chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He died from clotting in his lungs due to Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY THROMBOSIS (He died from clotting in his lungs due to Moderna vaccine) in a male 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 PULMONARY THROMBOSIS (He died from clotting in his lungs due to Moderna vaccine) (seriousness criteria death and medically significant). The reported cause of death was he died from clotting in his lungs due to moderna vaccine. It is unknown if an autopsy was performed.            Concomitant and treatment medications were not reported. Patient died in the hospital. He was forced to take vaccine. He died from clotting in his lungs due to vaccine.  Company comment: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the Fatal, unexpected serious (Death and medically significant) AESI event of Pulmonary thrombosis that occurred on unspecified day in context to a dose of mRNA-1273 bivalent BA.4/BA.5 vaccination. Vaccination dose number and vaccination schedule was not disclosed. The reported cause of death was he died from clotting in his lungs due to Moderna vaccine. It is unknown if an autopsy was performed. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, concomitant medication, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the Fatal, unexpected serious (Death and medically significant) AESI event of Pulmonary thrombosis that occurred on unspecified day in context to a dose of mRNA-1273 bivalent BA.4/BA.5 vaccination. Vaccination dose number and vaccination schedule was not disclosed. The reported cause of death was he died from clotting in his lungs due to Moderna vaccine. It is unknown if an autopsy was performed. No further information on risk factors, clinical course, relevant medical history, diagnostic investigations, concomitant medication, and treatment received were available for review. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.; Reported Cause(s) of Death: He died from clotting in his lungs due to Moderna vaccine
This spontaneous case, was received from other-non health professional on 13-Oct-2017, concerns a 68-year-old, elderly female patient. Since an unspecified date, the patient had allergy to latex, glutamate, and formaldehyde. On 13-Oct-2017, at 13:30 hours, the patient was administered with AFLURIA (dose: 0.5 ml, route of administration, anatomical location, batch number and expiry date: not reported). On 13-Oct-2017, 02 hours after the vaccination, the patient was flushed all over, felt dizzy, her heart was racing and had headache. The patient also experienced numbness in legs twice a day, which recovered in few days and she still experienced strong headaches. No treatment was given for the events. The patient inquired if there was anything in vaccine which could make her feel that way. The patient did not search for any medical assistance. At the time of this report, the patient had not recovered from the events (reported as symptoms persists) and recovered from the event numbness in legs. The reporter assessed the events as non-serious. Follow up report received on 18-Oct-2017: The new event numbness in leg was added. It was reported that, her leg started feeling weird (numbness), twice that day, which recovered after few days, she still experienced strong headaches and she did not search for any medical assistance. The narrative was amended accordingly. Significant case correction received 13-Oct-2017: HLT (high level term) of the event flushing was corrected to general signs and symptoms NEC from peripheral vascular disorders NEC.  Onset from the last dose of the event headache and dizziness was corrected to 2 hrs.
Discomfort in the back of both thighs, back of both knees and both calves (left worse than right).
This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Experiencing passing out or almost passing out whenever I stand up) in a patient of an unknown age and gender 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 information was reported. On 01-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Experiencing passing out or almost passing out whenever I stand up) (seriousness criterion medically significant), DIZZINESS (Severe with dizziness), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 100.6). At the time of the report, SYNCOPE (Experiencing passing out or almost passing out whenever I stand up), DIZZINESS (Severe with dizziness), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 100.6) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 (High) Fever of 100.6. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Syncope. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The patient experienced passing out or almost passing out whenever she/he stands up. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Sender's Comments: This is a Spontaneous case concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (medically significant) event of Syncope. The event occurred on an unknown date after the third dose of mRNA-1273 vaccine. The patient experienced passing out or almost passing out whenever she/he stands up. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (3 heart attacks) and Stroke.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.            No relevant concomitant medications were reported.  Treatment information was unknown.  Patient  was vegan for 10 yrs now. And use no oils in his diet."   This case was linked to MOD-2021-302607 (Patient Link).
10/18/02 provider saw pt at church event and noticed pt swelling, redness and pain in right arm. Pt started on Keflex. 10/21/02 provider saw pt in clinic. Pt reports fever and swelling was worse on Sunday. Redness improving swelling improving. Pt to continue on Keflex, ice and heat area.
Fever ranging from 99.6 to 101.7 and lethargy lasted about 24 hours
pt recvd 3 doses of Engerix-B for prevention of Hep B & had no response;
Large, firm, red circular spot at vaccination site. Lots of heat coming from the spot as well. Painful to touch and tender around the outside of the spot as well.  Began the next day and is still present with the circular area enlarging as the days pass. No other adverse symptoms, ie. headache, fatigue etc.
Woke up on 0/4/21 with nausea, vomiting and diarrhea, On 9/5/21 experienced bilateral hand numbness that lasted 5-10mn. She also states that she was unsteady. Was seen in the ED of 9/09/221 where she was experiencing abdominal cramping and handy numbness.
suspected vaccination failure; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shot a few years ago and had shingles a couple months ago, further stated it was no fun. The follow-up would not be possible as no contact details were available. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Chills, cold sweat, whole body shivers, then felt like I was burning up. No fever recorded.
