chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 04Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown, Manufacturer: Pfizer), administration date: 14May2021, when the patient was 40-year-old, for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 01Dec2021, outcome "not recovered". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: Other vaccine in four weeks reported as no. Other medications in two weeks reported as no. Treatment received for AE reported as no. Covid prior vaccination reported as no. Covid tested post vaccination reported as no. No Known allergies was reported. Other medical history reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial Report / Final. Event Term: Pneumonia. Subject Currently participating in the Janssen study protocol dosed with study med on 01/26/2023 Presented to the emergency department with worsening shortness of breath on 05/15/2023. A CT chest 3 days prior to hospitalization showed a right upper lobe pulmonary nodule with ground-glass opacities measuring 1.0 x 1.4 cm. On admission 05/15/2023 chest x-ray showed suspected multilobar atypical pneumonia. She was also noted to have an Acute Kidney injury with a creatinine of 1.9 on admission. CT chest in hospital on 5/15/2023 showed multifocal small airway disease with bronchopneumonia in the posterior right upper lobe and coarse broncho vascular and peripheral opacities in both lower lobes with more consolidative opacities in the basilar portions that may represent areas of organizing pneumonia. Pulmonology was consulted for bronchoscopy. Bronchoscopy was performed on 5/16/2023. Blood cultures had no growth , influenza, COVID negative mycoplasma pneumonia negative strep pneumo negative, Legionella urine negative, Blastomyces not detected, Histoplasma urine not detected, Fungitell negative, Aspergillus negative, MRSA negative, Pneumocystis negative, mycobacterial culture negative, respiratory panel negative, cytomegalovirus PCR negative, no cardia negative, pneumocystis smear fungal smear negative, Legionella culture negative, acid-fast for mycobacterium negative. All micro workup so far has been unremarkable. Given concern for possible tuberculosis with patient's recent travel history and location of lung imaging findings patient was placed on airborne precautions. Multiple cultures were negative, IPAC was. contacted. Subject was initially treated with ceftriaxone and azithromycin transitioned to oral cefdinir on discharge 5/19/2023 to finish out total extended 10-day course. Azithromycin was discontinued. Mycophenolate was held per renal transplant recommendation given active pneumonia. Patient will need to follow up with renal transplant outpatient to discuss timing of restarting this medication. Tacrolimus and prednisone were continued. Given cough and delayed mucus clearance, patient was given Mucinex, phenylephrine nasal spray, Flonase, pep therapy with Aerobika, DuoNebs, hypertonic saline and normal saline nebulizers. All which helped improve patient's congestion and shortness of breath. Patient was also initiated on Claritin to help with postnasal drip and allergic rhinitis. Subject was being sent home with nebulizers and instructions to continue the medications. Patient discharged on 05/19/2023 to home for further recover. Subject will have follow up with pulmonology. Admission: 5/15/2023 / Discharge: 5/19/2023 As per staff casualty/relationship is not study related.
Client received flu shot and then developed a localized rash and warmness at injection site. She took Benadryl and put Lotrisone Cream on it. If symptoms don't subside, she will go to ER. Redness and rash cleared the following day.
Booster; Pain and stiffness in injection arm; Felt feverish but temperature never rose above 98.4; stiffness in injection arm; body aches; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2) (Lot number: 320308D, Expiration Date: 15Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis", start date: 2005 (ongoing), notes: 4 colonoscopies; "Osteoporosis", start date: 2017 (ongoing), notes: Dexa scans lifeline screenings (Hospital name); "Heart block", start date: 2019 (ongoing), notes: One stay (Hospital name) no treatment tests done EKG ECHs etc. Concomitant medication(s) included: 6-MERCAPTOPURINE MONOHYDRATE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: 2017 (ongoing). Vaccination history included: Bnt162b2 (Dose 1 , Prior vaccinations: Covid-19 vaccine vial, Manufacturer: Pfizer, Anatomical Site of Injection: Left arm, No. of previous doses: 2, Date: 16Nov2021), for COVID-19 Immunization; Bnt162b2 (Dose 2, Prior vaccinations: Covid-19 vaccine vial, Manufacturer: Pfizer, Anatomical Site of Injection: Left arm, No. of previous doses: 2, Date: 16Nov2021), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain and stiffness in injection arm"; PYREXIA (non-serious), outcome "recovered", described as "Felt feverish but temperature never rose above 98.4"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered", described as "stiffness in injection arm"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He had no private car and take city buses 5-6 days week. Took third COVID-19 Vaccination. Felt feverish but temperature never rise above 98.4 was not disturbed during sleep this time. Pain and stiffness in injection arm body aches fatigue headache. All symptoms resolved in about 30 hours. Now ready for omicron booster.  Follow-up attempts are completed. No further information is expected.
