chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slept the entire day; Fever 100.4; fatigue; chills; Diarrhea; Projectile Vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea), VOMITING (Projectile Vomiting), FATIGUE (fatigue) and PYREXIA (Fever 100.4) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfur), Drug allergy (Codiene), Blood pressure high since 01-Dec-2000, Dementia since 01-Dec-2020 and Cholesterol (NOS). Concomitant products included DESLORATADINE for Allergy, ROSUVASTATIN for Cholesterol, DONEPEZIL HCL and MEMANTINE HYDROCHLORIDE for Dementia.    On 24-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills). On 28-Feb-2021, the patient experienced FATIGUE (fatigue). On 01-Mar-2021, the patient experienced PYREXIA (Fever 100.4). On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea) and VOMITING (Projectile Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 15-Mar-2021, FATIGUE (fatigue), PYREXIA (Fever 100.4) and CHILLS (chills) had resolved. At the time of the report, SOMNOLENCE (slept the entire day), DIARRHOEA (Diarrhea) and VOMITING (Projectile Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Body temperature: 100.4 (High) Fever 100.4. On an unknown date, Blood pressure measurement: 156/82 (High) blood pressure was at 156/82 and 160/79 (High) the second time 160/79. On an unknown date, Heart rate: 93 (High) 93 pulse rate and 92 (High) 92 pulse rate. On an unknown date, Oxygen saturation: 95 percent (normal) oxygen level was at 95%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       48 hours following the first dose administration of mRNA-1273 the patient experienced projectile vomiting and diarrhea, which lasted for 2-3 days as well as extreme fatigue that lasted for 7 - 10days. Lower level fatigue continued for an additional 14 days with all symptoms resolved by 15-Mar-2021.  At the time of the report the follow-up report received on 24-Jun-2021, the patient's caregiver's decided not to have the patient receive the second dose due to concerns over how her body might handle it.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Significant Follow-up - Patient demographics, relevant history, concomitant products, vaccine facility details, new event ''Diarrhea'' added and narrative updated.
Plaintiff suffered shingles; Information has been received from a lawyer referring to a female patient (pt) of unknown age regarding a case in litigation. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  In or around September 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, on an unspecified date, pt suffered shingles (herpes zoster) and as a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using this product. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Additionally, pt sustained severe and permanent personal injuries and suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Pt also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  At the reporting time, the pt was not recovered from shingles and it was considered to be related to zoster vaccine live (ZOSTAVAX).    Herpes zoster was considered a disabling event.
administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) 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 milliliter. On an unknown date, the patient experienced OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
-vibrations in right foot 2/27/22 and 2/28/22 -right knee starts to hurt 3/3/22 -went to PCP on 3/4/22;  x-ray of right knee ordered; inconclusive -went for bone scan on 3/11/22; no damage seen to right knee; arthritis in both feet seen -begin physical therapy on 3/16/22 -3/18/22 - 2nd toe on right foot swells up and is very painful -went to urgent care 3/20/22; prescription given for naproxen for 10 days -went to Podiatrist on 3/22/22; swelling had already reduced; maybe gout?;  blood uric acid level was normal -went for MRI on 3/23/22 - bone infarct in right knee -went to orthopedic MD on 3/28/22; right knee is much better by now; to follow up with orthopedic MD in 3 months if necessary
patient called 2 weeks after getting vaccine to say his arm continued to be extremely itchy. Advised patient to contact PCP, use topical and oral anti histamines.
The site of injection was warm; Feels a little lump; The site of injection was itching; Site of injection was red; The site of injection was tender; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching) and VACCINATION SITE ERYTHEMA (Site of injection was red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 14-Feb-2021, the patient experienced VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching), VACCINATION SITE ERYTHEMA (Site of injection was red) and VACCINATION SITE PAIN (The site of injection was tender). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (The site of injection was warm), VACCINATION SITE MASS (Feels a little lump), VACCINATION SITE PRURITUS (The site of injection was itching), VACCINATION SITE ERYTHEMA (Site of injection was red) and VACCINATION SITE PAIN (The site of injection was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter.
