chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: Unknown. The reporter is the patient. An 83-year-old male patient received BNT162b2 (BNT162B2), on 03Sep2021 as dose 3 (booster), single (Lot number: EW0183) at the age of 83 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "prediabetic", start date: 1997 (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing); "gastric reflux" (unspecified if ongoing); "swelling in lower legs" (unspecified if ongoing); "edema" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for rheumatoid arthritis, start date: 2007; METHOTREXATE oral taken for rheumatoid arthritis, start date: 2010; FOLIC ACID oral taken for rheumatoid arthritis, start date: 2010; TYLENOL oral taken for rheumatoid arthritis, start date: 2014; FLOMAX RELIEF oral taken for benign prostatic hyperplasia, start date: Mar2021; TRAMADOL oral taken for arthritis, start date: 2010; PROTONIX [OMEPRAZOLE] oral taken for gastrooesophageal reflux disease; TOPROL XL oral taken for blood pressure measurement, start date: 2021; ALLEGRA oral taken for seasonal allergy; FLONASE ALLERGY RELIEF nasal taken for rhinitis, start date: 2010; ELIQUIS oral, start date: 2020; CALCIUM & VITAMIN D [CALCIUM; COLECALCIFEROL] taken for arthritis; LASIX + K oral taken for oedema peripheral, start date: 2020; LIPITOR oral taken for blood cholesterol, start date: 2015. Vaccination history included: BNT162b2 (2nd Dose, lot EN6203, Location: Left Arm), administration date: 26Feb2021, when the patient was 82-year-old, for Covid-19 Immunization; BNT162b2 (1st Dose, lot EL9263, Location: Left Arm), administration date: 05Feb2021, when the patient was 82-year-old, for Covid-19 Immunization; Flu shot. The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset 11Sep2021, outcome "recovered" (Sep2021), described as "diagnosed with pericarditis". The patient was hospitalized for pericarditis (start date: 12Sep2021, discharge date: 13Sep2021, hospitalization duration: 1 day(s)). The event "diagnosed with pericarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram thorax: (12Sep2021) Unknown; Echovirus test: (12Sep2021) Unknown; Electrocardiogram: (12Sep2021) Unknown. Therapeutic measures were taken as a result of pericarditis. It was also reported that the pericarditis pain went away after 24 hours and he was treated with Colchicine for 90 days, and also reported that rheumatoid arthritis which is treated with Humira, methotrexate and tramadol daily for avoiding pain. Patient was also hospitalized, they took him off Eliquis and switched him to Aspirin for 3 weeks and then put him back on Eliquis. No follow-up attempts are possible. No further information is expected.
Within a short amount of time after my 2nd Pfizer shot, my lymph node under my right arm swelled like a softball. Over the course of time, the swelling went down, but now I have what feels like another lymph node there... so there are two?
pt recvd vax; devel inject site rxn characterized by swelling,itching,erythema,warmth;
Onset of numbness and tingling in lip, fatigue and "feels off" Referred to urgent care center
Severe pain in injected arm starting 5 hrs after pneumococcal vaccination in same arm, tingling fingers same extremity no localized redness.
irregular heart beat; over the weekend, worst on Monday; This is a spontaneous report from a contactable consumer or other non health professional (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6206), dose 1 via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, it was stated that patient had an irregular heart beat since and someday towards another, first two days it was all day all night, Wednesday and Thursday. Patient was better on Friday, better over the weekend, worst on Monday. The patient called doctor they said fetch fluids, give it a couple of days. The patient underwent lab tests and procedures on an unspecified date in Mar2021 which included heart rate: irregular. The outcome of event irregular heart beat was not recovered and for condition worsened was unknown.  No follow-up attempts are possible. No further information is expected.
and little feeling when shot was given; numbing kind of feeling; swelling in right hand; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (and little feeling when shot was given), HYPOAESTHESIA (numbing kind of feeling) and PERIPHERAL SWELLING (swelling in right hand) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J covid-19 vaccine (1st dose and Lot number 1808609.) on 26-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J covid-19 vaccine.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (and little feeling when shot was given), HYPOAESTHESIA (numbing kind of feeling) and PERIPHERAL SWELLING (swelling in right hand). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of Unknown. At the time of the report, FEELING ABNORMAL (and little feeling when shot was given) and HYPOAESTHESIA (numbing kind of feeling) outcome was unknown and PERIPHERAL SWELLING (swelling in right hand) was resolving.            No concomitant medication information was provided.  Reporter states that swelling was on hand and not near injection site.   24 hours after getting the moderna booster, patient noticed swelling in right hand, numbing kind of feeling, and little feeling when shot was given. when shot was given.
