chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DIED; MASSIVE HEART ATTACK; This spontaneous report received from a consumer by a company representative via social media concerned a 34 year old male of an unspecified race and ethnicity. 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, batch number and expiry date were not reported) dose, start therapy date was not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced massive heart attack and he died from unknown cause of death. It was reported as "My family member got it and had a massive heart attack and died he was only 34". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive heart attack was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20221147298-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221147298- massive heart attack. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Mother called clinic staff 9 days after clinic to report child developed symptoms of illness the week following the vaccination date. Mother reported malaise and fever. She was treating with Advil and Tylenol. Mother reports other children sick with similar symptoms at the school. Mother verbalizes concern with vaccine causing symptoms of illness. Mother encouraged to seek medical evaluation for child
p/each vax pt became extremely irritable starting 6hr p/vax cont for 5 days;irritability was worse w/each dose-out of control & hysterics
Information has been received from a nurse practitioner concerning a 40 year old male patient with a recent history of myocardial infarction who on an unspecified date, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. Subsequently the patient developed a severe localized reaction including pain, fever, and swelling. The patient sought unspecified medical attention. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M007764, expiration date: 30-JAN-2018, (dose number, route and anatomical location of administration were unknown). The temperature excursions reported were: 51.3 F for 40 minutes, and 50.2 F for 1 hour and 10 minutes. The temperature excursions were detected by a digital data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient given vaccine at a flu employee clinic here at the central office. The patient was eventually admitted into the hospital and diagnosed with Guillain Barre Syndrome.  10/21/2009 DC summary received for dates 10/5-10/9/2009. DC DX's: GBS, HTN and Chronic Back Pain   Patient admitted for 1 week hx of sx of progressive weakness, numbness  of lower extremities and difficulty walking     10/26/2009 rec ED and MR for 10/5/10/9/2009. Dx GBS  Neuro consult on PE reflexes were absent patellas and ankles bilaterally, decreased sensation to temp and pinprick bilateral LE's.  LP, TX: IVIG
Shingrix shot. Both times. Muscle pain and flu like symptoms that started 12 hours after shot and lasted 24 hours. Very uncomfortable but took Tylenol and discomfort reduced somewhat.
Woke  up early morning of the 11/6/21 covered in hives.  Medicated with diphenhydramine, Fenoxfenadine. Morning of 11/7/21 had progressed to all over body, swollen hands, face and difficulty breathing. Was seen at Hospital and treated with dipenhydramine, famotidine, breathing treatment and steroid injection. Discharged on Prednisone 12 day taper, Benadryl hs, famotidine bid and Fenoxfenadine daily.  Hives continued but more pronounced on hands and feet.   On 11/14/21 woke up again with hives on head, swollen face, chest tightness,  chest sore to touch and pain on inhalation. presented to ER. Once again given IV diphenhydramine, dexamethasone, and famotidine IV.   Blood work and chest x-ray again clear. Determined a prolonged reaction to booster and recommended completing steroid taper and continuing all antihistamines.
Information has been received from a physician concerning a 23 month old female patient (23 lb. 12 oz / 33 inches) with no illness who about 1 year ago (also reported as on 12-DEC-2008), was vaccinated SQ into the left arm which the first dose of VARIVAX (lot# 661999/1279X). On 20-NOV-2009 the patient developed rash and about 10 blister lesions. The patient sought medical attention via doctor visit on 24-NOV-2009, the patient recovered from the events. There was no illness at the time of vaccination. Additional information is not expected.
Patient stated that he was going to faint, was sweating, felt hot, stated he was having difficulty breathing
Employee states that he is reporting adverse event due to misuse as he believe that the  Provider self administered GARDASIL 9 outside of age indication.; No additional adverse events reported.; This spontaneous report was received from a female physician of unknown age, via company representative, referring to herself. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On an unknown date, the patient self-administered a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (doses, dose numbers, routes of administration, anatomical locations, lot numbers and expiration dates were not reported for both) for prophylaxis outside of age indication (product administered to patient of inappropriate age).  The company representative was unable to confirm if the patient self-administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). The company representative was unable to confirm the patient's age. No additional adverse events were reported (no adverse event).
migraines since 1st dose of vax p/18 hr w/migraine since, n/v, vision disturbances;h/a reported daily;
No symptoms reported; The patient received PREVNAR on 5/22/2017 and then had a PNEUMOVAX on 11/29/2017; This spontaneous report has been received from a pharmacist referring to a 65 year old (currently 67 year old) male patient. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-MAY-2017, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR) for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported). On 29-NOV-2017, after an inappropriate dosing interval, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose detail, anatomical location, route of administration, batch/lot # and expiration date were not reported) (inappropriate schedule of product administration). No symptoms were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA010231:
I woke up the next day feeling weak and light headed. Just within minutes of waking up and getting out of bed to urinate, I felt even more light headed.  Right after exiting the bathroom my vision was blacking out as if there was no blood flow going to my head. So I rushed over to lay down and maybe narrowly avoided the possibility of going unconscious. After I laid down I was shaking and sweating which is something I did not experience when I first woke up. 10 min later I get out of bed again and I feel much better as if nothing had happened. I have no history of blacking out and it was the first time I had ever experienced such a side effect in all my life.