Client reported yesterday afternoon she started to feel achey, fever, headache, and fatigue. No shortness of breath or cough.
SM with left upper arm pain, paresthesias, mild weakness, with onset of symptoms in late Aug to Sep 2007. Pain is migratory, focal, non radicular, not isolated to particular nerve distribution; paresthesias in ulnar distribution.
Patients left deltoid was swelled up 4" in diameter and 1/2" high. Redness, itching, hot to touch, w/no fever.
Narrative:  Male 64 yo patient died on 3/25/2022 of cardiac arrest at outside community hospital on 3/25/2022. Pt had received a covid EUA vaccine on 7/30/2021 (J&J). See pt's problem list below per medical chart: 12 Problems ST PROBLEM LAST MOD PROVIDER A Alcohol dependence (SCT 66590003) (ICD-10-CM 06/17/2021 F10.29) A Severe alcohol dependence (SCT 713862009) 12/23/2020 (ICD-10-CM F10.20) A Pulmonary emphysema (SCT 87433001) (ICD-10-CM 03/31/2020 J43.9) A House rented from housing association (SCT 04/06/2018 160939001) (ICD-10-CM Z59.9) A Unemployed (SCT 73438004) (ICD-10-CM Z56.0) 04/06/2018 A Full thickness rotator cuff tear (SCT 202843000) 12/01/2017 (ICD-10-CM M75.122) A Tear of left rotator cuff (SCT 08/20/2017 11892411000119102) (ICD-10-CM S46.092S) A Glaucoma (SCT 23986001) (ICD-10-CM H40.9) 08/20/2017 A Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.5) 02/23/2017 A History of mechanical aortic valve replacement 10/26/2015 (SCT 125411000119107) (ICD-10-CM I35.0) A Hyperlipidemia (SCT 55822004) (ICD-10-CM E78.0) 10/26/2015 A Persistent alcohol abuse (SCT 284591009) 10/13/2015 (ICD-10-CM F10.10) Likely vaccine not related to pt's death given history of heart condition. Info in chart regarding ER admission to community hospital below: Patient self-presented to community emergency facility Emergency Notification Intake Date Presenting to the Facility: 3/16/2022 Hospital Chief complaint: CARDIAC ARREST Primary Diagnosis:CARDIAC ARREST Patient Admitted? Yes Route of Admission: ER Date/Time of Admission:3/16/2022 Admitting Diagnosis:CARDIAC ARREST Community Care Provider: Confirm Level of Care: Acute Inpatient Care
Initial case was received from a physician, who is also the patient's parent, on 09 October 2009. The physician reported that this patient experienced a similar event following FLUZONE vaccination in 2008; this event is captured in case number 2009-04270. An eight-year-old male patient experienced localized swelling and redness, and diminished abduction of the shoulder, after receiving an intramuscular injection of FLUZONE (lot not reported) on 06 October 2009. The patient had a history of allergies to AUGMENTIN, Penicillin, and Amoxicillin, and had previously experienced similar adverse events following FLUZONE injection. The day of vaccination, the patient developed swelling and redness localized in the shoulder. He was unable to abduct his shoulder greater than 30 degrees. At the time of the event, the events had not yet recovered. Follow-up information received on 18 December 2009 from the patient's parent who is a physician. The patient had no concurrent illnesses at time of vaccination, and does not take any concomitant medications. The patient recovered; however a recovery date was not provided. No further information is expected. Documents held by sender: None.
