chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  90yo male patient with a h/o COPD, RUL lung nodule, and CAD s/p 4V CABG in 2002 transferred from inpatient care to rehab center on 1/8/2022.  Facility was informed pt had died on 1/16/2022, cause of death unknown. Pt had received covid vaccines on 1/13/21, 2/12/21, 12/29/21. This death is likely not related to the vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration. PROBLEM LAST MOD PROVIDER Seen by palliative care service (SCT 441874000) 12/29/2021 (ICD-10-CM Z51.5) Solitary nodule of lung (SCT 427359005) 03/10/2021 (ICD-10-CM R91.1) History of cholecystectomy (SCT 428882003) 03/13/2018 (ICD-10-CM R69.) Lap chole- CMH 3/1/2018 Abnormal findings on diagnostic imaging of lung 07/29/2016 (SCT 274533004) (ICD-10-CM R91.8) (ICD-9-CM 195.0); FACE 10/08/2008 (ICD-9-CM V43.64); Hip Joint replacement Status 12/13/2007 (Prosthetic or Artificial Device) (ICD-9-CM V43.64) (ICD-9-CM 820.8); Fracture, Femoral Neck 09/13/2007 (ICD-9-CM 719.45); Pain in joint involving 06/15/2007 pelvic region and thigh (ICD-9-CM 719.45) (ICD-10-CM J44.9); Chronic obstructive lung 01/10/2016 disease (CT 13645005) (ICD-9-CM 333.99); Restless Legs * (ICD-9-CM 05/22/2006 333.99) (ICD-9-CM M54.50); Back pain (CT 12/01/2021 161891005) Bruit (ICD-9-CM 785.9) 08/25/2008 1. Carotid , 1, 16-49% stenosis 12/04. neg r 2. Carotids with no sig stenosis 1/07 Postsurgical Aortocoronary Bypass Status (SCT 12/01/2021 399261000) (ICD-10-CM I25.810) 11/02 Old Myocardial Infarction (ICD-9-CM 412.) 04/19/2004 W Inf mi 11/02 Prostate Cancer (SCT 254900004) (ICD-10-CM 06/13/2018 D07.5) Dx 11/01, gleason 8, seeds, xrt, viadur Health Maintenance (ICD-9-CM V65.9) 02/02/2016 1. Pneumovax 6/03 & 11/2012 2. Td 6/03 3. Fobt neg x 3 11/04 4. Colonoscopy 7/07, f/u 10 yrs 5. Tdap 6/13 6.Prevnar 13 7/2015 (ICD-10-CM E78.5); Hyperlipidemia (CT 01/10/2016 55822004) Tobacco Use Disorder (ICD-9-CM 305.1) 04/27/2005 (ICD-10-CM I25.9); Ischemic heart disease 01/10/2016 (CT 414545008) (ICD-9-CM 278.00); OBESITY, UNSP 06/09/2003
First extreme pain down arm to fingertips then lethargic and severe rash with nodules itching burning in mouth throat gums tounge swelling
Swollen, tender, red and fine large area at site of vaccine. Prescribed compresses and Motrin PRN.
I developed costochondritis two weeks after my first vaccine.  It was hard to breathe, and I was in intense pain.  I got tested for Covid and was negative.  Then I went to the doctor and she diagnosed me with costocondritis, had a chest x-ray done to make sure it wasn't something else, and told me I could not start steroids until a week after my second vaccine. I am a teacher, and would lay on my classroom floor during my plan time because the pain was so bad.   The pain got worse right after my second vaccine, especially on the right side of my body (this vaccine was given in my right arm, don't know if that is a coincidence).  A week after my second dose my doctor started me on a steroid pack, and after a few days I was able to breathe better.  For 3+ months it was very painful to bend down, reach up, lean forward, sit, lay on my side or stomach, and carry anything over a couple of pounds.  At that 3 month point I went back to my doctor and got a steriod injection, but it did not help the inflammation.  I then went to the Orthopedics to see if they could help with pain management.  I did start taking 500 mg 2x a day of curcumin in mid-May, and over time that has helped decrease my pain level.  Now (5 months after the vaccine) I am able to do more physical tasks, but still can't do things like carry a basket of laundry without being in pain for hours afterward.  For the past 6 weeks I have been off work, and rest has also helped me heal.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient. The patient had no medical history or drug reactions/allergies. On 16-NOV-2013 the patient was vaccinated with ZOSTAVAX lot # J006832, expiry date 14-SEP-2013, dose 0.65 ml, route subcutaneous for immunization. Concomitant medications were none. On 18-NOV-2013, 2 days after vaccination, the patient developed a red area about a half dollar big around the injections site and some mild itching. At the time of report no treatment had been administered, and the patient had not yet seen her physician. The patient had sought medical attention by pharmacy visit. The outcome of events some mild itching and red area about a half dollar big around the injections site was reported as not resolved. Additional information has been requested.
