chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer or other non-health care professional via medical information team for a sponsored program. The reporter is the patient. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported), via unspecified route of administration on unspecified date as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Patient previously received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not reported), via unspecified route of administration on unspecified date as DOSE 1, SINGLE and DOSE 2, SINGLE for COVID-19 immunization. Patient medical history and concomitant medication were not reported. On an unspecified date the patient experienced Pericarditis, Myocarditis, Booster dose, chest pain, shortness of breath, fast beating and heart rate. The patient underwent the following laboratory tests and procedures which includes electrocardiogram, heart rate and troponin with unknown results. Reporter quired for how does the symptoms of chest pain, shortness of breath, fast beating and heart rate associated with Pericarditis and Myocarditis differ from Anxiety. Reporter stated that he received his third dose of the Pfizer Covid-19 vaccine and had no underlying medical condition. Reporter stated that he was trying to figure out how to reliably differentiate these symptoms. Reporter queried for what was the onset or time frame for an individual to develop these condition. Reporter queried for when to seek medical help when they experience such symptoms, to which health care professional does he need to consult with. In response to the query it was provided that referred to health care professional to assess and evaluate his symptoms. Advised the reporter on the likelihood of having Myocarditis based on PI Warnings and attached document. Post marketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. Outcome of events was unknown.
pt recv vax MAY96 & 8MAY97 pt devel serious case of chickenpox that consisted of 200 lesions over body including throat & ears;
Following vaccination: Left arm swelling, arthralgias/myalgias, temperature of 102F and nausea.
606 doses were given after expiration date; product stored after expire date of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product stored after expire date of vaccine) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (product stored after expire date of vaccine). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (product stored after expire date of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date when vial stored in refrigerator was 18 Oct 2021. No concomitant product reported by reporter. No treatment medication reported by reporter.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was stored in freezer, one to two vials were taken out and placed in the fridge each day as needed. Concomitant medications were not provided. No treatment was given.
HYPOTENSION 6/1/2021 CARDIAC ARREST DUE TO UNDERLYING CARDIAC CONDITION  ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/1/2021 CARDIAC ARREST DUE TO UNDERLYING CARDIAC CONDITION
Tested COVID positive 05Apr2022; Tested COVID positive 05Apr2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 at 15:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 at 15:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Oct2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Mild depression" (unspecified if ongoing); "OA" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Known allergies: Nickel" (unspecified if ongoing); "Known allergies: Thimerasol" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST SODIUM, start date: Mar2019; OXYBUTYNIN, start date: Nov2021; SERTRALINE HCL, start date: Jan2012; LOSARTAN/HCTZ, start date: Jan2015; ALBUTEROL SULFATE HFA, start date: Jan2015; FLOVENT HFA, start date: Jan2015. Past drug history included: Lotensin, reaction(s): "Known allergies: Lotensin"; Protonix, reaction(s): "Known allergies: Protonix". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Apr2022, outcome "unknown" and all described as "Tested COVID positive 05Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Apr2022) Positive; (09Apr2022) Negative, notes: cold-like symptoms mostly gone; (15Apr2022) Positive. Therapeutic measures were taken as a result of covid-19. The patient received other medication in 2 weeks were Montelukast sod., Oxybutynin, Sertraline HCL, Losartan/ HCTZ, Albuterol Sulfate HFA and Flovent HFA. Tested COVID positive 05Apr2022, took Paxlovid x 5 days, tested negative 09Apr2022, with cold-like symptoms mostly gone. Her symptoms rebounded 15Apr2022 and she tested positive again 15Apr2022, this time with much worse symptoms: cough, wheezing, sore throat, stuffy nose, plugged up ears, left enlarged lymph node under chin, lethargy, hoarseness, Shortness of breath and laryngitis. MD prescribed 5 day course of Prednisone 40mg/day and 2 Tessalon perles 3 x day, As of 27Apr2022 she was still coughing and have sinus drainage, mild tiredness and hoarse voice. Treatment start date was 05Apr2022 and Treatment stop date was 10Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, Covid 19 and the suspect product BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
pt recvd vax 1630 on 29OCT91 sx of pain/lump in throat while eating soup @ 2130; difficulty sleeping lump seemed to inc spitting up clear mucous & salivation; lump disappeared by AM; Describes feeling achy & hot for next 24 hrs;
Hives to left arm, chest, neck, upper back given children's chewable claritin while at office. Pt was monitored for 1 hr 30mins.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Systemic: numbness-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: fingers tingling
In 4/99, the pt received his 1st dose of Lymerix. 24 hours, post vax, he experienced pain at the injection site, then flu-like symptoms. He had a low-grade fever which lasted 3 days. Outcome:resolved. In 5/99, the pt received his 2nd dose of Lymerix. 24 hours, post vax, he experienced pain at the injection site and flu-like symptoms. Symptoms lasted 24 hours and then resolved. On 5/24/00, the pt received his 3rd dose of Lymerix. 3 days later, on 5/27/00, he experienced pain at the injection site, and did not feel well. The pt felt "achey". Additionally, he developed a tiny, red, flat rash behind one ear. On 5/29/00, the rash spread around his back, behind both ears, and down his back and chest. No treatment was given. Outcome: unresolved. The most recent information, received on 5/30/00, reports the condition of the vaccinee as unresolved.
