chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient's white blood cells dropped dramatically and it started after getting the 1st dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "Patient's white blood cells dropped dramatically and it started after getting the 1st dose". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: numbness on left side from neck to toes. did not go away for days
My left arm (at shoulder), at the injection site, is still red, warm to touch and it itches. This morning (01/09/2021) I felt pain under my arm (in my armpit).
Patient had flushing/sweating, dizziness. BP 70/32 -- > 83/52 -- > 100/64, HR 105 -- > 102 -- > 91, RR 18 -- >16-- >18. Given water and juice. Patient stable, released from vaccination site.
Patient reports she received second dose of Moderna Covid 19 vaccine lot #039K20A on 01/19/21. On 1/20/21, Patient awoke with  fever 100.4, body aches, headache, fatigue, nasal congestion, and sob. Patient contacted the Covid line and followed recommendation to get tested. COVID swab was negative. Patient reports symptoms self resolved on 01/23. Patient reports symptoms were bad enough that she was unable to cover 2 shifts. Patient reports she only developed chills and fatigue after initial dose of Moderna lot #039K20A. VAERS. Patient declines additional concerns at this time. D/c from health service.
About 2 hours, post vax, her knees started hurting. When swimming, said they felt like rubber. Symptoms lasted about 2 weeks.
injection site redness and vaccination site swelling; red big circle at injection site; fatigued; MIGRAINE; EXTREME DIZZINESS; NAUSEATED; foggy; pressure on forehead; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (EXTREME DIZZINESS), HEADACHE (pressure on forehead) and FATIGUE (fatigued) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced DIZZINESS (EXTREME DIZZINESS) and HEADACHE (pressure on forehead). On 10-Feb-2021, the patient experienced FATIGUE (fatigued). On 11-Feb-2021, DIZZINESS (EXTREME DIZZINESS), HEADACHE (pressure on forehead) and FATIGUE (fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatments for the events included, Tylenol, Ibuprofen, Benadryl.     Reporter did not allow further contact
Approximately 45 minutes after injection had shrill unconsolable cry, turned extremely pale then became limp. Was premature so age at time of injection was zero. Phone Dr. who stated he was fine, it was not a live virus. 9/21/07-well baby visit notes for DOS 9/1/05 and 12/2/05-patient did not have adverse reaction in the physican office. No longer treating patient. Per 60 day follow up: Residual symptoms related to adverse evernt are Encephalopathy, Cerebral demyelination, Global developmental delay, sensory integration disorder, Apraxia, and Austistic Spectrum disorder. 1/12/2010 Global developmental delay, cerebral demyelination, sensory integration disorder, dysarthria, Apraxia, dysphagia, toxic enphalopathy, Autistic spectrum disorder.
Fatigue; Joint pain; Dizziness; Fell a couple times; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 19th June 2019, the patient received Shingrix (intramuscular). In June 2019, less than 2 weeks after receiving Shingrix, the patient experienced fatigue, joint pain, dizziness and fall. On an unknown date, the outcome of the fatigue, joint pain, dizziness and fall were unknown.   It was unknown if the reporter considered the fatigue, joint pain, dizziness and fall to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient received Shingrix. Three or four days after the injection, the pharmacist followed up and the patient did not report any symptoms at that time.  On 27th June 2019 the patient's husband called the pharmacy to report the patient was experiencing fatigue, joint pain, dizziness, and she had fallen a couple times due to the dizziness.  The patient's husband denied fever and denied rash. The reporter consented to follow up. The pharmacist states he filed a VAERS report and he consents to follow up from safety.
it kind of itched a little for a week after the second dose; arm got a little sore or a weak feeling; arm got a little sore or a weak feeling; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 10Aug2021 at the age of 45-years-oldas DOSE 2, SINGLE for Covid-19 immunization. Medical history included covid-19 from May2021 to an unknown date She caught covid in May2021 , blood pressure abnormal from an unknown date and unknown if ongoing. She got her first vaccination on 20Jul2021 and second one was 10Aug2021.Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for hypertension from May2021 and ongoing; amlodipine besylate; hydrochlorothiazide taken for blood pressure abnormal from an unspecified start date to 17Aug2021. She is going through some health issues for the past month. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has been tested for Covid-19 Since the vaccination and caught covid in May2021. On an unspecified date, probably a week later after the second dose the patient got a red bump that appeared, it kind of itched a little for a week after the second dose. Then the arm got a little sore or a weak feeling. It was a little red bump as if she just got it. Nothing appeared when she first got it. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
April 15- late morning. Numbness right arm and hand and left arm. Loss of feeling in arm and hand. Difficult to raise arms, heaviness. Lasted less than 30 minutes. April 16- late morning. Left leg/foot very heavy, couldn?t walk.  Lasted less than 15 minutes.                      4:00 pm. Numbness again in left leg. Lasted less than 15 minutes.                      5:00pm. Numbness in left arm and thumb and first finger. Lasted less than 15 minutes.
