chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe fatigue falling asleep low energy unable to get REM sleep  sleep cycle. destroyed severe fatigue unable to remain awake wake up tired no energy informed my PCP at Health Center but records incomplete gave this info to my PCP is not my allergies causing severe fatigue still trying to get medical care and was not informed about the adverse problems by Health Services as requested medical care but refused to file form or write to my medical record
GROIN PAIN; This spontaneous report received from a patient concerned a 6 decade old adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-infectious intermediate, posterior and panuveitis.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 in total, administered on 21-APR-2021 for prophylactic vaccination (dose number series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The patient's age at the time of vaccination was 50 years. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported (therapy ongoing) for non-infectious intermediate, posterior and panuveitis.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unspecified date, the patient experienced groin pain. (dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient had not recovered from groin pain. This report was non-serious. This case, involving the same patient is linked to 20211231043.
FEVER, INCREASING TO 101.9. INJECTION SITE SWOLLEN, BRILLIANT RED, HOT TO TOUCH AND EXPANDING IN SIZE. PULSE 109. DIFFICULTY SWALLOWING. REACTION TIME FROM APP 4 PM TO MIDNIGHT OR SO.
Mild spotting; Painful menstrual cramps; Urine has been darker and smells more than usual; Urine has been darker and smells more than usual.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on 09Apr2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks, prior to the vaccination. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), birth control pill (MANUFACTURE UNKNOWN) and probiotics (MANUFACTURER UNKNOWN); all for unspecified indications from an unknown date and unknown if ongoing. On 11Apr2021 at 09:30, the patient experienced having mild spotting and painful menstrual cramps since from the Sunday after first dose of the vaccine and nothing like that had ever happened before. It was reported that, sometimes the patient got mild spotting, but it was only lasts three or four days. Also, patient had urine in darker and smells more than usual. The patient period was too painful due to endometriosis, hence used to take birth control pills on everyday without skipping a week. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events mild spotting, painful menstrual cramps and urine had been darker and smells more than usual was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Left Supraclavicular lymphadenopathy after Tdap in left arm. Headaches, fatigue, low grade fever that lasted one day.
This spontaneous report as received from a nurse via a company representative refers to an about 17 or 18 years old female patient. The patient was a fraternal twin. There was no information about the patient's concurrent conditions, any known allergies or reaction, medical history or concomitant medications. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL or GARDASIL 9, for prevent human papillomavirus (HPV) (dose, route of administration, lot number and expiration date were not reported).  On an unknown date, after received the vaccine, the patient experienced Tourettes (Tourette's disorder). It was unknown if the patient sought medical attention, treatment was given for the adverse event or laboratory diagnostics studies were performed. The outcome of Tourette's disorder and the causal relationship between the event and therapy with GARDASIL or GARDASIL 9 were not reported. No product quality complaint was involved. Upon internal review the event Tourette's disorder was considered to be medically significant. This is one of two reports received from the same reporter. Additional information is not expected because the reporter did not consent for further follow up.; Sender's Comments:  US-009507513-1706USA008242:
Initially had (unconcerning) soreness/pain at the injection site hours 6 through ~60 after the vaccination. Soreness completely resolved after hour 60 then on day 7 post vaccination my arm began to feel tender again. Day 8 post vaccination it is painful at the injection site and the pain is only moderate but somewhat limiting. I have no other sx and did not injure or over-use my muscle. I don?t intend to take any medication for the discomfort. There is no redness/swelling at the site, just pain like there was immediately following the vaccine. I stopped getting VSAFE check ins after my third day of no symptoms which is why i?m completing this form.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unspecified dates, the patient was inadvertently vaccinated with improperly stored doses of GARDASIL 9, lot # N020353, expiry 28-APR-2020 (dose, frequency and route were not reported). It was reported that the sterile diluent (MERCK) used to reconstitute GARDASIL 9 was properly stored. The administered doses of the GARDASIL 9 experienced a temperature excursion of 10.9 degrees Celsius (°C) for 30 minutes, as recorded by a data logger. The vaccine had a previous temperature excursion of -3.5°C for 660 hours. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA005930: Original Case: 1808USA005930; US-009507513-1811USA010211: Original Case: 1811USA010211; US-009507513-1811USA010214: Original Case: 1811USA010213; US-009507513-1811USA010215: Original Case: 1811USA010213.
