chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 92-year-old female patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9264), on 20Feb2021 as dose 2, single (Lot number: EN6198) and on 13Jan2022 as dose 3 (booster), single (Lot number: FJ1614) at the age of 91 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: hepatitis B, administration date: 06May1930, for Hepatitis B immunization; dtap/dt/td, administration date: 06May1949, for Immunisation; herpes zoster, administration date: 06May1949, for Immunisation; dtap/dt/td, administration date: 06May1980, for Immunisation; pneumo (pcv), administration date: 06May1995, for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient received PAXLOVID treatment.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300157702 same reporter/patient, different drug/event;
Pt. returned to clinic 2 hours later with swelling of eyes L > R. No rash.
Initial misuse report received from a healthcare professional on 12 August 2013. This case is invalid as the individual patient identifiers were no reported. A patient received first dose of IMOVAX Rabies vaccine in the gluteal region. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Suspected COVID-19 virus infection  Acute non-recurrent sinusitis, unspecified location
pt recv vax 22DEC95&25DEC95 pt exp febrile sz&was seen in ER:reporter felt that the febrile sz secondary to the upper resp infect
Red, swollen left arm and elbow below injection. No fever and chills. Benadryl 50 Mg. by mouth every 6 hours PBN, ASA pie by mouth, by mouth every 6 hours PRN, warm compressions. Call if symptoms worsen.
6 YO received adult dose; 6 YO received adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 6-year-old male patient who received HBV (Engerix B adult) (batch number N73FA, expiry date 31st May 2024) for prophylaxis.   On 5th December 2022, the patient received Engerix B adult. On 5th December 2022, unknown after receiving Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt date: 07-Feb-2023. Reporter's Comment: An adult dose of Engerix-B was administered to a pediatric patient by accident. The reporter consented to follow-up. Additional Supportive Information: An adult dose of Engerix-B was administered to a pediatric patient by accident which led to accidental overdose and adult product administered to child.
Patient started feeling dizzy and sick. While caretaker was trying to get him into the car, he had a seizure and wet himself. He recovered from the seizure. Patient was diagnosed with vaccine flu reaction, questionable seizure and vasovagal syncope.
Day 1 (4/16/21): non-emergency allergic reaction =  itching all over Day 2 (4/17/21): still  itching all over, scratchy throat, hurt to swallow,  (normal side effects = elevated temp 100.3, steady headache, dizziness, slight achiness) Day 3 (4/18/21): itching all over, small number of hives on right arm, scratchy throat, inside ears itchy; (normal side effects = nauseous - worse after eating, dizzy, headache, elevated temp 99.6 Day 4: itchy all over, hives now  up & down both arms, scratchy painful throat (normal side effects: above but less. Day 5: all improving
Cause: Complications of metastatic non-small cell lung cancer; OSC: positive COVID-19 test on 05/17/2021; shock liver; pulmonary HTN; acute on chronic respiratory failure; DM2; cardiomyopathy; acute on chronic diastolic CHF
Redness, swelling, at injection site. Size of an "orange." Advised to take Benadryl, apply cool compresses and call back if no improvement.
Severe shivering and chills, teeth chattering, cold extremities, fever, and nausea that went on for 2 hours.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A 74 year-old patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "allergic to nickel, leather, rubber products and numerous chemicals in everyday products" (unspecified if ongoing); "allergic to nickel, leather, rubber products and numerous chemicals in everyday products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), administration date: Feb2021, for COVID-19 immunization. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "eczema"; PRURITUS (non-serious), outcome "unknown", described as "itch". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient received both shots. Prior to that, patient never even had a flu shot, yet 9 months later, patient developed serious eczema conditions covering 80 percent of patient's body. Patient finally got a patch test the week of 3/14. Patient body continues to itch and sometimes feels like it was on fire. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. Sender's Comments: Linked Report(s): US-PFIZER_INC-202200489858 same patient, different dose of vaccine.
8/17/2021 at 1210, approximately 10 mins post vaccination, reported feeling jittery "I feel like I'm running" . VS checked:  BP 129/80, HR fluctuates between 112-120 bpm.  RR 12-20.  Oxygen Sat 96% on RA.  Denies CP, Palpitations, SOB, light headedness, HA.  Symmetrical smile, No c/o of extremity weakness.  transported to  ED for further obseravation.
Information has been received from a licensed practical nurse concerning a 68 year old female who "about three weeks ago" on approximately 13-MAR-2008 was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Subsequently, the patient developed BELL'S PALSY, paralysis of the facial nerve. The patient sought medical attention in the office. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Follow-up information from a physician's assistant indicated that the 68 year old retired female with penicillin allergy, diabetes mellitus, hypertension and scleroderma and a history of myocardial infarction who on 13-MAR-2008 at 13:15 was vaccinated IM with her first dose of zoster vaccine live (Oka/Merck) (lot# 659762/1874U) in the left deltoid. There was no illness at the time of vaccination. On 01-APR-2008, the patient developed right side BELL'S PALSY. The patient was not recovered at the time of this report. Follow-up information from the physician assistant indicated the patient was seen on 10-APR-2008 and had mild persistent weakness on the right side of her face. At the time of the report it was noted that the patient was improving (recovering). Additional information is not expected. 7/18/08-records received-DOS 4/3/08-C/O right sided facial weakness and droop since yesterday. Started with pain behind right ear. Right eye tearing , unable to close eye at night. 4/10/08-visit-Bell's palsy improving with increased strength in face.
