chrisvoncsefalvay/vaers-outcomes huggingface dataset:
positive for a COVID infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Dec2021 (Lot number: FK5618) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot, administration date: Oct2021, for immunisation. The following information was reported: COVID-19 (non-serious) with onset 04Jan2022, outcome "recovered", described as "positive for a COVID infection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: Caller is the patient's mother, she is reporting that her 8 year old son received the first dose of the Pfizer's COVID-19 vaccine on 28Dec, on 04Jan the patient started to develop COVID symptoms and he started to cough on 06Jan, and on 06Jan he tested positive for a COVID infection with both the rapid test and the PCR. He was scheduled to receive the second dose of the vaccine today but was informed that the vaccination provider (pharmacist) that she should contact Pfizer as they advised that the patient should wait 6 weeks before receiving the second dose of the vaccine. Caller is not sure if the patient received the vaccine or the adult vaccine. No other vaccines were administered 4 weeks prior to Covid 19 shot. Reporter stated, "He weighs about 103 pounds. I guess he's like 4 feet (Unclear hence not captured in tab). I am not sure for the height." For treatment for adverse events, reporter stated, "No, he's taken the over the counter medication. Tylenol, yes just Tylenol." Patient had no more symptoms and events were not persistent. Reporter stated if it was okay for him to get the second dosage now. Investigational results were received for Lot number FK5618. Conclusion of Previously Completed Investigation: The complaint for "PFIZERBIONTECH COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported F-Lot: FK5618. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality regulatory, validation and stability. (name withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Follow-up attempts are completed. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA  drive thru vaccination clinic - Approximately 50 mins after vaccination, pt reports transient sensation of something coming over her, dizziness and short period of tongue swelling, SOB and facial flushing. Pt taken to the ED. Prednisone 40mg po at 1312 and discharge prescription for prednisone 40mg daily x  3 days.
Pt called call center reported taken J&J on 04/08/21. C/o SOB and Palpitation. Advised pt to go to nearest ED, pt agreed and verbalized understanding.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-Mar-2022; Patient recieved 0.3 ml of booster; Patient received vaccine past its 30-days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30-days expiry date), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-Mar-2022) and INCORRECT DOSE ADMINISTERED (Patient recieved 0.3 ml of booster) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health conditions was reported as unknown.     On 15-Mar-2022 at 2:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 15-Mar-2022 at 2:13 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30-days expiry date) and INCORRECT DOSE ADMINISTERED (Patient recieved 0.3 ml of booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30-days expiry date), PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 15-Mar-2022) and INCORRECT DOSE ADMINISTERED (Patient recieved 0.3 ml of booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter.  On 15-Mar-2022 at 14:13:06, patient received an expired booster dose.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination or at the time of the adverse event were reported as unknown.  Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown.  No treatment medications were provided by reporter.
recieved 4 doses of the Pfizer Covid 19 Vaccines/to start Paxlovid since he has been taking the other medication; recieved 4 doses of the Pfizer Covid 19 Vaccines/to start Paxlovid since he has been taking the other medication; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Heart attack" (unspecified if ongoing). Concomitant medication(s) included: COLCHICINE taken for gout; BRILINTA taken for myocardial infarction. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "recieved 4 doses of the Pfizer Covid 19 Vaccines/to start Paxlovid since he has been taking the other medication". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical course: The patient takes Colchicine that is optional for his gout. He also takes Brilinta 1/2 dose due to his heart attack 12 months ago. Caller was inquiring on how much time does he needs to be off on blood thinner before he can take Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccination site pain; Neck pain; Jaw pain; Shoulder blade pain; Joint pain; Lower extremities weakness of; Tiredness; Initial information received on 14-Nov-2022 regarding an unsolicited valid serious case from consumer/non-HCP via the regulatory authority under reference GB-MHRA-ADR 27463488.   This case involves a 50-64 years aged female patient who experienced tiredness, vaccination site pain, neck pain, jaw pain, shoulder blade pain, joint pain and lower extremities weakness of after receiving influenza vaccine.  The patient's past medical treatment included influenza virus. The patient's past medical history, vaccination(s) and family history were not provided.   On 09-Nov-2022, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown strength, formulation, dose, frequency, route, expiry date, batch number, administration site) for prophylactic vaccination.   On 09-Nov-2022 the patient developed a serious event of tiredness (fatigue) same day following the administration of influenza vaccine.    On an unknown date the patient developed serious events of vaccination site pain, neck pain, jaw pain (pain in jaw), shoulder blade pain (musculoskeletal pain), joint pain (arthralgia), lower extremities weakness of (muscular weakness) (unknown latency) following the administration of influenza vaccine.   No lab data reported.  Action taken  was not applicable.  It was not reported if the patient received a corrective treatment for the events    Outcome was Unknown for all the events  All events were assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 18-Nov-2022: This case involves a 50-64 years aged female patient who experienced tiredness, vaccination site pain, neck pain, jaw pain, shoulder blade pain, joint pain and lower extremities weakness of after receiving influenza vaccine. Based upon the reported information, the role of a vaccine cannot be assessed. However, lack of information regarding past and concomitant medication and medical history precludes comprehensive case assessment.
