chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizures; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures) outcome was unknown.            Concomitant medications was not provided by the reporter.  Treatment information was not provided.  Company comment: This case concerns a patient of an unknown age and gender with no previous relevant medical history reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender with no previous relevant medical history reported, who experienced the unexpected event of seizure. The events occurred on an unknown number of days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
LOSS OF APPETITE; FEELING WARMER THAN USUAL; FEELING ACHY; FEELING SICK; WEAKNESS; CHILLS; HEADACHE; WOOZY/DIZZINESS; This spontaneous report received from a patient concerned a 40 year old male. 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 not reported and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced woozy/dizziness. On 13-APR-2021, the subject experienced loss of appetite. On 13-APR-2021, the subject experienced feeling warmer than usual. On 13-APR-2021, the subject experienced feeling achy. On 13-APR-2021, the subject experienced feeling sick. On 13-APR-2021, the subject experienced weakness. On 13-APR-2021, the subject experienced chills. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feeling sick, headache, chills, loss of appetite, weakness, woozy/dizziness, feeling achy, and feeling warmer than usual. This report was non-serious.
Return of muscle soreness to left deltoid with tenderness to touch at almost 2 months post vaccine.  Also radiates to shoulder.
HYPOXEMIA 7/8/2021 SEPTIC SHOCK  HYPOXEMIA 7/8/2021 URINARY RETENTION
Patient developed red whelps/urticaria on left arm, then left leg, then right arm and leg within 2-3 minutes after vaccines were administered. Benadryl was given po and rash began to resolve within 10 minutes. No further symptoms developed that day. 3 days after the vaccines, patient had vomiting that lasted a few hours .
For 48 hours after the injection I had pain at the site, and then it disappeared.  However, 8 days after the injection, I have the same pain at the injection site.
Start to not feel well around 4:00 pm.  Had a headache and runny nose and a fever of 99.8. At est 8:45, fever was 100.2, still headache and runny nose and little body aches Felt like a head cold. Was tired also. I took ibuprofen and fell asleep shortly afterwards. Woke up at approx 10:30 pm to go to bed.  Fever was at 99.0, with no headache.  Woke up next morning felling much better, with no fever and no headache.
febrile seizure approx 14hr post vax 06:30) transported to ER via emergency squad (07:00);pt given med & released @ 09:03-carried by parents;t100.8 R @ 8:35 post APAP @ 6:00 t102 R on adm to ER @ 07:02;
a lot of arm pain in her right arm; pain radiating down arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a lot of arm pain in her right arm) and PAIN (pain radiating down arm) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Infection urinary tract and Blood pressure high.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a lot of arm pain in her right arm) and PAIN (pain radiating down arm). At the time of the report, PAIN IN EXTREMITY (a lot of arm pain in her right arm) and PAIN (pain radiating down arm) had not resolved.            Patient has COPD, Urinary infections, blood pressure and are on medications for all of those conditions. Patient went to the doctor and got a steroid shot but it did not help.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received contains non-significant information
Information has been received from a Nurse Practitioner concerning a female who was vaccinated with the first dose of Gardasil and fainted.  Medical attention was sought.  The patient recovered.  Additional information has been requested.
flare ups of herpes simplex; This case was reported by a nurse and described the occurrence of herpes simplex aggravated in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex aggravated. On an unknown date, the outcome of the herpes simplex aggravated was unknown.   It was unknown if the reporter considered the herpes simplex aggravated to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The patient asked if the Shingrix could ever cause flare ups of herpes simplex. Was this a possible side effect.
This is a new (12/17/2020 ) problem. Episode onset: swelling under left arm pit and left shoulder after injection of shingles vaccine. The problem occurs constantly. The problem has been gradually improving (after Keflex and steriod taper- given at clinic). Associated symptoms include fatigue. Pertinent negatives include no chest pain, chills, coughing, fever, headaches, nausea, sore throat, visual change, vomiting or weakness. Associated symptoms comments: Shooting pain down arm.  Weak grip with numbness and tingling.. Treatments tried: Keflex and steriods.