Pt received IM Influenza vaccine 0.5cc in right deltoid at 10:18AM 12/11/02. She woke up this morning at 03:00 with swollen, hives on neck, upper arms and chest walls
diareah, vomiting, chills, fever, headache, tightness in chest, sore arm, increased heart rate
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a healthcare professional (patient's wife) concerned a 40-year-old, male patient. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure (stable at the time of report). The patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805031, and expiry: 26-MAY-2021) dose was not reported, 1 total, administered on right deltoid on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date (couple of weeks before this report), the patient and his wife had been to a restaurant. On 14-APR-2021, the patient experienced nasal congestion which resolved on 17-APR-2021. On 21-APR-2021, the patient experienced cough and his wife recognized it as COVID cough'. On the same day, the patient was tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was described by his wife as a breakthrough infection (suspected COVID-19 infection and suspected clinical vaccination failure). The patient's wife mentioned that she thinks her husband probably caught the infection at the restaurant they had been to earlier. The reporter (wife) stated that the patient's symptoms were very mild, he had no fever and did not need an HCP consultation or any medication to treat the symptoms.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was unknown. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Severe migraine for 36+ hours, nausea, vomiting, low grade fever. Headache so debilitating could not get out of bed. When I did, I would get dizzy and vomit. BP normal, heart rate still elevated.
Extreme Dizziness for approx 24 hours.  Had to stay basically still or move very slowly. ---reporting now again because I experience this dizziness every so often ever since.  Never had a dizzy spell prior to the Vaccine.
Seizure; Major weakness (cannot walk or stand unsupported, cannot lift objects more than a pound or two); Major weakness (cannot walk or stand unsupported, cannot lift objects more than a pound or two); Major weakness (cannot walk or stand unsupported, cannot lift objects more than a pound or two); Minor weakness (wobbly legs); Minor to moderate stabby headache; Abdominal cramps; Joint pain (especially left wrist which has buckled under pain a few times and right pelvis area); Muscle pain (is decreasing, but flares up, especially in legs); Dizzines; Severe fatigue; Sore arm from injection; Minor fever; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 12May2021 02:45 PM (batch/lot number: EW0712) as 1st dose, single for COVID-19 immunization. Medical history included Tourette's syndrome, tarsal tunnel (right foot), hyperreflexia, and known allergies to lavender. Concomitant medication included multivitamins; minerals ( DAILY MULTIVITAMIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocodone, acetaminophen (VICODIN) and experienced allergies. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced seizure on 12May2021 03:05-03:45 PM, then on 15May2021 02:55-03:25 AM; major weakness (cannot walk or stand unsupported, cannot lift objects more than a pound or two) on 12May2021 03:05 PM; minor weakness (wobbly legs) on 12May2021 02:50 PM (this weakness increased); dizzines on 12May2021 02:45 PM to evening 14May2021; severe fatigue, has been increasing since shot, having to spend longer and longer in bed, nap a lot, very tired on 12May2021 02:45 PM; sore arm from injection around 12May2021 (reported as 02:40 PM; pending clarification) to morning of 14May2021; minor fever (estimate 99-100 degrees max) on the night of the 12May2021, broke around 02:00 AM on 13May2021, night of 14May2021, broke around 2:45 AM on 15May2021, afternoon of 15May2021, broke around 06:00 PM; minor to moderate stabby headache on 12May2021 02:50 PM, intermittent, managed by paracetamol (TYLENOL); abdominal cramps on 12May2021 02:45 PM; joint pain (especially left wrist which has buckled under pain a few times and right pelvis area) on 12May2021 02:45 PM; and muscle pain (was decreasing, but flares up, especially in legs) on 12May2021 02:45 PM. No treatment was received for the events, except for the event headache which included treatment of paracetamol. The outcome was recovered on 14May2021 for the events dizziness and sore arm from injection; and not recovered for the rest of the events.   No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after third vaccine Pfizer 3/18/21 Lot# En6202 Pfizer 10/28/21 Lot# 30155BA Pfizer 6/10/22 Lot# FM9992
The pt experienced redness, warmth at injection site. (7cm x 2 1/2 cm) to the left thigh. Was seen my MD on 5/6/00. The MD advised Motrin, Benadryl Elixir, cool compresses. Redness was gone by 5/8/00 per Mom.
