chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extensive Pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Dec2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (caused and prolonged hospitalization, medically significant, life threatening) with onset 22Dec2022 at 09:00, outcome "not recovered", described as "Extensive Pneumonia". The patient was hospitalized and prolonged hospitalization for pneumonia (hospitalization duration: 5 day(s)). The event "extensive pneumonia" required emergency room visit. Therapeutic measures were taken as a result of pneumonia.  Clinical Information: The patient received Other vaccine (Pfizer) on 20Dec2022. AE resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. It was unknown that if COVID tested post vaccination. No, other vaccine in four weeks. Life support was given AE as treatment. No, known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No adverse event; 2 doses of the vaccine were given today after they expired on 13FEB2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023) and NO ADVERSE EVENT (No adverse event) 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 considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses of the vaccine were given today after they expired on 13FEB2023).    No concomitant medications was reported.  Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient had no reported symptoms.   No additional medications, doses, or treatments medications was reported.  This case contains information for the 1st out of 2 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712225:2nd child
Fainted; Arm soreness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 08-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant). On 05-Apr-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, SYNCOPE (Fainted) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication included Ibuprofen. On 08-APR-2021, patient fainted at the work place. Patient was seen by the HCP on the same day and they did some blood work and all the blood work reports came within normal limits. So the HCP mentioned that possibly it could be a delayed reaction to vaccine and suggested to call the manufacturer and report it.; 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.
Immediate numbness and tingling down right arm.  Sustained numbness and tingling in right hand for 4 months.  Immediate neurological and muscular burning in legs.  Muscle seizure in things causing me to fall down multiple times (occurred 5 times over 3 month period).  Immediate heartburn from time of injection to present.
Approximately 9/23/21 or 9/24/21 this patient started becoming ill with headache, cough, shortness of breath, temp 104, and fatigue.  On 9/2721 the patient had a positive Covid test done at the health department.  On 9/30/21 the patient continued to decline so he went to emergency department, while in the ER he had a chest x-ray labs and steroids and was discharged home to manage symptoms.  On 10/6/2021, he went to his primary care provider and he was noted to be hypoxic with oxygen saturation anywhere between 85 to 90% on room air.  The patient was sent to the emergency room for further evaluation and he continued to be hypoxic upon presentation requiring oxygen to keep his oxygen saturations greater than 90%.  He eventually required up to 55L of heated high flow.  He also received dexamethasone x 10 days and baricitinib x 14 days.   He was discharged home on 5L of oxygen and a prednisone taper.
About 5 minutes after receiving vaccine, pt felt "hot" then became dizzy, nauseous and pale.  She complained of pain in her right arm and a "tingly" feeling in her fingers and arms.  + diaphoresis. Pulse 60 BP 92/58 Recovered after about 20 minutes of laying down with her feet elevated, few sips of juice and a hard candy.
headache, body aches, fatigue which increased to severe muscle cramps, utter exhaustion, weakness, chills, body shakes, inability to sleep all night due to pain
Dizziness, HYPERtension, metallic taste Narrative: Patient experience metallic taste in mouth, dizziness, BP of 150/90 during 15 minute observation period post-vaccine. BP returned to 134/85 during observation, patient went home under without further care required.
Chills for 3 hours, followed by high fever.  Low fever next morning and splitting headache and pain behind eyes.
Patient called the DOH on 07/25/07 at 0900 and reported that she hasn't felt good since she got her shot.  She reports that during the night of 07/23 - 07/24/07 she reports thst she began itching on her face and neck, and was unable to sleep.  She also reports low grade fever, headache and a rash on her face.  She also reports that the injection site is swollenm, and has a red line coming from it.  The patient denies any diffuculty breathing, talking or swallowing.  The patient reports that she does have an allergy to fish, but forgot to tell staff on the day of her appointment.  The patient was reffered to her primary doctor for a review and exam.
Felt bad for 3 days; Pain in legs; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt bad for 3 days) and PAIN IN EXTREMITY (Pain in legs) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt bad for 3 days) and PAIN IN EXTREMITY (Pain in legs). At the time of the report, FEELING ABNORMAL (Felt bad for 3 days) had resolved and PAIN IN EXTREMITY (Pain in legs) outcome was unknown.            Concomitant medications were not provided Treatment medications were not provided Patient got booster dose last week.
