chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in left arm that has now continued almost a week. Pain has gotten to the point that I feel like I'm constantly losing circulation in my arm with the pins and needles feeling. I get this feeling almost immediately when anything touches my upper arm or shoulder. It's keeping me from sleeping. I had to move to a recliner to get enough weight off of my arm to not feel pain. Even laying on my back with my arm touching the bed or on my back with my arm above my head, on my back with my arm on my stomach/chest, or on my right side with my arm laying on top of the rest of me causes too much pressure and I get pain, pins and needles. This was not an issue prior to receiving the flu and Pfizer vaccines.
She has 7 minutes into her waiting time after the vaccine. She states she became hot and dizzy. She had a feeling of swelling to her throat and tongue and hoarseness. She was given Benadryl orally and EMS was activated. They took her to the hospital and she left before getting seen. She comes into clinic today with continued complaints of dizziness, hoarseness, and diarrhea. This has been going on since her injection on 5/6/2021.
really bad chills; really ill; weak; tired; body aches; headaches; She was in bed for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EW0171) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure", start date: 2016 (ongoing); "Chronic kidney disease", start date: 2014 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot: EP7533, Expiry: Unknown, Right arm, first time she received the shot in Apr2021 she broke out in hives and itched and went to urgent care and they gave her Benadryl.), administration date: 01Apr2021, when the patient was 53 years old, for Covid-19 immunization, reaction(s): "she broke out in hives", "itched". The following information was reported: CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "really bad chills"; ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "really ill"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weak"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tired"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "headaches"; BEDRIDDEN (non-serious) with onset Apr2021, outcome "unknown", described as "She was in bed for 2 days".  Additional information: No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She said that she had the second dose on a Thursday and came home from work early on Friday and stayed in bed on Saturday and Sunday.   No follow-up attempts are possible. No further information is expected.
Severe body wracking chills beginning at 530pm CT, diminished temporarily with the use of Advil, but lasting until 8am CT the next morning (4/24/2021). Fatigue, lack of energy, lasting until 7pm CT on 4/24/2021. Body soreness lasting until morning of 4/25/2021.
losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out; little bumps on the scalp; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out) and RASH (little bumps on the scalp) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L10A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS, Hypercholesterolemia and Thyroid disorder NOS. Concomitant products included FAMOTIDINE for Allergy, ATORVASTATIN and EZETIMIBE (ZETIA) for Hypercholesterolemia, LEVOTHYROXINE for Thyroid disorder NOS.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ALOPECIA (losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out) and RASH (little bumps on the scalp). At the time of the report, ALOPECIA (losing her hair; started in the crown of her head and now she is starting to lose her hair in the front; used a hairbrush and her hair started coming out) and RASH (little bumps on the scalp) outcome was unknown.             Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow Up received on 20-JUL-2021 contains non significant information. Contact information (email address) for the reporter was updated.
loss of color in the fingertip of right ring finger - returned a few minutes later- Never happened before  body aches lasting longer and are more difficult to manage more than with the first two doses of Moderna -  general exhaustion  Have photos ..
Sore arm, tiredness, chills during the night on day of vaccination, chills during the evening and night on the day after, rash on the arm at injection site, about 3 inches square, on the second night.
Had sore arms the same evening and next day. Severe malaise and body aches starting 24 hours later. 24 hours after vaccine state she had severe joint pain that moved from one joint to another lasting 1-3 days in each area-shoulders, hips, fingers, toes, wrist, elbow. Hip pain caused difficult walking. Right thumb was sore and swollen 2+ weeks. Used Advil, Aleve, warm baths and cold packs at 4 weeks states "90% better" with gradual easing of symptoms. Patient did not see a doctor. She called Dr.'s office for advice on 11-20-06. They advised her to take Aleve regularly and see her family doctor if no improvement in a few days. She still has not seen a doctor because pain is decreasing slowly but steadily.
Starting 05/05/2022. I got a dry cough. Friday 05/06/2022, I got a stuffy nose. Then, I did the COVID-19 at home test on 5/07/2022 which was positive. I didn't have a fever and my pulse oximeter said my oxygen level was 95 (normal for me). Sunday I felt a little worse but not bad. I feel a lot better today but I still have a cough, stuffy nose and slight fatigue. This hasn't been bad and I have had worse flu episodes before.
