chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech Dose Number 4 ... Moderna Dose Number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cancer survivor 2x" (unspecified if ongoing); "inflammatory arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer / BioNTech Dose Number 4 ... Moderna Dose Number 3". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment start date 10Apr2023, Treatment stop date 15Apr2023, Indication-Treatment of COVID-19, No Known allergies.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
11 WEEK OLD INFANT BROUGHT TO OFFICE AFTER BEGINNING TO VOMIT "GREEN EMESIS" IN THE NIGHT. NO FEVER. HAD NO STOOLS DURING THE DAY AT DAYCARE ALTHOUGH HE USUALLY HAVE SEVERAL STOOLS DAILY. KUB 2 VIEW SHOWED SMALL-BOWEL OBSTRUCTION WITH DILATED SMALL BOWEL.  DR TRANSFERRED INFANT TO HOSPITAL FOR SURGERY BECAUSE OF THE POSSIBILITY OF MALROTATION OF THE BOWEL.  09/15/2008 MR received for DOS 7/2-3/2008 and 7/3-7/2008 with D/C DX:  Intussusception and Recurrent Intussusception. Pt initially presented with projectile vomiting, eventually bilious, intermittent crying then bloody stool.  PE later (+) for an abdominal mass.  BE was unable to reduce the IS so pt taken to OR for Exploratory Lap, Reduction of ileocolic intussusception and inversion appendectomy. D/C home 7/3/08 but returned same day with bilious projectile vomiting and lethargy.  Mucousy stool in ER. Repeat BE did not show IS but CT confirmed IS. Pt returned to the OR for reduction.. NG tube placed post-op which was removed and po advanced. D/C on POD#2.
Information has been received from a physician concerning a 5 year old female who on an unspecified date was vaccinated with PROQUAD (Lot # 657878/0651U). Subsequently the patient experienced redness and swelling at injection site. The dimension  of the swelling was about 7 cm in diameter. The patient was given MOTRIN and BENADRYL. At the time of reporting the outcome was unknown. Unspecified medical attention was sought. There was no product quality complaint. This is two of three reports received from the same source. Additional information has been requested.
(Immediately) Day 1 - itching and swelling. (Day 1 - 7) - fever, chills, fatigue, shortness of breath, nerve pain/ burning, achy joints and rash.  Day 8 -30  - shortness of breath, heart palpitations, chest pain/ pressure nerve pain/ burning, achy joints and rash, malaise, burning soles of feet, headache, dizziness, lightheaded, loss of appetite, sweating and clammy  and difficulty sleeping and concentrating. Day 30 to present - heart palpitations, chest pain/ pressure nerve pain/ burning, achy joints and rash, malaise, burning soles of feet, headache, dizziness, lightheaded, loss of appetite, sweating and clammy  and difficulty sleeping and concentrating.
Fever,  super cold, sweating, fatigue, migraine, bossy aches and sore,  sore arm
(L) arm pain > than 1 wk redness & swelling 1 day after the  shot
This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine given too early) and PAIN IN EXTREMITY (arm soreness) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 23-Feb-2021 at 2:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine given too early). On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccine given too early) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided. No concomitant medications were provided.
Information has been received from a  physician concerning a 9 year old male who on 12/19/1996 was vaccianted with a dose of varicella virus vaccine live. On 5/3/2005 the patient developed breakthrough varicella on his back with less than 50 lesions and no fever. It was reported that the patient had upper respiratory infection symptoms before the rash. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 71 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or about 12-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Fever; Chills; Tiredness; Headaches; feeling unwell; Minor cough; This is a spontaneous report from a non-contactable consumer.  A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EL2437, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the vaccination. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Jan2021, the patient experienced fever, chills, tiredness, headaches, and feeling unwell but I had developed a minor cough. Patient had a covid test done two days ago and it came back negative, same day as the side effects started; post vaccination nasal swab was done on 19Jan2021 was negative. The events reported resulted in doctor or other healthcare professional office/clinic visit. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). No treatments received in response to the events reported. The outcome of the events fever, chills, tiredness, headaches, feeling unwell and a minor cough was not recovered.  No follow-up attempts are possible. No further information is expected.
