chrisvoncsefalvay/vaers-outcomes huggingface dataset:
died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: Reporter mentioned (name withheld) died as well after the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300031962 same reporter/drug, different patient/event.;; Reported Cause(s) of Death: died
Radicular nerve pain extending from shoulder blade into the arm. Pain may be related to impingement at the level of the cervical spine. Treat w/Medrol dosepak & therapy.
Injection site redness, swelling, warm to touch and hurts; Injection site redness, swelling, warm to touch and hurts; Injection site redness, swelling, warm to touch and hurts; Injection site redness, swelling, warm to touch and hurts; patient with compromised immune status received bnt162b2; patient with compromised immune status received bnt162b2; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231), via an unspecified route of administration at the left arm on 16Jan2021 09:00 at a single dose for COVID-19 immunization. The patient medical history includes being diagnosed with allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She had COVID in Nov2020. She did not take any medication when she had it. There were no concomitant medications. The patient received the vaccine on 16Jan2021, and by that evening at 19:00, she started to have a reaction. She experienced injection site redness, swelling, warm to touch and hurts. She went to the doctor on 19Jan2021 and the doctor said it was a reaction from the vaccine. He gave her steroids (Prescribed Medrol dose pack). On 16Jan2021 09:00, a patient with compromised immune status received bnt162b2. The vaccine was administered in a hospital, not in military facility. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events injection site redness, swelling, warm to touch and hurts was not recovered.
Tested positive for COVID-19 after 2nd vaccination.  Son tested positive first and went to get tested.
Accidentally gave a patient a dose of 1ml instead of 0.5 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Accidentally gave a patient a dose of 1ml instead of 0.5 ml) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (Accidentally gave a patient a dose of 1ml instead of 0.5 ml). At the time of the report, ACCIDENTAL OVERDOSE (Accidentally gave a patient a dose of 1ml instead of 0.5 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 8/25/2021-9/16/2021. Death 9/16/2021. Vital records data not available yet.
flu like symptoms; headache; Shaky; pass out; feel faint; felt a bit achy; sweat; very weak; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 29Apr2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. at the age of 51 years old. The patient medical history was not reported. The patient was not pregnant.  Concomitant medication(s) included loratadine, pseudoephedrine (CLARIDIN-D) (medications the patient received within 2 weeks of vaccination). The patient previously took bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:30 AM (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced pass out, feel faint, felt a bit achy, sweat, very weak,shaky all on 30Apr2021 07:30, flu like symptoms and headache on an unspecified date. Reported as: I received my shot on Thursday afternoon. Friday morning, I woke up and felt a bit achy, but otherwise OK. I drove my daughter to school and in the car on the way, I began to feel faint. I pulled over, broke into a sweat, and proceeded to pass out in the drivers seat. My daughter called my friend who picked us up. I was shaky, and very weak. I went home, had fluids and slept for the remainder of the day with flu like symptoms and a headache. By Sunday, I was back to normal. Since the vaccination, the patient has not  been tested for COVID-19. The outcome of the events was recovered.   Information about lot/batch number cannot be obtained. No further information expected.
sudden onset April 2021 headache pressure in head ringing in ears - constant worse when lying down dizziness BP very high medication increased  then very low - all medication stopped 7/5/21
Patient states that the next day after she got the covid vaccine, the injection site turned red and blackish , about 2 inches round the area.
HIVES NEAR LEFT ELBOW 45 MINUTES AFTER RECEIVING VACCINATION.
Went to ICU with 4 blood clots  in the left leg from the hip-down; Pulmonary embolism; Unable to walk; Used to go to the bathroom (pee) 3-4 times at night; Not too well; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down) and PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included High cholesterol and Nerve pain. Concomitant products included ATORVASTATIN for High cholesterol, GABAPENTIN for Nerve pain, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well). The patient was treated with Surgery (To clear blood clots) for Thrombosis. At the time of the report, THROMBOSIS (Went to ICU with 4 blood clots  in the left leg from the hip-down), PULMONARY EMBOLISM (Pulmonary embolism), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inconclusive (Inconclusive) His lungs were clear.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the  2nd dose on 23rd or 24th of February 2021.   Patient reported being in ICU for 9 days and in acute care for 2 days. Prior to the surgery to clear blood clots, the Eliquis was stopped, had staples, put tubes through for the surgery and was put back on Eliquis afterwards.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Second dose after day 42; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose after day 42   ) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose after day 42   ). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose after day 42   ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Fever, headache, body chills, body aches, fatigue, and swollen right side supraclavicular lymph nodes.
offender was given 2nd dose 22 days after 1st dose.   Offender denies adverse side effects.