Lacy vascular rash on both calves.  Calf pain and cramping.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. 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: Unknown) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had tested negative for multiple antibody tests (confirmed immunological vaccine failure). According to reporter, the patient received vaccination 10 weeks ago. The reporter believed that the patient did antigen test for immunoglobulin G (IgG) and immunoglobulin M (IgM) .  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 report was associated with product quality complaint: 90000179671. The suspected product quality complaint has been confirmed to be not voided, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210529730-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
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. From 25-OCT-2017 through 07-NOV-2017,  the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # N000175, expiration date 20-SEP-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. The temperature involved was 35 degrees Fahrenheit for 16 hours. There was no previous temperature reported, and a data logger was not involved.; Sender's Comments: US-009507513-1711USA010360: Original Case : 1711USA003934 US-009507513-1711USA010361: Original Case : 1711USA003934.
Nausea that begins around 11am and lasts up to 6 hours; headache that goes away with TYLENOL.
Subcutaneous nodules (x2 on (R) thigh) with overlying erythema and a few pinpoint papules, first noted by mother on 7/14/18 (vaccine given on 7/5/18). Non tender. Recommended topical steroid (HC 1%) BID x 1 wk and monitoring for increased redness, pain, swelling, fevers.
Golf ball sized red, hot, & sore knot at injection site still present 72 hours after vaccine; general "flu" type symptoms; 36 hours of fever up to 102 degrees; 48+ hours of general body soreness, aches, pains and exhaustion; 72+ hours of general tiredness and weakness; currently  I feel that I am 80% recovered from the "flu type" symptoms, however, the knot at the injection site is still very much present
Approximately 2 days post vax, this pt developed injection site swelling and redness of the entire upper arm. The pt was treated with prednisone and cyproheptadine hydrochloride sesquihydrate and advised to notify the physician if the symptoms persisted.
I was seen for a regular specialist visit and my doctor noted the my blood pressure was elevated. She told me to schedule a follow-up with my primary to have continued monitoring or treatment if needed.
Information has been received from a physician concerning an approximately 19 year old female with no known allergies and a history of folliculitis due to Razor who on 24-JUN-2008 was vaccinated with the third dose of GARDASIL vaccine (lot no. 660391/0063X). There was no concomitant medication. On approximately 26-JUN-008, "approximately two days later," the patient developed raised spots on her forearms and legs. The patient was treated with oral BENADRYL and she was recovering from the symptom. Additional information has been requested. This is in follow-up to report (s) previoulsy submitted on 7/15/2008. Information has been received from a physician concerning an approximately 19 year old femaled with no known allergies and a history of folliculitis due to RAZOR who on 24-JUN-2008 was vaccinated with the third dose GARDARSIL vaccine (lot no. 660191/0063X). There was no concomitant  medication. On approximately 26-JUN-2006, "approximately two day later", the patient developed raised spots on her forearms and legs. The patient was treated with oral BENADRYL and she was recovering fromthe symptom. Follow-up information was received from the physician stating that the physician could not recall which patient this was. Additional information is not expected.
fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number T4952, expiry date 18th June 2021) for prophylaxis.   On 21st March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The husband reported that his wife had the Shingrix and experienced a fever of 101 to 101.5.  The reporter consented to follow up. No additional details were available as the reporter's cell phone died in a remote location. This case has been linked with US2019AMR149970, reported by same reporter.      Lab Comments: Lab test performed on an unknown date
Got a mild COVID case, with fever of 101.5 and malaise.  No other symptoms.
This spontaneous report was received from a registered nurse and refers to 5 patients of unknown ages and genders. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # N010247 or lot # N010865 for prophylaxis. Concomitant therapies included sterile diluent (DILUENT MRK). No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA008323:
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 5 (booster), single (Lot number: GL0446) at the age of 52 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: ER2613), in right arm, on 02Apr2021 as dose 2, single (Lot number: EW0150), in right arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "GuillianBarr", start date: 1985 (unspecified if ongoing); "Encephalitis", start date: 1985 (unspecified if ongoing). Concomitant medication(s) included: VITAFUSION WOMEN'S, stop date: 13Oct2023; KIRKLAND SIGNATURE VITAMIN C, stop date: 13Oct2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (21Oct2023) Negative, notes: getting two negative covid tests results 48 hrs apart; (24Oct2023) Negative, notes: getting two negative covid tests results 48 hrs apart; (26Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date 17Oct2023, stop date 21Oct2023). Clinical course: The patient had positive Covid Test result and symptoms two days after finishing Paxlovid and getting two negative covid tests results 48 hrs apart. 21Oct2023: last day on Paxlovid 24Oct2023: negative covid test 26Oct2023: negative covid test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300351006 same patient, different drug/event;US-PFIZER INC-202300351009 same patient, different dose/event;
