chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a 14 year old patient, of unknown gender. Patient's current conditions, medical history, concomitant medications, drugs allergies or reactions were not reported. On 22-MAR-2019, the patient was vaccinated with improperly stored dose of the following vaccine: VARIVAX lot # R018780 and expiration date 01-JUL-2020, (strength, dose, dose number, route and anatomical location were not provided) for prophylaxis. Non improperly stored sterile diluent used was reported. The vaccines was exposed to a temperature of 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.9 Fahrenheit degrees) for 66 minutes. There was a previous temperature excursion from 6 Fahrenheit degrees to 14 Fahrenheit degrees (12.0 Fahrenheit degrees) for 35 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This case is one of six same reporter cases. Sender's Comments: US-009507513-1903USA011480: US-009507513-1903USA011573: US-009507513-1903USA011572: US-009507513-1903USA011571: US-009507513-1903USA011570.
Painful upper (L) arm: Pain radiates from deltoid to above elbow; to (L) side of neck. Inflammation minimal erythema minimal
Telephone call from the client on 4-20-2021. She states that she is experiencing new onset today of difficulty thinking and completing her train of thought in speech. She denies having COVID-19 disease. After the 1st vaccine 3-17-21, she reported "headache and body aches as expected for her history of fibromyalgia" .  She had her second vaccine on 4-16 and reports that within one hour she had headaches, body aches and shoulder pain. the symptoms did improve. Today she is reporting acute headache worse than before with vision changes like an ocular migraine which she has had in the past. She is most distressed concerning her train of thought. She client reports she did hit the back of her head 4-17-21. Client advised to call her PCP.
Information has been received from a registered nurse referring to a patient of unknown age and gender Information about medical history and concurrent condition was not reported. On 13-FEB-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
12-01-2021- Patient received second Pfizer-COV (5-11) Immz, 0.2 mls/ IM. (parent had forgotten to bring COV-Card from first Immz). This was given in Error on Day 15, post first COV-Immz Date (11/16/2021). As soon as error was discovered -while patient & father were still in office; Dr ; who began investigating for proper protocol steps.  Dr spoke with father in exam room and then again by phone, providing all COV-Immz.-Information with Recommendations. Father stated he will discuss with Mother and call back with their decision concerning another Immz. Patient had no immediate s/s of any  adverse reaction, when leaving office. Proper Error Reports /VAERS & MO-Incident Report will be completed by the nurse. A new plan was put in place to prevent this error in the future, with several "double checks & confirmations".  12-02-2021- Follow Up call has been placed to parent of pt.; Mother reports; pt is doing well, no s/s of adverse reactions. Asked Mom to call back if anything changes, mom voiced understanding.
Narrative: COVID infections following completion of COVID vaccine series 03/08/21 COVID vaccine dose #1 04/05/21 COVID vaccine dose #2 07/27/21 Pt presents to screening reporting runny nose, sore throat: COVID POSITIVE 07/29/21 PT reports cough, muscle pain, nausea, runny nose, mild SOB, sore throat that started 07/26; rx given for albuterol, viatmin C, vitamin D, DM/guaifenesin, zinc 08/21/21 Pt reports dry cough, congestion 08/03/21 Pt reports cough and intermittent SOB 08/04/21 Pt continues to improve but complains of ongoing dizziness; denies being lightheaded
Patient reported a welt and itching  on day 2, then  very high blood pressure about 3 days after which she went to the ER to get evaluated and nothing determined to be for certain  related and she was sent home .  about a week after shot , she developed Covid Arm (rash and itching on arm and neck) and also had nausea.
