chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm  following the covid 19 vaccine; Atrial fibrillation; garteriovenous malformation in the duodenum; arteriovenous malformation in the duodenum; MARKETING PROGRAM NAME NOT AVAILABL  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4387006-00.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1159098) at citrate free, subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 01, Intramuscular), administration date: 16Feb2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (Dose 02, Intramuscular), administration date: 11Mar2021, when the patient was 80-year-old, for COVID-19 Immunization. The following information was reported: ARTERIOVENOUS MALFORMATION (medically significant) with onset 29Mar2022, outcome "unknown", described as "arteriovenous malformation in the duodenum"; GASTROINTESTINAL ARTERIOVENOUS MALFORMATION (medically significant) with onset 29Mar2022, outcome "unknown", described as "garteriovenous malformation in the duodenum"; ATRIAL FIBRILLATION (medically significant) with onset Apr2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm  following the covid 19 vaccine". The action taken for adalimumab was unknown. clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (ADALIMUMAB) and PFIZER BIONTECH COVID-19 VACCINE. The reporter's causality for the event(s) of Arteriovenous  malformation in the duo-denum, sore arm following The COVID 19 VACCINE and atrial fibrillation with Humira and Comirnaty was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Arteriovenous malformation, Gastrointestinal arteriovenous malformation and atrial fibrillation which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. 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.
Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19) in a 63-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Moderna (had some shakiness and shivering, Dose 1, lot number 026L20A) on 07-Jan-2021, Moderna (Dose 2, Lot number 030L20A) on 04-Feb-2021, Moderna (Dose 3 and Lot number 058E21A) on 29-Oct-2021; for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Cold with Moderna; and No adverse event with Flu shot, Moderna and Moderna. Concurrent medical conditions included Heart disorder. Concomitant products included SACUBITRIL, VALSARTAN (ENTRESTO) and CARVEDILOL for Heart disorder.    On 27-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced COVID-19 (Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19). At the time of the report, COVID-19 (Normal cold symptoms/a bit of a cold with cough and congestions/tested positive for Covid-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient received the regular flu shot two weeks before the Moderna vaccine. Did not have additional information. Patient had some side effects after receiving the Bivalent Booster dose.  Patient was having normal cold symptoms, nothing terrible, a bit of a cold with cough and congestions.  Patient had an appointment scheduled for later the day. The treatment medication was not reported by reporter.   This case was linked to MOD-2022-667350 (Patient Link).
Patient's Rt. arm, deltoid area, became red and swollen, warm to the touch.  Redness extended down to the Rt. elbow.  No fever, weight- 151lbs.
Information has been received from a physician concerning a 6 month old patient who on 09-MAY-2008 was vaccinated with the second dose of ROTATEQ.  The patient was in the physician's office at the time of the event.  The infant was out of the country when the dose would have been administered.  It was noted that the patient received his first dose at 2 months old.  There was no product quality complaint.  No additional information at this time.  Additional information has been requested.
Patient received 1st dose of Moderna vaccine on 1.27.21. Eight days later, on 2.3.21, the patient reports a delayed injection site reaction (arm itching sore, red, and warm). Patient reports no other symptoms at this time. Encouraged the patient to seek medical attention if symptoms worsen or are bothersome. Encouraged patient to seek emergency care for ShOB, facial swelling, or difficulty breathing.
pt experienced a large local rxn involving lt upper arm /p receiving Td. Edema, Erythema & discomfort. While syptoms have abated, pt noted her arm is still bigger than her rt
fever, chills, achy all over, fatigue   ---- later dizziness & weak muscles in my legs
1/17/2023  That morning I presented with acute onset of pain in my abdominal area, really sharp pain. I then developed a headache. I already had gestational hypertension, so I went urgently to the hospital where the planned c-section became an emergency c-section.  I had developed pre eclampsia. Post operation, there were some complications. I had a small bowel obstruction and significant fluid building up in the abdominal cavity.  I had blood loss which required multiple units of blood and 4 units of blood plasma. There was also presumed infection of unknown origin post op and electrolyte imbalance, calcium and magnesium in particular.  Upon discharge, I later developed a drug rash to Amoxicillin, not confirmed, but suspected.  I have had a couple of episodes of lower left sided abdominal pain.  Possible remnants from the infection. No outstanding symptoms at this point. I am still dealing with some of the fluid buildup.Birth weights Baby A 4lb 2oz Baby B 5lb 9oz
About 1½ hours after immunization, she complains of fever, chills, vomiting and pain at the injection site which lasted approximately 36-40 hours. A rash developed on the underside of the arm about 8 hours later and has continued until now (approximately 48 hours after immunization) and seems to be spreading further down the arm toward her elbow.
