chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; minor aches; heart attack; kidneys were compromised; chills; had a cough; muscles were tightening, could hardly walk; lethargic; This is a spontaneous report from a contactable consumer or other non hcp.   A 80-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 14Jan2021 as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included bypass surgery. The patient's concomitant medications were not reported. On 16Jan2021, the patient experienced headache, minor aches, had a cough, muscles were tightening, could hardly walk, lethargic, chills and heart attack on an unspecified date. Caller states that on 14Jan2021 she and her husband had the 1st Pfizer vaccine dose. 2nd dose was scheduled on 04Feb2021. Caller reporter that 2 days after the 1st dose, her husband's muscles were tightening, could hardly walk, had a cough, was lethargic, had chills and was c/o having reflux in his chest. Caller stated they had appointments that day with their Internist and their Cardiologist. Both HCPs felt all his symptoms were probably from the vaccine. That night she took him to the ER and he had had a heart attack. They did a cardiac Cath and had one of two stents put in. His kidneys were compromised and the HCP couldn't give the amount of dye needed to add another stent. So he still needs another stent. Also the blood count went down. Caller states her husband had cardiac bypass surgery years ago. The caller also mentioned her son is a surgeon and had bad flu like symptoms after second shot and only had a headache and minor aches after the first dose. She was concerned about her husband as he had a heart attack and if he should get the 2nd dose. The patient underwent lab tests and procedures which included blood count: went down. Outcome of the events were unknown.  Upon follow-up on 16Apr2021: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and pertinent medical history were not provided. On unspecified dates, these unspecified patients were vaccinated with ROTATEQ (oral, lot #, dose and frequency were unknown), that were improperly stored outside the recommended storage temperatures in the product insert. No adverse effects reported. No product quality complaint (PQC). The outcome of the events was unknown. This is one of several reports received from the same source. Additional information has been requested.
Breakthrough case admission after 3 vaccines Pfizer 3/11/21 Lot# EN6207;  Pfizer 4/1/21 Lot# ER8737;  Pfizer 10/26/21 Lot# FE3590
Viral meningitis. 12/29/2008 MR received for DOS 11/24-26/2008 with D/C DX:  Viral Meningitis. DM Type 2. HTN. Hyperlipidemia.  Gout. Pt presented to ER with 2 day hx of worsening H/A, neck & abdominal pain and double vision. PE (+) for nuchal rigidity and stiffness and abdominal tenderness. Admitted for IVF, pain meds and anti-nausea meds with improvement noted. Assumed r/t YF vaccine.
Child received immunizations (Varicella, IPV, Prevnar, Hep A). Left office and was about 4 miles away. Mom called - came back in. Red raised rash to face; splotchy on neck, back, shoulders, over body, "was in a daze", per mom. Administered Benadryl 1 tsp. at 1540.
History of Present Illness  80 year old male patient who presented to the ER this morning after sustaining a fall at home.  Patient was in the living room in his recliner this morning.  He stood up and felt dizzy.  He lowered himself to the ground, denying loss of consciousness.  He sustained a small posterior scalp laceration that required two staples in ER.  He denies ongoing dizziness at time of encounter, just after arrival to the inpatient ward.  It is unclear if the laceration was sustained during this episode or another fall.  At baseline patient is independently ambulatory without need for assist device.  He denies headache, vision changes, fever, chills, chest pain, shortness of breath, diarrhea/ constipation.  He reports one episode of nausea/vomiting without hematemesis around the time of the near-syncope.  He reports occasional constipation, if he does not have an am bowel movement he will take a stool softener at lunchtime.  He drinks alcohol daily, 4 ounces of liquor and then 4-5 beers each evening.  He never misses a day.  No history of withdrawal symptoms.    Incidental COVID-19 positive in ER.  He had cold symptoms a few days ago and his wife continues to have cold symptoms.  He no longer has the cough or runny nose.  He has no idea where he may have come into contact with COVID-19.  He was vaccinated with Pfizer x 2 doses this summer.  He wears a mask in public.  He will contact his wife about quarantine and testing.
Rash over left arm, neck, and face as well as ear swelling in both ears. After taking Allegra ear swelling and much of rash on neck has dissipated, but face and arm still have rash/getting more red.
Patient experienced some redness and swelling around injection site (minor after vaccination). 2 days after vaccination patient experienced additional redness, and a rash on left arm, below injection site but above elbow. Patient stated the rash was itchy. Patient also described minor pain to the touch "if you press really hard" upon examination on 3/31/18 by RPh. RPh (myself) was told patient that I was not overly concerned, as the rash is a possible side effect of the live vaccination. Advised patient to keep the rash covered and away from any persons who may be immunocompromised. Advised patient that if rash does not show any improvement for another week she should follow-up with a physician for further evaluation. However, patient did state that rash has been improving.
