chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed localized swelling redness, pain and fever to 102 for 3 days after vaccine administration.  Got antibiotics and benedryl with good relief
Information has been received from a physician concerning a 5 year old male who was vaccinated several years prior with varicella virus vaccine live. Subsequently, the patient came to the physician's office with a full blown case of chicken pox. There was no product quality complaint involved. The reporter also indicated that another physician reported two sisters who had similar experiences following exposure to varicella virus vaccine live (WAES0405USA00652 and 0405USA00653). Additional information has been requested.
atrial fibrillation with rapid ventricular response identified at acute office visit on 12/9/21. Transferred to Emergency Department. Treated with IV antiarrhythmics and converted to sinus rhythm.
shingles, both doses of Shingrix/Suspected Vaccination failure; I had an outbreak/second outbreak; not as inflamed; just as painful; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (suffered from shingles outbreaks for years, isolated to a single spot about the size of a quarter just above my right eye), pain and inflammation. Previously administered products included Shingles vaccine (had the original shingles vaccine when it first came out).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, inflammation and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, inflammation and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, inflammation and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had suffered from shingles outbreaks for years and outbreaks was mild by most standards. They are isolated to a single spot about the size of a quarter just above right eye. The concern of course was the proximity to eyes so patient watch it closely. The patient had the original shingles vaccine when it first came out and then both doses of Shingrix.  The second vaccination was approximately in December 2020 and was everything was fine until about 6 weeks before the date of reporting, when patient had an outbreak. The patient experienced, less than 6 weeks later, second outbreak.  The outbreaks was not as inflamed as they were prior to the vaccine, but they remain just as painful. The patient wanted to report the lack of effectiveness for records. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles was unknown at the time of reporting.
6 days after shot, arm started itching and developed a rash. The next day, itchy red spots developed on palms, fingers, bottoms of feet and chest. Lasted 3 days and resolved on it own.
Colectomy; This spontaneous case was reported by a consumer and describes the occurrence of COLECTOMY (Colectomy) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis. Concurrent medical conditions included Ulcerative colitis.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COLECTOMY (Colectomy) (seriousness criterion medically significant). At the time of the report, COLECTOMY (Colectomy) was resolving.  The case level outcome was reported as recovering/resolving. She felt humira was giving her side effects and doctor took her off humira and placed her on entivio.  It was unknown if patient was enrolled in a covid-19 vaccine trial.  Primary reporter did not have the lot number information, because the packaging was discarded. It was reported that there is no reasonable possibility that the event of HAD SURGERY TO REMOVE COLON is related to HUMIRA(ADALIMUMAB). This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This is a spontaneous case reported by a consumer. A 51-year-old female patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days and experienced medically significant event of colectomy 3 months 19 days after receiving second dose. Relevant concurrent medical condition included ulcerative colitis treated with Adalimumab that was switched to Entivio because Humira was giving her side effects. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of ulcerative colitis is a risk factor for colectomy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 51-year-old female patient completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days and experienced medically significant event of colectomy 3 months after receiving second dose. Relevant concurrent medical condition included ulcerative colitis treated with Adalimumab that was switched to Entivio because Humira was giving her side effects. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Concurrent medical condition of ulcerative colitis is a risk factor for colectomy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
A  week after the initial vaccination, I started getting a headache. The night of the second vaccine, had joint pain, headache and lethargy. Since the second vaccination I have daily pain in my arm and a headache at least every other day. The pain in my left arm is painful at times excruciating. The headache is also much concern to me. I have not been to a doctor guessing that they may not do anything for me.
Pt recv vax on unknown day; within 48 hr pt exp vax site swelling
Swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Accidentally cut hand at work - they took me to Urgent Care. 12/30/08 - Light headed and nausea, head hurting real bad, extreme vomiting, arm hurting, red from shot, weak and tired (about 1 hr after shot). Sent home from work. (Daughter called to report to Urgent Care I was sick). Time went on then on 3/1/09, I woke up in excruciating pain. I was told it was (arthritis), (sprain), (rotator cuff muscle) (cervical). I now believe it was brachial neuritis from tetanus vaccine.
