chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional Information: The patient wanted to cancel appointment on 07Apr2021 because of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm swelling with itchiness, general fatigue Tylenol or panadol , bendaryl was recommended. Physician visit recommended if worse of symptoms
Feeling unwell; nosebleeds; vomiting; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling unwell), EPISTAXIS (nosebleeds) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), EPISTAXIS (nosebleeds) and VOMITING (vomiting). At the time of the report, MALAISE (Feeling unwell), EPISTAXIS (nosebleeds) and VOMITING (vomiting) had not resolved.            No concomitant medications were reported.  Patient received the booster shot and she was feeling unwell. She was vomiting and having nosebleeds after receiving the booster dose. The patient asked for information on how long did it take to go away.  No treatment information was provided.
12/6/01 numbness of soles of feet and palms of hands. Weakness of legs and knees. 12/11 continuance of above; excruciating pain in shoulders, neck, upper arms. This was an extreme situation until second week in January. symptoms persist but milder
tingling of feet- patient said it felt like bees were stinging her, swelling of fingers, fatigue, body aches, headache
raised rash over legs and right upper right shoulder and neck . I still have rash after 13 days. Stiff neck Sever headache and flu like symptoms for 3 days.
On the 14th I woke up feeling congestion and a cough and tickling in my throat the next day I took an antigen test at home and it was positive. I called my PCP the next day and we did a PCR test which was positive. I started feeling tired and then by Monday I was really fatigued and tiredness. I have started a prescription of Paxlovid for my symptoms.
increased liver enzymes and white count; increased liver enzymes and white count; They didn't rule out Covid illness; They didn't rule out Covid illness; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (Age at vaccination: 67-years-old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. About 3 weeks after her dose she ended up being transported by ambulance (for the first time in her life) to the hospital. She reported increased liver enzymes and white count. They didn't rule out Covid illness. Caller has an opportunity to receive her second dose this Saturday, but doesn't know if she should? After returning from hold and providing information to caller, she indicated she would forgo a second dose. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). At the time of the report, PAIN IN EXTREMITY (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-100840 (Patient Link).
I experienced a strong metallic taste approximately 2-5 minutes after receiving the vaccine that lasted about an hour.
Four days after receiving Pfizer booster shot, patient went into complete heart block requiring hospitalization and placement of a pacemaker.
7/27 = vaccine. 8/3 = swollen lymph nodes. 8/13-8/15 = headaches/body aches. 8/6 = changed bandage. 8/7 = lesions in genital area. 8/10 = swab and blood work done b/c Dr diagnosis is HSV for lesions. 8/26 = follow up appt neg blood work and viral culture.
Rash of arms, legs, chest, back, eye swelling. Took Benadryl and fell asleep. Rash minimally improved, and swelling of eye improved. Was advised for worsening sx to seek emergent medical attention.
This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced bone pain. On APR-2021, the subject experienced back pain. On APR-2021, the subject experienced leg pain. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone pain, back pain, leg pain, chills, and fever on APR-2021. This report was non-serious.
11/29/21- Patient received 0.5ml Moderna IM injection as a booster. NHDHHS contacted-nurse advised that patient may have increased symptoms related to the higher dosage. Patient is contacted at approximately 1530 on 11/29/21.  Patient states that they are feeling , 'perfectly fine'.  Aware that NHDHHS and VAERS will be receiving their contact information, that they may receive a phone call.  Health Services plans to reach out to patient daily for 30 days to assess for signs or symptoms and if support is needed.  Email to patient morning of 11/30/21, no response at the time of this report. Human resources is made aware of the incident, not who has been affected. Moderna has been contacted regarding the expiration date of moderna vaccine.  Vial has been stored in a medication freezer with no temperature excursions.  Vial was taken out of the freezer the morning of 11/29/21, was not punctured prior to this time as well.
Noted leaning to side in waiting room, c/o nausea and dizzy when approached. Incontinent of urine, pale, diaphoretic, emesis on way to lie down. P48 initially once lying - up to 52 with BP 86/46 within 5 minutes. Pillows under knees, frequent vital signs home at 4:20 PM. Mom driving, brief loss of consciousness just before laid down.
03/14/2022, I started to develop a scratchy sore throat and a hacky cough. I've never had a cough like this before. On 03/15/2022, I took a rapid test and it was negative. My fever got up to 102 and I started to feel worse. 03/16/2022, I went to the health department to get a COVID-19 test. That same day I had a doctor appointment and I went in. She did a flu test and it was negative. She did a chest X-ray and it indicated some pneumonia and she put me on antibiotics. On 03/17/2022, I received an email stating I tested positive for COVID-19.
Developed chills, muscle aches and unable to lift her arm with injection site the evening of her shot. She had to call off work on 1/8/21
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown gender and age. Information about the patients' medical history and concurrent condition was not provided. On an unknown date, the patients were vaccinated with doses of GARDASIL injection (lot/batch#, expiration dates, dose, dose numbers and route of administration were not reported) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same source. Additional information has been requested.