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 55 or 56 years. The reporter stated she had a little symptom after receiving the 1st dose of SHINGRIX. The reporter gave consent to follow up. For tolerance to next dose, refer case US2019GSK055804.
RN on duty at Mobile Vaccine Clinic.   Patient was vaccinated with J&J @0910, hx of anaphylaxis with pneumococcal vaccine. Patient was eating an orange in observation area. RN observed patient flushing with decreased awareness and pallor . Patient was able to respond to verbal assessment, stated that she felt like fainting. RN lowered patient to the floor and elevated her feet. Loss of consciousness for <10 seconds, Vitals assessed and were stable. Patient responds to questions. Reports chest tightness. 911 activated per employer. Tended to by site medical staff. Patient assessed by EMTs, responded to verbal stimuli and sternal rub. Patient remained lethargic with both pallor and facial flushing. Patient transferred to ER by ambulance
Ever since getting the vaccine a week ago his blood sugar has been out of range relative to before the vaccine. Also, he has not been acting himself mentally.
05/07/2021- Day after vaccination, Patient called and said both hands were numb, his motor skills were lacking, and he was shaking.    05/12/2021- Call to follow-up with patient and clarify symptoms reported on 05/07/21. Patient said when he called on 05/07/21, both hands were numb, right hand more than left, he said he put his hands in his pockets because they were shaking so much, and his motor skills were slowed, his legs felt very heavy and slow, and both hands were tingling. Patient stated there was pain with touching anything. He reports that over the weekend he began with respiratory symptoms of cough and congestion as well. He said he called his primary care physician and started steroid dose on Monday 05/10/2021 and is now on day 3 of steroid dosing and feeling much better.
Headache, Myalgia, tired, soreness right arm, chills Narrative:
Patient had syncope at time of injection.  Patient reported having syncope with every shot they receive.  Patient slouched in chair, then within 15-30 seconds was conscious and back to normal.  No additional care was needed.  Patient waited in the pharmacy 30-45 minutes before mother drove home.
Narrative:  Patient admitted to hospice care and dies shortly thereafter. Patient was 87 years old with multiple medical diagnoses.
Severe neutropenia with absolute neutrophil counts ranging from 180 to 900 noted on a routine annual CBC drawn on March 18, 2 weeks after the second Moderna dose.  Subsequently, neutrophils counts remain very low with the most recent on May 4 measuring 200.
optic neuritis, bilat;tx w/steroids & recovered w/in 3wk tx;
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: WHITE BLOOD CELL DISORDER (non-serious), outcome "unknown", described as "WBC are going into her fat cells". Additional information: Per caller she had the bone marrow test and computed tomography (CT). Per caller her dermatologist let her know that her WBC are going into her fat cells since receiving the Pfizer Covid 19 Vaccine. Caller reported that she knew a guy this was happeneing to since the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
devel sore throat, dizziness, tightness in chest, feeling airways closing up, chills, shakes & fast heart rate @ 8AM 7/7/99;sx eased in PM 7/7/99 while lying down but resumed on 7/8/99;sx cont but lessened by 4PM 7/8/99;no rx;referred MD;
REDNESS OF EYES, SWELLING OF FACE, AND SCRATCHY THROAT.
Redness; Itching; Feeling hot; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Feeling hot) and CHILLS (Chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and FINASTERIDE (PROPECIA) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Feeling hot) and CHILLS (Chills). At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Feeling hot) and CHILLS (Chills) outcome was unknown.            No treatment medications were provided.   This case was linked to MOD-2021-221142 (Patient Link).