Within 1-2 minutes of receiving vax, an area approximately 1-1.5 cm diameter that was pink and warm developed. By 11 AM, area had decreased redness and warmth.
Redness, warmth, pain and swelling at injection site approximately 24-36 hours after injection
First shot resulted in joint soreness, headache and fatigue.  Second shot in March resulted in same, more severe, with redness and extreme swelling of arm from shoulder to elbow.  Since that time I have inflammation and pain between ribs and lungs front and back, both sides of body.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-DEC-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 01-JUL-2016, the patient was treated by a physician's assistant at an office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. On or about 08-NOV-2016, she sought subsequent treatment at the same office for ongoing and worsening zoster complications, which was diagnosed as trigeminal neuralgia, which is a secondary diagnosis of chronic herpes zoster rash. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Flu shot given 10/27/20, less then 24 hours later a large raised and red rash appeared on side of torso (under arm) on the right side. Rash was solid (not individual bumps) and was extremely itchy, Topical cream did not relieve symptoms and so Benadryl was taken for several days. I am 13 weeks pregnant and due May 18, 2021. The rash is still visible at this time but resolving.
"COVID Arm"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ("COVID Arm") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY ("COVID Arm"). At the time of the report, PAIN IN EXTREMITY ("COVID Arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report was received on 19-OCT-2016 from a registered nurse who reported that an unspecified number of improperly stored vaccines were administered to an unspecified number of patients (gender and age not specified) on 19-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. An unspecified number of improperly stored vaccines of GARDASIL (dose and route of administration not reported) were administered to an unspecified number of patients (gender and age not specified) on 19-OCT-2016. Temperature was reported as 47.8 degrees Fahrenheit. Time frame was reported as 11 hours. There was no previous temperature excursion. The Call was because of data logger. No adverse effects reported. No additional information was available. The nurse reported the following Lot number L036301 with expiration date of 20-DEC-2017 was for the GARDASIL. [The nurse also reported that this same lot # and expiration date was for the M-M-R II vaccines (Reference MARRS 1610USA010944.)] This is one of several reports received from the same reporter. Additional information has been requested.
Employee reports signs and symptoms onset on 4/2/21 of congestion and runny nose. Employee tested for Covid 4/5/21. Employee travelled to Mexico 4/23/21-5/2/21.
Uncontrollable chills for over 3 hours followed by a few hours of extreme perspiration. Inability to sleep soundly.  Fatigue during following day and muscle soreness.
chills, fever of 103, headache, bodyaches for 24 hours Narrative:  Symptoms lasted 24 hours. Took Tylenol
After taking  Covid 19 Vaccine,  getting some Chills, and Shaking,  some headaches, and  feeling  sensitive.  I awaken next day with some Chills, and Headaches, and feeling sensitive.   Feeling some  Nausea, a feeling of sickness.
She has more tingling; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer reported for a 56-year-old female patient (mother) that: A 56-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included ongoing neuropathy and was having neuropathy from trauma long ago. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced more tingling. The patient was a teacher and need to go back to school. The patient was not diabetic. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
15mins after 1st dose burning sensation travelled through my whole body 15-20mins and then you were safe to drive. I felt this way during the time I had covid 27dec2020.  Chest pains 2 months ago. Went to the doctors on 30Aug2021.
She started getting symptoms she thought were side effects the day after her injection.  She ended up being admitted to the hospital a week later on 7/9/21 febrile with bacteremia (MSSA positive) septic emboli and thrombocytopenia. She has since had complications of pulmonary embolism and right empyema s/p mechanical thrombectomy and chest tube placement. Now s/p pacing lead and generator removal due to infection (7/30), cardioversion 08/12, pulmonary thrombectomy 8/24, removal of infected teeth 9/9,  with initial improvement of fever and again became febrile with increasing WBC and CRP.  On  9/13/21, she underwent redo sternotomy with removal of vegetations from TV, PV, and pulmonary arteies, as well as replacement of TV, RVOT, and PV with bioprosthetic valve replacements and patch material, along with repair (RA, left brachiocephalic vein and ascending aorta) with bovine pericardial patches. She was discharged 9/23
Inflammation in my right hand, and rash in one finger. Not sure if the vaccine caused this.  Also I felt bad for two days, and got mucus.
