chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history or concomitant medications. In 2010, the patient was administered ZOSTAVAX by a physician (dose, route, and lot # not provided). The physician recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, the patient was treated by the same physician for shingles. She was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered.  Causality assessment was related. Additional information has been requested.
Rash appeared at the localized injection site on right deltoid area (size of palm of hand).  Patient states she experienced some itch, redness, and that the area feels hot to the touch.  Patient also reports a fever and sore arm and that Tylenol provided relief.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, FEELING HOT, ERYTHEMA, and HEADACHE in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 028A21A, and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy to Tetracycline, causes yeast infections, Blood pressure, Cholesterol, and Inflammation. Concomitant products included OMEPRAZOLE for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced FEELING ABNORMAL, HEADACHE, PYREXIA. On 05-Nov-2021, the patient experienced FEELING ABNORMAL. On an unknown date, the patient experienced FEELING HOT and ERYTHEMA. On 05-Nov-2021, PYREXIA had resolved. At the time of the report, FEELING ABNORMAL and HEADACHE had not resolved and FEELING HOT and ERYTHEMA outcome was unknown. Patient was taking a medication for blood pressure, cholesterol and an anti-inflammatory medication. No treatment medications were provided.
Information has been received from a medical assistant concerning a 21 year old female with penicillin allergy (cause edema), anxiety, depression, asthma, migraines, thalasemia and seizure disorder (as a baby) who on 07-AUG-2007 was vaccinated with the first dose of Gardasil (Lot # 657868/0523U), on 05-OCT-2007 was vaccinated with the second dose of Gardasil (Lot # 658558/1061U), and on 08-FEB-2008 was vaccinated IM with the third (0.5 ml) dose of Gardasil (Lot # 658282/1263U).  There was no concomitant medication.  After the first and second doses of Gardasil the patient experienced nausea.  Three hours after receiving the third dose of Gardasil the patient became nauseous, had trouble breathing, and developed hives.  The patient was instructed to take BENADRYL and her symptoms resolved.  Medical attention was sought through a phone call.  No product quality complaint was involved.  Additional information has been requested. Followup information received from a nurse indicated that after receiving the third dose of HPV Gardisil vaccine (yeast) on 08-FEB-2008, the patient left the office after 15 minutes waiting time. No complication/adverse reactions noted. Telephone call to office about 3hours later by the patient was complaining of redness on left arm at injection site and facial irritation (hives). The patient was instructed to take diphenhydramine hydrochloride (BENADRYL) and if the symptoms continued to go to the emergency room. During a telephone call from patient at 4:443 pm the patient stated that she did not take diphenhydramine hydrochloride (BENADRYL) and her "throat seems to be closing". She was told to call 911 and go to the emergency room. Telephone call back tp patient indicated that she never went to the emergency room or took diphenhydramine hydrochloride (BENADRYL) and feels fine. The patient had no reaction to the previous two doses of HPV Gardisil vaccine (yeast). Additioanl information has been requested.
Fever 105+; refused to walk, sit or roll over x 3 days; screamed when touched;
Fatigue, intense full body pain, rapid heartbeat, winded by just walking, diarrhea, loss of appetite, chills, sweats, fever, abnormal headache- shooting pain in back rt side of head Fever broke after about 24 hours. Heartbeat, breathing, chills after 36 hours. Pain and fatigue lasted 48 hours+  Able to eat after 48 hours . Still have headache but not severe.
Pt experienced Fever, Stiff Neck, Body Aches, Swelling in arm of injection. Symptoms occurred this morning.
pt had felt ill since the vaccine. pt now on week 3 of body aching, anorexia, nausea, epigastric pain, nightly fever to 101. sx started quickly after the vaccine.having diarrhea, brown stool.extreme fatigue
Vacinee rec'd a "full course" of 3 Engerix-B vax according to 0, 1, 6 schedule; 31AUG90 (about 1 mo p/ 3rd dose) "drew surface Antigen" & it was determined that the vaccinee "did not respond."
