chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported pain in her arm, shoulder, and neck the night of the injection. Patient sought treatment on 03/30/2017 and was given a Medrol dose pak, and Zanaflex. x-ray on the shoulder (or arm) was ordered according to patient. Meds are in day 2 and not even picked up.
Arm became itchy, bad headache, eyes sensitive to light, vomiting x 12 hours, chills, body aches, weakness.
Patient is diabetic, but well controlled with insulin. He had his second COVID vaccine on March 5. His wife noticed some increased confusion and drowsiness for the last 2 days (starting 3/9). He came to the ED on 3/11 with a blood sugar of over 600. He was admitted for observation to our unit 3/11.
Had Td on 03/22/2002 in LD for inury to leg. No pain, redness, swelling noted until 04/01/2002 when taking shower noted a dime size red mark on left upper arm "where the shot was given."
Fever 99.9 to 102 for 3 days.  Chest rash  evening of shot until next morning. Severe headache, dizziness, nausea, fatigue for 4 days.  Stomach pains for 3 days.  Took 2 Tylenol q 6 hours for 3 day which reduced fever. . Took 1 Advil for severe headache which increased indigestion.
2 days following vax pt presents w/a 3" diameter raised, warm, painful, closed lesion to lt deltoid area; referred to MD;
pain, nausea, constant dizziness, tachycardia occurring the day after vaccine administration. Patient reports taking  ibuprofen 800 mg and Acetaminophen 500mg every 6 hours for pain and swelling at the injection site, unrelieved . Patient went to ER due to nausea, dizziness, and tachycardia. Discharged home from the ER
Uncontrollable chills alternating with sweating for 48 hours Joint ache for 48 hours Unbearable headache for 60 hours Fever over 101 Unable to get out of bed other than for basic needs for 36 hours Huge swollen area around injection site (with shot #1 this lasted 2 weeks) Site very itchy (with shot #1 this lasted 2 weeks)
After my daughter got the shot she started having seizures, passing out and was finally hospitalized and put in the intensive care unit. She had over fifty seizures in four days. She is still having a lot of problems.
Intermittent dizziness, nausea, chills. Persistent 4-cm round area of redness/pain/swelling around injection site of yellow fever vaccine.
has a temperature of 100.5 degrees Fahrenheit; spinal issues; Arthritic issues; I do feel very fatigue and achy like I am getting a flu; Tingling on my right lowest foot; being lethargic; I do feel very fatigue and achy like I am getting a flu; Kind of like a flu/I do feel very fatigue and achy like I am getting a flu; This is a spontaneous report from a contactable consumer or other non hcp.     A 65-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Right on 29Aug2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, blood pressure measurement, multiple sclerosis. Concomitant medication(s) included metoprolol (METOPROLOL) taken for blood pressure measurement; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) .It was Reported that, The patient experienced tingling on my right lowest foot on Aug2021 with outcome of recovered , being lethargic on Aug2021, do feel very fatigue and achy like am getting a flu on Aug2021 with outcome of unknown, kind of like a flu/i do feel very fatigue and achy like am getting a flu, has a temperature of 100.5 degrees Fahrenheit on 30Aug2021 with outcome of unknown , spinal issues , arthritic issues, do feel very fatigue and achy like iam getting a flu  on Aug2021 with outcome of unknown.  The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on He also said it would be okay, blood test: unknown results  on ,body temperature: 100.5 Fahrenheit on 30Aug2021 degrees , magnetic resonance imaging: no change on it said there was no change.
pt recv vax; devel redness at inject site which the reporter felt was related to therapy w/ varicella vax;
pt recv vax 21JAN97 & same day pt exp redness, swelling, warmth @ inj site as well as itching;48hr post vax pt exp sudden hearing loss;72hr post vax pt exp stiff neck & severe shoulder pain w/movement;unable to hyperextended neck;
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patients of unknown age and gender. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560 exp date 17-JUN-2017) (dose and route not reported. This is one of several reports received from the same source. Additional information has been requested.