This spontaneous report was received from a 72 year old female consumer with high blood pressure, reporting on herself. The patient had no pertinent drug reactions/allergies. On 17-JAN-2012 the patient was vaccinated with ZOSTAVAX (lot number 671452/1124AA, exp. date 12-OCT-2012) (Dose and route were not reported) in the left arm for shingles prevention. Concomitant therapies included hydrochlorothiazide (manufacturer unknown), meloxicam (manufacturer unknown), lisinopril (manufacturer unknown) and levothyroxine sodium (manufacturer unknown). On 22-JUL-2013, patient experienced shingles after received ZOSTAVAX vaccine. Patient was treated with bacitracin ointment (manufacturer unknown) (dosage unspecified), methylprednisolone (manufacturer unknown 4mg/(dosage varies), valaciclovir (manufacturer unknown) 1 gram/Every 8 hours. No lab diagnostics studies were performed. Patient sought medical attention, went to the eye doctor. The outcome of shingles was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7; EKG showed palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (EKG showed palpitations) and PAIN (Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7). In January 2022, the patient experienced PALPITATIONS (EKG showed palpitations). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PALPITATIONS (EKG showed palpitations) and PAIN (Caused her pain on the left side underneath the rib/ is a dull pain that is there 24/7) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, Electrocardiogram: palpitations (abnormal) Showed palpitations.         Concomitant medications were not provided by the reporter.  Patient experienced a pain on the left side underneath on rib. The patient was being sent by the doctor on a referral for chest X-rays, full panel blood work including troponin levels on 17JAN 2022. The patient stated that her doctor said that the pain is not due to myocarditis and pericarditis. Doctor told that there were no antibiotics for such pain. Pain had been there for 3 weeks as of no and it was not full-on chest pain, it was a dull pain. It was reported that palpitations started a week after the pain started. Patient did not had a history of COVID-19 and Myocarditis/Pericarditis.
no adverse event; the patient received a positive pregnancy test; This spontaneous prospective pregnancy report was received from a medical assistant refers to a 24 year old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 16-FEB-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # T033134 with expiration date on 26-MAR-2022, at 0.5 milliliter dose, given intravenously for prophylaxis (strength and location of administration were not reported). On the same date, the patient had pregnancy test which was negative.   On 16-APR-2021, the patient received a positive pregnancy test (maternal exposure before pregnancy). Her last menstrual period (LMP) was on 14-FEB-2021, therefore the estimated date of delivery EED would be on 21-NOV-2021. Concomitant therapies included prenatal vitamins. The patient  discontinued the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series after learning of the pregnancy. At the reporting time, no adverse events occurred.  There was no product quality complaint involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033134; expirationdate: 26-MAR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
No reaction immediately following injection.  Arm became sore at the injection site as the day progressed, but not red and not worse than any other vaccine (flu, etc.).  Went to bed earlier than usual but did not sleep through the night.  Got up for breakfast on Tuesday 5 April, then went back to bed for about 3 hours sleep.  Got up again about noon, took two aspirin and lazed around all afternoon, finally showering at about 4pm (NOT my usual routine).  Not hungry, but ate a little dinner.  Took one tylenol. Now I felt as if I were having a constant "hot flash" of the very worst kind I had experienced 20+ years ago:  as if a wire brush were inside me pushing out of my skin.  Also chills/shivering inside my torso.   At about 2:30am on Wednesday 6 April, I awoke and my nightgown arms, chest and torso were soaked with sweat, but I felt better at that point and have had no other problems since then.  This is the first time (of the four shots) that I have had immediate side effects.  I will be on the lookout in about two weeks for dizzy spells, which have accompanied the previous shots about 14 days after the injection.
Itchy pustular all over body rash.  Swollen lymph node on L side between neck and shoulder. Treatment- veggie and fruit fast for 3 days.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, a medical assistant was distracted, pulled a dose from the wrong box and vaccinated the patient with a dose of VARIVAX subcutaneously, lot number L029466 with expiration date 06-AUG-2017 (dose and anatomical location were not reported) for prophylaxis instead of ZOSTAVAX (wrong drug administered ). The patient had not experienced an adverse effect. Additional information has been requested.
C/o of hand and arm tingling in opposite arm around 15 mins post vaccine At 30 mins complained of tongue numbness. Escorted to er by RN
No signs of any problem until 2 1/2 hours later ringing in my ears, passed out, woke up vomiting. Weak for an hour then felt okay.
