chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left upper arm reported as red, swollen, indurated and warm to touch-given BENADRYL, ice to arm, ibuprofen-went to ER as this did not improve condition.
was vaccinated, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient was vaccinated with Shingles vaccine and got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting This case has been linked with US2021AMR195106, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR195106:Same reporter
Approx. 2?W x 3?L bright red spot that was warm to the touch appeared distal to the vaccine site 9 days post vaccine. The bruise from the vaccine was still visible, and the redness only appeared where my deltoid was sore for several days after the injection.   By the next morning, it got approx. 1? larger in both directions (still distal to vaccine site), was still red towards the edges but the center looked greenish, like a bruise.  As of this morning, day 14 post-vaccine, it appears to have cleared up. It was never painful or itchy, just... there. No treatment sought nor performed at home.
bronchitis; SARS-CoV-2 test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive ) and BRONCHITIS (bronchitis) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (chronic).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive ). On an unknown date, the patient experienced BRONCHITIS (bronchitis). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 1 dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive ) and BRONCHITIS (bronchitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, X-ray: normal (normal) no signs of COVID damage.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included inhaler forasthma   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information included new event, treatment medication, medical history and lab data.
Case number PHEH2014US025098, is an initial spontaneous report received from a nurse on 09 Dec 2014. This report refers to a 72 year old female patient. Medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. Nurse reported that patient received FLUVIRIN that was at 49 degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F during each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
A few hours after receiving the shot I felt extremely cold, shivering. When I went to bed the cold and shivering was worse, despite many blankets and warm bedclothes. I took a Tylenol and after 20 minutes felt fine. That is all. I am reporting it because this was not listed as a side effect and I believe it should be. It was not serious, I did not contact a medical professional to report because the next day I remained fine.
Information has been received from a health professional as part of the Merck Pregnancy Registry concerning a 19 year old female with a history of an elective termination who on 05-JUL-2007 was vaccinated IM with a first 0.5 ml dose of Gardasil.  She received the second dose on 01-NOV-2007.  Concomitant therapy included fluoxetine.  On 05-OCT-2007 the patient had "hormone levels" due to irregular periods and a negative HCG level.  On 11-DEC-2007 the patient had a positive HCG level.  On 03-JAN-208 the patient experienced abdominal pain and had an ultrasound which showed healthy intrauterine pregnancy 11 weeks, 6 days.  Additional information has been requested. Informatoin has been received froma nurse practitioner, for the Pregnancy Registry for GARDASIL concerning a 19 year old female with a history of one previous spontaneous abortion and sinusitis who on 05-JUL-2007 was vaccinated IM with a first 0.5 ml dose of GARDASIL. She received the second dose on 01-NOV-2007. On 05-OCT-2007 the patient had "hormone levels" due to irregular periods and a negative HCG level. On 11-DEC-2007 the patient had a positive HCG level. On 03-JAN-2008 the patient experienced abdominal pain and had an ultrasound which showed healthy intrauterine pregnancy 11 weeks, 6 days. Follow-up information was received. On 14-JUL-2008 the patient delivereda normal, healthy male baby weighing 8 pounds and 2 oz. The baby was 21 inch. There was no congenital anomalies, complications or abnormalities. There were also no complications during the pregnancy or during labor/delivery. No further information is available.
Patient was at daycare, experiencing a typical day, sitting and eating a snack, when she made a sqeak/squeal and her arms first curled and then went straight up overhead. The daycare staff stated patient's entire body when stiff which caused her to push away from the table. She fell back off of chair and landed on left side. Patient had loss of consciousness after the accident for about 30 seconds before becoming alert again. When she was alert, she was confused of what happened, pale, and a little weak feeling. Patient correctly answered all cognitive questions immediately after the incident. Staff also stated patient was afebrile after accident. This incidence prompted her parents to bring her to the ED.
