chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The patient's past medical history included Heart attack in 2006. Concurrent medical conditions included Drug allergy (Ativan), Brain injury and Short-term memory loss (Brain injury resulting in short term memory loss). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In March 2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. An autopsy was performed. No concomitant medication provided. No treatment information mentioned. Patients wife reported that patient died 4 days after he was in the hospital. Patient had a heart attack as per autopsy and died at home. No other vaccines were given a month prior to Moderna. Has never had a COVID positive test or diagnosis. Company comment. This spontaneous fatal case concerns a 63-year-old, male subject with a medical history of heart attack (2006) and brain injury that resulted in short-term memory loss, who experienced the unexpected serious (Results in death, medically significant) AESI of Myocardial infarction. The event occurred approximately 5 days after the first dose of mRNA-1273 VACCINE and had a fatal outcome. As reported, 5 days after vaccination, patient died at home, cause of death was heart attack, and an autopsy was done.  However, autopsy result was not provided. The patient's age and medical history of heart attack and brain injury, which has the same risk factors as myocardial infarction, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous fatal case concerns a 63-year-old, male subject with a medical history of heart attack (2006) and brain injury that resulted in short-term memory loss, who experienced the unexpected serious (Results in death, medically significant) AESI of Myocardial infarction. The event occurred approximately 5 days after the first dose of mRNA-1273 VACCINE and had a fatal outcome. As reported, 5 days after vaccination, patient died at home, cause of death was heart attack, and an autopsy was done. However, autopsy result was not provided. The patient's age and medical history of heart attack and brain injury, which has the same risk factors as myocardial infarction, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Heart attack.
This spontaneous report was received from a registered nurse concerning an unspecified number of unspecified patients who on unknown dates might have received improperly stored dose of M-M-R II (dose, route and lot # not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected.
swollen eyes and blood; discomfort on her throat; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (swollen eyes and blood) and OROPHARYNGEAL DISCOMFORT (discomfort on her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included clot forming.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (swollen eyes and blood) and OROPHARYNGEAL DISCOMFORT (discomfort on her throat). At the time of the report, EYE SWELLING (swollen eyes and blood) and OROPHARYNGEAL DISCOMFORT (discomfort on her throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pt presented to UC for unrelated knee injury and was incidentally noted have an elevated HR at 134 a 12 lead was performed and 1st degree AV block and sinus tachycardia at 136 was noted. Pt was sent to hospital for children.
Lightheaded, increased respirations, tingling in hands and feet (numbness), pale, hyperventilation.  EMS checked, helped her to regulate her breathing.  Stated this happens when she gets shots.
Diagnosis: Myocarditi  HPI on 8/25: 15-year-old male here with mother, little brother and little sister.  Mother called this morning stating the patient start having chest pain last night.  We called and added him into clinic today.  Patient states that last night he was awakened from sleep with substernal chest pain.  This has continued today.  He states that he had the second Pfizer vaccine on 8/23.  He is feeling some mild shortness of breath like he went out and exercised.  He has had only one other vaccine outside of the Pfizer vaccine that was an influenza vaccine last year.  Mother does not feel that he has had any fevers or body aches sweats etc.  No sick contacts in the family.
I?ve experienced severe fatigue, daily elevated temperatures,  occasional nausea, headaches and muscle aches.
Anaphylaxis: abrupt throat swelling, shortness of breath, facial redness, GI distress
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Apr 1, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), on Mar 10, 2021, for COVID-19 immunisation. The patient experienced vasodilatation (patient and her mom experienced veins popping-up on their arms after taking the COVID-19 vaccine), with outcome of unknown. Additional information: Reporter and her mom experienced veins popping-up on their arms after taking the COVID-19 vaccine. Patient  experienced this symptom after taking the 1st dose. Her mom experienced the symptoms after taking the 2nd dose. Her mom got the 1st dose of COVID-19 vaccine on Mar 10, 2021 and her mom's 2nd dose was taken on Apr 1, 2021. Patient asked if this is a normal symptom. No follow-up attempts possible. No further information expected.
3 doses Engerix-B given 4DEC89, 4JAN90 & 4JUN90. 11JUL90, fourth dose was given. Vaccinee did not convert p/fourth dose.
Hot flash. Felt as if she became red. Vital Signs: BP 165/112 HR 83 Resp 18 O2Sat 97%  Skin Signs: Clammy, diaphoretic  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: V.S., observation, hx. 0 flushing rated. P/W/D. Initially hands felt diaphoretic  1:00 PM  Vital Signs: BP 182/110 HR 80 Resp 16 O2Sat 98%  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: Sx resolved. Monitoring  Notes:  D/C home with husband. 0 further symptoms noted at 1:15 PM.
Redness around injection site - approx 2 inches in diameter.  Warm to the touch.
