chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus if significant magnitude began soon after 2nd dose (April 2021 to present), audiologist tested hearing on 6/21/2021- general hearing found to be normal and found approximate frequency of tinnitus (ringing),  but no medical treatments exist
BLOOD CLOT IN LEFT LEG/MUSCLE IN LEG TIGHTENED UP/CHARLEY HORSE LIKE/LEFT THIGH STILL HURT; FATTY LIVER; This spontaneous report received from a patient concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included ustekinumab used for unknown indication.  On an unspecified date, the patient experienced blood clot in left leg/muscle in leg tightened up/charley horse like/left thigh still hurt, and had a fatty liver a few weeks ago and was hospitalized. The patient stated that she took the vaccine of covid-19 three weeks ago and developed a left leg blood clot and had muscle in leg tightened up (real tight) like charley horse. Then, she went to the PCP (primary care physician) who told her for the valley imaging an ultrasound laboratory test which discovered the clot. On 30-APR-2021, the patient got admitted to the hospital and was discharged on 02-MAY-2021. The patient was hospitalized for two days. Treatment medications (dates unspecified) included: apixaban and she was doubled up on eliquis (apixaban) for blood clot in left leg. On the day of report, she stated that left thigh hurt still ongoing. (The patient have a colonoscopy laboratory test on 09-JUN-2021). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in left leg/muscle in leg tightened up/charley horse like/left thigh still hurt and fatty liver was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210506567 -COVID-19 VACCINE AD26.COV2.S- Blood clot in left leg/Muscle in leg tightened up/Charley horse like/Left thigh still hurt, Fatty liver. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
A medical assistant reported that a 6 month old infant received an injection of Acel-Immune on 03/03/00 and developed an injection site reaction described as "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
numbness right arm, dizziness, lips numb. Evaluated by EMS-Cleared
administered expired QUADRACEL to a 4-year-old patient with no reported ae; Initial information received on 31-Aug-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 4 years old male patient who was administered expired DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (Quadracel) with no reported adverse event(AE).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 31-Aug-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at a dose of 0.5 ml total (lot C5763AA, expiry date: 26-Aug-2022) via intramuscular route in the left deltoid for immunisation.  On 31-Aug-2022 the patient was administered expired quadracel with no reported ae (expired product administered) (same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Difficulty sleeping; Aches; Chills; Fe ver; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fe ver) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Cyst.    On 09-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 INSOMNIA (Difficulty sleeping), PAIN (Aches), CHILLS (Chills) and PYREXIA (Fe ver). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Difficulty sleeping), PAIN (Aches) and CHILLS (Chills) outcome was unknown and PYREXIA (Fe ver) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.   This case was linked to MOD-2021-355812 (Patient Link).
Bright pink discoloration of skin and swelling, with itching, soon after injection. Felt like there was a lump or knot the size of a marble under site.  Lasted two weeks. At three weeks site is discolored and looks bruised. Is faintly sore to the touch.
No adverse effects; patient received a dose of VARIVAX following a temperature excursion; This spontaneous report was received from an office manager referring to a patient(age and gender unknown). The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided. On 16-AUG-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # N034553, expiration date 05-DEC-2019) for prophylaxis, following a temperature excursion (product storage error). Current temperature excursion was 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 hours. There was no previous temperature excursion. No adverse effects were reported. Data logger was involved.
Erythema, swelling at injection site. Acetaminophen 650 mg prn, cetirizine 10 mg every day.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information processed with additional information received from reporter on 05-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user (1 beer a week), and non smoker, and other pre-existing medical conditions included: Patient did not had any medical condition and was not on any medication other than the supplements of Aspirin, Vitamin C, Vitamin D3 and Zinc which he started after testing positive for COVID. Patient did not had any known allergies. There was no drug abuse or illicit drug usage. The patient previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 204A21A, expiry date: unknown) dose was not reported, 1 total, administered in left arm on 14-MAY-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). 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: 211D21A expiry: 11-APR-2022) dose was not reported, 1 total administered in left arm on 19-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-APR-2022, the patient experienced fever of 37.8 degree Celsius (dose number in series 2). On 01-MAY-2022, the fever was resolved and patient experienced mild symptoms of sore throat and runny nose (dose number in series 2). On the same day patient tested positive for covid via two self tests, one test was I-health brand and another was Abbott (suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 2). Patient stated that, he was not clinically diagnosed and had not taken any PCR (Polymerase Chain Reaction) tests, the patient was self medicating with Aspirin, Vitamin C, Vitamin D3, Zinc and consulted with his doctor over the phone for advice on medication to take after testing positive via the self tests and the doctor asked him to continue taking these supplements. Patient stated that his symptoms were mild because he had taken janssen COVID-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000229509.; Sender's Comments: V0: 20220506411-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
patient became very dizzy and light headed and began to pass out several times over a 10 minute period.  911 was called and patient was taken to ER
Vault saliva test taken on 2/03/2021 results Positive.  No symptoms
This case was reported by a pharmacist via call center representative and described the occurrence of feeling unwell in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell. The patient was treated with ibuprofen. On an unknown date, the outcome of the feeling unwell was recovered/resolved. The reporter considered the feeling unwell to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional (HCP) reported that, a nurse, in passing, mentioned that, she felt rough and later, felt fine. When asked, the caller stated that, she had limited information and cannot further expand on details other than the nurse stated she felt rough after receiving the vaccine. The date, time and site of vaccination as well as lot number and expiry dates are all unknown. The caller believed that, this occurred the day after the vaccination and lasted for about a day and resolved. She thought that, the nurse took a couple ibuprofen and assumed that, the nurse was fully recovered. No additional information was provided.
