chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart attack; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431061-00 (Agency).  A 67-year-old female patient received BNT162b2 (BNT162B2), on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 67 years intramuscular for covid-19 immunization; adalimumab (HUMIRA), from 18Jan2022 (Batch/Lot number: unknown) to 18Jan2022, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: coviD-19 vaccine (dose 1, single (1 in 1 Once), Intramuscular route), administration date: 08May2021, when the patient was 67-year-old, for COVID-19 vaccination. The following information was reported: MYOCARDIAL INFARCTION (medically significant) with onset 18Jan2022, outcome "recovered" (18Jan2022), described as "Heart attack". The action taken for adalimumab was dosage permanently withdrawn on 18Jan2022. Clinical course was reported as, Patient experienced COVID-19 from 10Jun2021 to 20Jun2021. It was unknown if patient was enrolled in a COVID-19 vaccine trail. Reported that event abate after stopping drug (Humira).  Causality for BNT162B2: The reporter considered "heart attack" related to BNT162b2 (reported as Possible). Causality for adalimumab (HUMIRA): The reporter's causality for the event (s) of heart attack with Humira (Adalimumab) was no reasonable possibility (Not related) and (as per Manufacturer) Agency's opinion is that the event of heart attack is not assessable.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
12 year old patient received a dose of DTaP instead of receiving TDaP; 12 year old patient received a dose of DTaP instead of receiving TDaP; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date:18-Jul-2022 Reporter's comments: The patient received the dose of DTaP instead of receiving TDaP. Additional supportive information: The 12 year old patient received a dose of DTaP instead of receiving TDaP, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Patient experienced tonic clonic seizure at 11.40 a.m., lasting approximately 45 seconds.  Patient recovered within a minute, vital signs and color returned to normal.  Parent was advised to take patient to pediatric clinic today for further work up and determination of  best way to administer second COVID vaccine..
Presented with SOB, fever, cough, nausea, myalgia, chills x 1 week; + Covid 3 d PTA; 9/20 OBS, Admit 9/21 Medical with Covid PNA; tx with 9/20 Vit C,  lovenox, singulair,  zinc 9/21 Maxipime, doxycycline, steroids; O2 minimal requirements throughout visit;
Psoriasis aggravated; Frustration; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis aggravated) and FRUSTRATION TOLERANCE DECREASED (Frustration) in a 38-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In March 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (Psoriasis aggravated) and FRUSTRATION TOLERANCE DECREASED (Frustration). At the time of the report, PSORIASIS (Psoriasis aggravated) had not resolved and FRUSTRATION TOLERANCE DECREASED (Frustration) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant Drugs Not Reported. Patient psoriasis was worsened since she was late on her shot. They were frustrated. She had a bad reaction to the Moderna COVID vaccine and broke out in psoriasis. She had been on Skyrizi for years and it worked for the psoriasis but without it, she had patches of psoriasis come up. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event(s) of FRUSTRATED and PSORIASIS WORSENING/PSORIASIS PATCHES/BROKE OUT IN PSORIASIS AFTER MODERNA COVID VACCINE was not provided. No treatment were reported.
17 y/o female, 5 minutes post vaccination c/o lightheaded ness, pt. Fainted for <15secs, upon assessment pt is pale, cold, clammy. Paramedics V/S taken, HR 72, BP 107/75 (sitting), standing HR 92, BP 80/50, NS bolus was given and pt still c/o lightheaded ness, dizziness, nausea. Taken to Hospital for further evaluation. Taken by Paramedics.
