chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This study case was received from the investigator in a trial on 15 March 2013. The reporter for this case is the same as for case number 2013-04133 (same subject, same vaccines). A male subject (age and birth date not reported) with no relevant past medical history, developed mild chest pressure and left ventricular hypertrophy, considered mild severity, at two and seven days respectively; after he received an injection of ACAM2000, SP Biologics Co., (lot number, route, site and side not reported); and concomitantly, TYPHOID VACCINE, manufacturer unknown, and ANTHRAX, other manufacturer (lot number, route, site and side not reported) on 06 March 2013. On 08 March 2013, two days post vaccination, the subject experienced mild chest pressure (also reported as the subject reported onset of mild intermittent chest pressure four days post vaccination, lasting three days with no other cardiac symptoms). The event of chest pressure had no exacerbating or alleviating factors and resolved on 10 March 2013. On 13 March 2013, seven days post vaccination, the subject was noted to have an electrocardiogram (ECG) with inverted T-waves and possible left ventricular hypertrophy at lead V2. Rapid and lab Troponin results were reported as normal on unspecified dates. The subject had no other cardiac symptoms and was referred for care, but no follow-up was available. The subject did not take any medications to treat the left ventricular hypertrophy or chest pressure. No concomitant medications were reported. The event of left ventricular hypertrophy was not considered resolved. The subject's outcome was reported as not recovered, lost to follow-up. According to the investigator, the events of left ventricular hypertrophy and chest pressure were considered other important medical events and possibly related to the trial product. Documents held by sender: Medical Record.
Patient has on history of gout. He informed immunizer that his toe was of concern. He came in 10/8/14 stating he required an ER visit due to gout flare evening after vaccinated.
Shot given at approximately 8:30 am.  Patient vomitted at 3:00 pm later the same day.
pt lethargic in AM & large bowel movement;coughed when fed & V non bilious fluid;@ noon passed a grossly bloody stool w/mucus;seen by MD;contrast enema revealed Intussusception;surgery-ileocolic intussusception found & reduced;
Per MMQC and FDA proclamation of moratorium on use of mRNA monovalent vaccines and as booster doses after 31 AUG 2022, and DHA agency instruction to enter doses administered as such into VAERS; this report was entered for documentation purposes.
Received shingle vac 2014-or 2015 develop large amount of clear raised areas on back, upper lt side same on (lt) face itching profusely in these area. Whelps. MD stated had shingles.
Around 14 hours after vaccination, I woke up with a severe headache that lasted around 12 hours. It was the worst  headache I can remember ever having and it made me feel dizzy and nauseous. I also experienced chills and body aches. I never checked if I had a fever, but it felt like I did.
COVID-19 Treatment - Paxlovid; COVID-19 Treatment - Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6204), in left arm and on 05Apr2021 as dose 2, single (Lot number: EN8732) at the age of 27 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Nov2021 as dose 3 (booster), single (Lot number: 072H21B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 Diabetic" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; ALLEGRA D, start date: 08Aug2022; Z-PAK, start date: 09Aug2022, stop date: 12Aug2022. Past drug history included: Cefzil, reaction(s): "Known allergies: Cefzil". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment - Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Other medication in 2weeks was Yes. Anti-viral details: Product was COVID 19 Treatment, Brand was Paxlovid, Treatment start date was 10Aug2022, Treatment stop date was 14Aug2022, Indication was Treatment of COVID-19. Adverse event for paxlovid were Congestion in nose, cough, headache, Adverse event start date was 18Aug2022, adverse events were not recovered and patient was not received any treatment for the adverse events.   Follow-up attempts are completed. No further information is expected.
PATIENT EXPERIENCED SEVERE KNEE PAIN IN BOTH KNEES WHICH ARE ARTIFICIAL AND SHE WAS UNABLE TO WALK WITHOUT PAIN ABOUT ON THE SUNDAY FOLLOWING THE IMZ. SHE ALSO COMPLAINED OF RIGHT SHOULDER PAIN THAT WAS NEW AND MORE SEVERE THAN THE ORIGINAL INJURY. SHE ALSO WAS VERY FATIGUED. THESE SYMPTOMS LASTED ABOUT 3 DAYS AND THEN THE PATIENT SAID SHE FELT BETTER BUT KNEW IT WAS THE VACCINATION THAT CAUSED THE SYMPTOMS.