Pt received Influenza vaccine 11/01/2005, pt had fevers and then suffered a febrile seizure 11/3/2005, requiring admission to pediatric inpatient unit. Evaluation revealed leukopenia. Information from medical records states pharyngitis, hypothermia. msv Medical records state vomiting. msv
Client states on Thursday (4/11) he begin to have fever, headache and body aches.
This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with lot # (669631/0156AA) an unspecified dose of M-M-R II on 15-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. The patient was administered a dose of MMRII that had been exposed to 5 temperature excursions to a high temperature of 55 degrees Fahrenheit for an unsupportable cumulative total of 8.5 hours (Excursion dates 27-JUL-2012 for 1.5 hours; 08-SEP-2012 for 3 hours; 09-SEP-2012 for 4 hours). No adverse effect was reported. No treatment information was reported. No further information is available. This case is linked to case MARRS # 1211USA011055, 1211USA012758 and 1212USA000924 (same reporter). Additional information is not expected.
Very large swollen lymph nodes in left armpit; neck, arm pain; neck, arm pain; headache; hot flashes; low grade fever; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection and lot number: EL9265) via an unspecified route of administration on 03Feb2021 07:00 to Left arm at single dose for COVID-19 immunization. Patient medical history included Eosinophilia and colitis. Concomitant medications included Escitalopram, alprazolam and ibuprofen. Past drug included Wellbutrin and experienced allergy and first dose of BNT162B2 for COVID-19 immunization. On 03Feb2021 22:00 patient experienced Very large swollen lymph nodes in left armpit, neck, arm pain, headache, hot flashes, low grade fever still continues at 1 week after last dose. Seriousness was reported as non-serious. Patient did not receive any treatment for events. Outcome of events was not recovered.   No follow-up attempts are possible. No further information was provided.
No further AE details; HCP called to report a TE. 3 Administered doses. Dose was administered on 9/9/2023, excursion occurred on 9/7/2023.; This spontaneous report was received from a healthcare professional (HCP) and referred to a patient of unknown age or gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  The excursion of varicella virus vaccine live (oka/merck) (VARIVAX) injection occurred on 07-SEP-2023, and it was vaccinated to the patient on 09-SEP-2023 (lot #W039293, expiration date: 11-DEC-2024; strength, dose and route were not reported) for prophylaxis (Product storage error).   The excursion temperature was 0.2 degrees Celsius (C) with time frame from minus 14 C up to minus 10 C for 30 minutes, and from minus 10 C up to 8 C for 30 minutes. There was no previous temperature excursion. No further adverse event (AE) details were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2309USA009213:
Pressure in the head; Unable to think clearly; Vision Problem; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Pressure in the head), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and PAIN IN EXTREMITY (Sore Arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL for Hypertension.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Pressure in the head), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and PAIN IN EXTREMITY (Sore Arm). At the time of the report, HEAD DISCOMFORT (Pressure in the head), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and PAIN IN EXTREMITY (Sore Arm) outcome was unknown. Not Provided          Treatment information was not provided. The patient states that she thinks that the Moderna COVID-19 vaccine is a toxin to her body. She also states that the vaccine has propylene gycol which according to her is a carcinogen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-114293 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
received moderna covid 19 1/14/21 12 noon.  1600 hours developed severe sharp 7/10 peri umbilical abdominal pain that did not radiate, no associated signs/symptoms.  Pain persisted until 2300 hours, took one tab acetaminophen, went to sleep.  Upon arising in AM pain resolved. Has not recurred.  Upon arising did experiencing more typical side effects including fatigue and thought he had fever, no thermometer to check, these symptoms subsided over 1-2 days.  No recurrence of any above symptoms.
Systemic: tingly/fuzzy feeling around nose and upper cheek area-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: pt had tingly/fuzzy feeling around nose and upper cheek area. She sat in observation for a total of 30 mins, pt was given Allegra and after 30 mins, said she was feeling back to normal
Electrical shocks in different areas of body; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the right arm on 26Apr2021 at 09:45 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not have allergy. 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 vaccine. The patient did not take any concomitant medications. On 26Apr2021 at 13:00, the patient experienced electrical shocks in different areas of body. The event did not result in doctor or other healthcare professional office/clinic visit, and 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 event. The clinical outcome of the event electrical shocks in different areas of body was resolved on an unknown date in 2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
1 1/2 inch slightly raised area, red and sore to touch at ZOSTAVAX site. Red area one inch below FLUZONE site, slightly warm to touch about 2 inches long.
