chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced unspecified adverse event. The action taken with covid-19 vaccine  was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Patient was given immunization and felt dizzy and light-headed like he was going to pass out.  Myself and his mother had him sit in a chair for a minute and then walked him over to a bench area with his brother.  I was getting ready to give the mother her vaccine and the 10 year old patient fainted and fell to the ground.  He woke up immediately and didn't realize what happened.  We sat with him for about 10-15 min until he felt better.  He was able to drink some water and eat a cookie.  He said he was feeling nervous about the shot and this may have led to him passing out.  He seemed fine but a little shaken up and was able to walk on his own power.
This spontaneous report as received fro a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 21-AUG-2015, the patient was vaccinated with an unknown dose of VAQTA that was improperly stored (lot # L009445, expiry date 01-JUN-2017, route was not reported). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
10 cm width x 8 cm hight area of redness with firm 2 cm center. Warm to touch.
6 bumps  about the size of bee sting swole up around shot site , lasted for week , itched , getting better , no other symptoms
arms started shaking, legs started shaking; tingling in arms, tingling in legs; Hot flashes; swelling of her neck; swelling of her face; Skin reactions; anxiety; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck) and SWELLING FACE (swelling of her face) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.     On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced TREMOR (arms started shaking, legs started shaking) (seriousness criterion hospitalization), PARAESTHESIA (tingling in arms, tingling in legs) (seriousness criterion hospitalization), HOT FLUSH (Hot flashes) (seriousness criterion hospitalization), SWELLING (swelling of her neck) (seriousness criterion hospitalization) and SWELLING FACE (swelling of her face) (seriousness criterion hospitalization). In August 2021, the patient experienced ANXIETY (anxiety). On an unknown date, the patient experienced SKIN REACTION (Skin reactions). The patient was hospitalized from 12-Aug-2021 to 18-Aug-2021 due to HOT FLUSH, PARAESTHESIA, SWELLING, SWELLING FACE and TREMOR. The patient was treated with ALPRAZOLAM (XANAX) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (arms started shaking, legs started shaking), PARAESTHESIA (tingling in arms, tingling in legs), HOT FLUSH (Hot flashes), SWELLING (swelling of her neck), SWELLING FACE (swelling of her face) and SKIN REACTION (Skin reactions) outcome was unknown and ANXIETY (anxiety) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was hospitalized from 12-Aug-2021 to 18-Aug-2021.  Lab investigation performed included  EKG, stress test, MRI of her brain and spine, bloodwork, and a CT of her lungs with unknown result.  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.  However, more information is required for further assessment. Follow up is expected.; Sender'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.  However, more information is required for further assessment. Follow up is expected.
Received Tdap at 11:20AM - while standing at check-out reached (R) arm out to counter. He slid off counter and fell, slashing head, eyes open - staring. Nurses described twitching - last < 10 sec. C/o "blackness" didn't remember fall. Kept for about 1 hr before leaving. Felt lightheaded x 1 approximately 30 min later.
Narrative: 69 yo male w/a PMH significant for lacunar infarction, anemia, h/o alcohol abuse, chronic pain, HTN, and hyperlipidemia who received his first dose of the Moderna COVID-19 vaccine on 02/17/21. Fifteen minutes after receiving the vaccine the patient lost consciousness for about 20 seconds then regained consciousness. He had minor jerking of his upper and lower extremities and urinated on himself. The patient was given epinephrine and ondansetron 4 mg due to concern for allergic reaction to the vaccine and was transferred to the ED. Of note, the patient's creatinine was found to be 1.0 (baseline 1.4) in the ED. The patient was evaluated by neurology in the ED and it was suspected that patient experienced a seizure. The patient was discharged home in stable condition and will be following up with outpatient neurology soon.
Pt vaccinated with DTP/OPV developed fever 102, uncomfortable, poor sleep x 3 wks, poor appetite, occasional shakes, mother did not report until time for next shot-not examined at time of problems to r/o other illness, etc. Refused 2nd DTP.
At 15:00 Patient received Janssen vaccines, Lot 1805018 Exp 05/25/2021 At 5:15 Patient started experiencing tingling around the nose. VS: 74 HR , BP 137/101, O2   97 % Room air. Observed patient an additional 15 minutes. Offered patient a bottle of water. 15:35 VS: 62 HR, BP  135/93 Left arm. 98  O2, sat room air. Patient states he feels better and the tingling is gone.
