chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 at 02:30 as dose 1, single (Lot number: EN6203), in left arm, on 21Mar2021 at 02:00 as dose 2, single (Lot number: FR8727), in left arm, on 01Oct2021 at 01:00 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 08Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteopenia" (unspecified if ongoing); "highly cholesterol" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: I tested negative for Covid after the five day period; Positive, notes: and then when testing a couple of days later I tested positive; Positive, notes: I have now tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Mild chest pain day four post covid vaccine #2.  Evaluated in ED, cardiology and infectious disease consulted.  well appearing  and discharged home from ED with follow up with cardiology.
Patient reports feeling tingling in her right big toe later the same day of the vaccination. It lasted for 2-3 weeks after the vaccination before going away on its own.
extreme hallucinations; not feeling well; chills; aches and pains; headaches; slight numbness in his extremities; difficulty walking; he did not get much sleep; fever; This is a spontaneous report from contactable consumer (parent). An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 23Apr2021 at 12:45 (Lot Number: Ew0153) at the age of 18 years, as a single dose for COVID-19 immunization. Medical history included autism spectrum disorder, ADHD (Attention deficit hyperactivity disorder) combined, learning disabilities. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included alfetamine aspartate/alfetamine sulfate/dexamphetamine saccharate/dexamphetamine sulfate (ADDERALL) taken for an unspecified indication. Historical vaccine included BNT162B2, dose 1 in left arm, on 02Apr2021, lot # EK5730. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 21:00 the patient experienced extreme hallucinations, not feeling well, chills, aches and pains, headaches, slight numbness in his extremities, difficulty walking, he did not get much sleep, fever. The clinical course of events was reported as follows: My son reported to me at bedtime last night, the night of his second Pfizer vaccine dose, that he was not feeling well. I told him to take some Advil and go to bed. He had a very bad night with chills and aches and pains but most distressing was his description of having had extreme hallucinations. He said that he was aware they were hallucinations and not real during and after the experience, but it was nonetheless concerning. It is also concerning that he didn't wake me for help. At any rate, he did not get much sleep and I have to assume his fever went pretty high before morning. He described to me the need to hydrate during the night. He also relayed to me this morning an experience of headaches and slight numbness in his extremities, difficulty walking, but he is now feeling much better. He is dressed, has eaten, and is playing games on the computer. I am keeping a close eye on him today and should we return to that level of concern, we will take him to urgent care.  The clinical outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Rash few on chest, swollen glands. Rash started 1-2 days ago at least 7 days after immunization.
Tinnitus in ears, starting loudly in the right ear at 16hrs after vaccination and softer in the left ears. Left ear became louder over the next week. Called primary care doctor twice over the next couple days and saw ENT on 4/28/21 after vaccination. No hearing loss detected and no cure available for tinnitus.  ENT was unable to say if tinnitus will resolve over the next few weeks/months. Considering  it has been nearly 4 weeks, I consider this to be permanent damage.
tested positive for Covid; cough; colds; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: not provided), via an unspecified route of administration on 21Jan2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant were not reported. Patient stated on 23Jan2021 patient got colds and cough, tested positive for COVID-19 on 26Jan2021 after getting the first dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Complete disruption to previously regulated hormonal cycle. Heavy bleeding (up to 8 days, from previous 4-5days), cycle went from 27-28 days to 25-40 days. Extreme pms/pmdd symptoms. Sought weekly hormonal balancing treatments at acupuncturist, which did not resolve issue. Ceased taking hormonal birth control after consulting with doctor. 8 months after vax, still not on hormones, cycle is finally re regulating.
