chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Dtap and IPV left deltoid and MMRV and flu Right deltoid. About 5 minutes after administering patient developed aheal on at front shoulder, deltoid, arm and itchy. No respiratory distress. Chest normal in exam. Patient fussy called about 3 hours later patient seen. Patient seen clinic 11/30/06 and hives resolved and no symptoms.
It was reported that a 4-year-old female received Tripedia and IPOL vaccine IM in the right deltoid on 7/30/2002. Patient developed local reaction of redness and swelling. Parent was advised to watch for any worsening, and to use ice, Ibuprofen or Acetomenophen as needed.
Mild pain around injection site; tiredness; sore eyes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Aug2021 15:15 (Batch/Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Product name: Pfizer covid-19 vaccine , Batch/lot number: EW0173, Anatomical Location: Arm Right , Dose Number: 1), administration date: 31Jul2021, when the patient was 32 years old, for Covid-19 immunization, reaction(s): "Pain around injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 22Aug2021 15:15, outcome "recovered" (Aug2021), described as "Mild pain around injection site"; FATIGUE (non-serious) with onset 22Aug2021 15:15, outcome "recovered" (Aug2021), described as "tiredness"; EYE PAIN (non-serious) with onset 22Aug2021 15:15, outcome "recovered" (Aug2021), described as "sore eyes". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, eye pain.  Additional information: Lot was unknown reason unable to locate or read the details. Patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not received treatment. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe sepsis with septic shock. ED visit with hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Information has been received from a physician concerning a 14 year old male who on 04-JUN-1996 and 14-NOV-1997 was vaccinated with a first and second dose of MMR II respectively.  On 29-NOV-2009 the patient experienced mumps.  The patient was afebrile.  The parotitis was on both sides.  The mumps was diagnosed on 30-NOV-2009.  At the time of the report, the outcome was not reported.  Additional information has been requested.
second dose as day 22; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose as day 22) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose as day 22). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose as day 22) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient took second dose on 12-may-2021 patient want to ask is the second dose is valid dose. no concomitant medications are reported.
Day 1 soreness in sight injection and arm Day 2-3 soreness in arm and underarm area Day 4 sore throught, painful to swallow
pt recvd vax 4MAY94 & devel swelling & erythema down to elbow on 6MAY94; remained for approx 7 days; visited MD office for eval;
Tingling in his right hand and then subsequently developed tingling in his right leg and down to his foot; Chest pain; This is a spontaneous report from a contactable physician (patient's father) via Medical Information Team. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 18-years-old), 1st dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The vaccine was administered at a pharmacy. On 30Apr2021, the patient developed tingling in his right hand and then subsequently developed tingling in his right leg and down to his foot, and then developed chest pain. The reporter stated that the patient went to the emergency room and an electrocardiogram was done on 30Apr2021 that came back normal, so he was sent home. The reporter would like to know if there was any guidance that could be provided on the safety of the patient getting the second dose of the vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Is showing up ill; His arm is so sore he can barely move it; His arm is so sore he can barely move it; With chills; A sly fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Is showing up ill), VACCINATION SITE MOVEMENT IMPAIRMENT (His arm is so sore he can barely move it), VACCINATION SITE PAIN (His arm is so sore he can barely move it), CHILLS (With chills) and PYREXIA (A sly fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Is showing up ill), VACCINATION SITE MOVEMENT IMPAIRMENT (His arm is so sore he can barely move it), VACCINATION SITE PAIN (His arm is so sore he can barely move it), CHILLS (With chills) and PYREXIA (A sly fever). At the time of the report, ILLNESS (Is showing up ill), VACCINATION SITE MOVEMENT IMPAIRMENT (His arm is so sore he can barely move it), VACCINATION SITE PAIN (His arm is so sore he can barely move it), CHILLS (With chills) and PYREXIA (A sly fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.    No treatment medications were reported.
NONE.  PT GIVEN 0.5 ML INSTEAD OF 0.25 ML FLUZONE.  NO ADVERSE EVENT REPORTED.
I took my HPV shots abroad. The first shot I took was on December 27th 2007. It didn't feel anything special after this first one. I took my first shot before March 1st 2008. Days after my second shot, I start growing out breakouts (which looks like skin allergy) on my face. It has been bothering me until now. I have also experienced increase of hair loss compared to before taking the shot. After taking the 3rd HPV shot, my skin allergic problem has worsen. It also affected my monthly menstruation cycle. It basically shifted my cycle from normally 30 days to now 34 days. After having taken all 3 shots, i feel like i get tired alot easier than before. I went for an annual body check, I was now told that I have high blood pressure. My cardio result showed that I have irregular heart beat according to the nurse.
