chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A 51-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed nasal congestion/stuffy nose/nose stuffed-up and has to be blown all the time, pharyngeal disorder/throat changed a little bit and nasopharyngitis/described as "I got a sinus cold," with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021334756 same reporter and drug; similar events, different patient.
throwing up; feels nauseous; fever; rash, growing on the arm she got the covid vaccine; severe cramping; pain; This is a spontaneous report from a contactable consumer (patient). This 20-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW01S5), dose 2, via an unspecified route of administration in the left arm on 17May2021 08:35 (at the age of 20-years-old) as 2nd DOSE, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications were reported as none. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EW0167), dose #1, via an unspecified route of administration in the left arm on 26Apr2021 at 08:35 as 1st DOSE, SINGLE for COVID-19 immunization and experienced no adverse effects. After the first dose of the vaccine, the patient reported being fine. After the second dose, on 17May2021, the patient reported experienced severe cramps at 10:00. The patient developed a rash on the same day at 12:00 that is reportedly growing on the arm she got the covid vaccine. At about 23:00, she could not handle the pain and was going to go to the emergency room, but her mother talked out of it and told her to sleep it off. On 17May2021 at 23:30, the patient experienced a fever. And at 00:00 on 18May2021, the patient reported throwing up. At around 02:00 on 18May2021, the patient awoke screaming in pain. It was not a period cramp. She stated she could not tolerate it. She stated the fever comes and goes. The patient mentioned every time she smells food, she wants to vomit. She feels nauseous. The adverse events experienced did not require a visit to the emergency room or to a physician's office. Clinical outcome of the event severe muscle spasms was not resolved. Clinical outcome of the remaining events was unknown.
-Tenderness/soreness at injection site upon touch or over body movement. -Some nausea -only injection site of PNEUMOVAX.
Experienced numbness in face on lt side as well as in pinky and ringer finger. Also experienced swollen lymph nodes in arm pit region.
inflammation at injection site; redness at injection site; joint aches; bit of a headache; muscle aches; flu-like symptoms; felt blah and felt icky; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), VACCINATION SITE INFLAMMATION (inflammation at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and ARTHRALGIA (joint aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches). On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 08-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), FEELING ABNORMAL (felt blah and felt icky), ARTHRALGIA (joint aches), HEADACHE (bit of a headache) and MYALGIA (muscle aches) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (inflammation at injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included statin and blood pressure medicines
Patient was given vaccines and after administration, she began to tremble and her eyes rolled back. Pt conscious 2 seconds after. 911 was called and she was transferred to ER.
Developed varicella (clinical diagnosis) 19 days after vaccine administered. No adverse outcome.
10/18 ~1:00 AM I woke up to get our toddler whom was crying I was quite dizzy my husband found me unconscious on the floor. I have a pulse oximeter as I am Respiratory Therapist. My HR was 47bpm and my saturation 83%. My husband placed me on our couch and made me drink some water and I improved in HR and saturation but did not feel right. I went to an urgent care where they diagnosed me with complete Right Bundle Branch Block hypotension of 82/62 and referred me to a cardiologist. The cardiologist had me wear a 48hr monitor that showed I continuously stay in complete Right Bundle Branch Block along with an ECHO that showed no congenital abnormalities.  Today 10/29 I received medical records prior to my adoption that I was seen by a pediatric cardiologist with findings of intermittent right bundle branch block. They related these findings to severe asthma as a child stretching my conduction system and did not see the need for me to continue to see a cardiologist. I?ve had two children and pregnancies since with two c-sections all without findings of right bundle branch block. The cardiologist does not have an answer but the booster may have exacerbated it. I will now have Right Bundle Branch block permanently which increases my chances of Myocardial Infarction by 75% at the age of 30 years old. I am healthy, workout, first responder, and not overweight.
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates in April 2017 (reported as from 20-APR-2017 to 25-APR-2017), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number reported as M011840 with expiration date of 01-FEB-2018, lot number M023169 with expiration date of 13-JUN-2018, lot number M032650 with expiration date of 31-MAR-2019 and lot number M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour 17 minutes at a temperature between 9 degrees Celsius and 25 degrees Celsius on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. Additional information has been requested. Sender's Comments: US-009507513-1704USA014144: US-009507513-1705USA001802.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2012, the patient was with a first dose of GARDASIL (dose, route of administration, anatomical location, lot # and expiration date were not reported).   On 22-FEB-2017, the patient received his second dose of GARDASIL lot # M028323 with an expiration date 26-AUG-2018 (dose, route of administration and anatomical location were not reported) which was outside of the recommendations for GARDASIL prescribing information. No adverse effects were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
Had swelling in leg for a couple of days prior to the early morning of 1/31 where the knee and entire lower leg was swollen and painful and made it very painful to walk.  After sending photo to primary care physician had mom evaluated for a blood clot.  It was determined based on blood test, vascular ultrasound that right non occlusive (mid) Femoral vein DVT.
