chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 82-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 12:00 as dose1, single (Lot number: HH7595) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "obese scale 31" (unspecified if ongoing); "history of hypersensitivity pneumonitis" (unspecified if ongoing); "history of high blood pressure (controlled)" (unspecified if ongoing); "history of PACs and SVTs (no recurrence since 22Oct ablation)" (unspecified if ongoing); "history of PACs and SVTs (no recurrence since 22Oct ablation)" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "allergy"; Valacyclovir, reaction(s): "allergy"; Atorvastatin, reaction(s): "allergy". Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Vaccine lot number: EN6198, Vaccine location: Left arm), administration date: 26Feb2021, when the patient was 79-year-old, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE, Vaccine lot number: FP6955, Vaccine location: Left arm), administration date: 17Mar2021, when the patient was 79-year-old, for Covid-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Vaccine lot number: Booster 80130BA, Vaccine location: Left arm), administration date: 07Oct2021, when the patient was 80-year-old, for Covid-19 immunization; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number: FK9893, Vaccine location: Left arm), administration date: 19Apr2022, when the patient was 80-year-old, for Covid-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Vaccine lot number: GJ2524, Vaccine location: Left arm), administration date: 12Sep2022, when the patient was 81-year-old, for Covid-19 immunization, reaction(s): "history of PACs and SVTs (no recurrence since 22Oct ablation)"; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE, Vaccine administration time: 11:00, Vaccine lot number: GJ6796 Bivalent, Vaccine location: Left arm), administration date: 06May2023, when the patient was 81-year-old, for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Oct2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: obese: (unspecified date) 31, notes: obese scale 31; SARS-CoV-2 test: (unspecified date) negative, notes: Tested negative on home test 24 hours after ending Paxlovid,; (unspecified date) Positive, notes: This test was positive; (unspecified date) Negative, notes: 2 negative tests; (09Oct2023) Positive, notes: Tested positive on Day 1.  Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336611 same patient, different vaccine dose/AE.;
Seven days after receiving the vaccine, the patient's right arm itched, and she reached up to scratch it, and noticed that the area around the deltoid was red.  The area does not really itch, but is just red.  For the first two days, the rash didn't move.  Then over the next several days, the rash starting spreading down the upper arm. On February 18, the patient experienced bad diarrhea.  On February 21, the patient put a cold damp cloth over the area to soothe the area.  Some areas within the rash are improving, but the redness continues to spread down the arm.  The area felt like a bad sunburn, and the patient put some salve on it one day, but did not notice a difference.
Patient received the Pfizer vaccine at Hospital on 4/19/2021. Patient developed tongue and mouth numbness and tingling  20 minutes after the vaccine. She was evaluated by ENT who told her it was probably sinusitis. Four days after the vaccine, the numbness and tingling spread to her hands and feet. She was then evaluated at an Urgent Care who prescribed her Prednisone  x 16 days.
"Moderna Covid-19 Vaccine EUA"The day following the vaccine, she noted her tongue swollen and floor of mouth on 1/14/21. she drank hot coffee on felt discomfort, also noted the area was sensitive to cold and hot which lasted 2-3 days, still sensitive thru 1/25/21. Today 1/25/21 the swelling has subsided, but she has raised red, small, circular bumps in the area under her tongue, that remain sensitive. She administered a Benadryl oral rinse, did not swallow.
This spontaneous report was received from a physician via field employee regarding unspecified number of children under age of 2. The patients had a compromised immune system. The historical drug included PREVNAR 13. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 (strength, dose, frequency, product lot#, expiry date, route not reported). The physician stated that she only used the PNEUMOVAX 23 in the under 2 years of age group and only if the patients had a compromised immune system and if the patient did not respond to PREVNAR 13. There was no product quality complaint involved. The outcome of the events were unknown. The causality of the event, used the PNEUMOVAX 23 in the under 2 years of age group (off label use) was unknown. Additional information has been requested.
THE RIGHT ARM OF THE PATIENT WAS REDDISH AND WARM TO THE TOUCH, AN EDEMA.  HE ALSO SAID HE FELT TICKLING ALL OVER THE RIGHT ARM.
