chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given an influenza vaccine intramuscular left shoulder on 10/8/14. He remembers the injection being given very 'high up' on his arm. He had onset of left shoulder pain within hours. Patient is very clear that there was no prior left shoulder pain or injury prior to this vaccine. Interestingly, 1/3 of all workers at his school given this vaccine developed shoulder pain, and all vaccines were given by the same visiting nurse. The patient was seen by myself as worker's compensation patient for left shoulder pain on 11/13/14 after he was treated by his primary care physician with an intramuscular depo-medrol injection without relief. Diagnosed by myself with subacromial bursitis, given subacromial steroid injection under ultrasound guidance, prescribed physical therapy. 95% pain relief at 4 weeks. Released from care. Within 2 weeks of that he had return of increasing shoulder pain. Seen next by myself on 2/16/15, I ordered MRI due to persistent/recurrent pain. This showed a full thickness non-retracted anterior aspect supraspinatus tendon tear. He has today been referred to an orthopedic surgeon.
No adverse event.  Duplicate dose.   Previously received a dose at another facility on 3/13/21.
LEFT POSTERIOR UPPER ARM TO OUTER SIDE OF ARM WITH ERYTHEMA, SLIGHTLY WARM NO TRUE UNDERNATION AREA INFERIOR AND ANTERIOR TO INJECTION SITE.
On day 2-3 after receiving second shot patient developed difficulty breathing and a wet cough similar to bronchitis. These symptoms subsided after day  6
Pain in the body, joints, tiredness, lack of strength and energy, sore throat, headache, fever and chills.
Patient comes in accompanied by her mother with ongoing back, upper shoulder, and neck pain. She states about 1 1/2 week after receiving her second HPV vaccine in early October she developed achiness in the neck, periscapular area and down the thoracic spine to the low back. The achiness has been persistent and is quite bothersome when she is sitting for a long period of time. She is not currently taking gym. She is doing dance, which she has been able to do, but the pain does keep her up at night. They have been seeking chiropractic care and despite multiple chiropractic modalities, she has had no relief of symptoms. She denies any fever, chills, or sweats. She denies any other joints or pains. Her wrists, knees, and hand have been spared. There is no family history of any inflammatory arthritis according to the mother. She has had no skin rash. No fever, chills, or sweats. No mouth ulcers associated with this. No change in bowel or bladder habits. She has not missed any school with it, but she has been quite uncomfortable she tells me.
This spontaneous report as received from a registered pharmacist refers to a 14 year old female patient. On approximately 08-OCT-2015,"about two weeks ago", the patient was vaccinated with a dose of VARIVAX (dose and lot # not reported) subcutaneously. The pharmacist reported that "a few days later", on an unspecified date in October 2015, the patient experienced a shingles-type rash. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
A report has been received from a health professional concerning a 13 year old male patient who had been receiving nasal FLUMIST. FLUMIST was administered on 17-JAN-2014. The health professional reported administration of expired FLUMIST as expiration date of the drug was 13-JAN-2014. FLUMIST was discontinued on 17-JAN-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Initial unsolicited report received from a physician via other company (Pfizer) (Manufacturer Report Number: 2016336904) on 18-Jul-2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (Tetanus Vaccine) (batch number, expiry date, route and site of administration: not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, patient developed allergy to "tetanus" vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
Pt had Hepatitis B vaccine #1 1cc 20mcg IM to (L) deltoid on 2/14/13. On 3/14/13 pt returned for #2 but complained of intermittent arm pain & numbness since 2/14/13.
swollen, red arm. swollen to elbow and in neck. no trouble breathing, saw ER doctor
1/22/21 0800 AM noticed rash to left arm injection site, back, bilateral posterior legs along with itching to bilateral arms, legs, back, chest, and stomach. Pt. denies taking anything for it. Pt. states that the itching has become worse over the course of one week and is worse today.
shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a medical office for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.
