chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore throat; Diagnosed with upper respiratory infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and UPPER RESPIRATORY TRACT INFECTION (Diagnosed with upper respiratory infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and UPPER RESPIRATORY TRACT INFECTION (Diagnosed with upper respiratory infection). The patient was treated with AZITHROMYCIN for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and UPPER RESPIRATORY TRACT INFECTION (Diagnosed with upper respiratory infection) outcome was unknown.            No relevant concomitant medications were reported.
GIVEN EXPIRED VACCINE/PRODUCTS (HAD REACHED THEIR LISTED EXPIRATION DATES); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 08-SEP-2022) dose was not reported, administered on 10-NOV-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. No concomitant medications were reported. On 10-NOV-2022, the patient experienced given expired vaccine/products (had reached their listed expiration dates). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of given expired vaccine/products (had reached their listed expiration dates) was not reported. This report was non-serious. This case, from the same reporter is linked to 20230150340, 20230150255, 20230150157, 20230150423, 20230149982, 20230150588, 20230150716 and 20230150777.
Approximately 5 minutes after the injection, I suddenly began experiencing tachycardia (felt like I had way too much coffee). The nurse took my pulse and summoned the attending physician who sat with me for more than 30 minutes. I felt good enough to leave but did experience a somewhat rapid heart rate on and off through the afternoon. Upon leaving, I was told to call my allergist to have my Epi-Pen refilled (my current Epi-Pen had expired), which I did. Eleven hours post injection I'm feeling fine except for the expected arm soreness. In terms of my allergic history, I had previously discontinued allergy shots last year due to repeated systemic reactions to very low dose vials (itchy roof of mouth, swollen throat, etc).
Information has been received from a physician concerning a pt who on an unspecified date was vaccinated with 1 dose of Hep-B vaccine recombinant (yeast). Subsequently, the pt developed auto-immune hepatitis. Upon medical review, the pt's experience was considered to be an "Other Medical Event". Additional information has been requested.  Follow up on 03/28/2001: "Patient date of birth, patient age at time of vaccination, adverse event onset date/time, lot # for vaccine 1, vaccine administration date/time is not provided."
BLOOD PRESSURE HIGH; COUGHED; NOSE BLEED; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetes, penicillin allergy, and allergy to almonds and himalayan salt. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and talc. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total, administered on 11-MAR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 16-AUG-2021, after five months of vaccination, the patient had blown nose hard and had a smaller nosebleed that stopped on its own. On 17-AUG-2021, the patient coughed hard and had a big nosebleed occurred it was gushing. She took a picture of what came out in the sink she stated that it was a huge blood clot. The patient taken to emergency room via ambulance and patient stated that it was huge blood clot and was holding a shoe box to catch the blood in the ambulance and the patient's blood pressure (BP) was measured and it was 198/126 mm/Hg and patient stated that she could have had heart attack or stroke. On 17-AUG-2021, the patient admitted to emergency room and patient received anesthetic and catharized it. The patient didn't remember if any test or blood work done and on same night (AUG-2021), the patient was discharged and nose bleeding didn't occur again. On an unspecified date in 2021, the patient's blood pressure measure and it was high but not like previously measured on 17-AUG-2021. The patient stated that, "it was hard to tell with my diabetes cause it was similar symptoms. On 02-OCT-2021, the patient came to get flu shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nose bleed, was recovering from blood pressure high, and the outcome of coughed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211004085-Covid-19 vaccine ad26.cov2.s- Blood pressure high, Nose bleed. 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).
Client reported she experienced an unknown amount of dizziness that resolved on its own, and seemed quick. She thought it was normal. She ate that day and has no history of medical conditions. She takes no medications and has no allergies.
Client received immunizations for travel on 12-17-09 and came into the office on 3-2-09 with rash on his body.  Rash appeared to be pin point pustules sporatically over the body.  No complaints of breathing difficulties or other symptoms.
Back spasms; Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Back spasms) and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Back spasms) and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.). The patient was treated with PREDNISONE at a dose of UNK dosage form, qd. At the time of the report, MUSCLE SPASMS (Back spasms) and PRODUCT DOSE OMISSION ISSUE (Got the first dose of the Moderna vaccine around mid April and second dose has not been administered yet.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
3 inch red inflammation within 5 minutes. Nurse gave BENADRYL, 405 PM - Hospital 6 PM patient said his heart hurt. Took to hospital.
dose of Act Hib administered using an alternative diluent/ no AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 18 month old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB] (dose 3) using an alternative diluent i.e. diluent of MMR vaccine while he received first dose of DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (Pentacel) (lot: UJ117AAA, Expiry date 25-Nov-2020) 0.5 ml via intramuscular route in the right thigh on 14-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13), HEPATITIS A VACCINE (Hepatitis A) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was actual medication error case due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On the 8th day after my first Covid vaccine injection, I have a 2in diameter, slightly raised circle at the injection site.
