chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 39-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcohol use" (unspecified if ongoing), notes: less than 1 drink/ week; "HSV2" (unspecified if ongoing); "fever" (unspecified if ongoing); "chills" (unspecified if ongoing); "myalgias" (unspecified if ongoing); "lymphadenopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer, ), for covid-19 immunization. The following information was reported: LIVER INJURY (medically significant), 81 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Normal, notes: Return to baseline; Alanine aminotransferase: 596 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: unknown result; Antineutrophil cytoplasmic antibody: positive; Antinuclear antibody: unknown result; Aspartate aminotransferase: Normal, notes: Return to baseline; Aspartate aminotransferase: 454 IU/l; Biopsy liver: focal portal fibrosis. Perivenular, notes: necroinflamtion with hepatocyte dropout, mild lymphocytic inflammation and ceroid containing macrophages. mild predominantly centrilobular small-droplet steatosis. Consistent with acute drug/toxin induced liver injury; Blood alkaline phosphatase: 213 IU/l; Blood bilirubin: 1.7 mg/dl; Blood immunoglobulin G: Unknown result; Blood immunoglobulin M: Unknown result; Body mass index: 19.6; Hepatitis viral test: negative; Imaging procedure: mildly echogenic liver; anti-smooth muscle antibodies: unknown result; unknown result; Magnetic resonance cholangiopancreatography: Normal; Serum ferritin: 358 ng/ml; Transient elastography: 3.4, notes: Unit: kPa; CAP 155, notes: kPa 3.4; Ultrasound liver: mildly echogenic liver.; Sender's Comments: Based on the available information in the case, an association between the reported events LIVER INJURY and The suspected drug cannot be ruled out.  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.,Linked Report(s) : US-PFIZER INC-PV202300089305 Same article/ drug/event and different patient;
Fever, chills, mild body aches. Fever temperature at 4/8/2021 7:00 pm: 99.8F.  Fever temperature at 4/9/2021 7:30 am: 99.8F-100.3F
1)  Loud ringing in both ears began 3 days after 1st injection and has intensified and continued following 2nd injection (no treatment thus far). 2) Tingling in both feet (more intense in right foot) - Physician consulted. Referral to neurologist. 3) Minor tingling in both hands (more intense in left). Experiencing left baby finger spasm and curling under 4th finger multiple times per week which began after first covid injection and has become more frequent after 2nd covid injection. Physician consulted. Referral to neurologist.  4) New severe, lower back pain (new) that began on 9-19-2021 with no incident of injury.  Physician consulted. X-rays done-basically unremarkable with only minor arthritis. Pain has improved after 10 days. Neurologist referral.
Multiple  areas of inflammation in cervical lymph nodes and supravlavicular lymph nodes. Swelling throughout neck, collarbone, resulting in painful movement and touch.
Injection site was red, warm, swollen, tender to touch.  Patient went to urgent care on 9/19/2015 who instructed her to take Benadryl.  Spoke with patient today and symptoms are improving.
No side effects; HCP calling to report AE for patient who received improperly stored VARIVAX; This spontaneous report was received from other health professional, regarding to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 12-OCT-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, for prophylaxis subcutaneous injection, for prophylaxis (lot number: X007372, which has been verified to be valid, expiration date reported and validated as 12-MAR-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of -9.8 degrees Celsius (C), during a time frame of 12 minutes (product storage error). There was a previous temperature excursion reported of -8.8 C for 14 minutes and -12.1 for 11 minutes.   No additional adverse events were reported in the patient.; Sender's Comments:  US-009507513-2310USA007934:
Bad side effects/in bed for 2 days after; Arm pain; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad side effects/in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (9 months ago). Concurrent medical conditions included Asthma and Hypercholesterolemia. Concomitant products included ATORVASTATIN for Cholesterol.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Bad side effects/in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, VACCINATION SITE REACTION (Bad side effects/in bed for 2 days after), PAIN IN EXTREMITY (Arm pain), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2022-509431 (Patient Link).
Patient reported having puffy lips, numb and tingling sensation of tongue and mouth and subsided nausea Patient seen by medical team, blood pressure 185/105 and heart rate 97 Patient stated symptoms improved Patient refused medical transport and signed ama form
soreness at the injection site; fatigue; general myalgia; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On 17th February 2021 15:00, the patient received the 2nd dose of Shingrix. In February 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, fatigue and myalgia. On an unknown date, the outcome of the injection site pain and myalgia were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fatigue and myalgia to be related to Shingrix.  Additional details were provided as follows: The patient was reporting for himself. The patient received 2nd dose of Shingrix in right arm. In the morning of 18th February 2021, after receiving Shingrix, the patient experienced general myalgia, fatigue, soreness at the injection site and no apparent fever.   At the time of reporting, the patient's all symptoms had resolved but still felt a little fatigue. The patient stated he slept well last night from the date of reporting. The reporter consented to follow up with his healthcare professional.
