chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having a migrane on the left top side of my head. about a 1hour 30 after vaccine. I have experienced head pain every day since and pain in my left ear.; About a 1hour 30 after vaccine. I have experienced head pain every day since and pain in my left ear.; About a 1hour 30 after vaccine. I have experienced head pain every day since and pain in my left ear.; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of bnt162b2 (BNT162B2; Batch/Lot Number: ER8730), via an unspecified route of administration on Mar2021 as single dose, second dose via an unspecified route of administration, administered in Arm Left on Mar2021 (Batch/Lot Number: EWB153) as single dose for COVID-19 immunisation. Medical history included blood pressure measurement from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. The patient was diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced migraine, headache, ear pain on 24Mar2021 14:00. Clinical course reported as I started having a migrane on the left top side of my head. about a 1hour 30 after vaccine. i have experienced head pain every day since and pain in my left ear. Therapeutic measures were taken as a result of adverse events as Medication, Mri, Nerve block. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Information has been received from a healthcare worker (medical assistant) referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. The healthcare worker reported that doses of ZOSTAVAX (lot # L006392, expiry date 25-MAY-2016) which were exposed to temperatures outside of the recommended range, had been administered to the unspecified patients on unspecified dates since 20-JUL-2015. At the time of the report, no adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
getting pain in hip; became very, very painful; very bad lower back pain; She could hardly walk; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Feb2021 (Lot Number: EN6200) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included Alzheimer's from an unknown date. The patient's concomitant medications were not reported. The reporter (patient's husband) stated, "I am calling about the Pfizer's COVID shot. About six hours after she received the shot yesterday, there are a couple of things. She is 83. She has Alzheimer's. She received the shot yesterday, about six hours later she started getting this pain in her hip. And it became very, very painful. And I am just wondering if that could be from the shot?" The patient got very bad lower back pain. She could hardly walk. Events occurred in Feb2021. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
COVID19(MODERNA) was given as second dose and upon filling out patient's  vaccine form . I discovered that he got Pfizer as first dose. Patient stayed 15 minutes after the vaccination and was feeling fine.
Headache, fever, lasting around 6-12 hours. Body aches lasting 24 hours.
This case was reported by a nurse via a sales representative and described the occurrence of injection site pain in a 25 year old female subject who was vaccinated with FLUARIX, GlaxoSmithKline. On an unspecified date on or prior to 17, January 2007, the subject received unspecified dose of FLUARIX (0.5 ml, unknown, right arm). On 18 October 2006 after vaccination with FLUARIX, the subject experienced injection site pain, joint stiffness and unable to raise arm. At the time of reporting the outcome of the events was unspecified. Follow-up information received - The events completely resolved by 18 November 2006. In the reporter's opinion, the events were possibly related to treatment with FLUARIX.
severe pain in my right foot/wife developed the same thing; This severely affects our Mobility; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Consumer reported for two patients. This is one of two cases.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (disability), outcome "not recovered", described as "severe pain in my right foot/wife developed the same thing"; MOBILITY DECREASED (disability), outcome "not recovered", described as "This severely affects our Mobility".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202200157481 Same reporter/ drug/ event for different patients
received an expired booster dose; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017621A, 028L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired booster dose). 24-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (received an expired booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications were reported. No treatment details were reported.
This spontaneous report as received from registered nurse refers to unspecified patients of unknown ages and genders who on unknown date in January 2015 (reported as since 21-JAN-2015) were vaccinated with a doses of RECOMBIVAX HB, intramuscular (dose, lot # and expiration date were not report4ed) which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
I had a little soreness in my arm after the receiving the vaccine. I tested positive for COVID-19 on 06/12/2022I had  a fever, fatigue, wheezing and bad cough. I took over-the-counter medicine for the symptoms.  I had a telemedicine visit with my doctor and I got a prescription for Paxlovid.
After 1 wk of SHINGRIX vacc, pt noticed rash then pustules that spread from chest to forehead and cheek of (L) side. Pt couldn't get in to see primary doctor, but saw dermatologist who told pt to wait 1 mo before during skin abrasion. Pt has appt with primary MD next week to discuss about the pustules.