Received 2nd dose Moderna vaccine at 3pm on 5/11 High fever reaching 102 degrees at worst- started 5/11 at around 10pm, lasted until 5/13 at 12pm. Exhaustion, migraine, nausea, severe all-over muscle pain lasting from 5/11 at 8pm to 5/13 at 12pm. Pain and swelling at injection site from when vaccine was administered, still ongoing.
Headache - diarrhea - dizzy - heavy chest - shortness of breath 11-12-07. 9-9:30 AM vaccine given, 10-10:30 AM symptoms started.
her whole left side where her arm all the way to her elbow and around her back its hurting; headaches; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting; her whole left side where her arm all the way to her elbow and around her back its hurting /Verified that she was referring to injection site; up to her neck it hurts; maybe that's part of the body aches; it's like some weight is on me; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 48-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 10Apr2021(Saturday) (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, patient experienced headache and this morning when she woke up her whole left side where her arm all the way to her elbow and around her back its hurting this has been since Saturday and verified that she was referring to injection site, up to her neck it hurts, it was like some weight is on her and maybe that's part of the body aches. Patient wants to know how long side effects will last and stated people say it couple of days, but it has been almost 5 days. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This morning (2-24-17) noticed red welt about size of silver dollar on back of red arm. Slightly itchy. No fever. No breathing problems. No egg allergies.
Headache, muscle and lymph node pain, nausea, dizziness. fog, chills, loss of bladder control, sense of semiconsciousness, from 7am Tue until 7am Wed
On Tuesday the 13th I was not feeling 100% and feeling fatigued. I found out I had direct contact with influenza on 14th, the next two days I felt ran down, headache. On Saturday I awoke with a sore throat, felt even more fatigued, fullness in my head. I my doctor and had a telehealth visit, showed the doctor a picture of my sore throat with the white spots on my tonsils. We both decided I should start antibiotics in case it was strep. By this week after taking the round of antibiotics and no strep test I was still feeling bad. I called and left a message to with my primary care who confirmed that I should rest, hydrate continue the antibiotics. I am still fatigued, the white spots are still on my tonsils, the head congestion remains especially in my left ear.
None--pt was given vaccine that had been stored in a conventional freezer for > 2 weeks.  Pt offered another dose.
I received my first Pfizer COVID shot on June 2, 2021. On June 13, 2021 I started having water diarrhea. I was having to go to the restroom at least 20 times a day with it being the same consistency, keeping me up all night long. Stomach cramps associated with this. I had the second Pfizer COVID shot on June 23, 2021. I am still experiencing these issues.
About 1 hour after getting the meningitis vaccine, his right shoulder became swollen, red, hot, and he has pain when trying to move his arm.
a lot coughin flem; sleepy; monday full flown strep throat with flem; coughing; small headaches; sore throat; feeling like the flu/still flu feeling; saturday in bed; very tired/tiredness; This is a spontaneous report received from a contactable consumer (Patient). A female non pregnant patient of an adult age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot Number: EN0178) via an unspecified route of administration, administered in left arm on 10Jun2021 14:00 as single dose for COVID-19 immunization. Medical history included high blood pressure and thyroid hipo. Concomitant medications included Synthroid And Losartan. The patient previously took vitamins NOS, losartan + hydrochlorothiazide and Synthroid. Patient did not receive any other vaccines within 4 weeks. prior to the COVID vaccine. Patient was not diagnosed with covid-19 prior to vaccination, and she was not diagnosed with covid-19 since vaccination. On 11Jun2021 16:00, Friday afternoon the patient experienced very tired/tiredness, on 12Jun2021 on Saturday in bed, on 13Jun2021, on Sunday sore throat, feeling like the flu/still flu feeling, on 14Jun2021, Monday full flown strep throat with flem, coughing, small headaches and on 15Jun2021, sleepy and a lot coughing flem (flu type, tiredness, sleepy, Wednesday a little better, mind you been taking zythromax and congestion medicine. It was not normal, as she had not been sick in over three years. Therapeutic measures were taken as a result of adverse event. The outcome of events was recovering.   Information on Lot/Batch number was available. Additional information has been requested.
