chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DISORIENTED; DELUSION; VOMITING; SLEEPINESS; LOSS OF APPETITE; COULD NOT DRINK LIQUIDS; LETHARGIC; HEADACHE; FEVER 99; TIRED; This spontaneous report received from a vaccine facility concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced tired. On 16-MAR-2021, the subject experienced sleepiness. On 16-MAR-2021, the subject experienced loss of appetite. On 16-MAR-2021, the subject experienced could not drink liquids. On 16-MAR-2021, the subject experienced lethargic. On 16-MAR-2021, the subject experienced vomiting. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced fever 99. Laboratory data included: Body temperature (NR: not provided) 99 deg. On 17-MAR-2021, the subject experienced delusion. On an unspecified date, the subject experienced disoriented. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of appetite, and disoriented on 18-MAR-2021, was recovering from headache, could not drink liquids, lethargic, and fever 99, had not recovered from delusion, and the outcome of sleepiness, tired and vomiting was not reported. This report was non-serious.
Large Welts under skin, muscle feels very tight even after constant massage. Also high fever of 102.9 degrees. High pain in legs - enough to prevent child to cruise/crawl/walk.
Patient received 1st COVID vaccine on 1/20/2021 and second on 2/13/21 so was fully vaccinated when he tested positive for COVID-19 on 8/4/21.  Four days prior to his positive COVID test he developed runny nose, cough, fatigue, and sneezing.
Started w/ shortness of breath mid to late June 2021. This was intermittent x 6-8 weeks. Started with upper calf pain end of July 2021. This was also intermittent. Started with cough and had increased shortness of breath first week in August. Went to his PCP. She thought it was asthma. Started on albuterol. This did not help. I found him 8/9/21 on our bed when I came home from work and he had passed away. Verbal autopsy report from Coroners office told me DVT in R calf and 2 pulmonary emboli. My husband was a non-smoker and worked out 7 days a week including long distance running, gym twice a week, playing basketball  and hiking 14,000 ft mountains. No one can explain to me why he developed clots. No history or family history of any clotting disorders.
Patient bled and formed a raised bruised within seconds from injection. Patient stayed in store for a few minutes, then left, even after advising them to stay for 15-20 mins.
Fever on 28JAN91 seen by MD swelling @ site on 4FEB91; Redness @ site on 16FEB91. Painful site 20FEB91. 20FEB91 MD aspirated 1cc fluid from site. Given Suprax.
approx 15 days p/ vax pt exp rash @ inject site w/3 small vesicles.
Last evening arm left became sore, by this morning arm swollen, hurts is reddened.
Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-OCT-2016, at age 66, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
pt devel fever 103 & total body shaking/sz in late afternoon on 12JUL96;fever cont APAP inc per order of PP;taken to ER @ MN following another sz;d/c to home p/ 2 1/2 hr in ER;also had vomiting & diarrhea, lethargy;
large raised red area at the injection site that grew larger and went away after about a week; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 34-years-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0185, Expiration date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 11May2021 09:45 (Age at Vaccination 34 year) as dose, single for covid-19 immunisation. Medical history included Hashimoto disease from an unknown date and unknown if ongoing, patient was covid-19 positive before vaccination. patient received first dose of bnt162b2 (BNT162B2, Lot number: EW0170) via unspecified route administered in Left arm on 20Apr2021 09 :15 AM as dose 1 single for covid-19 immunisation and patient experience No reaction on previous exposure to vaccine. Concomitant medication included spironolactone (ALDACTONE A) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. Since the vaccination, has the patient had not been tested for COVID-19. patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced large raised red area at the injection site that grew larger and went away after about a week on May2021. adverse event resulted in patient visit to Physician office. The patient underwent lab tests and procedures which included sars-cov-1 test positive before vaccination on an unspecified date. The outcome was not recovered.  Additional information has been requested
Gave first Rotavirus over 15 weeks old, 5 days. Should not start if > 15 wks.
rash from the elbows to the wrists in both arms; Moderna arm; a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RASH (rash from the elbows to the wrists in both arms) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported. ). Concomitant products included SIMVASTATIN (ZOCOR) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (rash from the elbows to the wrists in both arms) (seriousness criterion medically significant), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching). At the time of the report, RASH (rash from the elbows to the wrists in both arms), PERIPHERAL SWELLING (Moderna arm) and RASH MACULAR (a very red splotch that was 4x3inches for the first 3 days but know it has been spreading reaching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling.  Event onset 11 days after first dose mRNA-1273. Event outcomes unknown. Based on 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.; Sender's Comments: This case concerns a 79 Y/O M with a serious unexpected event of rash, and nonserious unexpected rash macular and peripheral swelling.  Event onset 11 days after first dose mRNA-1273. Event outcomes unknown. Based on 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.
