chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 29 year old male with occupation of landscaping maintenance with type I diabetes mellitus and no known allergies or adverse drug reactions reported who on 09-NOV-2006, at 08:30, was vaccinated intramuscularly, into the left deltoid, with 0.5 mL first dose of Pneumovax 23 (Lot# 651356/0089F) concomitantly with a first dose of ADACEL (Lot C2492BA) intramuscularly, into the right deltoid. Other concomitant therapy included insulin. On approximately 09-NOV-2006, "a few hours after vaccination" the patient developed severe pain and moderate swelling at the left deltoid injection site with fever of 102, chest pains and dyspnea. The patient sought unspecified medical attention. A MEDROL dose pack was prescribed and the patient had gradually recovered over 5 days. Additional information is not expected.
This spontaneous report as received from a 74 year old female consumer refers to herself. On 16-APR-2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot number not reported). On an unspecified date, approximately in 2013 the patient experienced attack of the dreaded shingles. Treatment medicines included: antiviral medicine, pain medicine, antidepressants and topical creams given for her shingles outbreak, skin rash and blisters that accompanied it and for the pain and complications associated with it. Consumer also stated that doctor and emergency room visits were necessary when shingles occurred. She was concerned about she could get postherpetic neuralgia. The outcome of dreaded shingles wasn't reported by the consumer. The relatedness between ZOSTAVAX and dreaded shingles was not reported. Additional information has been requested.
started with a migraine then nausea/vomiting, chills, fever, severe swelling of the injection site with redness, fatigue, muscle and joint pain. This lasted for over 24 hours then got better.
Fever (103.4); chills; nausea; injection site pain; fatigue; severe headache; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0179), dose 2 via an unspecified route of administration in left arm on 15May2021 15:15 (at the age of 33-years-old) as second dose, single for COVID-19 immunization. The patient medical history was not reported. The patient have no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0172), dose 1 via an unspecified route of administration in left arm on 25Apr2021 03:30 PM (at the age of 33-years-old) as first dose, single for COVID-19 immunization. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient experienced fever (103.4), chills, nausea, injection site pain, fatigue and severe headache on 16May2021 04:00. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the events was resolving.
pt noticed small papular pimple to body chest, back, arm, thigh, legs & neck; also c/o not feeling well & aching in legs;
Extreme fatigue, elevated oral temperature, violent shivering.  Temperature shortly after time of onset was 101.8.  No further readings were taken.  Patient slept for 10 hours and slowly returned to a normal state.
swollen lymph node; Headache; A spontaneous report was received from a nurse who was an 28-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen lymph node and headache.  The patient's medical history was not provided. Concomitant medications reported included dexamfetamine sulfate and unknown birth control.  On 31 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039k20-2a) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced swollen lymph node near the collarbone in the same arm that the patient received the vaccine and headache. Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, swollen lymph node and headache was unknown.; Reporter's Comments: Based on a temporal association and the established safety profile of mRNA-1273 vaccine, a causal association between the reported events and the product use cannot be excluded. Headache, and lymphadenopathy are consistent with the known safety profile of the vaccine.
Ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.  No Medical History information was reported.  On an unknown date, the patient received first 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 (Ache). At the time of the report, PAIN (Ache) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This cas was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
ARM HURT; This spontaneous report received from a patient and concerned a 42 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced arm hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurt was not reported. This report was non-serious.
11-9-13 to ER R/T legs "giving out" during a basketball game. Continued to have "burning" sensation and weakness through November. Referral to neurology, per neurologist, patient diagnosed with Myasthenia Gravis at the beginning of this month (Jan. 2014).
Site: Bruising at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: Administered Shingrix vaccine in left deltoid. After admin, injection site started to bleed. I applied a cottonball to which stopped bleeding. When I removed cottonball, injection site appeared slightly swollen and bruised. Pt. stated she had no pain. I asked my supervising pharmacist to look at it. We then applied an ice pack and gave pt. water as she stated she felt a bit lightheaded, but she said was likely due to her feeling a bit anxious/nervous. Observed & she felt better when she left.
This is a spontaneous report from a contactable consumer reporting for her husband. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Jan2021 at 05:44 PM or 05:45 PM (at the age of 65 years old) as a single dose in the arm for COVID-19 IMMUNIZATION. Relevant medical history was not provided. The concomitant medication included acetylsalicylic acid (ECOTRIN) 81mg, potassium chloride (KLOR-CON M10) 750 mg, 2x/day, olmesartan 40-25 mg, 1x/day, rosuvastatin calcium 5mg and other non-prescribed supplements. On 24Jan2021, the patient experienced bump in his arm and was a little stiff and sore. The patient did not receive any treatment for these events. The outcome of the events bump in his arm and was a little stiff and sore was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
This spontaneous report as received from a healthcare worker refers to a 1 year old female infant. On 14-APR-2014 the patient was vaccinated with a dose of PEDVAXHIB, 0.5 ml, intramuscular in the left thigh, that had been improperly stored. On the same date, the patient also received a dose of ROTATEQ, 2 ml orally, that had been improperly stored. There was no adverse effect. Additional information has been requested.
