chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 64-year-old male patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 29-AUG-2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosaje, route of administration and indication were not provided). On an unspecified date in 2016, the pt suffered shingles and hearing loss, including any and all of its sequelae. It was also specified that the pt suffered severe personal injuries, pain, suffering and emotional distress, as well as incurred in substantial economic damages. The outcome of the events was not provided. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, deafness was considered medically significant. Additionally, the events were considered to be disabling.
bruised very easily on her tummy, legs, waist, thigh and arm; bruised on shot area; little sore on shot area; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruised very easily on her tummy, legs, waist, thigh and arm), VACCINATION SITE BRUISING (bruised on shot area) and VACCINATION SITE PAIN (little sore on shot area) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Blood pressure. Concomitant products included AMLODIPINE for Blood pressure, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruised very easily on her tummy, legs, waist, thigh and arm), VACCINATION SITE BRUISING (bruised on shot area) and VACCINATION SITE PAIN (little sore on shot area). At the time of the report, CONTUSION (bruised very easily on her tummy, legs, waist, thigh and arm) and VACCINATION SITE BRUISING (bruised on shot area) was resolving and VACCINATION SITE PAIN (little sore on shot area) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatments were reported. Concomitant medication included hormone for an unknown indication.   This case was linked to MOD-2021-220863 (Patient Link).
fatigue; aches; chills; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced fatigue, aches, chills on an unspecified date. The patient was hospitalized for fatigue from Mar2020 to an unknown date. The patient was hospitalized for the events from an unknown date in Mar2020 to an unknown date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown.   Information on batch/Lot number has been requested.
pt recv vax & pt was exposed to hep b;following exposure, titers were taken & noted to be negative;therefore;pt exp joint pain 11MAR97;pt devel  cold which was snot felt to be r/t vax;
noticed a "light pink dry itchy area" at her injection site; noticed a "light pink dry itchy area" at her injection site; noticed a "light pink dry itchy area" at her injection site; This is a spontaneous report from a contactable consumer. A patient 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. the patient experienced light pink dry itchy area at her injection site about the size of a police badge, where she received the shot. Wanted to know if this could be a side effect from second dose. Attempted warm transfer to the DSU, all agents were assisting other callers, e-transmitting AE. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
she does not feel well; blood sugar started getting high; her vitamin D level is also low; A1C is high now again/; the glands on her neck is swollen; till have an inflammation in her body,; fever; Chills; headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/) and LYMPHADENOPATHY (the glands on her neck is swollen) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/), LYMPHADENOPATHY (the glands on her neck is swollen), INFLAMMATION (till have an inflammation in her body,), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache). At the time of the report, MALAISE (she does not feel well), BLOOD GLUCOSE INCREASED (blood sugar started getting high), VITAMIN D DECREASED (her vitamin D level is also low), GLYCOSYLATED HAEMOGLOBIN INCREASED (A1C is high now again/), LYMPHADENOPATHY (the glands on her neck is swollen), INFLAMMATION (till have an inflammation in her body,), PYREXIA (fever), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.                Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), PAIN (Pain, in morning next day it was really bad), RASH (Rash all over around neck, chest, breast) and MYALGIA (I had muscle ache, in morning next day it was really bad) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in September 2020. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN (Pain, in morning next day it was really bad), MYALGIA (I had muscle ache, in morning next day it was really bad) and ARTHRALGIA (I had joint pain, in morning next day it was really bad). On 14-May-2021, the patient experienced ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), HEADACHE (I had headache), PYREXIA (Fever 100 F) and NAUSEA (Nausea). On 15-May-2021, the patient experienced RASH (Rash all over around neck, chest, breast). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness), VACCINATION COMPLICATION (vaccination related malaise), PAIN (Pain, in morning next day it was really bad), RASH (Rash all over around neck, chest, breast), MYALGIA (I had muscle ache, in morning next day it was really bad), HEADACHE (I had headache), ARTHRALGIA (I had joint pain, in morning next day it was really bad), PYREXIA (Fever 100 F) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
DIZZY FOR 3 DAYS; FEELING SICK; LIVER PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 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 APR-2021, the subject experienced liver pain. On APR-2021, the subject experienced feeling sick. On 09-APR-2021, the subject experienced dizzy for 3 days. The action taken with covid-19 vaccine  was not applicable. The patient recovered from dizzy for 3 days on 12-APR-2021, and the outcome of feeling sick and liver pain was not reported. This report was non-serious.