W/in 10 min of MMR & Chicken Pox vaxs, pt broke out in hives. Nurse administered epinephrine.
Swelling, erythema, tenderness, streaking consistent with cellulitis within 24 hours.  No abscess at this time.
Breakthrough case admission after 5 vaccines Pfizer 1/16/21 Lot# El0142;  Pfizer 2/11/21 Lot# EL9261;  Pfizer 9/29/21 Lot# Ew0179;  Pfizer 4/7/22 Lot# FK9893;  Pfizer GJ5342; 11/16/22
fatigue; runny nose; headache; I have a sore throat; fever/mild fever; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (batch/lot number and expiration date not provided), via an unspecified route of administration, on 16Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had  fever on the day she got the vaccine on 16Dec2020. The patient no longer had fever. The patient worked with high risk patient, since this morning on 23Dec2020 the patient had a sore throat. The patient wondered should she be worried because it's a covid symptoms. It's been a week she got the vaccine. It's mentioned fatigue, headache, runny nose and mild fever as some of some of the symptoms the reporter experienced. The outcome of the event" fever/mild fever" was recovered and of the other events was unknown.  Information about lot/batch number has been requested.
Large (3 in) diameter, raised, erythema, warmth, and itchiness on L deltoid. Feels like a big mosquito bite. Using steroid cream  & Zyrtec.
vial thawed on 1/11/21  and due to expire on 1/16/21 - patient was immunized with this expired vaccine on 1/22/21
Patient received a 5th dose of Pfizer vaccine. Vaccination card not available at appointment. Pharmacy records showed only 3 previous doses given at facility. First COVID-19 vaccination given at a different facility per records. Previous Pfizer booster given 3/11/2022 at our facility.
Information has been received from a nurse practitioner concerning an 18 year old female with conjunctivitis at the time of vaccination who on 11-JUL-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil (Lot #654535/0960F). There was no concomitant medication. On 13-JUL-2007 the patient developed a headache, nausea, vomiting and dehydration. The patient was evaluated in the emergency room and treated with unspecified intravenous fluids. Blood chemistry and complete blood count were within normal limits. Subsequently, the patient recovered. The physician considered headache, nausea, vomiting, and dehydration to be other important medical events. Additional information has been requested.
Tiredness started at 6PM the day of vaccination went to bed at 7.45 and woke up around 10 because of pulse rate of 112 and BP 149/101 these symptoms lasted for about 5 hours.  Next morning I call the Pharmacist and she told me to keep monitoring my pulse and BP and that she thought it would stabilized by that afternoon.  BP and pulse continued to be high throughout the day. At midnight I started having pain in my left upper back and left rib cage and was unable to take a deep breath bc of the intense pain even that I had been taking aspirins through the night the pain continued so in the morning (Sunday) I went to an urgent care clinic and saw Dr. who listen to my lungs and did a chest X Ray. X Ray was clear but he sent me to an ER for possible PE secondary to COVID19 vaccine.  In the ER they did blood test to look for blood clots and it was positive so they performed a CT scan with contrast to look for blood clots. CT scan was negative so they sent me home and to follow up with Dr since my Blood Pressure was still high and my pulse was still in the 90s. I followed up with another Dr. and now I am on BP medication.
vertigo, double vision, headache, inability to stand.  Went to ER, given meclizine and lorazapam.  Symptoms improved over 6 hours but, other than headache, have never disappeared completely
experiencing some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing some side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experiencing some side effects). At the time of the report, VACCINATION COMPLICATION (experiencing some side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.
The patient received Pfizer BIVALANT instead of Pfizer MONOVALENT; no reaction observed
So a day later i had soreness in the arm shortness of breath body aches and chills. I had headaches and fevers on and off. I still have the shortness of breath every thing else stopped after 3 days.
Generalized tonic clonic seizure not associated with fever on 9/26/13. Had another generalized tonic clonic self-resolving seizure 9/30/13 associated with a fever.
Initial report received from a health care professional on 02 Mar 2010: This patient was inadvertently vaccinated with a expired dose of FLUVIRIN (Batch No. 10127806), intramuscularly, on 02 Mar 2010. The outcome of the event was not reported.