Sharp pains in chest, nausea, sweating, knot in chest (soreness still there), numbness in hands & feet, sob, fash heartbeat. Still have sob & fast heartbeat, at times.
Same day as vaccine, patient developed fever, seizure lasting longer than 15 minutes requiring hospital admission. Patient remains febrile despite treatment with antipyretics. Treatment is ongoing.
Pt recvd 3 doses of Hep B & exp a h/a which persisted for several days; pt later recovered; No further details were provided;
"combining with alcohol" her brother began to have suicidal ideations and threatened to commit suicide; "combining with alcohol" her brother began to have suicidal ideations and threatened to commit suicide; This is a spontaneous report from a contactable consumer (patient's brother). A 35-year-old male patient received first dose of BNT162B2 (PFIZER COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 13Apr2021 (Tuesday) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 14Apr2021 (Wednesday) night, after "combining with alcohol" her brother began to have suicidal ideations and threatened to commit suicide. The patient was placed in a 72 hour psychiatric hold. The patient was "being monitored and medicated" and that there is no other follow-up to report. The outcome of the events was unknown at the reporting time.   Follow up attempts are needed; information about batch/lot number can be obtained.
This literature marketed information has been received from a published literature article title as stated above and refers to a 5-year-old boy with a history of known beef, pork, and milk allergy whoon an unspecified date, was vaccinated with M-M-R II and VARIVAX, (strength, dose, route of administration, lot number and expiration date were not provided for both vaccines). Concomitant vaccines, included Hib conj vaccine (unspecified carrier) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. In approximately 2010, after receiving the vaccines, he developeda large local reaction, disseminated urticaria, shortness of breath, nausea and vomiting. Emergency department treatment with medications and diagnosis were not reported. The sIgE was not reported. The outcome of the event was not reported. The author considered the events as reactions associated to M-M-R II and VARIVAX. This is one of several reports from the same reporter (Case #  US-009507513-1809USA012067, US-009507513-1809USA012063,US-009507513-1809USA012064, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA012060: US-009507513-1809USA012067: US-009507513-1809USA012063: US-009507513-1809USA012064: US-009507513-1809USA012065: US-009507513-1809USA012066: US-009507513-1809USA012061: US-009507513-1809USA012062:
massive pain in the mouth area/ear, jaw pain as well; ear & jaw pain as well; ear & jaw pain as well; my right side of my face goes numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid", start date: Jan2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ORAL PAIN (non-serious), outcome "unknown", described as "massive pain in the mouth area/ear, jaw pain as well"; EAR PAIN (non-serious), PAIN IN JAW (non-serious), outcome "unknown" and all described as "ear & jaw pain as well"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "my right side of my face goes numb".  Additional information: Since the patient got vaccine had massive pain in the mouth area, right side of face goes numb; there's ear and jaw pain as well. The patient didn't have this until took the Jab December of last year. It was highly annoying and now the patient had to see a neurologist. The patient asked if they had any idea why this happened. The patient had Covid in Jan2020, doctor has it in record. it's like it shot up what the patient fought without anything; brought it back in system. The patient was highly upset. Medical inquiry was forwarded to MI.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received DTaP on 9/23/02 in L ant thigh. Over next 48 hrs- increase in swelling of entire L upper leg, tender. No fever, walks but with a limp.
After initial vaccination given, arm was sore, no other symptoms. On 1/26, I started itching under both arms. It progressively got worse throughout the day, and when I took my shirt off to look, I was broken out in hives, and injection site is also red and a little raised. Not "hard", and the injection site is not itching. The hives elsewhere are bad enough that 50mg of Benadryl and over the counter cortisone cream are not relieving. Telehealth visit with PCP's office this morning and a prescription strength cortisone cream is ordered as well as a oral steroid pack if symptoms do not improve.
Symptomatic, started on 7/9/21 with cough, runny nose, nasal congestion, & fever.
nurse told her the rash looks like an allergic reaction; Rash on the arms, legs and thigh; Fever; Tiredness; Nausea; Headache; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (nurse told her the rash looks like an allergic reaction), PYREXIA (Fever), the first episode of HEADACHE (Headache), the second episode of FATIGUE (Tiredness) and NAUSEA (Nausea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced the first episode of HEADACHE (Headache) and the first episode of FATIGUE (Tiredness). On 15-Apr-2021, the patient experienced PYREXIA (Fever), the second episode of FATIGUE (Tiredness), NAUSEA (Nausea) and the second episode of HEADACHE (Headache). On 19-Apr-2021, the patient experienced HYPERSENSITIVITY (nurse told her the rash looks like an allergic reaction) and RASH (Rash on the arms, legs and thigh). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Rash, at an unspecified dose and frequency; HYDROCORTISONE ongoing since an unknown date for Rash, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 18-Apr-2021, PYREXIA (Fever), the last episode of FATIGUE (Tiredness), NAUSEA (Nausea) and the last episode of HEADACHE (Headache) had resolved. At the time of the report, HYPERSENSITIVITY (nurse told her the rash looks like an allergic reaction) outcome was unknown and RASH (Rash on the arms, legs and thigh) was resolving. Not Provided          Concomitant medication included: Hormone IUD.   This case was linked to MOD-2021-081298 (E2B Linked Report).; Sender's Comments:  MOD-2021-081298:First dose
Rash on arm down to elbow; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash on arm down to elbow) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol, Thyroid disorder NOS and Ileostomy. Concomitant products included ibrutinib (irbutinib), alendronate sodium, allopurinol, amlodipine besylate, biotin, ezetimibe, folic acid, glucosamine chondroitin, levothyroxine sodium, magic mouthwash, magnesium, simvastatin, temazepam, allantoin, aloe vera, citrus aurantium, magnesium sulfate heptahydrate, silver colloidal, tocopheryl acetate, tramadol hydrochloride and multivitamin adults for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash on arm down to elbow). At the time of the report, RASH (Rash on arm down to elbow) 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.
