chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administered on 14Apr2021, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Covid 19 Vaccine on 14Apr2021, then tested positive for the Covid 19 Virus on 21Apr2021. Her Second dose of the Covid 19 Vaccine is scheduled for 05May2021. Patient asks what happens next, if she still had her second dose or what. The outcome of the event was unknown.  Information about Lot/ batch number has been requested.
12-14 hours after the injection, I felt arches all over my entire body more to the left side of the body from neck down to the legs.  veins popped up in dark blue color on my left arm and upper chest more to the left side.  the aches lasted about 2 days and the dark blue  veins disappeared about the same time.   Since this injection, I have been sneezing more often and hair falling in bunches more than usual.
Employee from agency called 3/19/15 explaining pt had red in area of injections in left arm, as well as rashes and itching since vaccination was given. Has been taking BENADRYL and has been working. Informed to see dr. if problem worsens or does not go away.
Arm was kinda sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was kinda sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was kinda sore). At the time of the report, PAIN IN EXTREMITY (Arm was kinda sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-101922 (Patient Link).
Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 31-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Developed swelling, tightness, slight warmth of left arm, no redness, no fever, child was "ornery".  Swelling was from just below the elbow to the shoulder, "3/4 the way down the shoulder blade."  Woke up in morning with these symptoms.  Was worse the first 1-2 days, gone after 4-5 days. Took Tylenol for discomfort, ice to arm, child was encouraged to keep moving the arm.  This was the child's 5th DTaP and 4th IPV.
HEADACHE FOR 3 WEEKS-----PAIN IN LEFT ARM DUE TO SHOT------     ---SHARP HEART PAIN FOR COUPLE OF WEEKS------ABNORMAL CARDIOGRAM
Fever (104 F), chills, nausea, muscle tension, elevated heart rate, all sudden onset. Symptoms lasted approx. 36 hours.
Dental abscess; Swelling of left eye; Swelling of left cheek; Headache; Muscle pain; Chills; Joint pain; Fever; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of TOOTH ABSCESS (Dental abscess), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and ARTHRALGIA (Joint pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced TOOTH ABSCESS (Dental abscess) with EYE SWELLING (Swelling of left eye) and SWELLING FACE (Swelling of left cheek). In February 2021, TOOTH ABSCESS (Dental abscess) had resolved. At the time of the report, HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint pain), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved and MYALGIA (Muscle pain) had not resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: Er8730), on 15Apr2021 as dose 2, single (Lot number: En5318) and on 22Nov2021 as dose 3 (booster), single (Lot number: Fh8027) at the age of 38 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Slight asthma when sick" (unspecified if ongoing); "Slight asthma when sick" (unspecified if ongoing) and had no known allergies. The patient took concomitant medications on 01Nov2020 and patient had Prenatal Multivitamin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.   Clinical course: It was reported as patient had treatment for COVID 19 with Paxlovid (Anti viral) with treatment start date 06Aug2022 and treatment stop date 10Aug2022. The patient reported that Covid rebounded after taking Paxlovid.
2/19 patient presented for chest pain with occasional palpations. admitted for overnight observation. Troponins borderline elevated. Cardiology did not suspect ischemia. Patient discharged 2/20. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine
Headache; Nausea; Tiredness; Sore arm, still very sore; Arm is very swollen; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th June 2022, the patient received the 1st dose of Shingrix. On 8th June 2022, 1 days after receiving Shingrix, the patient experienced headache, nausea, tiredness and pain in arm. In June 2022, the patient experienced swelling arm. On an unknown date, the outcome of the headache, nausea and tiredness were unknown and the outcome of the pain in arm and swelling arm were not recovered/not resolved.   It was unknown if the reporter considered the headache, nausea, tiredness, pain in arm and swelling arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comments:  The patient reported case for herself. She stated the next day, she experienced headache, nausea, tiredness, and a sore arm. The patient stated that on the day of reporting her arm was still very sore and it was very swollen. The reporter did not consent to follow-up. The consumer declined to provide any further information.
