chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/12/21 (EN6201) Pfizer Dose 2 3/8/21 (EN6203) COVID Positive 9/13/21  9/23/21: The patient was diagnosed with COVID-19 infection more than a week, referred to our hospital due to generalized weakness with episodes of fever and chills and episodes of dry cough with shortness of breath, decline orthopnea or chest pain or productive cough or nausea or vomiting or diarrhea. At emergency, she was mildly dyspneic and hypoxic 86% on room air required 2 L of oxygen. Her labs show CKD, stable anemia.  9/27/21: The patient presented to the hospital from assisting living facility complaining from worsen generalized weakness with cough, she was dyspneic and hypoxic requiring 3-4 L of oxygen initially at the ED, had wheezing and crepitation her chest exam, chest x-ray unremarkable for acute anomalies, her labs show moderate stable anemia, her CMP unremarkable, she was diagnosed with moderate COVID-19 pneumonia and she was started on dexamethasone IV with vitamins, initially had worsen renal function/AKI on CKD require IV fluid then her renal function improved and the patient started on Remdesivir with improvement in her symptoms.  We have been able to wean her of oxygen and clinically improved.  She had episodes of severe diarrhea require dedication management system and her C diff is negative.  Patient tolerated her diet and improved clinically.  Discussed with the patient, will discharge to her assisting living facility with VNA.
Started with burning eyes about 1 hour after vaccination.  progressed to itchy, painful rash on both arms, abdomen and face about 4-5 hours post vaccination.  She was seen in ER and treated with benadryl, pepcid, prednisone.  rash resolved 1 week later.    Some dyspnea prior to ER visit.
12 year old received the Moderna COVID-19 vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna COVID-19 vaccination) in a 12-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna COVID-19 vaccination). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received the Moderna COVID-19 vaccination) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  The reporter thinks that is the patients gender and that it was the first COVID-19 vaccination.  No treatment medications was provided.
Patient said she had the same symptoms with the 1st shot but more extreme with the 2nd shot. Extreme chilling, some sweating. Chilling from the inside out - had never experienced that before! Ached from head to toe for 46 hours followed by headache for another 3 days.
Pt experienced persistent uncontrollable crying accompanied by fever of 100.8F.  ????
Patient indicated that he wished to receive the vaccine and denied having received a previous Covid vaccine. Staff utilized the state covid vaccine management system to identify inmates who may have already received a Covid vaccine; this inmate may have been added to list after checks were completed. The patient received the Janssen Covid vaccine; vaccine administration was entered into the Covid vaccine management system and at that time it was found that the patient had received Covid vaccine, Moderna, at another correctional institute on 3/25/21. The nursing director was notified on 8/13/21 and was advised to monitor inmate for vaccine reactions.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J013394, expiration date: 25-AUG-2016; lot # L019298, expiration date: 22-JUN-2017) (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
First day after the shot the arm was extremely sore; could not lift. Now, 5+ weeks later the arm is burning and the fingers are extremely burning and tingling. Pain is a 9 and 10.
This case was reported by a healthcare professional via a sales representative and described the occurrence of an unspecified, severe event in a pediatric subject of unspecified, severe event in a pediatric subject of unspecified age and gender who was vaccinated with HAVRIX. On an unspecified date the subject received unspecified dose of HAVRIX 0.5ml (prefilled syringe). At an unspecified time after vaccination with HAVRIX, the subject experienced an unspecified severe, adverse event. At the time of reporting the outcome of the event was unspecified. The reporter expressed concern over the quality of the vaccine as severe events occurred in two other pediatric subjects that received the same lot of HAVRIX (product complaint). For details surrounding the other two subjects, refer to case numbers A0741170A (master case - involving an event of seizure) and A0741173A (event unspecified).
pt hospitalized within 6 weeks of COVID vaccine: Hosp 4/1/21 ED to hosp 4/2/21 ED to hosp  4/9/21
INCORRECT PRODUCT STORAGE; TEMPERATURE EXCURSION FOR FEW MINUTES AT 34.97 F; This spontaneous report received from a pharmacist concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 29-JUN-2021) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUN-2021, the subject experienced incorrect product storage. On 16-JUN-2021, the subject experienced temperature excursion for few minutes at 34.97 f. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and temperature excursion for few minutes at 34.97 f was not reported. This report was non-serious.
extreme tiredness,  low fever, chills, nausea, headache, sore arm and hot at the injection site.
Screaming, inconsolable crying for 2 days, fussy, wasn't feeding or sleeping as usual.  Nurse follow up on 07/28/04 states: "SIDS."
With both shots, my neck would be too stiff to turn and I would have flu-like symptoms. With the 2nd shot, I had uncontrollable shivering and then a fever. All of my joints ached and I was too tired to do anything the following day.
POTENTIALLY ADMINISTRATION OF AN EXPIRED DOSE; DOSE ADMINISTERED ABOUT 15-30 MINUTES AFTER THE RECOMMENDED STORAGE PERIOD FOR PUNCTURED VIAL; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:1808980, and expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 16:30 for prophylactic vaccination. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced potentially administration of an expired dose. On 18-AUG-2021, the patient experienced dose administered about 15-30 minutes after the recommended storage period for punctured vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the potentially administration of an expired dose and dose administered about 15-30 minutes after the recommended storage period for punctured vial was not reported. This report was non-serious.