This is an instance of COVID-19 breakthrough disease after which a death occurred.   The individual was vaccinated with the Pfizer product on 01/27/2021 and 02/17/2021.   The individual became symptomatic on 04/10/2021 and was admitted to hospital on 04/11/2021. PCR tests on 04/11/2021 and 04/18/2021 were both positive.  They were discharged from hospital on 04/13/2021 and then re-admitted on 04/18/2021 and left against medical advice on 04/21/2021.  The individual had contact with the health department on 04/21/2021 regarding release from isolation and the individual reported that they had recovered from their illness and were no longer experiencing symptoms; based on the individual's self-report, they were released from isolation. The individual was then re-admitted on 04/23/2021 which required ICU admission.  They were discharged to an out-of-state advanced care hospital on 05/13/2021, and died at that out-of-state facility on 05/15/2021.   Death certificate details as follows:  Part I Cause of Death A: Acute Respiratory Distress Syndrome B: Sequela of COVID 19 Viral Pneumonia C: Rheumatoid Arthritis D: Severe Protein Calorie Malnutrition Part II Other Significant Conditions: Urothelial Carcinoma
No adverse event; Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours) and NO ADVERSE EVENT (No adverse event) in a 5-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 06-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture/ Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours).    No concomitant medication was provided by reporter.  The vial was initially stored in the refrigerator: 31Dec2022. The vial was first punctured: 5Jan2023 at 3:30 PM. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 19.5 hours.  No treatment medication was provided by reporter.
Tingling sensation of (L) arm lasted approximately 21/2 - 3 hours after flu vaccine was given.
This is an initial non-serious spontaneous case, received on 02-Mar-2018, reported by other non-health professional, concerning a male patient of unspecified age. On an unspecified date (5 years ago), the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient experienced nausea, vomiting and diarrhoea. At the time of this report, the outcome of the events was not reported.
She got her vaccine on Thursday afternoon, noticed redness on her left forehead and around her eye.  When she got up Sunday morning her eyelid was swollen, partially closed, swelling on the area that had been red on her forehead and around her face.  She went to UC and then they sent her to the ER.  In the ER she got Prednisone and another pill to last 7 days.  In the meantime she has gone to Dr.  and that she had shingles.  She does still have shingles reaction with the itching and some swelling, but it keeps getting better.
Developed ITP - given steroid boost and will F/U with blood work to make sure platelets recover back to a normal level.
Pt had a negative pre-operative COVID test, but during his procedure (four-vessel bypass grafting), he was not noted to have a significant fever and the test was repeated and positive.
Eye irritation; Clogged nose; Plastic Syringe ( "Vanish Point" Syringe / "Retractable Technologies" Brand) malfunctioned while reconstituting the MMR  II vaccine; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; inadvertently splashed into the face of the unspecified provider/The unspecified providers face was exposed topically, in the eyes and mucus membrane; This spontaneous report was received from a pharmacist referring to a 49 year-old female patient. The patient's current conditions included sulfa allergy and latex sensitivity. The patient's medical history and concomitant therapies were not reported. On 03-OCT-2019, the patient was exposed with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) topically (lot # R036581 with expiry date of 17-DEC-2020) and sterile diluent (lot # S008565 with expiry date of 09-AUG-2021) (strength, doses, frequencies) which was indicated for prophylaxis. On 03-OCT-2019, the reporter reported that plastic syringe ("vanish point" syringe / "retractable technologies" brand) malfunctioned while reconstituting the MMR II (syringe issue), inadvertently splashed into the face of the provider who was exposed topically (accidental exposure to product) (occupational exposure to product), in the eyes (exposure via eye contact) and mucus membrane vaccine (exposure via mucosa) and experienced eye irritation and clogged nose. The events of eye irritation and nasal congestion did not recover at the time of report. The outcome of accidental exposure to product, exposure via skin contact, exposure via mucosa, exposure via eye contact and occupational exposure to product was unknown. Causality assessment was not provided.  This is one of the two reports obtained from the same reporter.; Sender's Comments:  US-009507513-1910USA005558:same reporter
I developed a fast heart rate 4 days after the first dose and dizziness.  I have had it on and off since then and I am now under the care of a cardiologist.  I have had ekgs, stress test, a heart cath.  I am currently awaiting an mri of the heart and an electrophysiology study to find out what the problem is.
