chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after the first two COVID-19 shots and the 1st booster shot, caller started having atrial fibrillation and that is when caller started taking Eliquis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2), for Covid-19 Immunization; Moderna covid-19 vaccine (Dose: 1), for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "after the first two COVID-19 shots and the 1st booster shot, caller started having atrial fibrillation and that is when caller started taking Eliquis". Therapeutic measures were taken as a result of atrial fibrillation.  Clinical course: Patient was supposed to take the Pfizer 2nd booster shot today but took the medication Eliquis and was asking for recommendations. She was referring to the Pfizer COVID-19 vaccine 2nd booster shot. Patient started taking Eliquis after receiving the 1st booster shot, however, caller was told when she had her 1st vaccine shot, which was the Moderna COVID- 19 vaccine, and then switched to the Pfizer COVID-19 vaccine for her 2nd shot and her 1st booster shot, caller was told when she got the 1st dose of the Moderna COVID-19 vaccine, not to take Aspirin. After the first two COVID-19 shots and the 1st booster shot, patient started having atrial fibrillation and that was when caller started taking Eliquis. The atrial fibrillation started after patient received the first two COVID-19 vaccine shots and her 1st booster shot. Started taking Eliquis about 2 months ago for this condition, the irregular heartbeat. Patient's first two shots were the Moderna COVID-19 vaccine and only her booster shot, which was caller's 3rd dose, was the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received from a consumer on 16 September 2013. A female patient whose age at the time of event was not reported had received an intradermal dose of FLUZONE (batch number, dose number and anatomical site of administration were not reported) on an unspecified date of September 2013. The patient's medical history and illness at the time of vaccination were unknown and concomitant medication was not reported. It was also reported that when FLUZONE dose was administered some vaccine ran down the patient's arm leading to vaccine underdose On an unspecified date of September 2013, after vaccination the patient developed small bleb and experienced little redness at the injection sire. Corrective treatments and laboratory investigations were not reported. On an unspecified date, the patient had recovered from the events. Documents held by sender: none.
This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 29-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX lot# reported as K00884, expiration date 20-SEP-2015 (dose number, site and route of administration not reported). Concomitant therapies included valacyclovir hydrochloride (reported as "the patient may have been using valacyclovir at the time of the ZOSTAVAX administration"). On an unknown date in October 2014, the patient experienced burning at injection site and around the injection site, which appeared as though the fat in her arm was being melted. On 30-OCT-2014, the patient visited the pharmacy because of the adverse events and was advised by the reporting pharmacist to treat the reaction with unspecified topical steroid, an unspecified antihistamine and ice. No lab diagnostic studies were performed. The patient was slowly recovering from the adverse events at the time of the report. Relatedness between use of ZOSTAVAX and the adverse events was not reported. This is one of several reports from the same reporter. Lot number K00884 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Initial pregnancy report received from healthcare professional on 21 January 2014. A 18-year-old female patient, who has no medical history and concomitant medications were not reported, had received intramuscular first dose of ADACEL, batch number: C4332BA (anatomical site of administration was not reported) on 20 January 2014. The patient's last menstrual period was not reported and the expected date of delivery is 25 March 2014. The patient did not experience any adverse event. List of documents held by the sender: none.
1-2 hours after vaccine eyes became red shortly thereafter patient felt nauseous/faint then had difficulty breathing. First went to urgent care where received ASA & steroid then to hospital & given MEDROL, Atenolol, & ASA rxs. Follow up w/cardiologist.
pt recv 1 dose of varivax 7/10/96 & on 4/6/98 exp a rash consistent w/varicella.
Slight head ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight head ache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Bipolar disorder and Vitamin D deficiency. Concomitant products included CLONAZEPAM (KLONOPIN), PROPRANOLOL HYDROCHLORIDE (INDERAL) and FLUOXETINE HYDROCHLORIDE (PROZAC DURAPAC) for Anxiety, CARBAMAZEPINE (TEGRETOL CR) for Bipolar disorder, VITAMIN D NOS for Vitamin D deficiency.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEADACHE (Slight head ache). The patient was treated with IBUPROFEN on 12-Jan-2021 for Headache, at an unspecified dose and frequency. On 13-Jan-2021, HEADACHE (Slight head ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-142851 (Patient Link).