pain and soreness/ soreness where he took the shot, in the left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "pain and soreness/ soreness where he took the shot, in the left arm".  Additional Information: Patient and his wife took their first dose on 28Apr2021. The both had their shot in the left arm and after a while they experienced pain and soreness. Patient's events went away after the second day. Patient experienced some soreness where he took the shot, in the left arm. The patient was fine now.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021524897 Same reporter/product/event, different patient
NO ADVERSE EVENT CURRENTLY. PLUNGER STOPPED THINKING VACCINE ADMINISTERD. UPON WITHDRAWING NEEDLE, SYRINGE STILL HAD VACCINE LEFT.  ONE-QUARTER INCH OR LESS AWAY FROM 1ST INJECTION, SECOND INJECTION IN ALCOHOL SWABBED AREA GIVEN TO FINISH VACCINE.  PATIENT WAS OK WHEN LEFT PHARMACY.
After getting the vaccine I came home and I fell asleep for a couple hours and I woke up very sick to my stomach and vertigo really bad. I was coughing a lot and I could not breathe and it was terrible. I was also tired and my muscles were sore. I made a doctor's appointment and I was waiting on the car and I tried eating some chips and I could not taste them.  Then they let me in the hospital and I had a Covid test done and it was positive. That happened in 04/09/2021.  They gave me a medicine for vertigo and an inhaler, Ibuterol and a medicine to control wheezing in my lungs
Patient called 4/4/11 c/o red lump with larger circle around it. Brought pt in for review of reaction. Pt does have quarter-sized red, raised area on Lt. deltoid. No longer warm to touch & per pt. has decreased in size.
Pt recvd DTP/HIB on 20FEB92 & had t104.9 R on 23FEB92; pt seen @ ER no definite dx of rxn made; 24FEB92 diarrhea, vomiting that subsided t98; 25FEB92 diarrhea occasional vomiting; 27FEB92 devel rash;
STOMACH PAIN; DIARRHEA; EXTREME MUSCLE WEAKNESS; SEVERE FATIGUE; VERY BAD HEADACHE; FEVER (100.8 F) THAT IS GETTING WORSE; NAUSEA; FELT PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 positive test, and other pre-existing medical conditions included the patient was not pregnant and no breastfeeding at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 28-JUL-2021 17:45 for prophylactic vaccination. No concomitant medications were reported.  On 28-JUL-2021, the subject experienced felt pain at the injection site. On 29-JUL-2021, the subject experienced stomach pain. On 29-JUL-2021, the subject experienced diarrhea. On 29-JUL-2021, the subject experienced extreme muscle weakness. On 29-JUL-2021, the subject experienced severe fatigue. On 29-JUL-2021, the subject experienced very bad headache. On 29-JUL-2021, the subject experienced fever (100.8 f) that is getting worse. On 29-JUL-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 100.8 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt pain at the injection site, severe fatigue, very bad headache, fever (100.8 f) that is getting worse, extreme muscle weakness, stomach pain, nausea, and diarrhea. This report was non-serious.
On May 4th, I fainted shortly after waking up. Light headed and unable to sit upright, stand, or walk. Had a fever. Called out of work.  Headaches, chills, nausea, pain at injection sight, bedridden for most of the day. Around 3/4 in the afternoon I called the doctor's office (phone kept ringing) so I called the nurse through the insurance company. Nurse advised me to stay home for now but to seek medical care if symptoms persisted for more than 3 days. Symptoms continued but were less severe on Wednesday May 5th causing me to miss another day of school. On Friday May 7th at about 12:50 AM I awoke to severe abdominal pain-the kind the pharmacist had warned me of when getting my vaccine. I could not stand or move. I never take aspirin and yelled for a family member to give me Tylenol. I called the nurse from my insurance company and she asked me a series of questions and advised me to seek immediate medical attention. My family called 911 and an ambulance was sent to the house. They checked my vitals and suggested a family member take me to the ER. My family took me to the Emergency Center. I was wheeled into the ER. ER did test but put "Abdominal Pain, Unknown Cause, (Female) on my paperwork.  I missed another day of work due to my ER visit. Symptoms lessened but persisted for several days.