Itching and rash around the injection site for 2 days.  4 areas of red dots resembling spider bites in different areas of the left arm.  Am not sure if this is related, as it could have been actual insect bites.  Spots are still here today.  (2/15/)
This spontaneous report was received from a medical assistant via field representative and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2017, the patient was vaccinated with dose of ZOSTAVAX (expiration date: 09-FEB-2017, route, site of administration and  lot # were not reported) after the dose had expired. No adverse effects were reported. Additional information has been requested.
Some soreness and pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Some soreness and pain in the injection arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Shoulder replacement in November 2020.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Some soreness and pain in the injection arm). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of 500 milligram. At the time of the report, MYALGIA (Some soreness and pain in the injection arm) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-259974 (Patient Link).
Information has been received from a medical assistant on 15JUN2015 concerning a patient (age and gender not specified). The medical assistant reported that on 09JUN2015 the patient was vaccinated with a dose of improperly stored LIQUID PEDVAXHIB. No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.
Patient received dose 1 of an undiluted Pfizer Vaccine. ( 6 times the dose).  Patient reported no adverse effects after 24 hours
The patient had a seizure and vomited several times post-vaccine.  911 was called and EMS took him to the hospital for further evaluation.
RECIEVED SHOT ON THE 22., FELT FINE THAT DAY.  NEXT DAY TOWARD EVENING I FELT UNWELL, NO APPETITE. RESTED HAD A LITTLE CEREAL BEFORE I WENT TO BED. TOKE SOME TYLENOL, SLEPT WELL, FELT GREAT NEXT DAY AND AGAIN LATE AFTERNOON FELT SICKLY, MY LEFT JAW FELT SORE,  NOTICED WHEN I WANTED  TO EAT IT HURT TO OPEN MY JAW, VERY PAINFUL  WHEN I NEEDED TO  JAWN, WAS HUNGRY AND TRIED TO EAT A BANANA  WHICH I WAS ABLE TO EAT BY LIKE SCRAPING THE FRUIT WITH MY TEETH. SINCE THEN THE PAIN LESSENED TODDAY I STILL HAVE PAIN WHEN I OPEN MY MOUTH WIDE, I FEEL IT IS GETTING BETTER DAILY AND SINCE I HAVE ONLY THE OTHER SIDEEFECT OF HAVING NOW AND THEN HOTFLASHES , I THINK I WILL BE FINE AGAIN IN A COUPLE OF DAYS.
"COVID ARM" Delayed skin reaction with itchy, red welt and swollen lymph gland
Patient given covid-19 Bivalent (Pfizer) IM Left Arm,  on 10/03/2022 as first primary dose in series.  No adverse event. Vaccine administration error. Patient given covid-19 Monovalent (Pfizer) on 11/04/22, no adverse event.
Roughly one week after injection I had a large red itchy rash appear on my arm that lasted a couple of days.
Swelling of Lips and little bumps on lips - after the swelling and initial itching went away - chapped lips
Dull on and off headache 24 hours post second dose that lasted for 24 hours; Diarrhea 34 hours post second dose that lasted approximately 6 hours.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiry date was not reported), via an unspecified route of administration, administered in arm right on 25Feb2021 at 02:15 as a single dose for covid-19 immunisation. The patient had no medical history. Concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiry date was not reported), via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No medications in 2 weeks. On 26Feb2021 (reported as at 16:00), 24 hours post second dose patient experienced dull on and off headache post second dose that lasted for 24 hours and diarrhoea 34 hours post second dose that lasted approximately 6 hours. No treatments were received for the events. The outcome of the events was recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Patient family had been noticing onset confusion for a few weeks prior to vaccine and event. Patient was taken to ED when found unconscious and died of a subdural hemorrhage a few days after vaccine clinic at retirement home.
11 TO 12 HRS AFTER INJECTION, PT EXP NAUSEA, EQUILIBRIUM DISTURBANCES, HEADACHE ON LEFT SIDE OF HEAD, SOME SWELLING ON LEFT SIDE OF FACE. NO TREATMENT. SIX HRS LATER, NO SYMPTOMS.