Severe headache. Body temperature modulation was difficult, chills the fever. Extreme vomiting. This lasted about 24 hours.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 06-JUL-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L042266 (dose, strength, route of administration and expiry date were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Trouble getting and maintaining an erection; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0178) at single dose via an unknown route on 08Sep2021 14:00 at 29-year-old in right arm for Covid-19 immunization. Medical history was reported as "none". Patient had no known allergies. Concomitant drug was not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported event was trouble getting and maintaining an erection on 09Sep2021 12:00 AM. No treatment received.  Outcome of the event was not resolved. Since the vaccination, the patient had not been tested for COVID-19. The report was assessed as non-serious.   No follow-up attempts are possible. No further information is expected.
High Fever (102.4) lasting about 8 hours. Arm where I got the shot was swollen, Hot and real sore
Breakthrough COVID-19 infection. Pt received Moderna on 1/21/2021 and 2/18/2021
Started with itchy, swelling (hard) at site of vaccine.  Hot to touch.  Iced after 12-36 hours after symptoms started. Swelling reduced and redness subsided but after a week, rash is still there with some itchiness, tenderness, and elevated topical temperature of about 3 degrees F.  Started using topical Benadryl on day 6 of symptoms developing.
Patient stated arm sore at 5:00pm day of vaccination.  Pain increased and was excruciating by 8:00pm same day. Tylenol and ice pack did not alleviate discomfort.  Patient did not eat dinner that evening due to nausea and overall malaise.  Patient experienced restless sleep due to nausea and pain. During following 2 weeks, patient lost appetite and was forcing herself to take in nourishment.  At end of 2 weeks, patient had lost 5 lbs and the nausea lingered, although the soreness and general malaise had subsided.   Patient's condition slowly improved but never recovered to feeling as before the vaccination.  Patient followed up with her physician and blood tests showed no abnormalities.  May 2, 2023 the patient was admitted in the hospital after visiting the ER with symptoms exactly as after the vaccination.  All tests (CT, ultrasound, blood test) came back normal and patient was discharged on May 4, 2023.   Patient followed up with her GI specialist who stated this may be lingering effect from vaccination.  Patient continued to feel tired and "not herself".  Patient states as of June 1, 2023 that all symptoms are improving.  Patient attributes her condition to the vaccination.
Persistent swelling at the site of injection on left forearm.  Was given subcutaneously, instead of IM.
SYMPTOMS FROM VACCINE:  Heart Palpitations, Neck Pain, eventually feeling a lump in neck; pain also in the lumbar spine. Arthritic symptoms. Neck lump and pain wouldn't go away so had an MRI in July which came back with multiple demyelinating foci of brain and demyelinating of par of the cervical spine.  Now have tingling in hand foot  face eyebrow on right side. FYI:  Second dose was on 03/29/21 at about 9:30 am  symptoms got exponentially worse
Breakthrough case admission; Moderna X 3 1/26/21 Moderna Lot# 027L20A 2/18/21 Moderna Lot#011M20A 1/4/2 Moderna Lot#059J21A
Brain fog; This is a spontaneous report from a non-contactable healthcare professional. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an intramuscular route of administration in the left arm on 01Mar2021 at 11:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. 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 COVID-19 vaccination. The concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9261) via an intramuscular route of administration in the left arm on 08Feb2021 at 11:15 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 13:30, the patient experienced brain fog. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event brain fog. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event brain fog was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Bodyache Chills Fever Headache Symptoms- headache and slight body ache began the first day but fever, chills and bodyache developed after 1 week from taking the vaccination.
Dizzy; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 17-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) in the left arm on 22Mar2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included alopecia and eczema. The patient was allergic to peanuts, tree nuts, sesame, shellfish, gluten, corn. Concomitant medication included ALLEGRA, PROBIOTIC, unspecified birth control pill and biotin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, within 20 minutes of vaccination, the patient was dizzy and had a headache. The event of dizziness lasted for a couple of hours. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of event dizziness and headache was resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
I have some sort of rash on my upper body/chest/back area. They seem to be small pimples. Almost like razorburn. I have been showering consistently and am not using any new products or eating anything unusual. This breakout is covering a majority of my chest and upper back/shoulders.
Sweating; Anxiety in her chest; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) and ANXIETY (Anxiety in her chest) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 16-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating) and ANXIETY (Anxiety in her chest).   At the time of the report, HYPERHIDROSIS (Sweating) and ANXIETY (Anxiety in her chest) outcome was unknown. Not provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Continued Dizziness/lightheadedness accompanied by nausea. Exhaustion. The night after receiving the shot no symptoms, not even a sore arm. The next morning woke at 8 am feeling like I had been hit by a bus. Severe dizziness, lightheaded feeling, nauseous, left arm pain at injection site along with redness and itching. No appetite. These symptoms continued for over 5 days. Now a month later still suffer daily from dizziness and nausea.