Mother reported child turned bright red, became stiff, fluid coming out of nose, shaking and this went on for a few minutes.  Mother retrieved sleeping father and they both rushed infant to the local ER.  Infant was back to normal baseline by the time they arrived at the hospital.  Child had a fever of 100.4 and mother had given Tylenol prior to the event occurring.  Temperature at the Wishek ER was 99.8.
I was just tired; body ache; Chills; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; arm was kind of hurting where the injection site is and where I got the shot; like a whip over top of it and its kind of like red; This is a spontaneous report from a Contactable consumer (patient).   A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in arm on an unspecified date, as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date, as a single dose for covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, a next day after received vaccine (a day prior to this report (yesterday "it was 08:30 in the morning and then today), the patient felt just tired/ body ache, chills but actually patient's arm was kind of hurting where the injection site was and where patient got the shot it was like a 'whip'(Not clear and not clarified), like a whip over it now whip over the top of it and its kind of like red, it has a whip and it was kind a red in arm." Out-come of the event was unknown, at the time of this report.  Information on Lot/Batch number has been requested.
Severe muscle pain (7:10 pain scale); shortness breath; weak; nausea; restlessness; diarrhea; moderate headache; 100.1 temp; This is a spontaneous report from a contactable consumer, the patient. A 66 years old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6198) in the left arm on 16Mar2021 at 09:15 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included high cholesterol and triglycerides, obesity, tachycardia, hypertension and IBS (irritable bowel syndrome). The patient's concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), valsartan 5mg (MANUFACTURER UNKNOWN), amlodipine 320mg (MANUFACTURER UNKNOWN), ser (MANUFACTURER UNKNOWN) for unknown indications from unknown date. The patient was allergic to demerol and had vomiting. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266) in the left arm on 23Feb2021 at 09:15 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 16Mar2021 at 17:00, the patient experienced severe muscle pain (7:10 pain scale), shortness breath, weak, nausea, restlessness, diarrhoea, fever (100.1 temp) and moderate headache. On the same day, (16Mar2021), the patient underwent a pulse oximetry test and the result was 97% and temperature was 100.1. No therapeutic measures were taken as a result of the events. The clinical outcome of the events shortness breath, weak, muscle pain, nausea, restlessness, diarrhoea, fever and moderate headache was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Child received flu shot on 10/18/22.  Documentation was not on parent consent form that it was administered.  On 10/22/22 when administering flu shots to those absent on the initial flu shot date, he received another dose of the flu vaccine in the same arm.
FEW HRS AFTER INJECT, ARM ACHED WARMLY, DEV PINPOINT RASH, CHEST FELT WARM AND ITCHY. HAD MALAISE AND SORENESS. FELT TIRED 2 DAYS. TREATMENT BENADRYL AND TYLENOL. RASH LASTED FOR 24 HRS;OTHER SYMPTOMS(TIREDNESS AND RUN-DOWN FEELING)ONE WEEK
pt cried ``pitched a fit''; vomited; cool to touch & clammy; then fell asleep; became diffusely erythematous; somnolent for 30 minutes; observed overnoc in hosp;thought to be consistent w/vasovagal type rxn w/compensatory vasodilation
Patient fainted & experienced seizure-like activity shortly after receiving vaccine. Event lasted approx 30 seconds. She was moved from sitting to laying on floor w/feet, elevated & began responding normally. 911 was called & EMT took her to ER. BP & P were WNL
day of vax, pt devel fever 101f & irritability for 12 hrs & loss of appetite
Patient complained of injection site itching immediately after injection, itching spread until generalized, red splotches appeared on site arm, pt rapidly progressed to uncontrolled coughing, diaphoresis, metallic taste in mouth, sore throat, phlegm in throat. Vital signs were monitored, patient never became short of breath, liquid Benadryl given orally, symptoms did not decrease, so DepoMedrol was administered intramuscularly. Pt's symptoms resolved 15 min following administration. Pt was contacted 3 hrs later, symptoms had not returned, patient reported feeling fine.
