chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd Engerix-B & antibodies were checked 4-6 months p/3rd dose & there was no antibody; 4th does of Engerix-B was given in AUG90;
acute hypoxic respiratory failure; This literature-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      Concurrent medical conditions included Hypertension, Congestive heart failure, Atrial fibrillation and Lung cancer.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Acute hypoxic respiratory failure. It is unknown if an autopsy was performed. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ACUTE RESPIRATORY FAILURE (acute hypoxic respiratory failure) to be possibly related.    Treatment medications were not reported Concomitant medications were not reported  Company Comment: This fatal regulatory case concerns a 66-year-old, male patient with medical history of Hypertension, Congestive heart failure, Atrial fibrillation and Lung cancer who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The medical history and concurrent conditions remain as confounders. The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.   This case was linked to MOD-2021-371501, MOD-2021-371537, MOD-2021-371538, MOD-2021-371539, MOD-2021-371540, MOD-2021-371541, MOD-2021-371543 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Follow up received by safety 03-Nov-2021 included an Email with FTA received from SARA team and  contains significant information.; Sender's Comments: This fatal regulatory case concerns a 66-year-old, male patient with medical history of Hypertension, Congestive heart failure, Atrial fibrillation and Lung cancer who experienced the unexpected fatal event of ACUTE RESPIRATORY FAILURE. The event occurred unknown days after a dose of Moderna Covid 19 vaccine. The rechallenge is not applicable The medical history and concurrent conditions remain as confounders. The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.; Reported Cause(s) of Death: acute hypoxic respiratory failure
Received Td at 11 am. Approximately at 2 pm took 2 Aleve for discomfort. 30 minutes later had acute onset of rash on hands, feet and behind knees with itching noted. Patient called health department, to report event. it was noted that rash was spreading. Denied SOB.
Information has been received from a registered nurse referring to patient of unknown age and gender.  The patient's medical history, concurrent condition and concomitant medication were unknown. On unspecified date, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (dose and route unknown, lot # M035486, expiration date: 05-JUN-2019) for prophylaxis. The vaccine was stored in -1.5 degrees Celsius for 2 hours 53 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About 10 days after first Pfizer shot I developed red, itchy rash on left side of neck (same side as shot). It was improving then 2 weeks after second shot in other (right) arm it flared back up and worsened significantly. Bright red, itchy painful rash all over neck, red swollen eyes, rash patches on face, down arms and hands. Treated with antihistamines and cortisone ointment. Overall rash symptoms lasted about 6 weeks, while worst symptoms lasted several days. While not formally diagnosed with covid, I believe I had it Jan-March 2020 and the final symptom was a very similar rash on my neck. These are the only 2 times I have ever had such a rash. I have photos to share of you want to see them.
Woke up with a rash on trunk of my body. Rash also noted on my back and top of both thighs.  Woke up around 4 am with body aches/headache. I took 400 MG of Advil. Rash was not there at that time. Went back to bed and woke up around 730-740 AM  and noted the rash to my stomach. I took 1 Benadryl at that time, then itching got worse and took another Benadryl. Currently rash continues to be red and raised and the body aches/headache remain the same.  Placed call to medical clinic and left a message.
Patient fainted after receiving vaccines. He was treated immediately with placing in position to increase blood flow to head and given Apple juice to drink. Ice pack applied to bump on forehead.  Patient recovered quickly and was stable, ok to go home after approximately 15 minutes.
Eyes swollen and red since vaccine.  Swollen on second day after vaccine and went to DR thought it was pink eye.  They did Covid test and I was negative but been putting drops in eyes and still red.  One week after that I started having ringing in the ears.  Went to my primary health care provider but never thought about it being because of the vaccine.  Said that if it continued would need to see ENT.  Constant ringing and am seeing ENT today.
This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the right arm, on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient felt exhausted and like catching a cold and had fluid pouring out of his nose. His eyes was tearing and eye lid blew up on 2021. Everything happened on his right side and it lasted 4 days. He was told to take allergic medication. Outcome of the events was unknown  Information on the lot/batch number has been requested.
vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023; No adverse event; HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7172B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Apr-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 (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP Pharmacist reporting that Moderna Bivalent vaccines that were put it in the fridge, was administered to patients 1 month beyond Use by date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 11-Jan-2023/vial was administered to the patient on 06-Apr-2023).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The vial was initially stored in the refrigerator on 11-Jan-2023. The vial did not undergo any temperature excursions.  No treatment medications were reported.
