chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 4pm my arm started to get sore , by 4:30 I was shaking uncontrollably and So bad I couldn?t walk.  My hands and lower legs became icy cold and the shaking didn?t stop until around 7pm.  I took my temperature and it was at 100.  I took a Tylenol and drank water and lay on the couch until 10am the next morning after fitfully sleeping.  I took another Tylenol as my temperature was still high, but now I also had the most awful pounding sinus headache.  I decided to take a sinus medicine for the pain.  The rest of Wednesday was a blur.  On Thursday I started to feel better but found that I had a big rash on my left arm all the way to my elbow, one day later and it is starting to itch.  I also developed a blood bruise on my right shoulder blade close to my underarm.  My appetite hasn?t returned and I still feel a bit like I spent ten rounds with Mike Tyson.  I?m still glad I got the shot.
Patient fainted 15 minutes after receiving vaccine; based on  witness report, patient regained consciousness right after falling (patient was caught and did not receive injury from fall).
Information has been received from a physician concerning a 5 year old male who on 07/30/1998 was vaccinated with varicella virus vaccine live. On 02/09/2002, the pt developed chicken pox and presented with a severe rash. The physician reported that another pt developed chicken pox post vaccination with varicella virus vaccine live (see WAES0203USA00690). Additional info has been requested.
New onset Torsades de pointes with syncope; New onset Torsades de pointes with syncope; New onset recurrent orthostatic hypotension requiring medication to manage; This is a spontaneous report from a contactable physician.   A 50-years-old non-pregnant female patient received bnt162b2 (Covid vaccine, Brand Pfizer ), dose 2 intramuscular on 08Sep2021 at her 50-years-old (Lot Number: FC3180) as dose 2, single for covid-19 immunisation.  There were no concomitant medications, no medical history. No Other vaccine in four weeks, no Covid prior vaccination, no Covid tested post vaccination, no known allergies. Historical Vaccine included first dose BNT162B2 on 06Aug2021 at her 50-years-old (Lot Number: FC3180) Intramuscular as dose 1, single for covid-19 immunisation.  On 22Sep2021, The patient experienced New onset Torsades de pointes with syncope. Required two hospitalizations and implantation of AICD. New onset recurrent orthostatic hypotension requiring medication to manage. No prior history of any cardiac issues, no prior medications, no pre-existing comorbidities, no Family History. Required 2 ER visits, 2 overnight hospital stays (2 different facilities). Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage].  The patient was hospitalized for events for 3 days.  Therapeutic measures were taken as a result of all events included Multiple diagnostic tests, AICD implantation, medication. Outcome of events was recovered with sequelae.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Torsade de pointes, Syncope, Orthostatic Hypotension and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Severe rash all over body. Arm where vaccine give red, swollen down to hand all happened w/in 24 hours after injection.
Documentation of second Gardasil shot was not done correctly. Gave pt her third (believing it was her second) 3 months too early and less than 1 month from her actual second shot.
an injection of MMR II vaccine was given IM instead of SQ; This spontaneous report was received from a pharmacist and refers to a 63-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 16-SEP-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot # S035356, expiration date 05-NOV-2021, intramuscularly instead of subcutaneously for prophylaxis (exact dose was not reported).
Headache,cold chills,mild fever Treated with Tylenol Was given Augmentin 875mg BID
I started feeling a little achy and flu-ish at bedtime -- about 8 hours after receiving my 2nd dose of the Moderna vaccine. (I'd had no ill effects after the first dose, save for a sore arm.)  The next morning, I felt a little under the weather but nothing serious. It wasn't until bedtime *the next day* (about 30 hours after receiving the shot), that more serious symptoms kicked in.  I started running a low-grade fever (100+ degrees F), had chills and bad aches. It was a rough night.  Today -- day 2 after receiving the shot -- I feel a little better. No fever and aches and chills have subsided. But I'm not at 100 percent.
I heard the second dose might give more of an adverse reaction than the first but I felt I needed to report what happened to me because of how bad it was. After about 9 hours from getting the shot I got a headache that turned in to the worst migraine I've ever had in my life that lasted over 30 hours. I had a fever that ranged from 101F to 103F that has lasted for more than 30 hours, I also developed severe muscle and joint pain so much so that I could only get out of bed to go to the bathroom and that was with great pain. I also have had nausea that has lasted over 36 hours. I took Tylenol (1000mg) every few hours, 4 times with out relief. I also took a Tramadol which helped a little with the pain but then my fever spiked for a few hours. I'm now on day 2 of bed rest and waiting for the symptoms to subside so I can get back to my regular life.