Shingles after being vaccinated./ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 provided as follows: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated the patient got a terrible case of Shingles after been vaccinated with Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Narrative:  COVID infection following COVID vaccine series 12/29/2020 Pfizer, dose #1 01/04/2021 Pfizer, dose #2 01/20/2021 Pfizer, dose 3 01/26 NASAL PCR: COVID-19 result: not detected 01/26 FLU A, FLU B, RSV PCR result: negative 08/12 pt cc: cough, chills, fatigue, fever, headache, loss of taste or smell, myalgias, fever exposure: unknown 08/12 Pt presented to facility (non-agency), received antibody infusion (IBAL infusion) and Azithromycin 08/13 COVID swab, result: detected 0813 pt admit ED dx: COVID 19 LOS: 1 day 08/13 DDIMER result: 0.68 08/13 SARS-COV-2 LINEAGE AY.4 08/13 SARS-COV-2 CLADE 21A DELTA 08/13 CTA PE impression: No pulmonary embolus. A 7 mm nodule at the left lower lobe. Consider follow-up to demonstrate stability at 6 months. 08/13 CXR impression: No acute cardiopulmonary process. No acute pulmonary finding.
Tinnitus was mild and has worsened.  Attempting to do various exercises to remedy as well as starting to take herbal anti-inflammatory to see if it will help.
soreness in the arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS. Concomitant products included METOPROLOL SUCCINATE for Heart disorder, CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    In February 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 PAIN IN EXTREMITY (soreness in the arms). At the time of the report, PAIN IN EXTREMITY (soreness in the arms) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-423761, MOD-2021-423994 (Patient Link).
The client reported that he received 1st dose of Janssen COVID vaccine (LOT#: 1821286) on 06/17/2021. Client reported dizziness, fever, sweating, and headache 7 hours after vaccination. Client stated dizziness lasted about 7 hours after onset. Client stated their last meal was at 10 am on 12/05/2021.  RN provided client with crackers. Client?s vital signs were a blood pressure of 150/88, an O2 saturation of 99%, and a heart rate of 86 beats per minute. The client denied any shortness of breath and any other signs and symptoms of anaphylaxis after first dose. Client stated he did not follow up with any providers after experiencing symptoms with his first dose. Client has no chronic conditions, no known allergies, and is not currently taking any medications.
(L) arm is red, warm & swollen. Slight discomfort in muscle. No itching no burning.
sore ribs; sleep loss; Sinus congestion; Headache; Cough; Sore throat.; cough worsened; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot: EN6207) via an unspecified route of administration in the Left Arm on 14Mar2021 at 13:30 (at the age of 68-years) as a single dose for COVID-19 Immunisation. Medical history included Neuropathy in feet, Seasonal allergies and Corn products. The patient previously took Caffeine and experienced allergy . Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Zolpidem (MANUFACTURER UNKNOWN), Doxepin (MANUFACTURER UNKNOWN), Alendronate (MANUFACTURER UNKNOWN) and Multivitamins (MANUFACTURER UNKNOWN) and Flute. Since the vaccination, patient had not tested positive for COVID-19. On 14Mar2021 at 19:30, the patient had experienced sinus congestion, headache, cough and sore throat and cough worsened. Four days later, patient still had sinus congestion, headache and cough which had resulted in sore ribs and sleep loss. Therapeutic measures were taken as a result of sinus congestion, headache, cough, cough worsened, sore throat, rib pain, sleep loss and included treatment with aspirin, drinking hot liquids, applying warm compress and benedryl, but it did not help with congestion. The clinical outcome of sore throat was recovered, of the sinus congestion, headache, cough, rib pain, sleep loss were not resolved and of cough aggravated was unknown.   No follow-up attempts are needed. No further information is expected.
(R) deltoid swollen and tight with increased warmth & redness around injection site. No streaking. Improved today.