Developed blood clots after the second dose/got blood clots after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 7-decade-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Company comment-This spontaneous case concerns an adult female patient (in 60s) with no reported medical history, who experienced the unexpected serious (medically significant) ADRs of Cerebrovascular accident and Thrombosis unknown days after administration of second dose of mRNA-1273 vaccine. Details regarding age of the patient, dates of vaccination, date of onset of events, medical history, concomitant medications, clinical course, investigations, and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-566820, MOD-2022-566822, MOD-2022-566828, MOD-2022-566808, MOD-2022-566718, MOD-2022-566821, MOD-2022-566839, MOD-2022-566813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow up received with Information as reporter information, verbatim for event thrombosis and new event stroke.; Sender's Comments: This spontaneous case concerns an adult female patient (in 60s) with no reported medical history, who experienced the unexpected serious (medically significant) ADRs of Cerebrovascular accident and Thrombosis unknown days after administration of second dose of mRNA-1273 vaccine. Details regarding age of the patient, dates of vaccination, date of onset of events, medical history, concomitant medications, clinical course, investigations, and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
kind of fatigued; But now it is a little sore and it hurts him to blink, it feels bruised; He aches in his upper back bones; body aches; low grade fever; his right eye lid is swollen and tender; his right eye lid is swollen and tender; This is a spontaneous report from a contactable consumer (patient). A 49-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in upper left arm on 14Mar2021 15:00 (age at vaccination 49 years old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took Keflex and had a slight reaction to it 15 years ago. He had not taken Keflex since. Vaccine Administered at military facility was not provided. There was no family medical history relevant to AE. There was no history of all previous immunization with the Pfizer vaccine. There was no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). Patient received the covid vaccine at 3:00PM on Sunday, 14Mar2021. It was reported that the patient's right eye lid was swollen and tender: Began on the morning of 15Mar2021, he did not notice until a few hours after he woke up. There was no pain, nothing. The swelling was about the same. But now it was a little sore and it hurts him to blink, it feels bruised. Low grade fever: Started 3PM 15Mar2021. His fever had been off an on. Right now it was off. It was a very low grade fever, it had been less than or right at 100. Body aches: He aches in his upper back bones. Noticed this morning, around 7AM. Unknown outcome. It had only been an hour so he does not know. His body aches are very mild. If he had to rate it from a 1-10 pain scale, he would rate it a 2 out of 10 or 3 out of 10, it was something you notice, it's tight. Kind of fatigued: His fatigue was off and on. It started yesterday morning around the same time as the eye thing. Clarified as 9:00AM. He was feeling tired again. Caller stated he had no clue if he would like to provide any medications, medical history or tests relevant to our report today. Stated he had never had any reactions to anything before, if he had ever then he only turned pink. There was no require a visit to emergency room. Patient went to a doctor in Physician Office. The outcome of event was not recovered for his right eye lid was swollen and tender, kind of fatigued, recovered for low grade fever in 2021 and unknown for other events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
The patient was administered an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Global Medical Information (Reference number- 00487421) and transmitted to Sanofi on 22-FEB-2021.  This case involves a 3 months and 27 days old female patient who was administered 0.5 ml second dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ179AAB, expiry date: 20-Feb-2021) via intramuscular route in the left thigh for prophylactic vaccination on 22-Feb-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMONIA-13 for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day)  At the time of report, no adverse event was reported.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Patient inadvertently received vaccine after expiration date. Moderna Company analyzed lot 007B21 and advised vaccine maintained  activity necessary to protect against covid 19 at time of administration. Also patient did not call in to complain of adverse event.  This is administrative error without adverse event.
She received Prevnar #13 on 4/27/21 in our office. Given into right deltoid.  Four days later she noticed redness on right deltoid. It was itchy. Still red and swollen. Swelling was worse. Treatment: ice pack, Hydrocortisone ointment
got sick; Initial information was received on 06-Dec-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient) via social media.  This case involves patient (age and gender unspecified) who got sick (illness), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Case Summary:  Product Name: Product name was not provided. Since this is a public post on the Sanofi Site we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: It has been filmed and medically documented live on international television that you can get sick from a flu shot. Not only saw the documentary but got one, got sick, never will get another or recommend it to anyone.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported for event.  There will be no information available on the batch number for this case.
red sore rt deltoid area @ point of administration w/mild edema, sl hot;pain radiated to rt scapular area & rt neck;
Myalgia, Fever, Tachypnea, CougyWheeze, chills. Delayed reaction of SOB, cough 2-8-21 w/flare of asthma & COPD, myasthenia gravis.   Narrative:  Seem by neurologist & pulmonologist for flare of symptoms attributed to vaccine since testing x2 for COVID, flu, &  RSV neg.