On last summer heart started racing to 177. I went to urgent care from there went to ER. I was admitted got  a shot to bring my heart rate down. I was discharged and referred to Cardiologist. The Cardiologist prescribed three medications for A fib. My doctor stated I don't have Afib took me off the medications that I got SVT. I'm scheduled for a ablation on next week. I do have cancer in my family no history of heart problems.
I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had  a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80.  Sounds normal, but I?ve never had a blood pressure reading that high!  I felt ok enough to leave with my husband, but later got dizzy, nauseous  and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance.  Note: I run 5K every other day and bike or walk on off days, so I?m pretty active.  I took Tylenol and went to bed early and was stiff, but better the next morning.  Made myself get outside for a light run and was basically fine (albeit very tired) the next day.  First day was a little scary though.
I have had severe postnasal drip for weeks to months after every mRNA vaccine that I have received. I did not make a report previously after receiving Bivalent Pfizer or my initial 2 doses of original Pfizer vaccine (12/2020 & 1/2021), but I decided that I should due to the consistency of the symptoms. I am a nurse, so I have not sought additional medical care.
Not the typical fainting and syncope; This case was reported by a nurse via call center representative and described the occurrence of syncope in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced syncope (serious criteria GSK medically significant). The action taken with Menveo was unknown. On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Menveo.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter routinely administers Menveo and had the demonstrated wealth of experience with the vaccine. On 2nd August, the they began administering Menveo under a new lot number. The reporter stated that they were alarmed not only at the unusual high rate of adverse event but also the degree and severity of the adverse event where they had not previously witnessed before. These adverse events were documented in the product prescribing information and included over time after the product launch. There was no change in the health care professional administering Menveo and no change in the syringe or needle. The reporter stated  that this had not just been your typical adverse reaction of syncope. The reporter had work within the immunization program for 7 years and had never seen these types of reactions. They had all been completely different than your typical fainting and syncope. This case is one of the 4 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021167017:Same reporter. Patient 1 atypical case. US-GLAXOSMITHKLINE-US2021AMR167723:Same reporter. Patient 2 atypical case. US-GLAXOSMITHKLINE-US2021AMR167724:Same reporter. Patient 3 atypical case.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-OCT-2015 11:59, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 16.2 and -2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Evening of 10/1/20 mom noticed large red area surrounding injection site on right thigh. Area is warm to touch. It is red, raised and blotchy.   Mom brought child to clinic on 10/2/20 for evaluation. Confirmed 9cm area of erythema to right thigh. Area is warm to touch. Child does not appear in any distress and denies pain. No changes in appetite or day to day activities. Mom did give Children's Benadryl the night of the shot. Will treat with benadryl and prednisolone daily for 5 days. Also use cool packs to area for short periods of time.
BREAKTHROUGH COVID: FULLY VACINATTED 94-year-old female who presents to the ED on 6/1/2022 after a fall at home as well as with difficulty breathing, cough, lethargy and decreased appetitie for past few days. On arrival her O2 sats were 80%on RA.   Initially she was started on BiPAP and admitted to the ICU under critical care.  She has hx of OSA and Acute respiratory failure present on arrival.Diagnosised with acute distal HF with exacerbation, pernicious anemia.  She was noted to have pulmonary edema and was given iv  diuretics and her breathing improved. She is currently on 4 L nasal cannula. She was + for COVID PCR.  Patient was treated with Decadron. Treated and weaned off oxygen completely.
Redness, heat and swelling at site. Hard in the center around vaccination entry. Redness continued to spread along with heat and hardness to 4 inches in circumference at this time.
4JUN91 approx 9AM was OK x/for minor erythema @ inject site; 6JUN91 began crying/screaming almost constantly w/inc loudness & duration, fever 101F rectally, shaking -tremor of extremities;
The night of the shot, I began having symptoms: fever, shakiness, headache, nausea, neck pain, severe arm pain, and tiredness. My fever remained at 102 until the following morning when I began taking Tylenol every 6 hours for the fever. The tiredness, headache, neck pain, and arm pain lasted until 4/16/2021 (4 days).
