chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Myalgia, chills, fatigue Narrative:  f. Date of Vaccination - second dose: 1/6/2021 g. Symptoms/Complaints -extreme fatigue, headache, body aches, cold chills
This spontaneous report as received from a healthcare worker (medical assistant) refers to a 12 month old patient of unknown gender. The healthcare worker confirmed that ZOSTAVAX was mistakenly shipped to this office instead of VARIVAX. The patient was then inadvertently vaccinated with the first dose of ZOSTAVAX (dose, route not reported, lot # K007986, expiration date 03-SEP-2015) instead of VARIVAX, "within this past week", in approximately in September 2014. Concomitant medications were not provided. No adverse effects were reported. This is one of eight reports received from the same reporter. Additional information has been requested.
9 y/o male received vaccine (Varicella) yesterday during well exam. Took shower last night - arm itchy and didn't sleep well. Left arm initially look like had a long bite but this morning bigger 1.5 x 2.5 in erythema/inflammation. No induration. No tenderness. evid of infection. No meds given and no ice applied.
Child had 2 vaccines simultaneously - Hep A and HPV approx 5 min after injections, child felt lightheaded, nausea, stomach cramping-sweats-vomited 3/4 times and had diarrhea - dizzy - was transported to ER for observation.
3 DAYS POST-VACCINATION, PRESENTS TO PHARMACY COUNTER COMPLAINING OF REDNESS, SWELLING, ITCHING, PAIN AT INJECTION SITE. DR. VISIT THAT MORNING, DIAGNOSIS CELLULITIS. ANTIBIOTIC PRESCRIBED AND PICKED UP. RPH COUNSELED TO APPLY ICE PACK AND TAKE BENADRYL TO MINIMIZE REACTION.
Information has been received from a pharmacist concerning a female with no pertinent medical history or drug allergies who on 14-NOV-2007 was vaccinated SC with one dose of Zostavax (Oka/Merck) (lot# 658839/1411U). There was no concomitant medication. On 23-NOV-2007 the patient developed shingles. The patient was seen by the physician for medical attention. No labs or diagnostic studies were performed. The patient was treated with acyclovir. The patient was recovering. There was no prodcut quality complaint.
Suspected vaccination failure; shingles illness; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the vaccine in February and just finished a week of severe shingles illness. The patient stated Shingrix was 85 percent effective. Unfortunately, it did not prevent or lessen shingles for the patient. 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.
Arthritic type flare in right hand with  pain, swelling.  Unable to grip due to stiffness and pain.
I believe I developed Covid Arm, based on the following: On day 9 after injection, my upper arm at and below the injection site suddenly got hot, swollen and red and itchy like a really bad insect bite. By day 13 (today) it is less inflamed but the raised red area wraps almost the entire way around my upper bicep.
Prolonged crying day of vaccine, accidental admin of Menactra to a 2 month old (was supposed to be Prevnar).
100.8 fever, 18 hours  Severe body pain - all joints, muscles, lymph nodes
pt reported on 6/6/2023 that they had spot rash on chest , neck, and arm
Treatment of COVID-19; Treatment of COVID-19; Name of Drug as Reported: Moderna; Dose Number:3 and 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6203), in right arm and on 19Mar2021 as dose 2, single (Lot number: ER2413) at the age of 67 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 3 (booster), single (Lot number: 032F21A), in right arm and on 14Jul2022 as dose 4 (booster), single (Lot number: 016B22A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ACETAMINOPHEN, start date: 01Jun2022; CELEBREX, start date: 01Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Nov2021, outcome "unknown", described as "Name of Drug as Reported: Moderna; Dose Number:3 and 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2022) Positive, notes: Tested positive with at-home test and at Clinic  09Dec2022; (09Dec2022) Positive, notes: Tested positive with at-home test and at Clinic  09Dec2022; (16Dec2022) Negative, notes: Tested negative 16Dec2022; (19Dec2022) Positive, notes: Tested positive AGAIN 19Dec2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Anti viral drug Paxlovid for COVID 19 Treatment from 09Dec2022 to 14Dec2022. Known allergies: Not that I am aware of. Other medical history: None.
pt recv vax 4NOV98 & 5NOV98 fever 103 was seen by MD on 5NOV98 instructed to given APAP of this during waking for next 4 days;pt more irritable & sleeping more;
Site of immunization red, swollen, tender with patient c/o arm, shoulder and neck pain - 1st local reaction I've seen with.