My mother, received the 1st vaccine for COVID 19 last week on Tuesday, Jan 26th.  On Friday, Jan 29th, she started having diarrhea and continues to experience the same.  She feels bad all over, can't get up and move around. When she stands and walks, she said she feels pain in the back of her neck and head. She is out of breath and generally laid in bed all day today.  She is not eating much on a daily basis, today just some cheese and crackers and orange juice.
20 minutes after vaccine rash on face and bilateral arms. **Pt states still has rosey cheeks and chin**
This spontaneous report was received from a nurse practitioner via company representative and refers to a male patient of unknown age. The patient's current conditions, medical history and concomitant medications were not reported. On 10-NOV-2015, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route and lot number were not reported). On 18-NOV-2015, the patient experienced "a skin reaction with burning and itching down the back of the arm and under the armpit on the left side". On an unknown date in November 2015, the patient experienced rash. Product quality complaint (PQC) was not involved. The outcome of the events was unknown. The reporter did not provide the causal relationship between the events and suspect therapy. Additional information has been requested.
Extreme swelling and redness at site of injection-(round circle 3" x 4" in diameter).  Flu like symptoms started in the middle of the night-fever, chills, body ache, nausea lasted 2 1/2 days. My mother who is eighty-one (81) also received her second dose of the vaccination the same day, and had the same symptoms.    My husband had his first dose who is sixty (60) and had these exact symptoms,   My concern is that these are not symptoms listed on the pamphlet.
52 days since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days since 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days since 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (52 days since 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-223807 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-Jun-2021: Second dose events were updated.
THYROID OVER 150; HERNIA ABOVE NAVEL TO RIB CAGE; BODY ACHES; Chills; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (THYROID OVER 150), ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE), PAIN (BODY ACHES) and CHILLS (Chills) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    It was unknown if the patient was enrolled in any clinical trials.  Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. On an unknown date, the patient experienced THYROID DISORDER (THYROID OVER 150), ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE), PAIN (BODY ACHES) and CHILLS (Chills). At the time of the report, THYROID DISORDER (THYROID OVER 150) and ABDOMINAL HERNIA (HERNIA ABOVE NAVEL TO RIB CAGE) had not resolved and PAIN (BODY ACHES) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood testosterone: Testosterone zero. On an unknown date, Thyroid function test: Thyroid over 150. Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  The concomitant medication was not reported.  The reporter causality for the events with respect to Rinviq was reported as not reported.  The treatment medication was not provided.
daily I have a headache every day on the right side more intense; tired I can't exercise like I used to; Dose Number: 1 25Mar2021 Dose Number: 2 04Aug2021; 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 04Aug2021 as dose 2, single (Lot number: EW0198) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single; Batch/Lot No: EN6207; Location of injection: Arm Right), administration date: 25Mar2021, when the patient was 29-year-old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Aug2021, outcome "unknown", described as "Dose Number: 1 25Mar2021 Dose Number: 2 04Aug2021"; HEADACHE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "daily I have a headache every day on the right side more intense"; FATIGUE (non-serious) with onset 08Aug2021, outcome "not recovered", described as "tired I can't exercise like I used to". Therapeutic measures were not taken as a result of headache, fatigue.  Additional information: Patient did not received any other vaccine in four weeks, other medications in two weeks: No.  No follow up attempts are possible. No further information is expected.
Resident came by my office to report an adverse reaction to the first COVID vaccine given around 11 am on 01/30/2021. She describes her tongue feeling slightly swollen while eating her dinner around 6pm 1/30/21. The next morning around 5 am she woke with tongue very swollen. She took Benadryl 25 mg at 5 am, 10 am and 8 pm. Today the tongue no longer appears swollen but is reddened the distal third. She reports unable to drink anything hot.Adverse reaction report filed with VAERS.
Patient presented to the ER on 3/2 for urinary frequency and lower abdominal pain. He was hospitalized at Medical Center- on 3/2/2021 for small bowel obstruction and acute kidney injury. Patient passed on 3/2/2021.
thrush in mouth has little bump on leg & blisters on mouth & wont stop crying, not eating or drinking hasn't urinated since vax but has started to now; lt thigh mildly swollen;
Headache, chills, joint/body ache, fatigue, low grade fever started on 3-26-2021 & are still present as of 3-31-2021
pt recv vax 12APR97 & on 16APR97 pt devel a rash in the rt axillary area w/urticaria was seen by MD;rash spread to trunk & became follicular;
Vasovagal syncope fainting. Patient had stood up, despite being instructed to sit, passed out and hit face on carpeted floor. Although he did slightly bust his lip, no other injuries were noted, and patient was immediately alert and responsive. He lied on the floor, then slowly rose a bit later. He was observed for 20 more minutes, then allowed to leave with his mother.