Received 2 doses Pfizer vaccine Feb and March 2021, no booster; admitted Dec 2021 for hypoxic respiratory failure 2/2 covid19 pneumonia. Discharged home next day.
Chills; Stomach ache; Gagging; Fever; Dizzy; Tired; I just feel sick; unwell, I am not feeling great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, single), for COVID-19 immunization; Bnt162b2 (DOSE 2, single), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach ache"; RETCHING (non-serious), outcome "unknown", described as "Gagging"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; ILLNESS (non-serious), outcome "unknown", described as "I just feel sick"; MALAISE (non-serious), outcome "unknown", described as "unwell, I am not feeling great".  Additional information: Consumer stated, "I had my booster today, this afternoon and it was about 2:30 in the afternoon and I was doing fine all afternoon and this evening I laid down, I started getting chills and I stared getting the side effects and I covered up and got me a cup of tea and I did not vomit but I was gagging around and now I got slight fever and I got a stomach ache and what else. Anyway, kind of dizzy, tired and I was just wondering how long will it last?".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2d after receiving injection, patient develoved right-sided headache with subsequent painful blistering rash, classic for shingles in right facial nerve dermatome
BRUISES; This spontaneous report received from a patient concerned a 61 year old female of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included: heart attack (heart attack in 2020 because of blood clots) and stomach upset because of Aspirin and concurrent conditions included: seasonal allergies and acid reflux.  The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: unknown) dose was not reported, 1 total administered at left arm on 04-FEB-2022 for prophylactic vaccination. No adverse events reported following vaccination with first dose of covid-19 vaccine ad26. cov2.s. (Dose number in series 1). The patient was ok until she got the booster.  The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190 and expiry: unknown) dose was not reported, 1 total administered at left arm on 05-APR-2022 for prophylactic vaccination.  Concomitant medications included acetylsalicylic acid for blood clots. The patient stated that, she had stopped taking her medications, she stopped taking the aspirin too soon in 2018 because it was upsetting her stomach. She stopped it for a couple of years. Then again restarted on an unspecified date JUN-2020. On an unspecified date in APR-2022 started a couple of days after vaccine, the patient experienced bruises (Dose number in series 2). The patient reported, she looked like somebody had beaten her. She had bruises that were humongous. She had a bruise right up her hand and one two inches from her wrist, one in the middle of the arm, and then there were six on her right leg, three on her left leg and got one on her elbow and one on wrist on her left arm. When they show up they were almost black, that's how dark they were. It took two and half weeks for that bruise to go. The patient used Vaseline for the bruise. She stated that, she was on other medications at the time of reporting but not wanted to provide the information. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bruises. This report was non-serious. This case, from the same reporter is linked to 20220600703.
Moderna COVID-19 Vaccine EUA - my arm was sore and very red around the site, swollen, during the day of the 11th I started getting chills and body aches, fatigue, and felt feverish,  by 6 pm I had a headache. The headache was shooting pain on my right side of my head that lasted until about 5 am this morning.  I took Tylenol and alternated IB with it.  So far this morning all symptoms are gone except my arm is still red around the site and sore.
Afflicted with Bell?s Palsy. Paralysis on left side of face.  Still paralyzed to date (9/24/2021)
little soreness at the injection site; feeling like I was coming down with a sinus infection; sore throat; runny nose; felt stopped up; cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "little soreness at the injection site"; SINUSITIS (non-serious), outcome "unknown", described as "feeling like I was coming down with a sinus infection"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt stopped up"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold". Therapeutic measures were taken as a result of vaccination site pain. Additional information: The patient took acetylsalicylic acid (ASPIRIN) as a treatment for the little soreness at the injection site. Patient denied having fever. He was scheduled to take the second dose on 26Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a couple of adult patients of unknown demographics. On an unknown date the patients were vaccinated with VARIVAX. It was reported that patients who received VARIVAX reported that their genital herpes improved for 1 year after vaccination with less outbreaks. The outcome of the event was unknown. Additional information has been requested.
Rash starting on neck and chest, 2 days ago. Rash spread over entire body. Denies fever.
Patient felt dizzyness, cold sweats, nausea, and paleness post vaccination while awaiting the 15 minute monitoring period. Pharmacy staff stayed with patient while ambulance arrived and took patients vitals. All was normal and patient began to feel better 10 minutes later. Patient went home. Followed up with patient later in the day and patient feeling much better/no pain in arm/no redness/etc.
headache; sore arm, achey, felt feverish (no fever) for the first 3-5 days On Day 8, developed an itchy rash at the injection site