From telephone correspondence received on 10/14/02, it was reported that an adult male was vaccinated with Fluzone (lot # U0872AB) IM on 10/9/02. The following day, on 10/10/02, the patient experienced a red and itchy body. Benadryl was administered and helped. On 10/14/02, it was reported that the patient's hands and feet were swollen. It is not reported whether the patient recovered from these adverse events.
Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Approximately 12 hours after the vaccine felt nauseated, and then she passed out.  She got really cold to the point that she was layered up with blankets, shivering with 4 layers, teeth shattering, possibly going into shock, took Tylenol, her temp was 100.  She went to sleep and was just trying to get warm.  The next morning she still had a fever of 100.  She continued to take Tylenol and by Friday 2/5/21 was okay.   She is 4'11 and weighs 85#, wondering if the dose was too strong for her body frame, otherwise healthy person.
This spontaneous report ass received from a physician as well as the patient of unknown age. The physician was vaccinated with VAQTA (dose and route not reported) (lot number reported as 0669AE expired date 07-DEC-2014) on 01-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-NOV-2012 while aspirating a prefilled syringe of VAQTA the plunger came out and some of the dose of the VAQTA got on the physician. No adverse event reported. The outcome was unknown at the time of report. Additional information is not expected.
approximately 2 hours day  after receiving the 2nd vaccination  ( vaccination was given approximately 3:15 pm and welt on my right forehead about 530 pm) i took Benadryl and fell asleep. When I woke  about 3 hours later the welt was gone.  The next day redness started at the injection site. It was slight. That Sunday evening 07Feb2020, the left arm was swollen a bit painful and very red. I took ibuprofen and Benadryl. The next day, Monday, the site was inflamed, i had to take off from work that day. I iced the arm with minimal  improvement. That Wednesday, it appeared as if the redness was expanding. I noticed a new area. I showed my arm to an immunologist who recommended I try Zyrtec and Motrin. I took Zyrtec for three nights . I noticed decreased redness and swelling after the first dose of Zyrtec. After the third dose my arm was better. No swelling or redness.
2 weeks after the first dose, I had extreme pain in my joins and abnormal fatigue. I went to my doctor and my blood work revealed Rheumatoid Arthritis. I've never  had it before. I also suffer from brain fog, memory loss.
Pt started to have a metallic taste in her mouth immediately after administration of the Covid-19 vaccine. She started to feel nauseous and myalgias. The patient was seated, given Zofran 4mg once and Benadryl 25 mg once. After 10 min patient was eating juice + crackers. Reports she feels better. A co-worker verbalized he would drive her home, patient agreed.
Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High.         Concomitant medication and Treatment medication use was not provided by reporter.  Company Comment: Very limited information regarding this events has been provided at this time.   Further information has been requested.   This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.   Further information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the patient had an antibody test done and the result was negative (confirmed immunological vaccine failure). The test name was SARS COV2 AB (IGG). The test was done at facility. For result, less than 1, which means negative and have no antibodies.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number 90000180817. The suspected product quality complaint has been confirmed to be void: N based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20210551477 and 20210551575.; Sender's Comments: V0: 20210550960-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
States woke with hallucinating dreams and had nausea, headache, neck, back, and joint pain.  Pain so severe almost went to hospital.  States was having hot and cold flashes but never took temperature.  Also complained of soreness at injection site that is now red with a lump.
cold like mild side effects; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (cold like mild side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (cold like mild side effects). At the time of the report, FEELING COLD (cold like mild side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT HAD SIGNS AND SYMPTOMS OF NAUSEA, VOMITING, AND CHEST TIGHTNESS ON LEFT UPPER SIDE.
10cm x 8cm area of warmth/induration and erythema surrounding injection site with pain and fever.
Day 1 after vaccine patient short of breath.  Went to ER.  Admitted to Hospital.  Was in CHF, sustained MI.   Eventually tranferred and underwent 4 vessel CABG and wears Defibrillator vest.
Pulsation in my left ear, going on 7 months, had 2 CT scans, it's all normal. No matter who I saw or given meds for, nothing is helping. Lucky if I get 3 or 4 hours a sleep at night with the help of a controlled substance. Saw an ENT assistant who fluffed me off telling me to learn to live with it, join a support group, or meditate. Everyone tells me there's nothing wrong with my ear yet it pulsate or throbs 24/7 now.
