chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is fully vaccinated and boosted 10/27/2021. COVID + 4/6/2022.72y.o. male with a PMHx of R sided partial Lung resection, carcinoid tumor present to the hospital with complaint of Chest Pain and SOB. Symptoms began today and describes chest pain as pressure that is worse with deep breaths. Admits to nonproductive cough. Denies fever, chills, nausea, vomiting. No acute PE. Mild leukocytosis. Patient hypoxic requiring initiation of O2 via NC. PLTS 131; CXR: Bilateral lung opacities as described above may represent pneumonia. Treatment:  O2 via NC, IV rocephin and azithromycin added, decadron. Patient discharged to home.
Attendee received first dose Pfizer vaccine at 10:03 in the Left arm.  Lot# ER8737. Attendee was directed to observation area.   At 10:10 the observation RN noticed redness in the attendee's left arm.  Upon palpation the arm was firm not just directly at the injection site but above and below the site as well.  The observation RN did an assessment and noticed that the attendee's tongue seemed to be swelling.  Attendee did not complain anything; she was very stoic, did grimace x 1 with palpation of the arm.  Attendee's skin was warm and dry. Attendee's respirations were not tachypneic or dyspneic. No difficulty with swallowing or speech. HR:  Not done   BP:  110/70   RR:   Not done   Temp:  98.3 10:12  Benadryl 50 mg was administered orally.   10:15 - 911 was called. The mother seemed upset about 911 being called and so the EOA had the mother feel how firm the attendee's arm was and then the mother seemed to understand why the site team was so concerned about the attendee.  The EOA was then informed that the attendee was a current participant in a medical study and received an injection of an unknown medication in the same arm, in the past 24 hours.   Medical Group  is where she is doing the clinical trial.  Neither the parents or the attendee were able to tell the site staff what the study is about or what injection she might have been given in the same arm as the Pfizer vaccine site. 10:20 EMS arrived and took over care of the attendee. Unsure of time  EMS left as the attendee was having no trouble breathing, swallowing, or speaking and the parents refused transport of the attendee to the emergency room.  10:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee. Advised to check on her every 30 minutes and if she developed any other or further symptoms to take her to the emergency room. They were also advised that if she develops any difficulty in breathing to call 911 instead of attempting to transport the attendee to the emergency room. She was then discharged to home with her parents, were she will be monitored by the parents.
Mostly long term gastrointestinal gas; Nausea; Exhaustion; Some brain fog; Almost flue like; Diarrhea, symptoms not getting better; No able to function as normal.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 28Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included environment illness and chronic inflammation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received pentazocine (TALWIN), codeine (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN), cortisone (MANUFACTURER UNKNOWN) and fluoroquinolone (MANUFACTURER UNKNOWN), for unknown indication from an unknown date and experienced drug allergy. On 30Apr2021, the patient experienced mostly long term gastrointestinal gas and nausea, exhaustion, some brain fog. Overall, in well, almost flu like. Diarrhea, symptoms were not getting better and not able to function as normal. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events mostly long term gastrointestinal gas, nausea, exhaustion, some brain fog (foggy feeling in head), flu like and diarrhea was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
a 11-years-old patient was inadvertently administered Flublok Quadrivalent/No AE; a 11-years-old patient was inadvertently administered Flublok Quadrivalent rather than Fluzone Quadrivalent/no AE; Initial information was received on 02-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case is linked to case 2020SA273042. (same reporter/15-years-old female patient)  This case involves a 11-years-old female patient who was inadvertently received a 0.5 mL suspect of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [prefilled syringe, lot number: UJ446AA and expiry date: 18-Mar-2021] rather than INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via an unknown route at an unknown administration site, on 01-Oct-2020, for prophylactic vaccination (product administered to patient of inappropriate age and wrong product administered). (Latency: at the same time of vaccination)  Medical history, medical treatment, vaccination and family history were not provided.  It was reported that, patient received no other vaccine as concomitant medication.  It was a case of an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  At the time of report, no adverse event was reported.  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 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.
Mom described infant as very lethargic, unresponsive, dusky, no fever. Taken to ER and admitted to PICU for extensive work up. Required NC O2 only. After a few days, returned to baseline, 30-35 episodes of apnea in first 24 hours. Increased dose of Zantac and Caffeine. Medical Records received on 1/10/2005 states final diagnoses were encephalopathy secondary to DTaP, and viral URI. Additional information included mild anemia.