Patient received both PPSV-23 and an unknown flu vaccine while hospitalized recently.  Patient developed fevers and presented to an urgent care. Was prescribed oseltamivir at this visit.  Developed redness, pain, and swelling over the injection site over the next day, and went to see his PCP 10/11, was given sulfamethoxazole-trimethoprim for cellulitis. Minimal improvement of redness and swelling, and new onset rash (whole body) with continued fevers prompted patient to come to emergency department where he was admitted for cellulitis. ID consult determined the whole body rash to likely be an allergic reaction to the sulfamethoxazole-trimethoprim.  Vaccine site remains with induration and erythema.
Arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The reporter stated that several patient's experienced arm pain following Shingrix vaccination. The reporter consented to follow up.
Received flu clinic on 10/15/2020. On 10/16/2020 patient developed headache. Persisted for another 12 days before patient contacted office to notify. No temperature, no congestion. Headache located "middle of head, from one ear to another". Eyes are light sensitive. Headache worse some days than others.  Patient currently taking: metformin, Montelukast, famotidine, meloxicam, primrose oil, black coshosh, Zyrtec, acetaminophen, spironolactone, nifedipine ER.   Provider sent in prednisone burst and taper. Symptoms resolved after treatment.
Lymph node swelling under the arm I received the vaccine; Tenderness under the arm; A spontaneous report was received from a consumer concerning a female patient of unknownage,  who experienced lymph node swelling under the arm where they received the vaccine and tenderness under the arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the events, the patient received her first of two planed doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, after receiving the vaccine, the patient experienced lymph node swelling under the arm and tenderness under the arm.  On 06 Jan 2021, the patient had swollen lymph nodes in both the arms.   Treatment of these events were not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the events, lymphadenopathy and axillary pain were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Began complaining of dizziness shortly after getting hte vaccine. She did not eat anything since the day before. Gave juice and a granola bar.  Shortly after finishing food, began complaining of her heart feeling fluttery, a medical emergency was called. She was evaluated and found to be tachycardic. Refused further medical treatment, then ate lunch, and returned to work. She was observed on site for an additional 30 minutes beyond the 15 minute observation period.
period last for more than 3 weeks and is not stopping; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (period last for more than 3 weeks and is not stopping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (period last for more than 3 weeks and is not stopping). At the time of the report, HEAVY MENSTRUAL BLEEDING (period last for more than 3 weeks and is not stopping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-311208 (Patient Link).
Awoke 11/28/21 with severe pain and redness in left eye.  Called Eye Institute for an urgent appointment.  Was seen by Dr. (not my usual doctor at Eye Institute) who examined me on 11/30/21.  He diagnosed me with uveitis, and referred me to Dr. a Uveitis specialist at Hospital.  Dr. also started me on a prescription of 800 mg Ibuprofen 4x a day.  At first appointment 12/10/21 with Dr., they ran a series of eye tests.  Dr. confirmed the diagnosis Uveitis, Anterior Scleritis.   Dr. had me taper off Ibuprofen, and then start a prescription for Difluprednate 0.05% eye drops until bottle completed.  Followed up with Dr. in March 2022, and eye was clear.  Have a follow up appointment with Dr. in September 2022.  In the meantime, if any flare up must call either Dr. immediately.
At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken to a room for observation, after about 30 minutes taken to Prompt Care Facility on premesis.  Had slight nausea, shakiness, weakness, little dizzy, headache.  Treatment:  observation, asking questions, checking vital signs, checked Glucose: Normal. Stayed at Clinic approx. 1 Hour.  Considered going to ER but continued to feel better as time passed and went home.  BP was at 167/66 when leaving.  Later same evening 10:30 p.m. at home: BP at 136/72/66, Next day 2/21/2021 BP at 128/70/63.  2/22/2021 BP 123/66/61.  Continue to have headaches.
Pt vaccinated w/MMRII, 2 days following vaccination she experienced generalized achiness, fever, fatigue, rash & intermittent vomiting w/loose bowel movements.  See WORM for more details.
Pediatric dose given to an adult; Pediatric dose given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 32-year-old female patient who received HBV (Engerix B pediatric) (batch number A9349, expiry date 19th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th January 2023, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 18th January 2023, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The nurse called to report a pediatric Engerix-B dose was administered to a adult patient. The reporter consent to follow up via email. Additional supportive information: The patient was given Engerix-B pediatric instead of Engerix-B adult as per the patient's age at time of vaccination, which led to underdose and adult use of a child product.