02/20/2021Shortness of breath on climbing 15-20 stairs,  02/24/2021/D-dimer test very high, 02/24/2021Admitted to hospital.  CT Angiogram showed blood clots in lungs. Administered IV Hyperin. scans of legs-no blood clots, Scan of heart and arteries.  02/26/2021Released with perscription of Eliquis. 03/04/21 Blood test by Hematologist Normal;  03/08/21 CT Scan of body-Normal-no tumors/cancer detected
VERY SORE ARM - COULD HARDLY MOVE IT VERY PAINFUL iF I HAD TO USE iT WAS LiKE THAT FOR A COUPE DAYS THEN PAiN LESSENED, BUT WAS SORE FOR ABOUT A WEEK
Received Flu vaccine on Friday 10/8/10 Sunday had redness & pain in (L) arm ? Cellulitis.
Patient received the Moderna Covid 19 injection as a booster in the a.m of 11/10/2021.  I saw him on dialysis rounds in the afternoon on 11/10 and he reported this injection occurence to me.  He had previously received the Johnson and Johnson injection 03/31/2021.  He was not reporting any side effects of the Moderna injection to me in the afternoon of 11/10.   He presented to a local ER on 11/11/2021 at approximately 12:15pm complaining of brief right arm stiffness that occured during exercise that a.m. and troubles finding words as described by the ER intake RN.  The ER MD note descirbes a chief complaint of Dysarthria.  See the continuation page for details.  Patient was found dead in his home on 11/12/2021    the information below is copied from patient's medical record:  This patient is a 66-year-old male with a history of CAD status post three-vessel CABG, hyperlipidemia, hypercoagulable state (on Coumadin), end-stage renal disease (on HD), and hypotension (on midodrine) who presents to the ED with chief complaint of slurred speech that started approximately 1 hour prior to arrival while he was exercising with a trainer.  He reports that while he was exercising his right arm suddently "shot out" and became stiff followed shortly with the patient slurring his words and "trying to think of the right word to say but couldn't."  Patient reports that his speech is better now.  No fever, chills, nausea, vomiting, headache, chest pain/pressure, shortness of breath, palpitations, abdominal pain, change in bowel/bladder function, or other symptoms. ED work-up includes labs that were obtained and reviewed as below.  Of note the patient's ECG shows a first-degree AV block without other acute findings.  Troponin is negative x1, patient denies any chest pain/pressure; low suspicion for ACS.  BMP shows evidence of end-stage renal disease with a creatinine of 4.66 but normal potassium.  INR therapeutic at 2.63.  The patient currently does not have any focal neurological deficits.  Given pt's ABCD2 score of 3 (60 years old or greater, impaired speech, TIA duration for 10-59 minutes) 2-day risk for stroke is low (1.0%). CTA head/neck with and without contrast was done which was negative for acute intracranial pathology, did show approximately 40% diameter stenosis in the left ICA.     The patient is already on Coumadin and a aspirin daily.  He reports that he has had a statin medication in the past which has caused a rash (he is not sure which statin it was).  He reports that he has been able to tolerate pravastatin before without any adverse reaction and so this was prescribed as a preventative medication for TIA/CVA.  Given that his symptoms have resolved and per the TIA pathway he was advised to follow-up with the clinic.
Pain and redness at injection site and feeling of tiredness. Patient presented back to pharmacy at 10:00AM on 10/03/2015. Patient taking anti-inflammatory. Instructed to apply cold pack or ice to area of inflammation and continue taking anti-inflammatory. Instructed patient to follow up with primary care doctor if no change by Monday and to call 911 if shortness of breath or mouth or tongue swelling occur.
