chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via unspecified route of administration on 22Apr2021 as single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient experienced bumps on her right arm (she is having bumps on her right arm. She wanted to know if this is normal since she never experienced this when she took her first dose). The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Full body urticaria, self treatment w/cetirizine, resolved within about 4 hours of dose
Redness and 1/2 cm welt on right side of leg at the MMR injection site.  Patient monitored for an hour-stabile.  Benadryl provided in clinic. Motrin given to go home
dizziness and nausea, fatigue and head congestion, especially on left side of head it felt as though I was underwater also some eye fatigue. ear started ringing deep on the left side
Patient inadvertently received vaccine that had expired on 4/06/2022 (2 weeks prior)
Weakness; Vomiting; Nausea; Loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 14:30 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Failure to thrive" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Weakness"; VOMITING (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Vomiting"; NAUSEA (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Nausea"; DECREASED APPETITE (non-serious) with onset 04Dec2021 14:00, outcome "recovered" (Dec2021), described as "Loss of appetite". Therapeutic measures were not taken as a result of asthenia, vomiting, nausea, decreased appetite.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 56-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 56 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "renal insufficiency" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (09May2022) Positive, notes: Rebound of COVID-19 infection. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral details was COVID 19 Treatment, brand: Paxlovid, treatment start date: 27Apr2022, treatment stop date: 02May2022, indication=Treatment of COVID-19, Administrator route was Oral, Other mediation in two weeks product was Atenolol. No known allergies. No AE treatment was received. Other medical history: renal insufficiency, age, hypertension, lipid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
had a localized reaction to Pneumovax 23/ vaccine related adverse reaction; potentially contaminated; This spontaneous report was received from a pharmacist, via other company, concerning a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S024808, expiration date 02-JUN-2020) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis.    On an unknown date, the patient experienced a vaccination related reaction, she went to the emergency room (ER) and had localized reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). They were requesting to send off the needle or the vaccine box to see if it was potentially contaminated (suspected product contamination). The outcome of the event was not reported.   The reporter considered the event to be related to the suspect vaccine. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry:; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Flat, red, itching, burning rash all over her body; Flat, red, itching, burning rash all over her body; Flat, red, itching, burning rash all over her body; Sore throat; Low-grade fever; Drowsiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Flat, red, itching, burning rash all over her body), PRURITUS (Flat, red, itching, burning rash all over her body), RASH (Flat, red, itching, burning rash all over her body), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Low-grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced ERYTHEMA (Flat, red, itching, burning rash all over her body), PRURITUS (Flat, red, itching, burning rash all over her body), RASH (Flat, red, itching, burning rash all over her body), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Low-grade fever) and SOMNOLENCE (Drowsiness). On 18-Feb-2021, ERYTHEMA (Flat, red, itching, burning rash all over her body), PRURITUS (Flat, red, itching, burning rash all over her body), RASH (Flat, red, itching, burning rash all over her body), OROPHARYNGEAL PAIN (Sore throat), PYREXIA (Low-grade fever) and SOMNOLENCE (Drowsiness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Vaccine error not adverse event. The patient was supposed to receive the first dose of monovalent Pfizer Covid 19 6m-4 years vaccine.  The nurse inadvertently administered a Bivalent Pfizer  Covid 19 vaccine for ages 6m-4years.  The parents have been notified as well as consulted with the CDC for subsequent doses. The  parents were notified of the error and the patient did not experience an adverse event per the parents.
Seizure, gave Tylenol. 11/24/2009 ED records for 11/22/2009, patient with new onset seizure activity. DC'd home with Tylenol
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 51-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0176), at the age of 51, in left arm, on May 14, 2021, at 09:00; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EW0182), in left arm, on Jun 3, 2021, at 17:00; both single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed blisters (sores on both hands), onset Jun 15, 2021, with outcome of not recovered; and pain in extremity (painful to the touch), onset 2021, with outcome of unknown. No therapeutic measures taken. No follow-up attempts possible. No further information expected.
My left eye has a blurry spot. If I am watching tv i have spots that are blurry. I cannot define faces, license plate numbers, speed limit numbers, and this is all confirmed by my doctor. My retina is fine but my vision is compromised by blurriness.