Joints began feeling achy and body felt tired within a few hours of vaccination. About 10 hours later body began to feel warm and then within an hour began uncontrollable shivers and aching in testicles followed shortly after by a throbbing headache and pain behind eyeballs. I put on extra clothing and jumped into bed as symptoms persisted. Later in the night I began sweating profusely and removed the clothing. The headache and pain behind the eyes persisted. I also began feeling nauseous and almost vomited when I went to the bathroom. My body was so tired and achy I could barely move. I tried to wake up for work but my headache and pain behind the eyes was so bad I went back to bed for another four hours. I did not have any appetite for the rest of the day.  My headache subsided that afternoon and I went for a walk that night and my body still felt incredibly tired and achy. The pain behind my eyes persisted. The following day I felt somewhat better and could work. That night I went for a jog and my body felt extremely heavy, my joints ached, and I could not catch my breath. My symptoms continued to improve but I have had no sex drive for a week.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 24-JAN-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # N010706, expiry date: 02-DEC-2018) (route: oral) (incorrect product storage). The vaccine was exposed to a temperature of 9 Cº to 25 Cº (8.3Cº) for 1 hour 17 min, on 06-JAN-2018, 9 Cº to 25 Cº (11.5Cº) for 1 hour 59 min on 11-JAN-2018, 9 Cº to 25 Cº (15.6Cº) for 1 hour 33 min on 17-JAN-2018, 9 Cº to 25 Cº (11.9Cº) for 1 hour 2 min on 23-JAN-2018 and 9 Cº to 25 Cº (12.1Cº) for 1 hour on 30-JAN-2018. There was no previous temperature excursion. The call was because of a data logger. No adverse effects reported. The outcome of the event was unknown. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA004616: US-009507513-1802USA004629: US-009507513-1802USA002182: US-009507513-1802USA004692: US-009507513-1802USA004686: US-009507513-1802USA004673: US-009507513-1802USA004671: US-009507513-1802USA004663: US-009507513-1802USA004658 : US-009507513-1802USA004654 : US-009507513-1802USA004647 : US-009507513-1802USA004641 : US-009507513-1802USA004636:
PATIENT HAS A NEW HARD RED SWELLING STARTING TODAY AT SITE OF IMMUNIZATION (LEFT ARM)
Swelling of underarm lymph nodes of left arm. First noticed tenderness under arm on post vaccination day 1. Swelling noticeable on day 2 (Friday 1/15/21). Swelling still present as of 1/21/21, though reduced and no longer tender.
Redness in the area; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Redness in the area) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness in the area). At the time of the report, INJECTION SITE ERYTHEMA (Redness in the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
Vaccine Administration Error: wrong vaccine administered. Patient had two previous doses for Moderna COVID -19 Vaccine. Patient originally wanted an influenza vaccine. Patient experienced fatigue, nausea, vomiting, dizziness, headache and fever. Patient was seen at HCF. Final outcome unknown at this time.
injection site was painful and uncomfortable; fatigue/feeling of tiredness; nausea; chills; hot; pain in his arm of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old elderly male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot:Unknown),via an unspecified route of administration on 11May2021 as second dose, Single Dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine was bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration as 1st Dose, Single Dose for COVID-19 immunization Within 6-7 hours, on 11May2021,the patient experienced fatigue, nausea, chills, hot, feeling of tiredness, pain in his arm of injection ,injection site was painful and uncomfortable. The events resolved within 48 to 72 hours except for the arm pain which was still persisting. The outcome for the event pain in extremity was not recovered/not resolved, vaccination site pain was unknown and rest of the events was recovered/resolved.  No follow-up attempts are needed. No further information is expected.
discoloration; L 4TH/5TH MTP, R 1ST MTP burning sensation; Petechiae; This is a spontaneous report from a contactable other health professional (patient) in response to HCP follow-up letter sent in cross reference case. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202; Expiration Date: 30Jun2021), intramuscular, administered in arm left on 24Feb2021 06:50 as DOSE 2, 0.1 mg/ml SINGLE for (at the age of 45-year-old) COVID-19 immunisation. Medical history included known allergy of Sulfa, Kiwi and pineapple from Jun2010 and ongoing, sjogren's syndrome from Apr2018 and ongoing, raynaud's phenomenon from Apr2018 and ongoing. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for sjogren's syndrome from Oct2019 to an unspecified stop date; leflunomide taken for sjogren's syndrome from Jun2020 to an unspecified stop date; cyclosporine taken for sjogren's syndrome from Mar2019 to an unspecified stop date; nifedipine taken for raynaud's phenomenon from Feb2021 to an unspecified stop date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1284; Expiration Date: 30Apr2021), via an unspecified route of administration on 14Jan2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 15Jan2021, the patient had burning sensation and petechiae. On 15Jan2021, the patient was treated with Ibuprofen 600 mg TID (three times a day) PO (Per oral). On 07Mar2021, the patient had discoloration. On 27Jan2021, the patient had routine PCP visit and review Covid toes. On 25Feb2021 20:00, the patient experienced L 4th/5th MTP, R 1st MTP burning sensation and petechiae. On 07Mar2021, the patient had discoloration. It was reported that Nifedipine minimized pain, redness, swelling of toes. Burning sensation was not appreciated after 2nd Pfizer with nifedipine use. Enable wear shoes due to toe sensitivity, needing 1/2 size longer. Colour changes with sloughing skin affected toes with healing more than 76 weeks after each dosing. Therapeutic measures were taken as a result of L 4th/5th MTP, T 1st MTP burning sensation and petechiae (petechiae). The patient was treated with Ibuprofen for burning sensation/paresthesia. There was a reasonable possibility that the event was related to suspect product. Outcome of skin discolouration unknown and for all the other events recovering on an unspecified date.   No follow-up attempts are possible. No further information is expected.