She had progressively worse side effects from those but they happened within two hours of having the shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She had progressively worse side effects from those but they happened within two hours of having the shots) in a 75-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She had progressively worse side effects from those but they happened within two hours of having the shots). At the time of the report, IMMUNISATION REACTION (She had progressively worse side effects from those but they happened within two hours of having the shots) outcome was unknown.      Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-662616 (Patient Link).   Reporter did not allow further contact
After administration of Gardasil #2 and Menactra the patient went to the waiting room.  She became pale and dizzy and was brought back to an exam room and lay down supine.  Her Heart rate was 55 and her blood pressure was 106/64 with an O2 Sat of 98% room air.  She was able to talk the entire time.  She complained of feeling tired and wanted to go to sleep.  She did not fall asleep, and there was no loss of conciousness.  Her heart rate increased to the 70's over time.  Her pallor resolve over about 10 minute and she had decreased clamminess. At about 10 minutes she started to feel better, and was asked to stay for observation for an additional 1/2 hour.  Her repeat BP was 110/62 and her heart rate was in the 80s.  In retrospect mom reported that after Gardasil #1 she had tingling at the injection site while at school (hours after administration.)
Suspected vaccination failure; have shingles now. Got my vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. The patient wished that he/ she had of got vaccine sooner. The patient advised all to get the vaccine and stated that shingles was no joke. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
diarrhea; Nausea; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038321A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, DIARRHOEA (diarrhea), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-074920 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Lot number updated for first dose. Information regarding patient's second dose and events provided.
I was feeling perfectly fine during the majority of the first day after the second COVID-19 shot, but during that night I had chills and a fever. The next day, I had a couple body aches and at night at 3:25 am it turned into body aches and me getting chest pain/ache and upper spine back pain/ache. The current day is Wednesday 12:01pm and my fever and chills is gone but I still have body ache/pain and chest pain/ache and it's harder to breathe a little (especially when I'm laying down).
i notice a(n) knot on the left side of my neck at approximately 3:20 pm on Saturday, November 07, 2021.
Patient received first dose Pfizer, 10 minutes after patient complaints of itchy throat, nausea/ vomiting. Patient was transported to gurney, assessed and monitored. V/S were stable with O2 saturation @100%. After 10 minutes - patient still exhibits symptoms of vomiting with dizziness with no relief, EMS was called and arrive at the scene. EMS transported patient to Hospital.
Patient received FLUMIST. She has had flu injection in past. She has no h/o allergies. Soon after within 5-10 minutes, she developed urticarial rash on face, upper chest, neck, upper arms. She was given BENADRYL, prednisone and ZYRTEC.
he was sick for a day; chills; body aches all over; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over). At the time of the report, ILLNESS (he was sick for a day), CHILLS (chills) and MYALGIA (body aches all over) had resolved. Not Provided          No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2021-371343, MOD-2021-369390 (Patient Link).
really bad reaction; didn't feel like she could move; Feeling strange; Fever; Extreme fatigue; Horrible headache, piercing; Pain in the eyes and nose; Pain in nose; Heart racing; Flushed cheeks; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed cheeks), VACCINATION COMPLICATION (really bad reaction), HYPOKINESIA (didn't feel like she could move), FEELING ABNORMAL (Feeling strange) and PALPITATIONS (Heart racing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Cholesterol and Hypertension.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced FLUSHING (Flushed cheeks) and PALPITATIONS (Heart racing). On 28-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (Extreme fatigue), HEADACHE (Horrible headache, piercing), EYE PAIN (Pain in the eyes and nose) and RHINALGIA (Pain in nose). On an unknown date, the patient experienced VACCINATION COMPLICATION (really bad reaction), HYPOKINESIA (didn't feel like she could move) and FEELING ABNORMAL (Feeling strange). At the time of the report, FLUSHING (Flushed cheeks), PALPITATIONS (Heart racing), PYREXIA (Fever), FATIGUE (Extreme fatigue), HEADACHE (Horrible headache, piercing), EYE PAIN (Pain in the eyes and nose) and RHINALGIA (Pain in nose) had resolved and VACCINATION COMPLICATION (really bad reaction), HYPOKINESIA (didn't feel like she could move) and FEELING ABNORMAL (Feeling strange) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
EXTREME jaw pain, both sides, and ear pain in both ears.  Sore neck glands on both sides, and right shoulder pain.  Saw Primary care doctor after 2 weeks of pain.  Ate only soft foods for 2 weeks & took Tylenol.  Then saw Dentist who prescribed a muscle relaxant & Aleve.  I am still in horrid pain in my jaw & ear (right side).  Diagnosed with TMJ by both my Internal Medicine doc & my DDS.  I've been avoiding chewing, support my jaw when yawning, chew only on the left side.  Aleve, even 2 at a time (which exceeds the dosage) does NOT help.