unable to work; ESR of 124 mm/hr; CRP of 4 mg/dl; difficulty with ADLs; neck and leg muscle stiffness and pain; neck and leg muscle stiffness and pain; difficulty ambulating; neck and leg muscle stiffness and pain; fatigue; body aches; chills; sweats; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 18Dec2020 at single dose for COVID-19 immunization. No medical history. The patient's concomitant medications were not reported. Patient had been otherwise well prior to receiving the bnt162b2 on 18Dec2020. Within 72 hours, she experienced fatigue, body aches, chills and sweats since 21Dec2020, though she was able to work Xmas week. On 31Dec2020, she contacted her PCP to report neck and leg muscle stiffness and pain, difficulty ambulating, fatigue, chills and sweats. She had a negative COVID test on 02Jan2021 and essentially negative blood work, other than an ESR of 124 mm/hr and CRP of 4 mg/dl. I had a negative PET scan on 12Jan2021. Currently, she had pain/stiffness in her neck and legs, and progressive difficulty w/ ambulation (both of which are worst in the early hours of the AM), and difficulty with ADLs since 31Dec2020. She had been unable to work since 03Jan2021. Her physician had not indicated or endorsed any relationship between her symptoms and the vax. She forewent dose 2 out of an abundance of caution. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: The events muscle stiffness , neck pain and gait disturbance appeared 13 days after administration of single dose BNT162B2. The Company considers that the events are less likely related to suspect BNT162B2 injection given the weak time association. The detailed clinical course and cause of the events would be helpful for further assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
13MAR91 rt arm pain (severe); 12MAR91 pain lt leg; 13MAR91 fever progressed 101.7, chills, headache (severe); body aches; abd, cramping & pain; 14MAR91 temp 100, abd pain;
PARENTS OF INFANT NOTED DIFFUSE PINK RASH OVER TRUNK AND UPPER EXTREMITIES A FEW DAYS AFTER VACCINATION WITH HIB. (SANOFI - ACT HIB- UF550AA).  NO VESICLE.  NO RESP DISTRESS.  NO SWELLING OF LIPS/TONGUE.  NO OTHER SYMPTOMS.  PARENTS REPORTED TO PRIMARY MD.  THIS RN (THAT ADM. VACCINE) ENC. MOM TO TAKE INFANT TO MD FOR EVAL. TO ATTEMPT TO DETERMINE IF THERE IS A TRUE ALLERGY TO HIB VACCINE; NEXT DOSE IS DUE LATE NOV, 2009.
2 days of redness, warmth and local swelling at injection site. MOTRIN and cold compresses.
This report has been received from the nurse reported that VARIVAX (Merck) (lot# H020587, expiration date 13-NOV-2014) and PROQAD (MARRS# 1311USA012185) were through unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 27-SEP-2013 the patient (age and gender not reported) was administerd the unsupported VARIVAX (Merck) (dose and route not rpeorted). No adverse effects reported. This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003309, 1312USA003306, 1312USA003310, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003311, 1312USA003399, 1312USA003400, 1312USA003401). Additional information has been requested.
Injection site was welty; the injection site was welty but now it's flat and warm to the touch; Arm got red; It hurts a little bit; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red), VACCINATION SITE PAIN (It hurts a little bit) and VACCINATION SITE URTICARIA (Injection site was welty) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red) and VACCINATION SITE PAIN (It hurts a little bit). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Injection site was welty). On 20-Jan-2021, VACCINATION SITE URTICARIA (Injection site was welty) had resolved. At the time of the report, VACCINATION SITE WARMTH (the injection site was welty but now it's flat and warm to the touch), VACCINATION SITE ERYTHEMA (Arm got red) and VACCINATION SITE PAIN (It hurts a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up received on 14-Apr-2021 included no new information. The patient denied consent for further follow-up.
Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 05Apr2021 at 15:45 (at the age of 46-years-old) as a single dose for COVID-19 immunisation.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 20:30, the patient experienced severe headache with onset within 4 hours and tapered off within 48 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache was recovered on  an unknown date in Apr2021.   No follow-up attempts are possible. No further information is expected.
THE NEXT DAY OF VACCINATION. VERY SORE ARM AND FLUISH LIKE SYMPTOMS THAT KEPT THE PATIENT IN BED FOR A WHOLE DAY.
The day of the vaccine, I had a headache with muscle and joint pain all over my body. That night I had chills with my skin hot. I felt like that triggered my RA and made a flare up. On 05/01/2022 around 2:30AM, I woke up and then I experienced pain in my stomach. I went downstairs to get Gaviscon medication and milk. I bent down to get the quart of milk and I could not lift the milk. I could not move my right arm and it felt like my head was being pushed down. It was a weird feeling. I could not control my arm and spilled my medication. My arm was extremely weak and heavy. This completely stopped when I got halfway up the stairs. I wanted to call 911 because I thought I was having a stroke. I sat on my bed and then got extremely cold. I drove myself to the ER. I had a CT Scan and EKG. I was admitted and had a brain and Carotid artery MRI as well as blood work. Nothing was indicated. The neurologist at hospital diagnosed it as a TIA. I went to a cardiologist 5/2/2022 and I will have a TTE next week. I am still very week. I was prescribed Prednisone that may resolve the weakness due to the RA flare up.
Patient of 17YO received the vaccine; A spontaneous report was received from a health care professional concerning a 17 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 05-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event patient of 17YO received the vaccine was resolved on 05 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot #unknown)  with no associated AEs reported.
New onset of multiple bruises and petechiae on Friday 2/21/20 without fever, joint pain, abdominal pain or any other symptoms. Patient came to clinic on Tuesday 2/25/20 for evaluation. Immune thrombocytopenia suspectedand labs ordered. Thrombocytopenia confirmed on CBC, also slightly low PTT but all other findings within normal limits. Patient doing well, has been advised no collision/contact sports until thrombocytopenia resolves to avoid significant internal hemorrhage. Referred to hematologist for further evaluation.
