chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a sudden pressure in my head; my tongue started swelling; I could not swallow very well at all.; This is a spontaneous report from a contactable consumer (patient herself).  This 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration, on 17Sep2021 16:30 (at the age of 40-year-old) at single dose for COVID-19 immunization, administered at pharmacy/drug store. Historical vaccines included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FC3182), via an unspecified route of administration administered in the left arm, on 17Sep2021 16:30 (at the age of 40-year-old) for COVID-19 immunisation. The patient did not have known allergies. The patient did not have COVID-19 before vaccination. Relevant concomitant medications included bupropion hydrochloride (BUPROPION HCL XL). On 17Sep2021 at 18:00, the patient had a sudden pressure in head that lasted a minute or two and then her tongue started swelling and she could not swallowvery well at all. The events required Emergency room/department or urgent care. Therapeutic measures taken as result of the events included diphenhydramine hydrochloride (BENADRYL), prednisone, and famotidine (PEPCID AC). Post vaccination COVID-19 test was not done. The patient had recovered from sudden pressure in head on 17Sep2021 while the outcome of the remaining events was recovered in Sep2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
no additional AE's were reported; patient received a dose of GARDASIL 9 after it expired; This spontaneous report was received from medical assistant and refers to a patient of unknown age and gender (initials were reported). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-APR-2023, the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5ml, 1 dose, lot # U007477, expiration date: 14-APR-2023, administered intramuscularly for prophylaxis after it expired (strength, and route of administration were not provided) (Expired product administered). No other adverse event was reported.
Fever, body aches, fatigue on day 1 Swollen injection site area noted with hives on day 2 Swollen injection site with hives and a hard knot at the injection sight as well as a severe headache with nausea, vomiting, and visual disturbances on day 3
Pt recvd  10DEC93 & 11DEC92 devel erythema @ the inject site & a fever of 101; pt recovered; No further details were provided;
This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (The patient took first booster shots which was not approved as per two doctor advise and then took another full shots (fourth dose).) 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. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-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 received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (The patient took first booster shots which was not approved as per two doctor advise and then took another full shots (fourth dose).). At the time of the report, EXTRA DOSE ADMINISTERED (The patient took first booster shots which was not approved as per two doctor advise and then took another full shots (fourth dose).) outcome was unknown. No concomitant medications information was reported. It was reported that patient was going to have surgery in Aug-2021. Reporter informed that doctors recommended to get the booster that was not approved at that time and the patient got the booster and had no reactions at all and that patient got another full shot but Moderna was giving half a shot. No treatment medications were provided. This case was linked to MOD-2022-526020 (Patient Link). Reporter did not allow further contact.
Patient reports severe left shoulder pain to the extent her range of motion is limited due to pain even weeks after receiving injection. Patient denies any erythema, edema, induration or heat present to injection site.
10 mins after giving flu vaccine, pt. felt dizziness and sweating. Advised pt. to sit down and relax. Also advised pt. to take a deep breath. Pt. then started feeling better. No Epi-pen was needed. After 15 min of resting and relaxing pt. was fine and ok to go home.
On 10/05/2016 presented with photos of large red rash on left tricep where shot was administered. She complained of itching,too. No rash seen on that date.
Pt received Hep A and HPV vaccine at approximately 11 AM on 8-6-15-mom called at 4:30 the same day with concerns of chills-decreased appetite and fatigue-pt then had severe vomiting for several hrs and went to ER.
This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with an improperly stored VARIVAX at a dose of 0.5 (units not specified) from lot # N012488 with expiry date: 20-APR-2019 (dose number, route, anatomical location and site of administration were not reported) for prophylaxis. Concomitant medications included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA004945.
Left arm very sore and edematous 1/16/03. Decreased range of motion; heat to arm. Took ASA and Tylenol. 1/17/03 Temp 102.3F, arm red, warm, and swollen. Took ASA and Tylenol. MD checked--drug reaction. *Follow-up report on 2/12/03: Left arm ached after inject. 2 days later on 1/17/03, temp went from 102.6 to 103.3. Left arm red and three x edema. Several areas of red hard lump. Fever continued til 1/19/03. No other Sx. No resp Sx.
COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor 911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family to call us back for funeral arrangements.
