chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shots 1 & 2 only gave me sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01May2021 (Lot number: EW0173) at the age of 44 years as dose 2, single and intramuscular, administered in arm left, administration date 12Apr2021 (Lot number: EW0158) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Shell fish" (unspecified if ongoing), notes: known allergies: shell fish; "Cow dairy milk" (unspecified if ongoing), notes: known allergies: cow dairy milk; "Gluten" (unspecified if ongoing), notes: known allergies:gluten. Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; CALCIUM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Shots 1 & 2 only gave me sore arm". The event "shots 1 & 2 only gave me sore arm" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: No other vaccines were received within 4 weeks prior to the COVID vaccine by patient. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient been not tested for COVID-19.Patient received multi vitamin within 2 weeks of vaccination. Vaccine was not administered at Facility. No Relevant tests or specific relevant for Thromboembolic events with Thrombocytopenia test was done. No seriousness criteria was reported by patient which could result in death/Life threatening/prolonged hospitalization /Disabling/Incapacitating or Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from health care worker regarding unspecified patients of unknown demographics. There was no information regarding concurrent condition and historical medication. On an unknown date, patients received improperly stored PNEUMOVAX 23 (dose, strength and route was unknown). No adverse effect was reported. No concomitant medication was reported. No product quality complaint was involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
A serious investigator initiated study report of trouble breathing has been received from an investigator concerning a 20-year-old female, who is enrolled in a study. Neither medical history nor concomitant medications have been reported. The subject received FLUMIST on 03-Oct-2007. On 06-Oct-2007, the subject experienced trouble breathing. The event was described as "severe" and that the subject "could not work" or do "usual activities". The event resolved on the same day. The study investigator assessed causality as probably related to FLUMIST vaccine. The sponsor considered the event medically important and agreed with the study investigator's causality assessment.
Ran temp x 1 wk from 28FEB when recvd vax; pt given APAP off & on; went to bed @ 830PM on 7MAR92 p/having recvd APAP @ 7PM temp a/bed 102.7 ax ambulance called @ 955PM; pt seizuring & turning cyanotic per mom;
Severe allergic skin reaction, hives, welts severe itching to both arms, legs abdomen back neck and face and fingers and between fingers. Started 18 hours after injection, also had chills headache and fatigue 24 hours after injection Rash lasted 6 days  chills, headache and fatigue lasted 8-10 hours I used topical benadryl cream and cortisone cream
Migraine headache, vomiting, low-grade fever, fatigue, muscle pain.
This spontaneous report as received from a registered nurse (R.N.) refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates (before expiration date), the patients were vaccinated with improperly stored ROTATEQ (lot # K006805, expiration date 24-MAR-2016; lot #   K010325, expiration date 10=MAY-2016; lot # reported as L004453, expiration date 27-MAY-2016; lot # K011948, expiration date 07-JUN-2016; lot # K020183, expiration date 25-JUN-2016; lot # K024700, expiration date 30-JUL-2016; lot # L006184, expiration date 13-DEC-2016, lot # L013203, expiration date 28-JAN-2017; oral; dose was not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Expired moderna vaccines administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 11 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 11 patients). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  The HCP (nurse) who stated that 11 expired doses were administered to patients. The caller stated that it was mixed doses of the expired vaccines that were administered to 11 patients on 07-Dec-2021. Dose administered after 30-day Use By Date or after manufacturer date of expiry. Number of doses/vials 11 doses administered to 11 patients. The vial did not undergo any temperature excursions
Myalgia & Fever Narrative: dose 1: fever; sore arm: bodyache
COVID-19; Arm discomfort; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Arm discomfort), HEADACHE (Headache) and COVID-19 (COVID-19) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced LIMB DISCOMFORT (Arm discomfort) and HEADACHE (Headache). On 08-Jan-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, LIMB DISCOMFORT (Arm discomfort), HEADACHE (Headache) and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient had mild cough, nose congestion and was diagnosed with COVID-19. Treatment medication included Advil.  Company Comment: 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 except for the event of COVID-19 test positive.  The event of COVID-19 test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; 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 except for the event of COVID-19 test positive.  The event of COVID-19 test positive is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.