Within 5 minutes I started feeling 'not quite right'. I had a strange metallic taste and itchiness on the back of my tongue. I tried to meditate for my 15 minutes. When I got up I felt very stressed, nauseous, foggy. I waited another 10 minutes in the hall. I felt more nauseated and went back to holding area. The nurse had me lay down. My blood pressure was around 145/100 and is usually around 100/68. My pulse was between 44-60 which is typical form me. I felt very very cold and was shivering. My hands and feet were like ice. I typically have good circulation. I rested another 30 minutes or so and went home. It took hours to warm up. The next few days were more of what I had expected: flu like symptoms, chills, tiredness, malaise, fatigue, sore arm.
Bell Palsy; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell Palsy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell Palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bell Palsy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drugs included, valacyclovir and Prednisone. Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
1546 Pt with c/o heaviness in upper back and shoulders. b/p 158/98, hr-90, r-18, o2 sat 98% ra, no other issues noted.  Empolyee interrupted. 1555 pt states issues has resolved. b/p 156/90, hr-93, o2 sat 98%ra r-18. Pt husband with her and he will be driving her home. Instructed to f/u with MD as needed.
Fatigue, headache, nausea, muscle and joint aches. Treatment=sleep and fluids
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (concentration, dose, dose number, route, lot number and expiration date were not provided). Concomitant medication information was not provided. On an unknown date, the patient developed shingles after receiving ZOSTAVAX injection. No product quality complaint (PQC) was involved. At the time of the report, the outcome of herpes zoster was unknown. The primary reporter did not provide the causal relationship between ZOSTAVAX and herpes zoster. Additional information has been requested.
Area around the injection is hard, tender to the touch, red, and warm in a 3-inch diameter ring.  Sore within hours of the shot, but the hardness and redness appeared about a day later. Seems relatively harmless, but thought I'd report it for statistical purposes.
Patient developed pain, erythema, warmth & induration at site of injection. No fevers. Went to urgent care same day, started on doxycycline to cover for cellulitis. Seen by myself on 2/5/16, induration was about 6x8 cm, with surrounding area 8x10cm of erythema.
This spontaneous report as received from a licensed practical nurse refers to a 4 year old child of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated an improperly stored dose of VARIVAX (lot # J008443, expiration date 09-JUL-2015), 0.5 ml, subcutaneous (strength and indication not reported). No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. This case has been linked with case 1407USA003655, 1407USA005531, and 1407USA011075. Additional information has been requested.
So every vaccine I have ever had in my life I have gotten reactions from within the hr of getting them. With in the last 5 years I got the DTAP AND TDAP and the CDC said I was having Severe reactions and to see the ER. This year I got my flu shot in Oct, and again I had reactions. My reactions always start with in the hr of getting them. Yesterday I got the pneumonia vaccine, and a hr later I got body rashes, I was itchy, confused, skin on my body felt like it was on fire and burning all over my body... hard to think, ect. Dr said I was having mild vaccine reactions to the shot, and to report it here. Well today my brain still hurts, still have body itching and skin on entire body feels like it is badly burned, and I am still rashy but nothing like I was yesterday, muscles hurt badly still, and more. What do I do? Dr's say there isn't much they can do for me. These vaccine reactions are effecting my mood and my life right now. What do I do to rid these vaccine reactions? The skin itching and burning is currently the worst symptoms as of right now.
Information has been received from a licensed practical nurse concerning a female with an allergy to the flu vaccine who on 24May06 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 653284/0002P). That same day, post immunization, the pt experienced an anaphylactic reaction and was hospitalized. She was treated with epinephrine and diphenhydramine (Benadryl). Subsequently, the pt recovered. Anaphylactic reaction was considered to be an other important medical event (OMIC) and immediately life threatening. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 3/11/21 Lot# En6205;  Pfizer 4/1/21 Lot# EP7534
Seven days, post vax, pt had a febrile seizure. Went to ER after seizure work-up began; MD in ER dx'd otitis media. Rx Motrin and 2 days after ER visit, no better.