Abdominal pain; Runny diarrhea; This is a spontaneous report from a non-contactable other healthcare professional. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the right arm on 24Feb2021 at 16:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus syndrome, congestive heart failure (CHF), sjogren's, rheumatoid arthritis, raynauds, endometriosis, depression, cardiomyopathy, penicillin allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient received a long list of unspecified medications within two weeks of vaccination. The patient previously received hydroxyzine hydrochloride (HYDROXIZINE) and hydromorphone hydrochloride (DILAUDID) for an unknown indication on unknown date and experienced drug allergy. On 25Feb2021 at 16:00, the patient experienced abdominal pain and runny diarrhea. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abdominal pain and runny diarrhea was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case reported by a pharmacist, describes the occurrence of syringe issue (liquid squirted in her eye due to a faulty syringe) and occupational exposure to product (liquid squirted in her eye due to a faulty syringe) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced syringe issue (liquid squirted in her eye due to a faulty syringe) and occupational exposure to product (liquid squirted in her eye due to a faulty syringe). At the time of the report, syringe issue (liquid squirted in her eye due to a faulty syringe) and occupational exposure to product (liquid squirted in her eye due to a faulty syringe) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. It was reported while one of technicians was administering a vaccine, liquid squirted in her eye due to a faulty syringe.
Redness, itching, and swelling. Injection was given at approximately 1:30 p.m.; redness and swelling by 9:30 a.m. the next morning was approximately 2.25 inches in diameter.  Redness and swelling increased to 4.5 inches diameter and remained red and itchy for 5 days. Xyrtec dose was increased beginning day 2 (1 in morning, 1 at night). Redness, swelling, and itching started improving day 6 after injection. Approximately 24 hours after injection, experienced mild fever, slight headache, and fatigue, which lasted several hours but was gone by the following morning.
but not as bad as the first time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "not recovered", described as "but not as bad as the first time". Therapeutic measures were not taken as a result of feeling abnormal.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pruritic rash on legs, buttocks; exam revealed raised, erythematous patches; tx symptomaticallyw/antihistamine & topical steroid cream;
Large swelling at injection site, approximately 6? x 6?, hard and warm to touch, extreme soreness and pain, radiating through arm into armpit, burning
administered with expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were not stored in the refrigerator and directly thawed them from the freezer before administration. The vial did not undergo any temperature excursions. No treatment medications were reported
Patient recieved ppsv 23 and said she had swelling of arm and chest and pain.
Headache/Pressure/Burning in my brain Numbness in left arm and side of body - mostly resolved as of the date of this report.  Still have numbness in my left hand, face, chin, and lips Fatigue Brain Fog - difficulty focusing, concentrating, articulating   Balance feels off Drugged Feeling Nausea - mostly resolved as the date of this report. Burning tongue Burning throat - mostly resolved as the date of this report.
Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (Patient received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    Dosage text was reported as additional booster.  No concomitant medications were provided by the reporter.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow-up information included patient's age group updated.
Menstrual bleeding for 3 weeks (so far) despite being on continual birth control and not having any Menstrual bleeding for 3 months prior
Hot at the site of injection; Swollen arm; Itchy at the site of injection; Red at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the site of injection), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the site of injection), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection). The patient was treated with ASIMINA TRILOBA (LUCAS PAPAW) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot at the site of injection), VACCINATION SITE SWELLING (Swollen arm), VACCINATION SITE PRURITUS (Itchy at the site of injection) and VACCINATION SITE ERYTHEMA (Red at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender'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.
2 hours after shot: headache, 12 hours after shot: intense relentless body pain, fever, sweating, 24 hours after shot: extreme body pain, chills, sweating, 36 hours after shot: significant body pain.
patient was still not vaccinated with the 2nd dose at the moment of the conversation; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately one year ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-Oct-2022 Reporter's comment: The pharmacist requested to administer the second dose or to revaccinate the patient.  That means that patient was still not vaccinated with the 2nd dose at the moment of the conversation.  The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
wheezing, fever, up to 104F; sweats, frank confusion, hypertension
3 days post vax pt began to exp swelling, redness/inflammation @ inj site;pt also reported numbness in fingers & swelling in lt armpit;pt saw MD 24FEB97;per MD office tenderness @ inj site is resolving;cellulitis resolving;eczema;