chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 13Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right 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: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 29Sep2023 to 04Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300329792 Same patient, different product, different dose/event;
Lt shoulder pain that became progressively worse leading to impaired range of motion.  Patient has been treated with NSAIDS, Medrol dose pack, and physical therapy and continues to have symptoms; still currently treating.
A report has been received from a Health Professional concerning a 43 year old, female subject, who had been receiving nasal FLUMIST. FLUMIST started on 17-SEP-2013. The reporter stated that the patient had two full doses of FLUMIST, one in each nostril. The outcome of the event of two full doses, one in each nostril is unknown. The report was considered to be non-serious.
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date). Concurrent medical conditions included migraine. Concomitant products included paracetamol, aspirin, caffeine (Excedrin Migraine).   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 2nd October 2020, 2 days after receiving Shingrix and an unknown time after starting Excedrin Migraine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with 2nd dose of Shingrix. 2 days after vaccination patient experienced a headache but was not sure if it was migrainous. The patient normally aborts a migraine with Excedrin Migraine, but cannot get rid of it. At time of report, the headache was still present. The reporter consent to follow up.
expired daptacel was administered today with no reported adverse event; Initial information received on 13-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old and unknown gender patient to whom expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was administered today with no reported adverse event.  The patient's past medical history included Stem cell transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3V (vero) (IPOL Polio Vaccine); and hepatitis B vaccine RHBSAG (YEAST) (Engerix) for Prophylactic vaccination.  On 13-Jun-2023, the patient received 0.5 mL expired dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, suspension for injection (batch number: O5829BA; expiry date: 31-May-2023) via intramuscular route in unknown administration site for Immunization, today with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired daptacel was administered today with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Pain,tenderness and swelling of lymph nodes in left armpit, fatigue,headache,muscle pain,chills,nausea, fever
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 21-JUN-2007, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 04-AUG-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir and oxycodone for management of his painful symptoms and chronic pain.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Strange reaction to 2nd jab of Moderna; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Strange reaction to 2nd jab of Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced VACCINATION COMPLICATION (Strange reaction to 2nd jab of Moderna). At the time of the report, VACCINATION COMPLICATION (Strange reaction to 2nd jab of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  No treatment medication information was reported.
7NOV96 pt recv vax & 8NOV96 starting limping on rt leg & couldn't walk lasted one day;
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not provided by the reporter. On an unknown date, the patients were vaccinated with multiple doses of improperly stored ROTATEQ (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. The temperature and time frame to which vaccine was exposed was unknown by the reporter. There was no previous temperature excursion. No adverse events were reported. Digital data logger was involved. It was reported that there were multiple lots involved. There was no product quality complaint (PQC) involved. It was requested to send copies of data logger information as opposed to multiple excursion forms. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA003015: US-009507513-1708USA003603: US-009507513-1708USA003605: US-009507513-1708USA003607: US-009507513-1708USA003606.
Episode abdominal pain with nausea and vomiting on the following dates: 11-5-09, 12-30-09, 1-17-09, 3-06-10, 4-05-10.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unspecified by reporter. On 30-SEP-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J004332, expiry date: 26-SEP-2014, dose: 0.5 ml, route of administration and anatomical location was unknown). Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No further information was reported. Additional information has been requested.
Received Flu Vaccine at 1pm on 10/1/19. By 3pm that day, states she had a low-grade fever.  That evening she felt worse and temperature elevated to 103f.  She went to the Emergency room and while there she began to have vomiting and diarrhea.  She also had blurred vision 2 days after the shot.