5 hours after injection patient had sudden onset difficulty speaking, nausea and vomiting, and sore throat
Chill; Body aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL8982), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was inquiring if she can take paracetamol (TYLENOL) after the first COVID-19 vaccine because she was having body aches after the first injection on 21Jan2021. As of 03Feb2021, the patient was due for her second done on 11Feb2021. The patient had been hearing a myth that she wanted to know if it is true. After the patient's first shot she only had a small side effect which was the body aches. The patient got these about 12 hours after the shot, it happened through the night while she was sleeping. The following morning (22Jan2021), the patient also had what might have been a slight chill but just a slight one, but it was the body aches mostly. The patient took paracetamol (TYLENOL) extended release for the events. Then the patient was told that she shouldn't have taken the paracetamol and that people weren't supposed to take anything after getting the vaccine. The patient asked confirmation if this can't be true and asked what a person would take if they had a fever. The patient confirmed that she did not have a fever. The events subsided immediately, and it was like she never had them; they didn't last long at all. The patient recovered from the events in Jan2021.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient pertinent medical history was not reported. On 22-OCT-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot# K000456 and expiry date: 15-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Found dead by parent on 12/20/99 at 10:03. Autopsy gave cause of death as sudden infant death syndrome, pulmonary congestion.
Patient c/o lightheadedness, "feeling faint" directly after vaccination (had no c/o after 1st shot) Pt. became diaphoretic, pale-reclined with feet up, cool compresses-color returned to face. "felt as if lost consciousness" fro a few seconds. Pt. had eaten breakfast and exercised prior to coming in.
PATIENT RECEIVED HER FIRST DOSE OF THE MODERNA COVID VACCINE ON 5/24/21.  PATIENT IS POST-MENOPAUSAL AND REPORTED HAVING A PERIOD A DAY OR SO AFTER GETTING THE VACCINE.
Starting at 4hrs post injection: Very strong arm pain, unable to move arm  lasted 6hrs Headache  lasted 24hrs - resolved after 2x tylenol doses Chills lasted 24hrs  - resolved after 2x tylenol doses Low grade fever lasted 24hrs  - resolved after 2x tylenol doses Fatigue lasted 48hrs
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. There was no information on the patients' concurrent conditions, medical history and concomitant medications. On unspecified dates, the patients were administered doses of improperly stored PNEUMOVAX23 (lot # L029306, with expiry date 26-MAR-2017). No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 64 year old male with no past medical history who on 1/16/01 and 7/9/01 was vaccinated with the first and second dose (638450/0030L) (IM in the left deltoid) of hep A virus vaccine inactivated. There was no illness at the time of vaccination. This does not comply with the recommended dosage schedule. On 3/26/02 the pt's serology testing came back negative. It was noted that the pt will receive two additional doses. The pt sought unspecified medical attention. It was noted on 4/3/01 the pt began another vaccine series of hep A vaccine (Havrix). No further info is expected.
Information has been received from a physician concerning a 42 month old male with no pertinent medical history who on 08/23/2002 was vaccinated with a dose of varicella virus vaccine live.  on 02/21/2005 the patient developed a vesicular rash consistent with shingles, about 50 lesions, on the left side of his chest.  Unspecified medical attention was sought and the patient was treated with Acyclovir.  At the time of this report the patient had not recovered.  Follow up information from the physician indicated that the patient developed shingles two years after vaccination with varicella virus vaccine live, but he did not consider this to be an adverse reaction.  Additional follow up information indicated that a VZV specimen was sent for testing.  The memo stated that the swab was inadequate but the capillary was positive for beta globin and would be analyzed via PCR to determine the strain.  No further information was available at the time of ths report.  Additional information is expected.
Limited range of motion in left arm, very weak, pain in arm and shoulder from the very first dose of injection on 7/27/21 ongoing as of today 10/4/21
Swelling, redness-2" in diameter, hot to the touch, arm stiffness.  Started 1-2 days after injection was given.
This spontaneous report was received from a physician and refers to about 90% of 60 female patients of unknown age. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates (reported as when the patients were children), the patients were vaccinated with M-M-R II, RECOMBIVAX HB and with VAQTA for prophylaxis (frequency, route of administration, lot# and expiration date were not reported for any of the vaccines). On unknown dates between January 2017 and June 2018, vaccine titers were performed as part of prenatal testing on 60 patients, who were also substance abusers (it was unknown what substance was being abused) since unknown date. About 10% of that population had negative titers for one or all of those vaccines (captured in case # 1808USA001708). The outcome of the event was unknown. The relatedness between the event of substance abuse and vaccination with M-M-R II, RECOMBIVAX HB and VAQTA was not reported. Upon internal review, the event of substance abuse was determined to be medically significant. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1808USA001708:
Towards the end of April 2022 I began to notice allergies that had never occurred including eye itching, scratchy throat, no trouble breathing. I did consult ophthalmologist, I was given eyedrops for two weeks that have antihistamines in them. It helped and a steroid set of drops helped with relieving the inflammation as well.  Allergies have definitely improved however they have not gone away.