mom reports T103;joint pain;took pt to MD on 14APR98;pt did not return to school until following wk;mom reports fever until 16APR AM;cont joint pain, although less;reported 17APR-still some knee & back pain;seen by MD & mom reports lab work
Information has been received from a health professional concerning a 20 year old female patient who on 27-JUL-2007 was vaccinated IM in the left deltoid with the first dose of Gardasil vaccine. Three to four hours post vaccination, the patient developed a swollen left eye. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
A bump developed on my arm where I got the shot. Its painful and red, slightly swollen and itchy
Information has been received from a consumer at a public exhibit concerning her daughter who was vaccinated with a dose of GARDASIL.  Subsequently the patient experienced seizure.  The patient's mother reported that the patient would have to take seizure medication "for the rest of her life".  At the time of this report, the event persisted.  Upon internal review, seizure was determined to be an other important medical event.  No further information is available.
pt recv vax 16NOV95 & it was noted that many classmates have broken out w/chickenpox;16OCT96 pt devel classic chickenpox w/20 lesions on front of trunk, 20 lesions on back of trunk & some on shoulders;
This spontaneous report as received from a registered nurse refers to a 15 years old female patient with no pertinent medical history and drug allergy. The patient was vaccinated with the first, second and third dose of GARDASIL (Lot# unspecified) intramuscularly on 17-AUG-2009, 11-NOV-2009 and 06-MAY-2010 respectively with no concomitant medication. No other co-suspects were reported. On 09-MAY-2010 the patient developed neck pain, dizziness, headache, unspecified "vision problems," shoulder pain, and "trouble sleeping." The patient went to an unspecified emergency room where she was diagnosed with post vaccine encephalopathy and hypothyroidism. She was given levothyroxine sodium and amitriptyline hydrochloride. She was then discharged from the emergency room. She was still recovering at time of the report. Magnetic Resonance Imaging, blood tests, electrocardiogram, echocardiogram, x-ray and spinal tap were performed (no results reported). Upon internal review, post vaccine encephalopathy was considered to be an other medically significant event. Additional information has been requested.
Concern with sleep walking - For 2 weeks - restless sleep. Stuttering day after immunization 9/5 and also difficult verbalizing - after Rx improving as of 9/22/08
Basically I had right arm weakness that I noticed while holding my arm up to do my hair. It is still the same I had an MRI done and I'm seeing a urologist and a physical therapist for it. They're planning on doing a second MRI of my neck along with nerve conduction studies.
I tested positive for COVID-19 on 5/14/22. I developed a scratchy throat, runny nose and I and fatigue. Reached out to my doctor on 5/15/22 and received PAXLOVID. I took the 5 day course. On 5/23/22 I tested negative. On 5/30/22 I tested positive again. I have since tested negative again.
Severe joint pain; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 17Apr2021 at 15:00(at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 27Mar2021 at 15:00(at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 00:00, the patient experienced severe joint pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of severe joint pain and included treatment with ibuprofen (MANUFACTURER UNKNOWN) and liquids. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe joint pain was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
I developed a runny congested nose which progressed into a cough, fatigue and general malaise on 3/29/2023. The cough, fatigue and general malaise became worse throughout the day. By nighttime the cough was productive (tan phlegm) and I took to and stayed in bed. I was tested by the cruise ship's medical staff for Covid-19 on 3/30/2013 and was positive. I was prescribed Paxlovid and a cough medicine. I got worse the next day, then plateaued-staying that ill for several days, and then gradually got better but I continued to test positive until 4/10/2023. Finally, I tested negative by 4/13/2023 but had a non-productive cough until 4/20/2023. I continue to fatigue easier than usual upon activity. Also throughout the course of Covid-19 until today I am more forgetful and less able to concentrate.
