chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. On 12-SEP-2017, the patient was vaccinated with an expired dose of VARIVAX 0.5 ml, once, subcutaneously, lot number L002216, expiration date 21-JAN-2017, for prophylaxis. Concomitant therapies included a sterile diluent (lot number M001834, expiration date 08-MAR-2018), which was used to reconstitute the vaccine. At the reporting time, no adverse effects were reported.
in July she contracted lyme disease; This spontaneous case was reported by a consumer and describes the occurrence of LYME DISEASE (in July she contracted lyme disease) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2OA) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced LYME DISEASE (in July she contracted lyme disease) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, LYME DISEASE (in July she contracted lyme disease) had resolved.            No relevant concomitant medications were reported.  Patient was treated with antibodies for 10 days and recovered from the event.  Lot number for First dose is 01 (2 or Z) L20A, however caller was not sure if it was a 2 or a Z.  Patient stated it was "dexaciclin" or something like that, but was not sure on what the name was.  Company Comment: This case concerns a  71 year-old female patient with no reported medical history, who experienced the unexpected event of Lyme disease. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a  71 year-old female patient with no reported medical history, who experienced the unexpected event of Lyme disease. The event occurred approximately 5 months after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This case, manufacturer control number 2015-0180667, received via Gilead, is a non-serious case of a patient who experienced: drop in oxygen level from 95 to 88%. The initial receipt date was 02 November 2015 and follow up information was received on 25 November 2015 (case remained non-serious). On 07 January 2016, upon medical review, the event of drop in oxygen level from 95 to 88%, was upgraded to medically significant per the safety physician. A full narrative has been generated below. This case, manufacturer control number 2015-0180667 is a report from a solicited Patient Support Program, referring to a 67 year old female patient. The other HCP reported the following event drop in oxygen level from 95 to 88% for this case. Medical history included: Current conditions: Pulmonary arterial hypertension, Asthma. Historical condition: None Reported. Historical drug: None Reported. On 19 October 2015, the patient received Ambrisentan 10 mg, QD (daily) for treatment of Primary pulmonary hypertension. Additional suspect products included: REMODULIN, ADCIRCA, TRACLEER and an Influenza vaccine. Concomitant medications included CYMBALTA, BONIVA, LIPITOR, SYMBICORT, Potassium, Furosemide, ACIPHEX, PLAVIX, SPIRIVA, Calcium + Vit D, XOPENEX, LASIX. On 26 October 2015, the patient's oxygen level dropped from 95% to 88% after switching from Bosentan to ambrisentan. The patient's physician was aware of the event and was monitoring the patient. Relevant laboratory/diagnostic tests included: 26 October 2015: Oxygen saturation: Dropped from 95 to 88%. Ambrisentan was continued. Drop in oxygen level from 95 to 88% was Serious with an outcome of unknown.
Patient presented to Hospital Friday morning 3/19/21 with severe dark black liquid stools. Stated has been going on for 2 days. Patient was admitted for dehydration and continued diarrhea and medical work up.
The patient developed a severe migraine headache approximately 8 hours after receiving the vaccine. It persisted for 4 days and she finally presented to the hospital ED for evaluation. She had a head CT scan and full neurologic examination and was discharged home on Percocet for pain control.
Felt sick to stomach, took usual medications with 400 mg. IB, went to bed.
27Nov90 pt vax w/ MMR; 10Dec90 devel low-grade fever + parotid swelling. seen by MD 11Dec90 w/ parotid and submandibular swelling w/ no fever. Mumps titer less than 1:8, repeat mumps titer on 21Dec91 was 1:16
The COVID-19 vaccine administered through vaccine administrator, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
Soon after the vaccination her arm is Red and hot; Soon after the vaccination her arm is Red and hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Soon after the vaccination her arm is Red and hot) and VACCINATION SITE ERYTHEMA (Soon after the vaccination her arm is Red and hot) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (getting allergy shot every week).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Soon after the vaccination her arm is Red and hot) and VACCINATION SITE ERYTHEMA (Soon after the vaccination her arm is Red and hot). At the time of the report, VACCINATION SITE WARMTH (Soon after the vaccination her arm is Red and hot) and VACCINATION SITE ERYTHEMA (Soon after the vaccination her arm is Red and hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
COVID vaccine was administered on day 35 of refrigeration, 5 days after fridge shelf life date. Patient denies any symptoms from vaccine.
Pt developed a large ( 8 inch diameter) swollen red area at the injection site and a fever of 102 F.
SUSPECTED COVID-19 INFECTION; SNEEZING; HURTING OF TEETH; SINUS PAIN; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 67 year old white, not Hispanic or Latino female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker and no alcohol use. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 205A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 10-APR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 22-MAY-2021, the patient started to have symptoms of coughing, fever, body aches, shortness of breath (subsumed under suspected covid-19 infection), sneezing, teeth hurt and sinus pain. She decided to take a covid-19 test and it came back positive (coded as suspected clinical vaccination failure and suspected covid-19 infection). She also stated that she lived healthy clean life. On an unspecified date, laboratory data included: Covid-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sneezing, hurting of teeth, sinus pain, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality compliant: 90000181578. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information was received from Central Complaint Vigilance on 03-JUN-2021. The following information was updated and incorporated into the case narrative: Product quality complaint number, additional reporter as contact, and narrative was updated accordingly.; Sender's Comments: V0:20210604940-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Approximately two days following both doses of Pfizer for my COVID19 vaccine (dates: 04/03/2021 and 04/24/2021) I experienced  a very unsettling and constant heart palpitation/flutter throughout the day and night for a few days. I also had what felt like acid reflux, which is not at all my norm and bought OTC medicine for that. Both resolved on their own. I did not report at the time because after asking friends and family if they experienced the same nobody else had. At the time, it was not prevalent in the media that this was a possible side effect but after consulting the COVID19 hotline for guidance about if I should get a booster (with the concern being I may have an even stronger response/ side effect to the third dose) they advised I should report it. I still don't know what is the best route for me to go with consideration to the booster as they said they could not give medical advice.
death-19MAY98;coroner says SIDS-unable to obtain death certificate d/t state privacy laws
A non-serious spontaneous report of we administered expired H1N1 was received from a health professional concerning a six-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Moderna COVID-19 Vaccine EUA Tenderness injection site, fatigue,headache,chills,muscle pain,nausea. Migraine lost two days of work because of the reaction.
Narrative: Pt reports developing dyspnea in february after receiving 2nd dose COVID vaccination. Went to ED March 28th diagnosed with PE and hospitalized for 3 weeks. This event was supposedly sent to VAERS by outside facility.
My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.) in an elderly female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE HAEMORRHAGE (My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (My elderly mother got the vaccine yesterday and today her eye had a hemorrhage.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment information was reported by the reporter. Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
So far:    8/17/2021. Same day as third vaccine shot- Bad Headache a couple hours after shot.  Ok w Tylenol then ok for a few hours and come back. 8/18/2021.  Day after, pain at injection site.  Fatigue 8/19/2021.  Fatigue, pain at injection site.
Patient presented to the ER with chief complaint of weakness and fatigue. He was diagnosed with COVID-19 pneumonia on December 11th, he spent 2 days in the hospital during which her received a course of Decadron and supplemental oxygen. He was discharged home on the 12/12/2021.   Patient returned 10 days later. In the ER,  the patient was hypotensive but improved.  Labs were significant for creatinine of 1.1, calcium 7.6, leukocytosis 13.26, hemoglobin 11.1, procalcitonin 0.23.  UA was negative for UTI and chest x-ray revealed interval stable patchy bilateral pulmonary infiltrates presumably acute distress disease.   Patient was started on empiric cefepime and vancomycin for hospital-acquired pneumonia.   Pt improved in strength during his hospital stay and weaned off oxygen. Pt's respiratory cultures did not have any growth and he remained afebrile and no signs of infection were evident, hence antibiotics were discontinued.