Patient received dose 1 on 9JUN.  Was stung by bee on 29 JUN with a local reaction typical of many previous bee stings.  Received shot 2 7JUL.  Was stung by bee again 17JUL and on this occasion suffered anaphylaxis requiring ER visit, epi pen, and other medications.  Patient has never previously had any serious allergic reactions or anaphylaxis.  He is concerned that the vaccine may have contributed to his hypersensitivity.
Received GARDASIL #2 5/21/12. Client was asked to sit for 20 min. Before 20 min. she fainted & fell off her chair. Regained consciousness after few seconds.
patient was administered vaccine which had undergone several temperature excursions; No Adverse Event; patient was administered vaccine which had undergone several temperature excursions; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered vaccine which had undergone several temperature excursions) and NO ADVERSE EVENT (No Adverse Event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    Concomitant product use was not provided by the reporter. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was reported that the vaccines had undergone several temperature excursions in August 2022. Vials were moved from freezer to refrigerator on 7SEP2022 It was reported that Refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department made aware of the situation. No adverse reactions reported to the knowledge for any of these patients. Treatment information was not provided.
Narrative:  89yo patient obtains most of his care outside agency with- CURRENT PROBLEM LIST - per patient and review of Code Description M48.06 Spinal stenosis of lumbar region (SCT 18347007) D49.519 CA - Cancer of kidney (SCT 363518003) I10. Benign essential hypertension (SCT 38341003) V58.89 Patient uses the Hospital primarily for Medications (ICD-9-CM V58.89) Hx of nephrolithiasis Pancreatic cyst CAD CKD 3 Insomnia Constipation Died at home on 11/16/2021. Pt had received covid vaccine from NON-agency provider on 1/8/21 & 1/29/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
patient developed dizziness about 5 hours after vaccine and began sweating profusely. initial blood pressure was quite low in the 77/46 however subsequent reading was 108/76 and patient exhibited no other signs of anaphylaxis. paramedics were called in case reaction became more severe but patient recovered and was back to baseline within 15 minutes or so. no intervention given.
Severe chest pains that woke me out of sleep 3 times the first night followed by sitting on the couch all day. the second morning I woke around 4:00 am and felt like I had swallowed a beach ball. I drank carbonation but could not burp yet I almost could not even talk. by noon It felt like my rib cage was going to split apart. I had a hard time breathing and became dizzy.
DEATH; This spontaneous report received from a consumer via a company representative via social media concerned multiple patients of unspecified race and ethnic origin. No past medical history or concurrent conditions were reported. The patients received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified dated in 2021, 178 patients died (cause unknown) after Covid shot. It was unspecified if an autopsy was performed. The reporter stated that, 318 people had cardiac arrests and 178 people had deaths in 2021, after COVID Shot. It was stated that It was definitely not normal for young athletes to suffer from cardiac arrests or to die while playing their sport, but this year it was happened All of these heart issues and deaths came shortly after they got a COVID vaccine. While it was possible this could happen to people who did not get a COVID vaccine, the sheer numbers clearly point to the only obvious cause. So in response to their pronouncement, here was a non-exhaustive and continuously growing list of young athletes who had major medical issues in 2021 after receiving one or more COVID vaccines. Initially, many of these were not reported. We know that many people were told not to tell anyone about their adverse reactions and collapse in the middle of a game due to a heart attack. Sidelined Athletes with Illness. Their immune systems are likely to have been compromised by something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220146936, 20220156495, 20220156651 and 20210842132.  Version created to amend previously reported information on 21-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event.  : 20220153841-COVID-19 VACCINE AD26.COV2.S-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Pain in right muscle area where shot was given. Pain has been intense since given. Can't raise are, lift or pick up anything without intense pain. This has been going on for almost a year.
Patient presented to the pharmacy on 2/2/18 with raised erythema at the injection site. It had first appeared the previous day & had grown in size to approximately 3.5in in diameter. The patient reported injection site pain on 1/30 (vaccination given) and 1/31, but denied any pain on 2/2. The patient had marked the margins of the erythema the previous night with a marker, the affected region had grown by ~1 inch in diameter since then. I recommended the patient see a provider at student health, as I suspected it was cellulitis.
A few minutes after patient received dose this morning around 9:20am, he became pale, developed hot flashes, shaking, nausea, dizziness, and hands feeling numb/tingling. Provided the patient with a cold pack for the back of his neck and water to drink, and encouraged him to sit with his head lowered. The patient's father pointed out that he had not had anything to eat that morning, which could have contributed to his response. After a few minutes, most of the symptoms abated, and patient was feeling much better. His father left the store with him at that time. Called the father later that day, and he said patient was feeling better. Had taken nap and was only feeling a little tired. I explained possible side effects from vaccine and father thanked me for our time and concern.