requested.
Patient admitted for COVID-19 pneumonia, hypotension, metabolic encephalopathy, acute hypoxemic respiratory failure. Treated with decadron and remdesivir and inhalers. Once stable pt d/c home
dx in APR91 w/occular myesthina gravis 10 months p/vax 1st sx appeared OCT90;
Right arm pain for two weeks; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 4th March 2021, 1 hr after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.   Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in right arm and experienced right arm pain for two weeks. Till the time of reporting, arm pain was not resolved. The reporter consented to follow up with physician.
Injection Site is RED; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection Site is RED) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection Site is RED). At the time of the report, VACCINATION SITE ERYTHEMA (Injection Site is RED) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain) and PRURITUS (itching) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Broken bones (survived  a massive car accident in February 2021, from which she has several bones broken) in February 2021 and Blood transfusion (Received Blood transfusion). Concurrent medical conditions included HIV disease (very long term HIV survivor (since age of 17) was reported). Concomitant products included BUPROPION for Antidepressant drug level therapeutic, HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for Anxiety, LITHIUM CARBONATE for Bipolar disorder, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV infection, CLONAZEPAM for Insomnia and Anxiety, GABAPENTIN and GABAPENTIN (GRALISE) for Nerve pain, OXYCODONE for Pain, DABIGATRAN ETEXILATE MESILATE (PRADAXA) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain), PRURITUS (itching), COVID-19 (Tested positive for Covid-19 last week/ER doctor thinks it's the Delta variant), ILLNESS (Have been really sick), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Two red spots in left arm where injections where given). The patient was treated with GUAIFENESIN (MUCINEX) for Headache and Ear ache, at a dose of UNK, q6h. At the time of the report, PERIPHERAL SWELLING (repeated arm swelling), ASTHENIA (Weakness), DIZZINESS (Dizziness), EAR PAIN (Ear pain), PRURITUS (itching), COVID-19 (Tested positive for Covid-19 last week/ER doctor thinks it's the Delta variant), ILLNESS (Have been really sick), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Two red spots in left arm where injections where given) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive, Delta variant. Patient reported that tested positive for COVID-19 and her doctor thought that it was the Delta variant. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up information received and contains significant information. Email address added. Lab data added. New events Sickness and COVID-19 added.
Tightening around heart and chest area. Heart feels constricted and squeezed/tightening. Have a hard time trying to breath deeply. Headaches, felt fatigued, and  heart hurts,, which lasted for 2 days.
10 minutes post second COVID vaccine, reported "floaters in vision," mild central  chest pressure and  elevated blood pressure 200sys/100dias and felt her "heart racing" pulse measured 101.  after monitoring for approximately 30 min we decided to send to ER.
Patient states she had usual sore are following the shot.  Muscle pain has not improved in spite of ice and pain reliever.  States heaviness in elbow and hand of affected arm.  Continues to have pain when removing clothing or turning steering wheel of car.
Felt so hot like his body is burning inside; BP was through the roof; Increased Heart rate; chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate), CHILLS (chills) and HEADACHE (Headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate) and HEADACHE (Headache). 24-Mar-2021, the patient experienced CHILLS (chills). The patient was treated with DIAZEPAM at an unspecified dose and frequency; BETA BLOCKING AGENTS at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Felt so hot like his body is burning inside), BLOOD PRESSURE INCREASED (BP was through the roof), HEART RATE INCREASED (Increased Heart rate), CHILLS (chills) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: Positive. In January 2021, SARS-CoV-2 test: Negative. On 24-Mar-2021, Heart rate: 140 BPM.            Concomitant product use was not provided.  Treatment information included diazepam, beta blocker, Tylenol and advil. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
This is a spontaneous report received from a contactable other HCP (patient), via a Pfizer sponsored program (159558). The reporter is the patient. A 72-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Feb 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history not reported. The patient took concomitant medications. The patient had fatigue/felt tired the next day, onset Feb 27, 2021, with outcome of unknown, and malaise, with outcome of unknown. Additional information: The patient reported that, after getting first dose injection, it was weird. She did not feel like anything went in there. She felt tired the next day. She took medications that made her feel tired, but this was different. She believed she may had gotten malaise. But was not sure. She wanted to know if she had no antibodies, what should she do. She was scheduled for the second dose on Mar 19, 2021. Patient needed physiological tests and antibodies tests to get done so that she could know. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information  expected.