on 03/01/22 pt present with c/o chest pain, nausea, and vomiting. on  03/02/22 pat admitted.  See below for copy of note: 16 yo with suspected myocarditis. She has increasing troponin but reassuringcoronary angiography and appears to have good heart function. She is immunized and also had abreak through covid infection in January. She does not meet criteria for MISC. This morning the patient awoke with burning discomfort in her chest as well as epigastric pain and 3episodes of vomiting prompting her to go to the ED. The pain was not positional. Nodiarrhea. No ST, cough, fever. She had a recent Covid infection in January in which she had 3 days ofmild symptoms. She is also immunized with two doses of the Pfizer vaccine with the most recent dose,2-3 months ago. She has had no other symptoms like rash or conjunctivitis to go along with possibleMISC. l Work-up at that time including labs and EKG were reassuring. She was given IV fluids and Zofran as well as a GI cocktail. This seemed to help and she was discharged. Lab work-up revealed a reassuring CBC, reassuring CMP with normal LFTs. A CRP of 0.5 and procalcitonin of 0.08. Covid was negative. Lipase was 17. Urine pregnancy test was negative. She has no significant past medicalhistory with a negative family history for significant early onset coronary artery disease and suddencardiac death . This evening she presented back to the emergency department with increasing nausea and increasingchest pain. The pain is better when she lays flat that hurts more when she is sitting up.
pt recvd vax & exp hypotension, passed out, fell to the floor & exp loss of bladder control; pt was noted to have sz activity; regained consciousness & was transported to ER for observation; pt was adm to hosp for overnight observation;
Pt had hypersensitivity reaction, hives, and wheal covering entire body within 10 min of shot. Given PO Benadryl 6.25mg PO qd/ Solumedrol 1 mg/kg IM. Did very well with excellent improvement of sx.
The day of the dosage at 3:30PM symptoms started, Aches pain wheezing sore arm and it lasted 36 hours and disappeared. On 5/5 all 10 of my fingernail tips are blue/pink with no other symptoms, I tried to run my hands under warm water but that didn't work. I took a COVID-19 test and reached out to my doctor and he said if it doesn't get better in a couple of days to go to the ER.
silver dollar size rash on arm; A spontaneous report was received from a Consumer concerning a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events silver dollar size rash on arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, reported as a few days the patient experienced the events silver dollar size rash on arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event silver dollar size rash on arm was not reported/unknown on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
completely paralyzed temporarily/inability to move my limbs for maybe an hour or two; Muscle weakness; not feeling bad but not really very energetic; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (completely paralyzed temporarily/inability to move my limbs for maybe an hour or two) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (completely paralyzed temporarily/inability to move my limbs for maybe an hour or two) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Muscle weakness) and ASTHENIA (not feeling bad but not really very energetic). At the time of the report, PARALYSIS (completely paralyzed temporarily/inability to move my limbs for maybe an hour or two), MUSCULAR WEAKNESS (Muscle weakness) and ASTHENIA (not feeling bad but not really very energetic) outcome was unknown.            The patient birth year was given as PRIVATE and body weight as 194. The patient was not sure about age at vaccination whether 83 or 84. It was probably 84. The patient had the first two right away, within two four weeks or so and that the third shot was about the one year ago, that was the problem.  Company comment: This spontaneous case concerns male patient of unknown age (patient reports he was either 83 or 84-years-old) with no medical history reported, who experienced the unexpected, serious (medically significant) event of paralysis an unknown time after a dose of mRNA-1273.222. the patient reports that he felt muscle weakness, with complete temporarily paralysis, as well as asthenia. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns male patient of unknown age (patient reports he was either 83 or 84-years-old) with no medical history reported, who experienced the unexpected, serious (medically significant) event of paralysis an unknown time after a dose of mRNA-1273.222. the patient reports that he felt muscle weakness, with complete temporarily paralysis, as well as asthenia. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Systemic: Headache-Severe, Systemic: Nausea-Mild, Systemic: increasing blood pressure upwards of 170/101 while lying down, heart rate 119, 100% o2 sat, difficult breathing. Patient was visibly nervous and apprehensive prior to receiving vaccine. ER via EMS.-Severe
chest tightness, difficulty breathing, feeling of something stuck in her throat , weak,  patient was given EpiPen 0.3 mg 1 dose and we called 911
Beginning one day post Pfizer COVID vaccine dose 2 on 1/9/21, experienced dyspnea /increased work of breathing with very mild exertion (i.e. ambulating around the house). Intermittently unable to talk in full sentences with ambulation one-day post administration. Shortness of breath generally resolved with sitting down, lasted 72 hours in total, and was accompanied by fatigue, chills, body aches, stomach cramps, and headache. Home pulse ox showed O2 saturation at 98% during periods of dyspnea, HR 100. Contacted primary care provider's office on day 3 post vaccine to notify of symptoms and determined COVID-19 test was clinically indicated. Test obtained day 4 post-vaccine with negative results. Of note, unable to report post vaccine side effect data in V-Safe day 1 post administration due to error in V-Safe system.