MMR, Varivax, IPV and PPD (TB test) given on 8/16/03. Raised, red patches noticed on torso from 8/27. On 8/30/03, rash worsened, clearly erythema multiforme. Confirmed by dermatologist.
neurological issues and one a blood clot; neurological issues and one a blood clot; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated I know two patients of mine that reported neurological issues and one a blood clot on an unspecified date. Outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recv vax 27OCT97;28OCT97 pt devel 1 1x3cm hard, hot, red welts @ inj site;saw MD who prescribed ice to site;MD did not feel this was an allergy;
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Rash/Itch on Neck and one Butt Cheek-Mild
Information has been received from a medical assistant concerning 9 year old male with no pertinent medical history who on 08-OCT-2002 was vaccinated with the first dose of VARIVAX (Merck). On 28-SEP-2010, the patient received another dose of VARIVAX (Merck). The patient may had received a dose of VARIVAX (Merck) on 03-AUG-2010. There was incomplete documentation and the office and parents were not sure. After the dose of 28-SEP-2010 the patient developed redness and soreness at the injection site. There was no lab diagnostics studies performed. The patient had sought medical attention by calling the healthcare professional. The Medical assistant said that patient often develop a mild injection site reaction after the second dose of VARIVAX (Merck). At this time of reporting, the patient's outcome was unknown. Additional information has been requested.
Information was received from Freedom of Information Act (FOI line listing) regarding a 17 years old male patient. Current illness and history was reported as none. On 06-JUN-2016, the patient received GARDASIL 9 lot# L048459, 1 DF, intramuscular in the left arm. Other vaccines received on the same date were MENACTRA lot# U5272AA, 1 DF, intramuscular in the left arm and BEXSERO lot# 151301C, intramuscular in the right arm (also dose was reported as 0.0). Vaccines were administered at private doctor's office/hospital. 07-JUN-2016, the patient called the doctor complaining of severe pain in RA and not being able to lift the arm. The pain continued, on 08-JUN-2016 when the doctor saw him for a well check. She advised him to take ibuprofen. Other medications included mefloquine. Outcome of the event was reported as recovered. Causality of the events was not reported. Additional information is not expected as the report was received from agency.
16 years old patient received her 1st dose of the Moderna COVID 19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received her 1st dose of the Moderna COVID 19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received her 1st dose of the Moderna COVID 19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient received her 1st dose of the Moderna COVID 19 vaccine) 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.
Patient reports intermittent increase in dizziness, fatigue, chills, and muscle aches Patient reports significant increase in baseline blood pressure reading before and after taking medication
Localized reaction. Left arm tripled in size, turned red, began itching and extremely painful. Strangely, this didn't start until about 7-8 hours after the actual shot. My husband is a physician of hematology and oncology, so he monitored me. I took a tablet of Benadryl by 11:00 pm. I could not elevate the arm until the following night due to an interview at a hospital out of state.
Pt.'s mother reports that after receiving the 1st dose of Phizer 07/20/2021, started experiencing 07/26/2021 numbness of hands and arms. Hands are white at the knuckles, Urgent Care visit 07/27/2021 vitals within range, tenderness in the feet and hands including tongue (pins and needles). Reporting temporary dizziness lasting a week, hands numb upon wakening. Currently in route to ER for continuing symptoms.
ACUTE ST , INFERIOR WALL 1/3/2022 NONTRAUMATIC ACUTE KIDNEY INJURY  ACUTE , INFERIOR WALL 1/3/2022 CKD STAGE 3B    COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
TEN SECOND PERIODS OF VERTIGO, NAUSEA, AND HEADACHES, S/S HAVE PERSISTED FOR OVER A WEEK.
I felt hot within 15-30 minutes after receiving the vaccine. Then 5 days later, I noticed hives on my back, swelling of my eyelids,  and lips.
Reportedly sometime after the vaccination, the pt developed a raised erythematous reaction at the site of the JE-VAX injection.
Rash - Information has been received from a physician concerning a 38 year old female with a penicillin allergy who on 21 Nov 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  On approximately 22 Nov 2000 the patient experience pruritis rash with pox like lesions.  As of 27 Nov 2000. the patients condition continued.  Unspecified medical attention was sought.  Additional information has been requested. This is a follow-up to report previously submitted on 5/30/01. Information has been received from a physician concerning a 38 year old female with a penicillin allergy, hypothyroidism, hypercholestermia, polyclona gammopathy and proteinuria who on 21-Nov-2000 was vaccinated in the left deltoid with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (sencond generation) lot # 637093/1260K). On approximatly 23-Nov-2000 the patient experienced a pruritic rash with pox like lesions. As of 27-Nov-2000, the patient's condition continued. Unspecified medical attention was sought. Follow-up information from the consumer who is a nurse reported that "approximately 36 hours post-vaccination she developed a pruritic rash that lasted for weeks." Follow-up information from a physician indicated that the patient developed red spots, like mosquito bites which were itchy with red dots and blotches. The patient was initially treated with diphenhydramine hydrochloride (Benadryl) and then took fexofenadine (Allegra) and famotidine that was recommended by the physician she works with. It was reported that the rash resolved after approximately 10 days on approximately 30-Nov-2000 and subsequently the patient recovered. No further information is expected.