chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; burning down her left arm, left breast and axillary swollen painful; charlie horse like cramps in left arm, hand and shoulder.; left breast swelled up; left armpit swelled up; This is a spontaneous report from a contactable consumer (patient). A 66 -year-old female patient received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263), via an unspecified route of administration (on left arm) on 27Jan2021 10:00 (at the age of 66 -years-old), single dose for COVID-19 immunization. Medical history included back surgery, knee surgery both on 2018. The patient's concomitant medications were not reported.  Caller received 27Jan2021: 15 min after injection burning down her left arm, left breast and axillary swollen painful, charlie horse like cramps in left arm, hand and shoulder. She is drinking water, taking Tylenol, and using a heating pad but symptoms are persisting. Consumer states she is getting some interesting side effects from the vaccine. Adds she received the vaccine on 27Jan2021 10:00AM. Reports within the first 15 minutes she noticed just some burning down her left arm but then her left armpit swelled up; her left breast swelled up and she started to experience charlie horses in her arm. Adds now the pain has come down a little. She has been drinking water, taking Tylenol, and using a heating pad and that has helped a little. The pain comes and goes. It is worse at night when she lies down. Now it is in her hand, charlie horsing in her hand. She thinks maybe the shot got into her lymph nodes. Mentions the swelling her left armpit and breast has gone down some but the pain is still there. Clarifies patient received the first dose of the Pfizer COVID 19 vaccine on 27Jan2021 at 10:00AM on the left arm. She is scheduled for the second dose 24Feb2021. The outcome of the event Swelling arm, Breast swelling, Axillary pain, Axillary lymph nodes enlarged  was recovering, other events was not recovered.
Fever kept getting higher, between 101-103.9 by 9:00 PM. He had a softball size welt on each arm, and he was lethargic.
Bilateral numbness in arms night 1, more numbness in face and down right side of body next day. Described as a "pulsing" numb feeling, sometimes burning, ebbing and flowing, and gradually seeming to improve after 4 days. Drinking alcohol worsens symptoms, movement seems to improve symptoms.
This spontaneous report was received from a physician via a company representative, refers to a patient of unknown age and gender. On an unspecified date the patient was given the first dose of the HPV series on an unspecified date with GARDASIL. Physician reports that patient received the second dose of the HPV series on an unspecified date "11 months later", with GARDASIL 9. No adverse effect was reported.
Information has been received from a 36 year old female who on 23-JUL-2008 was vaccinated with her second dose of GARDASIL 0.5mL intramuscularly. "Immediately after dose" (on 23-JUL-2008) the patient reported hair loss. The patient's hair loss persisted. The patient did not seek medical attention. Additional information has been requested.
Brief history and medical decision making:  Volume over loaf, secondary to missed HD on Monday 08/23. Break through Covid -19 infection, continue isolation per infection control. Hold off Steroids ( anticipating HD will help with breathing) Elevated troponin mostly due to ESRD and volume overload.  Asymptomatic. History CVA with expressive aphasia: Cognitive impairment: Patient have guardian. HD per Nephrology.    Shortness of breath  Volume overload  ESRD MWF    In setting of missed dialysis on Monday and patient being 5 kg above dry weight.  Chest x-ray with evidence of congestion and small bilateral pleural effusions.  Differentials also include breakthrough COVID-19 infection and possibility of flash pulmonary edema. History defers from patient shortness of breath worsening over last week worse in last 3 days compared to facility awareness of acutely short of breath last evening.    Plan: -consult nephrology discussed with Doctor regarding dialysis today -assess SOB hypoxia with activity after -Lasix if delayed planned to start round 1pm    Hypertensive urgency  In setting of volume overload with no antihypertensives given on day of dialysis even though missed dialysis and without blood pressure medications today.    -Continue amlodipine, imdur, coreg initial dose now and continue on none dialysis days    Breakthrough COVID-19 infection Symptomatic with positive test in November 2020, vaccinated  Johnson Johnson vaccine 3/2021, negative testing previously now positive test 8/24.  No COVID outbreak at facility.  Patient has been afebrile.  Does have cough, headache.    -discussed with infection control will place in isolation 10 days -Received 6 mg dexamethasone in ED. Currently not hypoxic on RA. Will hold on additional treatment currently.  -With ESRD would not be candidate for remdesivir. -With current volume overload will avoid convalescent plasma unclear utility with past infection and COVID vaccination.       Elevated troponin Myocardial injury In setting of ESRD with volume overload with elevated blood pressure without EKG changes remains atrial paced with right bundle-branch block previously seen. Denies chest pain. Troponin 224 -- > 224. Previous admissions 150 to 250s.    Diastolic heart failure Status post permanent pacemaker Afib not on anticoagulation due to GI bleed.  Last echo 3/2021. EF 57% mild LVH.  Atrial paced.       Dementia Prior CVA with expressive aphasia General debility Frequent falls Currently AOx3/4 name, place, president not to date.    Has court-appointed guardian.  -PT/OT   Chronic pain -Continue fentanyl patch q 72 hr      Code Status: full unknown. Call out to guardian  DVT PPX: SQH  Diet: Renal fluid and sodium resricted Dispo: Obs assess after HD.     Discussed with Doctor, please see their addendum.   Internal Medicine Resident PGY-3
Patient received a dose of Menveo instead of her second dose of Shingrix; Patient received a dose of Menveo / DOB: 24-MAR-1957; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 64-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA549A, expiry date 28th February 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 4th January 2021).   On 20th May 2021, the patient received Menveo. On 20th May 2021, unknown after receiving Menveo, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: MA reported that the patient received a dose of Menveo instead of second dose of Shingrix which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.