11/09/2021 Around noon I started experiencing flu symptoms. I was fatigued, had a low-grade fever and hurt all over. This lasted 24 hours. The next time I was sick was Dec. 1, 2021. I was sick for over 14 days with a horrific sore throat. Then I got the worse head type cold, I was up all-night coughing and had trouble breathing. I tested negative for COVID-19. I went to the ER. They did x-rays and a CT.  I was diagnosed with bronchitis, and they gave me an antibiotic and cough syrup. It started to get better the middle of December. It was at that time, my upper arm started to hurt me really bad. I thought it was because I was in bed so much and coughing so much. As time went on, my arms became worse to the point where I could not sleep at night. I can't put my eye drops in or get dressed by myself. I am having a hard time. I continue to have problems with my arms. On March 23,2022, I had an appointment with neurologist APN. I started thinking it was not fibromyalgia. I was having neck pain and upper arms still hurt. She examined and said there was a weakness in my arms. She ordered an MRI. An MRI was done on 4/15/2022. It showed interval development of modern edema in the Left C3-C4, and Right C4-C5 articulating facet and development of periarticular inflammatory stranding in the adjacent fat plains suggesting active arthropathy. Involvement of the left C4 and right C4 is suspected. There is a stable reduction at C5 and C6. There is a 5m collection of fluid in the sub tissue overly left C3. There is clinical concern for septic arthritis or possibility of a small periarticular access. Finding could be synovial cyst. There is a mild core compression and C4,C5 and C5, C6. Physiotherapy was ordered and I started it on 4/25/2022. Tomorrow, I will see a neurosurgeon. The physiotherapist, said she is very interested in what the effects of COVID-19 vaccines have on people with Fibromyalgia.
Fever up to 100.8, achey skin and muscles, headache, swelling at injection site
Information has been received from a licensed practical nurse referring to three patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. On 22-SEP-2016, the patients were vaccinated with three doses of improperly stored dose of VAQTA (lot # M017982, expiration date 13-SEP-2017, dose and route were not reported). No adverse effects were reported. This is one of the several reports received from the same reporter.  Additional information is not expected as there is no contact consent to follow up.
Patient presented to the ED on 1/21/21 for evaluation of SOB stating her husband tested positive for COVID earlier that week and she has been around him. The patient states her symptoms started 3-4 days prior to presentation. She admits to cough, nausea, and an episode of vomiting the day of presentation. She had been intermittently using her husband's oxygen prior to presentation which she says has helped with her symptoms, but does not use oxygen at baseline. Upon presentation the patient's oxygen saturation rate on room air is 89%. Patient was placed on 2L oxygen via nasal cannula and then was saturating in the mid 90s. CXR demonstrated bilateral patchy infiltrates in the ED which the ED physician felt to be consistent with COVID infection. The patient's rapid COVID test resulted as positive. The patient was admitted to the hospital for further management of hypoxia related to COVID infection. The patient remains hospitalized on the day of report submission (1/28/21)
A pediatrician reported that a 17 month old female received injections of Prevnar, MMR, and varicella vaccines on 10/18/2000. She was noted to be a healthy child with no past history of illness and no pre-exititng illness at this time of vaccination. The child was found dead in her crib on 10/26/2000. Sudden Infant Death Syndrome was reported. An autopsy was reported to be negative. NOTE: this report of a serious, labeled event (SIDS) is being submitted in a 15 day time frame as requested by the FDA.
Patient received vaccine 03/29/2016 and next morning patient broke out in a mild case of hives. Patient's dad called and asked what he could do for hives. I informed him to take son to doctor.
Headache, sensitivity to light, joint aches, chills, insomnia. Per patient, all symptoms started the evening after vaccination and have almost completely resolved
FEVER; HEART RATE INCREASED; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route and batch number: Unknown) dose was not reported, administered on 05-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced fever and heart rate increased. Her heart rate was115 beats per minute even at rest. Treatment medications included paracetamol for fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and heart rate increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: Fever and heart rate increased. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.
Evening before on 11/18/2021 I noticed a Tick attached to my arm and removed it completely. The next day 11/19/2021 I went in to get my booster and discussed the Tick bite as well and ruled it as a black legged deer tick. Public health decided it was okay to administer booster shot and I also received Doxycycline from nurse practitioner for tick bite. Roughly six hours after booster I began to experience horrible frontal headaches, body aches and pain got extremely bad, and chills, and my temperature went down to 95 degrees which is very low for me, and fatigue set in very bad. The following fatigue was bad as well. Symptoms started to improve slowly after about 36 hours and after 5 days I started to feel much better. During this time, I was feeling heart palpitations as well. Currently, I do have slight headaches, the heart palpitations have ceased, and I have changed heart medications to Metoprolol.