Narrative: COVID infection following COVID vaccine series 01/16, Pfizer, dose #1 02/06, Pfizer, dose #2 05/27 CXR impression: No significant change. No acute abnormality. 08/20 pt cc: cough, diarrhea, fever, loss of taste or smell rhinorrhea, fever exposure: unknown 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Sequencing result: pending 08/30 COVID swab, result: detected 09/07 COVID swab, result: not detected
Pt was given vaccine while standing and a few minutes after vaccine asked for a glass of water.  I asked her if she felt lightheaded and she said yes, I had her sit in chair and pt began moaning, her hands turned blue and then patient threw her head back, body became rigid and she straightened her arms and legs.  Episode lasted approximately 10 seconds and she regained consciousness.  Patients eyes did not roll back in head, but gaze was fixed and pt did not appear to be breathing during episode.
Information has been received from a physician concerning a female who was vaccinated with the first dose of Gardasil and had tingling in both legs after the vaccination. The physician is doing follow up tests to see if the patient had peripheral neuropathy. Medical attention was sought. Additional information has been requested.
This spontaneous report as received from a consumer refers to a 77 year old male patient. On 24-SEP-2013 (estimated date, reported as "about a week ago") the patient was vaccinated with ZOSTAVAX. Route, dose, dose number and lot number were not reported. Concomitant therapies included LIPITOR. The patient reported that he received an unspecified flu vaccine (manufacturer unspecified) about a few weeks prior to ZOSTAVAX vaccination. On 26-SEP-2013 (reported as "two days after the shot") the patient experienced injection site reaction of redness and swelling but no pain or itching. The patient to a pharmacist. No treatment was given. The outcome of injection site reaction of redness and swelling was reported as recovering/resolving. Reporter causality assessment was not reported. Additional information is expected.
Fever developed with highest reading at 103.2. Fever has persisted the last 9 days.
4 days post receiving TDAP developed diffuse red, warm, swollen indurated lateral arm extending to lateral condyle.
Per Dr's admission H&P: " HISTORY OF PRESENT ILLNESS 58 yo F presenting via PH EMS with complaints for fever and SOB and  weakness and dizziness. was brought in on 3L NC with Spo2 around 93  but was down to 84% on RA. initialy BG was 79, s/p 15g oral glucose  with BG up to the 90s.  speaking with patient she will awake to noise and starts her story  and hen will stop. starts off by saying she had her covid shot on  wednesday. patient denies any pain. speaking with her daughter over  the phone, reports she had her COVID shot on wednesday and started  to have HA and get weak and sob. reports she believes this is a  reaction to the covid vaccination because the same thing happened  to her when she received the singles shot a couple of months ago.  reports she had a mild reaction when she received the first covid  shot which was feeing tired and arm pain.  "
Patient noticed mild tingling and itching after vaccine was given.  Patient denies the need for any medications or creams to treat her reaction.
Red bumps covering legs - began at back of thigh, spread all over legs, then to feet, then arms and hands, then cheeks.
Case number PHEH2014US025106, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 62-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 10 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
I had symptoms for Covid with Pneumonia.; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm right, administration date 27Oct2021 08:30 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillian" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; PROTONIX [OMEPRAZOLE]; TIZANIDINE; AMITRIPTYLINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 08:15 AM), administration date: 15Feb2021, when the patient was 45 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right, Vaccine Administration Time: 08:30 AM), administration date: 25Jan2021, when the patient was 45 years old, for COVID-19 Immunization. The patient did not receive other vaccines within four weeks of the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 27Oct2021 08:30, outcome "unknown", described as "BOOSTER"; PNEUMONIA (medically significant) with onset 28Dec2021, outcome "recovering", described as "I had symptoms for Covid with Pneumonia". The event "i had symptoms for covid with pneumonia" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pneumonia which included antibiotics. Clinical course: Patient reported he had symptoms for COVID with pneumonia which began on 28Dec2021. Emergency Room visit was on 03Jan2022 for treatment. Patient stated that although he tested negative, he was told he still had COVID-19.