Patient presents to the emergency department complaining of right shoulder pain that radiated to his chest after his COVID vaccine. He also complained of uncontrolled high blood pressure, dizziness and headache despite being compliant with his medications. He was admitted for further management of his symptoms. He was discharged home the next day in stable condition.
currently (right now) she has covid; Jun2021 as dose 2, single and patient received first dose of bnt162b2 on Jun2021 as dose 1; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown), dose 1 via an unspecified route of administration on an unspecified date in Jun2021 as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she was received both doses of the pfizer covid vaccine back in Jun2021 and currently (right now) she had covid (drug ineffective) on an unspecified date in 2021. patient stated she can't find information what causes of that. She understood there are different strains and a percentage will get it. But she did't understand and can't find any information as to why she had a loss of taste and smell. she had a mild headache and thought it was sinus issue. Monday morning patient realized she can't smell. Patient tested with covid test and it was positive and then she had a loss of taste. She can't find any clinical trials that explains why this happened and what's causing it. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Nov2021. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I have a big red rash on the front side of my neck. It?s really itchy and dry. When I put on lotion, anti-itch cream, or soap when I shower it stings really bad. I though the allergy could have been other stuff but I can?t think of anything else. So, it has to be the vaccine.
Initial information regarding unsolicited case received from nurse on 08-Nov-2013: This case involves 49-year-old male patient. The patient's past medical history and concomitant medications were unknown. On 01-Nov-2013, the patient received FLUZONE ID (Lot# UT4719AA and expiration date unknown) intradermal left deltoid. Within 24 hours began experiencing stiff, sore arm and swollen side of neck. Stiff sore arm resolved but patient continues to have swollen neck. No further relevant information provided. List of documents held by sender: none.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 at 11:00 as dose 1, single (Lot number: EL9264), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 01Oct2021 at 14:00 as dose 3 (booster), single (Lot number: ER8732), in left arm and on 18Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: YUVAFEM, start date: 12Jul2022, stop date: 12Jul2022; VITAMIN D NOS, start date: 13Jul2022, stop date: 13Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included with Paxlovid. Clinical Course: It was reported that rebound Covid symptoms (runny nose, fatigue, sore tongue) began on 23Jul2022. Paxlovid for initial infection completed morning of 19Jul2022 and all Covid symptoms were gone at this point.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events  Vaccination failure, COVID-19 and the suspect drug BNT162B2.
vaccine administered to patient after excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine administered to patient after excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine administered to patient after excursion). On 21-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine administered to patient after excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter stated that the vaccine was pulled from the refrigerator at 6:25 AM at 4.3C and was placed in a vericooler at 2.2C. The cooler bricks were left in the freezer overnight, but the vaccine coordinator thought they were ok since the initial reading was 2.2C. While in transport to the site from the Health Department, the temperature had dropped to -3.4C at 6:28 AM and continued to drop until the bottom brick was removed from the cooler at 6:50AM. Vaccine was removed from the cooler at this time also and was at room temperature until 7:53AM when the DDL was reattached and the cooler temperature was at 5.3F. DDL data was attached with excursion temperature. Concomitant medications were not provided. Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received and contained no new information On 27-Jul-2021: Non-Significant follow up received.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot# L034369, expiration date 08-SEP-2017), (lot# L037561, expiration 29-SEP-2017). (lot# L034369, expiration date 08-SEP-2017), (lot# was reported as L041205, expiration date was reported as 20-OCT-2017) ( dose and route were not reported). Concomitant drug was not reported. No adverse effects were reported. This is one of the two reports from the same reporter. Additional information has been requested.
60 mm red area to injection site from 3 days ago. Area is warm to touch.