This case was reported by a nurse via call center representative and described the occurrence of lymphadenopathy in a 35-year-old female patient who received HAB (Hepatitis A and Hepatitis B vaccine) for prophylaxis. On 18th February 2019, the patient received Hepatitis A and Hepatitis B vaccine. In February 2019, less than a day after receiving Hepatitis A and Hepatitis B vaccine, the patient experienced lymphadenopathy and swelling of legs. On an unknown date, the outcome of the lymphadenopathy was not recovered/not resolved and the outcome of the swelling of legs was recovering/resolving. It was unknown if the reporter considered the lymphadenopathy and swelling of legs to be related to Hepatitis A and Hepatitis B vaccine. Additional details were provided as follows: This case was reported by the patient's mother who was also a retired nurse. The patient received a dose of Hepatitis A and Hepatitis B combination vaccine (name unknown) on the left arm. Less than 24 hours after vaccination, the patient experienced swelling in her feet and legs. With 48 hours, the swelling became extreme. The physician office was called and was told that the patient might be suffering from Lymphadenopathy. The patient began wearing support hose and the swelling was reduced slightly as of the day before reporting. The reporter consented to follow up.
Spondylitis ankylosing aggravated; Cardiac disorder; Stress; Heart rate increased; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4228486-00.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANKYLOSING SPONDYLITIS (medically significant), outcome "not recovered", described as "Spondylitis ankylosing aggravated"; CARDIAC DISORDER (non-serious), outcome "not recovered", described as "Cardiac disorder"; STRESS (non-serious), outcome "not recovered", described as "Stress"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Heart rate increased". The patient underwent the following laboratory tests and procedures: heart rate: went up; heart rate increased. The action taken for adalimumab was dosage permanently withdrawn.   Clinical course: It was stated that It was unknown if patient was enrolled in a covid-19 vaccine trial.   The reporter's causality for the event(s) of cardiac issues with humira(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of ankylosing spondylitis flare up due to stress unknown onset and ankylosing spondylitis flare up due to stress unknown onset with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of heart rate went up was not provided.   The reporter's assessment of the causal relationship of the cardiac disorder with Pfizer Biontech Covid-19 Vaccine was Possible. The reporter's assessment of the causal relationship of the ankylosing spondylitis flare up due to stress and for the event stress was possible. The reporter's causality for the event(s) of heart rate went up was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the  information in the case report, a possible causal relationship between the events  and suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Symptoms started with headache and fatigue.  Red circle around injection site developed.  Right axillary Lymph node became slightly  enlarged, armpit had dull ache.  I took Advil and Benadryl to help resolve symptoms.  This helped resolve headache.  Red area still present as it just developed today.
localized rxn-tenderness, redness, swelling-pain (size of tennis ball);
Body aches; itchy and redness at injection site; itchy and redness at injection site; Redness on entire upper arm; Hot to touch; Sensitive to touch; Lump at injection site; Tiredness/extreme exhaustion; Bruising; Initial pain at injection site; Limited arm movement; This is a spontaneous report from a contactable physician via Pfizer sales representative. A 73-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number: X93809), via an unspecified route of administration on 06May2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 06May2019, the patient experienced initial pain at injection site, limited arm movement. On 08May2019 to 10May2019, bruising developed. By 11May2019, redness on entire upper arm, hot to touch, sensitive to touch, lump at injection site, and tiredness. On 14May2019, patient continued with extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site. The outcome of the events tiredness/ extreme exhaustion, hot to touch, sensitive to touch, body aches, itchy and redness at injection site was not recovered, bruising recovered on 10May2019, while the outcome of the events initial pain at injection site, limited arm movement, redness on entire upper arm, and lump at injection site was unknown.