My throat was swollen; my tongue was swollen; my lips are swollen; I had the first one but it was more than 4 weeks, so it was on 08/23/2021, that was when I had the first one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 17:00 (Lot number: FF2590) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Anatomical Location: Left Arm), administration date: 23Aug2021, for COVID-19 immunization. The following information was reported: PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "My throat was swollen"; SWOLLEN TONGUE (non-serious), outcome "not recovered", described as "my tongue was swollen"; LIP SWELLING (non-serious), outcome "not recovered", described as "my lips are swollen"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "I had the first one but it was more than 4 weeks, so it was on 08/23/2021, that was when I had the first one". The events "my throat was swollen", "my tongue was swollen" and "my lips are swollen" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of pharyngeal swelling, swollen tongue, lip swelling.  Additional information: My throat was swollen, my tongue was swollen and my lips are swollen, my tongue and my lips are still swollen and I know it's from the shot Patient stated she wants to report some side effects that she having but I do not know if it's the side effects but I went down on the 12th of October to get my second COVID shot at about 5 o'clock in the afternoon. And I woke up the next morning my throat was swollen, my tongue was swollen and my lips are swollen. My tongue and my lips are still swollen and I know it's from the shot. I don't know what to do. No other medical condition. Concomitant medications are for my heart. Treatment: Patient stated, she went to Urgent care, they didn't know what to do, they gave my antibiotic (Unspecified medication). It didn't do any good, I am still having the side effects on my lips and my tongue.  Follow-Up (08Nov2021): .No follow-up attempts are possible. No further information is expected.
COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; COVID-19 positive after receiving three Pfizer COVID-19 Vaccines; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 17Jan2021 at 11:00 as dose 1, single (Lot number: EL1283), on 06Feb2021 at 11:00 as dose 2, single (Lot number: EN5318) and on 18Sep2021 at 15:00 as dose 3 (booster), single (Lot number: FE3592) at the age of 67 years for covid-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma Diagnosed in her twenties; "Obesity" (unspecified if ongoing), notes: takes Contraze for weight loss, prescribed by her HCP.; "Viral cardiomyopathy" (unspecified if ongoing); "congestive heart failure" (unspecified if ongoing). Concomitant medication(s) included: SPIRIVA taken for asthma; ALVESCO taken for asthma; CONTRAVE oral taken for obesity. Vaccination history included: Shingles (Worst would have been newest Shingles vaccine: , Date: 2 years ago , NDC/LOT/EXP: unknown), for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Jul2022, outcome "unknown" and all described as "COVID-19 positive after receiving three Pfizer COVID-19 Vaccines". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: She was a cardiac patient and has been taking half of her digoxin while taking Paxlovid and right now. Had completed 5 day Paxlovid, that ended on Monday. Started Paxlovid in morning of 07Jul2022. No other vaccination within four weeks prior to the first administration of the suspect vaccine. Flu vaccine one month after 3rd COVID-19 Vaccine on 21Oct2021. Headache and muscles aches most with second COVID-19 Vaccine. No antipyretic use.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event COVID-19, Vaccination failure and the suspect drug BNT162B2 cannot be excluded.
patients received vaccine after temperature excursions; product storage error; Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions), PRODUCT STORAGE ERROR (product storage error) and EXPIRED PRODUCT ADMINISTERED (Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions) and PRODUCT STORAGE ERROR (product storage error). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired product administered/vaccine was given from a punctured vial of moderna past 30 day BUD) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients received vaccine after temperature excursions) and PRODUCT STORAGE ERROR (product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 02 Nov 2021, the vial was initially stored in the refrigerator and was first punctured. The Vial was stored in refrigerator post puncture.  No concomitant medication was provided.            No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Follow up received and included Non Significant information. On 10-Jan-2022: Follow up received included vaccine information, event start date and stop date was updated.
Breakthrough case after Covid vaccination. 1st dose given 3/15/2021. 2nd dose given 4/12/2021. C/O sore throat, loss of taste/smell and fatigue
Patient developed fatigue about 7 hours after vaccine administration , which waxed and waned over the next 7 days before he developed fever and myalgias for a 24 hour period which led him to present to the emergency department.
Severe shortness of breath, and decrease in oxygen saturation to 61%, 2 weeks after second Covid Vaccine dose. He was rushed to the hospital and was diagnosed with pulmonary embolism and received oxygen therapy. He also received Lovenox injections and then apixaban orally.
11:15 Pt reported itchy throat and odd taste in mouth; no swelling, denied difficulty breathing/swallowing. Vitals taken (B/P 136/90, H/R 88, SPO2 94%) reviewed Pt medical history. Pt observed for additional 30 minutes. Despite complaint of itchiness, no hives were observed 11:45 Vitals reassessed (B/P 132/78, H/R 78, SPO2 95%) denies any other concerns, states going home to rest, advised to call 911/doctor if condition worsens, pt has no questions, pt released
Fever of 99.9 - 102.5 for 36 hours +. Aches, pains, dizziness, extreme fatigue, dehydration (flu-like symptoms)
Left supraclavicular swelling and left neck swelling with a lump. Tender to palpation, red, hot. Started one day after vaccination was given.
Rash on left side of face, numbness or sensitivities on left side of face. Patient is assuming allergic reaction on left side of face.