MENSTRUAL CYCLE DISRUPTED (BREAKTHROUGH MENSTRUAL BLEEDING); This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was not reported and height was 165 centimeters. Patient had 1 gravida. Patient's Expected due date (EDD) was 20-Aug-2022. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced menstrual cycle disrupted (breakthrough menstrual bleeding). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from menstrual cycle disrupted (breakthrough menstrual bleeding) on 12-APR-2021. This report was non-serious.
Pt reported soreness and difficulty lifting arm plus some mobility issues beginning a few days after the vaccination and has continued. It is unknown if the extent of these s/s has remained constant. Pharmacist on duty at the time the patient came in (10-26, site was unavailable due to maintenance which is why it is being put in today) advised the patient to use cold compresses/tylenol
had a blank stare; This spontaneous report was received from a physician via company representative referring to a 2 year old male patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.    On 24-AUG-2017, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, anatomical location, route, lot # and expiry date not reported) for prevention. On an unknown date, the patient had a blank stare for four days (staring). The outcome of staring was unknown. The reporter's causality assessment was not reported.
Painful arm, redness that extended to elbow, red area "hot" and onset of fever later in the evening; went to walk-in clinic and received antibiotics the evening of 11/14/2013.
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 16-OCT-2015 21:44, 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 6.5 and 1.2 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.
allergies; allergy induced asthma; This is a spontaneous report from a contactable physician (patient). This physician reported similar events for 2 patients. This is the first of two reports. A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included HTN (hypertension, Asthma, Allergies and allergy to penicillin.  Concomitant medication included varicella zoster vaccine rge (SHINGRIX), olmesartan (OLMESARTAN), nebivolol hydrochloride (BYSTOLIC), hydrochlorothiazide and triamterene (MAXZIDE).  It started several days after the vaccine. Patient have allergies and allergy induced asthma on 25Jan2021. It started slowly and became worse. Patient had to take allergy pills and double his steroid inhalent. Its the middle of winter and this never happens. No treatment was received. Outcome of the events was not recovered. The reporter considered the events non-serious.  Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021125841 Same reporter/product/event, different patient
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L044694, expiration date 04-FEB-2018; lot # was reported as L040458, expiration date 04-FEB-2018; lot # L027733, expiration date 13-SEP-2017, lot # L033343, expiration date 13-SEP-2017; dose and route were unknown). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Joint pain, fever, chills, arm pit pain, sinus pain & pressure, and long lasting Tinnitus. Overall, continuing to feel ill and I am over 2 weeks post second vaccine and this Tinnitus is still happening.  I've been to ENT doctor and they can't find cause.
