chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to unspecified patients of unknown age. On 18-APR-2014 the patients were vaccinated subcutaneously with 0.5 ml of VARIVAX (dose and lot# not reported). It was reported that unknown number of doses of improperly stored VARIVAX has been administered to unspecified number of patients. The therapy of VARIVAX was exposed to two separate temperature excursions. 34F for 12 hours on 13-APR-2014 and 7.5F for 10 minutes on 02-JUL-2014. No adverse effects reported. The medical assistant called back on 03-JUN-2014 to report second excursion (which occurred on 02-JUN-2014) for VARIVAX and from this second inquiry, it was found that some doses of improperly stored VARIVAX were administered to patients since the initial temperature excursion on 18-APR-2014. Additional information has been requested.
Initial report received from health care professional on 04 September 2012. A 04-month-old patient of unspecified demographics, whose concurrent conditions and medical history was not reported, had received DAPTACEL, ACTHIB, IPOL, ROTATEQ and PREVNAR vaccines on unspecified date when the patient was 6 to 8-week-old. The route, site of vaccination and lot number of all vaccines were not reported. On the day of vaccination, the infant's body turned pale and lips remained pink. The episode lasted for 30 to 40 minutes. The next i.e. day after vaccination, the infant had two same episodes of pale body with lips remained pink. The infant had no other symptoms. The event of pale body except lips remained pink had recovered on unspecified date. Corrective treatment was not reported. List of documents held by the sender: None.
heart attack caused by blood clot in heart.  I am reporting this beacause the doctor said it was rare to see a heart attack of this type with so little plaque.   I also had polycythemia (forgot to list it earlier)
Unable to use my arm/shoulder, extreme pain & tightness.  Unable to work due to some of the requirements of my job.  I had X-rays taken & have been sent to physical therapy to try to repair the damage done to my muscle & nerve.
Shingles; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: L3802, expiration date not reported), via an unspecified route of administration, administered on the right arm on 29Jan2021 (at the age of 66-years-old), as second dose, single for COVID-19 immunisation. Medical history included ongoing multiple sclerosis from 1995 and immunodeficiency (reported as compromised immune system). The patient's concomitant medications were not reported. Patient was not receiving any drugs or injection for multiple sclerosis at this time. Patient reported that she did not receive additional vaccines on the same date of the second dose administration. Patient was not pregnant at time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176, expiration date not reported), via an unspecified route of administration, administered on the right arm on 08Jan2021 (at the age of 66-years-old), as first dose, single for COVID-19 immunisation. It was also reported that the patient did not receive any vaccines within 4 weeks prior to the first COVID-19 vaccine. The patient experienced shingles on an unspecified date in 2021 (reported as 1 week after the second vaccine but patient cannot remember specific date). Patient reported that the marks were still there, but she is no longer contagious. There were no dripping of any kind and it had dried up. The event did not result to physician office visit nor emergency room visit. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
per patient upon getting  in his car after his vaccine  he noticed that his stomach was itching , his chest felt and throat felt tight. The patient stated he went to swallow and his throat didn't right , it felt tight. Pt was noted to have  red bumps on the right side of his stomach. Patient was given 50mg of Benadryl and water. Patient requested to drive himself home  upon feeling better. Patient educated on side effects of medication and stated he felt okay to drive home and didn't want to call a ride. Pt released at 0908  Patient vitals were:  0841 BP: 146/91 HR 76 RR 22 SpO2: 99; 0848 BP: 136/77 HR 60 RR 18 SpO2 99 0900 BP: 136/90 HR 62 RR 18 SpO2 96
I woke up in middle of night and my arm was killing me, I did not take aspirin for it because I was so tired and for days I was so fatigued I could not even lift my head, I had brain fog and trouble breathing. I'm still really fatigued. I can not get through the day without taking a nap. I have been having horrible sweats like drinch sweating. Foods have started disagreeing with me, an example dill and garlic since my vaccine. I have lived off garlic.