Patient was symptomatic for COVID-19. Symptoms began on 4/24/2021. Patient tested positive for COVID-19 on 4/24/2021.
back kind of hurt like back ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: (159558). The reporter is the parent.   A 13-year-old female patient received BNT162b2 (BNT162B2), on 10Aug2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset Aug2022, outcome "recovering", described as "back kind of hurt like back ache". Therapeutic measures were not taken as a result of back pain.   Additional information: Other Medical Conditions was reported as No. Reason for no lot number of COVID-19 Vaccine was I do not know that I just know she got it from doctor's office. The reporter was calling on behalf of her daughter. The reporter mentions her daughter experience some side effect after taking COVID-19 Vaccine. So, said that her daughter experiencing back kind of hurt like back ache and that was the only information that she provided. When asked for any further help: Reporter stated, "So, I guess my question was is that a normal side effect from the vaccine, because have the vaccine." Reporter was informed about the Pfizer medical information and was provided with number as ((Phone number) option 3 working timings as 8 Am to 9 Pm Monday to Friday. When again asked for any further help: Consumer stated, "No, thank you." Age at the time of Adverse event was reported just about an hour ago. Patient not received Concomitant Medication she just took some Ibuprofen. Number of Vaccine administered was It's a third one. date Today 10Aug2022. No treatment was received she has been putting heat on it right now, like heat pad. Outcome of event was It has improved. I think it has got little bit better. Reporter stated, So, I guess my question was that a normal side effect from the vaccine, because have the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a physician refers to 5 patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients inadvertently received doses of improperly stored ROTATEQ lot # L039297, expiry date 19-JUN-2017 orally. No adverse effects were reported. Additional information has been requested.
caller had three vaccine doses and tested positive; caller had three vaccine doses and tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient received BNT162b2 (COMIRNATY), on 10Mar2021 as dose 1, single (Lot number: EL3247), in arm, on 31Mar2021 as dose 2, single (Lot number: EL3247, Expiration Date: May2021) and on 14Dec2021 as dose 3 (booster), single (Lot number: FF8839, Expiration Date: Mar2022) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jul2022, outcome "unknown" and all described as "caller had three vaccine doses and tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Jul2022) Positive, notes: BinaxNOW ; (05Jul2022) Positive, notes: caller had three vaccine doses and tested positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The patient said her symptoms have been fairly mild for her, and she has done no treatment at this point. She said she has stuffy sinuses, but did not have a fever or anything so she hasn't had to take anything. She said the stuffy sinuses started on the Tuesday the 05Jul2022, and seemed like allergies but then they got worse and she found out she was exposed to someone who was positive with Covid and that is why she took the test.
Information has been received from a physician concerning an 8-year-old male who in approximately 1999, at "12 months of age", was vaccinated with a dose of Varivax. "About two weeks ago", on approximately 14-JUL-2006, the patient experienced varicella breakthrough of more than 50 lesions. Unspecified medical attention was sought. No outcome information was reported. No product quality complaint was involved. Additional information has been requested.
Patient began to feel nausea after several minutes and then approx. 25 minutes after vaccine patient began to cough. Patient was transported to ER department on same location as clinic to be monitored by ER.
