chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, on 3/15/2021.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. An ID requirement has been put in place to prevent this situation from occurring in the future. Per supervising doctor, this patient is able to receive the second dose of Moderna on an off-label, compassionate use basis.
This spontaneous case reported by a nurse, describes the occurrence of incorrect dose administered (11-year-old pediatric patient might have received adult Moderna COVID-19 vaccine; red cap vial) in an 11-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 059M21A) for COVID-19 immunization. No medical history reported. On Jul 12, 2022, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 12, 2022, patient had incorrect dose administered (11-year-old pediatric patient might have received adult Moderna COVID-19 vaccine; red cap vial). At the time of the report, incorrect dose administered (11-year-old pediatric patient might have received adult Moderna COVID-19 vaccine; red cap vial) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Myalgia, Diarrhea, NauseaVomiting,  chills
On day of vaccine administration-"fussy all evening." 15-20 hours post inj. inconsolable crying with high pitch. Post 48 hours much better, smiling, playing normally, napping approximately.
sore arm; little fatigue; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A contactable consumer reported for a 13-year-old female patient who received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 20May2021 (Batch/Lot Number: EW0177) as a single dose for covid-19 immunization. Medical history included athletic induced asthma (she was diagnosed maybe 3 years ago, 2018 or maybe it was 2016) and horseshoe kidney (the patient was diagnosed with a horseshoe kidney a year or two ago, meaning when the patient was in the her mother's womb, her kidneys while they were developing never separated so she has to be careful not to get kidney infections and not to get hit in the stomach when she's playing sports). On 20May2021, the patient experienced sore arm, little fatigue. Caller (reporter) stated that there was a report that came out. Caller states her daughter got her first dose, she was 13, and had no reaction other than a sore arm and a little fatigue the first day. Caller states the reports says it's causing enlarged heart in a lot of teens; she asked her doctor about it and the doctor said the benefits of getting the vaccine outweigh the risks and advised the caller to still get it for her daughter. The outcome of the events was unknown.   Pfizer Covid Vaccine: Caller confirms the patient received the Pfizer Covid Vaccine. NDC: Unknown; Expiry Date: Unknown; Unknown Dosage; Indication: Caller states they are pretty good about not going anywhere, but they certainly venture out more than she does. Caller states she wants to make sure she was protected. Caller states she learned a day or two before she scheduled the shot that her daughter's school is not offering school from home next year. Caller states it's called E classroom, they are also doing hybrid but her daughter opted to stay home. Caller states she learned they weren't doing any of that next year. Caller confirms her daughter is scheduled for her second dose on 10Jun2021. PSCC Communication: Report 2 of 7. Caller does not provide any further information on patient; therefore, no further information obtained or verified.  Additional information has been requested.
myalgias & fatigue for 3wk prior to vax;pt exp little red spots on abd;also mildly pruritic salmon colored maculo papular rash on trunk & arm;size up to 1cm diameter impression:pityriasis rosea;
VACCINE WAS ADMINISTERED 2 DAYS AFTER EXPIRATION DATE; This spontaneous report received from a health care professional concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 21-DEC-2021) dose was not reported, administered on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-DEC-2021, the patient experienced vaccine was administered 2 days after expiration date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered 2 days after expiration date was not reported. This report was non-serious.
Extreme chilling, no fever, weak, achy all over.  Lasted 8 hours.
This spontaneous report was received from a consumer refers to multiple patients of unknown age and gender. On an unknown date, the patients was vaccinated with ZOSTAVAX(dose, route, frequency and lot not reported). On an unknown date, people suffering horrible side effects. The outcome of the event was unknown. The reporter considered the event to be related to ZOSTAVAX. This is one report of several reports from the same source (MARRS#1302USA009042). Additional information is not expected.
Patient, who is 17 originally received her first vaccine of Moderna on 3-29-2021 IM in left deltoid.  nurse reached out  for guidance for her second vaccine. advise to administer her second Moderna, IM Left deltoid.  Patient tolerated the first vaccine well and no problem with the second vaccine, during her 15 minutes of observation.