Patient started with hives on the right arm about 26 hours after vaccination that spread over her entire body , trunk and extremities along with itching. She was started on prednisone by an ER doctor.  I spoke with her today to follow up and she has been to the ER twice this past weekend and started on prednisone, methylprednisolone, Benadryl and Pepcid as well as 3 rounds of IVs in the ER. She has continued to have hives , itching, swelling of her throat, ears and eyes.
p/vax pt exp a full blown case of chickenpox;devel addtl vesicles;devel approx 85 lesions on the secondary day;medical attention was sought;viral cult performed;
Within a minute post-injection, felt warmth over the body-more in upper torse, then chest/neck/arm muscle tightness and discomfort, tingling, some sweating on forehead. Within 10 minutes the feelings dissipated and by 20 minutes post-injection completely gone, felt normal. Later that evening, still felt normal with minimal soreness at injection site
Severe Headache; Higher Fever; This case was reported by a consumer and described the occurrence of headache in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose in October 2020 and experienced ferer, headache and arm pain. For the tolerance of 1st dose, refer linked case US2021007475).   In December 2020, the patient received the 2nd dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced headache and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the headache and fever were recovered/resolved.   It was unknown if the reporter considered the headache and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was reporting for himself. After receiving Shingrix, the patient experienced a higher fever of 101.5 degree Celsius for four to eight hours, a severe headache for six to twelve hours. The reporter consented to follow up. All information was not available. This was 1 of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021007474:Wife's 2nd dose US-GLAXOSMITHKLINE-US2021AMR008109:Wife's 1st dose US-GLAXOSMITHKLINE-US2021007475:same patient, 1st dose
Patient reported feeling "Lightheaded" 15 minutes after vaccination and for a period of approximately 45 minutes duration. Patient went home, ate, and was "feeling better". Four  hours after the vaccination.
Twenty minutes after receiving vaccine, I experienced discoloration in my legs that looked like a bruise.  On 10/20 I went to my PCP because this discoloration was redder and brighter. The spacing also looked like it moved.
Pt has complained today of pain and has gotten tx and rehab the past 6 months, -> frozen shoulder?
(L) arm painful after injection and 2 days later noticed upper arm (L) to (L) side of neck "really swollen". Did not seek medical attention. Still taking BENADRYL in PM no arm or neck still swollen - but improving slow improvement.
Lupus flairups that are relentless; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flairups that are relentless) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Systemic lupus erythematosus.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flairups that are relentless) (seriousness criterion medically significant). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flairups that are relentless) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       The concomitant and treatment medication was not reported. The patient was asking where to get Moderna booster shot and the 6 month follow up shots. Treatment information was not provided.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with a concurrent medical condition of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) event of Systemic lupus erythematosus aggravated (lupus flare-ups that are relentless) which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's concurrent medical condition of Systemic lupus erythematosus, which can have flares and remissions, remains a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with a concurrent medical condition of Systemic lupus erythematosus, who experienced the unexpected serious (medically significant) event of Systemic lupus erythematosus aggravated (lupus flare-ups that are relentless) which occurred unknown number of days after receiving a dose of COVID-19 vaccine mRNA-1273, dose number unknown. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's concurrent medical condition of Systemic lupus erythematosus, which can have flares and remissions, remains a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored GARDASIL 120 Y (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
PT describes redness & itching of left upper arm approx 24 hrs post vax with Anthrax (#2). PT states he didn't feel well, but denies Sx's of N/VID, chills, or fever. Provider advised cool compresses, topical antihistamines and return to clinic PRN.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium
PATIENT HAS A SWOLLEN, RED, ITCHY ELBOW. VACCINE SITE LOOKS FINE JUST LOTS OF INFLAMMATION IN THE ELBOW AREA AND VERY RED. HE WENT TO THE URGENT CARE  AND HAD TO HAVE A STEROID SHOT. HE SAID THE PROVIDER THERE ALSO TOLD HIM TO TAKE BENADRYL.
Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 13 JAN 2022. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-482212, MOD-2022-482218 (Patient Link).