Marked worsening of chronic (previously stable for 4 decades)  tinnitus.
Staff combined the 2 liquids together and administered to patient; Staff combined the 2 liquids together and administered to patient; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, when reconstituting menveo the staff combined the 2 liquids together and administered to patient in left arm, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Information has been received from an office manager concerning a six month old female who on 25-SEP-2008 was inadvertently vaccinated with the first dose of ROTATEQ. The office manager reported that it was a staff error only. No adverse effects at the time of the report. The patient sought medical attention at the office. A product quality complaint was not involved. On 26-SEP-2008, a health care professional followed up with the patient's mother who reported no adverse events at that time. Additional information has been requested. 03/05/09 This is in follow-up to report(s) previously submitted on 10/13/2008. Initial and follow up information has been received from an office manager concerning a six month old female with no medical history who on 25-FEB-2008 was inadvertently vaccinated with the first dose of ROTATEQ (Lot# was unknown). The office manager reported that it was a staff error only. No adverse effects at the time of the report. The patient sought medical attention at the office. A product quality complaint was not involved. On 26-SEP-2008, a health care professional followed up with the patient's mother who reported no adverse events at that time. No further information is available.
This spontaneous report was received from a nurse referring to herself. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient stated that she got PROQUAD (dose, lot# and expiry date were not reported) into her mouth while she was drawing the product up into a syringe (accidental exposure to product, exposure via mucosa and occupational exposure to product). She stated that she had discarded the syringe and did not use it for any patients. No adverse symptoms reported.
Pt received Tdap & Flu vaccine 12/06/11. She called 12/12/11 to state that 4 days later she awoke with hives under buttock, behind knees, elbows and around lips. She self-treated with OTC Benadryl and called to inform our office 12/12/11. No medical treatment was done per pt.
pt recv vax & pt exp six lesions, sl fever, & failure to seroconvert;
Given  1 dose Varicella vaccine and 1 dose DTaP;was mistakenly given varicella. Was authorized to receive TDaP vaccination only
Ache in her legs; Not much appetite; Feels like she's been hit by a truck; Chills; Steady headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Steady headaches), PAIN IN EXTREMITY (Ache in her legs), DECREASED APPETITE (Not much appetite), CHILLS (Chills) and FEELING ABNORMAL (Feels like she's been hit by a truck) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Steady headaches), PAIN IN EXTREMITY (Ache in her legs), DECREASED APPETITE (Not much appetite), CHILLS (Chills) and FEELING ABNORMAL (Feels like she's been hit by a truck). At the time of the report, HEADACHE (Steady headaches), PAIN IN EXTREMITY (Ache in her legs), DECREASED APPETITE (Not much appetite), CHILLS (Chills) and FEELING ABNORMAL (Feels like she's been hit by a truck) outcome was unknown.            No treatment information was provided.
Information has been received from a RN concerning a 9 year old male who on 25Jun98 was vaccinated with a first dose of varicella virus vaccine live (lot 625475/0644H). There was no illness at the time of vaccination. On 12Apr04 the developed a rash on his chest. He was seen at the doctor's office with the rash, which was present for 24 hrs and was diagnosed with varicella. It was reported that no lab tests were performed. Follow up information indicated that the pt has recovered with no ill effects. The reporter also indicated that the pt's sister (WAES0404USa01705) had a similar experience following exposure to varicella virus vaccine live. No further information is available.
day 3 woke up feeling need for more air, went for walk outside came back very tired, went back to bed, cont to feel worse, h/a, backache, joint pains;took advil;day 4 chills;day 5 t102.2, urinary tract sx;day 6 t101;day 7 felt washed out
BODY ACHES; DIZZINESS; FELT SO COLD; FEVER; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 05-AUG-2021 16:45 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 06-AUG-2021, the patient experienced body aches. On 06-AUG-2021, the patient experienced dizziness. On 06-AUG-2021, the patient experienced felt so cold. On 06-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, body aches, and dizziness, and the outcome of felt so cold was not reported. This report was non-serious.
red tongue, red lips, bumps on tongue,  reactive airways . Cough and asthma symptoms, airways filling with mucus. Zyrtec, albuterol sulfate
Information has been received from a registered nurse (RN) concerning a 42 month old male who on 10 March 2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The RN reported that on 15 February 2006, the patient developed chickenpox. Unspecified medical attention was sought. At the time of this report, the patient's chickenpox persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 05/12/2006. Information has been received from a physician and a registered nurse concerning a 42-month-old male with no medical history who on 10-MAR-2005 was vaccinated SC in the left arm with the first dose of VARIVAX (Merck) (lot #649846/0767P). The RN reported that on 05-FEB-2005 (also reported as 15-FEB-2006), the patient developed chickenpox characterized by vesicles and pustular papules on his trunk. Unspecified medical attentionwas sought. In 2006, the patient's chickenpos subsequently resolved. Additional information is not expected.