At 730pm day of vaccine, I was cold (when I'm usually very hot due to menopause).  Did not sleep well that night.  In the morning and for the next 36 hours, my temp was between 102-103, even with acetaminophen and ibuprofen.  I was nauseous, unbalanced and little appetite.  Varying hot and cold.  Couldn't read, or watch TV,.  Very flu like.  Felt better after 36 hours, but not 100% until after 72 hours.
Patient intiated two dose Covid vaccination series with Moderna on 01/07/2021, but received Pfizer covid19 vaccination as second dose on the date of her visit.
Approximately 10 minutes after receiving her first Pfizer dose IM, Patient was experiencing a headache rated 4/10 on the pain scale as well as light headedness.  Patients vehicle was directed to the ambulance on standby, paramedic crew assessed the patient.  Vitals were stable and since the patient was a minor, the patient mother made a decision to refuse transport and exited the facility without issue.  End of report.
Had shot at 10:00 am. Came back home, took a nap. Woke up around 2:00 pm to itching in my ears, nose, eyes, mouth and throat and arm pits. Lasted till about 1:00 am.
Pt recv vax on 10/20/98; on same day pt exp fever (104) x 5 day
103 fever, severe headache, severe body aches, severe nausea, severe chills and hot flashes for 24 hours Severe headache lasting over 36 hours so far
contracted covid 19; contracted covid 19; This is a spontaneous report from a contactable consumer.  A 38-years-old female patient (not-pregnant) received bnt162b2 (BNT162B2), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation when 38 years old. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced contracted covid 19 on 19Jul2021 with outcome of recovered in 2021. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not treated due to the event. Since the vaccination, the patient has been tested for COVID-19 on unknown date (positive).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dose number: 3; loss of taste; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69 year-old female patient (not pregnant) received BNT162B2 (BNT162B2), solution for injection, intramuscular, administered in arm left, administration date Oct2021 (Batch/Lot number: unknown, expiry date was not reported) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose:01, prev dose vaccine location: Left arm, prev dose administrator route: Intramuscular), administration date: Feb2021, for COVID-19 Immunization; BNT162B2 (Dose:02, prev dose vaccine location: Left arm, prev dose administrator route: Intramuscular), administration date: Mar2021, for COVID-19 Immunization, reaction(s): "loss of taste". The patient experienced IMMUNISATION (non-serious) with onset Oct2021, outcome "unknown", described as "dose number: 3"; AGEUSIA (non-serious) with onset 2021, outcome "not recovered", described as "loss of taste". Therapeutic measures were not taken as a result of ageusia.  Additional information included: Patient did not have any other vaccine in 4 weeks. The patient did not have covid prior to vaccination and did not test for covid post vaccination. The patient had no known allergies.Patient had experienced continuous loss of taste since the second dose. She never had symptoms of covid infection. The start date for event ageusia is Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site is swollen; redness at injection site; redness at the injection site and it hurts to touch; injection site was also warm to the touch; was warm to the touch and it is hard; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), intramuscular in left arm on 06Jan2021 11:00 at single dose for COVID-19 immunization. Medical history was reported as none. The patient previously had Flu vaccine around the beginning of October. The patient got the vaccine last Wednesday 06Jan2021, the patient noticed recently that the injection site is swollen, there is redness at the injection site and it hurts to touch. It was also warm to touch. She thinks it started yesterday and she did not realize it she just knew there was something involved there. Today she noticed it was warm to touch and it was hard. The patient said that it did not hurt when she got the vaccine. She is basically healthy and takes a world of supplements. The events were experienced in Jan2021. The facility where the most recent COVID-19 vaccine was administered was in the residence community. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Pt had onset of red maculopapular rash 6 days after vaccine given. No fever. No other symptoms. Some lesions coalesced on back. No treatment needed.