chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.    conclusion: the clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-245527, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for clinic so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
Pt received vaccine and began to feel her heart racing about 6 minutes later.  She has a history of tachycardia with hypertension.  She has a cardiologist and a PCP but she has never been prescribed medications for the events because they usually self resolve.  BP is 170-190s/110-120s with HR 130-140s most of the time.  Pt is on Emstat's monitor.  HR improves to 120s, then returns to 140s.  Pt remains elevated.  Pt elects to be transported to ER for further evaluation via Emstat.
This spontaneous report as received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 01-JUN-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot # N034005 and expiration date 31-JAN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 32 Fahrenheit degree up to 35 Fahrenheit degree (33.8 Fahrenheit degree), time frame of 2 hours 30 minutes with no previous temperature excursions. Digital Data logger was involved.
10-30-07:  Vaccine given.  11-05-07:  Had severe lower back pain radiating to the hips.  Also had bloating in the abdomen.  11-06-07:  Went to ER and had CBC and kidney function tests taken.  All tests were normal.  Received vicodin and norflex in the ER but only took one dose due to nausea.  11-7-07:  Went to PCP.  Pt has been taking ibuprofen to help combat symptoms all this time.  11-8-07:  MRI was obtained and revealed L2 edema of unknown reason.  Also on this day the pt's legs felt weak and still had back pain.  11-14-07:  Ultrasound of the abdomen was taken and was unremarkable.  11-15-07:  Pt started to feel better.
0 mins: Discomfort in arm flowing from injection site to the rest of the body 2-4 mins: Light-headedness 5-10 mins: About 2 minutes after sitting down at the 30-min waiting area, I began to feel more light-headed while checking my phone, though I don't remember it, I fainted and hit my head on the gym floor ~15 mins: I am awake and feel extremely foggy and have low blood-pressure and heart rate ~25 mins: I am told to sit back up in the chair ~26 mins: I start feeling light-headed again and lose consciousness again and am told that I had a seizure for 20 seconds before coming back again
Staff reconsituted Rotarix and delivered intramuscularly. Family notified,  injection site marked and second dose given orally. Staff was retrained on vaccine delivery.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 08:00 as dose 1, single (Lot number: EN6207), in left arm, on 15Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 03Oct2021 at 14:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 09May2022 at 15:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's disease" (unspecified if ongoing); "known allergy to Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Levaquin, reaction: "known allergy"; Cipro, reaction: "known allergy". The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered with sequelae" and all described as "COVID-19". The event "covid-19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 3 negative tests; (unspecified date) Negative, notes: 3 negative tests; (unspecified date) Negative, notes: 3 negative tests; (2022) Positive, notes: kept testing positive for a week; (01Aug2022) Positive, notes: after 3 negative tests, she tested positive again. Therapeutic measures were taken as a result of covid-19, which included nirmatrelvir-ritonavir (Paxlovid) full dose tablet combo therapy pack from 08Jul2022 to 13Jul2022. Clinical course: After 3 negative tests, the patient tested positive again on 01Aug2022 and kept testing positive for a week. The nurse (RN) at the doctors office told her to stop testing. Symptoms were not as severe, but came back. The patient had recovered with sequel on 02Oct2022 from the recurrence with no treatment received. The patient received fifth dose of Pfizer / BioNTech (BNT162B2;BNT162B2 OMI BA.4-5) on 30Oct2022 at 01:00 PM (Lot number: GH9697) in the left arm for Covid-19 immunization.
Pfizer-BioNTech Bivalent COVID-19 Vaccine EUA: case resulting in invalid dose given Patient received Pfizer-BioNTech vaccine on 12/6/21, 4/8/21, 4/29/21 and Pfizer-BioNTech Bivalent Booster on 11/11/22. Pt received Pfizer-BioNTech Bivalent booster at 9:30AM, 12+ hours after dose was expired. Pt was monitored and no harm came to patient.
Patient had starting spell with associated head jerking for 1 minute. Postictal (irritable & drowsy) for 1 hr after event. Seen in local Emergency dept with negative workup. Symptoms c/w seizure.