The pt had a seizure at approx. 20:45. It involved the right side of his body but was not unconscious during the seizure, though it lasted approx. 2 minutes. ER visit proved nothing. One month later, his 2nd seizure occurred. He was put on Tegretol to control but a week and a half later, he developed infantile spasms. He is on Predinose now to try to control.
This spontaneous report was received from a pharmacist referring to an 81 year old male patient. There was no information about the patient's  pertinent medical history, concomitant medications and drug reactions or allergies provided. On 16-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, subcutaneously (dose, site of administration , lot# and expiration date were not reported) for prevention of shingles. On 17-NOV-2016 (reported as the following day), the patient returned to the pharmacist and was experiencing swelling from the shoulder to the elbow and it was tender, itchy and red (onset date on 17-NOV-2016). An unspecified treatment was given for the events. Product quality complaint was not involved. The outcome of swelling from the shoulder to the elbow, tender and itchy was considered to be recovering/resolving, while the outcome of redness was considered to be not recovered/not resolved, as  the patient returned on 21-NOV-2016 (reported as today) and stated that the symptoms "had gotten better but still a little red". The relatedness between the events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
pt was given a 4th full dose of Moderna vaccine. He did not qualify at the time
Pain & induration (6cm x 4cm) on upper left thigh. Started shortly after injection & increased in size pt was seen in clinic 3 days after vaccine administered and was given PEDIAPRED, BENADRYL & sulfamethoxazole-trimethoprim.
Patient describes having no problem for a couple of hours and then all of a sudden he was overcome with excruciating pain in his right arm. He laid on the floor and could not do anything the rest of the day. Patient took prescribed oxycodone for the pain. Patient could not move his arm. The day after the immunization he is not bothered by pain unless he moves his arm. Upon moving the arm, patient feels a shooting pain.
My mother who is with me had a reaction to the vaccine; pharmacist said it was bad enough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 87 -old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) at the age of 87 years 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: VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "My mother who is with me had a reaction to the vaccine; pharmacist said it was bad enough". Therapeutic measures were not taken as a result of vaccination complication.  Additional information- Reporter was informed about the Pfizer Medical Information department and  was provided with the number of Pfizer Medical Information as (phone number) and was requested to select option 3, timings are 8 AM to 8 PM from Monday to Sunday as per.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, might between 07-SEP-2016 and 22-SEP-2016, the patients were vaccinated with doses of frozen ZOSTAVAX (lot #, expiration date, dose and route were not reported). It was reported that the vaccine was reconstituted with improperly stored sterile diluent (lot # K024556 with expiration date 01-OCT-2017; lot # M019199 with expiration date 16-OCT-2018; lot # K019030 with expiration date 21-AUG-2017; lot # L044085 with expiration date 29-MAY-2018). The sterile diluent was improperly stored at -0.1 Celsius (C) for cumulative 131 hours. There was previous temperature excursion: 15 C for 15 hours. Data logger was involved. ZOSTAVAX was properly stored. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
SORE ARM; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, start therapy date were not reported 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 patient experienced sore arm, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and fever. This report was non-serious.
he had reaction broke out into rash all over his body; Itching all over; Headache; fever; chill; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RASH (he had reaction broke out into rash all over his body), PRURITUS (Itching all over), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chill) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (he had reaction broke out into rash all over his body), PRURITUS (Itching all over), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chill). At the time of the report, RASH (he had reaction broke out into rash all over his body), PRURITUS (Itching all over), HEADACHE (Headache), PYREXIA (fever) and CHILLS (chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient went to the emergency room and was given an unspecified shot. The patient then left as he felt better.
11/17/21 presents to EC ED for "very fatigued with episodes of nausea and vomiting". PMHx "breast cancer diagnosed in 2016, DVT/PE in 2020"
R arm swollen, erythematous and feels hard to touch - Fever 101 degrees. ER physician called it "allergic reaction". Recomm. Tylenol and Benadryl.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 08-MAY-2013 the patient was vaccinated with GARDASIL dose 1, 1DF, intramuscular (strength, lot # and expiration date not reported). Concomitant medications and other relevant medical history were not reported. The patient received the second dose of GARDASIL on 21-MAY-2014. No adverse effects were reported. No further information was provided. Additional information has been requested.