Bone and muscle ache; muscle pain; joint pain; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bone and muscle ache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (treated for cancer and is on immunotherapy).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced BONE PAIN (Bone and muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BONE PAIN (Bone and muscle ache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-090440, US-MODERNATX, INC.-MOD-2021-090431 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-Apr-2021. AE contact information Updated and additional event added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090431: US-MODERNATX, INC.-MOD-2021-090440:
Activities of daily living impaired; This case was reported by a consumer via interactive digital media and described the occurrence of activities of daily living impaired in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the activities of daily living impaired was recovered/resolved.   It was unknown if the reporter considered the activities of daily living impaired to be related to Tdap Vaccine.  Additional details were reported as follows: The reporter reported for lady patient. The age at vaccination was not reported. A patient took the vaccine and had to be out of work a week and see her doctor.  They were given by the local health department. The follow up would not be possible as no contact details were available. This case is linked to the case US2021AMR172337, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR172337:Same reporter
Patient got the first Gardasil shot 7-25-12, the second 9/26/12, and the third shot 1/28/13.  Im not sure the exact onset date except to say she got the second and third shot during her junior year in high school and she was continually telling me how fatigued, tired, dizzy, light headed and tired she was.  She also had continued to complain about her heart racing, short of breath, heart pains, sleeping difficulty, chest pain, rib pain under her breast, brain fog, headaches, back aches, stomach pain, limb heaviness, neck pain random pains everywhere, seeing different shapes and colors in her vision, severe hip pain, electrical shock pain, and numerous other pains.  In Aug 2013 (the beginning of her Senior  year in high school) she was walking slowly like she had rode a horse to long, Sept 2013 she needed a walker because she was starting to trip and had trouble standing, Oct 2013 she had to use a wheelchair and unable to walk by herself.   We have had MRI, bone scans, CT scans, xrays and numerous bloodwork.
The first dose I only suffered from a sore arm and redness near injection site. The second dose roughly 6-8hrs after injection (4pm/5pm), I began feeling the onset of: fever, chills, immobility, hot and cold sweats, loss of appetite, fatigue, headache, and I was unable to function or perform any daily routines for 2 days while recovering. Afterward I began feeling chest pains in the night and felt generally fatigued for more than 2 months afterward. I continue to feel chest pain almost every night since the 2nd dose.
doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Reporter called to report they gave 26 doses after the 30-day use by date. It was reported that the vial was initially stored in the refrigerator on 14 Jan 2022. The dates of vaccine administration were 14 Feb 2022, 15 Feb 2022, 16 Feb 2022, 18 Feb 2022, 21 Feb 2022. The vial did not undergo any temperature excursions.  No treatment medications were provided.
While pt. was receiving 1st dose of vaccine the needle disconnected from the syringe, Per the nurse more than half of the vaccine was administered. Needle was removed from pt's arm by vaccinator. Per Dr. and ASIP 2nd dose was successfully administered in pt. right arm.
immed p/vax mom picked child up crying child, w/in sec pt became hypotonic & pale;pt placed on exam table to check HR & RR, color was now pink;pt recovered w/in seconds;was observed in office for 5-10min;
HIVES/ITCHING DENIES SOB  VITALS WITHIN NORMAL LIMITS 50MG BENADRYL GIVEN IM.
Intially came to Public Health reporting nausea, vomiting x1.  Body aches and sore right arm.  Reviewed VIS.  Advised to seek medical care if persists.  Returned to PH 3/10/2011 reporting she still has constant dull pain in right arm radiating to fingers.  Has seen medical provider who sent back to PH.  Taking ibuprofen and Vicodin for pain.  Reports today felt a "twang" at time of administration that went to two middle fingers and small finger.
Pt reported heart racing.  Denies all other symptoms: chest pain, shortness of breath and respiratory symptoms.
COVID INFECTION Narrative:  PT TESTED POSITIVE DURING SCREENING FOR WORK TRAVEL, NO SYMPTOMS. COMPLETED VACCINE SERIES ON 3/9/2021
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated subcutaneously with an expired dose of ZOSTAVAX (Lot# 669746/0356AA, expired date 09-JUN-2012, dose not reported) on 12-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. It was not known if the patient sought for medical attention. No adverse effects reported. Additional information has been requested.
worried and concerned; dizzy; she feels yucky and miserable; she's experimenting blurry vision, blurred vision; headaches; achy/ got hit like a ton of bricks; one minute she has fever, next minute the fever is broken; her arm aches from the shot; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY, dizzy, VACCINATION COMPLICATION, VISION BLURRED, and HEADACHES in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced ANXIETY, DIZZINESS, VACCINATION COMPLICATION, VISION BLURRED, HEADACHE, MYALGIA, PYREXIA, and VACCINATION SITE PAIN. At the time of the report, ANXIETY, DIZZINESS, VACCINATION COMPLICATION, VISION BLURRED, HEADACHE, MYALGIA, PYREXIA, and VACCINATION SITE PAIN outcome was unknown.            No concomitant medications were reported. No treatment details were reported. She provided one lot number 033C21A, but could not specify of which dose it was.