Patient states that approximately two weeks after receiving the vaccination she had leg and hip pain on her left side and that her arm was numb for about a week. As of 9/20/12 she only had leg pain. She took Neurontin for the pain which was started on 9/10/12.
dizziness and vertigo on and off since 5/18; evening of 5/18 had intense digestive issues and diarrhea; period started suddenly at this time as well and extremely heavy with clots, very intense cramping, period will be like this for about 8 hours and then stop and start again about 8-12 hours later; fatigued but can't sleep
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. On an unknown date, an unspecified patients were vaccinated with a dose of improperly stored M-M-R II (dose, route, therapy type, lot number and expiration date were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
16 y.o was given the Moderna shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y.o was given the Moderna shot) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021 at 8:20 AM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y.o was given the Moderna shot). On 19-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 y.o was given the Moderna shot) had resolved.        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.   No concomitant medications were reported.   No treatment information was provided.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 05-FEB-2019, the patient was vaccinated with a dose of improperly stored PROQUAD lot # R017803, expiration date: 21-OCT-2019 (reported as 19-DEC-2019) for prophylaxis (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent. Administered dose of vaccine experienced the temperature excursion of 21.7 degrees Fahrenheit for 3 hours 45 minutes and previous temperature excursion of 12.9 degrees Fahrenheit for 30 minutes. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA004129: US-009507513-1902USA003115: US-009507513-1902USA004131.
Covid arm 8 days after the 1st dose; on and off nauseous after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (on and off nauseous after the 2nd dose) and VACCINATION SITE REACTION (Covid arm 8 days after the 1st dose) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (on and off nauseous after the 2nd dose) and VACCINATION SITE REACTION (Covid arm 8 days after the 1st dose). At the time of the report, NAUSEA (on and off nauseous after the 2nd dose) and VACCINATION SITE REACTION (Covid arm 8 days after the 1st dose) outcome was unknown.            No concomitant and no treatment medications are reported.   This case was linked to MOD-2021-170018 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up case booked in
The client stated about 15 minutes after receiving the 2nd dose of Moderna COVID vaccine she developed shortness of breath and felt like "my throat was closing." The client stated she focused on being calm and the shortness of breath and throat tightening resolved without medication within 2-3 minutes. Client also reported chills, fever, and nausea that started 24 hours after the 2nd dose of Moderna COVID vaccine that lasted 24 hours. The client reports a history of episodes of shortness of breath related to anxiety. Client reports a history of insomnia and stated she didn't sleep last night. The client reported a history of hypertension not currently managed with medication. The client has no known allergies.
Fever; chiils; vomiting; This is a spontaneous report from a contactable consumer (patient). A 14-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 03Jun2021 09:00 at the age of 14-years-old as dose 2, single for covid-19 immunisation at Pharmacy or Drug Store. The patient's medical history was not reported. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left leg on 13May2021 11:30 (at the age of 14-years-old) as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 04Jun2021 at 01:00, the patient experienced Fever, chills and vomiting. No treatment was received for adverse events. The outcome of events was recovering.  Lot/batch number has been requested.
This spontaneous report received from a physician via a company representative referred to a 13 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 05-OCT-2016, the patient received first dose of GARDASIL 9 (dose, site of administration, lot number and expiry date were not reported) intramuscularly. The patient became nauseous and light headed. She was monitored for 15 minutes and recovered. There was no treatment given for the events. The reporter did not provide the relatedness of the events with GARDASIL 9. Additional information has been requested.
vaccine side effect. Patient reports slurred speech, difficulty forming sentences, SOB, R arm tingling x 3 hours. Patient reports symptoms have improved but not resolved. J&J vaccine today at 1045. Denies chest pain, N/V/D, HA, vision changes. Patient is a 74 year old male who presents to ED following a 10 second episode of right arm tingling followed by a 90 minute episode of difficulty finding words. This happened tonight at 8:30pm after dinner when he was with his wife. His symptoms resolved upon arrival at the ED at 10pm. He denies any weakness, no syncope, no chest pain or shortness of breath, no new visual symptoms. He does have a history of CHF, MI in 2013 s/p stend placement, he takes Plavix. He takes a beta blocker for PVC's. He reports he had a J&J COVID shot this morning at 11am and is wondering if his symptoms are a reaction to the vaccine.  He is followed closely at Ajou hospital for all his medical care.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse events were reported. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
7 minutes post vaccines, patient's mother informed nurse of patients upper lip swelling. Dr. notified. Pt. crying and anxious. Whelps to face, neck and chest. Administered EPI JR, 10 mg IV Solu-Medrol, 10 IV diphenhydramine. 911 called and transferred to hospital.