Cellulitis diagnosed by MD - patient had pain, swelling, itching at injection site. Patient was prescribed an antibiotic and steroid.
Patient presented to the ED and was subsequently hospitalized for Acute metabolic encephalopathy within 6 weeks of receiving COVID vaccination.
She ran a fever of 101 F for 24 hours beginning beginning 4-6 hours after the administration of the second dose of the vaccine.
Large red welt and swelling at injection site, warm to the touch, painful, and itchy
Rash beginning on right arm. Swelling both arms and face. Throat tightness. Treated with Benadryl and Prednisone.
Patient received vaccination 8/20/16. On 9/1/16 had productive cough, aches, pain, fever. Went to walk in clinic and received KEFLEX for 10 day tx. On 9/7/16 say primary care and MD was given AZITHROMYCIN (stop warfarin). Patient is recovering.
Rash and hives on neck from ear to ear; Redness; Rash and hives on neck from ear to ear; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA) (Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 10:30AM as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. Patient reported she was allergic to Bee sting and beeswax. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Concomitant medications were not reported. On 16Mar2021 at 3:45 PM, the patient experienced Rash and hives on neck from ear to ear, redness, and continuous Nausea. The patient contacted Doctor via telephone for treatment advice and he was advised to take Benadryl every 4 hourly for the event. The clinical outcomes of the events Rash and hives on neck from ear to ear, redness and Nausea were recovering. Information about lot/batch number cannot be obtained. No further information is expected.
On December 5th my symptoms began with a sore throat. I took a rapid test and it was positive. The next day I called my doctor and explained my symptoms. He recommended that I take PAXLOVID and began taking it on December 7th. The only other symptom I had was a headache. The symptoms lasted about 5 days.
C/C OF CHEST PAIN AND DIZZINESS CODE GREEN CALLED VSS PT STARTED TO FEEL BETTER EKG WNL REFUSED HOSPITAL SPOUSE DROVE HOME
Tachycardia with heart rate that reached over 140bpm. The tachycardia lasted a few days with average heart rate those days over 100bpm.
EXECUTIVE SUMMARY Obtained suggested CDC shots for international trip on 11-17-2017 (Hepatitis A, Tdap and Typhoid) Below is a time sequence of event with diagnoses occurring after the shot Current team of current doctors: ? Dermatologist (2x) ? Rheumatologist (2x) ? Nephrologist ? Urologist ? Gastrologists ? Naturopathic & Dietitian Ref: 1 Date: 4-18-2018 appointment with Dermatologist: Rash appeared on face in December of 2017 and progressed to get worst: Diagnosed with Vitiligo. Have since been to half a dozen dermatologist for treatment ? see evidence Ref 2a: Date 9-18-2018 appointment with skin cancer: Confirmed with a positive abnormal: ANA (auto immune disorder) Ref 2b: Date: 10/2018 appointment to retest: Confirm with again with positive abnormal: Ref 3: Date: 6-03-19 diagnosed with CKD Stage II Ref 4: Date: 8-16-2019 diagnosed with bladder disorder and enlarged prostate Ref 5: Date: 10.01.2019 diagnosed with inflammation in the eye (tell-tale sign of auto immune disorder) Ref 6: Date: 10.02.2019 Rheumatologist has indicated lab work is abnormal in 30 days want to see if numbers continue trending downward before troubleshooting which type of auto-immune disease. Multiple Lupus markers have since been revealed, constant doctor visit happening now to get to root cause of problem.. All started after the shots in 2017..
Evening of 10/4/04: noticed right arm hurt and it was hard to sleep. No swelling at that time; morning of 10/5: arm still sore. Took 1x Advil, arm sore all day. That night arm swollen and could only lift arm to shoulder, able to sleep. This morning 10/6 arm increased swelling, redness and sore: right arm swollen from deltoid to mid forearm, elbow right arm red and swollen, better ROM this morning. No other symptoms.
My mouth staying dry; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (My mouth staying dry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (My mouth staying dry). At the time of the report, DRY MOUTH (My mouth staying dry) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were reported.   No Treatment information was provided.