Itchiness throughout the body similar to shingles; Itchiness throughout the body similar to shingles; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itchiness throughout the body similar to shingles) and HERPES ZOSTER (Itchiness throughout the body similar to shingles) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PRURITUS (Itchiness throughout the body similar to shingles) and HERPES ZOSTER (Itchiness throughout the body similar to shingles). At the time of the report, PRURITUS (Itchiness throughout the body similar to shingles) and HERPES ZOSTER (Itchiness throughout the body similar to shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.
I woke up 2 days after the shot was administered and my left armpit lymph nodes were severely swollen. It looked like a tennis ball was cut in half and under my skin. I didn?t do anything except take some Tylenol and Motrin. Neither of those helped. It was painful to the touch. I wasn?t able to even put on a shirt. It was gone within 6 days. I had no other issues aside from this. I had no fever, no headaches or anything.
Pt  reported flushing/sweating and dizziness Vitals: 15:10 148/70, 100, 81, 18, 96.7F -- > 1520 152/85, 100,102,18, 96.7F -- > 1553 134/72, 100, 87, 18, 96.6F Pt  stable and released from the vaccination site @1553
This spontaneous report as received from a pharmacist, refers to a 63 year old female patient. The patient had no pertinent medical history nor drug reactions and allergies. On 28-MAY-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L000448, expiration date 08-MAR-2016), subcutaneously, in the left arm (dose was not reported). On the same day, the patient was concomitantly vaccinated with a dose of PNEUMOVAX 23 (lot # L003188, expiration date 06-JUL-2016), in her right arm via an unspecified route (dose was not reported) and with ADACEL in her right arm, at a different injection site than PNEUMOVAX 23. Concomitant therapies included atorvastatin, vitamin D, oxybutynin (manufacturer unknown), lisinopril (+) hydrochlorothiazide (manufacturer unknown), CIPRO, promethazine w/DM and sulindac (manufacturer unknown). On 30-MAY-2015, the patient developed redness and a pus-filled blister at the ZOSTAVAX injection site. No injection site reaction was reported for either PNEUMOVAX 23 or ADACEL injection sites. No lab diagnostic studies were performed and no treatment was given for the adverse events. The patient's present status was reported as not recovered. The patient sought medical attention - she visited the pharmacist. The relatedness between adverse events and ZOSTAVAX was not reported. Additional information has been requested.
Client passed out upon reaching vehicle. Her eyes were dilated approx. 1 to 1.5 cm. unresponsive. Was able to get small response out of patient. O2 at 4L placed BP taken 160/98 pulse 66. but was weak and thready. Patient passed out once again and did sternal rub while calling her name. Patient came slowly to and pupils returned to normal. Patient confused on what had happened. States she has passed out before from shots but states this was different. States when she was out she had dreams but couldn't remember them. Patient remained extremely pale but was communicating normally. Stayed with patient another 20 minutes. Paleness getting better. Patient did not want to go to ER. Encouraged her to f/u with PCP ASAP. Ver Patient verbalizes understanding. She was with her parents so did not have to drive. Parents verbalized patient would not be alone. Patient called early evening of that same day. Patient states she is feeling fine denying any left over symptoms. Called patient Sunday 04/11/2021 and she verbalized doing fine.
Intense itching on day 11 and 12 after being given the booster and then traveling hives head to toe all over body.  Benadryl and Pepcid for a week with no relief.  Prednisone and hydroxyzine for 8 days with some relief but daily give outbreaks
swelling at the injection site, pain, headache, feeling like numb, change in the taste, fever the 1st day x2, body ache, lower back pain.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccines was stored in freezer, they take out one to two vials and place in fridge each day as needed.  No concomitant medication were reported.  No treatment medication were reported.
injection site pain; headache; joint pain; nausea; feeling unwell; tiredness/tired; swollen lymph nodes under left arm; achy; This is a spontaneous report from a contactable consumer reporting for herself. This 67-year-old non-pregnant female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jan2021 at 09:30 AM, in left arm, for COVID-19 immunisation. Medical history included allergies to sulfa and COVID before vaccination. Concomitant medications included calcium, glucosamine/chondroitin and unspecified multivitamin. On 30Jan2021 at 16:00 the patient experienced injection site pain, headache, joint pain, nausea, feeling unwell, tiredness, swollen lymph nodes under left arm and achy. The events got progressively worse the following day. On 01Feb2021 the patient was too tired and achy to go to work. The events did not require any treatment and were resolving at the time of report. COVID was not tested post vaccination.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
A nurse reported that a 13 month old female received an injection of Prevnar on 5/17/00. That evening her face became red and swollen. She recovered after several hours without treatment. Followup info received 8/14/00 indicated that the infant developed redness and swelling of the face and a fine rash on her abdomen within 30 to 45 minutes of immunization. She recovered by lunchtime the next day, without treatment. The reporter considered these events to be medically important (OMIC); therefore, this report has been reclassified as serious, unexpected.