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. Pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On 06-JUL-2016, the patients were inadvertently vaccinated with improperly stored MMR II injection (lot # L028273 with expiry date 28-JUL-2016, dose and route were not reported). No adverse effects reported. There was no product quality complaint (PQC) involved. Additional information is not expected as the reporter denied consent to be contacted for further information.
One hour after receiving influenza vaccine. Felt an itch at injection site and noticed one raised red area by the injection site. Benadryl 25 mg PO taken. Raised area resolved at 10/09/2005.
Info has been received from a health professional concerning a 14 month old white female described as healthy with no known medical history or allergies who on 1/28/2005 at 10:30 AM, was vaccinated SC in the left arm with a 1st dose of MMRII. In the right arm, an IM 4th dose of Daptacel, in the left thigh and an IM 4th dose of ActHib, in the right thigh. There was no illness at the time of vaccination. On 3/20/05, the pt developed breakthrough varicella that started with a few, about 25-30, lesions in the diaper area after exposure to a child with chickenpox in a church nursery. The pt also had a runny nose and a slight fever. It was reported that the pt's illness lasted about 1 1/2 weeks. Unspecified medical attention was sought. There was no treatment given. There were no relevant lab or diagnostic tests performed. The pt's vaccination history included a 1st , 2nd and third dose of DTAP on 3/4/04. 5/14/04 (lot FU1258DA), 7/23/03 (lot FU1314DA), a 1st, 2nd and 3rd dose of Hib on 3/4/04, on 5/14/04 (lot PUE089AE) and on 7/23/04 (lot P1216M), a 1st, 2nd and 3rd dose of poliovirus vaccine inactivated on 3/4/04, 5/14/04 (lot FX05542) and 7/23/04 (lot FX05542), a 1st and 2nd dose Hep-B on 1/05/04 and 3/4/04, a 1st dose of Hep-B virus vaccine rHBaAg: yeast) (+) Hib conj vaccine on 7/23/04 (lot F1216M), and a 1st dose of pneumococcal conj vaccine on 3/4/04. There were no adverse events following prior vaccination. Subsequently, the pt recovered. There was no product quality complaint involved. Additional info is not expected.
Injection Site Pain - 20:30 on 11/11 Fevers, chills, myalgias (specifically lower back), headache, nausea, vomiting
My initial time that I thought I was getting it was 11/25/2022. I had a very minor irritation in my throat, and I was slightly congested in my sinuses. I did not develop a fever. My first at home COVID-19 test was 11/27/2022. I checked my temperature twice a day and I called the doctor on Monday 11/28/2022. He prescribed prednisone and PAXLOVID, but I never took it. I took MUCINEX to treat my symptoms. I began to feel better after about 3 days or 4 days afterwards. Within 5 days all my symptoms were gone but I continued to test positive until 12/08/2022. During this time my blood glucose levels have been higher than normal. I am in the 135 mid-range and I have a follow up appointment with my doctor in February regarding this.
This is the seventh of eight spontaneous reports as received from a physician refers a female patient between 14-15 years old who throughout this year "in 2012", was vaccinated IM with a dose of GARDASIL (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. The physician stated that the patient suffered from syncope after having GARDASIL vaccination. The syncope was also more prevalent with the first dose given than with subsequent doses. Orange juice was given as treatment. The patient did not seek medical attention. The patient improved before leaving the office. The patient's outcome was recovered. The relatedness for syncope was unknown for GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Rash, red skin color - came and gone twice. Complaint: feels nerve pain, tremendous pain. On-going. MD says nerve damage - reports headache due to pain - reports shoulder pain. Cannot bend elbow - chronic pain since administered - feels like needle attack, chronic.