The morning after the vaccine, I experienced soreness in the left arm which subsided quickly. One week after first shot, I broke out in a rash on my arm that was about 3-4 inches diameter. I went to the doctor who gave me Prednisone (do not remember the dosage) which I took for 7 days. Had appt. with rheumatoid arthritis doctor, the rash had not gone away. I received a steroid injection.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 69.53. Concomitant products were not provided. On 27-OCT-2021, Excursion time was reported at 9:00 A.M and 10:00 AM with temperature as 29 and 32 degrees Fahrenheit, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-SEP-2021 and 05-OCT-2021, vial was moved to clinic on 27-OCT-2021. 2 and 4 vials were sent to clinic. Vaccine BUD date was 29-OCT-2021 and 04-NOV-2021. Vial was stored on cooler 1, on 27-OCT-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Have not been having regular periods anymore; Still have not had a period after receiving my last dose; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Epilepsy" (unspecified if ongoing); "Childhood asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: DEPAKOTE; FOLIC ACID; VITAMIN D [COLECALCIFEROL]. Past drug history included: Cephalexin, reaction(s): "known allergies: cephalexin", notes: known allergies: cephalexin; Bactrim, reaction(s): "known allergies: Bactrim", notes: known allergies: Bactrim. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: ER8737, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "have not been having regular periods anymore"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6208, Location of injection: Arm Left), administration date: 09Mar2021, when the patient was 38-year-old, for COVID-19 immunization, reaction(s): "have not been having regular periods anymore". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Have not been having regular periods anymore"; OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Still have not had a period after receiving my last dose". The events "have not been having regular periods anymore" and "still have not had a period after receiving my last dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of menstrual disorder, oligomenorrhoea.  Additional information: Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria- Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No. There were no other vaccines in four weeks. Other medications in two weeks: Depakote, Folic Acid, Multivitamin, Vitamin D. Ever since receiving her COVID vaccines the patient had not been having regular periods anymore. After her initial COVID vaccine she thought it could just be a coincidence but after she received her subsequent doses it was apparent that it was related. She still had not had a period after receiving her last dose & her husband & her were hoping to have another child. Her PCP had done lab work & found no abnormal hormone levels or other factors that would indicate any other issues or early menopause etc. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Device Date: 29Jun2022  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 75-year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200), intramuscular, administered in arm left, administration date 01Mar2021. Relevant medical history included: "Diabetic", start date: 2014 (ongoing), notes: onset: 7 years ago Doctor checkup every 3 months w/tests diabetes contracted with w/med approx. 1975.; "gallbladder surgery" (unspecified if ongoing); "hysterectomy", start date: 1973 (unspecified if ongoing). Family history included: "cancer lungs " (unspecified if ongoing), notes: Deceased; "multiple illnesses" (unspecified if ongoing), notes: age 84 deceased. Concomitant medication(s) included: TOUJEO taken for diabetes mellitus (ongoing); HUMALOG taken for diabetes mellitus; TYLENOL taken for sinus headache; AFRIN [OXYMETAZOLINE] taken for sinus disorder. She had received her first dose Bnt162b2 (Dose 1, Single; 09:20 AM; Batch/Lot: EL9261; Expiration date: May2021, Anatomical location: Left arm, Administration route: Intramuscular, administration date: 15Feb2021, for Covid-19 immunization. She received her second dose of Vaccine earlier than recommended (14 days instead of the recommended 19-42 days) which is Off-Label dosing. The patient experienced DIZZINESS (non-serious) with onset 02Mar2021, outcome "recovered" (05Mar2021), described as "extremely dizzy"; THIRST (non-serious) with onset 02Mar2021, outcome "recovered" (05Mar2021), described as "cotton ensided thirst". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, thirst. Additional information: Morning after second injection awake very thirsty and extremely dizzy. Mouth felt like it had cotton inside thirst and dizziness lasted 3 days. Dosser giving first injection entered date for second injection at 2 weeks instead of 3. not thinking that it was set at 2 weeks and went on and got second injection. The staff could not filled my paper original had me to prepare a second one they now the original date on my card.Follow-up (13Apr2021): This is a spontaneous follow-up report received from contactable consumer (patient). Updated information: Batch number, expiry date, route of administration was added for vaccine. Concomitant medications were added. Patient's medical history was added. Family history was added. New events (dizziness and thirst) was added. Laboratory test were added. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
34 weeks pregnant w/gestational diabetes (Due date 3/14/21); the following symptoms developed after reporting to CDC v-safe. Chills, body aches, fatigue, joint pain, headache
18 hrs. after injection I started to feel off,  24 hrs. after injection I was very tired, ached all over and started to run a fever, took a 3 hr. nap in the afternoon. Ended up going to bed very early that evening (7:30) I woke up in the middle of the night covered in sweat, a fever of 101.4 degrees.  I woke up at 10:00am the next day still running a fever but on 99.4 but still ackey and tired throughout the whole day. I took a short nap in the afternoon. I woke on the 3rd day after my shot and all I have now is a little soreness in my armpits, fatigue and aches are gone.
Shingles.  Open weeping sores on L side of head.  Received prescription for 7 day course of Valtrex (anti viral).  Sores scabbed over by end of 7 day prescription.  Shingles vaccine had been received 2 years prior.