Patient experienced pain scaling to a 10 plus, arm swelled to almost twice its size and became stiff, injection site soreness, itching, cellulitis and extreme redness; arm swelled to almost twice its size and became stiff; itching; injection site soreness; This spontaneous report has been received from a 71-year-old female consumer, referring to herself.  The patient's concurrent conditions included an allergy to sulfonamide (reported as "sulfa drugs"). Her concomitant medications were reported as "traditional medication that had been taken for years". The patient did not have any medical history.   On 11-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) one dosage form via intramuscular, for prophylaxis (reported as due for second pneumococcal disease) (concentration, frequency of vaccination scheme, and anatomical location of vaccination were not reported; lot number and expiry date were unknown to the reporter).   Following the vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), the patient experienced pain scaling to a 10 plus, arm swelled to almost twice its size and became stiff, injection site soreness, itching, cellulitis and extreme redness (cellulitis, musculoskeletal stiffness, pruritus, injection site pain).   The patient sought medical attention and saw a physician. A site exam was performed on an unknown day in February 2020, and the patient's events were treated with acetaminophen (TYLENOL), diphenhydramine (BENADRYL), cephalexin and methylprednisolone 4 milligrams (mg).   On 14-FEB-2020, the patient recovered from the events.    The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) vaccination and the patient's events was not reported.    Upon internal review, cellulitis was determined to be a medically significant event
My left arm started to hurt during the night and when I got up on Friday, the 12th it was hard to move it without severe muscular pain.  The pain has persisted into today, Monday, the 15th,  but it is slowly getting better.  The pain is localized to my upper arm, and depending on how I move it, can become worse.   I am treating the symptoms with Tylenol and aspirin-containing creams.
BlurredVision, Dizziness, NauseaVomiting & HYPOtension Narrative: Patient had nausea and dizziness within one minute of vaccine. BP was relatively low when we checked it in clinic and the patient was sent to the ED.
Patient received moderna vaccine on 2/9/21, 3/11/21, and 12/6/21. Presented to ER on 7/12/22 and was positive on 7/12/22. He was tested for COVID at home by his wife and was positive.  He has no known other sick contacts.  Patient denies any chest pain.  While in the ER workup was essentially unremarkable however he states he feels short of breath when going up and down the stairs.  He has 17 steps to get into his house which she is unable to do currently.  He is saturating well on room air around 94%.  Chest imaging is unremarkable.  Lab work is unremarkable as well.  Patient will be admitted for overnight observation secondary to his severe weakness. No COVID specific treatments. Discharged on 7/15/22
Patient received expired vaccine - the expiration date on this product was 7/15/2023.
patient mother reported  via phone today 12/23/2020 at 1600 to PA at clinicare an approximately 1 inch circular reddened slightly raised area to left upper thigh at injection site.  No fever and mother reports that it does not seem to bother him.
Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; Severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion; This is a spontaneous report from a contactable consumer (patient). A 45 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 17:30 (Lot Number: EW0171) as SINGLE DOSE for covid-19 immunisation.  Medical history included colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication included linaclotide (LINZESS) taken for an unspecified indication, start and stop date were not reported; mesalazine (CANASA) taken for an unspecified indication, start and stop date were not reported; mesalazine (APRISO) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Prior to the vaccination, the patient was not diagnosed with COVID-19.  covid The patient was tested for COVID post vaccination.On 25Apr2021 17:00, the patient experienced severe chest pain, shortness of breath, inability to breathe, severe headache, sore throat, fatigue, muscle pain, exhaustion."The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care". The patient underwent lab tests and procedures which included chest x-ray: unknown result on unknown date, Rapid test Nasal Swab: negative on 26Apr2021.  Therapeutic measures were taken as a result of severe chest pain, shortness of breath, inability to breathe which included Prednisone, at home nebulizer. Outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Severe headache, joint pain, muscle pain,  nausea, chills, diarrhea.
After receiving my first dose, I started to experience joint and muscle pain, but mostly joint pain in my hands and feet.
2 hours after vaccine - fatigue, headache. 8 hours after vaccine  fever (100 F), headache, body aches, triggered migraine, nausea. Missed work the next day due to adverse reaction.  Took 400mg ibuprofen 24 hours after vaccine and fever went away. Fatigue and body aches lasted about 4 days. Felt like I had the flu for a day or 2.
This spontaneous report has been received from a medical assistant referring to a 12 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA010748:
Auto immune disorder: Lymphocytic colitis  diagnosed Feb 9, 2022 by colon biopsy after 35 days of acute diarrhea (6-8 x's per day) and loss of 14 pounds. Started 9mg Budesonide for 4 weeks (Feb 18-Mar 18), 6 mg for 4 weeks (Mar 19-April 9), 3 mg for 3 weeks, 3 days (April 10-May 3) Auto immune complication: Uveitis diagnosed Feb 14, 2022 with severe inflammation of cornea in both eyes, pain, and vision impairment.  Prednisolone drops each hour for 2 weeks. Gradual reduction in drops until last on April 16, 2022 Inflammation in nerves of right hand: thumb and middle finger May 6, 2022. Cortizone injection in right wrist May 26, 2022
Rash on opposite shoulder from vaccine administration; near right clavicle with 1 mm of vesiculation.
This 14 y.o. was inadvertently given J&J when it was planned for her to receive Pfizer