Stomach pain Narrative:  Patient received J&J vaccine on 4/7/2021. No adverse reaction experienced at time of administration or during immediate post-monitoring period. ~4-5 Days after vaccination patient reports having 1 day of stomach pain she rated as an 8/10. After the first day of stomach pain the pain subsided to just a "sensitive stomach", but this has persisted even through today. Patient denies any other concerning symptoms (vision changes, shortness of breath, leg pain).
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter reported that his/her physician told him/her that if he/she had chickenpox as a child then he/she would not get shingles as an adult. The reporter stated that he/she knew the patient who received Shingles vaccine and shortly after that experienced shingles. The patient further stated that it was sounds like another fear inspired cash cow for certain chemical companies. The follow-up would not possible as no contact details were available. This case had been linked with US2023AMR064968 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR064968:Same reporter
DOSE ADMINISTERED OUTSIDE OF APPROPRIATE STORAGE CONDITIONS; This spontaneous report received from a pharmacist concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced dose administered outside of appropriate storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose administered outside of appropriate storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210532970.
Mildly sore arm where injection; This is a spontaneous report from a contactable physician (patient) through a Pfizer sales representative.   A patient of an unspecified age and gender received BNT162B2 (Pfizer-Biontech covid-19 vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, one day after the vaccination, the patient experienced mildly sore arm where injection of vaccine was given. Clinical outcome of the event was unknown at time of this report.  Information on the lot/batch number has been requested.
Within a half an hour, I began to sweat profusely and feel lightheaded/dizzy followed by a headache.  I felt disoriented.  By several hours later, my arm was numb.  That night, I woke up numerous times sweating and aching.  My arm is still numb, tingling and prickly.  I am irritable and achy with a headache yet today.
No adverse event; received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 INCORRECT DOSE ADMINISTERED (received the Moderna bivalent booster vaccine for their first primary dose./patients had never received a primary series of the Moderna Covid-19 vaccine.).    No concomitant information provided Two patients walked into the Pharmacy yesterday and received the Moderna bivalent booster vaccine for their first primary dose. The patients had never received a primary series of the Moderna Covid-19 vaccine. No treatment information provided
Symptom started within a day of the 2nd dose.  Ongoing. Symptom: dry mouth, bad taste in my mouth, unusual amount of plaque within a short period of time. Treatment:  increase my dental cleaning to 1x a month.   Other treatments: brush teeth multiple times a day, dry mouth spray, soothing mouth wash, oral pro-biotic, chewing gum
"Feeling Hot" without fever and nausea 10 hours post vaccine and resolved within 1 hour. Seizure, Hypotension, Unresponsive followed shortly by cardiac arrest and pulseless electrical activity 21 hours post vaccine. Pronounced dead 22 hours post vaccine
Thigh very swollen. Very large welt. Extremely red area. Red area measured 2" x 2". Child kept awake at night crying about her leg hurting. Did this for three nights after receiving shot. Red swollen area lasted for about a month. Child complained of it hurting for about two weeks.
rash on arms excluding hands, itching rash per reporter on 21SEP96;seen @ clinic by MD dx contact dermatitis;tx w/meds;
Patient reported abnormal soreness on right arm, a patch of heated redness around underarms and chest area on right side. Also reported forehead and cheeks on face being heated and red, and felt as if getting sick. Patient states she has recovered and is feeling a lot better after 6 days.
1050 Patient received second dose of Moderna vaccine to right deltoid. At 1107 patient reported itchiness and redness to right arm. Patient denies SOB, C/P. No angioedema of the oral cavity. Patient has facial flushing, redness to right arm and upper back. BP 180/90, P 90, O2 98%RA, R 18. Patient on cardiac monitor in normal sinus. Patient given 25mg of Benadryl PO.  1115 Patient verbalized that her symptoms were neither improving or progressing. Patient asked if she would like to seek additional medial treatment. Patient opted to refuse transport to hospital, but stated that she would have her brother who was accompanying her, provide transport to the hospital. Prior to leaving, patients BP was 148/86, P89, O2 99%RA, respirations 18, easy and unlabored. Reference EMS.
No adversse event occured. We realized on 11/16/23 that we administered full vial instead of 0.25ml. Therefore, 0.5ml was given.
Patient became very lightheaded, pale, c/o HA, nausea, and severe muscle aching in all extremities. Mom had called to report as his symptoms came on quickly -by the time they got home after administration. His R deltoid area was also very sore. Mom wondered if he should go to the ER they were so concerned.
UPPER ARM SLOWLY BEGAN TO HURT MORE AND MORE AFTER INJECTION.  BY NIGHTTIME, I WAS UNABLE TO SLEEP DUE TO PAIN AND SWELLING IN ARM. THE BOX BELOW MAY NOT REFLECT ACCURATE OUTCOME DUE TO LESS THAN 24 HRS SINCE VACCINATION.