This initial spontaneous report was received in 09-OCT-2018 from the approximately 72 year old male patient and also from the supervisor of an unspecified vaccine injury compensation program.  The patient reported medical history of cataracts, heart attack, and stroke.  He is allergic to codeine, safrazine, povidone-iodine (BETADINE), and penicillin. On an unspecified date "over five years ago", the patient received ZOSTAVAX for shingles prevention (dose, route, and lot# not provided) as well as sterile diluent. The patient reported that in 2016, he experienced hearing loss, cataracts, a stroke in his optic nerve, and a heart attack. He was hospitalized (no further details provided) and he received unspecified treatment. The supervisor said he received a call about this patient who received the shingles vaccine and later developed an infarct in the optic nerve bilaterally and he also had "auditory issues." The supervisor further stated his program "does not cover shingles vaccine" and perhaps there was something the Company could do for this patient's issues. The patient was inquiring whether the Company was able to reimburse him in any way after experiencing adverse effects related to ZOSTAVAX. The patient was given information for the Division of Vaccine Injury Compensation.  Because the patient is visually and hearing impaired, he asked that they call him (visual impairment was considered a result of the stroke in the optic nerve and infarct in the optic nerve bilaterally).  The patient believed that the Company did not advertise these types of side effects "because people would sue them." At the time of reporting, the patient had not recovered from  the events.  The patient felt the events were related to ZOSTAVAX. Upon internal review, hearing loss, cataracts, stroke in his optic nerve, heart attack, and an infarct in optic nerve bilaterally were considered to be medically significant events. The patient did not provide consent to be contacted for follow-up.
3"x5" swollen, red, hot area; 3"x5" swollen, red, hot area; 3"x5" swollen, red, hot area; minor pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (3"x5" swollen, red, hot area), VACCINATION SITE PAIN (minor pain), VACCINATION SITE SWELLING (3"x5" swollen, red, hot area) and VACCINATION SITE ERYTHEMA (3"x5" swollen, red, hot area) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for High cholesterol.    On 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Feb-2021, the patient experienced VACCINATION SITE PAIN (minor pain). On 24-Feb-2021, the patient experienced VACCINATION SITE WARMTH (3"x5" swollen, red, hot area), VACCINATION SITE SWELLING (3"x5" swollen, red, hot area) and VACCINATION SITE ERYTHEMA (3"x5" swollen, red, hot area). On 19-Mar-2021, VACCINATION SITE ERYTHEMA (3"x5" swollen, red, hot area) had resolved. At the time of the report, VACCINATION SITE WARMTH (3"x5" swollen, red, hot area) and VACCINATION SITE SWELLING (3"x5" swollen, red, hot area) had resolved and VACCINATION SITE PAIN (minor pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment Medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information received on 25-05-2021 contains no new information.
This patient received travel vaccines (yellow fever, meningococcal, typhoid) at an outpatient travel clinic 4/1/09.  He developed a headache about 5 minutes later and the nurse gave him apple juice.  About 8 minutes after vaccine administration, he felt like his throat was closing and he became lightheaded.  He was given diphenhydramine 25mg PO in the office, which he states helped relieve his throat symptoms.  He was sent to our ER for evaluation, monitored and given 1 dose of prednisone 50mg and discharged home in stable condition.  His symptoms had resolved.
Patient developed redness, swelling, pain, warm, fatigue, bodyaches, chills, shortness of breath, congestion, temperature of 99°F on the evening. The shot was given.  Patient was evaluated in clinic on July 28, the day after her vaccination. she no longer had chills. She continue to have bodyaches congestion headache. She also had 2 1/2 cm x 2 1/4 cm area of redness, warmth, and tenderness of the right upper arm near the shoulder.  Her constitutional symptoms resolved by 8/3/23.  I saw her in clinic on August 7 for another follow up. This time she had pain and a bump still present on her right upper arm. She was having difficulty sleeping at times because of her arm pain Her exam showed a 2 cm x 2.5 cm tender Red bump of the upper arm.
initial right eye pain/edema day 5 post vaccine. She initially presented to her optometrist, who identified a sclerotic vessel and sent her to me for further evaluation in May 2021. At that appointment, she was not found to have active vasculitis but she did have a fibrotic retinal vessel, suggestive of a prior vascular event. She then went on to develop recurrent periorbital edema that required evaluation by an oculoplastics doctor as well as pulmonary complications, including desaturations in O2 that now require ongoing consultation w/ pulmonology.
URI symptoms 11/10 pm (mom later says there was fever). 11/11, right arm <1cm redness-No sx's (MMR). 11/13, left arm 4cm redness-No local sx's (DTAP). Two lesions on chest c/w Varicella, + exposed to Varicella, 10-12 days earlier.
pt recv vax approx 5PM; about 1 hr later went to dinner w/parents became flushed then lips blue, then eyes rolled back in head; became non-responsive, then jerking, shaking of all ext; to ER t104.2, posturing; adm for observation overnoc
Pruritis on left lateral upper arm around area of vaccination beginning 1/11/21. 14.5 x 7 cm erythematous, targetoid rash on left lateral upper arm at injection site and extending down arm, first noticed 1/14/21.
