chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer Dose 1 4/22/21 (EW0164) Pfizer Dose 2 5/14/21 (ER8736) COVID Positive 1/11/21  1/11/22: History is obtained from patient as well as by personal review of records. Patient is a 79-year-old gentleman with known history of diabetes mellitus, possible COPD, hyperlipidemia and other medical problems.  He presented to emergency department with history of worsening cough, worsening shortness of breath, generalized weakness, subjective fevers, nausea, decreased p.o. intake for last 5 days.  He reports getting 2 doses of  SARS-CoV-2 vaccinations.  He was hypoxic in emergency department.  Chest x-ray showed ground-glass opacification of both lungs.  He tested positive for  SARS-CoV-2.  He had uncontrolled diabetes mellitus and required IV insulin as per GlucoStabilizer pathway.  1/17/22: Patient is 79-year-old male from home with h/o history of DM, possible COPD, HLD, and other medical problems. He presented to the ED emergency department with c/o worsening cough, worsening shortness of breath, generalized weakness, subjective fevers, nausea, decreased p.o. intake for last 5 days. He reports getting 2 doses of SARS-CoV-2 vaccinations. He was very hypoxic in emergency department was initiated on supplemental oxygen . Chest x-ray showed ground-glass opacification of both lungs.  He tested positive for SARS-CoV-2.  He had uncontrolled diabetes mellitus with blood sugars over 400 required IV insulin as per GlucoStabilizer pathway.  He was initiated on remdesivir, IV antibiotic, dexamethasone, vitamin-C and zinc. Patient symptoms improved after few days he was able to work with physical therapy who recommended skilled nursing placement. Patient completed his IV antibiotics and remdesivir today. Patient has been afebrile and was able to maintain his sats above 90% on room air at rest and on exertion. Patient walked with physical therapy using a walker with 1 1 assess. Patient has stable vital signs and denies chest pain, nausea vomiting, abdominal pain, palpitation, headaches, dizziness and any other discomfort. Patient voiced  no concern and was updating on test findings. Patient is being discharged in improved and stable condition.  All questions answered.
States 15 minutes after vaccine, he felt a lump deep in throat at the level of sternum.  Also felt light headed and short of breath. He felt like his tongue was a little swollen.  Was taken to ER for further evaluation & treatment  Felt better later same day.
1/20 developed fever to 104.5 with period of altered mental status seen in ED for brief resolved unexplained event. Hospitalized x36 hrs for observation and evaluation for fever without a source. Blood culture negative fever resolved after 48 hrs. Rash 2 days later suggestive of Roseola as source rather than vaccine.
Never recieved the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never recieved the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never recieved the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never recieved the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Right leg became swollen and "rash" to entire body approx x 1 week after shot was given.
Experienced facial weakness, watering eyes and difficulty speaking, eating and drinking.  Went to Emergency Room concerned about stroke symptoms.  Blood pressure very high upon admission - initial concern for MI due to elevated troponin levels.
The patient recieved Pfizer series #1 vaccination on 4/21/2021. This vaccination was Pfizer series #2 given on 5/5/2021 which was 14 days later. Not 21 days later.
This case was reported by a consumer via call center representative and described the occurrence of swelling of eyelid in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug allergy and penicillin allergy. On 30th July 2018, the patient received SHINGRIX. On 1st August 2018, 2 days after receiving SHINGRIX, the patient experienced swelling of eyelid. On an unknown date, the outcome of the swelling of eyelid was not recovered/not resolved. It was unknown if the reporter considered the swelling of eyelid to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid, on Monday evening. On Wednesday, the patient realized that, her eyelids on the right eye were swollen which was not painful or red. The patient did not use anything to treat this adverse event and she was unsure if it was related to the SHINGRIX.
Lost hearing in right ear. Sounds extremely muffled but also has a very loud 'white noise' sound. It is constant, never stops. It's very difficult to concentrate and function with this noise constantly in my right ear. A low to medium constant loud hum like of something mechanical or a loud car bass or something. Sometimes has a rythm to it that varies, pulses. Started 14 days after 2nd Pfizer vaccine, now over a week of having this noise. Extra antihistamines don't seem to help.
Pt recvd 1st vax w/out rxn; Given 2nd vax 22JAN91 arched around site (silver dollar); a wk later had bubbles, like blisters; continues to have white dots; Also, ached down into elbow; Did not seek tx;
Vaccine was withdrawn from arm and some of the vaccine dripped out; A spontaneous report was received from a consumer regarding herself, a 44-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some of vaccine leaking out of the injection site/accidental underdose.  The patient's medical history was not included. Products known to have been used by the patient were not included.  First dose information was not provided.  On 11 Feb 2021, prior to the onset of the events, the patient received the second of two doses of mRNA-1273 (Lot number: 016M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 11 Feb 2021, as the needle was withdrawn, some of the vaccine leaked out. The patient is concerned about underdose.   Treatment information was not provided.  Action taken with mRNA-1273 was not applicable.  The outcome of the events, vaccine leaking out when needle was withdrawn, was considered resolved.; Reporter's Comments: This case concerns a 44-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Accidental underdose without any associated adverse events.