Patient received her first dose of the vaccine then fainted shortly after..  She appeared unresponsive and her cheeks were flushed. Patient only responded to verbal command with confusion.  Permission was obtained from ER Dr on duty to administer EpiPen at 0.3 mg  Patient was then transported to ER
Erythema-itching of neck; facial edema starting 24 hrs p/1st vax.
Pt. states that after receiving the 1st dose of J&J 08/17/2021, started experiencing symptoms 08/18/2021 of flu-like symptoms, nausea, muscle aches, teeth pain, and fever (1st day). Treated with Ibuprofen and rest. No noted Primary visit.
Received Moderna COVID-19 vaccine at 2pm.  2:15pm stated her lower lip was itching and her left anterior forearm was swollen.  Look swollen compared to her right arm.  Also stated feeling "heaviness" on her left side.  By 2:50 the symptoms were improved.  She stayed for 30 mins or longer after receiving her vaccine until her symptoms were gone.
13 year old received the first dose of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
10 days after receiving MMR vaccine:  Low grade fever followed by severe rash covering legs (plus swelling), arms, belly back, face (plus swelling).  Rash did not clear completely for another 10 days. No treatment given.
Patient experienced lightheadedness and fainted within 15 minutes of receiving HPV. She was standing at the onset of symptoms. We laid her down in the Trendelburg position after she awoke (lasting 10-15 seconds of unresponsiveness). She felt fine and fully recovered and left our office 15 minutes later.
COVID 19; COVID 19; Moderna Dose Number 1 and 2 / Pfizer, BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received bnt162b2 (BNT162B2), on 27Nov2021 as dose 3 (initial pfizer dose), single (Lot number: FM8030) at the age of 67 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Dec2020 as dose 1, single (Lot number: 025J20A), in left arm and on 24Jan2021 as dose 2, single (Lot number: 28L20A) for covid-19 immunisation. The patient's relevant medical history included: "Non Hodgkin lymphoma" (unspecified if ongoing); "HTN" (unspecified if ongoing); "DM-2" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Nov2021, outcome "unknown", described as "Moderna Dose Number 1 and 2 / Pfizer, BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measure taken as a result of the events included Zithromax from 23Oct2023 and Paxlovid from 25Oct2023 to 30Oct2023. The patient tested negative after Paxlovid ended but began feeling to have flu-like symptoms, cough, and fever 2 days later (02Nov2022). The patient did not have a cough with first round of COVID.
AMAN; ? Anemia     RA ? Anxiety   ? Arthritis     R.A.-HANDS, KNEES ? Cancer    ? Chronic pain     r/t RA ankles, hips, knees ? Complication of anesthesia 2013   DECREASED RESPIRATIONS POST-OP ? CPAP/BiPAP dependence 9/21/15   instructed to bring dos ? Depression   ? Disorder of bone and cartilage, unspecified   ? Dry throat   ? Encounter for blood transfusion   ? Frequency of urination   ? Hepatitis 2006   HEP C, from ex-husband being 'overseas' ? Hypertension 9/2015   off meds since 9/2014  117/88 ? Immune deficiency disorder      r/t non-hodgkins lymphoma ? Non Hodgkin's lymphoma 2001 ? PTSD (post-traumatic stress disorder)   ? Renal disease     renal insuffiency r/t stem cell transplant, stage 4 ? Skin disorder     bruise easily ? Sleep apnea   ? SOB (shortness of breath) on exertion   ? Thyroid disease   ? Wears glasses
This spontaneous report as received from a pharmacy intern refers to an approximately 70 year old (reported as above 70 years old) male patient with no drug reaction/allergies. On 11-SEP-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm (lot number not provided). The pharmacist got about 0.1 ml into the patient's arm when the injection site burned, looked like a bug bite and it was hart to the touch. The patient did not receive the remainder of the dose of ZOSTAVAX. No treatment was given for the adverse event. No lab diagnostic tests were performed. The patient sought medical attention as he was in the pharmacy. The outcome of the events was unknown. The action taken was not reported. Additional information has been requested.