Patient reported itchy inner arm about 15 minutes after shot. Her skin is red from scratching.
Acute Resp infect, pulmonary infiltrates, hypoxemia reported in pt receiving FLUOGEN; Approx 15FEB91 hosp for acute resp infect accompanied by fever, myalgia, ha/ & sputum initially not purulent; d/c p/11days & was well 2.5 wks later;
Several hours after the vaccine my head started to itch, the next day I had a full body rash and my skin was red and painful. My underarms, genital area, head, and eyebrow area was severely itchy. I went to the hospital where they gave me a 12 day steroid taper, steroids in the hospital and monitored me until my skin calmed down. They also gave me hydroxozine and Pepcid. Two days after the steroid taper was over the rash returned and my primary care gave me 7 days of steroids. The day that ended I felt itching in my head  and eyebrows and my skin began peeling, and I saw a dermatologist that day who prescribed a 21 day steroid taper. I have just finished this medication today. I have missed work due to symptoms. The second time the rash came back my face looked like I had shingles and was painful to the touch.
Chills, low grade temp, achy all over, sweats, headache, very sore arm
Suspected vaccination failure; Getting worst outbreak of shingles; Patient was 46 years old when 2nd dose was received; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 46-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (patient had outbreaks of shingles 2 to 6 times a year for the past 10 years). Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer linked case US2021AMR033939).   In December 2020, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix and less than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccination failure and inappropriate age at vaccine administration were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that she was a rare case who had been getting outbreaks of shingles 2 to 6 times a year for the past 10 years or so. The age at vaccination was not reported for 1st dose, it could be 45 or 46 years. The patient had received the 2nd dose at the age of 46, which led to inappropriate age at vaccine administration. Within weeks of getting the 2nd dose, the patient got one of the worst outbreaks they had ever had and presently she was getting her 2nd outbreak. The patient stated that they had received 2nd dose in December and it was presently only February for the outbreak. The patient was not sure if taking the 2nd dose made the vaccine less effective because they were younger than 50. The reporter could not see any studies or comments and was trying to get more information. This case was considered as suspected vaccination failure since the details regarding lab test confirmation and exact time to onset were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR033939:Same reporter, same suspect, same patient, 1st dose
6 days post vaccination pt reports lymphadenopathy in left auxiliary space that is tender to palpation.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/11/2021 and 2/1/2021. Admitted for Acute respiratory failure with hypoxia due to Covid-19 PNA. Treated with: baricitinib, dexamethasone, anticoagulation, and remdesivir. Respiratory status continued to decline. Troponin was elevated likely due to demand ischemia from hypoxic respiratory failure. Transitioned to inpatient hospice on 1/18/2022 and expired on 1/19/2022.
Patient was mistakenly given the Pfizer vaccine for her second dose of Covid vaccine, after starting the series with Moderna on 1/21/2021. Her Moderna lot # was 041L20A.
p/vax pt began to exhibit autistic behavior; lost the ability to speak or communicate; Annual FU: never recovered his ability to speak or comprehend.
About 3 weeks later of my first vaccine, my left arm got swollen. i had a knot as big as a tangerine, it was hot upon palpation. I went to urgent care because I had an infection and they placed antibiotics. i was advised not to receive the second vaccine.
Chills, fever, nausea, vomiting on second day after shot. Feeling faint.
Pt was seen in ER 7/20/03 - 12 x 11.5 cm red, raised area (RT) nontender. No fever. Swollen. 7/22/03 Followed up in PCP office - 4.5 x 4.5 red, raised, nontender, no fever.
PATIENT IS 62 YEARS OLD AND RECEIVED A HIGH DOSE FLU FOR 65 AND OLDER. NO ISSUES.
Case number PHEH2013US018222, is an initial spontaneous report received from a medical assistant on 27 Aug 2013, with a follow-up received on 17 Sep 2013 and a follow up report from the health are professional received on 24 Sep 2013: This case refers to a 22-year-old male patient. He received only 0.5 ml of Men A lyophilized conjugate component of MENVEO (batch number: A11066), reconstituted with sterile diluent intramuscularly in the right deltoid region on 08 Aug 2013 (2:30 pm). Reporter stated that patient did not experience any adverse event following this medication error. Follow-up was received on 17 Sep 2013: Information that patient did not experience any event was updated. Follow up report from the health care professional received on 24 Sep 2013: The vaccination site was updated.
Sever headache about 5 hours after dose.  By 10 hours after dose had chills, nausea, and body aches.  Had a low grade  fever and dizinessafter about 16 hours.  Fever, chills, and body aches ended after about 23 hours but severe headache and nausea remained.  Headache got substantially better after about 48 hours and it intermittent now at 56 hours.  Nausea continued well after 48 hours and still have it 56 hours after dose.
Rash - over most of upper body, very itchy. Took a dose of CLARITIN daily for 5 days or so. Feeling much better. Lasted 5 or 6 days.
Large red welt that grew in  size throughout the day, injection site is red, warm to touch, itchy  Applied cortisone to area several times throughout the day, took two benadryl at 7 pm