discoloration; it when to my neck and shoulders/it went to my head; Itchy; Hypersensitivity reaction; rash developed at the injection site; itchy bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (discoloration), RASH (it went to my neck and shoulders/it went to my head), PRURITUS (Itchy), HYPERSENSITIVITY (Hypersensitivity reaction) and VACCINATION SITE RASH (rash developed at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Hay fever, Hives (MSG), Diabetes since 2007 and Hypertension since 2013. Concomitant products included CHLORTHALIDONE and LOSARTAN for Blood pressure high, METFORMIN and GLIMEPIRIDE for Diabetes, ATORVASTATIN for Triglycerides high, CLOMIPRAMINE for an unknown indication.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). In February 2021, the patient experienced VACCINATION SITE RASH (rash developed at the injection site) and VACCINATION SITE PRURITUS (itchy bumps). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (discoloration), RASH (it when to my neck and shoulders/it went to my head) and PRURITUS (Itchy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and CORTISONE (topical) from 28-Apr-2021 to 07-May-2021 at a dose of 1 dosage form. On 25-Apr-2021, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. On 07-May-2021, RASH (it went to my neck and shoulders/it went to my head) and PRURITUS (Itchy) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (discoloration), VACCINATION SITE RASH (rash developed at the injection site) and VACCINATION SITE PRURITUS (itchy bumps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: high (High) 180s -190s.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication also included anti itch cream. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-055624, MOD-2021-055624 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received on 02-JUL-2021 and contains information's of patient demographic details,medical history,concomitant medication, dosing information, onset date and event outcome updated and new event(Hypersensitivity) were added.
19 y/o male, developed papular lesions single & in small plaques over bilateral hands (dorsal>palmar surfaces), bilateral elbows, knees & lower legs onset 3 weeks days following receipt of SPV, AVA #1, typhoid vaccines given 7/13/2009;  afebrile, no systemic symptoms.  Pt was seen by civillian NP 8/1/2009 (no notes) who contacted military call center;  derm images reviewed by Dr - felt consistent with non-IgE mediated hypersensitivity reaction & recommended oral steroid pulse;  pt was lost to f/u.  Symptoms:  Lesions, papule.
Awoke about 10pm on 1/31/07 couldn't see, hear, speak, had a cold, body hurt all over, vomiting, blacking out. Daughter called 911 transported to ER released about 11:45 pm received IV fluids and some lab work. Dr ruled it an adverse reaction to flu shot.
On 08/12/20, the donor called the center to disclose that she believed she was having a reaction to her Rabies booster shot that was given to her at the center on 08/10/20.  She stated that she felt fine the day of the booster but then on 08/11/20, she noticed hives covering both of her ankles.  As the day progressed, the hives spread to her entire body.  As of 08/12/20, the hives/itching did not subside.  The donor denied difficulty breathing/swallowing and denied any other symptoms.  Donor did not seek medical treatment.
2 days after the first vaccination I had pain while urinating, lower back pain on the right side pain just below the ribs and the kidney area on the right side and right side pelvic pain, lower abdomin pain around bladder area. Doctor thought it could be a UTI so I was prescribed antibiotics I've never had a UTI. After finishing the antibiotics there is no relief pain was worse. I received the second vaccination on 4/28. After receiving that vaccination my left side started hurting and the right side pain continued. After much testing with no results that came up with any issues I was sent to see a urologist. Who after hearing my symptoms and the timing of them believed that it was an adverse effect to receiving the covid vaccination. He put me on some pain medication to help me sleep as I had not slept in a month and now I am feeling much better. Symptoms started on 4/9 and it is now 5/27 and I am starting to feel normal again.