PATIENT REPORTED PAIN IN THE INJECTED ARM AS WELL AS TINGLING IN BOTH HANDS/ARMS (MORE SO IN INJECTED ARM.   AT SITE OF INJECTION SITE IS A HARD WHITE AREA SURROUNDED BY A BRUISE AND THEN REDNESS. HE DESCRIBED THE AREA TO BE THE SIZE OF A 50 CENT PIECE AND FIRST NOTICED IT THE DAY AFTER THE IMMUNIZATION.  HE ALSO REPORTED SOME NIGHT SWEATS FOR 3 DAYS FOLLOWING THE IMMUNIZATION.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 74 years old female patient who experienced tongue and body swelling, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 11-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1981AA. The patient developed a non-serious tongue and body swelling following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was tongue and body swelling. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for tongue and body swelling.
Completely covered in hives. Arms, legs, back, neck, face, feet. Allegy medicine doing little to stop break out despite using two claritin 24hour medicine (recommended dose 1).
I had went for a routine checkup at 14 weeks pregnant t. OBGYN.  I consulted her about my hesitancy to get the vaccine while pregnant.  I was due with a boy for 11/4.  I had an IUD in when I was discovered I was pregnant.  At was removed at 6 weeks pregnant.  I had multiple scans, checkups, a Natera Panorama evaluation he was doing great.  I scheduled my Pfizer at the local CVS for that evening.  My next appointment was  the Perinatal Center (due to advanced maternal age) when I was 20 weeks 5 days pregnant and the scans revealed no heartbeat and he stopped growing shortly after I received my first dose.  That was 6/22.  I was induced and delivered him at 21 weeks pregnant at hospital.  I have 3 living children.  They are 7.5, 5 and 2.5.  I have had 3 miscarriages prior.  One at 6 weeks, 8 weeks and 9 weeks.
This spontaneous report was received from a nurse refers to currently 12-year-old patient. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapies included sterile diluents. On 12-FEB-2018, the patient was vaccinated with improperly stored VARIVAX (Lot # N012619 and expiration date 21-APR-2019), (Lot # N025932 and expiration date 19-SEP-2019) for prophylaxis. The nurse stated that she has spoken to someone at Merck who determined that VARIVAX (lot # N012619) could still be used. Temperature excursion details were provided. Temperature/Time frame was -14 degree Celsius to -10 degree Celsius (-14.3 degree Celsius) for 1 hour 6 minutes. There were no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of the six reports linked via same reporter link. Sender's Comments: US-009507513-1802USA007855.
Rash; This is a spontaneous report from a contactable consumer (patient).   This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL3247), via an unspecified route of administration at single dose on 19Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced rash on 21Jan2021 with outcome of unknown.
Symptoms of Bells Palsy that have gotten progressively worse since 2/3 til today 2/6. TX with Valtrex and prednisone. Outcome- TBD
First Grand Mal Tonic-Clonic Seizure (3/28/2016). Second Grand Mal Tonic-Clonic Seizure 1/20/2017. Third/Fourth Grand Mal Tonic-Clonic Seizure 3/10/2017. Fifth/Final Grand Mal Tonic-Clonic Seizure leading to death: 4/8/2017.
Weakness, Dizziness and supraventricular tachycardia (SVT)
1/12/22 @ 11 pm  began to feel fatigue and headache.   1/13/21 in AM felt short of breath and winded, also felt as if he had congestion/phlegm in his lungs.   Went to PCP & got Covid tested.
Case number PHEH2012US008972 is an initial spontaneous report received from a nurse on 25 Apr 2012 with a follow up information received on 21 May 2012. This report refers to a 22-year-old female patient. Her medical history, concomitant medications and vaccination history were not reported. She was vaccinated with MENVEO vaccine (batch number: A11041, expiry date: 01 Mar 2014) at a dose of 0.5ml intramuscularly on to left deltoid on 24 Apr 2012. Fifteen minutes after vaccination she began to experience pain in her left lateral upper leg that slowly traveled up to her left arm and to left side of neck and jaw. Around this time she also began to experience fatigue and weakness. She was treated with ZYRTEC and BENADRYL along with TYLENOL and ibuprofen for pain. She was asked to return to the clinic if symptoms persisted. The outcome of the event was reported as completed recovery and the causality was assessed as not suspected. No further information was available. Follow up information received on 21 May 2012: Expiry date and treatment drugs updated, Event outcome and causality updated. Weakness was captured as an event.