Sinus infection; This is a spontaneous report from a contactable consumer (patient herself).   This 92-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on unknown date at single dose for COVID-19 immunisation. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on unknown date (at the age of 92-year-old) at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After receiving the second dose everything was fine. 5 days after the shot, the patient had sinus infection. She was prescribed penicillin amoxicillin. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Narrative: Anticoagulation started. Heme/Onc consulted, results pending.
Injection site red rash 2 inches down and 4 inches across. Area slightly hard and hot to the touch. Slightly itchy. Recommended ice, TYLENOL or ibuprofen, hydrocortisone, and CLARITIN since patient is allergic to BENADRYL.
Vaccinated in morning with Hepatitis A and given oral Typhoid which patient started taking at 12PM that day.  Vaccinated with Yellow Fever in afternoon of same day.  Began mild itching next day, gone 01/12/2006 but Yellow Fever site is a raised red welt, hot and sore to touch.  Denies fever, chills, achy.
History of hypertension, diabetes, CDPD, lung cancer with recent finding of METS to the brain presented to Regional hospital on 02/06/2022 with worsening SOB. She was found to be in AFib RVR and was treated with Cardizem. Chest x-ray showed bibasilar interstitial and alveolar infiltrates, CHF versus pneumonia with: small bilateral allusions. She was treated with Lasix, started on Levaquin today. Unfortunately on 2/9 she fell. CT of the head without contrast showed right temporal lobe mass, decreased in size. and decreasing cerebral edema in the right temporal lobe, but no acute findings from the fall. Patient continued to decline and expired on 02/13/2022.
Headache, Myalgia, Fever, NauseaVomiting, fatigue, chills Narrative: Low grade fever, body aches, chills, nausea, feels like the "flu", fatigue. Taking Ibuprofen OTC.
Migraines; This is a spontaneous report received from a contactable consumer.  An adult male patient received BNT162B2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious) with onset Mar2021, outcome "unknown", described as "Migraines". It was unknown if therapeutic measures were taken as a result of migraine.  Additional Information: The patient had two migraines within 1 week after first dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash spread on his face to his cheeks/rash spread to cheeks on face; This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (On 10th September 2020, the patient received 1st dose, please refer the case US2020248551.). Concurrent medical conditions included rash.   On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced rash aggravated. On an unknown date, the outcome of the rash aggravated was not recovered/not resolved.   It was unknown if the reporter considered the rash aggravated to be related to Shingrix.  Additional details were provided as follows: After the first Shingrix, the patient experienced rash on his forehead. The rash was unresolved when he received his second vaccine. After the second vaccine, he reported, the rash spread on his face to his cheeks. The patient permission to contact HCP; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248551:same patient
Within 30 minutes fever 102, child vomiting, arm right hot, swollen, red, c/o HA, TC to mom 6/26/06 child OK.
I have been feeling itchy all over my body.  If I start to itch then it becomes worse; skin reddens, bumps form, more area become itchy. I went to my primary doctor and they suggested Allegra. I was taking that for a month but there no change. Symptoms are still bad.
Received third dose even though it is not 8 months yet; Extra dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received third dose even though it is not 8 months yet) and EXTRA DOSE ADMINISTERED (Extra dose administered) 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.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Received third dose even though it is not 8 months yet) and EXTRA DOSE ADMINISTERED (Extra dose administered). At the time of the report, OFF LABEL USE (Received third dose even though it is not 8 months yet) and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.            No relevant concomitant medications were reported.  Treatment information was not provided.
INCORRECT PRODUCT STORAGE; VACCINE GIVEN AFTER A TEMPERATURE EXCURSION  COLLECTIVELY FOR 472 HOURS; This spontaneous report received from a health care professional concerned a 30 year old male. 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 not reported, batch number: 1855190 expiry: 24-SEP-2022) dose was not reported, administered on 19-APR-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 30 years old. No concomitant medications were reported.  On 19-APR-2022, the patient experienced vaccine given after a temperature excursion collectively for 472 hours. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after a temperature excursion collectively for 472 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20220945899, 20220945831, 20220945933, 20220948245 and 20220948255.