wide spread body aches; left bicep red and purple colored.; inflammed lymph nodes down the left side of my body; chills; slight headache; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (wide spread body aches), VACCINATION SITE PRURITUS (left bicep red and purple colored.), LYMPHADENOPATHY (inflammed lymph nodes down the left side of my body), CHILLS (chills) and HEADACHE (slight headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (wide spread body aches), VACCINATION SITE PRURITUS (left bicep red and purple colored.), LYMPHADENOPATHY (inflammed lymph nodes down the left side of my body), CHILLS (chills), HEADACHE (slight headache) and PYREXIA (Slight fever). At the time of the report, PAIN (wide spread body aches), VACCINATION SITE PRURITUS (left bicep red and purple colored.), LYMPHADENOPATHY (inflammed lymph nodes down the left side of my body), CHILLS (chills), HEADACHE (slight headache) and PYREXIA (Slight fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Had TWINRIX Hep A-B vaccine administered to (R) deltoid IM on 4-10-13. Client presented today (6-19-13) and reported "a bruise on that arm since then". On (R) later upper arm 2-3" above elbow there is a quarter sized deep green/black bruise. Client reports that this bruise appears within days of the injection. Denies other injury.
Profuse sweating, joints popping. 6/24/16 left sided weakness and pain, unable to walk. Left upper thigh pain and soreness. Urgent care visits: 6/29/26 - ibuprofen, TORADOL. Urgent care visit: 6/30/16 - tramadol, gabapentin. Office visit 7/12/16 Tests MRI, Sonogram, X-ray - uneventful.
This study case was received on 13 February 2013 from the investigator in a trial. A 23-year-old male subject, with no relevant past medical history, developed an elevated rapid Troponin result, seven days after he received the following vaccines: a left arm injection of ACAM2000, SP Biologics Co., (lot number, route not reported) and TYPHOID VACCINE, manufacturer unknown, (lot number, route, site and side not reported) on 05 February 2013. Seven days post vaccination, on 12 February 2013, the subject had an elevated rapid Troponin I result reported as not within normal limits (Positive) and an extra tube was drawn for Troponin I laboratory testing. The subject also reported worsening headaches and local site symptoms, but denied all cardiopulmonary symptoms. On 12 February 2013, an electrocardiogram (ECG) was reported as sinus rhythm with sinus arrhythmia, ST elevation probably early repolarization, borderline ECG. According to investigator, ECG appeared normal by preliminary reading. The subject was referred for care due to suspicion for myopericarditis. According the investigator, the elevated rapid Troponin level was mild severity. Concomitant medications were not reported. The subject did not take any medications to treat the adverse event. The subject's outcome was reported as not recovered (not resolved, still present and being treated). According to the investigator, the event of elevated Troponin was considered an other important event and probably related to the trial product. This represents a case of potential myopericarditis per the investigator and has subsequently been referred to the ACAM2000 Myopericarditis Adjudication Committee for assessment. Documents held by sender: Medical Records.
I was diagnosed with a missed miscarriage but was discovered due to lack of heartbeat on the ultrasound on 02/07/2023. This was reconfirmed by a follow up ultrasound on 02/10/2023. I have had follow ups to monitor my HCG.
Patient was given the Hepatitis A vaccine when they needed to receive the Hepatitis B vaccine.
Arm was sore; Chest feels tight and very ache; Chest feels tight and very ache; Terrible headache; This is a spontaneous report from a contactable consumer, the patient. This 20 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose  1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 09:15 AM (at the age of 20 years-old) for COVID-19 vaccination.  There was no relevant medical history reported.  Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included sertraline and buspirone. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021, the patient did a workout and "my arm was sore." About 4 hours after the injection "my chest feels tight" and very ache and had a terrible headache. The events, arm was sore, chest feels tight and very ache and headache were reported as non-serious. There was no treatment received for the events. The clinical outcome of arm was sore, chest feels tight and very ache and headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pityriasis rosea.   Herald patch 1 wk following first dose. 2 weeks after herald patch, rash all over body. Severe priuritis. Rash continued through to second dose, rash still present.