2-3 d after receiving rotavirus, developed diarrhea and vomiting requiring hospitalization for dehydration 8/8/08-records received-Progress note dated 6/26/08 -follow up visit after hospitalization on 6/8-6/10/08 for dehydration and watery non-bloody diarrhea. Loose stools continued until 6/17/08-then no stools for 2 days, straining to have BM for 10 days. Passes gas.
Bell's Palsy reported by Nurse Practitioner.  Patient has been experiencing for approximately 4 days at the time of reporting.   Patient will be treated with Prednisone, Artificial Tears, and Acyclovir.
21AUg92 pt recvd vax & 24AUg92 devel rt shoulder pain & dec ROM; later devel rt foot & ankle tenderness & pain w/inc joint swelling in hands & knees;
Tongue feel tingly; This is a spontaneous report from a contactable consumer reporting for herself. A 27-year-old female patient received bnt162b2 (BNT162B2) (lot# EK5730), via an unspecified route of administration, on 22Dec2020, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced tongue feel tingly on 22Dec2020 1 hour after vaccination with outcome of unknown. Therapeutic measures were taken as a result of the event and included treatment with Tylenol.
Itchy Rash all over the body hands, legs stomach back  it is very Urticaria - cold hives which i usually get in winter on exposure to cold.
Patient presented to the ED for right ankle pain and agitation on 8/1/2021. Patient presented to the ED on 8/6/21 with depression with suicidal ideation. Patient was hospitalized on 8/9/2021. These visits are within 6 weeks of receiving COVID vaccination. Patient did receive second dose on 8/13/2021.
No additional AE reported; administered after a temperature excursion; This spontaneous report has been received from a health care professional (HCP) concerning a 12-month-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 01-DEC-2022, several vaccines underwent a temperature excursion of 47.9 F for 47 minutes. On 14-DEC-2022, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) administered as prophylaxis, intramuscularly (IM) on the patient's right thigh (RT), lot number W023937 with expiration date 06-DEC-2023 (dosage regimen was not provided) (Product storage error). No previous temperature excursions were reported. No additional adverse event was reported (No adverse event).    This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA001175:
Within 2 hrs, not able to breathe, rash on arms, legs, and face. Patient went to the ER and was given steroids, benadryl, asthma treatments
Information has been received from a consumer concerning her 5 year old daughter with no pertinent medical history and no drug reactions or allergies who in 2001 was vaccinated subcutaneously  with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On January 21, 2005 the patient developed a breakthrough varicella rash with about 20 lesions. There were no lab diagnostic studies performed. The outcome was reported as not covered. No medical attention was sought. There was no product quality complaint. additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/12/2006.  Information has been received from a consumer concerning her 5-year-old daughter with no pertinent medical history and no drug reactions/allergies who in 2001 was vaccinated SC with a 0.5 mL dose of VARIVAX (Merck).  There was no concomitant medication.  On 21-JAN-2005 the patient developed a breakthrough varicella rash with about 20 lesions.  There were no lab diagnostic studies performed.  The outcome was reported as not recovered.  No medical attention was sought.  There was no product quality complaint.  Additional information has been received from a licensed practical nurse in response to correspondence she received related to a reported adverse event.  The nurse indicated that their records show that the consumer's 5 year old daughter, referenced in the correspondence, had not had an office visit since 2001, and therefore they were unable to complete the AE information requested.  The nurse further noted efforts to contact the family and identify their current physician were unsuccessful.  No further information is expected.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-JUN-2017, the patient was vaccinated with a first dose of ZOSTAVAX, subcutaneous for prophylaxis (dose, site of administration, lot # and expiration date were not reported). On 14-SEP-2017, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX, subcutaneous for prophylaxis (dose, site of administration, lot # and expiration date were not reported). Concomitant therapies included sterile diluent (MRK). No adverse effects were reported.