pt felt dizzy minutes after the vaccine, started vomiting, and had a headache. but all symptoms went away after a few minutes. Pharmacy called 911 and paramedic came in and measured her vitals, all were normal, and they left. no treatment was given and she was not taken to the hospital.
No additional AE reported; HCP reporting VAQTA, PEDVAXHIB, and ROTATEQ were administered after a temperature excursion. Caller stated she did not have the exact dates of administration nor the names of the patients involved. No additional information provided. No additional AE; This spontaneous report was received from a Health Care Professional and refers to a 2-month-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-DEC-2022, the patient was vaccinated with the first dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh, lot #U031544, expiration date: 23-JUN-2024, administered intramuscularly for prophylaxis (strength was not provided). and with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), lot #1892784, expiration date: 23-DEC-2023, administered orally for prophylaxis (strength was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA001175: US-009507513-2301USA009088: US-009507513-2301USA009024: US-009507513-2301USA009110: US-009507513-2301USA009878: US-009507513-2301USA009918: US-009507513-2301USA009933: US-009507513-2301USA009943: US-009507513-2302USA000412: US-009507513-2302USA000456:
1.- Headache, Dizziness, Nauseous, High fiber, and weakness for more than 17 days. Still I do not feel 100% well. 2.-I am taking Vitamin C, Tylenol 500mg., Water, Turmeric pills.
SAME THING HAPPENED (ADVERSE EVENT); This spontaneous report received from a patient via a company representative via social media (J and J Corporate) concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was not reported whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1, unspecified manufacturer). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 same thing happened (adverse event) (dose number in series 2). Reporter stated that, "I had the same thing happen with my booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same thing happened (adverse event) was not reported. This report was non-serious.
pt recvd 1st dose of vax w/no noted problem; pt recvd 2nd dose of Hep B vax on 18AUG92 & w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
10 CM SWELLING AND INDURATION WITH 3 CM SURROUNDING ERYTHEMA AT INJECTION SITE WITH TENDERNESS EXTENDING TO RT AXILLA
Itchiness, redness w/ swelling in 4" circle at injection site; 48 hrs later, slight breathing issue. Pt saw PCP on 05/20/16, and she stated this is a side effect and recommended cold compress. Pt states the swelling and redness are decreasing; but it is still very painful.
02/10/2021 Serious issues but two days later 02/12/2021 running fever for 16 days, primary care sent for test, drew blood, chest X-ray at hospital, urine test, trying to cause infection to run fever, would spike at night and morning no fever, the first week. Then in afternoon fever would start, for first week, fever 2 weeks in he called the CDC an she called Dr. wanted CT-A, looking for blood clots in lung scan of lungs and had to go to different hospital, insurance issue and machine issues and 3rd time Thursday 2nd week was waking up with a fever and he was called Levaquin and that day before he went to COVID PCR test on Thursday raid and flue test and both negative. The PCR test Friday was negative patient referred to virus as unknown virus. Got the Levaquin and was better the next day. Went back to the doctor for a check up and he thought it was Pneumonia and he asked why it did not show up on x-ray and he had hair fell out and he had a ball spot in his head. Fever that ran so long he had bald spots in dermatologist. 2nd week 2 COVIDs Test, one was PCR and Flu and all negative. Dermatologist thought it was due to the vaccination, since he had bald spots.
I had regular periods throughout the week in to the weekend that I was vaccinated.  Since then I have not had a single period, spotting, cramps or anything indicating a menstrual cycle at all.