Narrative: COVID infection following COVID vaccine series 02/23. Pfizer, dose #1 03/16, Pfizer, dose 32 08/30, Pfizer, dose #3 12/20 CXR impression: Stable examination. No acute cardiopulmonary pathology identified at present. 12/27 CXR impression: No focal airspace opacity. 12/27 COVID swab, result: detected 12/26 pt cc: diarrhea, myalgias, rhinorrhea, exposure: unknown 1/1 pt admit to Clinic cc: "crohn's flare up" abd pain x 3 days" DX: Covid infection, cute kidney injury LOS: 8 DAYS 1/1 BNP: 14,4 1/1 SARC-COV-2 IGG: 0.01 1/1 FIBRINOGEN: 485 1/1 DDIMER: 0.68 1/1 CRP: 0.446 1/1 PROCALCITONIN: <0.05 1/1 SARS-COV-2 Variant Sequencing: pending 1/1 CT ABD/PEL W/O impression: 1. No acute abnormality in the abdomen and pelvis. No evidence of bowel inflammation or obstruction. Colonic diverticulosis. Bilateral nonobstructing renal calculi. 2. Some minimal patchy groundglass opacity in the right lower lobe which could be inflammatory or postinflammatory. 1/1 CXR impression: No radiographic evidence of acute cardiopulmonary disease. Please note that early/mild COVID-19 pneumonia may be radiographically occult, and groundglass opacities seen on same day comparison CT abdomen and pelvis are not apparent on this examination. 1/2 FIBRINOGEN: 465 1/2 DDIMER:0.53 1/2 ESR: 34 1/3 FIBRINOGEN: 391 1/3 DDIMER: 0.39 1/3 ESR: 35 1/4 ESR: 11 1/5 FIBRINOGEN: 360 1/5 DDIMER: 0.39
No adverse effects were reported. No additional information was provided to further clarify these details. No additional AE.; improperly stored vaccines were administered to a patient on 24 OCT 2022.; This spontaneous report was received from a vaccine coordinator, concerning a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions or allergies, and concomitant medications were not provided.  On an unknown date, there was a temperature excursion registered for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ), of 33.6 Fahrenheit degrees (F) for 3 hours, and 46.9 (F) for 1 hour 48 minutes. Additionally, it was reported that there were previous temperature excursions of 34.3 (F) for 0 hours 48 minutes, 34.3 (F) for 1 hour 42 minutes, 34.9 (F) for 1 hour 18 minutes, and 34.3 (F) for 1 hour 18 minutes.  On 24-OCT-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U034522, expiration date: 22-JUN-2024 (dose, route of administration and anatomical location were not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #W011278, expiration date: 01-NOV-2023, given orally (dose was not provided). Both vaccines were administered for prophylaxis (product storage error).  No adverse effects were reported. No additional information was provided.
Patient received his 1st covid vaccine and parents and patient were asked to notify us if there are any concerns post vaccination. They did not contact our facility for any concerns. He returned on 8/6/21 to receive his 2nd dose of the covid vaccine and mom said his frequency of nose bleeds increased a few days after getting the pfizer vaccine. Per the history provided he typically has about 1 nosebleed per month in the summer however his frequency of nose bleeds started to increase 3 days after receiving his first pfizer vaccine. Per history he is having 1 nosebleed once every other day. A large amount of blood does not come out and the bleeding quickly stops but the frequency is more than before. Family later revealed that mom has a history of anemia. It's unclear if patient may already have an underlying bleeding disorder or if this was exacerbated by the vaccine. With this information he was not given the 2nd covid vaccine but instead labs were ordered to help determine if he has an underlying bleeding disorder or if this may be secondary to the vaccine. Is this a known side effect from the vaccine? Parents are wondering if he can still get his 2nd dose because they would like for him to.
Pt developed hemophagocytic lymphohistiocytosis with high fever, leucopenia, thrombocytopenia. Now in hospital. Sx first noted: approximately 8.27. Vaccine 8.14.
No additional AE/PQC; Nurse reported AE for improperly stored administered GARDASIL 9; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 25-MAY-2023, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product storage error) injection (lot number w013388 has been determined to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9); expiration date has been established as 16-DEC-2024, administered for prophylaxis (strength, and anatomical site of administration were not provided). No other adverse event was reported.
currently infecting Omicron variant; currently infecting Omicron variant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a program (005570), other case identifier(s) US-PFIZER INC-202101882352.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, and (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 DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome unknown. It was reported that, the patient currently infecting Omicron variant and wondering how long should the patient had to wait to get the booster shot once the patient get out of it. Enquired, can the patient get vaccinated right away or the patient had to wait.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Missed the second of the vaccine / past 42 days from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the second of the vaccine / past 42 days from the first vaccine) 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.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the second of the vaccine / past 42 days from the first vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the second of the vaccine / past 42 days from the first vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Expired vaccine used; Product administration error; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT ADMINISTRATION ERROR (Product administration error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported no symptoms , and wanted to know if the booster dose and any testing was to be done.  No concomitant medications reported. No Treatment medications reported.
This case was reported by a nurse and described the occurrence of limb swelling in a 4 year old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. In June 2003, the patient received the fifth dose of Infanrix. Subsequently, the patient's whole upper arm was very swollen and was very red and hard. The patient was seen by the physician. The outcome of the events is unknown.
Dates were 1/21/21 and 3/4/21  March 5 and 6th, fatigue, extreme soreness, pain, and vaginal bleeding (I had a hysterectomy in December 2016).  March 5th woke up at 3am sweating and have EVERY morning since that day.  My joints and body have ached since that day.  Just recently the fatigue, body aches had led me to believe I had RA ...I went to the doctor. I am now in hypothyroidism ( TSH 5.11) and I am in menopause.  My primary started me on Synthroid 50 mcg and my gynecologist feels the menopause will resolve after the thyroid is corrected.   September 17 presented to the ER with severe palpitations.  No myocardial damage discovered.  PVC continue but not as rapid.