chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of injection site redness in a 34-year-old female subject who was vaccinated with FLULAVAL. The reporter is the subject. A physician or other health care professional has not verified the report. The subject had no adverse events following receipt of prior immunizations (including no adverse events with prior immunizations with influenza virus vaccines) and no relevant medical history. Concurrent medications included SYNTHROID and NEURONTIN. On 14 October 2008 in the evening after 5:00 pm, the subject received unspecified dose of FLULAVAL (.5 ml, unknown, right arm). On 14 October 2008, within one hour after vaccination with FLULAVAL, the subject experienced injection site redness. On 15 October 2008, one day after vaccination with FLULAVAL, she experienced allergic reaction. On 16 October 2008, two days after vaccination with FLULAVAL, she experienced a larger area of redness. The subject was seen at a doctor's office. At the time of reporting the events were improved. Follow-up information received on 05 January 2009 indicated that the events of injection site redness, allergic reaction and area of redness began on 14 October 2008 and resolved ten days later on 23 October 2008. In the reporter's opinion, these events were possibly related to treatment with FLULAVAL.
Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; The vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 23-Dec-2022).    No concomitant medications were provided. It was reported that total 42 patients were affected. The vial size was 0.4 ml per vial . The vial was initially stored in the refrigerator on 23-Dec-2022. The vaccines were administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 ,02-Feb-2023, 06-Feb-2023, 08-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions. No treatment medication was provided. This case contains information for the 5th of 42 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
high fever for a few days, severe cold, cough, runny nose x 3 days later broke out in bad rash (11 days) entire body looks like 2 different rashes x 1wk;reoccurred x2 more times until finally went away;
Information has been received from a pharmacist concerning a 70 year old female patient with drug allergy to sulfa, codeine and neomycin cream who on 04-MAY-2011 was vaccinated IM with 0.5 ml PNEUMOVAX 23 (lot # 667915/1111Z, expiration date 02-MAR-2011). In May 2011, the patient developed redness and pain at the injection site as well as nausea. The pharmacist was not sure if the patient had previously received PNEUMOVAX 23 vaccine in the past. The patient sought medical attention by calling the pharmacist. No treatment was given to the patient. No lab tests were performed. At the time of reporting, the patient had not recovered from the adverse events. Additional information has been requested.
Fall     Fall on ice , came in with EMS. Rght leg/ankle injury.   Denies LOC, not on blood thinner.      Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 50y.o. female woman with history of end-stage renal disease on hemodialysis Monday Wednesday Friday, diabetes as well as hypertension was there to attend a funeral service for her niece slipped on ice and had a injury to the right ankle. She was identified to have right tib-fib fracture and what bedside reduction and then underwent external fixation last night. Incidentally the patient was infected to have COVID 19 positive result yesterday. She did report having some increased cough over the course of the last 3-4 days and reports that one of her dialysis nurses had tested positive last week. She is not complaining of any shortness of breath no diarrhea or any other respiratory symptoms. She has been vaccinated and booster. Currently she reports no pain and just recently received her pain medication earlier. She does report taking Norco at home for pain control   Past Medical History:
Numbness of face; Heart was pounding; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness of face) and PALPITATIONS (Heart was pounding) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock (from antibiotics).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness of face) and PALPITATIONS (Heart was pounding). At the time of the report, HYPOAESTHESIA (Numbness of face) and PALPITATIONS (Heart was pounding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.    Reporter did not allow further contact
Received 1st dose at 17 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose at 17 years of age) in a 17-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose at 17 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose at 17 years of age) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.
Lesion at the site of injection first notice Sunday 7/4/2021. Appeared initially as a small blister. Pt attempted to pop the blister. Now appears as a circular scab just beneath the skin.
Covid test result= Positive; Covid test result= Positive; Fevers; Off label use; booster; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FF2589), administration date: 22Oct2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 59-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 28Jan2021, when the patient was 58-year-old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 08Apr2022, outcome "unknown"; IMMUNISATION (medically significant) with onset 08Apr2022, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 10Apr2022, outcome "unknown" and all described as "Covid test result= Positive"; PYREXIA (non-serious) with onset 10Apr2022, outcome "unknown", described as "Fevers". The patient underwent the following laboratory tests and procedures: Body temperature: (10Apr2022) Unknown results; SARS-CoV-2 test: (10Apr2022) Positive, notes: Nasal Swab; (11Apr2022) Positive. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, pyrexia.  Clinical course: Facility type vaccine was Workplace clinic. It is unknown if the patient received other vaccine in four weeks. No covid prior vaccination. 08Apr22 got dose 4 COVID dose and then out to lunch and massage next day 09Apr22.- symptoms started Sunday night 10Apr22 fevers HA + ag test 10Apr night and 11Apr am. Treatment for AE was reported as unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. The at risk events Off label use and immunisation assessed as NA.
Soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (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: Bnt162b2 (Dose 1, administration time: 10:00 AM), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Tenderness at injection site", "mild headache ". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site".  Additional information: Unknown if there was other vaccine in four weeks and if there were other medications in two weeks. No covid prior vaccination. Not covid tested post vaccination. Known allergies: unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021448778 Same reporter/patient/vaccine, different dose/events
mom reported welts on body & swelling @ inject site; advised to use DPH prn;
Slightly sore arm with red  spot. Very sore underarm (lymph node area) - hard ball and tender area.  Discomfort is slowing subsiding.  Not treating with anything.
Pt c/o pruritis to L thigh. Moderate redness to outer L thigh, patella. Pt speaking full sentences, no SOB, no swelling or paresthesias to lips, tongue or throat. Pt reports similar reaction following tetanus vaccine. Waled independently with walker to traige area. VSS, HR 75, BP 136/86, RR 20. Pt remained stable, given Benadryl 25mg PO. Pt ambulated out of building w/friend
This spontaneous report as received from a physician refers to a 19 year old female patient. In 2008 the patient was vaccinated with first dose of VARIVAX (merck) (dose, route and lot# not reported). In 2010 the patient was vaccinated with second dose of VARIVAX (merck) (dose, route and lot# not reported). It was reported that a recent varicella titer of the patient was low at 0.91, in approximately May 2013. The outcome of the patient was reported as not recovered. Additional information has been requested.
Have been feeling pressure in head entire time, discomfort but short of pain. I have had a ringing or buss in my head from approximately  day 3 that still persists and is still the same today.
Pt reported to clinic the day after vaccination saying when he woke up his arm was swollen and painful. On exam patient had large area above and below inj site of redness and warmth. No shortness of breath-Rx'd with ice packs observation
I was given the shot 9/27/19 mid-morning and by early afternoon my arm hurt, I was getting achy feeling, like I was coming down with something.  I took two regular Aspirins and felt so much better after a short time.  I went home and slept.       I woke up the next day and felt achy again, like I did before I took Aspirins.  I got to work and I ached all over, my hand, my knees, my back, everywhere.. just like I would feel had I been coming down with something.  So I took two more regular Aspirins and they helped so much!  I was able to go about my day to day routine, as normal once the Aspirins kicked in!  I took a couple of regular Aspirins on Saturday and Sunday too.   By Monday I felt normal again and didn't  need any Aspirins,  I did not take my temp and I wish I had... sorry
Moderate chills and aches  8 hours after injection, fatigue, and light headache. Duration of all symptoms lasted for two hours.
Breakthrough case after 5 vaccines Pfizer 2/10/21 Lot# EL9267;  Pfizer 3/3/21 Lot# EN6205;  Pfizer 9/29/21 Lot# FF2528;  Pfizer 4/14/22 Lot# 33130BA;  Pfizer 9/20/22 Lot# GJ5342
Severe headache especially on top of head with heat radiating from top of head.  Pain also in forehead and occasionally in back or on sides of head.  Temporary relief achieved from tylenol and advil.  Relief also from myofascial release massage on top of head.
Information has been received from a nurse practitioner concerning an 8 year old patient who was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient developed a very severe local reaction to the vaccine. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
EYE INFLAMMATION; This spontaneous report received from a consumer concerned a 55 year old female. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-JUL-2021, the subject experienced eye inflammation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eye inflammation. This report was non-serious.
Arm pain, redness (not at injection site) and general arm swelling x 1 week.
Not exactly sure what time reaction started, but I was completely unaware of surroundings and slept all day until 2:00p,m. today.  I was weak all over. Fell off the couch I was sleeping on and was unable to get up due to muscle weakness. Had my son come over to get me up off the floor.    I'm feeling somewhat better today.  I'm able to walk and get up from a sitting position.  Still feel a little brain scrambled.  Unable  to concentrate long enough to read the paper.
INCORRECT PRODUCT STORAGE; VACCINATED WITH JANSSEN COVID-19 VACCINE WHICH WAS LEFT OUTSIDE IN ROOM TEMPERATURE MORE THAN 2 HOURS; This spontaneous report received from a pharmacist concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: 23-JUL-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours. On an unspecified date, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccinated with janssen covid-19 vaccine which was left outside in room temperature more than 2 hours and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210556518 and 20210556814.
Patient was requesting a bi-valent vaccine. Due to look alike vials, the patient received a mono-valent vaccine. Patient has been notified. No adverse effects occurred.
Patient reported feeling sick and he passed out while walking to lobby to sit down.  Upon regaining consciousness, he vomited.  He then showed no further symptoms/side effects. Nurses checked his blood pressure; he was then cleared and released.
Began approximately 17 days after injection Dull ache at the injection site with sharp pain radiating down my left arm and up into my left trapezius muscle; tingling sensation in fingers of my left hand
Started having what I thought was injection site pain within a day or two after injection.  Pain increased over time along with other symptoms such as fatigue, increased body odor, general malaise, headaches. Because of persistence of symptoms, visited my primary care provider on March 29 and she referred me for an MRI which was performed on April 2. On April 7 saw an orthopedist who said the MRI showed synovitis in my left shoulder and referred me to a rheumatologist and prescribed Meloxicam for the pain.  I met with the rheumatologist on April 23 and he prescribed tests and a course of steroids. My follow up appointment was today (May 12) and he said I have signs of Sjogrens and am HLA B27 positive. Perhaps a predisposition to autoimmune response trigged by vaccine.