Immediately after injection Pt felt lightheaded x 10 min. She was observed x 45 - 60 min. Recovered + d/c home. 1.5  - 2 hrs after shot c/o sensation of "splinters" in her throat. Returned to clinic 4/10/07 for evaluation = was seen in urgent care. Sx had slightly improved. Observed no tx.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport  refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by State o for COVID-19 vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Information has been receive from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 27-MAY-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # L002419, expiration date 23-JUL-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
Patient was given a bivalent pfizer 5y to 12yr instead of a monovalent pfizer 5y-11yr for the first dose in a primary series.
Right arm/hand swole Dizziness Chest pain Chest tightness Passed out at time of reaction  Fever Trouble breathing Headache Muscle aches Joint aches Fatigue Weakness Couldn't stand/walk at time of reaction
This case was reported by a physician and described the occurrence of dry throat in a 22 year old female pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's past medical history included migraine.  The pt's concurrent medications were not reported.  On 10/31/2003 the pt received the 1st dose of Engerix-B.  Approximately 25 minutes later, the pt experienced a dry throat and developed a pruritic rash on the anterior chest.  The pt was treated with diphenhydramine hydrochloride followed by methylprednisolone sodium succinate ten minutes later.  The events resolved.  The reporting physician considered the events were probably related to vaccination with Engerix-B.
From telephone call received on 11/12/01, it was reported "Fluzone was administered on 11/07/01. Two hours after vaccination patient developed generalized. Patient was seen by physician 11/09/01 and treated with Benadryl and Prednisone."
low-grade fever that ranged from 99.1 to 100.9 for a day; residual vertigo through today, June 4, but dissipating.  This was the second booster.  Sore arm but dissipating today and somewhat sore muscles elsewhere but not as sore as the arm.  The biggest issues for me were the low-grade fevers and the off-kilter equilibrium.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2021 at 12:00 as dose number unknown, single (Lot number: Fe3594) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "Blood clotting disorder" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: percocet, reaction(s): "Known allergies: percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This case was reported by a physician and described a 21 yr old female pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were not reported. On 24Nov03, the pt received the third dose of Engerix B. On 26Nov03, a hep B surface antibody titre was negative. On 02Jan04, a hep B surface antibody titre was again negative.
10/21/2010-Dime sized red area of left deltoid with itching and mild pain @ injection site. 10/22/2010 @ 2:30pm-Patient in to health office to report worsening of arm symptoms.  No previous hx of reaction to imunizations or tetanus. Left deltoid area reddened, warm to touch, area increased to 7cm in diameter, continues with mild pain 4-5/10 painscale and itching. Plan:  Loratadine 10mg po and  ibuprofen 400mg po given @ 3pm during 10/22/2010 visit.  Instruction re: Benadryl 25mg po @ hs through weekend, ice pack given with instruction to apply to left arm 20 minutes 4-6 x day as needed with follow up appointment for 10/25/2010 3:30PM with Nurse Practitioner.  If condition worsens go immediatley to local emergency room.
Headache that escalated to migraine level, then would slightly abate only to re-escalate. This has been a repeating cycle since the date of the vaccine through the date of this report on 10/31/2022, with no end in sight. Migraine medication seems to lessen it, but does not end the headache, then when the medication  wears off, the migraine returns.
ARM SWELLING (SIGNIFICANT) FROM JUST ABOVE ELBOW TO SHOULDER. MD VISIT 9/7/18 PRESCRIBED CEPHALEXIN 500MG QID FOR 5 DAYS.
Swelling of the injection site both times.  After the second dose experiencing swelling of the arm, tenderness, lymph nodes under the arm pit in the same arm of the injection.
Administered Pfizer 6mos-4yo monovalent dose as third dose in series when Pfizer bivalent 6mos-4yo dose was indicated.
approx. 4 weeks after immunizations were given, mother brought child to office stating that pus had drained from a lump on the right thigh
Red circle around injection site; Itchy circle around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red circle around injection site) and VACCINATION SITE PRURITUS (Itchy circle around injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around injection site) and VACCINATION SITE PRURITUS (Itchy circle around injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red circle around injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itchy circle around injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient called 09/27/18. To report that she was experiencing hives all over. She stated that a few hours after she got vaccination on 9/24/18, she developed a rash on her shoulder that resolved with BENADRYL. The following dat, the rash returned to her trunk, and arms, and has progressed to hives. We directed her to seek medical care at the nearest urgent care.