Information has been received from a nurse practitioner concerning a patient who was vaccinated with Pneumovax 23. Subsequently the patient experienced dramatic local reaction. The patient was not seen in the office. Additional information has been requested.
sore arm / arm hurts and is painful at the site of the vaccine; upset stomach; diarrhea; upset stomach; diarrhea; Muscle weakness; Tiredness; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.    A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9263) solution for injection, intramuscular in left arm on 26Jan2021 11:00 at a single dose for Covid-19 immunization. Medical history included Covid-19 from 2020 (patient had Covid 3 months ago; he was in the hospital for 9 days and his wife received treatment at home), ongoing urination problem (it was an ongoing issue and again nothing to do with this (to the vaccine)). The patient's concomitant medications were not reported. The patient experienced sore arm/arm hurts and was painful at the site of the vaccine, upset stomach, diarrhea, muscle weakness, and tiredness on 26Jan2021. Patient reported that he and his wife got their first Covid-19 shots on 26Jan2021. Patient wanted to know what the window was for the second shot. He later mentioned he had a sore arm, upset stomach, and muscle weakness in the body. The arm hurts and was painful at the site of the vaccine given and they both were tired that night. Has had diarrhea, but it's not terrible. His wife also had symptoms. Mentioned he went to the hospital yesterday (27Jan2021) for some testing, but it's not related to this (vaccine). No further details provided. They did book an appointment for the second shot and it was actually 4 weeks from the first one, but they thought Pfizer's vaccine was supposed to be 3 weeks and wants information about that. No further details provided. Patient stated he had full blood work done about 2 weeks ago (Jan2021) and everything was okay, except a urination problem he has. That was an ongoing issue and again nothing to do with this. He and his wife both had the Covid virus over 3 months ago and he was in the hospital for 9 days and his wife received treatment at home. No further details provided. Patient reported he weighs 250-255 lbs. Outcome of the event was not recovered.  No follow-up activities are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021117404 Same reporter, drug, and event, different patient
This spontaneous report was received from a consumer (patient's brother) refers to a 30 year old female patient. The patient was not pregnant. Information regarding her concurrent condition, drug reactions/allergies and concomitant medication was not provided. On an unknown date two weeks after giving birth to a child, the patient was vaccinated with GARDASIL via intramuscular route. Patient reported that she felt weak after receiving the vaccination. She also reported that she could not produce enough milk to feed her child. Outcome of the events were unknown. Causality assessment was not provided. Additional information has been requested.
Pain under left arm, arm pit area; Pain under left arm, arm pit area, that radiates towards the breast; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for unspecified indication from an unknown date. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 01Mar2021 at 10:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Mar2021 at 15:00, the patient experienced pain under left arm that radiated towards the breast. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain under left arm that radiated towards the breast was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered 3 patients/3 booster doses administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that on 24May2022, 1 vial was placed in the refrigerator from which 1 dose (0.25mL booster dose) was given. No temperature excursions were reported. No concomitant medication information were given. No treatment information were given.
Information has been received from a registered pharmacist concerning a 60 to 65 year old male patient, with no known allergies, who on 07-NOV-2008 was vaccinated with a dose of PNEUMOVAX. Concomitant therapy included Influenza virus vaccine (unspecified). On 10-NOV-2008 the patient experienced painful stiff neck, fever and rash under his arm. The pharmacist said the patient's wife described these as "meningitis like symptoms". The patient was placed on OXYCONTIN for the pain with his stiff neck and BENADRYL for the rash. The physician did not diagnose meningitis. At the time of this report the patients fever was improved but the stiff neck and rash under his arm persisted. On 11-NOV-2008 the patient was sleepy but able to go to work. The patient sought medical attention through an office visit. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2022 as dose 2, single at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 18Apr2023 to 22Apr2023.  Clinical course: No other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started to feel off. Heart palpitations, shortness of breath, brain fog, chest pain, dizziness/lightheaded.
