chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was just brought to our attention that this person went to the ER on 02/27/2021 and has elevated troponins.   then was transferred to another hospital.  this person's family doctor contacted  us and stated that the ER doctor said this was vaccine related.
Patient had been in good health previously, except for some ear infections, and tympanostomy tubes 8/2003.  Seemed to be fine the day of the vacination 10/08/03. Four days later she had a fever of 103 and small old bruises on her shins tripled and quadrupled in size.  The next day she was seen in pediatric office by the doctor who saw blood clots in her ears by tympanostomy tubes but no ear infection.  A platelet count was done and the results were normal however she developed another bruise under her eye where she was rubbing it because she was crying during the blood draw
Pt was given a 1mL dose instead of 0.5mL, resulting in a sore arm.  Pt was informed and directed to seek medical advice in case of any adverse events.
Injection site reaction; At the injection site there is a slight bruise about 1 inch in diameter and it is raised; there is an area about 3 inches by 2.25 inches that is erythematous and has a noticeable border around it and is warm to the touch; there is an area about 3 inches by 2.25 inches that is erythematous and has a noticeable border around it and is warm to the touch; felt a little pruritus, but it's not really itching; This is a spontaneous report from a contactable pharmacist. A 65-year-old male patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number X49142 , expiry date May2020) via an unspecified route of administration, on 14May2019 06:00, at 0.5ml single at right deltoid, for immunisation. Relevant medical history included type II diabetes mellitus diagnosed in 2008 and respiratory type illness or virus with his sinuses. Concomitant medications not reported. The patient previously received flu vaccine in 2016 (three years ago) for immunization and experienced injection site pain and weakness in the arm that lasted about 9 months. In May2019, the patient experienced injection site reaction described as at the injection site there is a slight bruise about 1 inch in diameter and it is raised. The patient also felt a little pruritus, but it's not really itching. Then there is an area about 3 inches by 2.25 inches that is erythematous and has a noticeable border around it and is warm to the touch. It is warmer than the other tissue around it, but it does not look infected. It was not sure if the reaction was worsening yet or not. It seems to be going through its phases. Outcome of the events was unknown.
Bad chills, slight fever that night for about 1 hour and moderate chills next morning for 15/20 minutes.
During office visit patient was suppose to receive 4 years vaccines. Quadracel, MMR, and Varicella. Patient instead received a Hepatitis A instead of Quadracel.  After vaccines patient did not display any adverse reactions. Dr. contacted parent on 08/02/2023 and described incident. Mother did not report any reactions or side effects. Patient parent was contacted to have patient come in office to administer Quadracel but we are pending appointment day.
Rash around site and blotchiness, body aches, severe nerve pain, ongoing headache, ear aches, sensitivity to sound, high blood pressure, nausea, diarrhea, dizziness.
Information has been received from a physician concerning a female medical assistant in her mid 20's who in January 2003, and in March or April 2003 was vaccinated with a first and second dose kof varicella virus vaccine live. On 30-Sep-2003 the patient developed chicken pox. She said that she felt awful and itchy and had one blister on her arm the first day. She counted about 6-10 blisters overall. She still has a couple red marks which she stated are scars. Unspecified medical was sought and no treatment was required. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
APPROXIMATELY 28 HOURS FOLLOWING THE SECOND VACCINE I DEVELOPED AN ENLARGED LYMPH MODE IN THE LEFT AXILLA. THERE IS NO FEVER
Pt complained of light headedness (approx. 30 min after injection) and nausea (approximately 2 1/2 hours and off and on since injection was given).
7hrs post- Fever, 100 & chills begin 9hrs post- Fever, 100 11hrs post- Fever 101 13hrs post- Fever 103, mild sore throat 15hrs post- Fever 103-104 16hrs post- Fever 102, headache begins (Ibuprofin Taken) 22hrs post- Fever 100, (Ibuprofin Taken) 28hrs post- Fever 100, (Acetometaphin Taken) 30hrs post- Fever 102, severe convulsing 36hrs post- Fever 100, headache 42hrs post- Fever normal, headache ends (Acetometaphin taken)
Premature infant born at hospital after premature labor was found to have injured brain tissue (PVL) on cranial ultrasound after delivery. Timing of the injury coincides with maternal clinical illness after second Covid vaccine, about two weeks prior to delivery. The mother and father asked me whether the Covid vaccine could have contributed to the brain injury. I reassured them that the Covid vaccine is felt to be safe during pregnancy, but that I would report the concern.
