chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart attack; Stroke; This spontaneous case was reported by a nurse and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Vasculitis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were provided. The patient had an underlying autoimmune condition and vasculitis. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No treatment medicine were provided.  Company comment: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) AESIs of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of vasculitis, who experienced the unexpected serious (medically significant and hospitalization) AESIs of Myocardial infarction and Cerebrovascular accident after receiving a dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset date of events were not reported. Clinical course and treatment details were not reported. The outcome of events was unknown. Concurrent vasculitis could be considered as a risk factor for events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.
Injection site swelled to baseball size is red and warm - advised to take BENADRYL as directed and apply cold compress.
58M with HLD, PreDM, Due to culture (declines blood products), OA of both knees s/p knee arthroplasty who presented with cough, fever, sweats, and SOB.    COVID Pneumonia/Acute hypoxemic Respiratory failure - symptom onset on 8/6. COVID positive on 8/9/21. Last fever 8/13/21 in ED. Received J&J vaccine 3/21/21. D-dimer remains >4. CRP improving. Chest CT on 8/13 negative for PE.  - FiO2 down to 1L NC, cont to wean as tolerated - cont decadron 6mg daily for up to 10 days (8/13 - ) or until no longer hypoxic - completed 5 day course of remdesivir (8/13 - 17)  - cont pepcid for GI prophylaxis - cont to trend inflammatory markers - continue isolation in hospital    Insomnia - slept well - cont melatonin 9 mg QHS - cont trazodone 25mg qHS   OSA (?) -  - cont CPAP q HS as tolerated - will need sleep study outpatient  PreDM - BS's Ok will dc ISS
Patient received one(1) booster dose with a date that exceeds the Beyond Use Date. Patient has been contacted. Patient primary care physician has been contacted. Patient will follow up with primary care physician to determine if revaccination is necessary at this time.
This spontaneous report as received from healthcare worker refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # L043213, expiry 28-AUG-2017 (dose and route not reported). No adverse effects reported. No additional information was provided. Temperature: 32 F. Time frame: 3 minutes and back in range. No previous temperature excursions reported. Data logger was used. This case is one of the 3 reports from the same source. Additional information has been requested.
Received MMR on 4-22-08.  On 5/8/08 patient noticed swelling of glands on both sides of her face.  Called MD but was not seen.  Swelling gone by 5/9.
28 year old male here for follow up of an L upper posterior arm abscess. Pt received a rubella vaccine on 5/10/10 and developed redness, swelling around 5/24/2010 with fever and chills 3 to 4 days later. He was on honeymoon and went to Medical Center where he was put on a 5 day course of clindamycin 300mg po QID x 5 days and BACTRIM DS 1 tablet po BID x 5 days. Pt also saw a surgeon who agreed with the Dx and his swelling, redness, fever and chills resolved. He still has some residual pain. Pt is on WELLBUTRIN for smoking cessation; NKDA; PMHX-none prior to the above; Exsmoker x few weeks, no alcohol, no drugs. Pt had blood cultures done but no aspiration of the L arm abscess.
Information has been received from a physician concerning a 20 week year old patient who on 10-SEP-2010 was vaccinated with a dose of ROTATEQ (Route and lot # no reported). No adverse effects reported. Additional information has been requested.
Patient presented to healthcare facility on 01/04/2021 for a booster shot of Pfizer. HCP was alerted that first dose of Pfizer was on 04/12/2021 (Lot #EW0161) and second dose was on 04/19/2021 (Lot #EW0171). HCP educated patient that second dose was administered too soon, and that today's dose will be documented as a second dose. Per documentation, shot was administered by HCP at alternative site. Pfizer (Lot #FL3197) administered on 01/04/2022 at 3:30 PM at healthcare facility. Patient did not have an adverse reaction during observation period and client left vaccination room with steady gait.
Mom called at 08:15 am and stated that he got vaccine a week ago and now red and whelpy with a knot the size of a baseball in diameter. Seen in office and will do 1% hydrocortisone cream and compresses.
Received on 0230 4/16/03 with pass. NI. smallpox vaccine 5 days prior. CPK 384 Triponin 5.0 Triglucerides 428 HDL 33. Hx of hypertension-tx with Lisinipril. Hx diaphoresis several days chest pain at 11:00pm 4/15/03 nausea/vomiting. No previous hx heart disease.
A patient whose age, gender, medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (lot number U4490AA, route, dose and site of administration not reported) on an unspecified date. On an unspecified date, the patient experienced an adverse reaction. Laboratory details and corrective treatment were not reported. The patient's outcome was not reported. List of documents held by sender: None.