Patient states that when she arrived home theat night a few hours later she felt nause and dizziness. WOke up the next am with a prickly rash on legs and arms that itched. secodn day also brought nasal congestion and dizziness with a scratchy throat.
I got a cyst on the outside of my right ankle, it was red and swollen and it hurt for about a day. Now it?s black and the ball is smaller. I don?t know if that?s good or bad but hopefully its good.  And no I don?t have healthcare so I can?t afford to get it checked out.
113 Bivalent doses administered after the BUD to patients 12 and up; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Dec-2022, 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 08-Dec-2022, the patient experienced NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    60 doses was received to several patient from Lot AS7148B. Concomitant medications were not reported.  No treatment information was provided.
after receiving the initial dose , I experienced a metallic taste in my oral cavity.  The second day after injection administered soreness at the injection site.
Rash, UrticariaPruritus & Purpura Narrative:  Patient called her PCP, due to growing rash, erticaria and hard bump on her left arm at site of covid 2nd injection site. She had not taken any benadryl, she stated that benadryl makes her sleepy. She was told to go home , call PCP, and take benadryl. She agreed. She did call Her pcp. He said to watch the site after Benadryl and alert him if does not improve, or go to E.D.
Narrative:  2 minutes after the administration of the vaccine patient became unresponsive, diaphoretic, couldn't hold his arm up on the walker, drooling and could not speak. per notes patient came to in an ambulance was seen in emergency room. EKG ordered and stat labs, patient discharged home
gross blood and mucous in stool, fussiness beginning afternoon after receiving vaccines. No treatment Self-Resolved after 72 hrs.
Stopped up ear, under water feeling.  Ringing, humming, loss of hearing.  Lasted approximately 3 weeks
anaphylactic reaction; This spontaneous report has been received from an approximately 57 years old male patient, referring to himself via Pfizer. The patient's concurrent conditions included an allergy to eggs. Medical history and concomitant medications were not provided.   On an unknown date in 1970 (reported at the age of 7 years old), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis.      In approximately 1970, the patient experienced an anaphylactic reaction and required treatment with epinephrine. The patient worked in a long term care assisted living facility and was unable to obtain the mRNA, lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2 [(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-Distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose (COVID-19) vaccine (Pfizer-Biontech) due to the facility refused to vaccinate him after the patient divulged that he had the previously reaction with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine.   The outcome of anaphylactic reaction was unknown.   The reporter considered anaphylactic reaction to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II).  Upon internal review, anaphylactic reaction was determined to be medically significant.
Within 48 hours, post vax, pt developed nausea, vomiting, diarrhea, abdominal cramping, shaking and fever. Lasted for 5 days and recovered.
HIT WITH FATIGUE ABOUT 3 THAT AFTERNOON AND WENT TO BED. WOKE AROUND 6PM SO ILL I CONSIDERED CALLING AN AMBULANCE. FEVER, NAUSEA, DIARRHEA, AND EXTREME MUSCLE PAIN. MUSCLES FELT LIKE THEY WERE FROZEN/SEIZED UP. TERRIFYING. MUSCLE ISSUES AN HOUR OR TWO. NAUSEA, DIARRHEA, AND FEVERE LASTED ABOUT 6 HOURS. I FELT LIKE I WAS RECOVERING FROM FOOD POISONING FOR ABOUT 3 DAYS. REACTION TO SECOND DOSE.
Lightheadedness, tickle in throat, sweating, anxious, jittery.
Arthralgia, Fatigue, Musculoskeletal stiffness, Arthritis, Myalgia, Muscle tightness. This report described the occurrence of joint pain in a female patient who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. The patient reportedly received an injection of LYMErix on 28 May 2000. On 03 September 2003, the patient's attorney alleged that the patient "suffered joint pain, fatigue, generalized stiffness, right knee inflamation, bilateral hip pain, malgias, tightening (sic) of her calf muscles and right kneee pain. The onset of her symptoms is not clear at this time."  Treatment and outcomes of the alleged events were not reported.
COIN STICK TO HER ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown expiry date: UNKNOWN) dose was not reported, therapy dates were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the patient experienced coin stick to her arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of coin stick to her arm was not reported. This report was non-serious..
Swelling at injection site, raised 3 inches. Hot to touch. Ran down to elbow.
This spontaneous report was received from a pharmacist via a company representative refers to two patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the two patients were vaccinated with doses of ZOSTAVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patients experienced rash after receiving ZOSTAVAX. The outcome of both patient's rash was reported as recovered/resolved on an unknown date. The reporter pharmacist considered rash to be not related to ZOSTAVAX. Additional information is not expected because the reporter did not consent further follow up.