chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEIZURE-LIKE ACTIVITY AND FAINTING IMMEDIATELY UPON SYRINGE WITHDRAWAL. PT COMMENTED THEY "FELT FUNNY" AND "NOT OK" BEFORE PARTIALLY COLLAPSING. PT WAS ASSISTED TO FLOOR, FELT BETTER AFTER ABOUT 5 MINUTES, AND WAS MONITORED FOR 5 MORE MINUTES BEFORE BEING ALLOWED TO DEPART.
Lump on the injection site (1-1.5") after first shot; Pain  left arm on Movement after first shot; Uncomfortable to move the left arm after first shot; Left arm is a little weaker after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lump on the injection site (1-1.5") after first shot), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Pain  left arm on Movement after first shot), LIMB DISCOMFORT (Uncomfortable to move the left arm after first shot) and MUSCULAR WEAKNESS (Left arm is a little weaker after first shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE MASS (Lump on the injection site (1-1.5") after first shot), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Pain  left arm on Movement after first shot), LIMB DISCOMFORT (Uncomfortable to move the left arm after first shot) and MUSCULAR WEAKNESS (Left arm is a little weaker after first shot). At the time of the report, VACCINATION SITE MASS (Lump on the injection site (1-1.5") after first shot), ADMINISTRATION SITE MOVEMENT IMPAIRMENT (Pain  left arm on Movement after first shot), LIMB DISCOMFORT (Uncomfortable to move the left arm after first shot) and MUSCULAR WEAKNESS (Left arm is a little weaker after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states that when he moves the left arm he has awareness that the lump is there. Concomitant product use was not provided by the reporter.  No treatment information was provided.
HEADACHE, N&V, OCCIPITAL PAIN, TREMOR, SUB-DERMAL HEMMORAGE
Left axillary lymph node swelling, pain, and tenderness; Left axillary lymph node swelling, pain, and tenderness; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 09Jan2021 (18:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the public health clinic/veterans administration facility. Medical history included asthma. Concomitant medication included etonogestrel (NEXPLANON). The patient was not pregnant at the time of vaccination. On 10Jan2021 (18:00), the patient had left axillary lymph node swelling, pain and tenderness. The patient did not receive any treatment for the reported events. The outcome of the events, 'left axillary lymph node swelling, pain and tenderness', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, had nasal swab test for COVID-19 on 12Jan2021 which was negative.
More than usual pain with injection and then localized swelling, redness, "lump", and tender. This occurred within a few hours after the injection and still present 24 hours later.
pt devel hives on face, neck & chest approx 90min p/vax;hives cleared in less than 60min p/DPH;
Clammy; Hot; In pain; Feverish; Fatigue; Red/Erythema at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-1900, the patient experienced VACCINATION SITE ERYTHEMA (Red/Erythema at injection site). On 27-Jan-2021, the patient experienced COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish) and FATIGUE (Fatigue). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, COLD SWEAT (Clammy), FEELING HOT (Hot), PAIN (In pain), PYREXIA (Feverish), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red/Erythema at injection site) outcome was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
sharp pain in feet (neuropathy); swelling at site of injection; felt yucky and not feeling good at all; bad diarrhea; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 Vaccine(mRNA-1273) and experienced sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 03 Feb 2020, the patient received their first of two planned doses of mRNA-1273 (batch number-010M20A) for prophylaxis of COVID-19.  On 04 Feb 2020, at 4:00 AM, the patient experienced sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good.  No treatment medication was reported.  The outcome of events sharp pain in feet, vaccination site swelling, bad diarrhea and not just feeling good were reported Recovering/Resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fever with chills bad headache achy all over my body just took tylenol for headache and rested in bed for 2 days
By afternoon - patient experienced redness at injection site and swelling/arm was firm to touch. Pt. had fever of 101-102 degrees.
This spontaneous report was received from an unspecified reporter referring to a 17 year old patient of unknown gender. Information about the patient's medical history or concurrent conditions were not reported. On 04-AUG-2015, the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown), (dose, route of administration, lot # and expiration date were not provided). Concomitant medication was not reported. On an unknown date, the patient experienced a vaccine adverse experience. At the time of reporting, the outcome of vaccine adverse experience was unknown. The causality between vaccine adverse experience and quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. vaccine (manufacturer unknown) was unknown. This is one of several reports from the same source. Additional information has been requested.