COVID INFECTION; KIDNEY INFECTION; This spontaneous case was reported by a consumer and describes the occurrence of KIDNEY INFECTION (KIDNEY INFECTION) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Kidney stones.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient received third 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) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, the patient experienced KIDNEY INFECTION (KIDNEY INFECTION) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID INFECTION). At the time of the report, KIDNEY INFECTION (KIDNEY INFECTION) was resolving and COVID-19 (COVID INFECTION) outcome was unknown.            No concomitant medication was reported.  Patient was enrolled in a COVID-19 Vaccine Trial.  Patient received Humira as Solution for injection in pre-filled pen.  The reporter's causality for the event(s) of KIDNEY INFECTION and COVID INFECTION with Humira was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 47-year-old female patient, with relevant medical history of nephrolithiasis, who experienced the unexpected serious (medically significant) event of Kidney infection and unexpected non-serious AESI COVID-19. Kidney infection occurred 7 months and 7 days after receiving the 2nd dose of mRNA-1273 vaccine, and COVID-19 unknown. Clinical course and treatment details were not reported. The outcome of kidney infection was reported as resolving and COVID-19 unknown. Nephrolithiasis and co-suspect Adalimumab for rheumatoid arthritis remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 47-year-old female patient, with relevant medical history of nephrolithiasis, who experienced the unexpected serious (medically significant) event of Kidney infection and unexpected non-serious AESI COVID-19. Kidney infection occurred 7 months and 7 days after receiving the 2nd dose of mRNA-1273 vaccine, and COVID-19 unknown. Clinical course and treatment details were not reported. The outcome of kidney infection was reported as resolving and COVID-19 unknown. Nephrolithiasis and co-suspect Adalimumab for rheumatoid arthritis remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Tested positive on 19Jun2022/Treatment of COVID-19; Tested positive on 19Jun2022/Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: E19261), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Mar2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Fresh pineapple" (unspecified if ongoing), notes: Possibly fresh pineapple in large quantities. Concomitant medication(s) included: VALSARTAN/HCT, start date: Dec2002, stop date: 30Jun2022; FENOFIBRATE, start date: Dec2009, stop date: 30Jun2022; MONTELUKAST SODIUM, start date: Dec2011, stop date: 30Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jun2022, outcome "recovering" and all described as "Tested positive on 19Jun2022/Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (Jun2022) Increased, notes: mostly increased temperature that went up and down; SARS-CoV-2 test: (19Jun2022) Positive; (27Jun2022) Unknown; (01Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, Paxlovid.
Sore arm Body pain - bone and muscle Mild fever  Constipation Fatigue
blood pressure has been going high; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8736, Expiry Date: Unknown), dose 2 via an unspecified route of administration on 21Apr2021 as a dose 2, single for covid-19 immunisation. The patient's medical history included ongoing chemotherapy and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for covid-19 immunisation. The patient experienced blood pressure has been going high on 21Apr2021. Patient did went to the emergency room. Patient stated, on 21Apr2021, the patient had second vaccine Pfizer, Pfizer Vaccine from that day the patient had been having blood pressure. The patient did not know, patient was not sure it was because of the vaccine, blood pressure has been going high everyday ever since afternoon, Saturday patient did went to the emergency room so patient was just asking to find out you know to see because at the moment patient was on chemo and patient was receiving Chemotherapy every 3 weeks so but patient blood pressure ever since patient got second vaccine has been going high so patient did not know there was something to do with the vaccine if you received any complained in terms of the blood pressure in relation to the vaccine? patient was on the bed rest and blood pressure at the moment was too high. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
information has been received from a physician concerning an approximately 36 month old female who at 12 of 15 months of age was vaccinated with varicella virus vaccine live. subsequenly, the pt experienced "herpes zoster on her arm" It was reported that the pt wa not treated no titers were done to check the origin of the herpes zoster and the pt has recovered. No other information was provided. No product quality complaint was involved. Additional information has been requested.
Day after vaccine I woke up with loggy heavy feeling across chest and shoulders. At 1pm I gushed out bright red blood with my urine along with excruciating pain in my urethra while urinating. This happened several times and red blood filled toilet bowl. I took photos. Saw my internist--gave  urine sample(same day) bright red  wine colored cup of urine--she referred me to ER. Urine there was darker red. Several more urines were darker brown. Bleeding stopped on its own. Doctor at ER said he though (1st impression) it was immune reaction to vaccine.
3-13-21 2:30PM RASH TO FACE & NECK.  NO SOB/DYSPNEA, NO PAIN. 2:32PM BENADRYL 50MG PO.  2:36PM STATES SHE IS 'OK AND READY TO GO HOME'.  NO ACUTE OR OBVIOUS DISTRESS. A/O X3, PINK, W/D, RESP REG WITH EASE. NO CHANGE IN RASH AT THIS TIME.  AMBULATORY, GAIT BRISK AND STEADY. 3-15-21 9:30AM TC: STATES 'RASH IS GONE, EARS STILL FEEL RAW AND STILL TAKING ALLEGRA'. WILL CHECK WITH PCP R/T DOSE #2.