Patient received a vaccine from an expired vial. The vial was punctured on 6/1 @ 9:24 PM and expired in the early hours of 6/2. It was given on 6/5/21
Massive cold sore in mouth; Knocked out for 1 and a half days; Fever; Chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of asthenia in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) and COVID-19 BOOSTER. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced asthenia (Verbatim: Knocked out for 1 and a half days), fever (Verbatim: Fever) and chills (Verbatim: Chills). On 23-MAR-2023, the patient experienced cold sore mouth (Verbatim: Massive cold sore in mouth). The outcome of the asthenia was resolved (duration 1 day) and the outcome of the fever and chills were resolved and the outcome of the cold sore mouth was unknown.   It was unknown if the reporter considered the asthenia, fever, chills and cold sore mouth to be related to Shingrix.     It was unknown if the company considered the asthenia, fever, chills and cold sore mouth to be related to Shingrix.   Additional Information: GSK Receipt date: 23-MAR-2023 The reporter was a female patient.  The Patient reported that she received the 1st dose of Shingrix vaccine on 20th March 2023 in her left arm  The patient received the vaccine at her doctors office.   The patient reports the vaccine knock me out for 1 & half days with fever and chills. The patient reports that she also had a covid vaccine booster on the same day of the Shingrix vaccine. The patient reports that 23rd March 2023 patient woke up with massive cold sore in her mouth.  Not all information is available, lot and expiration dates were unknown.  The customer provided consent to follow up with health care practitioner (HCP), but stated she does not have this information at this moment.  The customer reported he/she have provided enough information for now. The customer then disconnected without providing additional information. It was unknown if the reporter considered the asthenia, fever, chills and cold sore mouth to be related to covid 19 booster.    The reporter consented to follow up.
Covid test Positive; Covid test Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 8-year-old male patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 1 (orange cap), single (Lot number: KF6127), in left arm, on 28Dec2021 as dose 2 (orange cap), single (Lot number: FK6127), in left arm and on 18Jul2022 as dose 3 (orange cap; booster), single (Lot number: FL8094) at the age of 8 years, in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 22Jan2023, outcome "unknown" and all described as "Covid test Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Vaccine was thawed on 1/11/21, use by date 1/16/21, but was used to immunize patient on 1/22/21.
Pt reported on 02/25/2021 at 12:45 pm stating her left hand was swollen. The shot was administered on her left arm. She stated she has a rash of goose bumps are red on both arms that are itchy off and on. Her entire arm is sore. We advised pt to contact her primary care physician and to keep us updated. We also told her it may subside with time.
Reported Left sided facial numbness approximately 30 minutes after vaccine given. Numbness from below eye to lip/jaw. Advised monitoring, no intervention recommended. Still with symptoms, though slightly improved, approximately 2 hours later.
Drowsiness due to medicines; Bladder Infection; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder Infection) and SOMNOLENCE (Drowsiness due to medicines) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced CYSTITIS (Bladder Infection). On an unknown date, the patient experienced SOMNOLENCE (Drowsiness due to medicines). At the time of the report, CYSTITIS (Bladder Infection) and SOMNOLENCE (Drowsiness due to medicines) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided She has her second dose scheduled on April 5th 2021. Caller wanted to reschedule the 2nd dose. Duration between two doses may exceed 35 days.  Gave consent for safety to follow up.
This spontaneous report as received from a 46 year old female nurse concerning herself with high blood pressure and LORTAB, as well as an anaphylactic reaction to erythromycin eye drops. On 01-APR-2013 (earlier today) the patient was vaccinated with PNEUMOVAX23, intramuscular. Concomitant therapies included lisinopril, PAXIL, vitamin d (unspecified), iron (unspecified) and cyanocobalamin (vitamin B-12). On 01-APR-2013, her arms was swollen to twice its size the eight inches around the injection site, the site was also red and warm, the arm arches, and the joint hurts. At the time of report, the outcome of events was not recovered. None lab diagnostics studies performed. Action taken was not provided. Additional information has been requested.