Resident tested positive for COVID on 01/11/2021. Resident received out patient monoclonal antibody treatment on 01/12/2021. Resident received out patient IV fluid bolus (NS  2 liter) on 01/13/2021
PATIENT RECEIVED AN EXPIRED DOSE OF PFIZER.  HE HAD A SORE ARM, HEADACHE, AND FELT SLUGGISH.  HE WILL BE IN FOR A REVACCINATION
Information has been received from a licensed practical nurse concerning a 73 year old female who on 10/21/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647635/0864N), in the right arm deltoid area.  On 10/21/2004, in the evening, the patient developed cellulitis band around the muscle and vomiting.  The patient was treated with diphenhydramine HCL (Benadryl by mouth) and ice pack as needed.
Nausea; Feeling still tired; Fever (100.5-100.7); Uncomfortable and druggy; chills; Throwing up; Real bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and NAUSEA (Nausea) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 030L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and PYREXIA (Fever (100.5-100.7)). On 07-Dec-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Feeling still tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Uncomfortable and druggy), CHILLS (chills), VOMITING (Throwing up), HEADACHE (Real bad headache) and NAUSEA (Nausea) outcome was unknown and PYREXIA (Fever (100.5-100.7)) and FATIGUE (Feeling still tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2021, Body temperature: 100.7 (High) High. On 07-Dec-2021, Body temperature: 100.5 (High) High.         No concomitant medication was reported.   This case was linked to MOD-2021-406043 (Patient Link).
Gastro-enteritis sx p/1st dose & flu-like sx p/4th dose;
At time weakness in extremities, numbness, difficulty walking and climbing stairs. Diagnosed with GBS, later changed to CIPD due to recurring symptoms. Still under IVIG out patient treatment. Not certain of definite causality. But have deep concerns due to other GBS outbreaks in past.  03/18/2009 MR received for multiple DOS 7/20-26/2008 with DX:  Myasthenia Gravis.  Guillaine-Barre Syndrome.  ER visits 10/10/08 with same dx and 11/9/08 with DX: Chronic Relapsing Inflammatory Polyneuropathy.  Weakness.  Initially presented to PCP with c/o urinary frequency and urgency and leg weakness which began ~7/10/08, tx with abx.  Returned several days later with numbness and weakness in the feet which was progressing to numbness and tingling in fingertips. PE (+) for decreased strength in legs, sensory loss, and inability to walk without support.  Admitted with provisional dx of GBS. Tx with IVIG with some improvement. Returned 10/10/08 with mild bilateral paraparesis, most prominant in hip flexors and paresthesias.  Admitted for repeat course of IVIG.  Now entertaining dx of CIDP vs MG flare. Pt again returned  with increased weakness and pain bilaterally of lower ext, abd and torso with difficulty breathing. DX canged to CIDP-relapsing.
I likely had COVID-19 during the week of Feb. 14, 2021. My hematologist was sure I had it, in retrospect.; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose.  A 73-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL9265), via an unspecified route of administration, administered in Arm Right on 12Feb2021 16:30 as 1stdose, single covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced i likely had covid-19 during the week of feb. 14, 2021. my hematologist was sure i had it, in retrospect. on 14Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on   Nasal Swab. No patient did not have any other vaccine in four weeks, patient had other medication in two weeks, Patient had physician office visit. Treatment was not received. No, covid prior vaccination, yes it was tested Covid post vaccination, no known allergies. Upon follow -up on 09Sep2021 Follow-up attempts are completed. No further information is expected. Outcome of the event was unknown.    Follow-up (09Sep2021): Follow-up attempts are completed. No further information is expected.
Sedation, Myalgia, inj site soreness, body aches, fatigue, decreased concentration, feeling flush, sleepy x2 days Narrative:
Fever of 102°F, pretty intense body aches starting at 3 AM after vaccine. Took Advil, went back to bed around 4:30AM. Woke up at 8:30AM feeling mostly okay. On and off body aches rest of the day.