11/9/99, immediately following injection, pt was anxious, pt developed localized redness at injection site, flushing, diaphoresis, pulse of 102, respirations - 32, b.p. 144/86.  Pt then developed dyspnea, glassy eyes and became agitated.
received 1st dose of vaccine on 27Jan2021. Daughter tested positive for covid 19 on "valentines day" (14Feb2021).; received 1st dose of vaccine on 27Jan2021. Daughter tested positive for covid 19 on "valentines day" (14Feb2021).; This is a spontaneous report from a contactable consumer reported for patient (Daughter). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient tested positive for covid 19 on valentines day (14Feb2021). Patient was supposed to get 2nd dose today. Caller asking if her daughter can get the 2nd dose today or if she needs to wait 90 days. Caller says she had also tested positive for covid but has not received a dose of vaccine and will be waiting 90 days. Caller asks, can she have good days and bad days after covid (symptoms improve and then get worse). The outcome for the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Fluzone Quadrivalent MDV (opened) experienced a low temperature of 32.2F for 7 hours and 10 minutes, no AE; Initial information received on 31-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2020SA030249, 2020SA030235, 2020SA030239, 2020SA030240, 2020SA030241, 2020SA030242, 2020SA030243, 2020SA030244, 2020SA030245, 2020SA030246, 2020SA030247 and 2020SA030248 (same reporter).  This case involves a 63 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot UJ270AA, Exp. Date 30-Jun-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 24-Jan-2020.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due product storage error temperature too low.   It was reported that Fluzone Quadrivalent MDV (opened) experienced a low of 32.2 F for 7 hours and 10 minutes related to a data logger malfunction-no human error and was opened on 09-Jan-2020.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
heart failure; very mild case of covid; very mild case of covid; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient. A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "very mild case of covid"; CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: She explained that she has the first shot of the covid vaccine, but she had some health problems, particularly, heart failure and did not feel to get another one as she prioritized getting medication for this. The patient inquired about bivalent formulation if she needs to complete the first 2 dose before she could get the bivalent formulation. It was further reported that during the summer of 2021, she contracted a "very mild case" of covid, and her primary care provider recommended that she get the monoclonal antibodies which helped her greatly. She also mentioned that her PCP told her she can get the bivalent vaccine.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
I'm pregnant 6 month; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I'm pregnant 6 month) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I'm pregnant 6 month). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I'm pregnant 6 month) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported. It was reported that she was 6 months pregnant.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup has been attached.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stores VAQTA (dose and route were not reported) lot # L031196, expiration date 05-FEB-2017. It was reported that the vaccine was exposed to 29 Fahrenheit degrees for 96 hours. No adverse experience has been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm following for 4 days, Headache for weeks, bit of confusion, unwell feeling. two weeks after vaccine left breast was tender and patchy red, enlarged breast, dimpled unwell feeling. This continued and a lump was found a few days later under the arm, with a long cord like lump to the nipple area. The pain was increasing. Went to a doctor, diagnosed mastitis and antibiotics. Week later went to local doc and ultra sound and mammogram was ordered. Pain worsened and I got worried went to another doctor who said it was lymph nodes and cases of moderna were known and to report it. Week later went to emergency in pain,sweating,numb arm,breathing. Mammogram and ultra sound have been done, no results yet.2nd vaccine???
Patient had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a reaction) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a reaction). At the time of the report, IMMUNISATION REACTION (Patient had a reaction) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.   Reporter did not allow further contact
I received my 2nd dose of the Moderna vaccination on1 /26/2020 @ 3:16 pm.  The following day at 10 am I had severe throbbing headache (forehead).  I took Tylenol but was unable to work the rest of the day due to the throbbing headache.  One week later- 2/1/2021 my arm at the injection site is very bruised and sore.
Within 8 hr of vax pt devel chills,rigors,myalgia & fever 102-103 & severe & diffuse h/a. No focal neurologic findings. Lumbar puncture, CT of the head, serology & CBC normal. Tx w/narcotics & steroids & gradually recovered after 8 days.
Information has been received from a company representative concerning a 12 year old female with braces, who was vaccinated with a 0.5 mL dose of Gardasil (lot # not reported). It was reported that the patient experienced acute demyelinating encephalomyelitis after getting the vaccine. The patient's mother reported that two weeks post vaccination. The patient was walking through the house and collapsed. The patient stated that she could not feel her leg. The patient was taken to the hospital. It was reported that two months later and after hours of physical therapy, the patient still had no feeling in her left leg. It was also reported that it was difficulty for the patient to walk and balance and she often needed a little help. The patient's mother reported that her daughter was "mad." The patient was also learning how to cope with crutches, and a walker. The patient was diagnosed by her physician to have Acute Demyelinating Encephalomyelitis or ADEM. At the time of the report, the patient's status was not reported. Acute demyelinating encephalomyelitis was considered to be disabling an other important medical event. No further information is available.