. Caregiver for my 78 y/o  Day 1: 3/9/21 - low grade headache.  Day 2: 3/10/21 - headache stronger (took Tylenol); Day 3: 3/11/21 - debilitating headache. Couldn't work. Eyes hurt.  Headache felt like hammers hitting the side of my head.   I was so concerned I wanted to go to the hospital. The headache stopped around 2pm on March 11.   Day 5: 3/14/21 - face has welts on my left cheek (shot was in the left arm).
Pt presented to pharmacy 11:22, got 1st dose on Moderna vaccine, stayed 30 minutes after vaccine, no adverse effect at time of leaving pharmacy.  Say after 1 hour and about 15 minutes she felt a rash on her upper left shoulder, she took benedryl 50 mg.  Says her tongue felt tingly and called 911.  EMS arrived told her to take another Benedryl 25 mg as her meds were expired.  They checked her out and said she was in not breathing or other distress.  Pt says her itchy feeling lasted another "couple days".  She never took  more meds afterwards.  Came to pharmacy inquiring about risks of 2nd shot.
Fever; This case was reported by a physician via call center representative and described the occurrence of fever in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Z29K, expiry date 15th April 2022) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient started with fever 24 hours after receiving 1st dose of Shingrix. The healthcare professional would like to know if the fever was attributable to the vaccine or could it be associated with Coronavirus. The reporter consented to follow up.
Allergic reaction at site of injection, started approx 2-3 days after and worsening. Circular erythema, mild edema, itching, warmth. Seen at hospital urgent care 1/10/21 and prescribed MEDROL DOSE PACK and ice/heat regimen. Also instructed to take OTC BENADRYL.
7/16 - 7/19: 35-year-old G5P0312 at 37w2d by 8 week sono. Patient reported feeling significant vaginal and pelvic pressure getting worse over a few hours. She felt abdominal tightening, which she thought were contractions. Denied vaginal leaking or bleeding. Proceeded w/emergent C-section on 7/18. Baby delivered and healthy. Discharged home.
This case involves patient (unknown demographics) who experienced both times got sicker (illness), while he/she received vaccine INFLUENZA VACCINE. Medical history, medical treatment, concomitant medication, vaccination 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. On an unknown date, the patient developed a non-serious both times got sicker (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was also reported that both times got sicker than they have ever been, not getting another one. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. There will be no information available on the batch number for this case.
he tested positive for Covid-19; This is a spontaneous report received from a Pfizer sponsored program.  An unspecified age of male patient received first dose of bnt162b2 (BNT162B2; Formulation: Solution for injection), via unspecified route of administration on 18Mar2021 at single dose for covid-19 immunization. It was reported that caller (Patient Name) got his 1st dose last 18Mar2021 and he tested positive for Covid-19 last 26Mar2021 he is calling in today to know if he can take his 2nd dose on 8Apr2021. No unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was "unknown".  Information on the lot/batch number has been requested.
Patient is in her 3rd trimester of pregnancy. The day following receiving the BOOSTRIX vaccine, the patient's arm was sore. As days progressed, she began to experienced pain when moving her arm. She is having difficulty performing normal daily functions due to pain upon mobility.
1333-EE felt whoozy after receiving  first dose of vaccine.  HR 65 o2 96-97%; EE removed mask. 1335- EE refused snack and water; HR 66 O2 98-99 with mask off.  1338-HR 63 O@ 98; EE is talking, pink, alert, no distress noted,  EE denies itching, tingling in mouth and throat; 1339-EE reports still feeling whoozy, accepts water and popcorn.  EE reports NOT feeling dizzy or lightheaded but states if we ask him to do something complex that he would not be able to.  1342-EE declines EMS to ED or to go to MCN urgent care for further evaluation.  EE dc'd into care of friend.
Tingling sensation; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took valacyclovir (VALTREX) and experienced tingling sensation. On an unspecified date, the patient experienced tingling sensation. It was reported that the patient experienced tingling sensation a week and a half with valacyclovir before getting the vaccine. When the patient got the vaccination last Thursday and even after receiving the vaccine, the tingling started again. She's was asking if she can restart/retake the valacyclovir now that she had the vaccine. Outcome of event was unknown.  Information on the lot/batch number has been requested.
ever since the vaccine my spinal cord is hurting a lot this is from my neck all down to my tail bone. I can't even set for an hour. I need to get up and move.