Hashimoto's disease; Painful, cold, purple feet; Painful, cold, purple feet; Painful, cold, purple feet; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported), as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced Hashimoto's disease (medically significant) on an unspecified date with outcome of unknown and painful, cold, purple feet (non-serious) on an unspecified date with outcome of unknown.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow-up.
slight fever; nausea; feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired). At the time of the report, PYREXIA (slight fever), NAUSEA (nausea) and FATIGUE (feeling very tired) had resolved.            no treatment and concomitant medication reported.   This case was linked to MOD-2021-004903, MOD-2021-004903 (Patient Link).
2 weeks after the first dose I presented asking rash in both hands, first on the dorse and days later on the palms. the bumps on my palms are bigger and more sensitive and are located were I articulate my fingers.
Father reported that 5-6 days after immunization patient began having hives on legs, sore throat, temp of 101 degrees; Treated with Amoxicillin and Benadryl at Dr's ofc/ walk-in clinic.
Couldn't walk for first 2 days after whole body felt like Charley horses, weak and short of breath . Stayed short of breath and weak until  1/11/2022. This day he went into  cardiac  arrest and died.
Got Covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got Covid) 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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Got Covid). At the time of the report, COVID-19 (Got Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, SARS-CoV-2 antibody test: present (Positive) Present.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of COVID-19. The event occurred approximately 6 months after the second dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.; Sender's Comments: This case concerns a patient of unknown gender and age with no relevant medical history, who experienced the non-serious adverse event of special interest of COVID-19. The event occurred approximately 6 months after the second dose of mRNA-1273. The rechallenge was assessed as not applicable since the AE occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. The information regarding the vaccination dates is incomplete so lack of efficacy situation cannot be properly assessed.
My armed burned when I got shot for about 5 minutes. I got the shot at 2pm on Monday. Monday night my arm was red and sore but nothing worth worrying about. Tuesday morning, I woke up with a very red, swollen, tender arm that was hot to touch. I also felt tired and generally not well. I knew these were symptoms that were common. By Tuesday night, the symptoms on my arm were getting worse. I was in pain and the redness was growing. By Wednesday morning it was the size of my open hand. I went to the doctor and they suggested putting ice on it and taking Tylenol. It should go away in a few days. By Wednesday night, it was extremely red and growing. It is now Thursday night, the redness, swelling and pain are going down, especially in the middle. The outer areas are still very red. The pain comes and go. It is not as hot. I get headaches on and off.
Pt is a 40 y.o. male who is presenting today for his COVID-19 vaccination. Patient had requested the Janssen (J/J). Patient required to wait 15 minutes after injection to monitor for adverse events. Injection given at 0800  Approximately 15 minutes after injection (0814) patient reported that he had slight tingling/burning sensation in his left arm( arm he received the injection). Radiated from injection site down to elbow, as well as injection site to the posterior side, slightly inferior to his left shoulder blade. Pt was pulled back and vitals acquired and were WNL.Pt asked to stay for additional 15 minutes for a 30 minute total wait time.  0822 Vitals checked again d/t patient complaining of some chest "heaviness." Reported it felt like approximately 50% heaviness. Vitals WNL. Denied dizziness or headache. No longer was having burning sensation in his injection arm. Chest heaviness was worse with lying down, reported it at 100% heaviness. Pt reported that "I'm trying not to freak myself out right now. RN, consulted with APRN, discussed that if he was having any kind of chest heaviness that the ER would be the best option. RN discussed this with patient and he declined the ER due to expenses. He was open to waiting with us for another 15 minutes.  0825 Vitals checked again. WNL. Chest heaviness continued. Patient was then sat back up d/t it being worse with lying down. Denies radiating pain between his shoulder blades. PA was consulted after this. PA agreed that chest heaviness should be evaluated in the ER. Patient declined going to the ER.  0830 Vitals checked again. WNL Patient continued to have chest heaviness. PA then seen patient, listened to heart and lung sounds as well as pulses. Reported that everything sounded clear. Pt agreed to wait for an additional 15 minutes.  0845 Vitals checked again. WNL. Pt reported that his chest pressure is at 5-10% heaviness now. Discussed with PA. Will recheck in 5 minutes.  0850 Vitals checked again WNL. Continued to have the same level of chest heaviness as previously reported at 0845. I informed patient that since he was still having some chest heaviness that it would be the best option to go to the ER for a work up, including EKG. Patient did not feel that his chest heaviness was enough for the ER and declined visiting the ER. Patient was asked to sit until 0900.  0900 Vitals checked again. WNL. Informed patient that if he has any increase in chest heaviness, headache, vision changes, numbness/tingling in arms, radiating chest pain, that he needs to be evaluated in the ER. Pt was understanding. Pt was then free to leave.
Her arm is all red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her arm is all red at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), OXYCODONE and ACETAMINOPHEN for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Her arm is all red at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Her arm is all red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.