On 12/5/21 I had a rapid heart beat about 120 bpm and was laying on the sofa. I rested for about an hour and my heart was still pounding, I was flushed and at 10:40PM I took 25 mg of Metoprolol which is above my usual dose by 11:30 my heart rate was in 70's. At 1 am it was in the high 70's and when I woke up it was normal and I took my regular dose of medication. I sent an email to the Dr. when it started and he emailed me back saying that is what I was suppose to do. I have never been in A-fib before.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 6 (booster), single (Lot number: GH9697) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 30Jul2023 to 04Aug2023. The patient experienced rebound COVID-19 infection on 09Aug2023 at 08:00 PM.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a male patient in his sixties via a company representative refers to himself. The patient's concurrent conditions included diabetes, hypertension, and hyperlipidaemia. No information regarding the patient's concomitant medications, drug reactions or allergies was provided. On an unknown date in 2009 (reported as "eight years ago"), the patient was vaccinated with the first dose of ZOSTAVAX (route of administration, lot# and expiration date were unknown), reconstituted with sterile diluent (STERILE DILUENT) (lot# and expiration date were unknown) to prevent shingles. On an unknown date, the patient developed zoster rash outbreak. The outbreak was treated with a booster dose of ZOSTAVAX (lot# and expiration date were not provided) given on an unknown date. On an unknown date, the patient developed neurophaty and received a variety of unspecified steroids and antivirals. The patient sought medical attention. It was unknown if any lab diagnostic studies were performed. At the time of the report, the patient did not recover from zoster rash outbreak and neuropathy. The relatedness between the adverse events and ZOSTAVAX was not provided. This is one of two reports received from the same reporter. Additional information is not expected, as there was no consent to contact the reporter.; Sender's Comments: US-009507513-1705USA014929:
Itch on her left wrist; injection site was slightly swollen/elevated about 3inches in diameter and about 1 cc high; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in right arm (right upper arm) on 03Feb2021 08:50 as single dose for COVID-19 immunization. Patient's medical history included aspirin exacerbated upper respiratory disease from an unknown date to ongoing and asthma from an unknown date to ongoing and breast cancer. She had family history included diabetes (Father died of a brain hemorrhage at 86). She had historical vaccine as flu vaccine in Oct2020 or Nov2020. There were no prior vaccinations (within 4 weeks). There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. On 03Feb2021, patient experienced itch on her left wrist and injection site was slightly swollen/elevated about 3inches in diameter and about 1 cc high. She stated got the shot today (03Feb2021) and the 2 things she experienced after she got the shot. First she felt an itch on her left wrist immediately but it was given in the right arm. She notes she looked at it and it was red but gradually went down over 15 minutes. Also the injection site was slightly swollen. The itching felt like a pimple when she looked at it she described it as redness that followed the vein and muscle. It lasted about 20 minutes and is back to normal now. At the time, maybe it was swollen. She had been told to stay for half an hour and she did that due to having aspirin exacerbated upper respiratory disease and asthma. She has been a patient in the allergy unit and check with them before getting the shot and was told it was ok to get. It was given about 8:50am. When she got home she looked at the place she was given and it was slightly swollen around the injection site. She always gets shots in right arm due to having breast cancer. It was seen about 10 minutes ago for the first time and was not red but elevated about 3 inches in diameter and about 1 cc high. There was no emergency room or physician office visit. She will be getting amoxicillin when she gets a dental appointment but she has not taken or started that at this point. No treatment was received, she just hung around for a little more than a half hour, showed to the nurse who thought she was ok, she has had no fever or other issues. The caller explained she stayed out of work on Monday and Tuesday to insure she wasn't upset or getting any infection. She is prone to get sinus infections that affects her ear canals and that cause dizziness. She has had no dizziness. The outcome of event for vaccination site swelling was not recovered and for localised itching it was recovered.
Hives appeared only on legs and palms. The hives would later change appearance to look more like rings. His legs and hands were in pain, not really itchy but in pain even where no rash existed. Since then he has had swelling of his legs and ankles. He has been having a lot of fatigue as well. He has also had a visually bloated belly and complained of belly pains.
