chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight hot flash reaction; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (patient).   This case involves female patient (age unspecified) who had a slight hot flash reaction (hot flush), while she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a mega dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious slight hot flash reaction (hot flush) 1 day following the administration of INFLUENZA VACCINE for 45 minutes.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the event.  There will be no information available on the batch number for this case.
Mini Stroke/blockage in left eye; Mini Stroke/blockage in left eye; Sore arm for 1 day after 1st dose; Diagnosed with CRVO of the eye; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN1199), via an unspecified route of administration, administered in left arm on 09Mar2021 12:30 (at the age of 33-years-old) as single dose for COVID-19 immunisation. The patient had no known allergy and no other medical history. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm for 1 day. She was diagnosed with CRVO of the eye. On 30Mar2021 she had mini stroke/blockage in left eye. Symptoms noticed about 1 week prior to 30Mar2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for events. The patient did not have COVID prior vaccination and she was not COVID tested post vaccination. The outcome of events was not recovered.
Within a couple of hours I had intense stabbing chest pain.  It felt like constant heart attacks.   Yes, I should have gone to the ER, but I was alone with my kids and was worried about calling an ambulance.  The pain in my left chest around my heart was excruciating and pretty constant.  I read that it may be myocarditis so I self- treated with OTC anti-inflammatories.  That seemed to help.  So I waited 4 days taking lots of Ibuprofen before I felt up to going to the doctor.   They ran tests, but the symptoms had subsided greatly by then so they didn't diagnose it precisely.   I am way too scared to get the 2nd dose.  I feel like I wouldn't survive it.
PATIENT HAD WORKED HERSELF UP BEFORE THE ADMINISTRATION. WAS GIVEN CHOICE TO STOP OR PROCEED. CHOSE TO PROCEED BECAUSE SHE NEEDED FOR SCHOOL. AFTER ADMINISTRATION SHE STARTED TO BREATH FAST AND FELT LIKE SHE WANTED TO PASSOUT. 911 CALLED AND BEFORE TAKING HER OFF CONFIRMED SHE WAS HAVING A PANIC ATTACK
pt recv vax 14SEp96 & 15SEP96 pt exp a pruritic rash w/lesions from head to toe;it was noted that the pt may have been exposed to natural varicella;
Less than five minutes after vaccine administration, the patient developed pruritis, cough,  and headache.  Blood pressure was mildly elevated at 140/90 and O2 saturations were over 97% on RA.  She was given 12.5mg of Benadryl and symptoms mildly improved.  She was taken to the Emergency Department for observation.   She was treated at the ED and was discharged the same day.
I'm feeling pretty punk today; I have body aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I'm feeling pretty punk today), MYALGIA (I have body aches) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis.     Unknown information related to patient allergies (medications, food and other products), Covid positive test or diagnosis and medical history relating to mentioned AE and acute/chronic illnesses at the time of vaccination.    On 21-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2022, the patient experienced ILLNESS (I'm feeling pretty punk today), MYALGIA (I have body aches) and HEADACHE (Headache). At the time of the report, ILLNESS (I'm feeling pretty punk today), MYALGIA (I have body aches) and HEADACHE (Headache) had not resolved.            No Concomitant medication were reported. Medical care was not reported for events I'm feeling pretty punk today, headache and body aches and unknown whether similar events experienced in past. Symptoms were worsened for events I'm feeling pretty punk today, headache and body aches. No treatment drug were reported.   Reporter did not allow further contact
Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days; A vial  was punctured and left at room temperature for 5 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days) and PRODUCT STORAGE ERROR (A vial  was punctured and left at room temperature for 5 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 031L20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022 at 5:15 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 27-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (A vial  was punctured and left at room temperature for 5 days). On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patients were inadvertently administered a dose from a vial that was punctured and left at room temperature for 5 days) had resolved. At the time of the report, PRODUCT STORAGE ERROR (A vial  was punctured and left at room temperature for 5 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The patient received vaccine in the deltoid region.The vial was initially stored in the refrigerator on 27 Jan 2022. The vial was punctured on 27 Jan 2022 at 8:30am.The vial was stored at room temperature post puncture. The vial did not undergo any temperature excursions.  No adverse event occurred.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2022: Updated patient demographics, suspect details (dose time) and narrative.