Palliative care for over 1 year prior.  o2 dependent. 11/23/2021 with decline evident,11/23- Facial flushing with general malaise, congestion noted. BP 165/61. 98.5-101-28. Rapid Covid-19 tests negative. Had Covid-19 in May 2020 O2 sats initially 80%-increase of O2 to 4.5 L  via NC-O2 sat 94% CBC, BMP stat. CXR stat results: elevated WBC, CXR results with Right basilar  airspace disease N.O. Rocephin 1 gram IM X 7 days for leukosytosis 11/24- continued lethargy/fatigue. leukocytosis and COPD  exacerbationN.O. IV hydration, continue with IM rocephin, hold lasix and metformin N.o. Ativan 2 mg/ml-0.25 ml (0.5 mg) po q 6 hrs prn  for agitation, SOB. 11/25- N.O UA and C/S  11/26- D/C IVF, lethargic and with labored breathing Lorazepam intesol 11/27- not responsive, receiving comfort care and meds.  11/28 passed away     DNR/DNI, no hospitalizations or IV's per family. Passed away on 11/28/2021.
It was reported that a 53 year old male received Fluzone SV '99-'00 on 10/12/99. He experienced wheezing, tingling of fingers, sweating and dizziness 25 minutes, post vax. The pt was treated in the ER. No further information is available at this time.
The morning after H1N1 vaccination, child began a wet, persistent cough.  No other symptoms are present.  The cough remains unresolved as of today 02/15/2010.
This spontaneous report was received from a male patient of unknown age regarding himself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). On an unknown date, the patient developed rash after receiving ZOSTAVAX. The outcome of rash was unknown. Additional information has been requested.
Swollen lymph node in right armpit with soreness.  Estimated size of swelling 1/2 a tennis ball.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 26-NOV-2022, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221: US-009507513-2305USA004262:
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Mild, Systemic: Nausea-Mild
No adverse event; a temperature excursion for Gardasil 9; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.     On 19-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 dose, lot # 1621926 with expiration date 28-NOV-2021) via an unknown route for prophylaxis. The administered dose experienced a temperature excursion of 53 degrees Fahrenheit (F) for 24 hours. There were no previous temperature excursions. No data logger was involved. No other adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621926; expirationdate: 28-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
large benign mass (cyst) on left breast 5cm; inappropriate schedule of vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of BREAST CYST (large benign mass (cyst) on left breast 5cm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Menopausal symptoms, PROPRANOLOL for Tremor.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration). On 25-Apr-2021, the patient experienced BREAST CYST (large benign mass (cyst) on left breast 5cm) (seriousness criterion medically significant). On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved. At the time of the report, BREAST CYST (large benign mass (cyst) on left breast 5cm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2021, Ultrasound scan: a large benign mass (cyst) on left breast in the u (abnormal) a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm. On 25-Apr-2021, X-ray: a large benign mass (cyst) on left breast in the u (abnormal) a large benign mass (cyst) on left breast in the upper quadrant of the nipple approximately 5 cm.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Company comment: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 013M20A. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-127410 (Patient Link).; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 013M20A. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Client reports that a few hours after receiving 2nd COVID vaccine dose, he felt lightheaded and fainted for 30 seconds.  Lightheadedness resolved within 30 minutes.  Client did not follow up with his primary care provider after 2nd dose to make aware of symptoms.
G47.33 OBSTRUCTIVE SLEEP APNEA 4/7/2023 HTN (HYPERTENSION) G47.33 OBSTRUCTIVE SLEEP APNEA 4/7/2023 SUPERVISION NORMAL FIRST PREGNANCY, THIRD TRIMESTER
BLOOD CLOT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was vaccinated with with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose was not reported, 1 total, administered for prophylactic vaccination.  No adverse events were reported following administration of covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received an additional company suspect of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: Unknown expiry: Unknown) dose was not reported, 1 total, administered on 03-DEC-2021 for prophylactic vaccination. 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 an unspecified date in DEC-2021, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2), the patient had a blood clot and was taken to the emergency room. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clot. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211227747- Covid-19 vaccine ad26.cov2.s-blood clot. This event is considered unassessable. The event 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.
Information has been received from a female registered nurse (R.N.). It was reported that a drop of VARIVAX (Oka/Merck) (lot # not reported) splashed into the nurse's eye when she was vaccinating a patient. The nurse stated that she had contacts on but she removed the contacts and rinsed her eye with contact lens saline solution. The nurse stated that she "feels funny because she is wearing glasses but does not believe this was from the vaccine splashing in her eye". Her eye was normal except "for feeling like there is a little something in it". Additional information has been requested.