4 1/2 days after the shot, I woke with chest pain, pain down left arm.  Went to ER.  EKG was normal, but second blood draw showed elevated troponin level.  Admitted to Cardiac unit.  Tests included much blood work - nothing very abnormal. Left heart catheterization showed no significant obstructive coronary disease.  Echocardio transesophageal 2D performed, almost normal.  Cardiac MRI diagnosis is myocarditis. NSTEMI. Also had a couple episodes of Afib while at the hospital.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and CDC. As per recommendation from CDC, affected dose should be repeated. Pt was notified and all questions answered. Pt refused to repeat dose due to pregnancy. Will reconsider in post partum. EDC 1/13/2022. G3P2
have a blood blister on my right hand ring finger; On left hand index finger and middle finger i have 3 small red dots; This is a spontaneous report received from a contactable consumer (Patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:30 (Batch/Lot Number: EN6206) as 1ST dose, dingle dose for covid-19 immunisation. Medical history included blood cholesterol increased. Concomitant medications included rosuvastatin, sumatriptan, elderberry and ubiquinol. Patient had no allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 06Mar2021, the patient experienced a blood blister on her right-hand ring finger and on left hand index finger and middle finger she had 3 small red. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected
Feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect); Intermittent dizziness after an hour; H/A after an hour; that diminished over the next 12 hours but slightly lingered; Metallic taste in the mouth after an hour; Nausea after 8 hours (diminished by the next morning); This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular on the left arm on 29Dec2020 09:45 at a single dose for COVID-19 immunisation. Medical history included Hashimoto. Concomitant medication included omeprazole, rosuvastatin calcium (CRESTOR), levothyroxine, magnesium and ascorbic acid, retinol, tocopherol (OCUVITE).  The patient previously took zinc and experienced allergies. On 29Dec2020, the patient experienced intermittent dizziness after an hour, metallic taste in the mouth after an hour, H/A (headache) after an hour (that diminished over the next 12 hours but slightly lingered) and feeling of exhaustion (progressive during the day; diminished the next morning, but lingering at lesser effect), and nausea after 8 hours (diminished by the next morning). No treatment was given for the events. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of the events was recovered with sequel.
When my wife woke up in the morning. She started shaking all over. Her eyes were wide open. I tried to get her into bed and she did the same thing. I got her dressed and went to PCP. The MDF ran blood work and did covid and flu shot test. MD stated if she continues we would run a CAT scan.  She is now achy, has a bad headache and extremely exhausted.
Number two VARIVAX ordered by MD, ZOSTAVAX given in error. As of 7/22/10, no adverse reactions or events reported by patient. Error found on 7/22/10 by staff during data entry.
Patient exhibited initial signs of presyncope immediately following immunization administration. Symptoms were characterized by feeling faint, warm and nauseous. Patient remained seated for approximately 15 minutes, was given a glass of water and an ice pack. After initial episode patient felt better and was able to walk out of pharmacy without incident.
diagnosed with COVID-19 infection 9 days after she received her first dose; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was diagnosed with covid-19 infection 9 days after she received her first dose and 11 days after that she felt fine, and her physician informed her that she was out of the quarantine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Patient enquired whether she should be administered with the second dose of the Pfizer's COVID-19 vaccine. The outcome of the event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Red, hard, swollen area around injection site.  Area continued to increase in size over 48 hours.  patient seeked medical attention due to worsening symptoms.
he felt like he was unwell; sick; Nauseated but he is not going to throw up; feels like his head is stuffed up but he does not have a runny nose/  his head was getting ready to flood through his nose; feeling bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6208) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 1 diabetic", start date: 2003 (ongoing); "Prostate cancer", start date: 2016 (unspecified if ongoing), notes: PSA test was like 0.05 so it is pretty much under control.; "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN taken for blood cholesterol abnormal, start date: 2018. The following information was reported: MALAISE (non-serious) with onset Mar2021, outcome "not recovered", described as "he felt like he was unwell"; ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "sick"; NAUSEA (non-serious) with onset Mar2021, outcome "not recovered", described as "Nauseated but he is not going to throw up"; UPPER RESPIRATORY TRACT CONGESTION (non-serious) with onset Mar2021, outcome "not recovered", described as "feels like his head is stuffed up but he does not have a runny nose/  his head was getting ready to flood through his nose"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "not recovered", described as "feeling bad". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient has no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events did not result to Emergency Room and Physician Office visit. The patient was scheduled on 31Mar2021 for the second dose.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report based on information received by Pfizer from Merck (manufacturer report number 1-5810379005). A contactable physician reported that a patient (age, gender, and ethnicity unknown) received PREVNAR13, 0.5 ml, single dose, on an unspecified date. Relevant history and concomitant medications were unknown. The patient developed swelling in the arm at the injection site. At time of this report, clinical outcome of the event was unknown. Follow-up (25JAN2013): Follow-up attempts completed. No further information expected.