Pt experienced flu like symptoms for approximately 7-8 days following the vaccine. Migraine headaches, sinus drainage, joint aches and muscle aches were also experienced.
woke freezing to the core; twitching and her arms were flopping in and out; head was shaking back and forth; breathing was auditory but she could get air; 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 51 year-old female patient received bnt162b2 (COMIRNATY) (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: Covid-19 vaccine (1st dose), for COVID-19 immunization. The following information was reported: FEELING COLD (non-serious), outcome "unknown", described as "woke freezing to the core"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "twitching and her arms were flopping in and out"; TREMOR (non-serious), outcome "unknown", described as "head was shaking back and forth"; DYSPNOEA (non-serious), outcome "unknown", described as "breathing was auditory but she could get air".  Additional information: Caller stated that after her second dose of the Pfizer Covid Vaccine (purple label) she had an adverse event. Caller stated that 12 hours after receiving her second dose she woke but had no fever body. Caller stated that she was. Caller said that her and she could not stop it. Caller also said that her. Caller said she could not control anything, it lasted four hours and she thought she was gonna die. Caller asked should she get the booster dose. Caller said that she previously reported this adverse event to Pfizer. The Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the booster dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
contracted COVID; contracted COVID; This is a spontaneous report from a contactable physician. This physician (patient's wife) reported for a male patient (reporter's husband).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. It was reported that the patient contracted COVID-19 after having been vaccinated on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: contracted on an unspecified date. It was unknown if any treatment was received for the events. Outcome of the events was recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The possibility of COVID-19, Drug Ineffective cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
redness at the injection site and surrounding area; Initial information received  on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 71 years old female patient who had redness at the injection site and surrounding area after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s)and family history were not provided. Patient had no concomitant and other vaccines.   On 22-Oct-2022, the patient received a 0.7ml 1X(once) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, formulation was unknown, lot UJ932AD and expiry date: 30-Jun-2023) via intramuscular route in the right arm for prophylactic vaccination.  On 24-OCT-2022 the patient developed a non-serious event of redness at the injection site and surrounding area (vaccination site erythema) 2 days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. Patient had no swelling, no itchiness, no change in breathing, only redness.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event   Outcome: Not Recovered
This spontaneous case, was received from other-health professional (pharmacist) on 22-Sep-2017, concerning a 19-year-old, adult, male patient. On 22-Sep-2017, the patient was administered with AFLURIA (TIV) (dose: less than 0.5 ml, batch number: XT32208, expiry date: 30-Jun-2018, route of administration and anatomical location: not reported). It was reported that, the patient received dose of the vaccine less than the recommended dose (0.5 ml) due to syringe leakage. This report was associated with PTC reference Number: 431545. It was reported that by the information of PTC case reported on case SEQ17-2569, concluded that the leakage was between the syringe and needle. The reporter assessed the report as non-serious. Follow-up received on 25-Oct-2017: Patient's gender was updated to male and narrative was amended accordingly. Non-significant follow-up received on 27-Oct-2017: The PTC number (431545) was added. Follow-up received on 31-OCT-2017: It was reported that by the information of PTC case reported on case SEQ17-2569, concluded that the leakage was between the syringe and needle. The narrative was amended accordingly.
PT RECEIVED VACCINE AT 0921 AND IMMEDIATELY APPEARED TO BE HAVING A SEIZURE. EMS CALLED.   APRN ON SITE AS WELL AS PARAMEDICS ASSESSED PATIENT, VITALS WNL.  PATIENT BEGAN BECOMING RESPONSIVE AT 0927.  EMS ARRIVED ON SCENE AND PT REFUSED ANY CARE FROM EMS AS WELL AS TRANSPORT.  PT SIGNED AMA FORM.
Information has been received from a physician referring to a 39 years old female patient with recurrent sinusitis, thyroiditis and vertigo. The patient's medical history included seven times sinus surgery, pernicious anemia and shortness of breath (all medical history developed on unspecified dates). The patient developed lip tingling with AVELOX on an unspecified date. On 05-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 injection, (lot number and expiry date were not reported), intramuscular. 0.5 ml, for "immune deficiency evaluation". Concomitant therapies included cyanocobalamin. On 05-JAN-2015, the patient developed a fever "up to 103F" within "about 5 hours" after receiving PNEUMOVAX 23. The patient went to Hospital emergency room. on 06-JAN-2015, because of her fever, and she was started on KEFLEX 500mg. On an unspecified date, the patient was prescribed prednisone and ADVIL. On 08-JAN-2015, the patient had the following labs: titers for tetanus and diphtheria which resulted "normal", full blood count (CBC), immunoglobulin which resulted "normal", and titers for PNEUMOVAX which showed that she was reactive to 3 serotypes out of the 23 serotypes in PNEUMOVAX 23. On an unspecified date in January 2015, the patient developed erythema which measured "3.5cm by 2.5cm" and edema which measured "9 by 9" on her left arm at the injection site where she received the PNEUMOVAX 23. The patient had a significant disability on 12-JAN-2015 (reported as "yesterday") in which she was unable to move her arm due to the edema. On 12-JAN-2015, the physician started the patient on clindamycin. On 13-JAN-2015, (reported as "today"), the patient called the physician's office to report that she was "much better" and the patient did not have a fever on the same day. The outcome of erythema and edema at the injection site were reported as recovering. Additional information has been requested.