Case information amplified due to additional info from ENT seeing patient. Since date of report, pt has been advised she will probably not regain full hearing in left er. Additional history is tht she had sudden olfactory loss 9 years ago, thought to be sequel to viral infection. She relates problems of attempting to stay on Prednisone 80 mg x 2 weeks; dose reduced by pt w Drs knowledge. She also needed Toprol to control blood presure elevation provoked by steroid use. Pt feels she has made some improvement but still finds background noise helpful in ignoring the persisting "noise" she hears.  Follow up 10/07/2002: "Patient reported that she was on Prednisone for approximately 8 weeks as recommended by her physician (name of a physician's assistant provided).  She experienced many adverse effects from the Prednisone - specifically high blood pressure to the point she required medication.  At her last visit to the ENT specialist.  There was an improvement to her hearing in the left ear.  However, there is still significant hearing loss and the ringing continues.  Her physician told her that full recovery of hearing is not possible.  Information has not been medically confirmed."
I received my Covid-19 vaccine on 11/17/2022. On 11/22/2022 I started feeling ill around 08:00PM. I had fever; nose congestion with mucus; coughing and drowsy. By 11/28/2022 went to doctor and received antibiotics. Symptoms lasted about a month.
lost all sense of taste and still can't taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost all sense of taste and still can't taste) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013M20A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included LOSARTAN, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 AGEUSIA (lost all sense of taste and still can't taste). At the time of the report, AGEUSIA (lost all sense of taste and still can't taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test negative: negative negative.         No treatment medications were not provided.   This case was linked to MOD-2021-071678 (Patient Link).
Pain in arm; ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and LIMB DISCOMFORT (ARM WAS SORE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and LIMB DISCOMFORT (ARM WAS SORE). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and LIMB DISCOMFORT (ARM WAS SORE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment drug was provided by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt called me today saying the imz (flu shot) she received on 10/02/20 caused her arm to be swollen and in pain. She said she gets pains that comes and go in that arm when she uses it since then that has not gone away. I told her she should really go see her pcp and get the arm checked out to make sure it is not something else going on and is the flu shot. Pt is going to see her pcp to get checked out.
Patient fainted shortly after receiving vaccination. Patient came to about 30 seconds after fainting. Patient rested in chair for 30 minutes left on own accord.
CHILD RECEIVED 2 VACCINES OF TDAP. LAST ONE RECEIVED WAS 01/27/2017. NO ISSUES AT THIS TIME.
The pt complained of rash for 1 1/2 weeks. The pt experienced a cough, possible fever, sore throat, and a pink macular-papular rash on trunk, arms and on the face.
Patient reported hands and feet swelling within 15 minutes of vaccination; patient self-administered Benadryl.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Nov2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Apr2021 at 12:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07May2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 11Apr2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Oct2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Nov2022 at 12:00, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Narrative: COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/19 , Pfizer, dose #2 08/23 COVID swab, result: detected 08/22 pt cc: fever, HA, body aches, loss of smell, dry cough, nausea, diarrhea, and chills. Denies dizziness, CP, SOB, DoE, vomiting, abdominal pain, dysuria, or back pain, exposure: unknown 08/24 pt admit ED cc: flu-like symptoms dx: COVID-19 LOC: 1 day
Only 1" needles were available for the following 4 MERCE COVID-19 immunization clinics and 1 booster clinic documented on the Navigator site:; This spontaneous case was reported by an other health care professional and describes the occurrence of NEEDLE ISSUE (Only 1" needles were available for the following 4 MERCE COVID-19 immunization clinics and 1 booster clinic documented on the Navigator site:) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NEEDLE ISSUE (Only 1" needles were available for the following 4 MERCE COVID-19 immunization clinics and 1 booster clinic documented on the Navigator site:). At the time of the report, NEEDLE ISSUE (Only 1" needles were available for the following 4 MERCE COVID-19 immunization clinics and 1 booster clinic documented on the Navigator site:) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medication provided by the reporter no treatment information reported by the reporter
Joint Pain (Ongoing) Joint cramps (Ongoing) Tachycardia (Ongoing)
My blood pressure increasing over normal levels several days a week. It makes me very fatigued and "wossey" in the head.