Redness, itching and hard spot at vaccine site.  Started as hives at vaccine spot
Patient developed chest pain and fevers, 10 days after vaccination. Presented to ED on 20Jan2019.
Both of my hands numb burning painful and sometimes can't feel heat, same day both my feet same as my hands but hypersensitive on the bottoms of my feet then the numb tingling burning started going up both legs. I had never been so sick. I couldn't get out of bed, couldn't breathe, rapid heart beat, vomiting, and could not stay awake very long. This started the day after the numbness and burning in my hands and feet. Took a week and there was times I thought I was going to die.
Flu like symptoms including body aches; Flu like symptoms including body aches; alternating fever and chills on the second dose; alternating fever and chills on the second dose; This is a spontaneous report received from a contactable consumer. A 35-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration, on 13Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown if the patient had COVID-19 prior to vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration, on 23Dec2020, for COVID-19 immunization and had a sore shoulder (at point of injection) and foggy head for the few hours. On 14Jan2021 at 06:30, the patient experienced flu like symptoms including body aches, alternating fever and chills on the second dose. Treatment was not given for the events. It was unknown if the patient was tested for COVID-19 post vaccination. The outcome of the events was unknown.
Heart palpitations begin within 24 hours and lasted about 24 hours aspirin was taken... Within 48 hours joint pain in my groin unable to walk normally and put pressure on my leg.  My provider gave an EKG it turned out normal on that following Tuesday she thought I pulled something but I only rested the day after the vaccine because of the heart palpitations...no exercise or nothing was done to pull anything...I am still having groin pain a week later.
Rash on torso began day after vaccine.  Small red hives with no itch at first then has progressively gotten itchier.  Still have rash as of 8/24/2021.  Have not seen a doctor as no other major symptoms are evident.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 56.62.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09:00 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  Vial was stored on cooler 1, on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report as received from a nurse refers to a patient of unknown age. No medical history provided. On 23-OCT-2013 the patient was inadvertently vaccinated with VARIVAX (Merck) (0.65 ml, subcutaneous) instead of ZOSTAVAX. No concomitant medications were provided. No adverse effects were reported. No outcome provided. Additional information has been requested.
Right arm 9.5 cm x 10 cm area of erythema and warmth. Injection site - no drainage.
Patient was given immunization subcutaneously in the right upper arm and developed redness, swelling, warmth, tenderness, and firmness of the area.
MI (myocardial infarction); Severe limitation in my left arm movement; Frozen Shoulder; Booster; off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6199), in left arm, as dose 2, single (Lot number: EP7534), in left arm, as dose 3 (booster), single (Lot number: FC3184), in left arm and as dose 4 (booster), single (Lot number: F129896) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of other medications the patient received within 2 weeks of vaccination For the 3rd and 4th vaccinations. The patient had no known allergies. The following information was reported: PERIARTHRITIS (hospitalization, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "Frozen Shoulder"; MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "MI (myocardial infarction)"; JOINT RANGE OF MOTION DECREASED (hospitalization, life threatening) with onset 10Nov2021 at 17:30, outcome "recovering", described as "Severe limitation in my left arm movement"; IMMUNISATION (life threatening), outcome "unknown", described as "Booster"; OFF LABEL USE (life threatening), outcome "unknown". The patient was hospitalized for myocardial infarction, joint range of motion decreased, periarthritis (hospitalization duration: 2 day(s)). The events "mi (myocardial infarction)", "severe limitation in my left arm movement" and "frozen shoulder" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Dec2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of myocardial infarction, joint range of motion decreased, periarthritis.  Clinical course: The patient received all four doses on 23Mar2022. The patient was a healthy individual and experienced a MI (myocardial infarction) 10Nov2021.  Shortly after that she started to experience severe limitation in my left arm movement. Was then diagnosed with Frozen Shoulder. She received blood thinners for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.
Chills, HA, body aches, dizzy, pain in neck....On 9/23/09 pt went to ER and DX flu then returned 9/25 with urinary retention and required indwelling cath.
Right thigh redness and swelling 1/2 inch around indurated, left thigh 1 inch swelling induration
I had some severed issue with my period, My IUV came out and my blood was extremely thick.  It started out on October 3rd and I IUV fell out on the 4th.  I saw my doctor on October 13th.  They reinserted my IUV on that same day.
Vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time.