BLOOD PRESSURE DROPPED; NOT FEELING WELL; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. Batch number was reported. The company was unable to follow-up request for batch number. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure dropped, not feeling well, and headache. Laboratory data (dates unspecified) included: Blood pressure dropped (NR: not provided) Blood pressure dropped The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, blood pressure dropped and not feeling well was not reported. This report was non-serious.
BONE ACHES; CHILLS; FEVER 101 F; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bone aches, chills, and fever 101 f. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 101 f, bone aches and chills was not reported. This report was non-serious.
ocular herpes zoster; This case was reported by a physician via call center representative and described the occurrence of ophthalmic herpes zoster in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 61 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes zoster was unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 84 or 85 years. The patient developed ocular herpes zoster 2 months after getting Shingrix vaccination.
Irregular period- no period on my birth control and after my 2nd dose, I am now experiencing a heavy flow period with cramps and fatigue.
I was coughing a lot for three weeks and I'm still coughing and had the chills and I had a headache that morning March 25th 2023. I took a home COVID test positive. I had congestion in my throat. The doctor gave me Paxlovid.
The case report was received from a(n) Health Professional and concerns a(n) patient with unknown age and genger. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA on 01-OCT-2015 - 01-OCT-2015, Batch no: not provided, Route of administration: not provided, Dose: 1 ml. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On 01-OCT-2015, after starting / treatment with AFLURIA the patient received a 1 ml dose of AFLURIA, instead of 0.5 m./Overdose (non serious, outcome: Unknown). On an unknown date, after starting / treatment with AFLURIA the patient experienced error (non serious, outcome: Unknown). Action taken: Details manually to be entered. Event treatment: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The reporter stated that all the patients seemed fine and confirmed that none of the patients were pregnant. The 1 ml dose was due to clinical error, which did not confirm the dosage.
Pt. given PROQUAD, Hep B, Varicella at 7 mons. pregnant
pain, swelling and warmth at injection site starting 1 hour in, then fever, intense body and joint pain, nausea that lasted 24 hours.
70-year-old male who presents to the emergency department for evaluation of abdominal pain.  The patient was awakened from sleep this morning with severe sharp, stabbing pain in his epigastric region.  Pain radiates into his lower abdomen and his back.  He associates his symptoms with a bloating sensation.  He took omeprazole with mild relief of symptoms.  Symptoms recurred a few hours later.  States that he became confused and diaphoretic at that time.  He called EMS to transport him to the emergency department.  The patient was found to have an objective fever at that time.  He was given Zofran; Notes COVID vaccine several days earlier; on antibiotics, will need cholecystectomy while in hospital
expired vaccine administered, with no reported adverse event; Initial information received on 29-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who experienced expired vaccine administered, with no reported adverse event after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination; HPV VACCINE (HPV VACCINE) for Prophylactic vaccination; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Prophylactic vaccination.  On 01-Mar-2022, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6874AA  and expiry date 21-Feb-2022 via intramuscular route in unknown administration site for prophylactic vaccination.  On 01-MAR-2022 the patient developed a non-serious event "expired vaccine administered, with no reported adverse event (expired product administered) (latency same day) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired vaccine administered, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired vaccine administered, with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt recvd 3 doses of Engerix-B on 5SEP90 & 5OCT90 & 5MAR91 respectively & exp a non response; Outcome is pending;
Pt. reports symptoms of weakness, flu-like symptoms prior to getting vaccine dose on 9/23/22. Symptoms worsened and was admitted to Hospital on 10/2/22 and was discharged on 10/7/22. Pt. states she does have history of brain tumor and was discharged without a new diagnosis. Pt. states she is unsure if she had a stroke Pt. presented to second Jynneos and it was not given per Dr. Pt. is to follow-up with neurology for testing,
After approximately 5 minutes after receiving her second Moderna, Covid-19 vaccine, the patient reported have a dry mouth/throat and was coughing.  We gave her a bottle of water and continued to check on her.  About 5 minutes later she said her throat was "itching and was scratchy."  I gave her 50mg of oral liquid diphenhydramine.  After about 5 more minutes she said her throat was feeling some better.  About 10 minutes later, she said her throat felt much better.  She stayed an additional 15 to 20 minutes and when she left she said she felt fine.  I called her about 3 hours later at her home and she said she was okay and felt tine.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 30-OCT-2012 10:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Arm were vaccine was given 2 wks go-hard and painful-no redness.