09/05/2000 - High grade fever, body aches, large red, hot inflamed spot on leg.  06/13/2005 - Low grade fever, body aches, large red, hot inflamed spot on arm.
nausea; dizzy; vomiting; sometimes I feel hot; I feel chilled; This is a spontaneous report from a contactable consumer (Patient). A 49-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: 9NG198), dose 1 via an unspecified route of administration administered in Arm Left on 09Mar2021 at 11:30 (at 49-years age) as single dose of covid-19 immunisation. Medical history included seizure, endometriosis and had known Allergies: antibiotics sulfa medicines. Concomitant medications included zonisamide (ZONEGRAN) and levetiracetam (KEPPRA). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Other vaccine was not received in four weeks. On 09Mar2021 at 12:00, patient experienced nausea and dizzy and vomiting after first dose sometimes she feel hot and other times she feel chilled. No treatment was received for events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Fever, injection site pain, Chills, Fatigue Narrative:  Other Relevant History:
Patient got her 1st shot of COVID Moderna Vaccine at the pharmacy on 06/30 @ 11:40 AM. After 15 minutes of sitting in the waiting area, patient reports that she is feeling a general mild itchy feeling all over her body that comes and goes in phases. Patient did not report swelling, throat tightening, injection site pain, or injection site itching. Injection site redness or swelling was not observed. Pharmacist decided to administer one dose of diphenhydramine 25mg, gave one more capsule for patient to take home, and counseled on the sign and symptoms of anaphylaxis allergic reaction. Patient feels fine after another 15 minutes observation.
Redness, soreness, fever, severe local reactions cellulitis (6 inch), diarrhea. Treatment: KEFLEX 500mg tid x 7 days, DIFLUCAN 150mg.
TC client on Oct 30,05 states that she went to the doctor. Has been diagnosed with polymyositis want to know if any of vaccines could have caused signs and symptoms. Immunized with vaccines on 7-19-05. IPV,TD, HAD, Menomune tying and yellow fever given Doxycycline for malaria. Signs and symptoms started Aug 19-20 before going to doctor, went to doctor on 10-21-05 with pain in lower extremities , weakness in lower limbs.
Vaccination site pain/ sore arm from covid-19 booster; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/ sore arm from covid-19 booster) and FATIGUE (Fatigue) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Previously administered products included for COVID-19 vaccination: COVID-19 Vaccine by  and Johnson (1st dose, intramuscular) on 06-Apr-2021, COVID-19 Vaccine by  and Johnson (2nd dose and intramuscular) in 2021. Past adverse reactions to the above products included No adverse event with COVID-19 Vaccine by  and Johnson and COVID-19 Vaccine by  and Johnson. Concurrent medical conditions included Crohn's disease.   On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/ sore arm from covid-19 booster) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/ sore arm from covid-19 booster) and FATIGUE (Fatigue) was resolving. Not Provided          No concomitant medication information was provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On an unknown date biopsy and colonoscopy were performed, results not obtained.  The reporter's causality for the event(s) of SORE ARM FROM COVID-19 BOOSTER with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of FATIGUED FROM COVID-19 BOOSTER with HUMIRA(ADALIMUMAB) was a reasonable possibility.  No treatment medication information was provided.  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.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Live-Significant Follow up- Administration route and indication for medical historical vaccine, Moderna vaccine start date, HUMIRA drug lot number were updated and lab data and procedure information were added to inarrative supplement.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. The patient experienced headache, chills, vomiting, pain at injection site and very flu like all on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.
This report describes injection site swelling in a subject of unspecified age and gender who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The pt's medical history, concurrent conditions and concurrent medications were unknown. On an unspecified date, the pt received an injection of Infanrix; it was not known if the pt had received previous injections of Infanrix. Subsequently, the pt experienced injection site swelling. As of 08/07/2002, the outcome of the event was unknown.
In January of 2022 she began experiencing breathing problems, constant cough and began having allergies. In March she ended up with pneumonia, was admitted to the hospital for a couple of days. She was diagnosed with asthma. X-rays were performed and it showed left lower lobe damage. An EKG also showed irregularities. Her family has history of AFIB. She then went to a pulmonologist and tests were performed. She was prescribed an inhaler. She saw a cardiologist last week. She continues to have issues with breathing and her heart. Is wearing a heart monitor presently for 3 weeks.
extreme headache, nauseous, dizziness, entire left side unable to move, couldn't get up out of bed physically, fever up to 101.3
Client received the vaccine and post vaccination wait-period of 30 minutes she reported having a "thickness of the tongue." Client reports having no other symptom. Client's BP was 139/91 p84 and O2 sat 98. EMS was called and Medic assessed client and was determined that client was having a mild allergic reaction and she was transported to hospital.