The first side effect was an extremely sore arm (not only at injection site, but a DEEP ache lasting three days--difficult to dress)--a few hours after the injection.  Then, about 10 hours after, I began to feel run down and through the night, I felt feverish, and it was hard to sleep.  I never had a fever through the entire length of my side effects.  I also had a headache behind my eyes that was exacerbated upon moving my eyes.  By day three, I had gastrointestinal symptoms and slight feeling of cough by day two.  As the week progressed, I felt more and more fatigued and then I felt some mild shortness of breath.  In total, the side effects lasted seven full days.  I was sent for a COVID test by day six.  I was negative.   A few days later, I developed a mild rash (light-pink blotches on my torso--not itchy).  I was prescribed a fluticasone cream to apply and they went away after about a week of application twice per day.  I also took 12.5 mg of Benadryl for three nights during that time.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of over 101), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of over 101), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever of over 101), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-024802 (Patient Link).
redness (baseball diameter), warm, hard lump, sometimes itchy on upper right arm after Moderna booster.Zyrtec taken nightly for allergies.  still active for +4 days
pt recv vax & devel a raised, red, non-tender skin lesion @ the inj site;
This spontaneous report as received from an unknown type reporter refers to a 15 years old patient of unknown gender. On 01-APR-2014 the patient was vaccinated with a dose of GARDASIL (lot#batch# reported as J006350, expiry date: 31-MAR-2016) dose, frequency and indication unspecified. The reporter stated that GARDASIL was involved in temp changed. At the time of report, the outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
I tested positive for COVID-19 on 7/29/22. I was having flu like symptoms, fever, body aches, headache, congestion, and coughing. I was prescribed PAXLOVID on 7/29/22. My symptoms lasted quite a while. I think they lasted about 2 weeks.
Thurs: aches and pains, red arm; Fri: aches and pains, fever 102+, chills, red area on upper left arm, 3" by 3" which was warm to touch, with red lines going to underarm; Sat: aches and pains, fever 102+, red area increased to 6" by 6" with deeper red; Sun: same; Red area took over 1 week to lighten. Have pictures of the arm. Treatment: took doses of Tylenol and Benadryl every two to three hours, plus ice applied to arm.
Beginning a few days after my second vaccination and continuing to the present day I have had increased dizziness. It may stem from inner-ear instability. During the dizzy spells it is difficult to visually focus on things near to me. There have been 2 events in which I was driving and pulled over as a result. I am a fit and healthy person that regularly exercises 7+ times per week and did not have dizziness issues prior.
pt recvd vax 5OCT92 & the evening following vax pt had hives, erythema; pt did not receive treatment; sx resolved in 24 hrs;
On 3/15/2021 Moderna COVID19 Vaccine Vial Lot #014M20A was punctured at 10:45A, vaccine was given at 4:53P.  Vaccine expired at 4:45P (6 hours after punctured).  Reported to Moderna same evening, received response 3/18/2021.  Representative gave instruction that repeat dose was not needed as viability of vaccine was demonstrated 12 hours after puncture time, however as there was no preservative there was increased likelihood of infection.  Patient was informed, patient denied signs of infection.  Patient was instructed to monitor for signs of infection at vaccine site.
Information has been received from a registered nurse concerning a 17 month old female pt who on 5/25/99 was vaccinated with a dose (630105/0128J) of MMR II. Concomitant therapy that same day included a dose of oral poliovirus vaccine and a dose of DTaP. Several hours after the vaccinations, on approximately 5/25/99, the pt's lips became swollen and her skin became blotchy. She was seen and treated at the local emergency room and released the same day. Additional info has been requested.
Covid second shot recieved on May 15th. Rash on arm started a week exactly after shot 1 on May 22nd. Rash started on left arm, to shoulder, to side of belly, then to other arm, right side, kept spreading all over where I ended up driving myself to the ER on May 28th. Rash is red dots, not itchy, and not affected by anti-histamine.
PT HAS A 2 .5 INCH DIAMETER CIRCLE AROUND THE INJECTION SITE THAT IS HARD AND WARM THAT STARTED WITHIN A DAY AFTER THE INJECTION WAS GIVEN AND HAD CONTINUED FOR OVER A WEEK BEFORE SEE SAW A DR ABOUT IT.  DR.PRESCRIBED HEWR A 7 DAY COURSE OF CEPHALEXIN 500MG EVERY 12 HRS.
The mom gives a hx of fever up to 116 one day post vax. Fever resolved with Tylenol, Motrin and Lambs juice. Date of last shots on 2/7/00. Mom reported this to our office on 4/6/00.
No additional AE details available; a patient was administered an expired dose of PNEUMOVAX 23; This spontaneous report was received from a  medical assistance referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reaction or allergies were not reported.    On 14-OCT-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength and route were not reported; lot # T021329, expiration date: 03-OCT-2021) for prophylaxis (expired product administered).     No prior temperature excursion. No additional AE details available (no adverse event).
Breakthrough COVID-19 case with symptom onset 8/6/2021: Cough. Hospitalized 8/6/2021-8/7/2021. Death 8/7/2021. Vital records data not available yet.