chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a little less than 24 hours after receiving the 2nd dose of the Pfizer vaccine, my 6 year old daughter developed hives all over he body. The rash/hives were raised, blotchy, hot and very itchy. She was given 8ml of Benadryl and a bath. After her bath we used eczema lotion  to calm the itching of her skin. The hives and itching went away approx 2 hours after the treatment was given.
10 minutes after patient recieved the Covid vaccine, he reported feeling slightly lightheaded and dizzy. Blood pressure was monitered for an hr. It ran from 224/90 to 204/96. States it usually ran 130's systolic. Patient went to the Emergency Room where he was given amlodipine and monitered. Patient states it went down to 195 systolic. He was allowed to go home. States he had headache, nausea, dizzyness and fatigue in the evening. Those symptoms left around 11;00 the next morning. States he followed up with PA on Monday, who increased his B\PC med. States ED Dr and his PA both felt the symptoms were from the vaccination but both also felt he was okay to receive his second vaccination
Fever 101.1; Bones/Joints ache; joints ache/shoulder pain; blood pressure (BP) was increased to 164/80, 161/88; Pulse was low; threw up twice due to Covid vaccine issues; Horrible HA; back pain; This is a spontaneous report from a contactable consumer (patient) and nurse, based on information received by Pfizer from manufacturer control number is EC-2021-092764 for BNT162B2, and atorvastatin calcium. A female patient received her second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), unspecified route of administration on an unspecified date as second dose, single for COVID-19 immunization; atorvastatin calcium via an unspecified route of administration on an unspecified date at an unknown dose and frequency for an unspecified indication; lenvatinib mesilate (LENVIMA, strength: 4 mg lot number: 1391911, Expiration date:  30Apr2022), orally, on 04May2021 at 18 mg daily for malignant neoplasm of kidney except renal pelvis.  The patient's medical history included allergy on iodinated contrast media. The patient's concomitant medications included pantoprazole sodium, amlodipine besylate, and amoxicillin-clavulanate potassium. The previously took axitinib (INLYTA) and experienced tongue started to swell and blood pressure was elevated. On an unspecified date, the patient had second Pfizer COVID vaccine and had a fever (101.1), horrible headache, bones/joints ache, and couldn't get out of the bed. The patient reported that paracetamol (TYLENOL) has helped. The patient was advised to notify oncology physician. It was reported that the first couple days starting on lenvatinib mesilate blood pressure increased to 164/80, 161/88, hence the physician advised patient to take BP when on axitinib (INLYTA). After, the BP came down to 118/?. It was reported that pulse was low so physician wanted the patient to monitor BP and only take if BP shoots up. In the last two days, blood pressure has been 113/77 (19May2021), 103/78 (20May2021). The patient missed one dose since she threw up twice during COVID vaccine issues. It was reported that her shoulder pain was possibly due to the St. Bernard dog and center back pain (had prior to lenv, may be due to ergonomics, sitting at computer for job). The physician was not aware. The action taken in response to the events for atorvastatin calcium and lenvatinib mesilate was unknown. The outcome of the events fever 101.1, bones/joints ache, joints ache/shoulder pain, blood pressure (bp) was increased to 164/80, 161/88, pulse was low, threw up twice due to covid vaccine issues, horrible headache and back pain was unknown.  Pfizer is a marketing authorization holder of atorvastatin calcium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of atorvastatin calcium has submitted the same report to the regulatory authorities.  Information on the lot/batch number has been requested.
Information has been received from a 23 year old female with no drug reaction/allergies, who on 22-OCT-2008 was vaccinated with the first dose of GARDASIL vaccine.  There was no concomitant medication.  Patient mentioned that she was supposed to have her period on 26-OCT-2008, but until now she had not had her menstrual period yet.  Patient noted that she had not done any pregnancy testing.  The patient sought medical attention.  No further information is available.
Throughout the first couple of days after taking the vaccine, I experienced tiredness and what I thought was normal arm pain. The first concerning symptoms I had almost a week after the first shot and were shortness of breath and feeling like the top half of my body was swollen. I was worried this was an allergic reaction, since I do have experience with allergic reactions from having a food allergy. Vaccine site became red and largely swollen later that same day so I made an appointment with the walk-in clinic that evening, since it was a weekend. The symptoms I presented, swollen bi-lateral lymph nodes in my chest and under my arm, reminded the PA of cancer or even cat scratch fever so lab work was taken. The staff did find research about similar reactions to Moderna in women that mimicked signs of breast cancer. This reaction seemed to align with how I was presenting. I was prescribed steroids for the following week to help with the swelling. This help a lot and I got the call a week later that my lab work had come back normal.  I took the 2nd vaccine a month later and did not have any concerning side affects and little to no arm pain.  What's weird now, is on September 24th, I developed full body hives throughout the day and my joints began to swell. (the fingers on my hand were twice the size). My entire body wouldn't stop itching. So I took a trip that evening to urgent care again. This time, another location because the was the first appointment available. I had started taking Wellbutrin for anxiety/adhd symptoms earlier that month so that's really the only thing that's changed. I was prescribed another set of steroids and antibiotics in case my symptoms were from lyme disease. I have a follow-up with a rheumatologist because of bloodwork results. I have no idea if this is even relevant to the Moderna COVID vaccine. But I've never had anything like these two occurrences happen before. Totally would take the vaccine over again, I just have no idea what's going on. I figure it helps to document anything weird after.