Initial report received on 03 August 2012 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a four-year-old male subject (initials not collected) was identified by the investigator based on review of data from the State Electronic Disease Surveillance electronic database. The subject had received 1 dose of DAPTACEL; lot number C2951BA received on 23 June 2008 and 3 doses of PENTACEL; lot number C3176AA received on 16 September 2008, lot number C3176AA received on 12 November 2008 and lot number C3497AA received on 06 November 2009 (routes and sites of administration not reported). On 08 July 2012, the subject developed a cough, approximately 2 years and 8 months after the last dose. On 14 July 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced posttussive vomiting. Laboratory testing included positive PCR on 24 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 14 July 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 26 June 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 18 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Right upper arm with severe swelling, shoulder pain with clicking noise in the shoulder, that gradually increased from time of injection until seen in the office later in the day when pt returned with concerns. The right upper arm was very warm to touch, no redness. Injection given at 0800 pt returned to the office at 1600 with concerns.
11:17 complaining of inside of nose itching (had nasal vaccine) 11:30 stated no itching itching inside of nose anymore 11:40 difficulty breathing EMS called and patient taken to ER
100' Fever, Throat swelled, difficult To breath heavy chest, fast heartbeat, weak Took Benadryl and felt better by 11:00pm pulse up to 127
had an itchy red rash with the first dose; had an itchy red rash with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (had an itchy red rash with the first dose) and RASH ERYTHEMATOUS (had an itchy red rash with the first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Measles in January 1980. Past adverse reactions to the above products included Hives with Measles. Concurrent medical conditions included Hives, Iodine allergy (Hives), Allergy to chemicals (Eczema), Hypersensitivity, High cholesterol since 2010, Hypertension since 2002 and Depression since 2010. Concomitant products included DULOXETINE from 2010 to an unknown date for Depression, ATORVASTATIN from 2010 to an unknown date for High cholesterol, LOSARTAN from 2008 to an unknown date and HYDROCHLORIC ACID from 2002 to an unknown date for Hypertension.    On 12-Apr-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced RASH PRURITIC (had an itchy red rash with the first dose). April 2021, the patient experienced RASH ERYTHEMATOUS (had an itchy red rash with the first dose). At the time of the report, RASH PRURITIC (had an itchy red rash with the first dose) and RASH ERYTHEMATOUS (had an itchy red rash with the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was given by reporter.   This case was linked to MOD-2021-296722 (Patient Link).
disorientated; brain was foggy; totally crashed and had to go to sleep; severe diarrhea,like never before. Still not having normal bowel movements; sore arm; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) and PAIN IN EXTREMITY (sore arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements), PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue) and CHILLS (chills). On 10-Feb-2021, DISORIENTATION (disorientated), FEELING ABNORMAL (brain was foggy), SOMNOLENCE (totally crashed and had to go to sleep), FATIGUE (fatigue) and CHILLS (chills) had resolved. On 12-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, DIARRHOEA (severe diarrhea,like never before. Still not having normal bowel movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Imodium. No concomitant medications were provided by reporter.
Swollen lymph nodes under my left arm. I contacted the doctor about it the first sign of it. She said to wait to get a mammogram for 3 months. After the second vaccine, it got bigger. On 8/5/21 I was sent to get a mammogram and ultrasound and needed an emergency biopsy.  Now I have stage 2 breast cancer with no history of swollen lymph nodes or lumps.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history concurrent conditions and drug reactions/allergies were not reported. On 28-JUL-2016, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 (lot # L037554, expiration date 25-DEC-2017, (concentration and dose were not reported), via intramuscular. The patient's concomitant therapy was not provided. No adverse effects were noted.  A product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected because the nurse does not want to be contacted.
I gave client Hep-A and she stood up and turned around, sat down, was alert and talking. I gave her Hep-B and client said "I don't feel good" and fainted.