IMMEDIATELY DEVELOPED ELEVATED BLOOD PRESSURE, NAUSEA, HEADACHE. ON DAY 2, HAD FEVER OF 101.3, FATIGUE, WEAKNESS, SORE ARM, HEADACHE, NAUSEA, AND WAS UNABLE TO WORK.
feeling anxious and tight throat, benadryl 25mg given by mouth, monitored and dischared in stable condition advised to see PCP if necessary
EXAM: US THYROID, 06/11/2021 16:05 PM   CLINICAL INDICATIONS: severe soft tissue tenderness surrounding thyroid bilaterally M54.2:Anterior neck pain E04.9:Enlargement of thyroid   COMPARISON: No prior studies available for comparison.   TECHNIQUE: Real-time, grayscale ultrasound evaluation of the neck was performed in transverse and longitudinal orientations using a high-resolution linear array transducer. Color Doppler was utilized to assess vascular flow.   FINDINGS: Background thyroid parenchyma is heterogeneous with patchy ill-defined areas of decreased echogenicity. These regions are associated with mildly decreased internal vascularity relative to the background thyroid parenchyma. Background thyroid parenchyma demonstrates normal vascularity.. The right lobe measures 5.4 x 1.6 x 1.5 cm and the left lobe measures 5.0 x 1.5 x 1.4 cm. The isthmus is normal in appearance and within the upper limits of normal in size measuring 5 mm. No definite discrete thyroid nodules. Measured areas are favored to be related to heterogeneous parenchyma rather than lesions.   IMPRESSION IMPRESSION:  The thyroid gland is within upper limits of normal in size with areas of patchy decreased echogenicity. Findings can be seen with subacute thyroiditis, correlate clinically.   * Lesions are classified using the Thyroid Association guidelines of 2015.    Electronically Signed By: MD on 6/14/2021 9:32 AM   I personally viewed and interpreted these images and I have reviewed and approved this report.   Electronically Signed By: MD on 6/14/2021 9:33 AM
could not turn over, could not get out of bed; lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not turn over, could not get out of bed) and FATIGUE (lot of fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (could not turn over, could not get out of bed) and FATIGUE (lot of fatigue). At the time of the report, MOBILITY DECREASED (could not turn over, could not get out of bed) and FATIGUE (lot of fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided Patient reported her sister had to make sure if she didn't fell out of bed.   This case was linked to MOD-2022-441213, MOD-2022-441214 (Patient Link).
administered Monovalent vaccine after the recall of this vaccine on  04/18/2023. Pt did not report any symptoms
No additional AE.; A 20 years old patient receiving a pediatric dose of RECOMBIVAX HB; This spontaneous report has been received from a nurse, concerning a 20-year-old patient of unknown gender.  Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 11-JUL-2022, the patient was vaccinated with a pediatric dose of hepatitis b vaccine (recombinant) thimerosal free (RECOMBIVAX HB) at a dose of 0,5 milligram, intramuscularly, for prophylaxis (frequency and anatomical injection site were not provided) (lot number W012032 has been verify to be a valid lot number with expiration date on 19-NOV-2023) (inappropriate age at vaccine administration). No additional adverse event.
her husband might be having a stroke/ To her it almost looks like he had a mild stroke; his legs were weak; he was unable to speak clearly and was unable to open his mouth properly. She said he was just mumbling and muttering words, and could not speak clearly/he is not speaking clearly; Couldn't walk and was kind of falling over; falling over; unable to open his mouth properly; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 11May2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. Consumer said her husband received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine on 11May2021. Then on 20May2021, they noticed that his legs were giving out on him. She said he had to hold onto the furniture to walk, because his legs were weak. She also said he had to use a walker. And when he tried to speak to her, she said he was unable to speak clearly and was unable to open his mouth properly. She said he was just mumbling and muttering words, and could not speak clearly. Consumer thought her husband might be having a stroke. She wanted to know if these side effects have been reported before, and if they are associated with the vaccine. Consumer said her husband was scheduled to receive his 2nd dose on 01Jun2021, and was concerned whether he should still get it. Her HCP was in the best position to assist her husband with the appropriate actions to be taken and would be able to help him decide whether or not to still get the 2nd dose. The patient was due for his second on 12June2021 3 weeks later. On 20May2021, she noticed and he noticed that he couldn't walk and was kind of falling over. They happened to have a walker in the house, and he was using the walker. The other thing she was noticing was now that he came home, since he was not at home, he was not speaking clearly. To her it almost looks like he had a mild stroke. When he talked he was opening his mouth some and muttering. She was very concerned about this. She was looking at the side effects and it said there are others than what was listed. At first she thought maybe he had dizziness and weakness, but then it said there are others. She asked if his symptoms have been reported before. She was advising him not to get the second dose. From what she understands the side effects are worse after the second dose. He already has symptoms now 10 days after the first vaccine. She has never seen him acting like this before. The outcome of events was unknown.  Information on the lot/batch number has been requested.