After leaving Dr office, Child became Lethargic, Loss of Appetite and during car ride to home Vomited violently, and had one episode of Diarrhea. Vomited a total of 4-5 times consecutively after being Vaccinated. Once child fell asleep for 3 hr nap vomiting subsided. Diarrhea has lasted for 2 days since vaccination.
Developed large egg shaped bump where injection was. Upon standing up, legs shook & trembled jerkingly and felt like they were going to give way, arms trembled and shook uncontrollably. This lasted about 2 weeks then stopped.
Information has been received from a nurse practitioner concerning a female who at the age of 13 (approximately 1996) was vaccinated with a first dose of RECOMBIVAX HB (manufacturer unknown) and developed a fever of 104 degrees F.  No additional information was available.  Additional information has been requested.
No AE/PQC reported at this time; a temperature excursion on VAQTA; Information has been received from an other health professional referring to a 18 months old of patient of unknown gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 20-MAY-2021, the patient was vaccinated with improperly stored of hepatitis a vaccine, inactivated(VAQTA) (lot # T033304, expiration date: 02-APR-2022, strength, dose, frequency and route were unknown) for prophylaxis (incorrect product storage).  No adverse effects were reported.  The stored temperature was 36 to 46 Fahrenheit (48.2 F). The time frame was 15 minutes. There was a previous temperature excursion: 36 to 46 F (46.2 F) for 15 minutes. The temperature excursion was detected by a data logger.  This is one of the several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T033304; expirationdate: 02-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA000591: US-009507513-2106USA000663: US-009507513-2106USA000689: US-009507513-2106USA000712: US-009507513-2106USA000775: US-009507513-2106USA000779: US-009507513-2106USA000988:
Vaccinated 7/24/09.  7/25/09 evening (5pm) started w/ shortness of breath, chest tightness, palpitations.  Went to ER on Sunday 7/26/09 around 9:30.  Tues 7/28 shortness of breath, chest tightness, throat "felt hoarse".  Thick throat.  Had to remove bra felt tight.
Missed second dose and was beyond day 36; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Missed second dose and was beyond day 36) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Defibrillator/pacemaker insertion (The patient is using Defibrillator in his chest.).    On 15-Mar-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 INTENTIONAL PRODUCT USE ISSUE (Missed second dose and was beyond day 36). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Missed second dose and was beyond day 36) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient is under medication for diabetes. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received, TCR form  attached does not contain any  information
No adverse event- vaccine was expired as of 9/7/2022 and was administered on 10/27/2022
I exp sore arm and rash around the injection site. Then 3 days later had chest pains and vomiting went to the hospital.I was diagnosed with partial right bundle branch block. I'm still exp chest pains intermediately.
ABOUT 30 MINUSTES AFTER RECEIEVING VACCINE, I HAD A SLIGHT HEADACHE. THE HEADACHED LASTED ABOUT 4 DAYS. AROUND 7:30 PM ON 1/5/2021, I NOTICED PAIN IN MY RIGHT ARM AT THE INJECTION SITE . THERE WAS A SMALL RED KNOT. MAJORITY  OF THE PAIN WENT AWAY AFTER TWO DAYS BUT THE SWELLING CONTINUED. NOW A WEEK LATER MY ARM IS SWOLLEN, RED COLOR, AND WARM TO TOUCH.
Information has been received from a pharmacist concerning a 30 year old female physician who in April 2008, was vaccinated intramuscularly with the second dose of GARDASIL.  On approximately 08-APR-2008, "about two weeks ago," the patient developed a cyst like lump at the injection site.  The patient sought unspecified medical attention.  At the time of this report the patient not recovered.  No product quality complaint was involved.  Additional information has been requested.
Pain at injection site; Headache; Severe nausea; Diarrhea; Fatigue; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. An unknown gender patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included asthma and celiac disease. The patient had known allergies to latex, gluten (celiac) and sulfas. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), esomeprazole sodium (NEXIUM), cetirizine hydrochloride (ZYRTEC), ondansetron (ZOFRAN), montelukast sodium (SINGULAIR) and formoterol fumarate, mometasone furoate (DULERA); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously took oseltamivir phosphate (TAMIFLU), pseudoephedrine hydrochloride (SUDAFED) and metoclopramide (REGLAN); all for unknown indications and experienced drug allergy. On an unknown date the patient experienced pain at injection site, headache, severe nausea, diarrhea, fatigue and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, headache, severe nausea, diarrhea, fatigue and body aches were resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Expired Covid-19 vaccine was administered. So far no adr's reported and no symptoms noted. Will re-vaccinate in other arm to ensure full dose was administered.
localized skin mass beneath injection site 2cmx2cm in diameter ; mild redness with slight ecchymosis. 99F-101F fevers reported by mother and father 12-72 hours post injection.
Indurated red skin in roughly rectangular shape over left anterior thigh surrounding the injection site. About 9cm x 5cm. Emerged 6 days after vaccination. No fever.