T105 AX, vomiting, high pitched cry x 1 hr, glassy eyes, limpness all reported by mom; Given APAP for fever & used H20 for cooling;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm 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: "Migraine" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: MAGNESIUM, start date: 01Apr2022, stop date: 18May2022; WELLBUTRIN, start date: 01Apr2022, stop date: 18May2022; ADDERALL, start date: 01Apr2022, stop date: 18May2022. Past drug history included: Endomethicin, reaction(s): "Known allergies Endomethicin", notes: Known allergies: Endomethicin; Buspiron for psych effects, reaction(s): "Known allergies buspiron", notes: Known allergies: buspiron for psych effects. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02May2022) Negative; (03May2022) Negative; (04May2022) Negative; (11May2022) Positive, notes: Tested positive for covid 10 days after finishing Paxlovid round. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that tested positive for covid 10 days after finishing Paxlovid round. Had previously tested negative three days in a row on day 2, 3, 4 after finishing Paxlovid  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client stated that right arm was "reddened and sore" and she put a heating pad on it.  The client also was on blood thinners, but never disclosed that to the RN. The next day on 9/27/2016 she had a large area of ecchymosis on the right upper arm.  She noted also that she had an "itchiness on her upper chest, although there were no sign of rash, redness, or hives. No sign on any irritation although the client states "itchiness". She tried hydrocortisone cream and took Benadryl to relieve the itching. She came to Local Health Department today 9/30/2016 to talk to a nurse.  RN did note the ecchymosis on upper right arm approx. 8-10cm.  There was nothing noticeable on her upper chest area. No redness, no rash noted.  Explained we would fill out VAERS report and if she felt concerned to notify her physician.  She verbalized understanding of all discussion and nurse recommended that she should apply cold compress to injection site if needed. She stated "It is fine now, it just looks bruised."  She denied any other symptoms or problems and agreed she would consult her Dr. if the itchiness worsened or she had concerns.
Between February 25 and today's date March 1, 2011: Lethargic, rash, restless/difficulty sleeping, diarrhea, sore throat, excessive crying (even while sleeping), complaints of body aches (head, stomach, arms, legs) fever (102.2).
ErythemaMultiform employee reports redness and warm to touch at injection site  Narrative:  telephone nurse triage, employee reports redness and warm to touch at injection site 9 days post vaccine administration. applied ice pack to site, but no medication or further treatment needed. employee will continue to monitor if site does not improve.
Developed severe headache about 5 min after administration. Then described development of dizziness and mild nausea. Given water to drink. BP taken and 106 SBP. Given ice pack for back of neck. Laid patient on exam table. BP increased to 149 SBP and patient developed shaking chills. Capillary glucose 126. Evaluated by physician at facility. No urgent need for ED evaluation. Patient continued to rest and symptoms improved; BP decreased to WNL. Mom took patient home for rest. Called mom several hours later. Patient resting comfortably. Symptoms improved.
just feels an extreme sense of fatigue and is very tired; feels very, not like her self; was feeling very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY), administration date 12Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "was feeling very sick"; FATIGUE (non-serious) with onset 21Dec2021, outcome "unknown", described as "just feels an extreme sense of fatigue and is very tired"; FEELING ABNORMAL (non-serious) with onset 21Dec2021, outcome "unknown", described as "feels very, not like her self".  Additional information: Reporter stated regarding the Pfizer vaccine, the second dose. Clarified that she was referring to the Pfizer Covid vaccine, second dose. The patient got her second dose last Sunday (at the time of report) and knew they typically tell them that symptoms would last 1 to 2 days afterward. The next day (at the time of report), she was feeling very sick. Today was Tuesday (at the time of report), so it had been 8 days. She was feeling fine but, then again, she just felt an extreme sense of fatigue and was very tired. She had no loss of appetite but just felt very, not like her self. She was curious if with the Pfizer vaccine, if it was normal to last this long. It was very weird.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Information has been received from a registered nurse concerning 5 female patients (ages not reported) who on unspecified dates were vaccinated with the first dose of Gardasil.  The registered nurse reported that there was no adverse event involved with the first dose and all patients were administered with Gardasil vial.  On unspecified dates, the patients were vaccinated with the second dose of Gardasil with pre-filled syringe.  Concomitant medications were not reported.  Subsequently on unspecified dates, the patients experienced pain at injection site after receiving the second dose of Gardasil.  Unspecified medical attention was sought.  Subsequently on unspecified dates, the patient recovered from pain at injection site.  Additional information has been requested. Additional information was received from a nurse stating that there have been "NO reported adverse reactions" following the administration of over 250 doses of GARDASIL at this practice. The staff members at this practice have conveyed patients were experiencing increased pain when utilizing the prefilled syringes of the GARDASIL vaccine. After supplying the single dose vials, "only" becauseee this concern was expressed, the complaint of unusal pain has ceased. There are no specific details to submit as this merely was a general statement made during a meeting. No additional information is expected.