Pt has redness, swelling, and several pimple size fluid blisters on the left deltoid.  The skin is tight along the entire left upper arm.  The redness and swelling when measured is 16cm x 14cm.  Mom states the child complained about it hurting.  Child has no fever.   Cold compresses have been applied for 20 minutes at a time as tolerated.  Tylenol and Motrin have been alternated for pain.  Child is moving arm around with no issues and does not display pain at the time of observation.   Area was marked and instructed mom to watch area and to let us know if the redness extends beyond the markings.  Instructed to continue the compresses.
08/19/16-started to get red circular rash radiating in a circle around where the vaccine was administered. Itchy as well.
Patient developed a febrile illness accompanied by abdominal pain, rash, neck pain, headaches and conjunctivitis 5 days after vaccination. She was admitted to our hospital on 12/1 with hypotensive shock and is being treated with antibiotics and treatment for MIS-C given unclear picture of her clinical decompensation. At this time, all cultures including blood, urine, throat and sputum are negative. Imaging significant for mesenteric adenitis, cervical adenitis, and small b/l pleural effusions.  Patient is currently intubated and on vasoactive support.
Swollen, painful lymph nodes in armpit of left ram (injection side) very painful when moving arm and to contact symptoms started within 24h of vaccine. Worst pain after ~48h, recovered within 4d of receiving vaccine
did not feel that she got the full dose; person who vaccinated her subcutaneously with the vaccine; it came back the feeling of nausea; headache; a little bit of pain; muscle pain; She had nausea; She was headachy; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (did not feel that she got the full dose), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine), PAIN (a little bit of pain), MYALGIA (muscle pain) and NAUSEA (She had nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (a little bit of pain), MYALGIA (muscle pain), NAUSEA (She had nausea) and HEADACHE (She was headachy). On 12-Mar-2021, the patient experienced NAUSEA (it came back the feeling of nausea) and HEADACHE (headache). On an unknown date, the patient experienced UNDERDOSE (did not feel that she got the full dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 10-Mar-2021, PAIN (a little bit of pain), MYALGIA (muscle pain), NAUSEA (She had nausea) and HEADACHE (She was headachy) had resolved. On 13-Mar-2021, NAUSEA (it came back the feeling of nausea) and HEADACHE (headache) had resolved. At the time of the report, UNDERDOSE (did not feel that she got the full dose) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (person who vaccinated her subcutaneously with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported.  Treatment medication included Arnica Gel and Advil.   This case was linked to MOD-2021-114479 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Non significant follow up added On 07-May-2021: New events under dose, dose through subcutaneous route
Information has been received from a physician concerning a 49 year old male with coronary artery disease, who on 21-JUN-2008 was vaccinated IM with a single dose of PNEUMOVAX 23.  There was no concomitant medication.  On 22-JUN-2008 the patient experienced fever, chills, myalgia, lightheadedness, and some chest pain.  The patient was hospitalized.  A complete blood count was performed and showed leucocytosis.  At the time of the report the patient was still hospitalized and was recovering.  Additional information has been requested.
Myalgias, low grade fever, cough, anorexia. Doxycycline 100 mg BID X 10 d
urinary tract infection; Spots; itchiness; A spontaneous report was received from a consumer  concerning an 80 year old, female patient who developed urinary tract infection, spots (skin discolouration ) and itchiness (pruritus).   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.     The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient received the first dose of the vaccine in her left arm intramuscularly. One day after receiving the vaccine, the patient developed a urinary tract infection. She had never had one before. The patient also reported that she experienced spots and itchiness. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The events, urinary tract infection, spots and itchiness was unknown; Reporter's Comments: Very limited information regarding the reported events have been provided at this time. Patient's medical history, list of concomitant medications, onset date and are lacking including any laboratory test for UTI.  Further information has been requested
Booster given 12 hours after vial puncture; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) 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 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster given 12 hours after vial puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information were not provided. Vaccine administered to the patient more than 12 hours post vial puncture, specifically 4 days later.   This case was linked to MOD-2021-416295 (Patient Link).
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting Fatigue Narrative:
patient fainted 3 minutes after the vaccine , dizzy, problem breathing, headache. heavy chest. patient was given benadryl and epipen 5 minutes after. patient improved  after paramedic came, patient was able to walk out of the store with her father, father stated the will go to the hospital to further check her.
Area surrounding injection site very red and itchy.  About the size of an adult hand. Warm-hot over the weekend.  Area slightly bruised. Lasted until at least 10/22.