Patient received Janssen vaccine 3/15/2021.  Tested positive for COVID-19 on 4/1/2021.  Reported known exposure to COVID-19 positive person, however meets criteria to review for vaccine breakthrough as >14 days post vaccine.
approx 1 hr p/receiving vax pt c/o numbness @ rt side of mouth & tongue; ? Belles Palsey;
Non-specific symptoms began 1/12/2011, progressed to rash, fever, numbness in arms/legs 1/13. Taken to Emergency Department, experienced blood in tears, was intubated and crashed within 2 hours of arrival to hospital. Cerebrospinal fluid was collected and showed Gram-negative diplococci. Culture later tested positive for Neisseria meningitidis serogroup C.
Pain at site day of injection.  The next morning, patient began to feel flu-like symptoms. By that evening she had chills and fever of 102.5. Patient took Aleve. Patient remained febrile, chilled, and body ached. Patient temperature 100.7 this am (5 days later), took Advil. Injection site is so painful that she feels like the needle is still in her arm. Stiffness and pain goes all the way down her arm and also up into her neck on that left side. Today patient has golf ball size lump that is red and raised. Area of redness and swelling goes up her shoulder and halfway down her upper arm. Patient took a home covid test which was negative.
BLOOD CLOTS; This spontaneous report received from a parent via media via a company representative concerned a 45 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 in total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient died from blood clots. The reporter stated "My healthy 45 year old son died of blood clots after the jab". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221164062- blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOTS
PT RECEIVED VACCINATION. 10 MINUTES LATER DEVELOPED SCRATCHY THROAT, DIZZINESS AND VERTIGO. PT WAS MONITORED WITH STABLE VITAL SIGNS. HELD FOR 30 MINUTES. LEFT ON OWN ACCORD WITH RESOLVED SYMPTOMS.
Initial thigh temperature, shivers, developing into classical flu symptoms of fever, night sweats, headaches, body aches, shivers. Symptoms receding on 10/21/2014 but still weak on reporting day of 10/22/2014.
01/08/21 - 1700 Recieved Covid Moderna in L-upper arm 01/09/21 - 0900 Noticed Red Raised Lump 1/2" diameter w-fevers & chills 01/10/21 - 0800 - L arm sore, Red Raised Hot Lump 2-5" diameter Fever101 & chills 01/11/21 - 0800 - L arm sore continues Hot, red & raised 2.5" diameter 01/12/21 - 0800 - L arm sore Hot, red, raised 3" diameter
09:40- 2nd dose of Moderna COVID-19 vaccine was administered in pt's R deltoid, and pt was asked to remain seated for 15 min 09:55 pt alert and oriented, complained of injection arm "burning sensation," lightheadedness, dizziness, and headache rating 6/10. Sitting BP was checked=134/77, HR 51. Upon interview, pt stated that she DID eat a protein bar + yogurt and drank 8 oz of water prior to coming to imz appt. Upon observation, no visual changes were noted on injection arm, and upon touch, R arm was not warmer than L arm. Cold wet papertowels were applied to pt's head and neck. 09:59- sitting BP 139/80, HR 53- pt states symptoms were improving 10:05- sitting BP 139/85, HR 50- pt states "burning sensation in arm is relieved, headache now rating 2/10 and no longer dizzy, only "slight lightheadedness" 10:12- sitting BP 121/52, HR 51- lightheadedness is relieved and headache remains 2/10 10:19- sitting BP 139/74, HR 54- headache completely relieved, pt denies any complaints/distress 10:24 sitting BP 148/83, HR 51- pt denies any distress 10:27 standing BP 139/85, HR 51- pt denies any distress and left station to pick up groceries inside club. Pt was asked stop by station prior to leaving the premises. Pt verbalized understanding. 11:09 standing BP 140/83, HR 64- pt left premises alert and oriented with no complaints or signs of distress.
On the evening of the shot, urine was a dark orange color, this cleared by the next day.  For the 2 days after the shot my kidneys ached pretty bad.  There was also a large swollen lymph node in the right arm pit, starting on day 2.  Otherwise,  felt flu like for about 48 hours after the shot.
I had body aches, chills, and a headache for 24 hours.  I ran a fever, but it didn't last the entire 24 hours.  Ibuprofen and Tylenol helped my symptoms weaken for a couple hours at a time.
vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Jun-2021 and was forwarded to Moderna on 11-Jun-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.) 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 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.). At the time of the report, PRODUCT STORAGE ERROR (vaccination to a patient from a vial that was opened yesterday at 11 AM and refrigerated afterwards, then used again at 9 AM this morning to vaccinate another patient.) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.