Anaphylaxis; This case was reported by a physician via call center representative and described the occurrence of anaphylaxis in a female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Concurrent medical conditions included allergic to horses (horse derived products).   On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.   It was unknown if the reporter considered the anaphylaxis to be related to dTpa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine outside the country, but declined to state which country. A long time age before the reporting, the patient had a anaphylactic reaction to an unknown Diphtheria, Tetanus and Pertussis (Tdap) vaccine. The agent filing Boostrix, as unable to confirm product. The healthcare professional (HCP) was considering administering Boostrix to the patient on 26th April 2019 due to an injury she sustained. After hearing the information on product of animal origin, the HCP indicated that he would not vaccinate the patient.
Patient received expired dose of the Janssen Covid Vaccine. Vial expired on 5/6/21 at 4:46pm. Pharmacy Technician went to the ED to refill the vaccine and noticed the vial did not have an expiration date on it, just a time. This was notified to pharmacy management. A report was run and the vial was opened on 5/6/21 at 10:46am. Therefore it expired on 5/6/21 at 4:46pm. The other vial in the ED fridge was closed. Therefore, the dose must have come from the expired vial. The dose was given on 5/7 at 0534am. ED Director and ED Manager notified. Per instructions, Janssen contacted for direction on whether to revaccinate. No information available. leadership offered antibody testing to patient in a few weeks, with further direction based on results.
just felt a little tired; This is a spontaneous report from a contactable consumer (patient) received via the Medical Information Team. A female patient of an unspecified age (reported as patient's age: 81; unit: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. The patient just felt a little tired on an unspecified date, after receiving the first BNT162B2 vaccine. The patient asked if it's possible to overdose from the second dose of the vaccine if someone already had COVID and were the side effects more severe. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous reprot was received from a healthcare professional refers to unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with M-M-R II injection (dose, route, frequency and lot # unspecified). No concomitant medications were reported. On an unknown date unspecified patients received doses of improperly stored MMRII or ROTATEQ oral (related case). Patient did not experience any adverse effects. No further information was provided. There was no Product Quality Complaint (PQC) involved. The outcome of incorrect product storage was unkonwn. This case is linked to: 1507USA000919. Additional information has been requested.
I woke up on Monday morning with both feet feeling like they were asleep.  Tingling in the toes.  This has continued for the last three days and it has gone up my legs to my waist over the last 2 days.  Both legs feel numb most of the day.  I can still function but it is very noticeable.
Right side of top lip went numb. Right side of nostril opening went numb . Occurred after 2nd dose.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX vaccine (lot number, dosage, and route of administration not provided) on or about 01-OCT-2015, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles. On or about 10-SEP-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient was prescribed antiviral therapies (unspecified) for management of her painful symptoms and outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received Tdap & MENACTRA at visit. Both injection were placed in the same arm. Starting Wednesday evening (same day of injection) the left arm started to swell & become blotchy. Patient called & came in 1/27/12 (Friday) with redness & swelling, heat to left arm - has induration of 10x8cm. Father was informed on how to care for it.
Strong, pounding headache; 102 fever with chills and aches; arm pain from 1pm until 4am the next day. No treatment
Information has been received from a nurse concerning a 16 year old female who on 01-AUG-2008 was vaccinated with the first dose of GARDASIL vaccine (route and site not reported), on 19-SEP-2008 was vaccinated with the second dose of GARDASIL vaccine (route and site not reported). On an unknown date after receiving second dose of vaccination, the patient developed swollen lymph nodes under both arms. The patient sought unspecified medical attention. Additional information has been requested.