Chest pain  Myocarditis. Admitted to hospital. Diagnosis confirmed by cardiac mri.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: PAA156051) and on 29Mar2021 as dose 2, single (Lot number: EN6208) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 02Nov2021 as dose 3 (booster), single (Lot number: 939905) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Erythromycin for Allergy; Cephalosporin for Allergy. The following information was reported: VACCINATION FAILURE (medically significant) with onset 06Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 06Jun2022, outcome "recovering" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jun2022) positive, notes: I tested positive for Covid on June 6,2022 and started taking Covid on the same day; (09Jun2022) negative., notes: My symptoms cleared by June 8, 2022, and took an antigen test on June 9, 2022 which came back negative; (19Jun2022) positive, notes: Nine days later (June 18) I started sneezing and became congested and took another antigen test on June 19 which came back positive; (23Jun2022) positive, notes: am still recovering from Covid and continue to test positive on June 23, 2022. My symptoms are mild and consistent with a head cold. Therapeutic measures were taken as a result of vaccination failure.  Clinical course: I tested positive for Covid on 06Jun2022 and started taking Covid on the same day. My symptoms cleared by 08Jun2022 and took an antigen test on 09Jun2022 which came back negative. Nine days later (18Jun) I started sneezing and became congested and took another antigen test on 19Jun which came back positive. I am still recovering from Covid and continue to test positive on 23Jun2022. My symptoms are mild and consistent with a head cold.
felt like someone slugged him in that area; soreness at injection site/ soreness built up gradually throughout out the day; injection site was slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt like someone slugged him in that area), VACCINATION SITE PAIN (soreness at injection site/ soreness built up gradually throughout out the day) and VACCINATION SITE SWELLING (injection site was slightly swollen) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included TESTOSTERONE for an unknown indication.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced SLUGGISHNESS (felt like someone slugged him in that area), VACCINATION SITE PAIN (soreness at injection site/ soreness built up gradually throughout out the day) and VACCINATION SITE SWELLING (injection site was slightly swollen). On 11-May-2021, SLUGGISHNESS (felt like someone slugged him in that area), VACCINATION SITE PAIN (soreness at injection site/ soreness built up gradually throughout out the day) and VACCINATION SITE SWELLING (injection site was slightly swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.   This case was linked to MOD-2021-229879 (Patient Link).
So about a few months after my vaccine, I started to notice episodes of rapid heartbeats. It was bouncing around from 90-150 and then 60- 140. I would feel lightheaded at times, and it would go away on its own. I then went to my PCP who then sent me to the cardiologist. They then gave me a 24-hour monitor and then did a 2 week monitor which is when they found the Atrial Fibrillation.  Eliquis and Sotalol for heart arrhythmia, I did not tolerate the full dose well. History of Cardiac Ablation in October 2021 for arrhythmia at hospital. I am now taking a half of Sotalol in the morning and at night. I am also still on Eliquis.  I have not had any issues since utilizing the prescription in small doses.
Patient with history of cerebral palsy.   She was brought to the ED by EMS for shortness of breath on 11/10/22. Initially, she was seen in clinic and when taking vitals, was noted to be at 88% on room air so was sent to the ED for further evaluation. In the ED, she reported runny nose, congestion, and cough. In the ED, patient tested positive for both COVID-19 and RSV. Ultimately patient was admitted 11/10 with acute hypoxic and hypercapnic respiratory failure, COVID infection, and RSV infection. She was discharged 11/21/22. Patient has received the COVID primary vaccine series and 3 boosters.