This spontaneous report was received from a registered nurse concerning an approximately 12 year old female patient. On 13-JU-2012, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 18-SEP-2012 (reported as 18-SEP-2013), she was vaccinated with dose 2 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. On 24-JAN-2013, she was vaccinated with dose 3 of 0.5 ml of GARDASIL (lot number, expiry date unspecified) intramuscularly. No concomitant medications were reported. Approximately on an unknown date in January 2013 (reported as over the weekend), the patient experienced peripheral visual changes. The patient sought medical attention (physician consultation). She was examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment examined by an unspecified eye doctor who confirmed that the patient was experiencing a 10 percent loss of her vision. No treatment was provided. The outcome of a 10 percent loss of her vision was reported as not resolved. The relatedness for a 10 percent loss of her vision was unknown for GARDASIL. Additional information has been requested.
3JAN97 had early sx of heart problem;had major heart attack on 14JAn97;angioplasty w/stint opened up 100% blocked artery (told it was soft);FB97 was dx w/stage 4 (1-4, 4 being worst) osteoarthritis in both thumbs;Annual follow-up dated 10/5/00 states the pt has arthritis and takes medication to relieve the pain. The pt has not had any more heart problems since the origianal heart attack.
nausea, chills, fever, muscle ache, h/a, rhinorrhea, t99.0; APAP
Patient here for Kindergarten injections. Pt here 20-30 min after injections. Went home with father. Stopped for ice cream on way. Pt was complaining of SOB. Father brought pt back to clinic. Pt seen by Dr. He prescribed PEDIPRED .5 mg that evening et again next AM et BENADRYL OTC per age.
Initially, tingling tongue and gums.  Tongue felt ?big?.  All over body itching.  Excessive coughing.  Could not clear throat.  It felt as if I was put inside a CS chamber.  Went to ER.  Treated with steroid and antihistamine.  Coughing stopped with residual tightness in chest.  Tingly stopped and reduced itchiness.
debilitating migraine headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 19Mar2021 at 12:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and rheumatoid arthritis. Patient received unspecified concomitant medication on an unspecified date and for unspecified indication. Any allergies to medications, food, or other products were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 13:15, the patient experienced debilitating migraine headache. Treatment taken for adverse event was reported as unknown. The clinical outcome of debilitating migraine headache was not recovered.   No follow up attempts are possible; Information about lot/batch number has been requested.
runny nose; Coughing; now has a cold; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: not and expiry dates were not reported), via an unspecified route of administration, on an unspecified date, in May2021 as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first dose two weeks ago (in May2021) and now had a cold and wanted to know if he needed to wait to get his second dose. The patient was scheduled for his second dose on today (on 27May2021) at 2pm and he had mostly a runny nose and was coughing: Events were occurred to patient on an unknown date in May2021. The outcome of the events was unknown. Information on Lot/Batch Number has been requested.
Soreness at injection site, low fever, headache, muscle ache, lethargy for about 24 hours
p/ pt recv vax 17 days later pt exp lesions ``that looked like ant bites'' at time of rpt lesions`` were breaking out on the legs'' treated like chickenpox lasting 5-6 days.
Clinic nurse prepared flu vaccine syringe for administration to patient, assembled syringe/needle and injected needle in patient muscle. When she pushed on plunger to administer vaccine, the fluid came out around the syringe/needle juncture instead of being administered to patient. Upon inspection, she noticed a crack in the syringe on the connector section that connects with the needle. Nurse reports that needle was tight and appropriately placed on connector area of syringe.
Mom noted this morning redness and induration at injection site. No other symptoms. Injection site left thigh slight pruritus and some induration quarter sized. No streaking or signs of infection. Vomited x 1 today. New cold symptoms today.
Information has been received from a nurse referring to an unspecified patient of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On 12-SEP-2016, the patient was administered an improperly stored dose of GARDASIL 9 (lot # L037554 with expiration date 25-DEC-2017; dose and route were not reported). The vaccine was exposed to 31.7 degree Fahrenheit for 15 hours 15 minutes. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Severe body pain, chills, fatigue, severe hair loss about 6-8 weeks after 2nd dose. This reaction has occurred 2 times before with patient. After flu shots that contained egg
no additional AE; the physician administered an expired dose of PNEUMOVAX 23 to the patient; This spontaneous report was received from a physician and refers to a 64-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-FEB-2021, the physician vaccinated the patient with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) expiration date reported as December 2020 (exact dose, route of administration, anatomical location and lot # were not provided) for prophylaxis. The reporter stated that according to his knowledge, the administered vaccine did not experience a prior temperature excursion. No adverse event (AE) was reported.