Information has been received from a physician via a company representative referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were unknown). On an unknown date, the patient developed an "injection site reaction after the PNEUMOVAX 23 injection was given". No product quality complaint (PQC). The outcome of the event was unknown. The causal relationship between PNEUMOVAX 23 and the event was unknown. Additional information has been requested.
Extreme Body Aches, chills - started in the evening of 11/29  Headache, fatigue - started about 3 hours after shot
This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age. On an unknown date, the patient was vaccinated with PROQUAD, subcutaneous. On an unknown date, the patient older than 12 years of age was administered PROQUAD. It was inappropriate age for administration of vaccine. No adverse events were reported. Additional information has been requested.
Developed rash over all limbs and entire torso. Extremely itchy and red. Second vaccination 3/23/21: rash erupted into open sores, still extremely itchy. March 27th, left ankle and left foot swelled and skin ulcers appeared. April 7th, saw PCP; referred to Dermatology. Saw dermatology April 8th.  Currently on Prednisone, Keflex (staff infection at ulcer sites) and Hydroxyzine.
Felt very sick; Diarrhea; Couldn't get out of bed; Headache; Severe fatigue; Nausea; Fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache) and FATIGUE (Severe fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Reporter stated patient had COVID-19 on July 28.) on 28-Jul-2020.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache), FATIGUE (Severe fatigue), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 28-Dec-2020, MALAISE (Felt very sick), DIARRHOEA (Diarrhea), SOMNOLENCE (Couldn't get out of bed), HEADACHE (Headache), FATIGUE (Severe fatigue), NAUSEA (Nausea) and PYREXIA (Fever) 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 provided. Additional treatment medications were allergy medications.   Reporter did not allow further contact.
father stated pt had react ot DTP given 19OCT93; stated pt whimpered thru the noc & awake w/fever of 103; crying excessively while had the fever < 3 hrs;
The night I received the first dose my heart was racing and beating really hard when I tried to go to sleep. This happened every night for at least a week. By the fourth day I was also having really intense, frequent palpitations. Every other hour or so my heart felt like it was fluttering or skipping a beat. After a couple days of palpitations I also started having intermittent chest pain. After a few more days of racing, pounding heart, palpitations and chest pain I decided to make an appointment with my PCP.
Confirmed case of COVID from at home Antigen test. Prescribed Paxlovid from primary care. Used CDC 10 day protocol for isolation and masking. Symptoms: sore throat, coughing, malaise, headache, and fever.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender, who on unknown dates, were vaccinated with a dose of VARIVAX (lot number, dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. Physician reported that "every patient she saw who had received VARIVAX testes negative for titers" (date unspecified). No specific patient mentioned. No treatment information was reported. At the time of report, the patients' outcomes were unknown. The relatedness for the patient's events was not reported for VARIVAX. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Information has been received from a nurse concerning a patient of unknown age and gender. Concurrent condition, concomitant medication and medical history were not provided. On 02-NOV-2016, the patient was inadvertently vaccinated with a dose of expired ZOSTAVAX 19400 PFU (lot # L028284, expiration date 28-OCT-2016) (strength, dose, frequency and route were not reported). No adverse effect was reported. Additional information has been requested.
Did not work well; Initial information received on 02-Oct-2021 regarding an unsolicited valid serious case received from a consumer (patient) via social media.  This case involves an unknown demographic patient who reported did not work well (vaccination failure) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication 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 at an unknown administration site for prophylactic vaccination and reported (unknown latency) did not work well (vaccination failure).  This event was assessed as medically significant.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.; Sender's Comments: This case concerns an unknown demographic patient who reported did not work well after vaccination with INFLUENZA VACCINE. The time to onset is unknown. However, there is no information regarding patient's condition at time of vaccination, immune status, vaccination details, event details and lab test confirming diagnosis or excluding alternate etiology. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Day after vaccine I developed fever 102.5, aches, chills, severe headache, nausea. 4-5 days later my lymph nodes became extremely swollen. Approximately 6.5 months later I became extremely sick, jaundiced and I was hospitalized. I was diagnosed with Autoimmune hepatitis.  Found in December, i am now diagnosed with breast cancer.
Systemic: Fainting but was quickly responsive. 911 attended but Patient left on own abilities-Mild, Additional Details: 911 responded and attended her but patient refused to be taken by them afterwards and left on own abilities when husband arrived to go with her.  Patient fainted but very quickly (may not have been completely fainted) recovered.  Initially pale but skin color recovered very quickly
This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. No concomitant medications, medical history, drug reactions or allergies were reported. On 12-APR-2017, the patient was vaccinated with expired dose of M-M-R II (dose, frequency, route of administration were not reported, lot # L009213, expiration date 17-MAR-2017). Medical assistant reported no adverse effects. Additional information has been requested.
01/20/22 presents to EC ED for "dry cough, fever and chills". PMHx of "HIV"