chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 at 13:00 as dose 2 (booster), single (Lot number: FD0809), in right arm and on 15Apr2022 at 15:00 as dose 3 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 09Mar2021 at 14:00 as dose 1, single (Lot number: 1805022), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Hypertension" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Aging" (unspecified if ongoing), notes: Other medical history: Hashimotos, Hypertension, Aging; "Known allergies: Nickel" (unspecified if ongoing), notes: Known allergies: Nickel, Adhesive; "Known allergies: Adhesive" (unspecified if ongoing), notes: Known allergies: Nickel, Adhesive; "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 16Jan2010; CARVEDILOL, start date: 06Jun2019; ROSUVASTATIN CALCIUM, start date: 21May2022; XARELTO, start date: 21May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was reported that patient had received Other medication in 2weeks. Patient had received Paxlovid from 19Jul2022 to 23Jul2022 as a treatment of covid-19.
Information has been received from a RN concerning a female who a week ago was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (0.5ml) (lot 651332/1049P), SC. Subsequently, the pt experienced warm, red, swollen local reaction. The pt's primary physician was contacted and suggested application of ice and to continue monitoring the pt. The pt was also given diphenhydramine (Benadryl). It took approx four days for the symptoms to resolve. The pt recovered. There were no relevant diagnostic or lab tests performed. The nurse requested a lot check. The records of testing prior to release of this lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Sore arm beginning about 6 hours after vaccination, chills, body and head aches at about 18 hours after vaccination lasting about 12 hours before  subsiding.
I had a full body flat non itchy red rash that lasted 4 days Stinging pain and alternating numbness in both hands, more on the left hand, this lasted for four months, gone now I had fever for 2 days I stayed home and rested until I was better and rash was gone I am a registered nurse
first vaccine that her left arm was swollen; left arm was swollen and hurt from first one; could not move it for a week; This is a spontaneous report from a contactable consumer (patient, reported for herself).  A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734) via unspecified route of administered in left arm on an unspecified date (at the age of 56-year-old) as dose 1, single for covid-19 immunization. Medical history included autoimmune disorder and patient stated that, so she was weak anyway. The patient's concomitant medications were not reported. Patient stated that with the first vaccine that her left arm was swollen and hurt from first one and could not move it for a week, all on an unknown date. Stated that it got better. Outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
exacerbation of herpes zoster p/vax;group vesicles on erythematous base of lt upper arm; tx w/ acyclovir;pt cont itching x 5 days;med given;outbreak of herpes zoster may or may not be r/t vax; will cont w/ vax series & will monitor closely
Temp. 100.5 for 6 days. Swollen glands in neck 6-7 days.
Left arm swollen, swelling extending especially to the shoulder anteriorly, slight tenderness and warmth. No fever. Treated with Keflex and Benadryl. To RTC 9/19/05. 9/20/05 made phone call to home, child's arm ok now.
At 530pm 9/29/2010 arm very sore; by evening whole shoulder are very painful. 9/30 AM unable to raise arm or reach backward. Used ice compresses to relieve pain. Finally went to P.P. 10/11/2010.
This spontaneous report as received from a nurse (also reported medical assistant) via company representative refers to a 65 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-JUN-2016, the patient was inadvertently vaccinated with a dose of VARIVAX (dose, route of administration, indication, lot # and expiration date were not reported) instead of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
This spontaneous report was received from a currently 71 years old female patient who was sensitive to latex. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number, expiration date were not reported) in the left arm. Concomitant therapies included antiviral medicine (unspecified) and itching medicine (unspecified). On an unknown date, reported as "about 6 weeks later", the patient experienced a reaction included a rash and it was itchy. The patient got lesions on her right side of the arm and she felt a sunburn sensation. There was unspecified treatment given for the events. The outcome of the events was reported as recovering. Relatedness between the events and vaccination with ZOSTAVAX was not reported. Additional information has been requested.
No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced CHILLS (chills) and HEADACHE (headaches). At the time of the report, CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
hives/rashes started to appear first on the head; hives/rashes started to appear over the back; hives/rashes started to appear on the chest; hives/rashes started to appear first on the head; hives/rashes started to appear over the back; hives/rashes started to appear on the chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives/rashes started to appear first on the head), URTICARIA (hives/rashes started to appear over the back), URTICARIA (hives/rashes started to appear on the chest), RASH (hives/rashes started to appear first on the head) and RASH (hives/rashes started to appear over the back) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACLIDINIUM for COPD, HYDROXYCHLOROQUINE, ACETAMINOPHEN, SALBUTAMOL (ALBUTEROL HFA), AMLODIPINE, CARVEDILOL, FINASTERIDE, FUROSEMIDE, LISINOPRIL, PRAVASTATIN, SERTRALINE, TAMSULOSIN and WARFARIN for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced URTICARIA (hives/rashes started to appear first on the head), URTICARIA (hives/rashes started to appear over the back), URTICARIA (hives/rashes started to appear on the chest), RASH (hives/rashes started to appear first on the head), RASH (hives/rashes started to appear over the back) and RASH (hives/rashes started to appear on the chest). At the time of the report, URTICARIA (hives/rashes started to appear first on the head), URTICARIA (hives/rashes started to appear over the back), URTICARIA (hives/rashes started to appear on the chest), RASH (hives/rashes started to appear first on the head), RASH (hives/rashes started to appear over the back) and RASH (hives/rashes started to appear on the chest) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment medications included Betamethasone 0.5% cream and Augmenter cream oral Prednisone treatment for 10 days.