48 hours after first dose - extreme chills, joint and muscle aches, rash on legs.  Felt like symptoms of Covid.  (I have never had Covid)
sudden burning and tingling on right side of body (arm and leg). quickly turned into a "dead" right leg and almost total numbness on right side of body. cannot walk straight. bizarre pressure behind my right thigh. dizzy and light-headed. having hard time using right hand to type and open bottle lids. elevated heart rate. random waves of nausea. lower back pain in the center that randomly hurts.  i do not have health insurance and cannot afford an ER visit so i am hoping it resolves itself. very scared.
9 days after receiving first does, the area around the injection became red, hot and swollen.  Also experienced at this time achy muscles and joints, as well as a headache and fatigue.  Pretty much gone with 48 hours.
Within 8 hours, muscle weakness and joint looseness. By 14 hours, fever 102, severe kidney pain, entire body muscle and joint pain.
W/in 5-7 min post vax pt returned to clinic room c/o dizziness pt was diaphoretic & pale; BP 96/64(sitting); Cont to c/o dizziness laid down, BP 180/96, felt better, then reported room "spinning" again; BP 208/114; Diaphoretic; Given O2;
I received the vaccination at work, from health care providers where administering the shot there. The shot was given to me in my left arm at about 8:40 a.m. on Oct. 1, 2008. Immediately after receiving the shot, my arm was sore. As the day went on, I began to feel aches in my back and legs. These aches intensified throughout the night, and were accompanied by fever, sweats and chills. The worst of my symptoms seem to have abated by about 8 a.m. on Oct. 2, 2008. I did not go into work, however, as I have been exceptionally tired all day. I have slept most of the day, and only my upper back remains a little stiff. I took NyQuil and Ibuprofen to help reduce the fever and aches. I did not see a doctor, as I read on the CDC Web site that my symptoms sometimes do occur after getting a flu shot. I also have felt gradually better throughout the day. If I had not improved, I would have seen a physician.
Unusual menstruation. Have had the same menstrual cycle for 21+ years 4-5 days light, heavy, regular, light, light.. This cycle was 7 days and spotty. VERY unusual cycle.
The patient was given her flu injection at 3:01pm and appeared to be fine. She was standing waiting for her sister to get her injection when the patient's mother noticed she looked like she was going to pass out. The mother helped her to the ground as she fell and she was shaking some. The intern and the pharmacist assessed that the patient was breathing and became conscious again. 911 was called and arrived shortly after and cleared the patient to leave without additional treatment.
Crabby, congested, coughing. Very irritable. Dx with Bronchitis 10-24-09. Dx with Influenza A (H1N1 likely) 10-25-09.
Malignant neoplasm of tongue - : Transoral partial glossectomy and left staging neck dissection. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt was to receive Moderna-SARS-2-Covid 0.25ml booster dose instead, received 0.50ml dose. Denies any symptoms.
1st shot 7/07- cold symptoms. 2nd shot 1/08 -she missed her period, then severe cold symptoms with what seemed to be a massive herpes-type infection, sores on her gums, face and throat. 3rd shot 4/08- the herpes-like reaction recurred, but milder - then she stopped menstruating for 3 months!
The patient developed marked erythema , edema, and swelling but no pain (color, tumor) in early september . She was given a medrol dose pack by another physician which resolved the condition. The same symptoms came back October 20th  she was given Bactrim and keflex in the ER with no decrease in symptoms. The next day I gave her   solumedrol with resolution for 18 hours. After 18 hours the signs and symptoms returned . I then placed her on an ace inhibitor , oral prednisone, and removed the antibiotics and she is doing better.
Face reddened; breathing was heavy and slower; one hive on face; called Dr.; drove to pharmacy for Benadryl, symptoms of allergic reaction subsided within about 30 minutes.
Slight Fever; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight Fever) and PAIN IN EXTREMITY (Sore Arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Shingles in 2020.    On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PYREXIA (Slight Fever) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, PYREXIA (Slight Fever) and PAIN IN EXTREMITY (Sore Arm) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-059855 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059855: