chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intraparenchymal hemorrhage, right occiput; This is a spontaneous report from a contactable nurse (patient). This nurse reported that a 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) at the age of 76-years, via an unspecified route of administration on 04Feb2021 17:30 at single dose for COVID-19 immunisation, in hospital. Medical history included MGUS; thyroid nodule; hyperlipidemia; single episode A fib. Patient had no known allergies, no COVID-19 prior vaccination, no other vaccine in four weeks. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin; colecalciferol (VIT D3); cyanocobalamin (VIT B12); rivaroxaban (XARELTO). The patient historically received first single dose of BNT162B2 (lot number: EL3247) at the age of 76-years on 14Jan2021 05:45 PM for COVID-19 immunisation. On 09Mar2021, the patient experienced intraparenchymal hemorrhage, right occiput. This adverse event resulted in emergency room/department or urgent care, 5 days of hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Patient received XARELTO reversal and osmotic fluids to reduce brain s as treatments. The patient underwent lab tests and procedures, which included on 11Mar2021, COVID-19 test (Nasal Swab) was negative. Outcome of the event was unknown.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Case number PHEH2017US000760, is an initial spontaneous report received from a consumer on 05 Jan 2017. This report is also associated with a Quality Assurance number (QA Reference number: 1018884). This report refers to a 15 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: 185327, expiry: Apr 2017) at a dose of 0.5 ml intramuscularly on 08 Oct 2016. On 03 Jan 2017 after vaccination, the patient came home with high fever, chills and sweats. On 04 Jan 2017, the patient was tested positive for A strain influenza. The patient received treatment with TAMIFLU. It was reported that symptoms were much improved with no more fever. The outcome of the events high fever, chills and sweats was reported as complete recovery on 05 Jan 2017 and outcome of the event tested positive for A strain influenza was not reported. The seriousness and causality of the events were not reported. The seriousness assessment of the events influenza A virus test positive and vaccination failure was upgraded (medically significant) based on the information available in the source document. Batch review report reference number [1018884] received from quality assurance department on 17 Feb 2017. Based on the document review, it was stated that the concerned FLUCELVAX QUADRIVALENT batch number [185327] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow up information received from Quality assurance department on 17 Feb 2017: Added investigation summary.
310  pm after vaccine at 3 pm, itchy mouth,  throat and lips.  12.5 mg benadryl at 330 and by 340 she was fine.  7 pm patient had systemic itchiness and took 25 mg benadryl and felt better.  this am 1/14/2021 woke up at 6 amd and at 730 am she started itching .  Called office at 920 am.
pt had redness develop on her neck area the day after the imz and that turned into an itchy irritated rash all over her heck
Debilitating pain in groin area of both legs and not as severe pain in hands and arms. Continued for a few days. I had just completed a predisone Z-pak a few days before getting the vaccine.
Large lump, redness/inflammation 3" across at injection site. Soreness, fever. Have been taking EXCEDRIN for fever & inflammation. Still experiencing as of 10/5/99.
Vertigo started 3/20/2021.; I was extremely dizzy. This is still ongoing; I was extremely nauseated. This is still ongoing; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration in the left arm on 15Mar2021 at 09:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis) and hypothyroidism. Concomitant medications included unspecified medications within 2 weeks of vaccination. The patient was allergic to clindamycin, augmentin and adhesive. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been diagnosed with COVID-19, prior to the vaccination. On 20Mar2021, at 08:00, the patient had experienced vertigo, was extremely dizzy and nauseated. Therapeutic measures were taken as the result of adverse events, which included treatment with bonine, zofran, ativan and medrol dose pack. The patient underwent lab tests and procedures which included throat swab on 08Sep2020 and was tested negative. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as the result of adverse events. The clinical outcome of vertigo, dizziness and nausea was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. Approximately on an unknown date in 2013, the patient was vaccinated with a dose of PNEUMOVAX23 (Lot number, expiry date and route were not reported), 0.5 ml (reported as standard dose) in the arm. The patient had prior vaccination with PNEUMOVAX23 on an unknown date in 2012. Approximately on an unknown date in 2013, on the same day the patient was also vaccinated with influenza virus vaccine (manufacturer unknown) (Lot number, expiry date, route and dose were not reported) in the same arm. On 03-OCT-2013(also reported as 04-OCT-2013), the patient developed cellulitis in the arm that received these vaccinations. The patient sought medical attention with the practice where the shot was administered. Unspecified treatment was provided. The outcome of developed cellulitis in the arm was unknown. Additional information has been requested.
Covid arm, developed overnight. Redness, raised, slightly itchy, sore, and worsened through the course of day and into next day in terms of redness and soreness. Been icing it.
This spontaneous report as received from an office manager refers to a patient. On approximately 04-OCT-2012 the patient was vaccinated with a recommended 0.5 ml dose of PNEUMOVAX23 (Lot# and route not reported) co-administered with high-dose of FLUZONE which was indicated for the patient's aged 65 year old in either arm respectively. On 05-OCT-2012 the patient experienced redness and swelling in both wrists. The patient sought for unspecified medical attention. No lab diagnostics studies were performed. Redness and swelling in both wrists did not improve. At the time of this report the patient had not recovered. Additional information has been requested.
Rash around vaccine administrated area starting from 08/03/2020  swelling and redness  Observation with no special treatment
Pt received varicella on 12 Jun 2012. Pt returned to clinic on 14 Jun 12. Pt states area on (L) arm is red, and area has gotten bigger. Large redness noted on (L) arm. Warm to the touch. Pt states area itches. Pt denies any trouble breathing or SOB. But did have some wheezing about 4 hours after vaccination and extreme tiredness.
Patient was given a dose of vaccine that was past it's expiration date. Vaccine expired on 3/31/22- dose was given on 4/1/22.
Info has been received from a pharmacist concerning a male pt who was vaccinated with a dose of MMRII. Subsequently, the pt developed attention deficit disorder as a result. Unspecified medical attention was sought. No product quality complaint was involved. No additional info was provided. Additional info is not expected.
Patient received Moderna COVID19 vaccine on 2/11/21 and 3/11/21. Presented to ER on 1/1/22 and was found to be COVID positive.  presents to hospital with a ~ 3 hour history of nausea with vomiting accompanied by abdominal pain primarily in the LLQ and suprapubic regions.  She reports having had a single episode of diarrhea.  While in the ED she is noted on CT AP to have a small bowel obstruction with possible developing ischemia. Placed on dexamethasone and dexamethasone. Discharged on 1/12/22.
not feeling too well; fever; headache; body aches; shortness of breath; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (not feeling too well), PYREXIA (fever), HEADACHE (headache), PAIN (body aches) and DYSPNOEA (shortness of breath) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling too well), PYREXIA (fever), HEADACHE (headache), PAIN (body aches) and DYSPNOEA (shortness of breath). At the time of the report, MALAISE (not feeling too well), PYREXIA (fever), HEADACHE (headache), PAIN (body aches) and DYSPNOEA (shortness of breath) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2022 at 09:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high Cholesterol" (unspecified if ongoing); "migraines" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Paxlovid for treatment of COVID-19 on 11Apr2023.  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-202300154632 same patient, different drug/event;US-PFIZER INC-202200035067 same patient, different vaccine dose /event;
A non-serious spontaneous report of flu-like symptoms, vomited once or twice, fever (maximum of 105.3 F), and macular rash has been received from a physician (also the patient's parent) concerning a four-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient's older sister had recently recovered from a viral respiratory infection. The patient received a single dose FLUMIST the evening of 28-Sep-2009. On19-Sep-2009, the patient experienced flu-like symptoms of aching, sore throat, cough, congestion, and decreased appetite. During the next six and half days, the patient also experienced vomiting once of twice, fever (maximum was 105.3 F) and a macular rash on 25-sept-2009. All events resolved by 26-Sep-2009. The reporter assessed the flu-like symptoms, vomited once or twice (maximum of 105.3 F), and macular rash as not related to FLUMIST, but rather to the combination of viral exposure in the home environment and then the vaccine. Additional information received on 22-Feb-2010 and incorpaorted into case: lot number.
Feverish and chills; every joint in the body hurt, headache, general malaise, redness and swelling of injection site which looked like a first degree burn which felt hot to touch which started at 0500 10/16. On 10/17 symptoms included continuing pain and redness at injection sight, no fever, some joint pain but to a lesser extent
The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023; no adverse event; The patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023) and NO ADVERSE EVENT (no adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Mar-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 (The patient received expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023).    No concomitant medications was reported.  The vial size was 2.5 mL. The vial was initially stored in the refrigerator on 10-Feb-2023. The vial did not undergone any temperature excursions. Moderna bivalent was set to expire on march 12 and 5 patients were administered the vaccine. The pharmacist confirms that 5 patients received expired doses. Dose administered after 30-day Use By Date.    No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719094 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719094:same reporter
Gave Moderna to a 14 year old on 08/24/2021.  Called Covid vaccine provider line and was instructed to give 2nd dose as pfizer.  Call to father who is aware.  Second dose given was Pfizer.  No adverse reactions with either dose.
Body aches,  fever,  nose blister,  headaches  swollen and arm diarrhea.   0n 3/2021 I statdetedbtonget pain on my left foot and calf.   I went to the hospital and on 3/22/2021 I had a ultrasound and the results showed that I have a blood clot.