Fever of 101-103 which has lasted for the past 2 days and has not stopped. She also has a lack of appetite, refusing to eat more than a few morsels at meal times. Extreme lethargy - she's normally very energetic and has been lying down or sleeping the majority of the past 2 days.
Neurosis; Chest pain; kidney disease-Trouble urinating; Caller missed second vaccine appointment; Anxiety; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROSIS (Neurosis), CHEST PAIN (Chest pain) and DYSURIA (kidney disease-Trouble urinating) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Mental disorder and Cancer.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced NEUROSIS (Neurosis) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DYSURIA (kidney disease-Trouble urinating) (seriousness criterion hospitalization) and ANXIETY (Anxiety). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller missed second vaccine appointment). The patient was hospitalized on 06-Apr-2021 due to CHEST PAIN, DYSURIA and NEUROSIS. At the time of the report, NEUROSIS (Neurosis), CHEST PAIN (Chest pain), DYSURIA (kidney disease-Trouble urinating), ANXIETY (Anxiety) and PRODUCT DOSE OMISSION ISSUE (Caller missed second vaccine appointment) outcome was unknown.        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.   Treatment for the events was not provided.  Company Comment: This report refers to a case of Product dose omission issue for mRNA-1273, lot # 026A219  with associated Adverse Events of Neurosis,Chest pain ,Dysuria, and Anxiety. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # 026A219  with associated Adverse Events of Neurosis,Chest pain ,Dysuria, and Anxiety.Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Third day after vaccine a purplish large bump or sore appeared on tongue was sensitive; Third day after vaccine a purplish large bump or sore appeared on tongue was sensitive; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021 at 11:00 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included Graves' disease and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received levofloxacin (LEVAQUIN) on an unknown date and experienced drug allergy. On 15Feb2021 at 11:00, third day after the vaccine, a purplish large bump or sore appeared on the patient's tongue which was sensitive and was almost completely gone in 24 hours and totally gone in 48 hours. The patient reported that he had a picture. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event purplish large bump or sore appeared on tongue which was sensitive was resolved on 17Feb2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient's mother lied about age of patient at time of vaccine administration. Listed DOB as 9/7/08, when patient's DOB is 9/7/09. Patient's mother was asked again to confirm DOB prior to administration of the vaccine since insurance rejected claim since patient's age on file was 11 years old. Mother said patient was 12 years old and DOB is in 2008. Vaccine was then given. When patient was looked up on the Registry, the DOB listed was in 2009. Mother was then asked what the DOB was since both the insurance and Registry had a DOB of 9/7/09. Mother then said that she lied about patient's age, making him a year older than he actually is. Said she did that because he has a lot of allergies and other health conditions, so she thought he was at high risk for COVID, so he should receive the vaccine. Patient got his first vaccine on 5/13/21. There were no complaints of any adverse reactions after the first shot.
whelp formation around injection site; psoriatic arthritis flare up; This is a non-interventional study report from the marketing program received from a contactable reporter(s) (Consumer or other non HCP). This is a solicited report received via a sponsored program. Other Case identifier(s): 22K-163-4337752-00 (AbbVie).  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) citrate free at unknown for psoriatic arthropathy. The patient's relevant medical history was not reported. Concomitant medication(s) included: COSENTYX. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset Aug2021, outcome "unknown", described as "psoriatic arthritis flare up"; VACCINATION SITE URTICARIA (non-serious), outcome "recovering", described as "whelp formation around injection site". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of whelp formation around injection site with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of psoriatic arthritis flare up was not provided.  Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) of whelp formation around injection site with Pfizer Biontech Covid-19 Vaccine (Tozinameran) was Not Reported. The reporter's causality for the event(s) of psoriatic arthritis flare up was Probable.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on available information the events psoriatic arthropathy, vaccination site urticaria were assessed as possibly related to the suspect vaccine BNT162B2 based on  temporal association. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt came into clinic AM of 15OCt w/hot, red swollen area;Rn told pt to take APAP apply cool compress (3X) daily;pt returned 16OCT area was still red, no fever but area was hard;17OCT97 area still a little hard;
PATIENT STOOD WITHIN A MINUTE OR TWO OF GETTING 4 SHOTS, TURNED VERY PALE, THEN FELL AGAINST HER MOTHER  AND RN WHO LOWERED HER TO THE GROUND. SHE WAS OUT FOR A FEW SECONDS THEN WOKE UP, LAY FLAT FOR ABOUT 5-10 MINUTES THEN WAS ABLE TO WALK OUT OF THE BUILDING WITHOUT ASSISTANCE. MOM STATES NO FURTHER PROBLEMS THOUGH SHE TREATED HER WITH HER DOSE OF IBUPROPHEN Q 6 HRS TIMES TWO BECAUSE SHE HAD THE VACCINES.
