chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm Soreness; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 23Mar2021 at 13:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 infection prior to vaccination. The patient was allergic with penicillin. No concomitant medications were reported. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. On 23March2021 at 16:30, the patient experienced arm soreness. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of the arm soreness was not resolved at the time of this report.   No follow up attempts are needed. No further information is expected.
I started to feel pressure in my head. It went from the back of my head to the side of my ear. It was the inner and outer ear. It was one ear and the following month it was the other ear. The outer part of my ear was swollen. I went to the ER because I could not tolerate the pain and they did a CT scan, which showed the swelling in the ear. Then on 06/18/2021 I went to the doctor because I could not tolerate the discomfort anymore. She just checked both my ears and she said she could see the swelling on the inside and outside of my ears. She gave me a steroid injection and Tylenol. I have been experiencing chronic ear infections on both ears almost every 3 months.
Muscle aches, flushing, fever, sore throat, red eyes, headache.
Information has been received form an RN concerning a retired 90 year old white male with no known allergies who on 21OCT2003 was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medication. On 24OCT2003 the pt developed left upper arm redness and pain below the injection site. The RN reported that the pt recovered from left upper arm redness and pain below injection site on 26OCT2003. There were no lab or diagnostic tests performed. it was noted the pt was not ill at the time of vaccination and had not experience adverse events prior to vaccinations. No additional info is expected. The RN also reported three other pts who had similar experiences following vaccination with dose of pneumococcal 23v polysaccharide vaccine.
Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022; Vaccine was administered to the patient after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 10-Jun-2022 and was administered to the patient on 12-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Weight of the patient was reported as 118.6  No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  Patient did not experience any adverse events.  No treatment medications were provided.   This case was linked to MOD-2022-607720 (E2B Linked Report).; Sender's Comments:  MOD-2022-607720:Master case
Mother reported hives for 2.5 weeks after yellow fever vaccine. Reported to this RN on 10/16/2017 during a follow-up visit for other vaccines. No action from health department clinic since child was no longer having reaction. Unknown what the treatment was.
Extreme unremitting weakness, unable to walk without aid for 8 days.  blood tests negative on 4th day.  On 8th day neighbor said mother also collapsed and her ER said it was blood clots from the vaccine and gave her aspirin.  Exactly one hour after my wife took 325 mg of aspirin, all of her vigorous strength had been restored.
Fever; Chills; Diarrhea; Feel crappy; no energy; wonder felling of all that; Feel crappy; no energy; wonder felling of all that; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient's wife). This is the 2nd case out of 2 cases. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot Number: EWO169) via an unspecified route of administration on 15Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving the first dose of vaccine on Thursday her husband had a fever, chills, now diarrhoea a day, now today is the first day, he just feels like crap. No energy wonder felling of all that, so she just don't know how long that last. The patient's wife would like to know that does it last sometimes wonder felling of all that. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444648 same reporter/drug/event, different patient
Swollen lymph nodes, fever, fatigue, nausea, headache, pain at injection site, increased heart rate - 36 hours Scaly, itchy, dry, painful eyelid skin- going on 5 months
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 11/28/2022 & 11/26/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
pt began to feel warm to touch & while being held in father's arms approx 3hrs later became stiff, & flaccid & unresponsive;pt was tired looking; T103 R; dx febrile sz & meningitis leukocytosis
Feeling sick on stomach; Sick all night, sick as a dog; Couldn''t breathe hardly; Throwing up; Miserable; she's just sitting in one spot, that's it, not moving around much; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 12Dec2021 13:30 (Batch/Lot number: unknown) at the age of 82 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:2), administration date: 03Feb2021, when the patient was 81 years old, for COVID-19 immunization; Bnt162b2 (Dose:1), administration date: Jan2021, when the patient was 81 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021 13:30, outcome "unknown", described as "Booster"; NAUSEA (non-serious) with onset 13Dec2021 02:30, outcome "unknown", described as "Feeling sick on stomach"; ILLNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Sick all night, sick as a dog"; DYSPNOEA (non-serious) with onset 13Dec2021, outcome "unknown", described as "Couldn''t breathe hardly"; VOMITING (non-serious) with onset 13Dec2021, outcome "unknown", described as "Throwing up"; FEELING ABNORMAL (non-serious) with onset 13Dec2021, outcome "not recovered", described as "Miserable"; LETHARGY (non-serious) with onset 13Dec2021, outcome "unknown", described as "she's just sitting in one spot, that's it, not moving around much". Therapeutic measures were not taken as a result of nausea, illness, dyspnoea, vomiting, feeling abnormal, lethargy.  Addition information. The reporter considered events as non serious.The patient explained she did not know if her age had anything to do with these events. Causality of all events reported as yes; because she was feeling fine until she got the third dose. She wished she never took the third dose. Patient verified that there has been no testing, treatment or medical interventions performed relative to these events.list all vaccines administered on same date with the Pfizer vaccine considered as suspect was None. The patient not visited emergency room or physician office. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family medical history was none reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient was erroneously given Hep A vaccine when, instead, she was requesting the Hep B vaccine. No symptoms or adverse outcomes as a result of the mistake.