Within 15 min. of receiving a single dose preservative free influenza vaccine pt experienced numb lips + tongue, itchy tongue + sl. tightness in throat, symp. lasted approx 15-20 min. Pt. din not seek treatment.
The next day, pain in arm. Woke up in the middle of the night, arm itch/pain, had a big red welt. Arm still hurts after 7-8 days later. Spoke with the pharmacist and was told it's called COVID arm.
WOKE UP ON MORNING FOLLOWING VACCINE WITH PAIN IN RIGHT HIP WITH PAIN OF 8/10 WHEN SITTING AND STANDING. PAIN LOCATION IS DESCIBED AS HIP PAIN AND PATIENT POINTS TO RIGHT BUTTOKS CENTER. PATIENT STATES PAIN WAS NOTICABLE AND LASTED ABOUT 6 MONTHS AND THEN ONE DAY SHE JUST NOTICED THE PAIN WAS MISSING. PATIENT STATES THEY DO A LOT OF HIKING AND WALKING AND IT COULD BE TOTALLY NOT RELATED BUT WOULD LIKE IT TO BE REPORTED JUST IN CASE.
This case was reported by a other health professional via call center representative and described the occurrence of knee pain in a 64-year-old female patient who received ENGERIX B adult. Co-suspect products included ENGERIX B adult. On an unknown date, the patient received the 1st dose of ENGERIX B adult 1 ml and the 2nd dose of ENGERIX B adult. In July 2016, less than a year after receiving ENGERIX B adult and not applicable after receiving ENGERIX B adult, the patient experienced knee pain and leg pain. On an unknown date, the patient experienced arthralgia aggravated. On an  unknown date, the outcome of the knee pain, leg pain and arthralgia aggravated were not recovered/not resolved. It was unknown if the reporter considered the knee pain and leg pain to be related to ENGERIX B adult. It was unknown if the reporter considered the arthralgia aggravated to be related to ENGERIX B adult. Additional details were provided as follows: The health care professional reported that the patient experienced knee arthralgia, aching legs, knees, with the right knee worse than the left knee. In 2016, less than a year after the patient received their 2nd dose of ENGERIX B adult, the arthralgia worsened. The patient did not receive their 1st and 2nd ENGERIX B doses at this reporting physician office, but the patient was ready for their 6 month and final shot in the series. The reporter inquired whether to administer the third dose in series and if arthralgia was a common side effect of ENGERIX B. No product lot or expiration dates of the vaccine were available.
Three days post vax the patient complained of a sore throat and cough. The patient did not have a fever or chills. The patient saw the MD and was advised she has a viral infection associated with the flu shot.
Pt. developed Guillain-Barre 3 weeks foll. vaccination. No viral illness described. Travelled & came back from foreign country 8/23/09. D/A: 9/14/09. Intubated 9/17/09.  10/20/09 Hospital records received service dates 9/24/09 to 10/18/09. Assessment: Guillain Barre syndrome. Patient presents with intubation and respiratory failure secondary to Guillain Barre syndrome requiring plasmaphereses. Patient had presented earlier on 9/12/09 with increasing bilateral tingling and numbness, weakness, diarrhea, and was transferred for plasmaphereses. Acute symmetrical ascending flaccid paralysis. Bradycardia. Sinoatrial Node Dysfunction. Abdominal distention. Difficulty swallowing. Polyradiculopathy Immune Mediated. PT - Activities of daily life impaired. Pacemaker implantation.  10/21/09 Hospital Neurology progress notes received service dates 10/2/09 to 10/7/09. Assessment: Acute Inflammatory Demyelinating Polyradiculoneuropathy. Patient also presents with respiratory failure, autonomic dysfunction. IVIG. Undergoing plasmapheresis. Dyspnea. Dysphagia. ICD 9 Codes:  782.0, 357.0, V66.7, 401.9, 518.0, 518.81, 276.1, 344.00, 253.6,  486.0, 276.8, 780.4, 564.00.
After receiving the first covid vaccine, patient started feeling dizzy and hyperventilating after 3 minutes, I called the ER and 5ml Benadryl 12.5mg/ml was given to the patient. 5 minutes later, patient also started seeing doubles and spot. ER arrived after 10 minutes and took the patient to hospital.
crying incessantly for 6hr;no treatment, informed w/2nd set of vax;
Patient with ESRD due to diagnosis diabetic glomerulosclerosis, focal chronic interstitial nephritis, global glomerular sclerosis, renovascular HTN and historical noncompliance with medication treatment. There were no beds available in the State to transfer him.  He was started on high dose IV lasix 160 mg TID and metolazone to get control of his hypervolemia.   A dialysis catheter was placed on 12/10/21. Also was COVID positive. Patient discharged once stable. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.