June 26, shortness of breath and a heart palpitations. No indication that anything was coming on. Tests performed. Findings, blood clots in left leg and both lungs. Admitted to hospital on June 26. Discharge on June 28. Currently on blood thinners. Sonogram of both legs. Clots found in left leg. EKG, ECG of heart, CT scan found clots in both lungs. Numerous blood draws. Dr. advised I would not have made it to June 27 if I did not come in on June 26. States worst he?s ever seen for blood clots and lungs.
No adverse effects reported; a patient received an improperly stored dose of ROTATEQ on 10/03/2019; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 03-OCT-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R026391 and expiration date 09-JUL-2020 (strength, dose, frequency and anatomical location were unknown) for prophylaxis (product storage error).  The administered dose of the vaccine was stored with the temperature of 32.9 degrees Fahrenheit, for 3 hours and 40 minutes. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effect reported.
Pt reports that 3 hrs post #1 hep B vaccine felt severe generalized body aches, feverish, nausea and vomiting which lasted approx. 2 weeks. This was reported when questioned just before giving #2 hep in series. #2 not given.
The following day the patient developed a 1-2 inch oval patch of redness and bumps surrounding the injection site. Pt was advised to keep out of direct sunlight, use hydrocortisone and diphenhydramine as needed.
BODY ACHE; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 21 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, no alcohol use, smoking, and depression, and other pre-existing medical conditions included the patient has no known allergies and no history of drug abuse or illicit drug use. The patient was not pregnant at the time of event reporting.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: unknown) dose was not reported, administered on 06-APR-2021 08:00 for prophylactic vaccination. Concomitant medications included venlafaxine for anxiety, and depression, bupropion hydrochloride for depression, and ethinylestradiol/norgestimate. On 06-APR-2021 17:00, the subject experienced body ache. On 06-APR-2021 17:00, the subject experienced chills. On 06-APR-2021 17:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body ache, headache, and chills. This report was non-serious.; Sender's Comments: V0 : Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious
Onset of facial numbness localized to both sides of the face approximately 15 min after receiving the second dose of the Pfizer vaccine. Nubness was localized to both sides of the face, nose and  neck.  Symptoms resolved after 30 min of observation without any medical intervention.
11 days after MMR vaccination complained of severe exhaustion, severe headache, both lasting in excess of 12 days. 16 days after MMR vaccination complained of swollen glands behind both ears, inside ear canal itchy.
The pt developed fever (103.7 deg. F.)at 2am on 05/08/2002. To rule out otitis media, ears were checked at 5:45am and found to be normal. Child fussing and tired-looking, otherwise alert. Tylenol was given at 2am on 05/08/2002 and 4hours thereafter. On 05/09 temp 99 deg. F and the child feels better.
Two days after vaccine suddenly had sever central chest pain worse with lying flat. Ultimately EKG showed pericarditis. Troponins were done which showed significant elevations. Patient diagnosed with myopericaditis, likely 2/2 vaccine. No other illness whatsoever. Further diagnostic tests were ordered, patient unfortunately left AMA before further workup was completed.
Patient reported CHill, panic, Racing, Heart at ~2am on 09/10/2009. Pt said she talked to Hospital ER and was told told to take Benadryl. Pt got better by the next day.
giving Moderna vaccines subcutaneous instead of intramuscular; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving Moderna vaccines subcutaneous instead of intramuscular) in a  patient of an unknown age and gender 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) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving Moderna vaccines subcutaneous instead of intramuscular). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (giving Moderna vaccines subcutaneous instead of intramuscular) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Two nosebleeds. One at 2:30 AM on 12/1 and another at 6:30 AM on 12/1. Both significant bleeding.