Headache, Myalgia, Fever, pain, redness, and itching at the injection site Narrative:  fever was 100.1; resolved within 24 hours headache resolved within 24 hours pain at injection site resolved, but redness and itching persist
Pain at the injection site, feeling tired, a little bit unwell, chills, loss of appetite
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2021 as dose 2, single (Lot number: EW0170) and on 13Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Mild intolerance to cucumbers and squash" (unspecified if ongoing), notes: Mild intolerance to cucumbers and squash; "Mild intolerance to cucumbers and squash" (unspecified if ongoing), notes: Mild intolerance to cucumbers and squash. Concomitant medication(s) included: LOSARTAN, start date: 01Jan2021. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Symptoms flared up 4-5 days after Paxlovid treatment ended. Tested consistently positive for Covid (different brands of rapid tests on consecutive days) and had to enter isolation again.  No follow-up attempts are possible. No further information is expected.
Client came in to receive their second f dose of the covid vaccine, The first dose was received at  Medical Center on 4/22/21. They are no longer administering the vaccine so he was instructed to come to hospital to receive his second dose. During the screening process and vaccine administration it wasn't noticed that it was two days too early to be received so it was given.
Rec'd Flu vac 11-1-10 10:45AM 11-2-10 01:00AM woke up with fever chills body ache all over. Really bad HA ran fever all day 7PM everything stopped & felt better.
PUT ON A VENTILATOR; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 94 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: controlled diabetes, high blood pressure, and atrial fibrillation. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced suspected covid-19 infection and suspected clinical vaccination failure. On 18-AUG-2021, he was put on a ventilator, and was hospitalized on an unspecified date. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, COVID-19 virus test (NR: not provided) Positive, and Weight (NR: not provided) Normal. The action taken with covid-19 vaccine was not applicable. The outcome of the put on a ventilator, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0:20210837488- covid-19 vaccine PUT ON A VENTILATOR,SUSPECTED COVID-19 INFECTION. 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).  20210837488- covid-19 vaccine SUSPECTED CLINICAL VACCINATION FAILURE,. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
developed left arm rash and celluitis 1/12/21, on antibiotics. On 1/15, extreme malaise, headaches, hot/cold flashes, head fog.
high-pitch crying, unconsolible for 1 hr pt was warm, hardened area @ site;
Flu vaccine 0.25 ml was given to 12 year old instead of 0.50 ml dose. Recalled several times to get .5 Flu dose. Has not yet been revaccinated.
Chills which was handled with ibuprofen from 3 to day 32.  On 04-12 dark gray blister formed ~3/4 diameter fluid filled.  Enlarged lymph node in axilla from day 8 to day 34.  Blister filled with fluid didn't drain, I continued to fill it.  On 04-18 blister drained moderate amount of blood and pus.  It continued to drain blood and pus until 05-03-03.  On 04-29-03 I started putting antibiotic ointment on site.  Site is closed no open wound on 05-11-03.
(Right Arm) Swelling from shoulder to finger tips, Soreness from Neck(Right side) , shoulder blade, down arm to wrist, Hurts to move are especially to even with shoulder. I had trouble driving  as Transit driver it made it too difficult for me to complete my whole shift( left half way through my shift).
mom states gave APAP pt got sick on Friday noc following vax; t102-104 R; pt had rash, wouldn't eat or drink; on Monday arched back & cried;
BACK BRACE; Swelling; Feeling cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ORTHOSIS USER (BACK BRACE), SWELLING (Swelling), FEELING COLD (Feeling cold) and PYREXIA (Fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free,Solution for injection in pre-filled pen. In 2021, the patient experienced SWELLING (Swelling), FEELING COLD (Feeling cold) and PYREXIA (Fever). On an unknown date, the patient experienced ORTHOSIS USER (BACK BRACE). At the time of the report, ORTHOSIS USER (BACK BRACE) was resolving and SWELLING (Swelling), FEELING COLD (Feeling cold) and PYREXIA (Fever) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of BACK BRACE was not provided. The reporter's causality for the events of SWELLING, FEELING COLD and FEVER with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in
Pt developed a hard red, warm lump in her leg. Pt was seen in the ER and was diagnosed with cellulitis of the leg.
Patient was only administered the MenCYW-135 liquid conjugate component of the MENVEO vaccine.
About a week after I took the 3rd Anthrax shot, I started getting sharp pains in my joints.  About once or twice a week.  Sometimes the pain starts in my left elbow and goes down toward my wrist.  Sometimes in my knees down to my ankles.  It usually lasts 15 minutes or less.  I had pain once in both knees and ankles that lasted 7 hours.  Other than the pain I feel fine.
Severe chills for about 7 hours. Fever of 102.5 at 7 PM. Some breathing difficulty. Couldn't sleep. Had unusual aches and pains that lasted through the next morning. Used electric blanket, heating pad and lots of covers to get warm. Took full strength aspirin.