Swelling in throat, swelling of thyroid, start with tightness in throat on day1, Day 4 swelling increase difficulty swallowing and swelling of thyroid, Day 5 ER visit- swelling throat, swollen thyroid.  Given steroid shot, pepcid and benadryl. Swelling decreased a little. Continue medications for 10 days.
received a dose that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HBV (Engerix B) (batch number AN599, expiry date 8th November 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st November 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 21st November 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Nov-2022 Reporter's comment: The pharmacist asked that should they repeat the dose. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Later the night of the 25th of September, started feeling pain from the injection site all the way down to the bottom of the wrist. Could not move the arm with help with the Right arm. The pain was sever. Got nauseas and had chills and believes to have had a fever but isn't sure.
Itching, redness and swelling on the injection site. Dr. Prescribed  antiniotic Bactrim DS 800-160  Tab
headache, chills, body aches, temperature, fatigue, night sweats, 3 days
Fever up to 100; myalgias; chills; wheezing; coughing; some shortness of breath; This is a spontaneous report from a contactable Other Healthcare professional. A 41-year-old female patient received first dose BNT162B2 via Intramuscular at Arm Left on 18Dec2020 15:00 at the 41-year-old at single dose for COVID-19 immunization. The medical history included Asthma, GERD, insomnia, bladder pain syndrome and COVID-19(Prior to vaccination, was the patient diagnosed with COVID-19). The concomitant medications were Amitriptyline, Trazodone, diphenhydramine hydrochloride (BENADRYL), Omeprazole, macrogol 3350(MIRALAX), mometasone furoate (ASMANEX), Naproxen. Symptoms started 7 days after injection. On18Dec2020 12:00 the patient experienced Fever up to 100, myalgias, chills, wheezing, coughing, some shortness of breath.  The patient received treatment Naproxen for the adverse events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Metallic taste in mouth so bad that i cannot drink anything besides water as the taste is awful. Left side from arm to leg is hurting
Patient is admitted for management with concern for possible UTI and osteomyelitis of his left heel - Diabetic ulcer of left heel associated with diabetes mellitus . Treated and discharged. Hospital admission within 6 weeks of receiving the COVID vaccine.
Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Astrocytoma (Astrocytoma in brain,100 percent resection, no chemo  or radiation) in 2019 and Astrocytoma resection (Astrocytoma in brain, 100 percent resection, no chemo  or radiation). Concurrent medical conditions included Allergy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose one administered on 24-MAR-2021 and dose 2 administered on 17-Apr-2021) outcome was unknown.            Concomitant medications were not reported.  Patient had took third dose of Moderna vaccine on 02-Dec-2021 on right arm.  Treatment information was not reported.   This case was linked to MOD-2022-580358 (Patient Link).
Hives on chest, upper back, upper arms, and face, red and itchy, subsided with Childrens Benadryl (7.5 ml). Hives occurred again the following three nights, subsiding with Benadryl or Allegra doses of 5 ml each time.
One week after my shot my arm had became itchy and red. Now it is not itchy, but it is red and the swelling spot has grown from a small mosquito bite size to the size of my palm. Very warm to the touch and my right arm is sore.
Pallor, lifelessness, diapharesis; tachycardia, poor responsiveness; hypotonicity;
24hr p/vax pt became sleepy & slept for 3-4hr in AM;pt ate lunch & went back to sleep;pt roused & could not stand up for next 48hr;able to eat & drink lying supine;nauseated & vomit w/in 2-5min;tx w/med;
SEVERE BODY ACHES; NIGHTMARES; LETHARGY; ARM SWELLING; HEADACHE; FEVER; SEVERE FATIGUE; This spontaneous report received from a patient via a company representative concerned an 18 year old male. 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, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced severe body aches, nightmares, lethargy, arm swelling, headache, fever, and severe fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever, severe body aches, nightmares, lethargy, severe fatigue and arm swelling was not reported. This report was non-serious.
Pfizer 4/22/21, 5/13/21, 7/28/22. Positive on 11/28/22