I was throwing up all of Friday, had chills, fever, dizzy, weak, and exhaustion.  These symptoms lasted all day Friday.  I could barely get out of bed.  Saturday I was still dizzy, body was weak but no more throwing up.  The effects lasted until Sunday but my stomach is still having issues and still a little weak.
Information has been received from a nurse concerning a 21 year old female who on 08-OCT-2007 was vaccinated with a dose of Gardasil (lot # 657005/0314U). Concomitant therapy included hormonal contraceptives (unspecified). On 08-OCT-2007 the patient experienced redness, swelling and water blisters around the injection site. The patient's status was not reported. There was no product quality complaint involved. Additional information has been requested.
pt recvd vax; fever 101 by 3:30pm; given apap; by next day, only sl fever; won/t stand on leg & must be careful lifting pt;
Pt experienced extreme syncope after receiving immunizations. Pt vomited once after immunization. Pt was put in Trendelenburg and given juice and crackers. Pt was unable to recover and was sent to the emergency room by ambulance. The EMTs gave him a fluid bolus and transported him to the ER. The ER monitored him and gave him two sandwiches. Pt was discharged.
Starting 2 day after vaccine I woke up with pain in my arm, it feels like both arms are falling off my body, they felt just numb. The left arm was more sore than the other. My legs and knees are also hurting, I run 3 times/week. I can't feel the bottom of my feet so I am stumbling around. Less severe on the left leg. My arms are a little more numb than my legs. My neck is also hurting as of this morning, 07/12/2021. There is a sharp pain in my leg when water hits it in the shower, If I sneeze cough or swallow, pain goes down my neck. I cannot make my feet do what I want them to do. If I lift my neck, pain goes down the back of my neck; this has been every day since 2 days after vaccine. I have been taking all kinds of OTC pain medication. Has never received any other vaccines.
Tested positive for Covid after completing a two dose series of the vaccine; Tested positive for Covid after completing a two dose series of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Tested positive for Covid after completing a two dose series of the vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
stiff neck on right side extending down to shoulder  started on 1/25/21 upon waking in morning and still stiff today 1/27/21
Consistent pain in arm/muscle structure when raising arm. Also when bending/twisting arm slightly in directions, including backwards.   Difficulties sleeping on that side, changing cloths, exercising,   When these actions occur the pain is recognized as nerve pain. (Feels like)
The injection was done much higher than normal into my right shoulder and I firmly believe that instead of going into my deltoid, the nurse incorrectly injected the vaccine into my shoulder bursa, causing soreness in the joint, swelling, and pain when trying to move shoulder in certain directions. (Shoulder Pain After Vaccine Injection SIRVA).
ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI 6/20/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Headache 30 minutes after injection. Fatigue and muscle aches within 5 hours that lasted 24 hours. Chills 10 hours after injection that lasted 24 hours.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Palpable 2.5 cm Nodule at Injection Site; Redness at Injection Site; Pain at Injection Site; Initial Report Received on 26-Aug-2022  A physician's assistant reported that a 27 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed redness, pain and a palpable 2.5 cm nodule at the injection site.  Medical history was reported as Crohn's disease, immunocompromised, and open sores on legs and body. Additionally, medical history reported the patient currently had a draining wound on leg. Allergies were reported as an unknown reaction to amoxicillin and penicillin.  Medications at the time of vaccination were reported as a "biologic for Crohn's".   On 19-Aug-2022, the patient received the first dose of HEPLISAV-B (Lot # 937780, expiration date 14-Sep-2023 and NDC # 43588-003 [partial]) in the right deltoid.  On an unspecified date, after having been vaccinated with HEPLISAV-B, and "two weeks" before the date of the report, the patient developed redness, pain, and a palpable 2.5 cm nodule at the injection site. The redness was reported as "gone" on the day of the report. The pain and the nodule were reported as ongoing.   A registered nurse also reported that the pain and redness were resolved, however the nodule was ongoing.   No additional information was reported.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Palpitations and increased pulse rate (40%) for days 7-11+ (still ongoing) post vaccine, mainly in the evening Diarrhea for days 7-11+ (still ongoing) post vaccine
fever and disseminated varicella lesions after vaccine. advised calamine, supportive care. may use bactroban if skin breakdown. possible immundeficieny--immunology referral created.
Covid19 vaccine (Pfizer): Pt was employee receiving second dose of vaccine. Per report to had reaction to first therefore premeditated with 25 PO benadryl prior to shot. Pt received shot at 13:40. Around 13:44 pt felt right face and neck swelling, chest pain. BP 121/74, HR 93 and 100% on RA. Patient transported to ED for evaluation. symptoms improved. Discharged home after 2h of observation.
Doses given after date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after date of expiry) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses given after date of expiry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.   Date the vials were initially stored in the refrigerator 06-OCT-2021.   No treatment information was reported.