Seen at well check on 8/10. Discussed several developmental and behavioral concerns. Received Hep A and MMR vaccines. The following day patient started spinning around in circles, usually with his gaze lifted upward with eyes sometimes "rolled back." He would do this over and over, almost constantly that day. This has continued since that time, but has lessened in severity and frequency. Parents are able to more easily distract him toward something else. This is a new behavior. There has been some other restrictive and repetitive behaviors in the past. Parents are requesting more information about the vaccines that were given  Discussed how repetitive and restrictive behaviors, such as spinning, can be a prominent symptom of developmental disorders such as autism spectrum disorder. Discussed parental concerns with timing in regards to recent vaccines, Hep A and MMR. Parents were given detailed information regarding these vaccines including brand and ingredient list. Parents were also given education handouts from the Vaccine Education Center regarding this topic. VAERS report to be completed. Follow-up as needed
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after receiving Shingles vaccine, everyone he/she knew, got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were of shingles not provided.
Exactly 10 days post vaccine, patient spiked a high fever for two days then proceeded to get the measles rash which lasted for one week. There is a lingering rash on one thigh and one arm that has not subsided to date. The rash is raised bumps and differs from the initial measles rash
Patient stopped by the pharmacy on 8/21 to have pharmacist look at injection site. Patient complains of soreness, redness, swelling at the injection site; skin is also warm to touch. Advised patient to apply a cold compress and take ibuprofen for pain. Also advised patient if gets worse to contact physician.  Patient came back to pharmacy on 8/21. Pharmacist stated the site has improved since previous day; slightly red and warm. Again pharmacist advised a cold compress and ibuprofen for pain. If reaction gets worse, contact physician
Complaining of scratchy throat consistently clearing her throst. Unable to speak in complete sentenses due to clearing her throat. No shortness of breath and no difficutly breathing. Throat redness minimal and airway patent. Vital signs with in normal limits. No itching or redness noted on body and no hives present. Able to swallow water.
On Thursday evening 2/2/2022 I started having muscle spasms and pain in my neck, my swallowing felt difficult (more than previous).  A headache started but wasn't severe.  I woke up at 2am with a massive headache and the top of my left shoulder was as hard as a brick.  My range of motion in my neck was severely limted as it caused so much pain to try and move my head.  I took 2 Tylenol, put ice on my shoulder and fell back to sleep about an hour later.   I have been putting ice and heat on it and taking Tylenol every 4-6 hours.  I did have neck fusion surgery on 11/10/2021 and had just seen my doctor earlier in the day and I was feeling fine.  I did send them a note this morning.  I don't have any arm/finger pain that I did have when I was having the neck issues.  I'm just trying to find out if others have any of these side effects as I did nothing different that day other than the vaccine a day earlier.
fever; chills; body aches; headache; hand swelling; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Dec2020 at single dose on one of the deltoids, but not sure which one for COVID-19 immunization. The medical history and concomitant medications were not reported. It was known if the patient had prior vaccinations within 4 weeks. By the next day on 30Dec2020, she started to experience chills, fever, body aches, headache, and also hand swelling which all lasted for four days. Seriousness Criteria was stated as not significant. What was odd was the hand swelling. She did not have any redness or itchiness with it. It was just swelling that lasted four days and the patient thought this was odd. The outcome of the events was recovered on 03Jan2021. The Pharmacist want to known if the patient should still get the booster on the 19th.   Information on the lot/batch number has been requested.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 25-MAR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R027431, expiry date 08-SEP-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.
I started that day with a thick throat and sore throat.  No SOB.  The next day it evolved into body aches, joint aches, headache, fatigue,  and nausea.  The next night I started vomiting.  I felt like I had the flu.  These symptoms persisted 3-4 days.  The sore throat lasted maybe a week or more.  No fever at any time.  Had the usual arm soreness start the evening of the vaccine, much more than any other vaccine I've received.  The arm soreness awakened me at night if I rolled over.  FYI:  I received the 2nd vaccine 2/4/2021 and only had a sore throat and sore arm.