chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sleepy; no apetite; sore and pain at the injection site; swelling at injection site; fatigue; nausea; shortness of breath; very shaky; tremor; dizzy; difficulty breathing; chest pressure; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (no apetite), DYSPNOEA (shortness of breath), VACCINATION SITE PAIN (sore and pain at the injection site), FATIGUE (fatigue) and VACCINATION SITE SWELLING (swelling at injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Migraine. Concomitant products included CETIRIZINE.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced DYSPNOEA (shortness of breath). On 31-Dec-2020, the patient experienced FATIGUE (fatigue). On 01-Jan-2021, the patient experienced DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 01-Jan-2021, DECREASED APPETITE (no apetite), VACCINATION SITE PAIN (sore and pain at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown. On 05-Jan-2021, FATIGUE (fatigue) outcome was unknown. At the time of the report, DYSPNOEA (shortness of breath) 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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow-up received on 16 Apr 2021 included no new information; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of an unknown age and gender. There was no information about patients' concomitant medications, pertinent medical histories, drug reactions and allergies provided. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot# K026533, expiration date 07-AUG-2017, doses, routes and sites of administration were not reported). No adverse events were reported. There was no product quality complaints (PQC) were involved. This is one of several reports received from the same reporter. Additional information has been requested.
Red swollen at sight x 2 1/2 days (R thigh). Fever of 101 8-19-08 in am fever resolved by evening. Change in eating and temper x 4 days. Symptoms now resolved
Patient states noted swelling with reddish-purple color to right index finger with small blisters around 10:00 a.m. on 05/26/21. Denied any itching but had pain when bending finger due to the swelling. States blisters and swelling gone today but finger still discolored. Denies any history of arthritis but states parents had it. Also states she felt lightheaded and skin looked blotchy approximately 20 minutes after vaccine on 05/24/21 while still at the clinic but then started to feel better. States history of PCN (red whelps) and Erythromycin (rash, itching) allergies from many years ago. Advised to see PCP for evaluation and states she's better today and will see PCP tomorrow if condition persists.
Patient called to complain of arm pain and inability to lift arm on 07/10/18. On 07/11/18 I called to check on patient and they stated they had gone to ER and been diagnosed with hematoma via X-ray. ER told patient to follow up with primary physician if no relief within 3 days. Patient stated a knot formed on 07/11/18.
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/ allergies were reported. On 24-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ orally (which had a lot # of N029670 and an expiration date of 03-SEP-2019; however, was not reported), for prophylaxis. The diluent used to reconstitute the vaccine was properly stored. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursions: 47 F degrees to 77 F degrees  for 20 minutes. Reportedly, there had been no previous temperature excursions and the aformentioned one was identified due to a data logger. Furthermore, no product quality complaint was involved.  This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA011769: US-009507513-1808USA011770:
Right arm about 3 inches below injection site became red, swollen, hot to touch down to elbow and was very painful. Seen at Urgent Care, IV antibiotic administered and Rx for Keflex 500mg po TID given to patient. Diagnosis of Cellulitis. Patient applied ice pack and took Ibuprofen as needed.
3/7/08 Child was picked up from school with c/o red itchy rash all over body, sores in mouth, stiff neck, headache, and feeling very fatigued. 3/8/08 Child felt worse this day and was taken to clinic...@ that time no meds or treatment were given.  Caregiver was told to let it run it's course and child was sent home. 3/11/08 Child still not feeling well and not any better and all before mentioned symptoms were still present.  child was then taken to primary care provider and dx with a viral condition.  Prednisone dose pack was given. 3/13/08 caregiver states child is feeling 100% and is back in school today.  Still has a rash but not itchy and sores in mouth are better.
24 hours post vaccine, 10/24/2021 @ 03:00 PM, fever, chills, body aches, severe headache. I had a fever for like 4 days: Started Sunday afternoon, Monday, Tuesday, Wednesday, Thursday, I finally went to a doctor on Thursday, 10/28/2021. I was unable to go to work. I was extremely fatigue. Thursday morning, I had the COVID-19 test - the results were negative. The doctor thought I may have the flu prior to having the vaccine. I felt fine when I had the shot. I was not sick. I did not have the flu. Friday, 10/29/2021 afternoon was the 1st time I did not have the fever. I went back to work, 11/01/2021. All the symptoms have resolved. I can't get over the fatigue. I am still tired, 11/ 03/2021. The 2nd dose, I had the same symptoms happened 24 hours after the vaccine, but they only lasted 6 hours. It's very strange these symptoms to the 3rd vaccine lingered for this long.