More than normal bleeding at time of injection (pt. not on blood thinners etc.) 5-10 min. after injection, arm felt "asleep". About 30 minutes post-injection patient began to experience nausea, weakness and felt hot. These symptoms lasted about 30 minutes before patient began returning to normal. No treatment administered. (patient sat down).
Allergic reaction; flushing, sweating, dilated pupils, dizzy, fell off chair. Patient recovered, 911 was call but cancelled per patient.
Caused my breathing to be erratic, heart rate increased about 15% and Glucometer readings increased 50-70 points each reading. Breathing/heartrate has gotten better and sugars are almost back to my normal readings.
This spontaneous report as received from a Nurse and refers to 41 unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (which had a lot # M002254 with expiration date on 15-NOV-2016; however, dosage number and route of administration were not reported). No adverse effects were reported. The vaccines experienced the following temperature excursions during 3 hours and 45 minutes: 50.5 grades Fahrenheit. Reportedly, previous temperature excursions on 26-SEP-2016, during 2 hours and 30 minutes of 47.4 grades Fahrenheit, on 27-SEP-2016, during 1 hour of 47.6 grades Fahrenheit, on 05-OCT-2016, during 15 minutes of 46.2 grades Fahrenheit, on 06-OCT-2016, during 1 hour and 15 minutes of 48 grades Fahrenheit, on 12-OCT-2016, during 1 hour of 46.5 grades Fahrenheit, on 17-OCT-2016, during 1 hour 15 minutes of 49.2 grades Fahrenheit and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
Headache, nausea, redness at site of injection. Patient will call PCP.
LARGE RASH DIAMETER OF THE RASH WAS ABOUT THE SIZE OF AN ORANGE MAYBE SLIGHTLY BIGGER. JUST AROUND WHERE SHE RECEIVED THE SHOT, IT WAS PAINFUL, ITCHY. ARMPIT IS HURTING FOR 2 SOLID DAYS AND ITS PAINFUL TO TOUCH.  FAIRLY NORMAL IMMUNE RESPONSE TO FIRST ONE. BOTH SHOTS SHE WAS EXHAUSTED FOR A WEEK, HAD SOME SOB. FIRST 24 HOURS SHE HAD RANDOM SHARP PAINS THAT RAN DOWN HER ARM, LEFT ARM. HER ARM WENT TO WEAK THAT SHE FELT LIKE SHE WAS GOING TO DROP HER PHONE. RESOLVED AFTER 24 HOURS. PAIN AREA WAS INSIDE OF THE LEFT ARM. BODY ACHES, FEVER, NEVER ABOVE 100.5. SHE STATES THAT HER SKIN HERS MORE OF NERVE PAIN. WENT AWAY WITHIN 24 HOURS. ALL OF HER JOINTS HURT. SHE STATES HER JOINT PAIN WAS COMPARABLE TO THE FLU BUT EXAGERATED.  FIRST 24 HOURS WAS RANDOM NERVE PAIN THROUGHOUT ARMS. BODY HURTING REAL BAD HAPPENED SATURDAY MORNING. RUNNING LOW GRADE FEVER WAS RUN OFF AND ON THROUGHOUT SATURDAY NIGHT. AS OF TODAY IT IS JUST THE RASH THAT IS LEFT (11/15/2021). SHE IS RESTING AND STATES THAT SHE IS OKAY.
COVID POSITIVE; HEADACHE; CHEST PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had any problem before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-AUG-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the patient experienced chest pain, and headache. On AUG-2022, the patient experienced covid positive. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chest pain and covid positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000246109.
1-24-2011 I am still suffering pain in my shoulder and muscle. Difficult to sleep, always painful 24/7.
chills; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of CHILLS (chills), the second episode of CHILLS (chills) and PYREXIA (fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced the first episode of CHILLS (chills). On 13-Apr-2021, the patient experienced the second episode of CHILLS (chills) and PYREXIA (fever). At the time of the report, last episode of CHILLS (chills) and PYREXIA (fever) outcome was unknown.        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.   The patient reported taking concomitant medications for diabetes and high blood pressure.  Treatment of events was reported as none.
15 minutes after vaccination, became sweaty, dizzy, developed rash on neck, short of breath. BP-180/108. Given Benedryl 50mg IM. Patient was a doctor at a doctors conference and opted not to be transported since she was surrounded by knowledgeable colleagues. Symptoms settled after benedryl. I spoke with patient several days after the event. Sshe continued to have headaches and sore arm.  Has an appointment with her primary care doctor in mid December.
Induration in axilla of left arm headache fever pain and swelling of left breast pain on both thighs and knees redness at injection site urticaria and warmth generalized body pain  eye redness
I let my daughter get 2 of the 3 shots; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   Previously administered products included HPV vaccine (received 2 doses of HPV vaccine on an unknown date).   On an unknown date, the patient received the 3rd dose of HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: This patient was reporter's daughter. The age at vaccination was not applicable for this report. Till the time of reporting the patient had taken 2 doses of HPV vaccine and not taken the 3rd dose, which led to incomplete course of vaccination. This case has been linked with US2021AMR139467, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR139467:Same reporter
Site: Pain at Injection Site-Severe, Additional Details: Patient was nervous prior of getting her vaccine as she was worrying about side effects, however her son advised her to take vaccine anyway. Right after getting the vaccine at her arm, she started hotflashing/sweating, as well as complaining about the pain in her arm. She sat at the pharmacy x15min,she then left feeling better. After 2 weeks son reports she complains that she still experiencing pain in her arm and is getting MRI.