suspected vaccination failure; got it 10 times worse; 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK 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 reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient got the vaccine and got shingles, 10 times worst. Therfore this patient was angry and called the vaccine is a lie. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Face flushing right away within the first 15 minutes and that lasted until I went to bed - about 6 hours or so. When I woke up the next morning, I had really intense pain in my arm (injection site) and could barely lift my up and I had an inch big response on the injection site - it was pretty itchy, red and hot. It started going away on day 3. On day 5, it was 3 inches in diameter, itchy, hot and red . I took Benadryl at first - but it makes me super sleepy. I took for for two days and then I took it again on 8 or 9th day before I went to the doctor and my welt was still getting bigger. (Circle was getting bigger on my arm.) On day 10, I called the doctor - and they said  people were having a delayed response and they said to wait. I also got a fever and flu-like symptoms on Day 10. I had those flu like symptoms for twelves hours or so.  It (the welt on my arm) lasted 14 days.
Muscle spasms to (L) chest since receiving vaccine; sx are intermittent. ED eval 11/8/10, diagnosed as muscular strain, tx'd with ibuprofen.
Patient was due to receive her second dose of Pfizer Monovalent vaccine to complete her primary series. Pt was administered a Bivalent Pfizer booster instead. No adverse reactions were reported at the time.
Red solid rash around injection site that is growing over time. Current size 4.5inches x 5.5inches. Itchy, swollen, hot skin. Headache lasting from 1/13 to present time. Urgent care appintment on 1/21 prescribed 50mg benadryl and triamcinolone acetonide 0.1% ointment  twice daily. Follow up appointment 1/23 by 3pm.
He explains that he had being feeling pain in the muscle on the site of the administration of the vaccine. He assures that he had experience it since the administration. Today is more than a month after was administrated the vaccine and he is still feeling discomfort in the area. He went to the physician and was prescribed NORFLEX and TORADOL.
Seen at doctor's medical center on 7/22/02 with febrile seizure. Blood culture grew s. pneumoniae type 19F. Pt had three doses of Prevnar.
recieved Bexsero and passed out; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, less than a year after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown.   It was unknown if the reporter considered the passed out to be related to Bexsero.  Additional details were provided as follows: The patient was vaccinated and passed out. The reporter consented to follow up. This was 1 of 2 cases reported by same reporter.
This case was received from a physician on 06 August 2009. It was reported as part of a cluster of two patients; information for the other patient  is captured in case number 2009-03592. A 40-year-old female patient, with no past medical history, received the following vaccines on 04 August 2009: IPOL (lot number B0475); a left deltoid, subcutaneous dose of YF VAX (lot number UF645AA); Hepatitis A vaccine (GSK, lot number AHAVB302BA); and MMR II (MSD, lot number 3055Y). The patient had previously received oral polio vaccine and MMR as a child. One day post-vaccination, she experienced diffuse erythema, with generalized discomfort and tingling over her entire body surface. No additional information was reported. Documents held by sender: None.
First of all I am a Registered Pharmacist. I also consider myself very healthy and in good shape. 3-4 days after my vaccine my left knee got swollen and I experienced severe muscle and tendon pain. I had problems sleeping, walking up steps, basically Grade 3 pain. This went on for 5 days before things started to get better. I made an appt with my Orthopedic Office and saw the Physicians Asst. (9/21/18). I have both hips and rt knee totally replaced.
very fatigued; muscle aches and pains; Lethargy; Body aches; shaking chills; ran a temperature (fever 102.4); This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PAIN (Body aches), CHILLS (shaking chills), PYREXIA (ran a temperature (fever 102.4)) and FATIGUE (very fatigued) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Atrial fibrillation. Concomitant products included APIXABAN (ELIQUIS) and METOPROLOL for Atrial fibrillation, ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol high, ASCORBIC ACID (VITAMINS C), VITAMIN D3, CYANOCOBALAMIN (VITAMIN B-12) and PARACETAMOL (TYLENOL EXTRA STRENGTH) for an unknown indication.   On 15-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced LETHARGY (Lethargy), PAIN (Body aches), CHILLS (shaking chills) and PYREXIA (ran a temperature (fever 102.4)). On 16-Feb-2021, the patient experienced FATIGUE (very fatigued) and MYALGIA (muscle aches and pains). On 16-Feb-2021, LETHARGY (Lethargy) had resolved. On 25-Feb-2021, PAIN (Body aches) had resolved. On 28-Feb-2021, CHILLS (shaking chills) had resolved. On 09-Mar-2021, FATIGUE (very fatigued) and MYALGIA (muscle aches and pains) had resolved. At the time of the report, PYREXIA (ran a temperature (fever 102.4)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 102.4 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-040288 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: reporter Email, Demographic were updated