This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR13, via an unspecified route of administration on an unspecified date at single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced an allergic reaction to PREVNAR13. The clinical outcome of the event was unknown.
FAINT RED SILVER DOLLAR SIZE AREA NOTED AROUND INJECTION SITE, SMALL BUMP, 2 HOURS AFTER INJECTION FELT NAUSEATED AND DIAPHORETIC, EMPLOYEE FEELS IT WAS A PANIC ATTACT.
breathing issue; weakness; aching; wide joint pain; joints coming apart; palpitation; blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the events has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
24oct90 pt vax.  she has refused all attempts to nurse and has been sleeping 21hrs a day since 29oct90.  hospt 11/1.  sgot elevated and urine output has been poor,  spinal tap negative.
Visual disturbances.; Perceived left arm not to be his own; Tingling in hands, arms and feet; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 29Apr2021 at 09:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 14:15 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. On 03May2021 at 09:00 (also reported as 96 hours after the second shot), the patient experienced visual disturbances and perceived left arm not to be his own. The patient began to feel tingling in hands, arms and feet which increased in intensity and persisted for several days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events.  The clinical outcome of the events visual disturbances, perceived left arm not to be his own and tingling in hands, arms and feet were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
The day after the shot I noticed these side effects: ache in whole body fever nausea stomachache
sneezing bout; runny nose; congestion; This is a spontaneous report from a contactable consumer (patient). A 94-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9262) via an unspecified route of administration in left arm on 31Jan2021 02:15 AM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included parkinson's disease and allergies to medications, food, or other products was reported as trees. Concomitant medications (within 2 weeks of vaccination) included carbidopa, levodopa; amiodarone; calcium carbonate (CALTRATE) and docusate sodium (COLACE). It was reported that, during the night after receiving the vaccine, patient experienced sneezing bout. The day after the vaccine very runny nose and congestion all on 01Feb2021 04:00 AM. 2 days after the vaccine nose was still runny but not as much. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not received for the adverse events. The outcome of the events was reported as recovering.  Follow-up attempts are completed. No further information is expected.
ITCHING ALL OVER BODY; SKIN FEELS HOT; GENITAL RASH; BREAK OUT ON FACE; RASH ON FACE, BACK, EAR; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, smoker, allergy to clindamycin and allergy to zithromax. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 in right arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itching all over body. On 06-APR-2021, the subject experienced skin feels hot. On 06-APR-2021, the subject experienced genital rash. On 06-APR-2021, the subject experienced break out on face. On 06-APR-2021, the subject experienced rash on face/back/ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching all over body, skin feels hot, rash on face/back/ear, genital rash, and break out on face. This report was non-serious.
Information has been received from a pharmacist referring to 2 newborns (numbered 103 and 104). Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 16-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter.
Marked swelling, minimal tenderness or erythema (L) lower leg (above knee).
Approximately 14 hours post vax heavy breathing & observed thrashing/jerking of extremities. Child was unresponsive for approximate 1 minute or less. Temp 102. Tylenol were given by mom & she called our nurse for advice.
On an unspecified date, the vaccinee received his 1st injection of Engerix-B. Within 1 hours, he experienced nausea and vomiting. As of 5/2/02, the nausea and vomiting had "improved".
Bell's Palsy - Emergency Room Visit - still in treatment (physical therapy, PO steroids, anti-viral)