had a body ache for 24 hours; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (had a body ache for 24 hours) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 028L20A and 001J20A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (had a body ache for 24 hours). At the time of the report, MYALGIA (had a body ache for 24 hours) had resolved.            No concomitant product was provided.  It was reported that after the patient received the Pfizer COVID-19 vaccine she had very bad side effects and her blood pressure went so high. It was reported that the patient  was taking medication in regards with her blood pressure. It was reported that the patients blood pressure went so high happened last week, after she got the Pfizer COVID-19 vaccine booster. On 27-Sep-2022, the nurse took her blood pressure and it was normal, then she gave her the shot and she came home and her blood pressure had shot up to 189/100 she believes. Her doctor put her to more medication to bring it down. She was very, very not feeling well, she was very dizzy and her blood pressure had not gotten better even with extra medication. Her blood vessel popped in her left eye when her blood pressure goes up, this happened the day before yesterday. For the popped blood vessel in her left eye she had done no treatment, there is nothing she can do. She asked the doctor and there was nothing she can do, just wait until it goes away. It was reported that the body ache for 24 hour, It happened for each dose and then she was fine after that for Moderna. she was on two medications for high blood pressure but when took it was normal before received the shot. No treatment medication was reported.
Sore throat/cough/joint pains/headache/chills/nasal congestion/dizziness. Took DIMETAPP/BENADRYL/TYLENOL PM which made her feel better except for cough/nasal congestion/sore throat. TESSALON PERLES/warm saline gargles. Improved but not yet completely recovered.
Headache, dizziness, general sick feeling, nausea, redness and inflammation at injection site, itching.
feeling sick as a dog; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious), outcome "recovering", described as "feeling sick as a dog". Additional information: Patient reported feeling "sick as a dog" the day after the second dose of the vaccine and 70% better on the second day following.   No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-MAR-2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JUN-2016, the patient was treated at a clinic for a blistering vesicular outbreak which was then diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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. Additional information has been requested.
covid_test_result=Positive; covid_test_result=Positive; Right elbow/forearm inflammation,left knee inflammation; Right elbow/forearm inflammation,left knee inflammation; quality of life is a struggle with daily activities; Prevents me from fully straightening my arm out going on 6 months; Been in extreme pain; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0180, Expiry date was not reported), via an unspecified route of administration on 30May2021 (at the age of 42-years-old) in Arm Right as dose 2, single for COVID-19 immunization. The Patient Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) in two weeks included metformin taken for an unspecified indication, start and stop date were not reported; semaglutide (RYBELSUS) taken for an unspecified indication, start and stop date were not reported; glimepiride taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient previously took amoxicillin, erythromycin and experienced drug hypersensitivity. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0182 and Expiry date was not reported), via an unspecified route of administration on 09May2021(at the age of 41-years-old) in Arm Right as dose 1, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. The Patient did not received other vaccine in four weeks. The Patient was not diagnosed with COVID prior vaccination. The Patient was tested COVID post vaccination and COVID test post vaccination was yes. On 05Jun2021, the patient experienced COVID test result=positive (medically significant), right elbow/forearm inflammation/left knee inflammation (inflammation), right elbow/forearm inflammation/left knee inflammation (arthritis) no injury no previous history of inflammation or joint issues no autoimmune issues, quality of life is a struggle with daily activities, prevents me from fully straightening my arm out going on 6 months now, did PT with no success, been in extreme pain. The patient underwent lab tests and procedures which included magnetic resonance imaging: no injuries to the joint or arm, polymerase chain reaction: positive on 09Oct2021 COVID test name post vaccination=PCR, sars-cov-2 test: positive on 09Oct2021, x-ray: no injuries to the joint or arm. The Patient visited physician office visit. A lot of doctors appointments with nothing helping the inflammation. The Patient received treatment for the events with prednisone, Naproxen, Hydroxychloroquin. The outcome for the events was not recovered.  No follow-up attempts are possible. No further information is expected
a patient who received the 1st dose on 21Jul21, she came today with the shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles) outcome was unknown.        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.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Significant Follow up: Patient race and ethnicity are updated, Route of administration, lot no, anatomical location were updated.
Information has been received from a physician concerning a female who on 16-NOV-2006 was vaccinated with 2ml oral first dose of Rotateq (lot #655405/1113F). Concomitant vaccination that day included doses of Dtap, Comvax, Poliovirus and Prevnar. On the evening of 16-NOV-2006 the patient developed bloody stool. Unspecified medical attention was sought. The patients present status was unknown. On 21-FEB-2007 the patient did received the second dose of Rotateq. There was no product quality complaint involved. The patients blood in stool was considered to be an other important medical event. Additional information has been requested.