Patient advised her brother she felt like passing out. Grabbing her brother, leaned sideways, hit the right side of her head on wall and nurse caught her and lowered her to the floor. Had her sit down and gave her a drink.
allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination.  I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats.  They evaluatedI started feeling better towards the end of last week. Additional information for Item 18: allergic reaction, went to ED; 1/25 The symptoms first occurred about 7 minutes after the second vaccination.  I felt a "thickening" in my throat and it became difficult to swallow. A Rapid RN was called and my airway was assessed- no stridor, no decrease in sats.   me for another 15 minutes and they recommended that I be evaluated in the ED. The right arm was noticed to be red. The injection site was painful. I was evaluated by the MD and given medications per their protocol (epi, Benadryl, famotidine, steroid). I was discharged home around 1830 (with a ride) after my throat seemed to be getting better. I was discharged with an Rx for steroids, blockers and and epi pen.  Later that night at about 2200, I woke up with my face/scalp itching. I continued feeling achy, intense headache, hot/cold, foggy mind. I called in sick for my shift on 1/19. I returned to work on 1/20 with minor symptoms.I was evaluated by my MD on 1/21 and had minor expiratory wheezes (I have asthma). I seemed to be feeling better until Saturday and then stomach cramping/muscle cramping (noticeable on the right hand/injection side), bad headaches, fatigue have resumed. ; 2/2 I started feeling better towards the end of last week. Still feeling off but able to do my normal routines.
pt recv vax 23JUN95 & 22JAN98 pt exp a breakthrough case of chickenpox;23JAN98 pt had 30 to 40 lesions w/o fever & apparently looks & feels well;pt was seen by MD;
mid section pain; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (mid section pain), CHILLS (chills) and NAUSEA (nausea) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (mid section pain), CHILLS (chills) and NAUSEA (nausea). At the time of the report, ABDOMINAL PAIN (mid section pain), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pneumonia due to COVID 19 virus.  Hypoxemia requiring supplemental oxygen.  Patient is fully vaccinated. patient is a known case of morbid obesity who presented to the hospital acute respiratory failure related to COVID pneumonia.   Patient is status post been treated with IV steroid and IV Remdesivir patient condition continued to be improving.  Patient will continue on Breo inhaler daily.  Pt discharged to home.
The patient received a dose of Moderna before they have turned 18 years old. No adverse side effects were witnessed while they were on site for their shot or during their 15 minute waiting period after receiving the shot. Parental verbal consent was obtained for the second dose.
Patient administered Moderna Covid-19 vaccine at 1:21 p.m. on 3/3/21.  Patient at 1:36 p.m. experienced syncope while being monitored; EMS staff and RN responded to patient. EMS staff and RN spoke to patient and assisted patient to EMS cart.  EMS staff took patient's vitals:  pulse 70, respirations 22, blood pressure 159/85.  ABC's clear at this time of response.  Patient speaking after recovery from syncope.  Patient, while strapped on EMS cart, began gagging and provided emesis bag.  Patient transported to EMS ambulance (which was parked immediately outside the facilities doors). two to three minutes after syncope event where reportedly patient given Benadryl and IV fluids in ambulance and transported to ER.
experienced COVID-19; experienced COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 2022NVX-US-000003914 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "experienced COVID-19".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
S/S paresthesias in arms and legs. Shooting pain in neck. Dizziness. Patient is an otherwise healthy 20-year-old female without significant medical history who presents for evaluation of what she described as pain all over. She admits that she had a Tdap shot in her left shoulder and has paresthesias in her arms and legs as well as intermittent shooting pain in her neck. She denies any focal headache. She denies any hearing or vision changes. She denies any pain with neck flexion. She denies any chest pain or pressure. She denies any SOB. She denies any recent illness. She denies any vomiting or diarrhea. She denies any urinary symptoms. Admits her last menstrual period is now. Denies any skin complaints or rashes. Otherwise appears in no distress. Her mother on further questioning indicates the patient has actually been fatigued for the past several months and was supposed to follow up with her primary care physician at her appointment today but did not mention any of these things to them. She subsequently wanted her to be evaluated in the ED. Patient denies any complaints at the moment with the exception of the paresthesias in her arms and legs.
approx. 10 minutes after vaccine client stood up to throw something away and got dizzy. "I think it's an old people thing, I don't think it was related to the shot at all." Her vital signs were monitored and she was given water to drink. After a few minutes she was able to walk to her car accompanied by a nurse. No other problems noted.
Delayed cellulitis-like reaction/rash (delayed edema & erythema, pruritus at injection site lasting 5+ days, tenderness of injection site lasting 5+ days, pain and limited mobility of shoulder joint on side of injection, malaise & lethargy, mild posterior auricular lymph node swelling & tenderness)
pt recvd vax;1/2 an hr later, pt exp pruritic rash to bilat arms axilla & trunk;hive-like in appearance;lump @ inj site of rt arm-no edema or dysphagia;rash worsened & pt went to ER clinic;next morning hand & feet edema, erythema of eyes
Vaccine given at outside facility on 8/25, then seen at outside facility  and started on cipro and flagyl, allergic reaction started including diffuse , itchy, body rash with tongue and lip swelling, eye swelling, no dyspnea, currently admitted, stable
Pain in left armpit and surrounding area; Dose received 3; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030), via an unspecified route of administration in the left arm on 16Nov2021 at 11:45 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206), via an unspecified route of administration in the left arm on 14Mar2021 at 15:00 (at the age of 56-year-old), and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8730), via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 56-year-old); both as single dose for COVID-19 immunisation. On 18Nov2021 at 22:00, the patient experienced pain in left armpit and surrounding area. The pain in left armpit and surrounding area did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the pain in left armpit and surrounding area. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in left armpit and surrounding area was not resolved at the time of this report.