VIRAL PERICARDITIS ACUTE PULMONARY EMBOLISM 1/2/2023 --RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Suspected covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Suspected covid-19 infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Suspected covid-19 infection). At the time of the report, COVID-19 (Suspected covid-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.         No concomitant and treatment medication was reported by patient.  It was reported that report was associated with product quality complaint- 90000209945 and 90000209947, the suspected product quality complaint had been confirmed to be voided based on the PQC evaluation, investigation performed.  It was reported that patient received Janssen COVID-19 vaccine (Dose number in series 1) additionally received booster dose of Moderna mRNA-1273 vaccine(Dose number in series 2).  Company Comment: This spontaneous case concerns a female patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the booster dose of the Moderna mRNA-1273 vaccine on an unspecified date. On an unspecified date, the patient tested positive for the COVID-19 virus. It was reported that the symptoms were 'extremely mild'. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with history of co-suspect administration of the Janssen COVID-19 vaccine, who experienced the unexpected, non-serious AESI of COVID-19 after administration of the booster dose of the Moderna mRNA-1273 vaccine on an unspecified date. On an unspecified date, the patient tested positive for the COVID-19 virus. It was reported that the symptoms were 'extremely mild'. No further details were provided. The outcome of the event was unknown at the time of the report. The history of co-suspect administration of the Janssen COVID-19 vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
CHILLS AND SHAKES 12 HOURS AFTER VACCINATION, HAS  ALMOST COMPLETE SUBSIDED AS OF NOW
At end of office visit, patient was administered Gardasil-9 vaccine by MA. Per MA, patient stood up to leave and was advised by MA to wait for 15 minutes after vaccination before leaving clinic. Patient then stated he "couldn't see" and had near syncope. MA ensured safety of patient and asked for help from clinic manager.  Upon RN's arrival to room, patient was pale, diaphoretic and weak. BP was upper 60's over 40's. HR near 40. NP also was called to the room. Oxygen was 99-100 % throughout without supplementation.  Patient did not recover after a couple minutes, so RN and NP assisted patient to ground, elevated legs and patient immediately began to recover. Patient was no longer pale, stopped sweating and BP began to rise. Patient stated symptoms improved.  Prior to leaving the clinic, patients BP improved to 106/74, hr 56. Patient was not orthostatic. Total time in clinic after vaccination was 40 minutes.
Petechial rash beginning 10/28/22 1 day after vaccination & significant bruising on body on body @ injection site. Twin sibling vaccinated same day (not identical) is fine.
This case was reported by a pharmacist and described the occurrence of swelling injection site in an adult subject of unspecified gender who was vaccinated with FLUARIX, (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of FLUARIX (unknown route and injection site). On an unspecified date, 2 days after vaccination with FLUARIX, the subject experienced swelling injection site, injection site warmth and injection site hives. At the time of reporting, the events were improved. This case is one of the 5 cases reported by the same reporter for the same vaccine.
Fever with myalgias 10/18/04 HA ,10/19/04 stiff neck, 10/25/04 rash pruritic, 10/28/04 worsening of rash, myalgias continue, 11/1/04 rash persists, neck pain, 11/8/04 getting better, 11/23/04 adverse symptoms resolved, 12/7/04 tingling of hands, stiff in back/shoulders. Follow up 12/9/04: Treatments have included Tylenol #3 PRN for headache and body ache relief. Benadryl PRN for relief of rash, Ibuprofen PRN for shoulder and neck pain. Medrol Dose pack. 10/28/04 Prednisone 60 mg x5 days, 50mg for 3 days, 40mg for 3 days, 30 mg fpr 3 days, 20 mg for 3 days, 10 mg for 3 days on 11/01/04. Symptoms resolved with use of above measures but for short periods and them to return. Follow up 12/21/04: Update on possible adverse reaction to flu vaccine; 1. Patient had a + lyme titer on 12/10/04, 2. confirmation of + lyme titer by western blot on 12/15/04, 3. patient now being trated with Doxycyline 100mg  for 1 month, 4. Patient to see rheumatologist for evaluation of symptoms on 01/03/05.
Pt received immunizations on 3/14/06. Parents noted right groin swelling 3/19/06. Denies fever, rash. Groin area swelling same color/temp as surrounding areas with size "less than a dime" per father. Father took child to MD. States MD said it was lymph node reaction. To keep eye on it. Return if not resolved by 2nd week of April.