After receiving the vaccine I felt HOT, JUST NOT RIGHT.  IT WAS ABOUT 30 MINUTES DRIVING HOME WHEN MY THROAT SWELLED UP. DIFFICULT DRINKING,  MY BODY BECAME VERY ITCHY. I PULLED OVER TOOK A BENADRYL.  MADE IT HOME AND TOOK 2 MORE BENADRYL. FOLLOWING DAY I FELT SO DIZZY, WEAK STILL ITCHY WITH SWOLLEN THROAT I TOOK 2 MORE BENADRYL THAN ABOUT 2PM I HAD TO WAKE UP TO PICK MY DAUGHTER FROM SCHOOL JUST FROM WALKING DOWN THE STAIRS I BECAME SO DIZZY, MT FACE WAS FLUSHED. HAD NO CHOICE BUT TO CALL AN AMBULANCE AT THE HOSPITAL THEY GVE ME A EPIPEN FEW HOURS LATER SENT HOME. 3 DAYS STRAIGHT MY THROAT STILL SWOLLEN, FATIGUE JUST NOT MYSELF. BUT I CANNOT SEEM TO GET ANY HELP.  MY PRIMARY CARE DOCTOR DOESNT KNOW ANYTHING SHE IS CONSTANTLY GOOGLING EVERYTHING.  I CANNOT TRUST WHAT SHE SAYS AS SHE DOES NOT SEEM VERY EDUCATED.  I NEED A NEW pCp . WELL ANYWAY I NEED TO KNOW WHAT I AM ALLERGIC TO AND IF IT IS SAFE TO GET THE SECOND VACCINE. ALSO HOW LONG ARE THESE SYMPTOMS SUPPOSE TO LAST BECAUSE I NEED TO GET BACK TO MY DAILY ACTIVIES AND WORK BUT DOING BASIC CHORES ETC WIPES ME RIGHT OUT. I NEED GUIDANCE ASAP
The night of or next morning of receiving the shot. The injection site was swollen and painful. It was painful to raise my arm above my head. That went away within 24-30 hrs. 11 days after receiving the vaccine I noticed I had a rash 5 inches long and about 3 inches wide. I could have had the rash earlier, but did notice it until I subconsciously started scratching it. After realizing what it is, I have stopped myself from itching it further. It is now 12 days since taking the vaccine and I still have the rash-- it has not completely gone away as of 5/19/2021.
patient received a pediatric dose, should have received an adult dose. Mother was present and notified.
My son was given his 2 month  routine Vaccines which included the Rotavirus. This was done on Wednesday May 6, 2009 about 10:30am. On Friday about 3 pm my son awoke from his nap, and had more hoarseness, some audtory wheezing and a cough that sounded loose as he wanted to clear his throat. Although his breathing continued to be with in reason, NO retraction or change in skin color, his father and I are watching him closely.
3 mo old infant immunized 6MAR90 @ 11:30AM later evening mother reported afebrile, pale, lethargic, refustd to eat, having difficulty awaking.  Taken to ER.  Exp a couple of seizures. Hospitalized at time of this report.
Patient received the Moderna vaccine on 03/05/2021. Patient stated only experienced some soreness and fatigue after receiving the vaccine. Patient was 17 years old at the time of vaccination. No adverse reactions were noted as a result of receiving the vaccine.
Severe diarrhea, severe dehydration, high fever, muscle and joint pain, vomiting, extreme weakness, headache, redness at injection site, swollen injection site, extreme soreness and tenderness at injection site and at portion of arm between shoulder and elbow, disorientation, confusion, loss of short term memory, cough, and minor chest/lung pain.  Called doctor at onset of symptoms (diarrhea was the first symptom experienced approximately twenty one hours post vaccination).  Was told that was not a likely symptom of an adverse reaction to a vaccination.  Was not offered any help or assistance as doctor was moving his office.  Called doctor on call on Friday, July 27.  Was offered sympathy, but nothing more.  Patient self treated with motrin and two Phenergren tablets supplied by a friend (one taken the evening of 7/25, the second taken the evening of 7/26).  At time of vaccination, no consent form was signed by patient, none was offered by doctor, nor was any description of any adverse effects of vaccination given by doctor to patient.  Patient has lost ten pounds since onset of symptoms.
No Adverse Event; Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) and NO ADVERSE EVENT (No Adverse Event) in a 79-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Dec-2022, 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 19-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 Bivalent were administered BUD (17Dec2022) on 19Dec2022) 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 did not provide any causality assessments.   No concomitant medications were reported.  It was reported that Moderna COVID-19 Bivalent were administered with BUD 17-Dec-2022 (lot number 019H22A) on 20-Dec-2022 to 3 patients and BUD 16-Dec-2022 (lot number 015H22A) on 19-Dec-2022 to 4 patients.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-692428, US-MODERNATX, INC.-MOD-2022-692431, US-MODERNATX, INC.-MOD-2022-692432, US-MODERNATX, INC.-MOD-2022-690257, US-MODERNATX, INC.-MOD-2022-692423 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692428:same reporter US-MODERNATX, INC.-MOD-2022-692431:same reporter US-MODERNATX, INC.-MOD-2022-692423:same reporter US-MODERNATX, INC.-MOD-2022-690257:same reporter US-MODERNATX, INC.-MOD-2022-692432:same reporter
Positive covid test after 1st dose; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive covid test after 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 12-Jan-2021, the patient experienced COVID-19 (Positive covid test after 1st dose). At the time of the report, COVID-19 (Positive covid test after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information provided
About day nine after the first dose, I had a very quick onset of diverticulitis that hospitalized me for five days.  I had some bouts with it before but nothing that had come on so suddenly.  I have had an elevated immune system in the past and it felt like my body just went into an attack mode and previous location for diverticulitis was impacted.  It is important to note that my diet had changed to no red meat two years ago and I had no occurrences of DV and was feeling much healthier from a GI perspective.  Also, and of equal importance, is that following the second dose at about the exact time frame I got the normal post vaccine symptoms (headache, slight fever, etc.).  That nine-ten day mark is what is making me curious given my immune system.  Thanks.