Positive for the flu; Positive for the flu; This is a spontaneous case, reported by other health professional (nurse) to agency and initially received on 17-Apr-2020, concerning a female patient with unknown age.   The patient had no medical history.  The patient had no concomitant medications.  On an unspecified date in Nov-2019, the patient was administered INN Flu Vaccine Seasonal [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiration date: not reported] for prevention of flu.  On an unspecified date in Feb-2020, rapid flu test was performed and the patient was positive for the flu (explicitly coded as 'vaccination failure'). The patient did not receive any treatment.  On an unspecified date in 2020, the outcome of the event 'flu' was resolved.  At the time of this report, the outcome of the event 'vaccination failure' was not reported.  The events of 'flu' and 'vaccination failure' were assessed as serious due to criteria of medically significance, per company.  The reported did not provide causality assessment.  The reported did not give permission to be contacted for further information.  Company comment: The patient was administered INN Flu Vaccine Seasonal on an unspecified date in Nov-2019. The patient tested positive for influenza, on an unspecified date in Feb-2020. The patient was tested positive in time frame of 21 days and up to 180 days post vaccination (coded as vaccination failure). Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.; Sender's Comments: The patient was administered INN Flu Vaccine Seasonal on an unspecified date in Nov-2019. The patient tested positive for influenza, on an unspecified date in Feb-2020. The patient was tested positive in time frame of 21 days and up to 180 days post vaccination (coded as vaccination failure). Based on provided information, causal role of the suspect product is assessed as possibly related for both events, influenza and vaccination failure.
pt recv 1st dose varivax 3/12/98 & 4/13 pt exp an itchy rash on face, arms & neck. dermatologist  dx rosacea.
passing out; swollen arms; gastrointestinal distress; weakened immune system; dizzinesss; Food allergy; Condition aggravated; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced passed out (serious criteria GSK medically significant), swelling arm, distress gastrointestinal, decreased immune responsiveness, dizziness, food allergy and condition aggravated. On an unknown date, the outcome of the passed out, swelling arm, distress gastrointestinal, decreased immune responsiveness and dizziness were recovered/resolved and the outcome of the food allergy and condition aggravated were unknown.   It was unknown if the reporter considered the passed out, swelling arm, passed out, distress gastrointestinal, decreased immune responsiveness, dizziness, food allergy and condition aggravated to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced swollen arm, gastrointestinal distress decreased immune responsiveness, dizziness, and food allergy increased. This case has been linked with US2019AMR110932, reported by same reporter.
Rash that is red, itchy, warm to touch; rash itchy; warm to touch; developed another rash on the left elbow; Raised rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included osteoporosis. Concomitant products included denosumab (Prolia).   On 1st September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 3 days after receiving Shingrix, the patient experienced red rash, itchy rash, heat rash, rash and raised rash. On an unknown date, the outcome of the red rash was not recovered/not resolved and the outcome of the itchy rash, heat rash and raised rash were unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the red rash, itchy rash, heat rash, rash and raised rash to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix and 3 days later she developed a raised itchy area on the side of her left hand. Once this rash resolved, the patient developed another rash on the left elbow. This rash resolved and then the patient developed a rash on the right elbow that was red, itchy, warm to touch and 3 inches in diameter. The reporter consented to follow up.  The caller did not provide any additional details.
Initial unsolicited report received from a other non-health professional (office staff) on 15 November 2016. This case involves a patient (age and gender not reported) who was vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (batch number: UI678AB; dose, dose in series, expiry date of the product, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date and duration following the vaccination, the patient suffered from Inflammatory demyelinating polyneuropathy. Relevant laboratory data and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the causal relationship with Flu vaccine as possible. List of documents held by sender: none. Sender's Comments: This poorly documented case concerns of unknown age patient to be suspected Inflammatory Demyelinating Polyneuropathy after vaccination with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Hence Details regarding date of vaccination, onset of event, relevant medical history, prior history of vaccination and its tolerance are needed to further assess the case. Based on the available information, no conclusion on the role of the vaccine can be drawn.
12/16/2021 - complained of feeling like there was something in his left eye. 12/17/2021 - eye appeared swollen. 12/17/2021 - some visible changes to appearance of face, continues to be bothered by discomfort in left eye. 12/18/2021 - obvious paralysis in face, unable to close eye or swallow without difficulty. Was taken to the hospital emergency department and was diagnosed with Bell's Palsy.
patient called on 10/07/2019 to pharmacy to report cellulitis in left arm and fever after receiving the vaccine. she was seen in pcp and emergency room
Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history who in December 2007, was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  Possible concomitant therapy included hormonal contraceptives (unspecified).  In December 2007, one day after vaccination, the patient experienced tingling and paralysis in both of her feet.  She was taken to the emergency department of a hospital and they did many different tests.  A magnetic resonance imaging (MRI), spinal cord tests and many other tests were performed, (results not reported).  The physicians reported that she had an auto-immune response of her brain and spinal cord which had created lesions and had damaged her brain and spinal cord.  The mother did not believe that her daughter had to stay overnight in the hospital.  The patient was receiving care at home.  The mother did not know if her daughter had any reaction following the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  At the time of the report the patient had not recovered.  Upon internal review paralysis in both feet was considered to be an other important medical event.  Additional information is not expected.