Pt brought to office with redness and blistering to LT. RT. had redness with less, but still present blistering.
After 07 (seven days) of 2nd vaccine i.e. from January 29Jan2021 night my frequent nasal congestion; breathing problem; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 71-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: PFIZER EL3248) via an unspecified route of administration in left arm on 22Jan2021 at 11:00 as single dose for COVID-19 immunization. Medical history included blood pressure and cervical spondylitis. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not diagnosed with COVID-19. Patient's allergies were not known. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: PFIZER 3756) via an unspecified route of administration in left arm on 01Jan2021 at 11:00. On 29Jan2021, at night (after seven days of vaccine), the patient experienced frequent nasal congestion and breathing problem and it was still continuing even after three weeks of vaccination. On 17Feb2021, the patient was tested for SARS-CoV-2 Semi-Quant Total Ab; test results showed SARS-CoV-2 Semi-Quant Total Ab greater than 250.00 Abnormal i.e. antibody level was abnormally very high (normal less than 0.8 U/ml). Patient wanted to know if patient's nasal congestion and breathing problem was due to abnormally very high level of antibody, developed after Pfizer Covid-19 vaccination and if so, how long it would continue and what measures/precaution/remedies patient could take to reduce side effects. On 17Feb2021, patient also mentioned that oxygen level in oximeter and chest ray were ok. Outcome of the events was not recovered.
to have problems with their vision in one eye; they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy."; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (to have problems with their vision in one eye) and VITREOUS FLOATERS (they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy.") in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033f21a, 024M20A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, AMLODIPINE, AREDS 2 PLUS MULTI VITAMIN and ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced VISUAL IMPAIRMENT (to have problems with their vision in one eye) and VITREOUS FLOATERS (they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy."). At the time of the report, VISUAL IMPAIRMENT (to have problems with their vision in one eye) and VITREOUS FLOATERS (they have floaters in their eye, they are getting better, but they never have them  before and all of the sudden they have a lot  of them / The floaters are not just "black dots", but rather are "weblike" or "stringy.") was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient Reported that  The floaters are not just "black dots", but rather are "weblike" or "stringy." and He has  an appointment with a Retina Specialist set for 11-19-2012.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: significant follow up appended : patient Information, 1st Dose Lot Number and Concomitant Medication.
several people that get the flu shot regularly and they get the flu every year; several people that get the flu shot regularly and they get the flu every year; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Influenza vaccine with an associated reaction of influenza (patient received influenza vaccine on an unknown date, refer case US2020AMR157706).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the vaccination failure and influenza were recovered/resolved.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The case was reported by patient's daughter/ son. The age at vaccination was not reported. It was reported that the patient did get a flu shot and he did get a terrible case of the flu. The patient's family told him didn't get another flu shot.  The patient did not get any more flu shots and he never did get the flu again. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test was unknown. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR157706:same reporter US-GLAXOSMITHKLINE-US2020AMR165253:same reporter US-GLAXOSMITHKLINE-US2020AMR165248:same reporter
Date of Admission: 11/28/2022   Date of Discharge: 12/1/2022   Admission Diagnosis: COVID-19 [U07.1]     Hospital Principal Problem (Discharge Diagnoses): COVID-19   All Hospital Problems (Other Diagnoses): Active Hospital Problems   Diagnosis o Principal Problem: COVID-19 o Overactive bladder o Urinary incontinence without sensory awareness o Kearns-Sayre syndrome of eye, bilateral
Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-067589 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-067589:
she had high fever; her arm was swollen at the injection site; she was vomiting; she was kinda sick; This spontaneous report was received from a consumer reporting on herself, via Pfizer, a female patient of unknown age. Concomitant medications included atorvastatin calcium (LIPITOR). Information regarding the patient's medical history or concurrent conditions was not provided.  On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number and expiration date were not reported).  On the same day, several hours later, the patient had a high fever, her arm was swollen at the injection site, she was vomiting, she was kind of sick (pyrexia,  vaccination site swelling, vomiting and illness).   The outcome of the events pyrexia, illness, vomiting and vaccination site swelling and the causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccination were not reported.
Adverse reaction post Covid vaccine. Waited for 20 min post vaccine. Experienced S/S Heart palpitations, shortness of breath, tingling in extremities, diaphoretic after leaving clinic observation. Drove back to hospital, escorted by pre surgical testing hospital staff and taken by wheelchair to ED.