Initial information received from another manufacturer on 23 December 2013. This information was received from a healthcare professional (pharmacist). A 60-year old patient of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of Meningitis vaccine from unknown manufacturer (Route, dose number, lot number and anatomical site of vaccination was not reported) on an unspecified date. On an unspecified date after vaccination, the patient developed severe itching on unspecified areas of body. Laboratory investigations were not reported. The patient was treated with unspecified antihistamine injection. On an unspecified date, the patient had recovered from the event. Documents held by sender: none.
CHILLS AND LOW GRADE FEVER OF 99.4, TOOK IBUPROFEN AS DIRECTED
APPROXIMATELY 3 DAYS AFTER RECEIVING THE SHOT I BEGAN TO EXPERIENCE PAIN IN THE RIGHT SIDE OF MY NECK WHICH WORSENED AND EXTENDED DOWN INTO THE RIGHT SHOULDER BLADE AND THEN TO MY RIGHT ARM AND CONTINUED DOWN INTO MY RIGHT LEG.  THE PAIN HAS CONTINUED FOR OVER ONE MOTH NOW.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Woke up 1/9/2021 Saturday morning around 0700 with stabbing pain in my left chest/underarm area whenever I took a deep breath.  No other symptoms. No fever no real shortness of breath only when inhaling deep and exhaling.  Continued as a dull ache in the background.      I was due for my 2nd covid vaccine which I proceeded to get at 1045am on 1/9/2021.  The pain continued as a dull ache in the background.   I took Ibuprofen 600mg and then later took a Pepcid 20mg.   No real change with the pain and by 3:30pm in the afternoon it was starting to get worse so I when to ER.  All tests were normal, I was diagnosed with Pleurisy but no cause was identified.  Have taken Aleve  2 x a day for 3 days and tylenol as needed.  I self scheduled a covid test 1/11/2021 which was negative.  on 1/12/2021 I still have mild pain but it has slowly improved but has not resolved as of this date 1/12/21  Still no other symptoms.
Copied from e-mail received Parent: When I went to give the one, it had chunks of white floating in it, that did not dissolve with agitation.  The others had white sediment in them, as I agitated them, it swirled but was cloudy.
I had many of the usual side effects, including severe headache, body aches, chills, fever.  I am reporting this only because my fever spiked all the way to 106.1, before receeding.  This was the second dose of the moderna vaccine.  The first shot I had no side effects at all, aside from a sore arm.
Severe soreness at injection site started 3 hours after injection lasting to 18 hours after injection (3->18), swelling at injection site (3->18), general malaise and joint aches (6->18), headache (12->18), feeling of being cold (12->15), feeling of being very hot but without fever (15->18), unable to fall asleep until finally medicating with ibuprofen 800 mg 18 hours after injection. Day two arm soreness reduced down to manageable levels with ibuprofen. No significant symptoms day three.
headache, body ache, soreness, eyes hurt, respitory limitations, chill and sweats
Pt was given Hep A when the vaccination schedule calls for a Hep B. No reports of adverse effects. Pt will need to receive his Hep B at next visit to meet the recommendations.
Rheumatoid arthritis flare up; Inflammation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4460443-00 (Company).  A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in 2022 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), in Feb2022 as unk (citrate free) (Batch/Lot number: unknown) subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLAMMATION (non-serious) with onset 2022, outcome "recovering"; RHEUMATOID ARTHRITIS (medically significant) with onset 2022, outcome "not recovered", described as "Rheumatoid arthritis flare up". The patient underwent the following laboratory tests and procedures: X-ray: (2022) Inflammation, notes: Inflammation. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for Humira (adalimumab): The reporter's causality for the event(s) of inflammation and occasional rheumatoid arthritis flare ups was not provided.  Causality for Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter considered "rheumatoid arthritis flare up" and "inflammation" related to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events rheumatoid arthritis flare up and inflammation and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient experienced a fever, with gradual increased in temperatures, peaked at 105.3 degrees F. Acetaminophen 650mg PO to reduce fever.
Had healthy kidney function as of 2017 with eGFR at 98.  Recently diagnosed with IGA Nephropathy with possible link to Pfizer Covid 19 vaccines.  eGFR currently 38.  No kidney disease in family history.