Vaccine Leaked Out.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine Leaked Out.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 01-Mar-2021, the patient experienced UNDERDOSE (Vaccine Leaked Out.). On 01-Mar-2021, UNDERDOSE (Vaccine Leaked Out.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was provided.   Reporter did not allow further contact
Pt states that her arm is still sore 7 days later with impaired movement......very concerned about getting the subsequent shot! Was told by immunizer to ice at the beginning. I advised at this point to use heat pad and bring to the attention of her PCP.
Pt came to ED with nasal congestion, cough, nausea, vomiting, diarrhea.
Within 5 minutes of getting the shot, I got really lightheaded, and was given a bottle of water and more time to be monitored beyond the standard 15 minutes. Approximately 4 hours later, I developed flu-like symptoms for 36 hours, including an excruciating headache. I want to Urgent Care on the 3rd day (April 3rd) due to my headache and run blood work. That same day, I noticed that I was easily getting lightheaded. Even today (April 23rd) I continue to have lightheadedness every day, with certain things triggering it (e.g., tie my shoes, holding breath during deep breathing exercises to alleviate chest pain, lifting weights). Anything that requires my head to be below my chest makes me lightheaded after 2 seconds. I thought I was going to have a stroke or brain aneurism on the night of Easter Sunday due to my headaches, so I stayed up all night thinking that I could stay alive.
RAISED RED WELT AT INJECTION SITE; PAIN AT INJECTION SITE; REDNESS AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 18-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced redness at injection site. On 20-MAR-2021, the subject experienced raised red welt at injection site. On 20-MAR-2021, the subject experienced pain at injection site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness at injection site, pain at injection site, and raised red welt at injection site. This report was non-serious.
one woman has been breastfeeding; early menses after receiving the vaccine; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer. This consumer reported information for both mother and baby. This is the maternal report.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. Medical history included "has not had a period since 2019". The patient's concomitant medications were not reported. The patient had early menses after receiving the vaccine. She has been breastfeeding. Outcome of the event "early menses after receiving the vaccine" was unknown.  Information on lot number/batch number was requested.
subsequent mentstrual periods have been uncharacteristically heavy bleeding and more intense cramps/headaches; subsequent mentstrual periods have been uncharacteristically heavy bleeding and more intense cramps/headaches; intense cramps/headaches; This is a spontaneous report from a contactable consumer. A 37-year-old non-pregnant female patient of  received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 04Feb2021 10:30 (Batch/Lot Number: EL9264) as 2nd dose, single (at the age of 36 years) for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has no known allergies. The patient has not had Covid-19 prior to vaccination.  The patient received OTC multivitamin in two weeks. The patient received the first dose of BNT162B2 (Lot:EL3246), via unspecified route of administration in the right arm on 13Jan2021 at 10:30am (at the age of 36 years) for Covid-19 immunisation. The patient experienced since receiving her second dose, all of her subsequent menstrual periods have been uncharacteristically heavy bleeding and more intense cramps/headaches on 29Mar2021 at 18:00 than she experienced in many years. The patient was not treated for the events. The patient was tested negative for Covid-19 on 31Mar2021 via nasal swab. The outcome of the events was unknown.
Patient reports abdominal tenderness that was spread evenly across his abdomen. Reports the pain was a 6 out of 10. 10 being the worst, and that the pain was steady and not stabbing. Patient reports there was no diarrhea, gas, or constipation, but that he did experience nausea.
This case was reported by a pharmacist and described the occurrence of arm pain in a 75 year old female subject who was vaccinated with Fluarix for prophylaxis. The subject's medical history included high blood pressure. Concurrent medications included blood pressure medication. The subject had received influenza virus vaccine in previous years with no subsequent adverse events. On 11 October 2006 the subject received unspecified dose of Fluarix in the left arm. On 11 October 2006, less than one day after vaccination with Fluarix, the subject experienced arm pain when she elevates her arm over her head and injection site tenderness. At the time of initial reporting, 07 November 2006, the events were worse.