Severe headache, Fever, sleeping, sore throat, cough, and muscle aches from about 10 am - 6 pm Pain in neck and down back (spine) starting about 8:00 am Tuesday and lasting until about 4:00 pm the next day (Wednesday)  Woke up enough to take 2 Motrin about 4:00 pm (Tuesday) Red area approximately 2 inches wide and 3-4 inches dow snd diagonal from injection site that is warm and tender that appeared while sleeping during Tuesday day and is slowly fading still visible and aittle tender now (Thursday 8:00pm)
COVID WHILE FULLY VACCINATED; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced covid while fully vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid while fully vaccinated was not reported. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
11/23   Pt to Er vis EMS from senior center for SOB, lethargy , hypotension.Upon arrival patient is not responsive to physcial touch. Pt is 85% on 15L nonrebreather.Pt had COVID a month ago. Pt is tachycardiac. Pt is febrile. Pt has history of dementia, unknown baseline. Pt is on 2L NC @ home 11/24 Pt resting on bed, with eyes open but not alert or oriented. Respirations regular, unlabored.  O2 in place. Recent episode of moaning so dilaudid was increased to 1.5mg/hr.  11/25 Prognosis grave 11/26 DNR comfort status for patient.  Patient is discharged back to Senior Living Facility and Hospice will be taking over her care 11/27 Pt is still running a 99 low grade temp and facility will not accept patient with a low grade temp. Per their facility policy, patient must be without an elevated temp for 24 hours.  11/28 On dilaudid drip at 0.5/hr.Looking comfortable.  Mouth care being done. 11/29 Noted HR on the monitor was dropping until pt was asystole Went to check on pt, warm to touch, no respiration, no pulse. Verified by another RN. Pt was pronounced   At 0708.
Patient states developed muscle and joint aches the following day after receiving a Tetanus vaccine. Stated by 4:00 PM on 1/4/09 his joints began to ache and by 7:00 PM he felt worse. He follows up with his own Physician in 2 weeks.
Got the Covid around the same time you know he received the vaccine; This is a spontaneous report from a contactable pharmacist. A male patient of unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that the patient got the Covid around the same time you know he received the vaccine. Pharmacist reported that their technician who received first Covid vaccine and pretty much developed Covid 19. Pharmacist wanted to see and check what was the proper follow through on that. Pharmacist knew one supposed to wait for 90 days and then start administering the first dose and then second dose is in 21 days or wanted to know there was been any changes in that. He just got the Covid around the same time, he received the vaccine. The pharmacist did not know which Lot number he received. When probed for the Causality, Pharmacist stated, "No it was due to exposure to someone who had Covid." Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt needed second dose of varicella given and dose of Shingrix was given in error
Information has been received from a registered nurse concerning a currently 29 year old male patient with asthma and no known reactions or allergies who on 26-SEP-2008, was vaccinated with the first dose of VARIVAX (Merck) and on an unspecified date was vaccinated with the second dose of VARIVAX (Merck). It was reported that the patient had failed to seroconvert post vaccination. The patient did not seek medical attention. Additional information has been requested.
This spontaneous report was received from a registered nurse via company representative regarding two patients of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. One patient received improperly stored (Wistar RA 27-3) M-M-R II with lot# K020188 and expiry date: 22-OCT-2016 on 25-JUL-2016 and the second patient received improperly stored (Wistar RA 27-3) M-M-R II with lot# L011528 and expiry date: 03-APR-2017 on 26 JUL-2016 (dose and route of administration information was not reported). No adverse effects were reported. Temperature and time frame: 8.6 C for 3 hours and 41 minutes; 10.1 C for 1 hour and 10 minutes and 9.8 C for 4 hours and 5 minutes. Previous temperature excursion: 8.8 C for 43 minutes; -0.1 for 3 hours and 18 minutes. The temperature was adjusted back to range. The call was because of data logger. No product quality complaint was reported. This is one of two reports (Same reporter link: WAES1608005052). Additional information has been requested.
This spontaneous report as received from a register nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Oka/Merck) VARIVAX (dose, strength, route and lot number were not reported) which were improperly stored. No adverse effects reported. Additional information has been requested.
Case was vaccinated x2 for Covid by April 2021, then was hospitalized for Covid in January 2022.  Hospitalized at: (Privacy) Hospital.   * COVID?resolved as of 1/24/2022 Assessment & Plan Found to be positive 1/14 after developing symptoms. Completed course of Remdesevir, did not tolerate steroids well. Now asymptomatic. COVID precautions off 1/24 after 10 day quarantine. He received 2 doses of the Moderna vaccine > 5 months ago, encourage booster.
Arm pain, runny nose, fever, muscle aches. All symptoms resolved in 48 hours.