AIRWAY CONSTRICTION, SYNCOPE, DYSPNEA, LIP SWELLING, BLOODY NOSE Narrative:
I had a cry cough, body aches and a terrible headache. I had dizziness, nausea, sever anxiety and vomiting and shortness of breath. I also experienced and I am still experiencing severe brain fog and fatigue. I tested positive for the COVID-19 virus on Feb 16th 2021.
Began complaining of itching at injection site.  Took off bandaid and cleaned area.  After 40 minutes of injection, itching subsided.  No med given.
did not get his second dose within 2-6 months due to the Covid outbreak; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year and a half ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not get his second dose within 2-6 months due to the Covid outbreak, which led to social problem. The reporter was asking for guidance on getting the second dose. Spoke per Shingrix FAQ content containing clinical disease center guidelines to get the second dose as soon as possible. The reporter consented to follow up.
Pain at injection site for 2 weeks; Headache; positional Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6119) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease(CAD) and sulfonamide allergy. Concomitant medication included losartan (MANUFACTURER UNKNOWN); from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 10Feb2021 for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 04:00 AM, the patient experienced pain at injection site for 2 weeks, headache the next day and was still having them and also had positional vertigo. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the adverse events and included Duloxetine for headache. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, headache and positional vertigo was not recovered at the time of this report.
devel 6 erythematous papules on rt lower leg 6 days;also exp localized itching;
Abnormal Pap test due to HPV; Abnormal Pap test due to HPV; This spontaneous report was received from an office manager via a company representative and refers to 23-year-old female patient. Information on patient's pertinent medical history, concurrent condition, concomitant medication and drug allergies/reaction were not reported.   On 27-DEC-2007, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# 0524U (not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), the lot is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine), second dose on 17-MAR-2008, lot# 0930U (not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), the lot is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine) and third dose on 22-JUL-2008 lot# 1446U (not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), the lot is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine) (dose, route and expiration date were not reported) for prophylaxis.   On an unknown date in July 2019, the patient had an abnormal Pap test due to human papillomavirus (HPV) (human papilloma virus test positive and smear cervix abnormal). The patient was being treated through an unspecified obstetrician-gynecologist (OB/GYN). The outcome of human papilloma virus test positive and smear cervix abnormal was unknown. Causality assessment for the events human papilloma virus test positive and smear cervix abnormal was not reported.
This is a spontaneous report from a contactable consumer (parent). A female patient received TRUMENBA; (lot number and expiration date unknown) via unspecified route of administration in the arm on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. The reported stated that her daughter experienced pain in her arm after receiving a dose of meningococcal group B vaccine on unspecified date. The reporter needed to know the most common reactions in the administration site. Outcome of the event was unknown. Information on batch number has been requested.
Following day after vaccine had fever of 101.4, swollen lymph nodes in chest, armpit and collarbone. Fatigue, muscle aches. Had horrible night sweats. Two days later I do not have a fever but my lymph nodes are still horribly swollen/painful and my chest hurts. My heart rate shoots up if I try to walk around and I feel like I?m going to pass out. Chest also hurts to walk around.
severe itching with hives and red "scrape-like" rash all over body, hot skin and rash at injection site for over 3 weeks now
Hours after first COVID vaccine 12/18 developed facial and lip swelling then urticaria on arms and nonpruritic, erythematous rash chest to thighs.  Woke that night with tachycardia to 220's.  Tachycardia of varying degree and severe diaphoresis was constant through the next 72 hours.  Did not seek care. Since then, for 3 weeks she has had multiple runs of SVT.  Last one was Saturday 1/9 - went to ER, episode recorded.  Given rx of xanax which did not resolve her tachycardia.  Established care with me 1/14/2021 and noted to have 3/6 systolic murmur.  Patient (who is a PA) states it is significantly louder than it was prior to vaccination. Given rx of prn propranolol for home, outcome pending
Patient had myocarditis (elevated Troponin's) and abnormal EKG initially but normal Echo
Jansssen COVID-19 Vaccine EUA After taking the vaccine I had the following side effects: I had fever ( 38.8 degree Celsius for couple of hours )  and I had redness of the skin at time I had fever. I also have headache and feeling very tired.