Crohn's flare. Methotrexate increase, liquid diet. Some improvement but still ongoing symptoms
Just after waiting 15 minute period after injection, when I stood up I felt a dripping sensation all through the left side of my body.  Then over the coming days I started to have numbness and tingling all on the primarily lower left side of my body.   I kept waiting to see if it would go away - and it was not.  At 10 days post-vaccination I submitted a summary of symptoms through the pharmacy reporting system.  I continue today, after 14 weeks, to have numbness and tingling from my buttocks down to my toes.  Some days are worse than others.
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 22 year old male. 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: 1808986, expiry: 02-OCT-2021) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAY-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 20-MAY-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210915623, 20210915646, 20210915661, 20210915719, 20210915731, 20210915748, 20210915852, 20210916129, 20210913164, 20210916455, 20210916520, 20210916228, 20210916553, 20210916300, 20210916228, 20210916465, 20210916553, 20210916228, 20210916300, 20210916401 and 20210916415.
Feeling like sin crawling worse at night. Feeling like insects crawling on skin. Uncontrollable blood pressure hives dermatologist
On 12/30/2020, ten days after my first dose of the Pfizer-BioNTech COVID19 vaccine, I experience Raynaud's Syndrome in my left ring finger. As of today, that was my first and only episode of Raynaud's. On 6/28/2021 I had my annual labs done and requested to be screened for ANA. My result came back positive and my ANA Reflex was positive for RNP Ab and Centromere Ab. I was then referred to a rheumatologist. I had a very thorough office visit with my rheumatologist on 8/16/2021. He ordered additional labs - ANA titer and staining patterns. The results were a ANA titer of 1:640 with a speckled pattern and centromere pattern.  At this time, my doctor does not think the disease is active and I will be following up with him in August 2022, unless I experience any new or worsening symptoms of disease. With all the data that is now out there regarding molecular mimicry and autoimmunity from the COVID19 virus and vaccine, I do strongly believe that the vaccine triggered autoimmunity in my body.
pain at injection site; fatigue; swelling; vaccine administered after nonviable temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 21-OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain at injection site), fatigue (Verbatim: fatigue) and swelling (Verbatim: swelling). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: vaccine administered after nonviable temperature excursion). In OCT-2023, the outcome of the injection site pain, fatigue and swelling were resolved. The outcome of the incorrect storage of drug was unknown.   It was unknown if the reporter considered the injection site pain, fatigue and swelling to be related to Arexvy.     It was unknown if the company considered the injection site pain, fatigue and swelling to be related to Arexvy.   Additional Information: GSK receipt date: 25-OCT-2023 The pharmacist reported that a patient received a dose of Arexvy that was found not viable after temperature excursion, which led to incorrect storage of drug. The patient had experienced swelling, pain at injection site, and fatigue.  The reporter did not know exactly when the symptoms developed or resolved and did not have the lot or expiry date. The symptoms had resolved.  The reporter did not consent to follow-up. The case had been linked to the case US2023147954, reported by the same reporter.; Sender's Comments:  US-GSK-US2023147954:2 of 2 report
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were unknown. The reporter considered the fever and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist called to check the incidence rates of adverse events and commented that 3 patients who received SHINGRIX did report injection site pain or low grade fever. At the time of call, the health care professional did not have patient or vaccine information. The reporter was unsure if anything was done to treat the symptoms and if the symptoms were resolved, etc. This case has been linked with US2018077568 and US2018GSK082722, reported by the same reporter.
Patient came into walk-in child vaccination clinic. Approx. 10:58 am child sat down in chair--mother and uncle beside her. Mother and child--foreign speaking only--uncle was acting as translator. 11:00 am varicella vaccine administered in right arm SQ followed by Hep A vaccine in right deltoid. Pt. tolerated well--appeared to be happy with no SXS of pain, SOA -- child reported no pain at insertion site--no erythema at site seen by RN--covered with band-aid. 11:10am uncle carried patient back into immunization room--stated she had "fainted" in waiting area. Pt. sat down in chair--pt. appeared to be alert, but look extremely pale. Shortly after sat in chair---patient's arms stiffened up towards chest--body appeared to be rigid and eyes rolled back in head (EMS called)--pt. was lowered onto floor (pt. in supine position)---episode lasted no longer than 20 seconds---ammonia smelling salt placed under nose--pt. able to state name, age and place. Ice pack placed on forehead as well as on abdomen. Vitals were as follows: 11:15 BP (lying down) 92/51 P 57 (EMS arrived) 11:18 BP (lying down) 90/54 P 68 Orthostatic BP started----11:20 BP (lying down) 90/54 P 84  11:23 BP (sitting) 97/63 P 77  11:24 BP (standing) 97/68 P 74. Pt. appeared to be stable. Pt reported no pain, dizziness, or SOA. Pt. alert and oriented--still pale. Asked family if they would like EMS to transport pt. to hospital nearby--declined.  Informed pt.'s family if pt. should show any SXS of reaction or anything like previous episode to take pt. to physician or hospital--pt.'s family verbalized understanding.