This spontaneous report was received from a medical assistant, who refers to an unspecified numbers of patient of unknown age and gender. On unspecified dates, the unspecified number of patients were vaccinated with an improperly stored dose of RECOMBIVAX HB 5mcg/0.5 ml, lot # K008988, expiration date on 01-APR-2016, lot # K026666, expiration date on 22-OCT-2016 (dose #, dose and route of administration were not provided). There was not concomitant medication reported. No adverse effects were reported. There was not a product quality complaint involved. It was unknown if the patient sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received vaccine 9/20/16. She came to see me on 9/24 and mentioned she had a large red area around vaccine was administered. She noticed some malaise. Redness and malaise has since resolved. It lasted 203 days.
Day after vaccine, patient had tenderness (RD), swelling, redness with heat radiating down arm. It went almost from injection site to elbow. Recommended BENADRYL 50mg every 4-6 hours, ice, and TYLENOL. Recovered after 4-5 days. Ran mild temperature. Reaction happened in arm PNEUMOVAX was given.
12 hours after shot started to feel nauseous.  Then got chills, severe headache, stuffed nose, and ran 100.8 fever.  Lasted for about 12 hours except headache is still happening.  Tylenol is all I have taken to treat.
In spite of taking a 5mg Claritin 2 hours before shot I felt immediately my tongue and throat swell. I took another Claritin and sensations subsided in an hour. The next day my arm was bruised right above injection site. I couldn't lift my arm. I also had a fever and felt very tired. Both of these resolved by the third day. A few days later the rash began. All over my mid-body. It is itchy and has progressively gotten worse over the last couple of weeks.
slight pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 1st dose of Shingrix. After vaccination patient experinced slight pain. This case was linked with case US2020196160 as reported by same reporter. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196160:same reporter
I received my flu shot from the company nurse, in my left shoulder. A few minutes after receiving the flu vaccine, my arm was in pain from my shoulder to the top of my hand. The pain radiated down my arm until the evening, and the pain continued until the next morning. As of 10:15 AM the pain seems to be going away, and is not as intense. Vaccine information: Mfg. Seqirus, Inc. Lot 185327 EXP date 4/30/2017 Dose 0.5 cc IM.
I was 33 weeks and 7 days pregnant on the date of shot, estimated due date 4/24/21, previous pregnancy delivered preterm at 34 weeks and 3 days due to preeclampsia, currently no indication of preeclampsia in this pregnancy   Approximately 15 minutes after receiving the vaccine the right side of my face begin to tingle. It tingled off and on for the rest of the evening and in the morning the right side of my face was noticeably swollen for the first 3-4 hours of the day. It went away and I took no medication and have experienced no more symptoms.
bruising on injection site, severe pain and itching even after 11 days, extreme fatigue
Muscle aches and joint aches, headache, fever of 100.1, chills and lethargic from 11pm Friday the 22nd until Sunday morning of the 24th then tired for the rest of Sunday. 100 percent better by Monday, January 24th, 2021. Took ibuprofen (600mg) and acetaminophen (100g) three times a day which brought fever down to 99.7 but did not do much for aches.
Patient received pfizer vaccine on 8/13/21, reported dizziness and lightheadedness for a few days after, then on 8/18/21 she blacked out ( lost consciousness ) while driving a car, She received treatment in urgent care.
PATIENT RECEIVED VACCINE IN FEBRUARY AND MARCH 2021, TESTED POSITIVE FOR COVID-19 8/9/21
Vertigo, GI, migraine s/s - intermittent x 4-5x since vaccination, lasting 2-4d
Pt developed high fever (103 degrees) after taking 3rd dose of oral Typhoid vaccine, followed few days later by H/A and neck stiffness. PCP sent him to ER for eval. w/u was normal.
Erythema and warmth emanating from vaccine site within 1st 24 hours, spreading to 14cm by 48 hours.
Diffuse pruritic papular rash that spread over back, arms, legs, neck, etc