Nausea, fever, chills, severe joint pain, myalgia, headache, lack of appetite from 2/3/2021 2am until 2/4/2021 at 2pm
Narrative:  A 72yo male with PMH of Rectal Bleeding, Tremor, Old MI, CAD, Hyperlipidemia, Empyema, Rectal Carcinoma, PVD, Impotence, DM, HTN, Chronic PTSD, Depressive Disorder, A-fib, Disorder of Teeth and Supporting Structure, Syncope and CHF Per Nurse's documentation - he received Pfizer Covid-19 vaccine on February 24, 2021 per policy and protocol without complication No ADE reported The system shows he passed away on March 10, 2021
Patient reported redness at the site of vaccination about 2 inch in diameter, warm to touch. Patient was instructed to see her primary care provider.
08/25/22 presents to EC ED for "migraine". PMHx of "colon cancer s/p resection".
he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago; he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago; he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: IMMUNISATION (medically significant), outcome "unknown", VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago". Patient said his kids had the two shot vaccines and he had the two shot vaccines and the booster shot and they all contracted Covid about a week ago. The patient and the children, all had the vaccine. Patient just said his kids. He did not say how many children. The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a health care worker refers to unspecified number of patients with unspecified demographics. On an unknown date, unspecified patients received improperly stored ROTATEQ (dose and frequency unspecified) that were exposed to 26.2 F for 5.5 hours. Concomitant therapy was unspecified. No adverse effects were reported. No product quality complaint was involved. The outcome of patients received improperly stored ROTATEQ that were exposed to 26.2 F for 5.5 hours was unknown. No further information was provided. This case is linked with cases MARRS # 1405USA003793 and MARRS # 1405USA003490 as same reporter cases. Additional information has been requested.
Chest pain started in January 2021 (within 2 weeks of second Pfizer COVID-19 vaccine). Chest pain attributed to bicuspid valve; leading to surgery for aortic valve replacement. Post operative pain did not resolve and then diagnosed with pericarditis. Once treatment for pericarditis started, pain resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Current conditions and medical history was not reported On 04-APR-2014, the patient was vaccinated with ZOSTAVAX vial (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, ZOSTAVAX was exposed to temperature outside the proper storage range and administered to patient on 04-APR-2014. No adverse effect was reported. The outcome was unknown. No further information was provided. Product quality complaint was not reported. Additional information has been requested.
16 1/2 hours after immunization developed hives on stomach and back. 26 hours post-immunization hives on whole body. Went to hospital ER. BP increased. IV BENADRYL and prednisone give. Sent home with Rx for oral BENADRYL and prednisone. Returned to ER on Sunday 9/23 for severe itching. IV prednisone given and sent home.
For one day I had a slight fever and fatigue with this vaccine. I started to not feel well on 07/18/2022 with a sore throat and runny nose. I took a home test and it was positive. I had a telehealth visit with my doctor and they prescribed remdesivir which helped me. I still have a slight nasal congestion.
INTERMITTENT LIGHT HEADEDNESS WITH POSITIONAL CHANGES; This spontaneous report received from a health care professional concerned a 57-year-old adult male, of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have adverse event after any previous vaccination. The patient previously received covid-19 vaccine ad26. cov2. s. (suspension for injection, route was not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination (Unspecified manufacturer) (Dose number in series 1). It was not unknown if the patient had any adverse event with covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204B21A, expiry: unknown) dose was not reported, 1 total administered on 09-DEC-2021 10:27 at left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. It was reported that patient called clinic and reported that he had been experiencing intermittent light headedness on (16-DEC-2021) with positional changes, only (such as going from laying to sitting or sitting to standing) (dose number in series 2). The Patient denied passing out and denied having sought medical evaluation at the time of reporting. The patient stated symptoms lasted 3 days then subsided. The patient had not experienced recurrence to events till the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent light headedness with positional changes on 19-DEC-2021. This report was non-serious.