Oct. 26-COVID vaccine 2-Nov 2 - sudden vomiting-Nov 4 - queasiness after elevatorFriday 11/5 - severe palpitations, worse lying down, and dizziness/lightheadedness - near syncope - asked to call 911 and went to ERSaturday 11/6 - dizzy/lightheaded going up stairsSunday 11/7 - dizzy/lightheaded getting up in morning and after running in the parkMonday 11/8 - fatigue, poor appetite, malaiseTuesday 11/9 - felt okWednesday 11/10 - felt okThursday 11/11 - had palpitations, dizziness, near fainting at school - nurse called and said her heartbeat was irregular and the pediatrician said to take to ED. Chest pain a few times while in the ED.Friday-Sun - felt okMonday 11/15 dizzy after stretching head/neck at desk in schoolSaturday 11/20 nauseous a few times during day, then sitting watching movie at 8pm, palpitations and dizziness, then vomited a very large amount. Heart rate was 138Sunday 11/21 she slept in until 8, was ok, then at 6pm said she had a headache and at 7pm said she felt really tired and like her eyes were going to close, which continued until we got home and got her into bed around 8:30. She also seemed like she was nauseous again.Monday 11/22 - too fatigued to go to school.  HR 110 when she woke up. Diarrhea in morning.Tuesday 11/23 - dizzy after stretching head/neck at desk in schoolWed 11/24 - ok but still malaise and low appetiteThursday 11/25 - headacheFriday 11/26 - headache in eveningSaturday 11/27 - dizziness after going up stairs, headache (right forehead) in morning and evening.Sunday 11/28 - woke up at 4am to go to the bathroom and got very dizzy walking to and from the bathroom, almost falling twice. She was crying and scared after. In the morning, Dizzy/lightheaded laying in bed, upon getting up, standing up after sitting, and walking around. Headache on right forehead started @4:30pm. Mild diarrhea, stomach ache, low appetite, general malaiseMonday 11/29 ok, but very fatigued, so stayed home from school.Tuesday 11/30, dizzy once at school after stretching. Chest pain starting @11 and on and off rest of day, also malaise. Called pediatrician and they sent us to ER.Wednesday 12/1 - chest pain after school for a few minutesThursday 12/2 - dizzy/lightheaded walking to gym classFriday 12/3 - dizzy/lightheaded at school - abnormal orthostatic BP at pediatricianSaturday 12/4 - dizzy/lightheaded at ballet classSunday 12/12 - said it was the first time she felt like herself again (6 weeks after onset of symptoms)12/13 - 12/17 - some periods of fatigue and malaise as well as very fitful sleep. She said sometimes she feels like herself and sometimes still not good. May have over exerted swimming at pool birthday party 12/18 - very fitful sleep and too fatigued to go to horseback riding lessons. Noticed hair loss in shower 12/19 - fatigue, malaise, told me her distance vision is blurry. Queasy at dinner. 12/20 - fatigue, stomach ache
Have symptoms and test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Have symptoms and test positive) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Diabetes.   On 02-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 02-May-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022 at 4:45 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Have symptoms and test positive). At the time of the report, COVID-19 (Have symptoms and test positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   Patient took full dose of Paxlovid and 7 days later had symptoms and tested positive.  No treatment medications were provided.  Company Comment: This spontaneous case concerns a 62-year-old female patient with no relevant medical history, who experienced the and unexpected non-serious AESI of COVID-19 which occurred 12 days after receiving the fourth dose of mRNA-1273 vaccine. Its reported that patient took a full dose of Paxlovid as a covid-19 treatment and 7 days later she still had symptoms and was tested positive. COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient with no relevant medical history, who experienced the and unexpected non-serious AESI of COVID-19 which occurred 12 days after receiving the fourth dose of mRNA-1273 vaccine. Its reported that patient took a full dose of Paxlovid as a covid-19 treatment and 7 days later she still had symptoms and was tested positive. COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.
shaking episodes leading to PICU, sz by PICU nurse observing are work up (MRI, EEG, lytes, CSF);some non-specific abn in serum amino acids;on phenobarb w/o recurrence;development normal at this point
Wife states upon awakening this morning at 600 AM, 11/4/10, client's left side of face swollen (in jaw area) & his upper lip is swollen, mostly on the left side. Denies difficulty breathing; redness, hot to touch. RN advised wife to call his Dr. She agreed. See medication section - he started a new med 11/1/10.
Sporadic heart beat (rapid or skipped beat) and pressure in left chest and side area.  Rapid heart rate usually upon waking or when tired; skipped beats when physically active.  Aggravated dry cough.
I've had an almost constant dry cough since a few weeks after the first shot. I'm coughing most of the time, except at night. It's particularly bad when I try and talk. I've never had this sort of cough, and I don't suffer from allergies. It's been about a month like this.
This spontaneous report has been received from a nurse, concerning a 32 year old female patient. The patient's medical history and concurrent condition were not provided. On 07-SEP-2017, the patient was vaccinated with an expired dose of M-M-R II (albumin status rHA) lot # L029266 and expiration date 04-AUG-2017 (strengh, frequency and route of administration were not provided) for prophylaxis which was reconstituted with a sterile diluent(manufacturer unknown). No adverse effects reported.