Noticed 8 days after injection, a new soreness around injection site the evening of 1/13/2021.  Upon discovery, there was a large flat red rash around the injection site about the size of a tennis ball and blotchy. There was minor growth the following morning but is not as red. Monitoring growth and redness for the next couple of days.
Approx. 3 hours, post vax, pt had a measly rash over his entire body. He had swelling around his eyes and some coughing. He was brought into the pediatrics clinic and was given an RX for Benadryl. On 8/24/01, child was referred to allergy clinic for evaluation and work-up.
Period started early. I  have very regular periods, but right after vaccine shot #2, my period comes, which is about a week ahead of its normal date.
heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation; This is a spontaneous report from a non-contactable consumer (patient). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 07:45 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Medical history included allergies to medications of Clindamycin, Penicillin, Amoxicillin, Statins and hypertension (controlled on medication), type 2 diabetes (diet controlled), obesity, obstructive sleep apnea, thyroid nodules benign. Concomitant medication(s) included metoprolol (METOPROLOL), fosinopril (FOSINOPRIL, furosemide (LASIX [FUROSEMIDE]), niacin (NIACIN) and bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. On 20Mar2021 18:00, the patient started to have heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation. Cardiac, thyroid and all other labs were normal. Atrial fibrillation resolved in the emergency room without treatment. Discharged to home, appointment in clinic on 23Mar2021 with a cardiologist, who ordered Cartia XT (started 23Mar2021) and Eliquis (started 23Mar2021 after stress test). On 24Mar2021 a cardiac echo and a myocardial profusion imaging stress test were completed and results on both tests were reported as being normal. There was no past diagnosis of atrial fibrillation or of the above symptoms of heart palpitations and rapid irregular heartbeat. The symptoms have not been experienced since the initial episode on 20Mar2021. Plans are to remain on Cardia XT and Eliquis, and to be seen on 23Jun2021 in the cardiology clinic for an electrocardiogram and an appointment with the cardiologist. Therapeutic measures (Cartia XT 120mg per day, Eliquis 5mg two times a day) were taken as a result of the event. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021 the event was recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
CONFIRMED COVID-19 INFECTION; PASSED OUT TWO TO THREE TIMES; This spontaneous report received from a patient concerned a 54 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's past medical history included alcohol use, and concurrent conditions included high blood pressure, and  patient had no known allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 08-MAR-2021 for covid-19 vaccination. The batch number was not reported. Per procedure no follow up will be requested for this case. Non-company suspect drugs included: adalimumab (suspension for injection in pre-filled syringe, subcutaneous, batch number was not reported) 40 mg, 1 time every 2 weeks, therapy dates were not reported for moderate to severe rheumatoid arthritis. Concomitant medications included valsartan for high blood pressure.  On MAR-2021, the patient passed out two to three times. On 17-MAR-2021, the patient experienced shortness of breath, cough, fatigue, taste changed. On 18-MAR-2021, patient tested positive for covid 19 (coded as confirmed covid-19 infection). On 18-MAR-2021, patient had nasal swab test, mouth swab test, and covid 19 test (result was positive). On 19-MAR-2021, patient had chest X-ray, heart ultrasound and electrocardiogram and there was no problem as per result.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The outcome of the confirmed covid-19 infection and passed out two to three times was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210441069-covid-19 vaccine ad26.cov2.s-Passed out two to three times, confirmed COVID 19 . 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).
Headache, Myalgia,  chills and also reports headaches every other day  since first dose 1/5/21 Narrative:  Other Relevant History:
Admit 7/6, vacine 2/2, 2/23. Admit for SB, cough, sputum, chest pain. H/O TIA, COPD, HTN, OSA.  COVID +, COVID PNA. Tx w/abx, steroid, remdesivir, O2 including BiPap, nebulizers. DC'd home. One day of DC he was on 3L O2. At time of review still l on 3L O2 at home as of 7/28.