No other adverse event information; HCP calling to report patient was given RECOMBIVAX HB that was recalled; HCP calling to report patient was given RECOMBIVAX HB that was recalled/ improperly stored vaccine administered; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 23-OCT-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) who was also recalled; at a dose of 0.5 milliliter as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, anatomical location and route of administration were not reported; lot number T007984 and expiration date 01-NOV-2022) (recalled product administered and product storage error).  Information regarding temperature excursion was not reported. No adverse event was reported.
Fever with temp 101+ from 7pm until at least 9am the next day. No medications given to reduce the fever
Information has been received from a physician concerning a female patient who on an unspecified date received a dose of MMR II (Lot # not provided) and subsequently developed negative measles titers after receiving the vaccine. At the time of this report, the patient's outcome was unspecified. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
pain in the hands; high temperature; chills; body ache; head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the hands), PYREXIA (high temperature), CHILLS (chills), PAIN (body ache) and HEADACHE (head ache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L70A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the hands), PYREXIA (high temperature), CHILLS (chills), PAIN (body ache) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK, qd. At the time of the report, PAIN IN EXTREMITY (pain in the hands), PYREXIA (high temperature), CHILLS (chills), PAIN (body ache) and HEADACHE (head ache) had not resolved. Not Provided          Patient take 2 Tylenol in morning and an Advil in the afternoon.  No concomitant medications reported by investigator   Reporter did not allow further contact
pt recv vax 8APR98 & 15APR98 began w/restlessness & fussiness;16APR98 began w/fever of 105 & called mom 17APR98 still fever around 102 & dec appetite, no rash, dec sleeping;
Approximately 75 days later I awoke with swollen hands and could barely close my fingers to make a fist. Knucles were painful and swollen.
Coolness in her chest during the shot; tingling; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Coolness in her chest during the shot), PARAESTHESIA (tingling) and VACCINATION SITE PAIN (arm was sore) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011120A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced CHEST DISCOMFORT (Coolness in her chest during the shot), PARAESTHESIA (tingling) and VACCINATION SITE PAIN (arm was sore). On 10-Feb-2021, CHEST DISCOMFORT (Coolness in her chest during the shot) and PARAESTHESIA (tingling) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was sore) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.; 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.
My period showed up early.; My period showed up early and is VERY VERY heavy and painful; My period showed up early and is VERY VERY heavy and painful.; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 14:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy (sulfa meds). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication within two weeks of vaccination. On 17Apr2021 at 00:00, the patient's period showed up early and was very very heavy and painful, which was unusual for the patient. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period showed up early, was very very heavy and painful was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Dec. 27th developed red splotches on abdomen that spread to chest, back, face, arms, thighs by morning of Dec 28th. Rash preceded by one week of nasal congestion, cough, low grade fever 99-101.
Patient fell off chair and was convulsing and unresponsive. Has not eaten since breakfast.
rash and itching on back, neck, arms, started after booster   affects sleep and normal activities as itching is constant and worse at night.  used anti itch cream and only helped temp.  never have had this kind of rash and itch. sores are scattered on rash  started shortly after shot and continues to present
Hive like red rash on upper torso, neck, back and below injection site. Slightly itchy and very red. The rashes started 36 hrs after the vaccination. 48 hours later rash seems to be getting worse.
All skin surfaces became covered in erythematous macules and patches. Some were raised and the worst is over cheeks and deltoids. BENADRYL was given due to itching at injection site.
Shaking, dizzy, cold arm and loss of circulation. Pt took Advil and symptoms were better.
pt recv vax;gen rash for 10 days;apap given & aveeno bath
Dose administered after 30-day Use By DateProduct; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By DateProduct) and NO ADVERSE EVENT (No adverse event) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) Additional Booster. On 06-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By DateProduct) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By DateProduct) and NO ADVERSE EVENT (No adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date Product).    No concomitant and treatment medication were reported.   This case was linked to MODERNATX, INC.-MOD-2023-697843 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-697843:75-year-old Female patient case
Reported by Vaccinating nurse Pt reported dizziness at 09:40. EMS called to car, Pt pale, EMS monitored EKG Pt vitals per EMS bs in normal range, bp 90/60 manual, HR 58 97% o2 on room air. Pt states feeling better AOx4, Pt ambulatory with EMS paramedics. Pt refused hospital, leaves at 09:56 with female family member. Unit paramedics with county EMS unit.
moderate to severe axillary pain in vaccinated arm. Lasted for 3 days then diminished by 5th day.
seizures; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm at the age of 63-year-old on 02May2021 (Lot Number: EWQ0171) as single dose for covid-19 immunisation. Medical history reported as no. There was no known allergies. Concomitant medication included telmisartan (MICARDIS) from 2021 (received within 2 weeks of vaccination). The patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 11Apr2021 (Lot Number: ER8729) as single dose for covid-19 immunisation. The patient experienced vomiting and 3 episodes of severe seizures after 9 hours of last vaccine dose on 02May2021. The patient was taking to the hospital emergency room and ICU for treatment. The patient reported the case as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The was not pregnancy at time of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included covid test(Blood test): negative on 03May2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered in May2021.