Left side, jaw is sore.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 10:00 (Batch/Lot number: unknown) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN JAW (non-serious) with onset 10Apr2021 08:00, outcome "not recovered", described as "Left side, jaw is sore.". Therapeutic measures were taken as a result of pain in jaw.  Additional Information: The patient Left side jaw was sore, Pretty steady and also wife has same feeling. She got her shot right after patient. On day 3 Jaw still sore and started treatment with ibuprofen. Patient had no known allergies. Patient did not receive any medications within two weeks of vaccination and also did not receive any vaccine within four weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 after vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404247 Same reporter/drug/event, diff pt
Headache SEVERE MIGRAINE LASTED 24 HOURS Narrative: MIGRAINE THAT LASTED 24 HOURS. TOOK MIGRAINE MEDICATIONS BUT WOULD NOT SPECIFY WHICH ONES
patient that received VARIVAX during Supported TE; This spontaneous report was received from a medical assistant concerning a 1-year-old patient of unknown gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On unknown date in August 2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot number W006413 with expiration date 23-FEB-2024, administered as prophylaxis (dosage regimen and route of administration were not reported). The vaccine had undergone a temperature excursion (TE) at a range of 6 to 14 degrees Fahrenheit for 21 hours, 48 minutes and 0 seconds (Product storage error).  This was one of two reports from the same reporter.; Sender's Comments:  US-009507513-2308USA010842:
On 10/28/01 12 noon, pt started with headache "all over", more to L side of head front and back 10/30/01 in AM. 10/31/01 mom noticed rash on back & front of neck and L arm at injection site. Went to ER 10/31/01, 9pm. Dr States he had reaction to immunization. Benadryl and Ibuprofen given in ER. No migraines were diagnoses by Doctor.
Induration and redness over (L) leg (thigh) 30 x 30.
diagnosed with neurocardiogentic syncope; P.O.T.S/-POTS; tired the next day; experienced a headache for a couple hours; This is a spontaneous report from a contactable nurse. The nurse reported similar events for 2 patients. This is 1st of 2 reports. A 58-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 02Mar2021 as single dose for COVID-19 immunisation. Medical history included open heart, prostate cancer, lyme disease, neobladder, and sepsis, all from Aug2020; and blood pressure (abnormal). Concomitant medication included fludrocortisone for blood pressure (abnormal). Reporter stated that her husband seemed tired the next day, although husband says he wasn't. Today, 05Mar2021, patient experienced a headache for a couple hours, and was tired today. On an unspecified date, the patient was diagnosed with neurocardiogenic syncope and Postural orthostatic tachycardia syndrome (POTS) and given medication Florinef 0.1mg. Patient had been taking for about a week. Reporter was asking if it would cause issues with the vaccine since it was a corticosteroid and if it would cause issues if he was going to get a flu shot. Reporter was also asking what the efficacy after the first dose was. Outcome of events was unknown.  Information about the Lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021261960 same drug/reporter/event, different patient
pt devel an infect from measles vax;started out red & sore about a week ago & ended up swollen, hard & infected;dx cellulitis
Patient stated her right arm (from pneumococcal) was hurting really bad. It was red and swollen and she had a bad headache and neck pain on Saturday. Patient came by office and we looked at her arm. It was red, swollen and hot to the touch. Instructed patient to take a Benadryl and apply heat to the area. Possibly a reaction to the preservatives in the vaccine.
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fell over off chair and hit head on floor within 5 min of receiving vaccine. Pt quickly became responsive. Epipen was not given. EMT arrived shortly after to check patient. Patient did not leave in ambulance. Pt's family member came to pharmacy to ask me if I thought pt should go to ER, I said abosuletely being that patient hit head and had a raised knot on forehead. Pt did explain AFTER he became conscious that he always passes out after receiving a shot.
Supraclavicular lymphadenopathy 1 day after vaccination with tenderness. Treat with supportive care, potential antibiotic, ultraound/CT with persistent symptoms
General symptoms: General symptoms: Headache, fatigue- overnight including drowsiness Narrative:
Woke up this morning and had difficulty eating breakfast this morning. Turned into full pain on left jaw joint and I am unable to open mouth entirely without sharp pains. Previously had generic pain in area of vaccine injection site, but that has healed before this occurred. I called my school wellness center that gave me the vaccine and they thought it sounded like Temporomandibular joint disorder, said I should report it on this website and take ibuprofen for the jaw pain.
Mom noticed right lateral arm: elbow to shoulder hot, red, swollen, painful on 7/9/03 at 7 PM. Applied ice, gave Tylenol throughout the night. Called this office 7/10/03 AM to report. On 7/10 arm still swollen but less painful, less red. Moves arm actively. No fever. Using ice prn for comfort. Tylenol prn.
Dizziness; developed dizziness with the room spinning briefly; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 13:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included autoimmune disorder. The patient had a history of known allergies (unspecified). The patient received second dose of pneumonia vaccine within 4 weeks prior to the COVID-19 vaccine on 25Feb2021 in left arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient had received other medications (unspecified) within 2 weeks of vaccination. On 22Mar2021 at 11:15, the patient developed dizziness with the room spinning briefly. The patients husband took her blood pressure but it was normal. The patient sat for a while and upon getting up almost fell. She drank some Gatorade as a therapeutic measure to see if it would help. The spinning stopped but she still felt lightheaded and unstable when she bent over. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizziness and spinning briefly was not resolved.   No follow-up attempts are needed. No further information is expected.