Neuropathy; Numbness/ pins and needles in both hands and feet and abdomen; Numbness/ pins and needles in both hands and feet and abdomen; This is a spontaneous report from a contactable consumer. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 05Apr2021 (Batch/Lot Number: EW0170) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. On 26Jul2021, the patient experienced neuropathy and numbness/pins and needles in both hands and feet and abdomen. Conditions has been consistent for more than 2 months. The event neuropathy was assessed as serious (medically significant). It was mentioned that the adverse event resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Lab data includes nasal swab (SARS-CoV-2 test): negative on 30Aug2021. The patient did not received treatment for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient is a 51 year old woman who was admitted for multiple neurological symptoms following Covid /booster vaccination. She had vaccine on Tuesday. Within a few hours she developed a headache, nausea and tingling sensation on the left. She thought she was having a vaccine reaction. The same evening she had pain in her left leg diffusely, most severe pain localizing in left foot. Next morning she woke up with the left arm and leg heaviness along with numbness of her left leg. She thought her left side was weaker. She also felt tingling in her left face. Reportedly her family thought her speech was slower. She reports milder side effects with the first booster when she felt achy and had flu like symptoms. She feels improved today with left arm feeling is almost back to normal, left leg is still numb and heavy. She has chronic back pain with occasional radiation to her legs, usually in thighs.  Left hemiparesis and hemi anesthesia following covid booster vaccine. On exam there is intermittent left facial paresis only noticeable when smiling, goes away when talking and with distraction, she has no left arm drift, there is remaining left leg weakness with variable effort and give away weakness. I doubt she had CVA. A/w MRI to exclude the small infarct. Symptoms are likely related to vaccination with a functional component. She should refrain from additional vaccination in the near future. PT will be beneficial for strengthening.
This spontaneous report as received from a Registered Nurse refers to a 17 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On an unspecified date in August 2014, the patient was vaccinated with the first dose of GARDASIL, intramuscular (lot number and expiration date were not provided). The patient received a second dose on 10-MAR-2015 and a third one on 10-APR-2015, both of GARDASIL, intramuscular (lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse effect. This is one of two reports from the same reporter. Additional information has been requested.
Patient vomited 9/10/11 am and proceeded to have a headache and light-headedness for 48 hours.
Arm pain (severe) - physical therapy, orthopedic surgeon, MRI injections.
administered an expired pediatric dose of Engerix-B / expired on 06/3/2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B pediatric) (batch number unknown, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th June 2021, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th June 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. On 11th June 2021, patient received Engerix B pediatric which was expired on 3rd June 2021. The reporter asked if the vaccine should be repeated or not.  The Healthcare professional was not confortable giving any detail. The reporter did not consented to follow up.
Two days following smallpox vaccination, patient experienced mild fever and muscle aches.  He then developed a somewhat numb, uncomfortable feeling in his legs.  He believes the discomfort is in his joints.  His legs continue to tire easily.  Physician diagnosed "restless foot syndrome" per patient.
experienced swelling, warmth and redness at the injection site; experienced swelling, warmth and redness at the injection site; experienced swelling, warmth and redness at the injection site; This spontaneous report was received from a nurse refers to a 78 year old female patient. The patient's pertinent medical history and concomitant medications were not reported. Her drug reactions and allergies included allergy to sulfa drugs that gave her sore mouth. On 09-OCT-2019, patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, anatomical location, lot # and expiration date were unknown) via an intramuscular route for prophylaxis. On 25-NOV-2019, the patient was vaccinated with second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, anatomical location were unknown) with lot # S006777 and expiration date 28-NOV-2020 via an intramuscular route for prophylaxis. On 26-NOV-2019, the patient experienced swelling (injection site swelling), redness (injection site erythema) and warmth (injection site warmth). The reporter stated that the area of redness measured "17 cm X 19 cm". The patient received antibiotics as treatment for the events. The patient sought medical attention from physician office. The reporter stated that the "patient had no fever". The outcome of the events of injection site swelling, injection site erythema and injection site warmth was reported as not recovered. Causality assessment was not provided. There was no product quality complaint associated with the case.
4-6 hrs /p vax child had fever of 103, next morning childs fever 105 & had seizure. Child seen by MD & observed. Dx otitis media given antibiotics