Pt received the pfizer vaccine yesterday and at 0100 today began feeling short of breath, HA, chills, tachycardia with HR in the 160's, and disorientation.  Pt treated with IV fluids and EKG completed.
lymphadenopathy with marked pain, swelling and tenderness in left axillary and left cervical nodes.; lymphadenopathy with marked pain, swelling and tenderness in left axillary and left cervical nodes.; lymphadenopathy with marked pain, swelling and tenderness in left axillary and left cervical nodes.; lymphadenopathy with marked pain, swelling and tenderness in left axillary and left cervical nodes.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 20Oct2021 12:00 (Lot number: FG3527) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), administered in arm right, administration date 20Oct2021 (Lot number: UT7356NA). Relevant medical history included: "Allergies" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Reflux" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allegies: Gluten" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing). Concomitant medication(s) included: ENGERIX-B, administration date 17Oct2021; HBIG; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ORAL CONTRACEPTIVE NOS; OMEPRAZOLE; TRINTELLIX; VITAMINE D. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 07Jan2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 17Dec2020, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), PAIN (non-serious), SWELLING (non-serious), TENDERNESS (non-serious) all with onset 20Oct2021 16:30, outcome "not recovered" and all described as "lymphadenopathy with marked pain, swelling and tenderness in left axillary and left cervical nodes.".  Additional information: The patient received oral contraceptive (name unspecified). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had lymphadenopathy with marked pain, swelling and tenderness in left axillary and left cervical nodes. persistent, now day 3 after injection. started 4-5 hours after third COVID vaccine in left arm. Events were persistent now. It was unknown if the patient received any treatment. The patient was administered covid-19 vaccine in a pharmacy.   Follow-up attempts are completed. No further information is expected.
Fainting episode. Got patient on to table laying flat on back with legs elevated. Employee checked pulse a few times while patient was on table. Another employee grabbed ice pack and apple juice for the patient. Also checked BP. Patient laid on table for 30 mins, then we placed her in a sitting position for another 30 minutes. Patient left after feeling better and parent walked her out to the car. Parents were advice to look for headache and vomiting. If patient states to vomit parent were to notify the office.
pt recvd vax 18MAY95 & exp muscle spasms & rt neck pain;reporter believes d/t chronic arthritis-seen by another MD affirms w/chronic pain synd;
1. Diarrhea beginning 3-24-2021 and symptoms decreasing 4-4-2021. 2. 4-5-2021 Awoke feeling very achy in all joints, left arm at injection site hot, sore, swollen, itchy, and raised red rash. No fever.
Pt recvd 2nd dose of vax & exp tenderness @ inject site & noticed transient visual changes in lt eye manifested by appearance of hazy crescent shapes; lt pupil was noted to be larger than the rt upon exam;
Symptoms- extreme fatigue, migraine, loss of appetite, low grade fever, shortness of breath.  ALl symptoms lasted 24 hours
On 11/11/00 pt received Varivox . Pt came in for evaluation on 11/14 of swelling of right arm. (Vaccine given in right upper arm). On PE, patient's entire right arm was swollen and warm to the touch, including upper extremity, forearm and hand. No pain or redness was present. Area did not appear tender. Pt was placed on Keflex for possible cellulitis and Atarax for associated itch. Resolved without further incident.