This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 61-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved. It was unknown if the reporter considered the tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 60 years or 61 years. The case was reported by the patient's brother who stated that the patient experienced tiredness with the SHINGRIX vaccine. The patient recovered the next day. The reporter provided the consent to follow up. No further information was provided. This case has been linked with case US2019061856, reported for the patient.
Five days after my Pfizer shot (05/13/21), woken up by extreme dizziness while turning on my side in bed. Was nauseous, with vomitting and diarrhea, chills, sweats, tinnitus, for 4 hours. Had eaten shrimp for dinner, and thought I might have food poisoning, but was so weak, disoriented, and alone that I called 911 for help. Was taken to the hospital. Three hours later, was given meclizine and hydration intravenously, a CAT scan, and sent home. Felt ok Fri (05/14/21). Haven't picked up any meclizine yet, but was/am using dimenhydrinate, which is becoming less effective today (05/15/21).
Shingles and hives all over; Shingles and hives all over; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) at 56 years old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were none. The patient experienced shingles and hives all over (Disability) on 28Jun2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received Antiviral medicine as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome was not recovered.  Information on lot/batch number has been requested.
Moderate pain at site x 1 day, short intermittent sharp pain in chest, nausea; left side facial sensitivity to touch and cold, nausea, and diarrhea
Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the Moderna booster and was by error administered a dose from an expired vial (Lot 038C21A). Patient did not have an adverse reaction that was noted. Reporter notified and asked them  to return to receive a re-dosing of the Moderna booster with an un expired vial(Lot 037C21A) , per our supervisors instructions.  No concomitant medications were reported. No treatment information were reported.
Client received the Pfizer vaccine with lot number EW0161 exp. 07.31.21 at 1256 pm on 04/13/21. At 1312 client verbalized to EMT was experiencing light-headedness after receiving her first dose of the Pizer vaccine. Client was then assisted by EMT and vaccinator to lay down on the gravity bed at EMT station. Translator was called over to help communicate to client, who is Spanish speaking. Client's airway remained patent and client appeared pink/warm and skin dry. Client denied any nausea or vomiting. Client stated that she felt anxious and was light-headed. EMT took the first set of vitals from client manually, and subsequent vitals were taken from wrist cuff. Vital signs at 1312 were: blood pressure of 138/92, pulse of 70, pulse oximetry of 98% on room air with round equal and reactive pupils, remaining alert and oriented to person, place and time. Client then reported having a history of hypertension along with mild allergic reaction to peanuts and shellfish, which resulted in full body rash and some respiratory difficulties. Client also reports taking 16 mg hydrochlorothiazide, for hypertension. Client was then monitored for 30 minutes sand vitals were taken every 5 mins. Vital signs at 1319 were: blood pressure of 141/87, pulse of 79, pulse oximetry of 98% on room air with round, equal and reactive pupils remaining alert and oriented to person, place and time. Vital signs at 1324 were: blood pressure of 140/80, pulse of 78, pulse oximetry of 98% on room air. Vital signs at 1328 were: blood pressure of 132/80, pulse of 81, pulse oximetry of 98% on room air. Vital signs at 1333 were: blood pressure of 134/82, pulse of 79, pulse oximetry of 99% on room air. Vital signs at 1338 were: blood pressure of 129/80, pulse of 68, pulse oximetry of 99% on room air. After 30 minutes, client again stated that she felt fine and that she was just anxious about getting the vaccine. Client's vital signs were within normal levels for client. No medications were administered to client and EMS was refused by client. Client was given information about what to monitor and was instructed to seek medical help if symptoms worsened after leaving. Client ambulated to car which was driven by a relative at 1345.
01/13/22 presents to ED for "shortness of breath, cough, dizziness". PMHx of "afib on eliquis, DM, htn, ESRD on dialysis (T,TH,Sat), prostate cancer, CHF"
Injection site red and swollen. pt had vomiting and diarrhea x one day. acting fine today 05/31/2016.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. On unknown dates the patients were inadvertently vaccinated with doses of improperly stored ROTATEQ (lot # and expiration date were not reported) orally. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Just before falling asleep on day seven, my left upper arm was itchy, but thought nothing of it and went to sleep. The next morning I noticed a large red, oval lesion around the place where I had the vaccine shot. The rash appears to be fading slowly from the center out.