2021 04 24 Severe headaches, tinnitus, hearing loss, sfn, fatigue, disautomia, anxiety, adrenal rushes  DRUG TREATMENTS: Nimesil ? 2 weeks Nalgesin ? 2 weeks Paracetamol ? 2 weeks Ibumetin ? 2 weeks Ibuprofen ? 2 weeks Mydocalm? 4 weeks Sirdalud ? 2 weeks Amitriptyline ? 6 weeks Kodeine Ultracod ? 2 weeks Brexin ? 2 weeksArcoxia ? 1 week Gabapentine - 4 weeks Piroksikam ? 2 weeks Meldonio dihidrate since 2021-12 - now Kalio aspartate/Magnio aspartate ? 2 weeks Betahistino dihidrochloride ? since 2022-02 - now Piracetam/Cinarizin since 2022-02 - now B12 vitamins - 4 weeks Vitamin D - 4 weeks Ginkgo biloba - since 2022-03 - now Pentoksifiline- since 2022-03 - now Kvetiapine - since 2022-03 - now Mirtazapine - since 2022-03 - now Pregabaline ? since 2021 09 ? now Neurorubine injections - 2 weeks NON DRUG TREATMENTS: Ozone therapy - 2 weeks Acupuncture - 4 weeks Massages ? 4 weeks
Waiting on MD, signs of shoulder impingement, loss of movement, severe bruising, numbness, tingling
pt recv vax & 5 days p/vax exp fatigue, diarrhea, low grade fever, & sore breasts;sx cont;
Called to report hives to his chest, back and face.  Breathing DK at 6:30 pm 12-2-8.  No reaction at injection sites.  Pt. stated he has severe prostate issues.  I told him to call his PCP.  MD told him to take a few doses of BENADRYL & go to ER if no improvement.  Phoned Pt wife 9 pm she gave 1 dose BENDRYL.  He is improving quickly.
Spouse called 7/20/19 to report "very red, painful, warm" area at injectin site & extending 6-7 in beyond site. Pharmacist spoke with husband - recommended seeking medical attention to rule out cellulitis. He asked if that could wait until after weekend, Pharmacist recommended not, but did tell him to trace the line of demarcation to track spread of affected area. Pharmacist will follow-up with patient next day: 7/21/19.
About 2 days after the vaccine, I developed a very large bright red circle around the injection site.  It was about 4 inched in diameter.  It started to itch badly.  I also started to ache all over my body and got progressively worse as the day continue.  By nightfall, the ache would worsen and I could not sleep.  I can feel the ache and pain in my joints and soft tissue.  I did consult my doctor and he mentioned the  vaccine could have trigger my fibromyalgia  to flare.  I have a history of fibromyalgia in my 50s which has layed dormant for 20 years.   I do have to take Tylenol and a muscle relaxant to help me sleep.  The fibromyalgia has improved but not completely resolved.
Chest discomfort and heart palpitations after getting the vaccine on October 1. Symptoms still present on October 6.  Information from office visit on 10/6/21   Appointment with cardiology is scheduled for 1/11/22.   Chief Complaint Patient presents with ? Gastrophageal Reflux     patient states he received pfzier vaccine on Fri. states he started getting hiccups right away. felt indigested all night. states he has been feeling chest discomfort also   Diagnoses and all orders for this visit:   Chest pain, unspecified type - Electrocardiogram clinic - CBC and differential; Future; Expected date: 10/06/2021 - Troponin I; Future; Expected date: 10/06/2021 - Cancel: D-dimer, quantitative; Future; Expected date: 10/06/2021 - Ambulatory referral to Cardiology; Future   Palpitations - CBC and differential; Future; Expected date: 10/06/2021 - Troponin I; Future; Expected date: 10/06/2021 - Ambulatory referral to Cardiology; Future   Dyspepsia - omeprazole (PRILOSEC) 20 mg capsule; Take 1 capsule (20 mg total) by mouth 1 (one) time a day. May take twice daily if symptoms are severe.   Adverse effect of COVID-19 vaccine - Ambulatory referral to Cardiology; Future     -EKG shows sinus bradycardia (57bpm), otherwise no acute changes -vitals normal. Heart is RRR on exam -will order troponin I and CBC with diff. -will refer to cardiology to r/o myocarditis given he typically runs marathons. No running until cleared by cardiology. -Strict ER precautions discussed   Follow-up prn.