This spontaneous report was received from a nurse regarding to a 30-year-old patient of unknown gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 30-NOV-2018 the patient was inadvertently administered a dose of ZOSTAVAX (lot#, expiration date, dose, frequency and route were unknown) instead of second dose of VARIVAX (wrong product administered) for prophylaxis. The patient had no adverse effects (no adverse event). The outcome of events was unknown.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 11-MAR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number R021055 with expiration date in 01-APR-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001838: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000965: US-009507513-1907USA000970: US-009507513-1907USA000959:
pt came in to pharmacy....req flu vaccine...pt filled out flu questionaire.....we adm flu vaccine...pt then indicates wanted covid vaccine (already had flu vaccine)....per our administrater we were instructed to give covid....
pressure on her chest; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST DISCOMFORT (pressure on her chest) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (pressure on her chest). At the time of the report, CHEST DISCOMFORT (pressure on her chest) outcome was unknown.            Concomitant medication details were not reported by the reporter.  The reporter stated her mother got something similar. The patient felt it in a dream that had pressure on the chest and was trying to get the pressure off.  Treatment details was not reported by the reporter.
got COVID; got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2022 17:30 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single and administration date 18Aug2021 (Lot number: 330258D) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COVID".  Clinical course: Patient stated she lost card but luckily took a picture of it. She thought they do not put that on there. That was the problem why did they not put that on. Patient stated yes for Prior vaccination (within 4 weeks) and when probed to confirm if vaccination was four weeks ago then stated, that was basically six month prior to this one and did not have any sore arm or anything (further not clarified). Just immediately got COVID so, that was bad.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient's 5 year old Daughter was vacinated with Chicken Pox vaccine in July to allow her to attend school in the fall. The patient had not previously had the chicken pox and got the vaccine strain of chicken pox from her daughter in early August. Patient was not warned that she could acquire chicken pox from her daughter after her daughter was vaccinated. Course of illness lasted longer than a month.
Approx. 12 hrs. after receiving vaccine I had a severe case of chills, followed by sweats and a fever of 101.
I had a very sore arm for 2 days.  I was mildly nauseated for a few hours until I ate supper.
Information has been received from a physician concerning a 70 year old female who was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) 2 years ago. Subsequently the patient developed shingles that was diagnosed by her dermatologist after having gotten ZOSTAVAX (Merck) on an unspecified date. The outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
After two days from receiving these shots, I found myself literally paralyzed from the waist up, unable to move my upper body especially arms and my hands. Was in bed for 24hrs until a roommate found me and helped me up. Subsequent issues followed intense pain (again mostly upper body), a fever and headache that lasted a day, now suffering from joint pain and fatigue. Can't even firmly hold a pen on my right hand to assume writing. Have intense and piercing pain o my back and hips, feels like I have sharp objects embedded into my skin especially in the joints area.
About 1 hour after receiving TRUMENBA started c/o headache, nausea, SOB, pale. Mom offered ibuprofen, fluids, rest. Patient fell asleep-awoke the next morning feeling ok and went to school.
passed out 2 days after the shot; Fever of 102+; severe chills; severe fatigue; soreness of arm; slept almost two full days; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 71-year-old administered in arm left on 20Aug2021 08:30 at single dose for covid-19 immunisation. Medical history included completed chemo for splenic lymphoma 2 months prior to this report. No covid prior vaccination and no covid tested post vaccination. There were no known allergies. Concomitant medications included gabapentin, pantoprazole and hydrochlorothiazide in two weeks. There was no other vaccine in four weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient experienced Fever of 102+, severe chills, severe fatigue (slept almost two full days, soreness of arm, and passed out 2 days after the shot (which also happened after my second dose) on 20Aug2021 16:00. Facility type vaccine was reported as in pharmacy or drug store. The patient underwent lab tests included body temperature: 102+ on 20Aug2021.There was no treatment received. The outcome of event was recovering.   The lot number for [BNT162B2], was not provided and will be requested during follow up
Developed tinnitus; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Developed tinnitus) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Developed tinnitus). At the time of the report, TINNITUS (Developed tinnitus) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that, patient did not have tinnitus prior to the booster dose or after the first two doses. He has no other reason to have tinnitus. No treatment medication information was provided.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed on 7/13/2021 at a pharmacy. Case investigation interview with patient has not be conducted as of the time of this note.
1 hr after receiving FLUMIST/ pt developed facial numbness, chest and throat tightness with pain and wheezing
Very lethargic,  lightheaded,  sleeping a lot . On the third day of this now!
stopped producing testosterone; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A Non-contactable consumer(patient's parent) reported for a male patient (reporter's son) that: A 19-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was unknown) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stopped producing testosterone on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L045117, expiration date: 06-OCT-2018; dose and route of administration were not provided). The vaccine was exposed to temperature of 32 degrees Fahrenheit for 4 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
abdominal pain, diarrhea, nausea, flank pain, dizziness
Injection day slightly sore as expected. Soreness at injection site for 2 days; mild. Day 7 after injection , started experiencing intense itching at injection site, as well as red flat rash and swelling.  New tenderness where swelling is occurring. Day 8 after injection, itching, swelling & tenderness are worsening.
body aches; Fatigue; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), FATIGUE (Fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-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 PAIN (body aches), FATIGUE (Fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN (body aches) had not resolved and FATIGUE (Fatigue) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
The pt experienced a raised red rash with warmth and tenderness at the central area of fine clustered bullae.
positive COVID  Test; positive COVID  Test; This is a spontaneous report from a contactable consumer (Patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose number, unknown, single for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced positive COVID test on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date.  The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist concerning a 65 year old female who on 19-MAY-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 19-MAY-2011 the patient experienced large localized reaction in her arm and underarm after receiving ZOSTAVAX (Merck). Right or left arm was not specified. She was advised to go to her physician. It was unspecified whether the patient sought medical attention. At the time of the report, the patient's present status was unknown. Additional information has been requested.