FEVER, BODY ACHES, MILD SORE THROAT, NAGGING HEADACHE, NAUSEA, AND CHILLS
Pain in left armpit. Can only lift arm perpendicular to floor before pain begins. Looked online if this a reaction and this is listed as a possible side effect.   Currently resting and not lifting arm.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (LOT # L043213, expiration date 28-AUG-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
During first few minutes after the vaccination, the client began to cough repeatedly.  She stated that her throat was tingling and she was noted to be diaphoretic, with Shortness of breath, an increased heart rate and hives.  Epinephrine 0.3 mg IM given to client.  Client responded with less diaphoresis and cough subsided.  However, noted in 5 more minutes that the symptoms progressed.  (As we were in a hospital area administering the vaccine),  a rapid response team was activated and she was sent to the ER for further evaluation monitoring and treatment.
Broke out in hives 3 days after receiving shot. Mainly located on torso. flushing of the face and neck.  More prominent in morning
T12 macular papular itchy rash with scabs of 1-3 inches.
This initial spontaneous report was received on 12-SEP-2018 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history included breast cancer (diagnosed September 2012). No information was provided regarding concurrent conditions or concomitant medications. In or around August 2016, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). In 2016 (reported as shortly thereafter), the patient suffered a severe rash on the upper right side of her torso. In or around October 2016, the patient presented to her physician for this injury and was diagnosed with shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of this condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. At the time of this report, the outcome of the shingles was unknown. Causality assessment was related. The lawyer considered shingles to be disabling. Additional information has been requested.
Lips tingly, itchy swollen feeling eyes, tongue felt tingly and swollen 12 hrs after the shot--improved by BENADRYL PO 25mg.
severe dizziness; vertigo; This is a spontaneous report received from a contactable female consumer (patient). A 31-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of ad-ministration, administered in arm right on 27May2021 15:00 (at the age of 31-year-old) as a 2nd dose, single dose for COVID-19 immunization. The patient 's medical history was not reported. The patient had no known allergies. The patient's concomitant medication included doxycycline monohydrate 100 mg. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 06May2021 (at the age of 31-year-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe dizziness and vertigo on 01Jun2021 10:00 PM. Patient was not diagnosed for COVID-19 prior to vaccination. The patient had not tested COVID-19 post vaccination. The patient did not receive any treatment medication for the events. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
I, pharmacist accidentally gave patient a Pfizer covid shot which is 2 days past expiration date .
Patient was fine after administration, monitored for 15 mins. Around 3am next day, patient reported chest tightness (similar feeling to when he had chicken pox as a young adult), stiff neck (limiting neck rotation), felt a little dizzy. and had body aches w/ low grade temperature for 2 days. Did notice some sharp stomach pain, cough, shortness of breath - cough, and a headache not more than 3 days after the injection. Also reports fatigue but attribute it to his chronic fatigue syndrome. Symptoms resolved in 5 days.
Loss of consciousness, at my (black out) husband heard me fall and he was able to get me to respond, quite soon after he heard me fall. This happened when leaning over slightly to plug in the cell phone. Was hospitalized for one day and all tests negative for stroke or heart issue. Slight anemia noted. Otherwise all other labs within normal limit. Recently had a Holter monitor laced for 7 days and results pending. Echo with no significant new issues.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date in 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for the long-term prevention of shingles and/or zoster-related conditions by a pharmacist in a pharmacy. Subsequent to the patient's inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
When she came home started getting really cold around 5:30 pm yesterday.  Started having chills all night and slept with winter coat on.  Started getting sick to her stomach all evening, started throwing up last night beginning at 11:00 PM, throwing up bile.  Today having fever of 101, didn't take anything for it, but down to 100 now.  Took 2 Tums and had such achy joints and sat down in a chair and could not get up from the chair.  Took some Tylenol and that helped, but freezing cold.  Didn't sleep all night.  Has not notified her doctor of the symptoms, just calling us.
Severe fever, drenching sweats, freezing cold, fatigue, had to stay in bed for 36 hours, thought I was going to die. Unable to eat or drink for 48 hours
Information has been received from a physician concerning a female pt who on 6/28/06 was vaccinated with a dose of MMR II/Varicella vaccine (lot 652328/0956R). Subsequently, on 7/2/06, four days after vaccination, the pt developed a fever. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Coughed and wheezed for 5 years after Prevnar shot; Coughed and wheezed for 5 years after Prevnar shot; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient coughed and wheezed for 5 years after PREVNAR shot. Said stopped wheezing after heavy antibiotics, Ciprofloxacin and Cefazolin duplex. It was reported that event took place after use of product. The outcome of wheezing was recovered while another event was unknown.  Information regarding lot/batch number has been requested.