FEELING FEVERISH (SINCE THEN, HAD A FEVER ); HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 45 year old male. The patient's concurrent conditions included non alcohol user, non smoker. Other pre-existing medical conditions included The patient had no known allergies, no drug abuse or illicit drug usage, no medical history, and no medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 13-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, Laboratory data included Body temperature (not provided) 107-99.8 F. On 14-SEP-2021, the patient experienced feeling feverish. On 14-SEP-2021, the patient experienced headache. On 14-SEP-2021, the patient experienced fatigue. On 16-SEP-2021, Laboratory data included Body temperature (not provided) 101.3 F. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from fever, headache, and fatigue. This report was non-serious.
Patient stated that he noticed blood in his urine. The DR.  thought it was kidney stone. He was tested and that was not the issue.  Patient stated that he could taste blood. He was tested for cancer. He was having real bad kidney pain that kept him from walking and sleeping.
LOC after given injection for 5 seconds, recovered and was AAOx3, LOC again while conversing.  No control of motor movements until he recovered.  Sat him up in chair, maintained airway, prevented him from falling.
The vaccine was given and she was waiting her 15 minutes after the injection.  The pharmacist was checking on her occasionally.  When the pharmacist handed her immunization Covid card to her, she acted like she was going to pass out.  The pharmacist called for help.  The technician stayed with patient until a doctor and 2 nurses came to aid with the situation.  The doctor thought she was having a seizure and called the ambulance.  The ambulance got here within 5 minutes and took the patient to the hospital.
Hives - generalized, pruritis, shortness of breath CLARITIN Steroids - SOLU-MEDROL then SOLU-MEDROL dose pack BENADRYL topical steroid cream.
Patient said about 3 hours after receiving the immunization she could not mover her arm. Only able to raise arm above body about 30 degrees without severe pain. Is not able to touch arm around the injection site without severe pain. No redness, no change in temperature at all. No drainage. No fevers. Ice made it worse. Heat helped. Saw a physician the next day. No sign of infection at the injection site. Able to lift arm somewhat higher today. Pain at injection site. Continue with heat. Rx Diclofenac 75 MG BID prn x 5 days ordered.
Patient reported to facility with multiple scattered papules on all surfaces of skin, excluding the palms. Patient showed no ecchymosis.
Patient was meant to be given Bivalent updated booster, was given the regular Pfizer shot instead.
On day 6 after 1st dose of vaccine my left arm at injection site swelled, warm to touch, itching,  redness, pain, numbness,  tingling.  Upper left arm and shoulder doubled in size.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance and for the long-term prevention of shingles and zoster-related injuries. At the time of the vaccination, the patient relied on the information relayed through his healthcare providers, physicians, or pharmacists regarding the efficacy and safety of the ZOSTAVAX, which induced the patient to be vaccinated. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 18-SEP-2016, the patient was treated at a hospital for the onset of a blistering rash, which was diagnosed as herpes zoster. The patient was prescribed acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving the ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX vaccine, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
week after receiving the second dose, she experienced worsening edema in her legs; This is a literature report.  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "MCD", start date: Jun2018 (unspecified if ongoing); "MCD relapsed", start date: Oct2018 (unspecified if ongoing), notes: for 4 months; "CKD stage 2" (unspecified if ongoing); "moon facies" (unspecified if ongoing); "blistering skin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone. Vaccination history included: Influenza vaccine, administration date: 2018; Bnt162b2 (DOSE 1, Single, 1 week after the first dose), administration date: Jan2021, for covid-19 immunisation, reaction(s): "Glomerulonephritis minimal lesion"; Bnt162b2 (DOSE 1, Single), administration date: Jan2021, for covid-19 immunization, reaction(s): "Disease recurrence". The following information was reported: OEDEMA PERIPHERAL (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "week after receiving the second dose, she experienced worsening edema in her legs". The patient underwent the following laboratory tests and procedures: Biopsy kidney: Unknown result; Blood creatinine: 0.55 mg/dl; Protein urine: 9977, notes: Unit: mg/day; Protein urine: 85 mg/g. Therapeutic measures were taken as a result of oedema peripheral.  Clinical Information: She was treated with prednisone 50mg/day. The dose of prednisone remained 50mg/day during the 4 week period with a plan to taper the dose afterwards. She was encouraged to start treatment with rituximab, but the patient declined.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event oedema peripheral cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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-PV202300133576 Same article/patient/event and different drug;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative on day 7; Positive, notes: by day 11 positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 01Jul2023 to 03Aug2023. The patient experienced rebound COVID-19 (symptoms never completely went away. Tested negative on day 7 and by day 11 positive again).   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.
Pt also had Vaccine #2 on 1/26/2021 at 9:00, lot number 030L20A  Moderna.   On 2/21/21 She started noticing her hair falling out in large amounts than normal.  This has continued  including today.   no other complaints.