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect from a contactable healthcare professional. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient tested positive for COVID on 17Jan2021.  The patient underwent lab tests and procedures which included a positive COVID  test on 17Jan2021.  The outcome of tested positive for COVID was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the information provided, the positive COVID-19 test is unlikely related to suspect BNT162B2 administration. The available injection date and detailed clinical course would be helpful for further assessment.
A report received from a health care professional on 11/06/03, concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 11/04/03. No adverse event was reported at the time of the report. There was insufficient information to determine the reporters causality assessment. Follow up pending.
Patient developed Myocarditis and was hospitalized on 3/1/2023. His troponin levels were elevated, he was having difficulty breathing, felt dizzy, and had pain in his chest. His heart rate was elevated at the time of admission. Prior to discharge in 3/4/2023 Patient was having pain, SOB, and weakness in his legs when ambulating around the room. He was only able to walk short distances without taking breaks. As of today, 3/30/2023, Patient is still experiencing pain with any physical exertion. He reports feeling weak and tired all of the time stating that his legs feel like "jello". He is not tolerating physical therapy well and shows very slow improvement of his symptoms at this time.
Unknown if patient received COVID-19 vaccine that was prepared (diluted) 15 minutes prior to administration or prepared (diluted) 24 hours prior to administration. The 24 hour old diluted vial was not discarded appropriately at after 12 hours of dilution and it was put in the same draw bin as the vial that was prepared for the day off vaccinations. Unsure if the patient received the vaccine from the vial that was prepared (diluted) 15 minutes before vaccine or the vial that was prepared (diluted) 24 hours before the vaccine.was given.
Patient came to the pharmacy on 06/18/18. She had been to the doctor. She said she originally had one bump (which she thought was a spider bite) on the right upper back which developed 1 week after receiving SHINGRIX on 06/06/2018. The next day she had a "splotch" on the groin area about 2 inches long. Later that day she had 4-5 bumps on her waist area and on her right arm. The patient said the doctor told her to take ZYRTEC for itching. She stated the doctor still wants her to get the second dose. The nurse at her doctor's office faxed over the doctor's notes which says if the rash has totally resolved and it is time for her second SHINGRIX, ok to continue. Her rash did not appear immediately with SHINGRIX, and I (the doctor) don't believe it was related. The risk/benefit would support getting SHINGRIX (per doctor's notes). Talked to patient 06/20/2018 (today). She says she is still breaking out and she went to a dermatologist who sent in a prescription for triamcinolone.
Arm and breast pain on the side the vaccine was given. Chills for about 3 hours, extreme pain in the whole body, headache, tiredness.
Information has been received from a physician and registered nurse concerning a 9 year old male who on 02-DEC-1998 at another health care facility was vaccinated with varicella virus vaccine live (Oka/Merck). On 23-MAY-2007 the patient presented to the office with "full blown chicken pox" (actual onset date not provided). It was reported that the patient had chicken pox on the trunk of his body, and it looked like his back had more than fifty lesions which were not pustules. At the time of this report the patient's status was not reported. No other information was reported. There was no product quality complaint involved. Additional information has been requested.
Pt given HPV (GARDASIL), Meningitis (MENACTRA), Hepatitis A vaccines on 8/5/2014. On 8/13/14, pt. was seen for new onset migraine type headache with tingling in hands, spots in vision, facial numbness. As of 8/28/14, headache continues and fatigue. No preceding illness. No chronic disease or meds.
This spontaneous report was received from a nurse and refers to a 5 year old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 21-AUG-2017, at 16:02, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M021729, expiry date 29-OCT-2017, 0.5 ml, subcutaneously, in the left upper arm for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). The vaccine underwent a temperature excursion at -14 Celsius degrees to -10 Celsius degrees, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion. No adverse events were reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1708USA010724: US-009507513-1710USA011620:
Narrative: Fully vaccinated, COVID positive on admission after a fall while looking for new SNF placement. Patient developed a fever.
Patient experienced sweating after recieving vaccine.  He recovered in a short time then went home.
Arm swollen 2x's size and warm/red on 2nd day after immunizations.  Resolved slowly.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Pt came in to have TB test read 3/13/09 1300. Rt deltoid where Tdap injection had been given "circle slightly larger than a quarter is red, warm to touch, and tender. Reviewed with Dr." (on call) and pt advdised to take Benadryl prn, apply warm/cold pack to area. Pt to report if sx worsen.