This spontaneous report as received from a Medical assistant refers to an unknown number of patients of unknown age and gender. The reporter mentioned that an unknown number of patients have received VARIVAX (Merck) (lot number and expiry date not reported) (dosing regimen and frequency unknown) from January 2013 to 16-DEC-2013 that may had an unknown number of excursions with temperatures from 3 degrees C to 7 degrees C and each excursion being 64 hours. No adverse effects reported. No product quality issue was reported. Follow-up information has been received from a medical assistant (who called to report specific administration dates), concerning a patient of unknown age and gender. On 31-JUL-2013 the patient had received a dose of VARIVAX (Merck) (lot number # H011233, exp. date: 06-JUN-2014) (dosing regimen and frequency were not provided). This dose of VARIVAX (Merck) had an unknown number of excursions with temperatures from minus 3 Celsius degree to minus 7 Celsius degree and each excursions being 64 hours. No adverse experiences were reported. This is one of 9 reports from the same source (# 1312USA011519; #1312USA011525; #1312USA011520; #1312USA011521; #1312USA008561; #1312USA011523; #1312USA011524; #1312USA011526). Additional information has been requested.
Patient received first shot of Moderna vaccine at age 16 years; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient received first shot of Moderna vaccine at age 16 years) outcome was unknown. Not Provided      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 assessments.   Concomitant product use was not provided. No treatment was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-097800, US-MODERNATX, INC.-MOD-2021-098304 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-097800: US-MODERNATX, INC.-MOD-2021-098304:
Patient presented 3 days after vaccine administration to pharmacy with worsening/spreading pain, redness, and itching at injection site and down the left arm. Patient advised to go to the ER where she was diagnosed with cellulitis and given antibiotics, which were filled and picked up today.
No previous reaction from vaccine, found resident without respirations at 7:20 am. Resident had been up to bathroom through the night with no complaints. Resident died.
Bilateral Tinnitus developed two weeks after first dose received.  NEVER had ANY symptoms of Tinnitus before receiving the vaccine in my entire life.
No additional AE reported; HCP reported a dose of MMR II was inadvertently administered after the labeled expiration date. Caller stated the dose was administered on 21-APR-2023, but expired on 15-APR-2023. No additional informaion provided. Additional AE case 02376568 filed.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender.      The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 21-APR-2023, the patient was inadvertently vaccinated after the labeled expiration date with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) subcutaneous injection, at a dose of 0.5 mL, lot #U011993, expiration date: 15-APR-2023, administered for prophylaxis (strength, and route of administration were not provided).   The dose was administered on 21-APR-2023 but expired on 15-APR-2023 (expired product administered). No additional AEs or PQC were reported (no adverse event).
Fever within 12 hours reached 102.5.  Within 18 hours, fever subsided to near normal levels.  Severe chills.  Ongoing fatigue and muscle soreness and stiffness.  Still mild fever after 30 hours.
FELL; ROOM SPINNING; DIZZY SPELL WHEN HE LOOKS DOWN MORE THAN 5 SECONDS/ DIZZINESS UPON GETTING UP FROM LYING DOWN/LIGHTHEADEDNESS; HAVE NOT BEEN ABLE TO SLEEP; UNCONTROLLABLE STIFFNESS IN THE LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN LEFT SIDE OF NECK; UNCONTROLLABLE PAIN IN THE LEFT SHOULDER JOINT; UNCONTROLLABLE MUSCLE TWITCHING IN THE LEFT ARM; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's past medical history included right shoulder surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced uncontrollable muscle twitching in the left arm. On 17-MAR-2021, the subject experienced uncontrollable stiffness in the left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in left side of neck. On 17-MAR-2021, the subject experienced uncontrollable pain in the left shoulder joint. On 19-MAR-2021, the subject experienced have not been able to sleep. On 29-MAR-2021, the subject experienced dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness. On 29-MAR-2021, the subject experienced room spinning. On 01-APR-2021, the subject experienced fell. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrollable pain in the left shoulder joint, uncontrollable stiffness in the left side of neck, uncontrollable pain in left side of neck, have not been able to sleep, dizzy spell when he looks down more than 5 seconds/ dizziness upon getting up from lying down/lightheadedness, uncontrollable muscle twitching in the left arm, and room spinning, and the outcome of fell was not reported. This report was non-serious.
Reaction to Prevnar 13. Rash, redness and hardness to a large area of the right upper arm.