4 1/2" cm reaction with swelling, redness. Ice area, if reaction getting larger return to clinic.
Informed of event 3/28/2013. Cartilage problems in back of shoulder, sore shoulder. She has seen family doctor and orthopedic doctor. She had some physical therapy and some fluid drained from shoulder area.
Numbness in fingertips; Tingling in fingertips; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 26Mar2021 (at the age of 20-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the left arm on 16Apr2021 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced numbness and tingling in fingertips. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event numbness and tingling in fingertips was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
muscle soreness; difficult to lift arm above shoulder; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via unspecified route of administration in the left arm on 16Mar2021 at 14:30 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto (thyroid). It was reported that patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. Concomitant medication included NP-thyroid, daily multi-vitamins (MANUFACTURER UNKNOWN), gluco chondroitin (MANUFACTURER UNKNOWN). The patient experienced muscle soreness and difficulty to lift arm above shoulder on 16Mar2021 at 19:00. Therapeutic measures were not taken for the reported events. The clinical outcome of the muscle soreness and arm discomfort was recovering at this time of report.   No follow-up attempts are needed. No further information is expected.
Fine papular rash on trunk and extremities. Right leg: Erythema and two papules, 1 cm in diameter.
not feeling well; Headache; Rashes; feel weak; fatigued; Difficulty breathing, short of breath when she walks; Fever; swollen injection in the arm; muscle pain; redness; runny nose; sore throat; nausea; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Lot number: 11263) via an unspecified route of administration in left arm on 22May2021 at 14:30 as single dose for COVID-19 immunization. Medical history included known allergies (unspecified). Concomitant medication included in two weeks which included food supplement. Patient did not receive any other vaccine in four weeks. Patient did not had COVID before vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (Lot number: 11263) in left arm on 01May2021 at 14:15 as single dose for COVID-19 immunisation and experienced headache, rash. On 22May2021 (Saturday), at 16:00, patient experienced swollen injection in the arm, rashes, headache, fever, muscle pain, redness, runny nose, sore throat, nausea, shortness of breath. Reportedly, after second shot patient developed fatigue, fever, rash, headache, felt weak and fatigued and if walks, becomes short of breath and had difficulty breathing. Patient was supposed to go to work but since Monday (24May2021), she could not go to work, because she was not feeling well. States she still has a headache. Due to the events, patient visited doctor or other healthcare professional office/clinic visit. Therapeutic measures taken in response to the event included treatment with Tylenol. Outcome of the events were resolving.  Information on Lot/Batch number was available. Additional information has been requested.
45 min post injection of flu vaccine pt had episode of hives/welts. Pt. took Benadryl immediately at onset. Went home from work. Approx 1.5 hrs post-injection noted swellin to lips & tongue. Pt. to ER with chest pressure/pain. Tx with Benadryl, Solu Medrol, epi & Pepcid. Released to home. On 10/7/12 chest pain re-occurred; admitted for observation. Tx with nitropost & lidocaine. Released in 24 h.
3:30 Headache, dizziness, 5:00 chills, 5:30 body aches, 6:30 overall malaise, 9:00 PM. I took Tylenol around 1:00 PM because I was feeling headache and body aches. Took Tylenol again at 6:00 PM and every 6 hours after that through 11/8/2015.
Experienced dizziness approx 15 min after the COVID vaccine injection - the nurse had me sit down for a bit longer for monitoring and gave me water and candy (for blood sugar). Continued to feel dizzy but left the vaccine site so I could rest at home. Felt dizzy and nauseous the rest of the day, and lots of fatigue. Slept really early and slept in the next morning until about 1pm. I felt body aches, slight fever and lots of fatigue the next morning. Took Advil at 1:30pm to alleviate body aches and felt a bit better.
Suspected Immunological Vaccine Failure; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose not reported, 01 total, administered on an unspecified date 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 date, Laboratory data included: COVID-19 antibody test (NR: not provided), results: no antibodies to COVID-19 disease. The patient experienced suspected immunological vaccine failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210666824-covid-19 vaccine ad26.cov2.s -suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
A non-serious spontaneous report of positive for influenza has been received from a physician concerning a ten-year-old male, subsequent to FLUMIST. No medical history or concomitant medication information was reported. The patient received FLUMIST on 25-Sep-2009. Three days later on 28-Sep-2009, the patient presented to his health care provider with flu-like symptoms including a fever and sore throat, he tested positive for influenza. No outcome was reported for the event of influenza.