pt had a 101 degree fever and her arm got red and swolen (she reported it we didnt see it)
I had symptoms August 20 and I was taking my granddaughter to get tested and they were doing the tests in the parking lot and as soon as we drove away I started sneezing, and so I went back and had myself tested on August 23rd and I tested positive. I experienced like a bad cold, little bit of a fever, and it pretty much went away but I couldn't go to work for 14 days, and it took my energy. On September 5 I had leg cramps very badly and I had to call out of work, and I very gently got myself going again. It sucked my energy a little bit. I did start taking an aspirin everyday and they did put me on steroids for ten days because that's the only thing they gave me. I also started taking Zinc, Magnesium, B3, and C and I'm going to finish those bottles.  My symptoms lasted about 3-4 days altogether.
Approximately, two weeks after receiving the vaccine, patient presented with severe pain in all joints. Subsequent lab work showed an elevated white count consistent with an immune system response. At the time of this report patient is awaiting further consultation to review subsequent lab work to either exclude or diagnose patient with a possible autoimmune disorder such as lupus or MS, etc. However, current lab work results, while not conclusive, suggest the likely exclusion of those diagnoses. Upon consultation with my healthcare provider further investigation is suggested. It is unclear if the vaccine is a. the cause of original symptoms, b. if diagnosed with another condition, is the vaccine the cause or c. not related at all to the patient's illness.
Service member had symptoms of an allergic reaction about 45 minutes after his first dose of Pfizer vaccine. He began having a sensation of swelling in the throat. His voice deepened, but did not had difficulty breathing nor with his air way, he did experience an increase amount of saliva in his mouth. EMS was called on the scene to access his vital and his air way, he later was transported to the hospital as precautioning measures. On arrival to hi did not appear to be in acute distress. He had some mild swelling over the uvula in the posterior pharynx. He had a feeling that his voice was deeper, he was anxious and with no.n toxic appearance and not in acute distress. The degree at onset was minimal, he was given Decadron 10mg, IV Push once, Pepcid 20mg IV push once, Diphenhydramine 25 mg. After the above treatment service member was feeling much better and was discharged from ER, with a follow up with his primary care physician .
Patient was given an undiluted dose of the Covid 19 vaccine on Sunday, June 6th at 10:18 AM .  Patient was followed up with the day of, and several days after, with no adverse signs and symptoms reported.  Event also reported to patient's pediatrician.
I got out of work at 6:45PM 10/11/2021  and the left side of my face and neck as well as my forehead and my chin were all numb. I couldn't feel them so I went to the ER. They did a CT scan. MRI and blood work and determined I had a mini stroke and they kept me over night. They let me go home the next day and Wednesday I was still a little out of it but Thursday I was a lot better.
pt reports a knot in arm @ the inj site rt arm that is still present 2DEC97;reports site is itchy during the day;the muscle is still sore upon movement & the site recently devel red blood blisters;
Red, warm and hard area 3cm x 2cm to outer aspect of (L) upper arm. Painful with palpation. BENADRYL and CEPHALEXIN x 5 days.
The left deltoid became edematous, erythemic, pruitic, warm to the touch over entire upper arm, inferior to injection site. Body ache.
Shoulder and arm swelling x3. Made it difficult to operate a computer mouse.  Took Ibuprofen for 24hrs, and swelling/pain diminished.
This spontaneous report as received from a nurse practitioner refers to a 5 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
Had documented temperature by thermometer at 105F. Responded to bath and Tylenol.
Information has been received from a physician concerning a 68 year old white female who on 03-DEC-2007, at 16:27, was vaccinated subcutaneously with a first dose ZOSTAVAX (Oka/Merck) ( Lot # 658207/0883U). On 05-DEC-2007, in the early AM, the patient developed a painful rash developed at injection site and painful rash developed at injection site. No diagnostic testing was performed. At the time of reporting the outcome was unknown. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3302), in left arm, on 23Feb2021 as dose 2, single (Lot number: EN5318), in left arm, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 13Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Jul2022) Negative, notes: testing negative for CV-19; (Jul2022) Positive, notes: After testing negative for CV-19, I had a return of symptoms, although mild, and I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had other medication in 2 weeks. On 14Jul2022, patient received paxlovid (anti viral) (Lot number: GC4762)  for the treatment of covid 19  and treatment stop on 18Jul2022. Other medication details in 2 weeks product was Lisinopril started on 13Jul2022. It was reported that, After testing negative for Covid-19, she had a return of symptoms, although mild, and she tested positive again.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
Left low neck /shoulder ache and slight headedness.  BP 120/118, HR 66, RR 181, Afebrile.  Reports above symptoms resolved within 5 min