4-5 CM OF ERYTHEMA, ITCHING, FOCAL SORENESS. PATIENT ALSO COMPLAINED OF MYALGIAS. SYMPTOMS IMPROVED AFTER 3 DAYS WITH RESOLUTION OF SYMPTOMS.  RESIDUAL FOCAL PETECHIAE OCCUPYING A 1.5 CM AREA REMAINED.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a 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 19Oct2022 as dose 5 (booster), single (Lot number: gh9702) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19 with Paxlovid from 24Aug2023 to 28Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293623 Same patient, different drug/AE;
Pt. received MMR at 3-4 weeks gestation with LMP of 4/16/12, which wasn't diagnosed until June 20th with (+) HCG. She also had no records at time of vaccination which revealed 2 prior MMR vaccines.
I did not have an adverse event to my booster dose. I developed a + Covid test on 12/27/21 after being exposed to my son who had received his booster dose 12/19/21, then developed a +Covid test 4 days later.
She was having some symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (She was having some symptoms) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (She was having some symptoms). At the time of the report, ADVERSE EVENT (She was having some symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (She was having some symptoms) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (She was having some symptoms). At the time of the report, ADVERSE EVENT (She was having some symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter.   No treatment information was provided.
No adverse event; Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 1), COVID-19 VACCINE JANSSEN (Dose 3 booster) and PFIZER BIONTECH COVID-19 VACCINE (Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 01-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired blue cap Bivalent booster of Moderna COVID-19 vaccine two days after beyond use date).    No concomitant medications were provided. The vial size was 2.5 ml. It was unknown when the vial was initially stored in the refrigerator. But received as liquid on 28-Apr-2023. The vial did not undergo any temperature excursions.  No treatment medication was provided.
Hives on forehead. Lt shoulder and abdomen. Treated in emerg. room.
symptoms started within 24 - 48 hours  severe sore throat for 5 months fatigue autoimmune thyroid problems
MMRV was administered rather than MMR for a patient over the age of 12. Spoke to immunization registry, they stated that both doses will still count toward series and to not re-dose either. Pt shouldn't experience any adverse effects from MMRV.
SLEEPINESS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced sleepiness, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, and sore arm. This report was non-serious.
FAST HEARTBEAT; This spontaneous report received from a patient concerned a 52 year old male. The patient's height and weight were not reported. The patient's concurrent conditions included: depression, hyperlipidemia, insomnia and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included sertraline for depression and simvastatin for hyperlipidemia.  On 29-AUG-2021, the patient experienced fast heartbeat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fast heartbeat. This report was non-serious.
Pt experienced heart palpitations, anxiousness, diaphoretic, dizziness. BP 102/57; HR 85; RR 20.  Hx of passing out with shots. Patient stable & released after 1 hour of observation
Patient was counseled to wait around the pharmacy at least 15 minutes after they received both shots as they had not received either type of vaccine before (including flu shot). Noticed difficulty swallowing about minutes after receiving both vaccines, informed customer in line as well as my technician. About 5 minutes later after patient could swallow, was given liquid Benadryl. After paramedics arrived around 25 minutes after vaccine, patient felt normal again.
MENVEO POWDER DILUENT WAS MIXED WITH STERILE WATER DILUENT INSTEAD OF ACTIVE MENVEO DILUENT AND ADMINISTERED-PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS
threw up 13 times in the same day; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (threw up 13 times in the same day) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CHOLESTEROL, Vitamin D, LEVOCARNITINE TARTRATE (WEIGHT LOSS) and Acid reflux medication.    On 19-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Apr-2021, the patient experienced VOMITING (threw up 13 times in the same day). At the time of the report, VOMITING (threw up 13 times in the same day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported .   Reporter did not allow further contact