pt recv vax 2JAN96 & 21JAN96 pt devel flu-like sx manifested by arthralgia malaise, h/a, low grade fever;22JAN96 pt devel 3 lesions;24JAN96 approx 75 lesions distributed on back, trunk & face w/fever of 101;
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. This occurred on 3/7/21, 4/1/21, 4/3/21, 4/24/21 and 4/29/21. The patient died on 4/30/21
LOSS OF VISION; THYROID STOPPED WORKING PROPERLY; TREMORS; HEART POUNDING; NIGHT SWEATS; This spontaneous report received from a patient on social media  via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. The patient's pre-existing medical conditions included: Patient had normal thyroid in June. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on NOV-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On NOV-2021, the patient experienced tremors, heart pounding, loss of vision, night sweats, thyroid stopped working properly and patient stated that this happened 4 weeks after the shot and the covid shot ruined the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the tremors, heart pounding, loss of vision, night sweats and thyroid stopped working properly was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211212519-COVID-19 VACCINE AD26.COV2.S-Loss of vision. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
possible blood clot for the event of thrombosis; 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 THROMBOSIS (possible blood clot for the event of thrombosis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (possible blood clot for the event of thrombosis). At the time of the report, THROMBOSIS (possible blood clot for the event of thrombosis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported.  No Treatments were reported.  Company Comment: Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
10-29-07 when she went to bed felt uncomfortable when she layed on her left side. After her bath this morning at 0700 noticed red puffy area below bandaid where received injections. 10/31/07 1150 70mm x 5511 erythema warm to the touch. 10/31/07 0900 totally resolved. No further issues.
Feeling lousy, some cough and shortness of breath, and possible spread to left nipple.
Extreme pain in right shoulder radiating down arm resulting in iability to raise right arm. Numbness in right hand.
Dermatographia for over a month now. Started a rigorous regimen of anti-histamine therapy on 12/21/21 with the anticipation of completing 2-3 months from now.   Visited Urgent Care at start of reaction in November. Started with prednisone 50mg at start of reaction for 5 days. Reaction kept happening  and visted Teladoc appointment  have gone on a 12 day tapering prednisone dose starting at 50mg working down to 10mg. No improvement so starting the antihistamine treatment after visit to Dr.
Severe pain at the injection site, numbness in arm, severe headache, and vomiting that lasted 3 days.
felt tingling in my left arm at the injection site; I slept a lot.; felt tingling in my right arm, too; tired; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PARAESTHESIA (felt tingling in my left arm at the injection site), HYPERSOMNIA (I slept a lot.), PARAESTHESIA (felt tingling in my right arm, too), FATIGUE (tired) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PARAESTHESIA (felt tingling in my left arm at the injection site), HYPERSOMNIA (I slept a lot.), PARAESTHESIA (felt tingling in my right arm, too), FATIGUE (tired) and CHILLS (chills). At the time of the report, VACCINATION SITE PARAESTHESIA (felt tingling in my left arm at the injection site), HYPERSOMNIA (I slept a lot.), PARAESTHESIA (felt tingling in my right arm, too), FATIGUE (tired) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case is concerning a male patient of unknown age with no medical history reported, experienced the unexpected, AESI of Hypersomnia and other nonserious events. The event occurred 28 days after the third dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     This case was linked to MOD-2021-403276, MOD-2021-403277 (Patient Link).; Sender's Comments: This spontaneous case is concerning a male patient of unknown age with no medical history reported, experienced the unexpected, AESI of Hypersomnia and other nonserious events. The event occurred  28 days after the third dose of mRNA-1273 vaccine. The outcome was reported unknown. Patient was reported to be fully vaccinated before the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Hallucinations Fever Chills Weakness Fatigue Headache Muscle pain Insomnia Malaise Nausea Lack of appetite Disturbed sleep
Feel lousy; A loss of appetite; Fatigue; Muscle pain; Pain where shot was given; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel lousy), DECREASED APPETITE (A loss of appetite), FATIGUE (Fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain where shot was given) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced MALAISE (Feel lousy), DECREASED APPETITE (A loss of appetite), FATIGUE (Fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain where shot was given). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 12-Jan-2022 for Adverse event, at a dose of 2 Tylenol. At the time of the report, MALAISE (Feel lousy), DECREASED APPETITE (A loss of appetite), FATIGUE (Fatigue), MYALGIA (Muscle pain) and VACCINATION SITE PAIN (Pain where shot was given) outcome was unknown.            No concomitant medications were provided.  On 11-Jan-2022 the patient got the booster dose of the Moderna COVID -19 vaccine at around 6p. They gave her half a shot. The patient took 2 Tylenol about an hour ago at the time of reporting.  The age of the patient was reported as 80s.