2wk p/vax pt began to exp numbness in shoulders, elbows, hands, feet, knees & hips;was referred to rheumatologist who reports results consistent w/polyneuropathy, Charcot-Marie-Tooth disease;
STARTED HAVING A TIGHT FEELING IN MY CHEST, ARM GOT RED ITCHY RASHY . THE RASH THEN RAN ALL UP MY ARM TO MY CHEST COLLAR BONE  AND EAR. FELT A BIT OFF BALANCED SAT DOWN AND . THIS WAS APPROX. 3 -5 MIN AFTER SHOT. TOOK BENADRYL AND SYMPTOMS SUBSIDED. HAD TO BE MONITORED.
tumor in breast started hurting after shot; This is a spontaneous report from a contactable consumer (patient's neighbor). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history included tumor in breast. The patient's concomitant medications were not reported. The patient had a tumor in her breast that started hurting after her shot on an unspecified date. She had a mammogram to find out if it was cancer, and it was not cancer. It just affected the tumor in her breast. How long will it take for it to go away. She talked to her doctor, and he said her would go away. Outcome of the event was unknown.
C/o numbness/tingling in fingers - c/o itching neck & throat - Epipen administered transferred - in stable condition to ER.
Information has been received on 15-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider at a hospital administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2017, the patient was treated by a healthcare provider at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-409883 (Patient Link).
Patient complains of prolonged tenderness to the shoulder area especially when raising her hand above the shoulder level. The patient doesn't complain of any tightness of the shoulder itself however. I explained that it could possibly be bursitis caused by the vaccine but couldn't be sure without her seeing a doctor. I recommended ice multiple times a day and, if needed, over the counter antiinflammatories.  I also recommended she monitor it and if it gets worse or doesn't get better over the next month, to see contact us again and reach out to a doctor for evaluation.
Myocarditis and associated disrupted sleep (9 hours), heart fatigue and ache (2.5 days following)
Large localized reaction with swelling, induration and erythema at the site, no fevers, chills, SOB, pain, or respiratory distress.
Patient had her arm swell in area of injection. Also she noted that it was red, itched, and had a burning sensation. This continued for at least a week.
Patient first had a sore arm at the injection site for 2-3 days, she was massaging the area and after 4-5 days seems like the pain went down to her elbow area/muscle. There was never pain in the shoulder only injection site. There is no pain in the arm just the elbow area and she feels lightheaded.
Chest pain; Racing heart; Elevated blood pressure; This is a spontaneous report from a Pfizer sponsored program. This consumer (Co-worker) reported for reported for a male patient unknown age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on unspecified date, at unknown dose single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter had a co-worker (patient) ended up getting the vaccine and had the events chest pain, racing heart and elevated blood pressure on an unspecified date. Outcome of the events was unknown.  Information on Lot/Batch information has been requested.
bump at injection site; redness at injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (bump at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE SWELLING (bump at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at the injection site). At the time of the report, VACCINATION SITE SWELLING (bump at injection site), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PRURITUS (itching at the injection site) outcome was unknown. Not Provided          No concomitant drugs were reported. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074772:1st dose case
Fever (102 F) chills, headache, soreness at site of injection, redness at site of injection. All Sx resolved at 18 hours.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
First Vaccine given on 01/20/2021 at pharmacy. Moderna. Lot: 029K20A. Right Deltoid Intramuscular