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant history was not reported. The treatment history was not provided. The reporter said the patient received a dose of the Moderna COVID-19 Vaccine that expired on July 25th.
A few flat red areas noted on child's arms and upper torso shortly after vaccinations. No apparent signs of distress noted. EMS called Vitals: P-84, Resp-30, BP-111/69. EMS arrived head-to-toe completed, per EMS lung sounds clear to auscultation, no wheezing or stridor. Parents declined transport to hospital, release signed. Family counseled on what signs and symptoms to seek emergency medical attention for overnight. Symptoms resolved before leaving clinic to home. Phone call to Father 1/05/2017 no further events throughout the night.
Vasovagal syncope; Blood pressure drop - fainting; This is a spontaneous report received from a contactable consumer, the patient.  A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP6955), via an unspecified route of administration on arm left on 31Mar2021 08:00 AM at single dose for COVID-19 immunization. The patient medical history included methylenetetrahydrofolate reductase gene mutation from an unknown date and unknown if ongoing , wolff-parkinson-white syndrome from an unknown date and unknown if ongoing , blood cholesterol increased from an unknown date and unknown if ongoing , gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient concomitant medications included omeprazole (ZEGERID [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ10 [UBIDECARENONE]) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported, fish oil, quatrefloic within 2 weeks of vaccination. The patient previously took ampicillin and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 08:30 AM, the patient experienced Blood pressure drop,  fainting, vasovagal syncope.The seriousness criteria of the events has not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. The event was assessed as serious based on seriousness criteria. The patient did not receive any treatment for the events. The outcome of the events was unknown.
Patient admitted to hospital and diagnosed with COVID-19 on 4/12/2021 after receiving her first dose of Moderna COVID-19 vaccine on 3/27/2021
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L002310, expiration date 20-JUL-2016, exact dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of 62 degree Fahrenheit for 165 hours before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information is not expected as there was no consent for follow-up.
Patient received the vaccine on 6/11/2021. On 6/12/2021 he developed pleuritic chest pain. The pain worsened and he presented to the ED on 6/14/2021. He was found to have myocarditis and quickly improved--chest pain resolved on 6/15. Treated with a 5 day course of prednisone. Improvement started before treatment with prednisone.
received /first dose /on/2019/ not / the second yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter had no patient or vaccine data. The reporter consented to follow up via email.
3/14/18 20:29 Fever 100.8 TYLENOL given. 3/15/18 05:32 Fever 101.5. 3/15/18 08:19 Fever 103.1 TYLENOL given. 3/15/18 09:30 Seen by nurse practitioner in rounds. Pt. Pt offered complaints of withdrawal symptoms including abdominal cramps, anxiety, muscle and bone aches, shakes, fatigue, chills (hot/cold) and GI upset. Also complained of cold symptoms. Diagnosed with pharyngitis. Amoxicillin started. Fever continued to increase throughout the day. Pt. right upper arm noted to be swollen and tender. Fluids encouraged and tolerated well. 3/15/18 13:20 Fever 104.4 MD aware. MOTRIN given. Transported to Hospital via ambulance. Clinic notified of patient was admitted 3/16/18 03:27. Diagnosis of fever and pneumonia. Clinic was notified 3/16/18 10:38 that patient left Hospital and was returning to Clinic. VANTIN prescribed. Also on azithromycin and doxycycline for pneumonia/bronchitis. Sterile abscess at vaccination injection site. 03/17/18 05:15 temp 98.2. 03/17/18 patient discharged. Pneumonia/bronchitis improved. Injection site sterile abscess improving.
A report was received from a health care professional on 11/20/03 concerning a female vaccinee aged 2 years who inadvertently received Fluvirin on 11/5/03. On 11/5 a vaccinee under 4 years of age inadvertently received Fluvirin. No adverse symptoms were experienced at the time of the report. There was insufficient information to determine the reporter's causality assessment. A follow up report was received from a health care professional indicating that no adverse events had occurred at the time of reporting. No follow up pending, all information.
Breakthrough case admission after third vaccine 2/15/21 Pfizer Lot#EL9267 3/8/21 Pfizer Lot# EN6199 10/7/21 Pfizer Lot3 ew0183
Pt starting having arm pain when she pressed the site on 11/9/17 or 11/10/17. She also felt the pain when lifting something heavy or lifting her arm up.