Diagmosed with Covid-19 on 09/13/2021.  Patient reports having nasal congestion and itchy sore throat since 9-10-2021.  Patients reports being fully vaccinated with Covid-19 vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 04-NOV-2016, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2018, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
chills, deep muscle pain in injected arm (almost neuropathic);arm shook uncontrollably;diff concentrating;felt like vagal exp like blacked out & dizzy;stress like h/a w/photophobia;myalgia ,arthralgia, numbness;not eating/sleeping well
Information was received from a licensed practical nurse referring to a 4 year old male patient. The patient's concomitant medication, pertinent medical history and drug reactions were not reported. On 03-AUG-2018, the patient was vaccinated using public funds at a private doctor's office/hospital with improperly stored vaccines of PROQUAD (lot # R002935, expiry date unknown) subcutaneously in the right arm and KINRIX (lot # 95FR9, expiry date unknown) intramuscularly in the left deltoid. The patient previously received one dose of PROQUAD and "4 doses of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (DTaP) and 3 doses of poliovirus vaccine inactivated (Vero) (IPV)". No prescription treatment was required for the experience. The temperature and time frame the vaccines exposed were unknown. Data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1808USA007644:
Student was administered Tdap and MCV4 based on Immunization record provided at tie of immunization which did not included Tdap and MCV4 doses. Student tolerated immunization swell, no Sx reported.
Information has been received from a health care professional concerning a 36 month old male with a history of asthma and an allergy to gelatin who on 9/26/01 was vaccinated with the 2nd dose of MMRII (lot 637837/0373L) which is contraindicated in pt's with an allergy to gelatin. There was no concomitant medication. It was reported that approx. 20 minutes after vaccination, the child developed wheezing, shortness of breath, facial swelling and hives and was dx'd with having an allergic reaction. The child was treated by his father who is a physician (treatment not specified). The child also complained that his throat felt funny and he experienced coughing and sneezing. At the time of this report, the outcome of the events was unknown. It was also reported that the child did not experience any problems following vaccination on 9/23/99 with the 1st dose of MMRII. Upon internal review, the allergic reaction was determined to be an "Other Medical Event". Additional information has been requested.
On June 12,2021 patient woke up (10am) and felt chest pain, nausea and loss of appetite (poor oral ingestion. He was brought to Health Center after evaluation patient was transferred to Hospital. On June 12, he was admitted to the Pediatric Intesive Care Unit with elevated troponins levels. Patient continue hospitalized chest pain and other symptoms has been resolved.   Inpatient medications:  Toradol 30mg IV q6hrs PRN for severe pain (7-10) Ibuprofen 40mg PO q8hr PRN Famotidine 20mg Iv q12hr Zofran 6mg IV q8hr PRN for nausea
pt who children devel chickenpox 24MAR97 recv vax 25MAR97 when 5mo pregnant;9APR(7 pt devel a severe case of chickenpox which got in lungs;20APR97 pt devel varicella penumonia & was hosp;it was estimated that pt was 20wk pregnant @ the time
My doctor advised that I should have a shingles shot. I am 70 years old and had the shingles in November of 1998. So I said ok and got the shot on October 8, 2014. About 2 hours later after just getting home, my midsection tightened up into camp like feelings and pangs of pain and this is the same area generally that I had the shingles in 1998. These new feelings lasted for about 3 days and went away. On Wednesday, October 29, again the cramps and pain pangs developed in the same area and have stayed intermittently for 4 days including this day that I am reporting this. I have not been sick to me stomach, my bowel normal. normal appetite..... just have the cramping and pains.....I am male with diabetes and sometimes high blood pressure. My blood glucose and blood pressure haven't changed during these episodes.
Extreme body aches, headache, chills, fever throughout the first night and for 10 hours the following day.    Treated with two Aspirin every 3 hours for 24 hours.  Second night: 2 aspirin, and 25 mg Benadryl. Lethargy, fatigue and headache continued for 3rd day following vaccine.  Fifth day after vaccine, slight headache
arm swollen/swelling; arm redness; injection site warmth/arm hot to the touch; itching; This case was reported by a physician via sales rep and described the occurrence of swelling arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced swelling arm, erythema of extremities, skin warm and itchy upper limbs. The patient was treated with ibuprofen (Motrin) and paracetamol (Tylenol). On an unknown date, the outcome of the swelling arm and erythema of extremities were not recovered/not resolved and the outcome of the skin warm and itchy upper limbs were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and itchy upper limbs to be related to Shingles vaccine.  Additional details were reported as follows:  The age at vaccination was not reported.  The patient had shingles vaccine 2 weeks before the reporting date and her arm was still swollen and red. The patient states that it was hot to the touch and itching and swelling was increased.  The physician spoke to the patient and recommended Tylenol and Motrin.