Covid + on 10/26/2021. Received Janssen vaccine on 09/22/2021 Per ED Note:  29-year-old male who is on Zyprexa, noncompliant presents the ED for the above complaint.  Patient states that he was at work and got an altercation with a coworker, had made threatening remarks to coworker and was ultimately fired from his job.  Patient states that he also made suicidal remarks as well as homicidal remarks to police officer.  Patient states that he is post take Zyprexa daily however does not take it daily.  Patient has a history of inpatient hospitalization for psych.  Patient states that he "wants to stay in the hospital forever "and does not want to go back. Patient does endorse alcohol use as well as marijuana use.  Patient denies any other symptoms.  Patient denies any auditory visual hallucinations.    Patient was the ED for psych eval.  Patient has been petition for suicidal homicidal ideation.  Patient admitted to these statements.  Patient reportedly does take Zyprexa however does not take it every day, is noncompliant.  My assessment patient is agitated but otherwise is not responding to any internal stimuli and responding to my questions.  Patient is requesting to "stay in the hospital forever "and does not want to return.  At this time I did order a psych panel for patient and did consult social work.  Patient psych panel was unremarkable.  RUDS positive for marijuana.  Patient will be going upstairs to Annex.  10/26/2021:   9:38 AM  D/w social work - plan transfer   10:07 AM  Patient's Covid test resulted positive.   Update social worker as to patient's positive Covid test.  Social worker reports still in contact and will follow up regarding bed availability.   11:42 AM  D/w social worker - no Covid beds available at Kingwood this time.  Ambulance/transfer canceled.  Social work request Psychiatry consult, Dr.  Consult ordered.  Final Impression:  Homicidal ideations  Suicidal ideations     Schizoaffective disorder  COVID-19
Had Senior FLUAD vaccine. Two hours later was exhausted. Two hours later had migraine headache, painful sinus, vaccine site was very painful. Then I had aphasia. I was trying to talk with my husband and all my words came out wrong - substituted wrong consonants at beginning of words, used wrong vocabulary, was just not understandable. I was quite scared, and my husband volunteered to take me to the ER. I didn't want to go because I knew it would be an extremely long work up. Feel better today, but still very tired.
Pt fell of sidewalk outside of vaccination clinic, approx. 17 minutes after vaccine received. Mother was present when son fell. She stated "he hit back of head hard. When he fell it took him a minute to respond to me. He got up and walked back to the building okay." Unsteady gait was noted prior to vaccination. b/p was elevated after injury. Pt complained of feeling sleepy. Mother was advised to take son to ER or for ambulance to come check him out. Mother decided to transport son to ER. Pt was able to walk to the car.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported. On 14-APR-2015 the patient was vaccinated with expired dose of ZOSTAVAX 19400 Plaque Forming units (PFU), dose 0.65 ml, lot # K003602, expiration date 20-MAR-2015, subcutaneously. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
She got her vaccine, at the grocery store everything was fine, she shopped and left.  She had dinner, but the next morning she woke up and felt a little bit feverish.  She wasn't too sure, but didn't officially notice it until the next morning.  She woke up at 6:30 the next morning and she felt a little warm, she took her temperature, it was above normal arrow on the glass thermometer.   On the 30th she woke up to use the restroom around 6:30 and she was so dizzy, and got up 4 hours prior, and at that time she could not even stand up, she had to lie back down.  She had to hold onto the wall to use the bathroom.  She went back to bed, laid down and her head was spinning and felt like she was being swung around the  room and felt nauseous and wondered if she was going to throw up.  This would get up a few times to get something to drink, and had constant spinning of her head, and if she stood up she would spin around and fall back on her bed.  It gradually wore off and does not think that it was anything she did, just sort of ran it's course.  She is doing better today.  She went out, ran out an errand and did things around the house and everything is fine today.    She did not call her doctor as it was slightly easing up and so she assumed it was just a reaction and did not call, but she would have called her doctor if it had continued.
Headache, Fever, Injection site pain, fatigue, chills Narrative:  Other Relevant History:
The patient received his booster for pfizer early. He received it before 6 months. Previous dose was in September 2021.
At approximately 3:30AM on the 26th extreme headache, then nausea, then diarrhea, and chills. Fever continued to rise. When my temperature reached 100.2, I drank an Alka Seltzer.  This helped, with the nausea and fever but fever remained high. I drank another Alka Seltzer 4 hours later.  My fever continued to improve but did not go back to normal until 9:30PM on the Sunday, 28th.  I take my temp everyday at the office, I am consistently 97.5
Woke up with double vision, and an unstable gate.  admitted to hospital for testing.