This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient), for a Pfizer sponsored program (005570). A patient (no qualifiers provided) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient medical history and concomitant medications not reported. Vaccination history included the 1st dose and the 2nd dose of the COVID-19 vaccine (manufacturer unknown) for COVID-19 immunisation. The following  patient felt abnormal/foggy feeling, headache(s) and paresthesia/tingling in hands, with outcome of unknown. Additional information: Patient have had tingling in hands, headaches, foggy feeling, since taking the booster. It has lasted over a month. Patient had no side effects after the first 2 vaccines. The lot number for BNT162B2 not provided and will be requested during follow-up.
Case number PHEH2014US009974 is an initial spontaneous report received from a nurse on 13 May 2014 with a follow up report received from the nurse on 08 Sep 2014. This report refers to a 12 years old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with an expired dose of MENVEO (batch number: X11033 and A11033) intramuscularly at a dose of 0.5 ml into left deltoid on 12 may 2014 at 04:10 pm. It was her initial MENVEO vaccination. On the same day, she was concomitantly vaccinated with ADACEL (other manufacturer, batch number: not reported) intramuscularly at a dose of 0.5 ml and varicella vaccine (other manufacturer, batch number: not reported) subcutaneously at a dose of 0.5 ml. She did not experience any adverse event following this administration error (expired vaccine used). Follow up report received from the nurse on 08 Sep 2014: Updated patient demographics (height and weight), suspect vaccine description (time of vaccination, dose and site), added concomitant vaccines, concomitant vaccination details and reports statement (no event).
Had pain in injection area and in armpit/lymph node area for 36 hours after shot and then was fine. One week after shot couldn?t sleep night of 4/23/21 due to pain in my armpit.  Got up in the morning on 4/23/21 with very swollen and painful armpit/lymph node area. Contacted doctor.
03/30/2006 reaction to DTap entire left upper arm swollen, pink, warm, about 13cm x 12cm.
Pt vaccinated with DTP experienced generalized seizure lasting 10 mins. Ocurred less than 24 hrs after receiving vaccine.  No apparent fever.
This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching), ERYTHEMA (her face is a mess), AGEUSIA (No taste for coffee) and COVID-19 (COVID-19) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching) and ERYTHEMA (her face is a mess). On 26-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced AGEUSIA (No taste for coffee), OCULAR DISCOMFORT (eye issue) and INTENTIONAL DOSE OMISSION (intentional missed dose). At the time of the report, ERYTHEMA (big pinky, red reaction in the right site of her face and neck), PRURITUS (very itching), ERYTHEMA (her face is a mess), AGEUSIA (No taste for coffee) and OCULAR DISCOMFORT (eye issue) was resolving, COVID-19 (COVID-19) outcome was unknown and INTENTIONAL DOSE OMISSION (intentional missed dose) had resolved. 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 medications reported. Reported that events were treated with an unspecified cream and eye drops. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: AE details and outcome.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Patient's pertinent medical history and drug reactions o allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored Gardasil 9 (lot # L024993 and expiration date 17-OCT-2017, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PCQ) was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Pt became lethargic with pale lips after the first shot. Signs/symptoms which were reported by mother before the vaccines - mother stated that pt has been getting in this condition when he cries.