now is in the hospital with Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (now is in the hospital with Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (had Pfizer as his primary series). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Cancer.    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 COVID-19 (now is in the hospital with Covid-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (now is in the hospital with Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: results not provided Results not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  Patient never had any antibodies after booster vaccine.  Company comment: This spontaneous case concerns a male patient of unknown age with relevant medical history of cancer and with interchange of vaccine products (Tozinameran, pfizer biontech covid-19 vaccine), who experienced serious unexpected AESI event of COVID 19 unspecified days after receiving mRNA-1273 vaccine. It was reported that the patient did not develop any antibodies after vaccination and is now hospitalized with COVID 19. Medical history of cancer and the current pandemic situation of COVID 19 could be risk factors for the event. At the time of reporting the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with relevant medical history of cancer and with interchange of vaccine products (Tozinameran, pfizer biontech covid-19 vaccine), who experienced serious unexpected AESI event of COVID 19 unspecified days after receiving mRNA-1273 vaccine. It was reported that the patient did not develop any antibodies after vaccination and is now hospitalized with COVID 19. Medical history of cancer and the current pandemic situation of COVID 19 could be risk factors for the event. At the time of reporting the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pt recvd vax & mom exp difficulty arousing pt; pt eyes rolled back, appeared limp & sl dusky; pt was immed brought to clinic; initial observation generalized duskiness & when picked up started crying; pt seen by MD; poss fainted;
Information has been received from a physician concerning a patient, who on 21-JAN-2013, was vaccinated with the first dose of GARDASIL, 0.5 ml, intramuscularly (lot # not reported). It was reported that the patient received the second dose of GARDASIL on 24-JUN-2013 ("today"). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a nurse refers to multiple patients of unknown age.  Medical history, current conditions and concomitant medications were not reported.  On an unknown date the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # M007728, expiry date: 21-MAR-2018 and lot # M021407, expiry date: 30-APR-2018) (unknown dose) for prophylaxis. No adverse effects were reported. The product was stored at: 32 degree fahrenheit to 35 degree fahrenheit (34F) at 42 hours' time frame. There was no previous temperature excursion. Call was because of data logger. No product quality compliant. The outcome of incorrect  product storage and no adverse event was unknown.
Bad arm pain; Chills; Myalgias; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bad arm pain), CHILLS (Chills) and MYALGIA (Myalgias) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Bad arm pain), CHILLS (Chills) and MYALGIA (Myalgias). At the time of the report, PAIN IN EXTREMITY (Bad arm pain), CHILLS (Chills) and MYALGIA (Myalgias) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (Discomfort). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.     This case was linked to MOD-2021-007843 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
some inflammatory symptoms including an excess of spinal fluid; some inflammatory symptoms including an excess of spinal fluid; This is a spontaneous report from a contactable consumer (patient) received via a sales representative.A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNWON, SINGLE for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had COVID, which resulted in some inflammatory symptoms including an excess of spinal fluid. Patient was vaccinated and the long-term COVID symptoms were not resolved by the vaccine on an unspecified date.The outcome of the events were unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. .
Patient had witnessed syncopal episodes x 3 immediately after administration of Flucelvax (which was after COVID booster). Patient was transported to local hospital via EMS.
Clinic gave 9 doses of flu shipment that had spent too long in transit, no advese event; Based on information previously received on 04-Oct-2019, the following information updated: case validity has been amended due to number of patients involved specified.  Initial information received on 04-Oct-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  This case involves nine patients who were vaccinated with a dose each of vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (lot number and Exp. Date not reported) via unknown route in unknown administration site on an unknown date and for this vaccine shipment had spent too long in transit.   The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' s compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was not obtained despite contact attempts with the reporter.  Follow up information received on 07-Nov-2019 regarding an unsolicited non-valid non-serious case received from a consumer.  Report contain no new information.  Addendum: Based on information previously received on 04-Oct-2019, the following information updated: case validity has been amended due to number of patients involved specified.