Malfunction of needle, medication squirted out of the side of the needle in a weak spot or crack in the base of the seam. Patient received partial / no dose. Due to the amount of medication that squirted out, the decision was made to give additional dose to patient.
bronchitis; Arm soreness; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: A3246/H3246, via an unspecified route of administration from 12Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included asthma and ongoing cough. There were no concomitant medications. The patient had a minor cough and was spitting up phlegm but had no temperature before he got the vaccine. The patient had bronchitis but no virus currently. He still has a bit of cough. He wanted to know if it gets worse was, he allowed to take an antibiotic and if taking antibiotics or prednisone will interfere with the vaccine as he already received the first dose. He was asking if it got worse, should he wait five more days and then go to the doctor. He wanted to know if prednisone affects the vaccine. The only side effect of COVID-19 Vaccine was his arm was hurting for about four to five hours on 12Jan2021, but that was it. The patient took two Tylenol. Arm soreness went away maybe five to seven hours later. The outcome of the event arm soreness was recovered while bronchitis was unknown.    Information on the lot/ batch number has been requested.
Vomiting; diarrhea; migraine; scalp sensitivity; chest pain; fatigue; body ache; fever; chills; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 15:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included salbutamol (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 16Mar2021 at 16:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient previously received amoxycillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 07:00, the patient experienced vomiting, diarrhoea, migraine, scalp sensitivity, chest pain, fatigue, body ache, fever and chills. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events vomiting, diarrhoea, migraine, scalp sensitivity, chest pain, fatigue, body ache, fever and chills were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Tingling on upper part of back, looks like a semi light brown patch, no pain, no fever, no aches. nothing has been used.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 30 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "Known allergies: Honey" (unspecified if ongoing); "Known allergies: raspberry" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: TOPAMAX, start date: 13Jun2010; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; NEXPLANON. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received vaccine and other medications were received in 2 weeks. Anti-viral details included Product for COVID 19 Treatment, Brand was Pfizer. Treatment start date was on 10Sep2022. Treatment stop date was on 14Sep2022. Indication was for Treatment of COVID-19.   No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded
Fever, bad headache, after 24 hours,  droopy left side of face, numbness on left side of face (like the Bell's Palsey I had after contracting meningitis in 1992) after about 36 hours, extreme exhaustion for 3-4 days
Vaccine given too high in the arm, into the left shoulder joint. Caused severe shoulder pain, effusion, and extremely limited range of motion--patient is unable to use the left shoulder (unable to dress, unable to prepare food, unable to perform duties at work). Diagnosis: Shoulder Injury Related to Vaccine Administration
pt stated had raised areas on back of tongue the evening following vax;had a feeling that throat was swollen & swallowing was difficult;saw MD for 2nd dose of vax 27AUG96 & reported this rxn to 1st dose;
Full head headache 12 hours post vaccination to now (27.5 hours post vaccination) Chills on arms, body, and legs that are not going away, began 22 hours post vaccination and are still present.  Fever ranging from 101.5 to 102.8 F, started 22 hours post vaccination and still present.  Body aches, leg muscles, arms began at 22 hours post vaccination.  High heart rate, discovered when I put on my watch, since 22 hours post vaccination heart rate has been 95-130 beats per minute. Normal heart rate is about 59-60
Started to feel nauseous around 10:30 pm. As I got up to go to bathroom I became extremely dizzy. Barely able to walk and make it to the bathroom less than 10 feet away. Body was very weak. Lowered myself to the floor. Woke up a out 15 minutes later sweating, shaking, and having urinated on myself. Extremely weak body after until I fell asleep.