Bronchial pneumonia; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727 and expiration date not provided), via an unspecified route of administration, on 25Apr2021 (at the age of 85-year-old), at single dose, for COVID-19 immunization. Medical history included diabetes, high blood pressure. Concomitant medications included lisinopril; amlodipine; insulin glargine (LANTUS); nefazodone hydrochloride (NOVO - NEFAZODONE-5HT2), it was reported "Novo was whatever it was when patient take his reading anywhere to 2 to 15". The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. The patient experienced bronchial pneumonia (medically significant) in May2021. Patient got his second shot on 25Apr2021 and about may be not quite 2 weeks later patient had bronchial pneumonia that just about killed him and he was just wondering if that could be a possibility that he got that because other than that he was pretty healthy. No treatment received for event. The outcome of event was unknown.
15JUL92 pt recvd vax & 2 wks later became SOB & devel general weakness of arms & legs; lasted for 3 wks; 14AUG92 seen by MD;
he had a doormat virus that went viral in his brain; shut down his immune system; has to learn how to talk and walk again; has to learn how to talk and walk again; motor skills that were effected; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CENTRAL NERVOUS SYSTEM VIRAL INFECTION (he had a doormat virus that went viral in his brain), IMMUNOSUPPRESSION (shut down his immune system), GAIT DISTURBANCE (has to learn how to talk and walk again), SPEECH DISORDER (has to learn how to talk and walk again) and MOTOR DYSFUNCTION (motor skills that were effected) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CENTRAL NERVOUS SYSTEM VIRAL INFECTION (he had a doormat virus that went viral in his brain) (seriousness criteria hospitalization prolonged, disability, medically significant and life threatening), IMMUNOSUPPRESSION (shut down his immune system) (seriousness criterion medically significant), GAIT DISTURBANCE (has to learn how to talk and walk again) (seriousness criterion medically significant), SPEECH DISORDER (has to learn how to talk and walk again) (seriousness criterion medically significant) and MOTOR DYSFUNCTION (motor skills that were effected) (seriousness criterion medically significant). The patient was hospitalized for 5 days due to CENTRAL NERVOUS SYSTEM VIRAL INFECTION. At the time of the report, CENTRAL NERVOUS SYSTEM VIRAL INFECTION (he had a doormat virus that went viral in his brain), IMMUNOSUPPRESSION (shut down his immune system), GAIT DISTURBANCE (has to learn how to talk and walk again), SPEECH DISORDER (has to learn how to talk and walk again) and MOTOR DYSFUNCTION (motor skills that were effected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter stated that the patient's age was 50-65 years and he was in really good health. After receiving the vaccine, the patient spent five days in the hospital and was on ventilators. At the time of reporting, the patient was wearing diapers. The reporter stated that they were not able to document the exact details of the motor skills that were effected from the Moderna vaccine which shut down the patient's immune system.   No relevant concomitant medications were reported.  Treatment medications were not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is not expected.
Itching of face and body with swelling in face and tongue. Swelling resolved on it's own but the itching persisted. There were no skin lesions. There was no shortness of breath. Patient did not take any medication. He was seen at the MTF the next morning at approximately 9:30 for evaluation.
I haven't been this sick in years:  headache, neck ache, nauseous,  CHILLS (I should have taken my temp but felt too lousy to move), joint aches/HIPS, extremely tired. lasting 48 hours.  Continued to feel milder symptoms for 24 additional hours.  No appetite for 4 days, I mostly just kept hydrated.
45 minutes after given the vaccine. Severe dizziness, stumbling, couldn't see straight,  Had somewhat similar reaction to the first dose went down to the Emergency room on 12/31/20. They treated it as vertigo. gave zofran for nausea and valium to calm me down. Was sent home with Meclizine (motion sickness)meds. I am at 9 days after the vaccine administration and still having the vertigo and nausea due to being dizzy. I didn't go to the emergency room right away as I was treating it as they treated the first one. I fell asleep as soon as I got home from work at 130pm. I got the second dose at 0900 on 1/21/21. Fell asleep for several hours. Could barely wake up. Hands and feet were swollen. Couldn't make fists. Feet were tight. Stayed hydrated. since then for the past week I have been taking motion sickness meds the dizziness has not gone away. Went to the Emergency room on 1/28/21 as the symptoms still haven't gone away. They ruled me out for a stroke. I felt completely normal before the vaccine. I had CT scan done, MRI both came back normal. The diagnosis that was the outcome was vertigo.