Patient scheduled for 2nd COVID vaccine and was given Moderna. Patient 1st of COVID vaccine was Pfizer. Patient has only reported feeling "lightheaded" approx. 2 hours after vaccination.
PATIENT CAME TO CLINIC TO GET VACCINE. SKILLED NURSE  WENT TO VEHICLE AFTER CONSENT WAS SIGNED TO GIVE VACCINE. SN SAID" HERE TODAY FOR YOUR SECOND MODERNA VACCINE". PATIENT STATES YES.  ASK FOR CARD PATIENT COULD NOT FIND.  GAVE VACCINE AND THEN AFTER PATIENT FOUND CARD. PATIENT FIRST COVID DOSE WAS PFIZER NOT MODERNA. HAD BEEN 21 DAYS FROM FIRST PFIZER.
LIGHT FEVER, COUGH, NASAL & SINUS CONGESTION, RUNNY NOSE, SNEEZING, SORE THROAT PAIN, HEDACHE AND BODY ACHE.
This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH (site is warm to touch), FEELING ABNORMAL (felt washed out), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site) and VACCINATION SITE SWELLING (my arm is swollen at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006BUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced FEELING ABNORMAL (felt washed out). On 24-Mar-2021, the patient experienced PYREXIA (fever of 99.4) and FATIGUE (felt fatigued/tired). On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (site is warm to touch), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site) and VACCINATION SITE SWELLING (my arm is swollen at injection site). At the time of the report, VACCINATION SITE WARMTH (site is warm to touch), FEELING ABNORMAL (felt washed out), VACCINATION SITE INDURATION (the site is hard), VACCINATION SITE PAIN (my arm is painful at injection site), VACCINATION SITE SWELLING (my arm is swollen at injection site), PYREXIA (fever of 99.4) and FATIGUE (felt fatigued/tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 (Inconclusive) fever of 99.4. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case was obtained from a scientific literature. Contact transmission of vaccinia to an infant diagnosed by viral culture and metagenomic sequencing. This case refers to a male patient, an active-duty military member who had secondary vaccine infection from an unknown source, although presumable by contact from other military members recently vaccinated with ACAM2000 vaccine (PTs: Vaccinia virus infection and Secondary transmission). The patient developed a 1-cm vesicular, crusted plaque above his right upper lip, which he attributed to a cold sore. He had not received any recent live-virus vaccinations. At the time of this report, he had not undergone testing for vaccinia exposure, and a follow-up epidemiologic investigation failed to identify another potential source of exposure. The author deducted that the JYNNEOS vaccine was not available at the time of these events and therefore, ACAM2000 vaccine was in use during the time this patient developed infection. As many military members in the father's workplace receive ACAM2000 vaccine. Then, it was also possible a secondary vaccinia infection in the father to the mother and the infant. Based on the available information in the article, 3 individual case safety reports 21000032LT (infant), 21000033LT (mother), and 21000034LT (father) were created and cross linked in the database. Company Comment: The company agrees with the author that their patient developed a secondary vaccine infection and contaminated the mother and subsequently the infant. The causality of vaccinia virus infection and secondary transmission is assessed as possible. The case does not meet the seriousness criteria, but it will be submitted to the FDA as required. Sender's Comments: The company agrees with the author that there patient developed a secondary vaccinia infection and contaminated the mother and subsequently the infant. The causality of vaccinia virus infection and secondary transmission is assessed as possible. The case does not meet the seriousness criteria, but it will be submitted to the FDA as required.
3/10/21 10pm had N/V, fever 101.1; 3/11/21 woke up withR hand paralysis; caller reports she was unable to grasp objects such as coffee mug, utensils, etc caller states she is going to urgent care today (3/15/21) to get R hand evaluated
Pt to ED with SOB and AMS. COVID-19 test result on 01/04/2022, date of onset of symptoms approximately same time. Possible left lower lobe pneumonia.  Hypoxia.  The patient is on supplemental oxygen by nasal cannula. UTI. White count is 11.7.  She is saturating 95% to 97% on 2 L. remdesivir for COVID-19 infection and ertapenem for UTI. Pt prognosis poor. Hospice consult 1/5.  Code status is switched to DNR comfort. Pt expired 1/7.