Pt. states that after receiving the 1st dose of Moderna 12/22/2021, started experiencing symptoms 12/23/2021 (Midnight) of fever (100.4), muscle aches, fatigue, headache, nausea, and vomited x1. No noted Primary visit/communications
sweats; Nausea; Stayed on  bed all day; Arm was sore; No fever but warm; Muscle aches all over body; Injection site pretty sore; Chills; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), HYPERHIDROSIS (sweats) and MYALGIA (Muscle aches all over body) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included HIV disease since 27-Oct-1987. Concomitant products included TENOFOVIR and EMTRICITABINE for HIV disease.   On 23-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), MYALGIA (Muscle aches all over body), VACCINATION SITE PAIN (Injection site pretty sore), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERHIDROSIS (sweats) and NAUSEA (Nausea). At the time of the report, MALAISE (Stayed on  bed all day), PAIN IN EXTREMITY (Arm was sore), FEELING HOT (No fever but warm), HYPERHIDROSIS (sweats), MYALGIA (Muscle aches all over body), VACCINATION SITE PAIN (Injection site pretty sore), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up information received on 11-JUN-2021 Added reporter information. Added concomitant medications. and New events updated.
Diagnosed with Acute Myocarditis (unspecified Myocarditis type) on 9 June 2023 after experiencing flu-like symptoms for 3 days.  Received chest X-ray, CT angiogram, CBC, Echocardiogram, ECG, and ekg.  Received 100mg doxycycline, 15mg Toreador, and discharged with 14 days of doxycycline.
Low grade fever 100.2, severe body aches, fatigue, started around 8:00 pm 1/7/21, worsened throughout the night.  Intense fatigue and body aches continued throughout 1/8/21.  1/9/2021, Fatigue , intermittent chills subside.,mild generalized body aches continue.
This spontaneous report as received from certified medical assistant (C.M.A.) refers to approximately 3 year old patient of unknown gender. On an unknown date in 2014 (reported as "within last weak"), the patient was vaccinated with a dose of (Oka/Merck) VARIVAX Lot # J013730, exp. date 30-OCT-2015, (dose, route and site of administration were not reported) that was improperly stored. No concomitant medications were reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Ttemperature of 101.4; Achiness; Sore left arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 30th March 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 31st March 2021, 1 days after receiving Shingrix, the patient experienced fever, pain and pain in arm. On an unknown date, the outcome of the fever, pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the fever, pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The patient received 2nd dose in left arm.  After receiving Shingrix, the patient developed fever, achiness and sore left arm. The patient's body temperature was recorded as 101.4 degree Fahrenheit. The reporter did not give permission to contact healthcare professional. The reporter did not consent to follow-up.
Acute respiratory distress, to ER by 911, admitted to ICU on BiPAP, within 24 hours was intubated.  Remains ventilator dependent, and today had a tracheostomy performed.
Temp 101.8, lethargic for 2-3 days, decreased mental status
Patient reports 2 days after injection arm pain intensified and has lost strength in left arm, noting muscle atrophy. Patient reports being treated with cortisol injections and physical therapy.
He did test positive for COVID-19 after a couple of days after being vaccinated. Symptoms started around May 2022. He lost 20 pounds within a month on a half. He had increased thirst, and it soon resulted to bed wetting and dehydration. The bed wetting happened around July. He was tested for glucose, and it was about 2000. He sent straight to the ER. They started him on insulin, and they found trace ketones. He was diagnosed with Type 1 insulin Independent Diabetes. He was in the hospital for one night.
Bump near the corner of my left eye.; This is a spontaneous report from a contactable consumer. A 62-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 03mar2021 01:45 PM (at the age of 62-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history includes obesity and concomitant medications were not reported. Patient was not tested prior to vaccination. No known allergies reported. No other vaccines were taken in 4 weeks prior to vaccination and no medication taken in 2 weeks prior to vaccination. On 03mar2021, after 2 hours of vaccination at 16:00, the patient experienced a bump near the corner of his left eye. No treatment was taken by the patient and the reporter assessed all events as non-serious. The outcome of the events was reported as not recovered.  No follow-up attempts possible. No further information expected.