"COVID ARM" - 10 days after injection, 3" round swollen/raised bump.  Warm to touch, ichy.  No muscle soreness
Muscle aches throughout my entire body, Fever that got as high as 102.6, Headache, Chills, Nausea, Fatigue
Vomiting, Fever, Seizure. 8/25/09 Hospital records received service dates 8/18/09 to 8/21/09. Assessment: Fever, febrile seizure, vomiting. Baby woke up crying and coughing. Vomiting, then unresponsive for 20 seconds. Not breathing, shaking. Continued gagging and vomiting episodes. Appears ill.  10/6/09 ICD-9 Codes received: 780.31, Febrile convulsions, 780.32 Complex febrile convulsions, 079.99 Viral Infection NOS
Swollen, red, warm rash/hive at injection site appearing 8 days after vaccination. No immediate reaction.  Achy neck and shoulders, headache, sore lymph nodes in left armpit. Took Aleve.
Appr 2 hrs p/recving immuns awoke crying; cried unconsolably for >3 hours; went back asleep, then awoke in a happy mood; no elevated temperature;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 27-JUL-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (route oral, lot # L048854, expiry date 31-AUG-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. The vaccine was exposed to the temperature of 34 degree Fahrenheit for 53 hours. No digital data logger was involved. No product quality complaint was flied. This is one of the several reports from the same reporter. Additional information has been requested.
injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; injection site was a little swollen, red, itchy, and hard.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE INDURATION (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE SWELLING (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE ERYTHEMA (injection site was a little swollen, red, itchy, and hard.) and VACCINATION SITE PAIN (injection site was a little swollen, red, itchy, and hard.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE INDURATION (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE SWELLING (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE ERYTHEMA (injection site was a little swollen, red, itchy, and hard.) and VACCINATION SITE PAIN (injection site was a little swollen, red, itchy, and hard.). At the time of the report, VACCINATION SITE PRURITUS (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE INDURATION (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE SWELLING (injection site was a little swollen, red, itchy, and hard.), VACCINATION SITE ERYTHEMA (injection site was a little swollen, red, itchy, and hard.) and VACCINATION SITE PAIN (injection site was a little swollen, red, itchy, and hard.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Itching and Burning, 20 seconds after Tdap administered. Vaso constriction.
Hives and swelling of tongue.  Vaccination ~4:30PM and reaction started ~8pm Pt mother called PCP and recommended pt go to the ED.  It is unclear if pt went to ED. Appears that pt developed a moderate- severe reaction to second covid vaccine.  At this time, I would not recommend he get the booster until he has been evaluated and counseled from allergy clinic
Six days after the second moderna Covid shot  I got Shingles.  Blisters on my back neck arm and shoulder all on the right side of my body.  Body/ nerve pain also
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE  10/11/2022  -- RECURRENCE OF SAME SYMPTOMS
Shortness of breath, shakiness. Patient went to emergency room where they administered diphenhydramine.
Pain, swelling, looked like 2 injection sites for 5 days, joint/muscle aches, fatigue, nausea, chills. confusion/disorientation on day 3. Injection of Toradol on day 3. Finally better on day 6.
Sore arm; a low grade fever 99.6°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (a low grade fever 99.6°F) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (a low grade fever 99.6°F). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (a low grade fever 99.6°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99.6°f (Inconclusive) Body temperature-99.6.         No concomitant medication information was provided. Patient have not received any treatment medication. Action taken with mRNA-1273 in response to the drug was not applicable.
Day after the immunization, patient developed redness, swelling of the injection site, consistent with cellulitis. Felt febrile.
Cold sweats commencing about 10 hrs after vaccine, fevers, chills, body aches, fever of 101.5 with fever breaking approximately 36 hours after onset.  By Sunday morning Feb 21 all symptoms gonna except for fatigue.
red area to mid left thigh: 10 cm x 5 cm, hot to touch, treated with Duricef.
Information has been received from a registered nurse concerning a 14 month old male patient who on 04-AUG-2010 was vaccinated SC with a 0.5 ml dose of with VARIVAX (Merck) (Lot # 666917/0550Z). The nurse reported that on 13-AUG-2010, the patient experienced an 18 by 30 mm area that was red and swollen; this was his left thigh at the injection site. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot #N003702, expiration date 08-NOV-2019 (also reported as 08-NOV-2018). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 degrees Celsius for 4 hours 54 minutes. Data logger was involved. There were no previous excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA012843: US-009507513-1706USA004570:
Patient states about one hour after gett the vaccine, she felt nauseated and had to leave work. She also developed pain in the injection site immediately that progressed into redness, swelling, warmth, and limited mobility. Patient states these symptoms have lasted more than 5 days. They have improved slightly but the pain and limitation in mobility still persists.