Piriformis syndrome was made much worse after both shots. Pain from the injury increased by 80% after both shots. After first dose  this inflammation lasted 6 days. I am into my 2nd day of bad inflammation from the 2nd shot I had pain to the injection site and a slight headache, but the inflammation was the worst part.
Pneumonia due to infectious organism. The patient was prescribed Augmentin and doxycycline because he was short of breath. In the Emergency Department, patient was hypoxic. He was placed on nonrebreather and was admitted to the hospital. He has a history of obstructive sleep apnea. Patient also has a history of hemorrhagic intracerebral bleed. On admission, systolic blood pressure was 190. Labetalol was given.   Patient had acute-on-chronic hypoxic respiratory failure due to CHF and possible pneumonia. He was diuresed. Pneumonia was treated with antibiotics. He was discharged with home health. ED visit and hospital admission was within 6 weeks of receiving the COVID vaccine.
17hr p/vax pt devel flu like sx;fever 99.3, sore muscles, h/a;
Aches, soreness, HA - sx. started less than 24 hours after receiving GARDASIL vaccine (this was 2nd GARD injection - 1st was rec'd on 03/13/12) Felt to be possible serum sickness secondary to GARDASIL injection.
Day 48 since receiving 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Day 48 since receiving 1st dose) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Day 48 since receiving 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Day 48 since receiving 1st dose) had resolved. Not Provided      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 medications reported by investigator.
multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck; feels big tumors moving in the left neck; left upper arm was swelling; couldn't move left arm; had a huge swelling in her neck (left side); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm), SWELLING (had a huge swelling in her neck (left side)), BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck), FEELING ABNORMAL (feels big tumors moving in the left neck) and VACCINATION SITE SWELLING (left upper arm was swelling) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm   ), SWELLING (had a huge swelling in her neck (left side)) and VACCINATION SITE SWELLING (left upper arm was swelling). On 17-May-2021, the patient experienced FEELING ABNORMAL (feels big tumors moving in the left neck). On an unknown date, the patient experienced BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't move left arm   ), SWELLING (had a huge swelling in her neck (left side)), BENIGN LYMPH NODE NEOPLASM (multiple tumors in her lymph node/multiple tumors in the lymph node glands on the left side of my neck), FEELING ABNORMAL (feels big tumors moving in the left neck) and VACCINATION SITE SWELLING (left upper arm was swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) ct scan which has confirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck.. On an unknown date, Ultrasound scan: abnormal (abnormal) sonogram and ct scan which has confirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck and abnormal (abnormal) Ultrasound of left neck showed multiple tumors in lymph node.         No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant FU : email received in that she states that I obtained a sona gram and ct scan which hasconfirmed the vaccine caused multiple tumors in the lymph node glands on the left side of my neck.
Hives, runny nose, rash on her back. Tx: Benadryl 50mg po.
Migraine; intermittent pain in my head that goes from one ear to the other, like a string is inside my head and it connects to my ears or the place above your jaw.; intermittent pain in my head that goes from one ear to the other, like a string is inside my head and it connects to my ears or the place above your jaw.; pain in left arm for about a day 1/2,; Slight headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol, osteoporosis, migraines, allergies and known allergy to latex and a long list of foods. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included rosuvastatin calcium (CRESTOR), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), vitamin d nos (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received ibuprofen (ADVIL) and cefaclor (CECLOR); both for unspecified indication from unknown date and experienced drug allergy. On an unknown date in 2021, originally after shot, the patient had pain in left arm for about a day and half and a slight headache. On 05May2021 at 23:00, two weeks after shot, the patient experienced migraine but for the last 2 days, the patient had this intermittent pain in head that went from one ear to the other, like a string was inside head and it connected to ears or the place above your jaw. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pain in left arm was resolved on unknown date in 2021, after a day and half. The clinical outcome of the events slight headache, migraine and intermittent pain in head that went from one ear to the other, like a string was inside head and it connected to ears or the place above your jaw was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This is a spontaneous report from a contactable female consumer. A female patient, of unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on Mar 13, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. After the vaccination, patient experienced reactions in the neck and face; and difficulty in swallowing on an unspecified date. The 2nd dose scheduled on Apr 2, 2021 (not administered yet). She was wondering if she could proceed in getting the 2nd dose today. The outcome of the events unknown. Follow-up attempts completed. No further information expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, on 13May2022 as dose 4 (booster), single (Lot number: fm9992) at the age of 72 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "recent radiation treatments for prostate cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Patient received paxlovid from 22Jun2022 to 26Jun2022 for treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Additional information: There was no other medication in 2 weeks.