flu; Initial information received on 13-Feb-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced flu while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Influenza Vaccine (formulation, strength: unknown) produced by unknown manufacturer lot number not reported in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Dizziness; This non-serious case was reported by a nurse via sales rep and described the occurrence of dizziness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID 19 VACCINE for prophylaxis.   On 19-OCT-2023, the patient received Shingrix and COVID 19 VACCINE. In OCT-2023, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: Dizziness). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-OCT-2023 The patient was over age 65-year-old. The reporter stated that, the patient vaccinated with Shingrix and Covid vaccine around 6 days ago from the date of reporting and patient still experiencing dizziness.  It was unknown if the reporter considered the dizziness to be related to Covid 19 vaccine. No other information provided since vaccine administered at pharmacy. The reporter undecided if it was related to product but requested to follow up.
Body/ trunk and neck rash, no itching, burning, puss, etc. Completely asymptomatic.  Hydrocortisone cream, Benadryl ineffective. Spoke with physicians assistant, she was unsure and referred me to an allergist currently waiting on call back for blood test appointment.  Rash still  present after 13 days.
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 03-APR-2015, the patient was vaccinated with GARDASIL 9 (Lot#, dose and route of administration were not reported). On 03-JUN-2015, the patient received GARDASIL (Lot#, dose and route of administration were not reported) who was intended to receive GARDASIL 9. No adverse effects were reported. Additional information has been requested.
Episodes began around 09/02/2021 consisting of chest and abdominal pain and pressure, shaking in limbs, sometimes vomiting, and feeling of impending doom, Total of 4 episodes so far, lasting 1 to 2 hours. ECG at ER apparently normal, and I have requested a copy. Working diagnosis is panic disorder, but I am reporting due to temporal relationship to first vaccine dose for COVID-19 Moderna.
SORE TENDER ARM THAT HAD RED RASH AND NOW IS JUST PAINFUL
Fever of 105+ - Seen by Physician 5/19/17 and sent for a CBC and Blood Cx.
pt recv vax 28FEB96 & 10min p/vax pt eyelids were swollen;eyes appeared injected;did not exhibit any sx of resp distress;
Multiple ER and doctor visits and a week long hospital stay with a diagnosis of transverse myelitis.
Tingling hand; Sored left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling hand) and PAIN IN EXTREMITY (Sored left arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: JANSSEN COVID-19 VACCINE (first dose). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 02-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2022, the patient experienced PARAESTHESIA (Tingling hand) and PAIN IN EXTREMITY (Sored left arm). At the time of the report, PARAESTHESIA (Tingling hand) and PAIN IN EXTREMITY (Sored left arm) outcome was unknown.            It was reported that the patient does not take any concomitant medication.  Patient had not taken medication to fight the symptoms.   This case was linked to MOD-2022-557642 (Patient Link).
mom reports infant cried a high pitch, squeak-like cry throughout noc beginning 1-2hr p/vax;rt leg hot to touch, red, swollen;
I took the 2nd vaccine in the series and I did not know that I was pregnant at the time. I started experiencing light bleeding and ultimately had a  miscarriage 1.5-2 weeks after receiving the 2nd vaccine. My doctor did not think that the vaccine was attributed to the miscarriage. I have no previous history of miscarriage. Since this occurred within 30 days of receiving the vaccination, I believe that it should be reported.   I am a healthcare worker and there has been zero communication/education or plea to the healthcare community to report adverse events for patients that receive the covid vaccines. As a researcher for phase 1 trials, we are required by the FDA to report all adverse events to the FDA whether the adverse event is attributed to study drug or not.
No adverse event occurred. However, the vaccine was given after expiration. Expiration date 09/21/21. Vaccine given 09/30/21.
Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 28-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 25Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jun2022, outcome "recovering", COVID-19 (medically significant) with onset 18Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Jun2022) Contracted Covid. It was unknown if therapeutic measures were taken as a result of covid-19.  Clinical course:If other vaccine in four weeks: Unknown. If covid prior vaccination: Unknown. If covid tested post vaccination: Yes. Covid tested post vaccination: [{Covid test type post vaccination: Unknown, Covid test date: 18Jun2022}]  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Extreme lethargy and sleepiness, difficult to wake up, slept for long time, loss of appetite, rash that slowly spread up his body, itchy skin, deep cough.
Phone call from pt's mother 7/15/05 stating pt, her daughter, had Menactra 7/11/05 and had seizure that PM. Took her daughter to MD and referred to neurologist. States all test were negative.
not willing to get second dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INTENTIONAL DOSE OMISSION (not willing to get second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (not willing to get second dose). At the time of the report, INTENTIONAL DOSE OMISSION (not willing to get second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant products reported