Swollen hands/feet, arthralgias, arthritis, rash (urticarial) onset 29OCT91;
patient passed away; Initial information received on 28-Oct-2020 regarding an unsolicited valid serious social media case received from a consumer (non-healthcare professional).  This case was linked to cases 2020SA304724 and 2020SA282884.  This case involves a female patient of an unknown age who passed away (death), while she received INFLUENZA VACCINE (H1N1 vaccination).  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient passed away (death), three days following the administration of INFLUENZA VACCINE. This event was also assessed as medically significant. The medical examiner said from complications of the H1N1 vaccination, he/she would rather have the flu.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment before she died.  It was unknown if an autopsy was done and cause of death was not reported.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a female patient of unknown age who died 3 days after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). Also, patient's medical condition at the time of vaccination, autopsy result and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: patient passed away
sick; fever; chills; body aches; chest pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing); "reflux" (ongoing); "Heart disorder" (ongoing); "heart failure", start date: 07Feb2013 (unspecified if ongoing); "mitral valve failure", start date: 07Feb2013 (unspecified if ongoing); "mitral valve repair" (unspecified if ongoing); "Heart attack", start date: Feb2017 (unspecified if ongoing); "two stent placed in right coronary art" (unspecified if ongoing); "chronic obstructive pulmonary disease" (unspecified if ongoing); "cystic fibrosis" (unspecified if ongoing); "congenital heart disease" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder, start date: 2010 (ongoing); OMEPRAZOLE taken for gastroesophageal reflux disease, start date: 2013 (ongoing); CARDIZEM [DILTIAZEM] taken for cardiac disorder, start date: 2016 (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiac disorder, start date: 2013 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "chest pains", "chills", "body aches", "arm pain", "fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "chest pains", "chills", "body aches", "fever". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; PYREXIA (non-serious), outcome "unknown", described as "fever"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHEST PAIN (non-serious), outcome "recovered", described as "chest pains".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): US-PFIZER INC-202300180375 same patient/drug, different dose/event; US-PFIZER INC-PV202300029860 same patient/drug, different dose/event.
Shingles - intense internal left abdominal and side pain, followed by skin rash on left side a week later. Treated with pain medication, and anti-virus medication. Still experiencing some pain and some rash 2 months later, at the time of this report. Currently continuing pain medication.
Severe chills Fever over 102 degrees Aches Sore lower back Rapid breathing
Ears ringing; Ears burning; Facial burning, extremity burning; Phantom smells - Cigarette Smoke; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 12Mar2021 18:00 (at the age of 47-year-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced ears ringing, ears burning, facial burning, extremity burning, and phantom smells - cigarette smoke on 13Mar2021. Events resulted to treatment with Prednisone, Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Disability or permanent damage. The outcome of events was not recovered. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: ER8T32, Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 02Apr2021 18:00 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient developed a rash 4 days after receiving the flu vaccine. The following evening he developed knee swelling and pain with progression to limping. He then developed swelling in hands and around eyes on 10/21. Almost all resolved by time of eval in PCPs office.
l had a headache and muscle pain for the first few days then the symptoms worsened. I went to the grocery store and my blood pressure dropped severely. I had cramps in my upper back and should and got weak. The first time I checked my BP, I was unable to get a number because it was so low. After drinking water, My BP was 89/62. The 3rd time 75/61. I reached out to my doctor who was not in the office. I advised that I would go to the ER if it got worse. I was not feeling well the whole day. The next day I felt better after consuming more salt and water. I also experienced some additional symptoms like paresthesis where my lower and upper body went numb. I had agonizing upper back and shoulder pain. I had vertigo also on April 22, 2022. I am uncertain whether I have recovered. I do have physical therapy appointments scheduled. I am also having issues with double vision in my eyes.
Warm to the touch Injection Site; Red Rash ( Size 1" to 2"); Injection site pain/Tender Injection Site; Swollen Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site), RASH ERYTHEMATOUS (Red Rash ( Size 1" to 2")), VACCINATION SITE PAIN (Injection site pain/Tender Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRON for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site), RASH ERYTHEMATOUS (Red Rash ( Size 1" to 2")), VACCINATION SITE PAIN (Injection site pain/Tender Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site), RASH ERYTHEMATOUS (Red Rash ( Size 1" to 2")), VACCINATION SITE PAIN (Injection site pain/Tender Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment also included iron.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded. Vaccination site pain, vaccination site swelling and rash  are consistent with the known safety profile of the vaccine,
No fever had diarrhea in the morning. Rcd H1N1 in afternoon and then developed vomiting.--S/S lasted about 12 hours.
The patient received the vaccination, then stated she was feeling light headed. She was given water to drink and then she fainted. 911 was called and she was taken to a local hospital.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 12:17 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 12:17 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
5cm red area on lt arm where DT gven;diffuse muscle aches;temp 101-102, h/a;
This spontaneous report as received from a pharmacist refers to a male patient of over 65 years old. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. Approximately in February 2016 (reported as 2 weeks ago), the patient was vaccinated with ZOSTAVAX 0.65 ml (lot # and expiry were unknown) subcutaneously. Concomitant medications were not reported. Approximately in February 2016 (reported as following vaccination), the patient developed rash on the arm other than the ZOSTAVAX injected arm. On an unspecified date, the patient visited physician for rash, but no treatment was given to him. The outcome of rash was unknown. The relatedness of rash with ZOSTAVAX was not reported. Additional information has been requested.