chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning an 18 yea rold male with a serious mitochondrial genetic disorder and underlying condition of complete muscle spasms who on 07/05/2001 at 3pm was vaccinated with one dose of varicella vaccine. The pt did not experience any local injection site problems. On approx. 07/05/2001, the pt developed amplified complete muscle spasms. It was reported that "the family and the nurse are not sure if the vaccine is the cause, but nurse reported that there are some medications that have amplified his muscle spasms inthe past." The pt reportedly goes through cycles of muscle spasms, but these have been worse since receiving the vaccine. The pt sought unspecified medical attention. Additional info has been requested.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 80, 24, 168, 336, 1172 and 416. The lowest recorded temperatures were of 30 and -3. The highest recorded temperatures were 48, 49, 59 and 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)".No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Felt lightheaded, b/p 110/70. Reclined in bed for 10 min. b/p 118/75. Stated now felt better.
Situation/Background: The patient is an 85 year old foreign language speaking female who at 1000 today had a syncopal episode.  This was witnessed by her son who caught the patient, no trauma and the patient took 60 seconds to return to normal.  The patient has dialysis M-W-F, missed her run today and last received dialysis Friday 9/24/2021.  The patient has a medical history that includes Diabetes Mellitus Type II, ESRD, CAD, Aortic Stenosis with valve, HTN, poor vision and CVA.
Rash: continuous, oval shape, approx 6" along arm axis, 3" across, containing but centered slightly above the injection site. Rash is slightly itchy with mild inflammation. Most of the rash is not sensitive to the touch, except for a small patch very close to the injection site. The symptoms do not currently seem to require active management; I am functioning just fine without treating the symptoms.
8/9/06 child received Tdap L deltoid. On 8/10/06 had flu like symptoms, aching all over, fever (low grade, mom did not take). L deltoid region swollen about size of tennis ball. Tylenol, compresses and Benadryl given. Today 8/14/06 swelling and redness now under left arm, very tender.
Patient is a 38 years old male who presents to the clinic for cough on 11/09/2021. Today he has been coughing up bloody mucous, has body aches, chills, and sore throat. No fever.  Symptoms started on 11/3/21, patient states he got flu injection in left arm on 11/1/21 and is wondering if the symptoms are from the vaccine. He also had vomiting, which lasted for 4 days but now resolved. Patient rates pain 8/10 on left side of body. He feels exhausted and malaise.  Diagnoses and all orders for this visit:   Community acquired pneumonia, unspecified laterality Body aches after vaccination Vaccine reaction, initial encounter New problem, which required further workup.  Two days after patient influenza vaccine, patient started feeling unwell.  His symptoms have included left-sided body aches, vomiting, coughing blood in sputum, malaise, chills.  No fever.  Rapid COVID and influenza testing done in office, which were both negative.  Patient was sent to have chest x-ray to further evaluate for pneumonia.  There were infiltrates noted on the chest x-ray, consistent with pneumonia.  Prescription given for treating community-acquired pneumonia.  Advised patient if any worsening to go to ER or contact office.  Due to timing of this illness in relation to his influenza vaccine, will investigate reporting protocols for this. -     cefpodoxime 200 mg tablet; Take 1 tablet (200 mg total) by mouth 2 (two) times daily for 5 days -     azithromycin (ZITHROMAX Z-PAK) 250 mg tablet; Take 2 tablets orally on day 1, then take 1 tablet daily for 4 days.
shaking chills, fever, temp 103.3, body aches in shoulders, neck, head and backs of legs, pain in arm where shot was administered, elevated redness in arm the size of a baseball. Dr. suggested ice pack on arm and take antihistamine orally.
A few minutes after receiving the vaccination, I became extremely dizzy and sweaty, had blurred vision, and came extremely close to passing out (the only reason I did not pass out is because I laid down and focused very carefully on my breathing, having had practice doing this after blood tests I've received in the past and had syncope from). However, in the past when I have passed out or come close to it, I have never felt the way I did this time. This time, I felt extremely ill and had a very difficult time breathing. Throughout the next week after the vaccine I was extraordinarily weak and felt constantly ill, barely able to get myself out of bed. I also had pain and swelling at the injection site. My vision has been blurred since then, I have had a hard time seeing clearly beyond about 10-15 feet ahead of me.
10/03/2019  He developed severe chills & fever. with flu-like symptoms, a non-productive cough With pain on deep inspiration,  We were on vacation; with a normal temp the next am, he wanted to keep going; but he continued to have a low grade fever & flu-like SX.  Finally on 10/21/2019 he saw a nurse practitioner who diagnosed him with walking pneumonia.  His chest x-ray & CBC were unremarkable.  On 10/23 he was admitted to the hospital for 6 days; his DX was RLL pneumonia & 3 pulmonary emboli.  His recovery has been very slow, & he continues to have a temp of 99 to 100.4 every evening.  He has not been afebrile for 24 hrs since 10/02/2019.
tested positive for COVID she is asymptomatic.; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) and DRUG INEFFECTIVE (Lack of drug effect) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) and DRUG INEFFECTIVE (Lack of drug effect). On 17-Feb-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID she is asymptomatic.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-1 test: positive (Positive) Positive.         Treatment and concomitant medications were not provided by reporter.  This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  Asymptomatic COVID-19 is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2021: Upon internal review on 06-Aug-2021, event of Lack of drug effect was added. Lab data and dose 1 information were also updated.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  Asymptomatic COVID-19 is assessed as not applicable.
Mom came in for an acute visit and brought in a hard copy of the patients immunization to be filled out with the previous vaccines that the patient received on 06/07/2023. As MA was looking over the immunization card, she noticed some previous vaccines that were not added to System. Those vaccines were given by facility on 11/01/2022. The hard copy was scanned in by our clinic to patient docs on 05/01/2023 prior or receiving 06/07/2023 vaccines. With putting in the missing vaccines it showed the patient was given double the vaccines on 06/07/2023 by MA. The vaccines are DTap, Hib, PCV and IPV. Provider spoke with mom and let her know what happened and any affects. Notes were added to the visit as well. Mom seemed to take the information as well.
Patient is 60 years old and was given the high dose influenza vaccine which is indicated for patients 65 and older. Patient did not experience any adverse reactions or events.
hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 034F21A, 040B21A and 007B21A) for COVID-19 vaccination.     The patient had no known allergies. The patient neither had COVID positive test nor diagnosis.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, at an unspecified dose and frequency; PREDNISONE for Hives, at an unspecified dose and frequency and HYDROXYZINE (ATARAX [HYDROXYZINE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) had not resolved.            Concomitant medications of the patient were unknown.  The patient had adverse reaction with the 2nd booster shot, as he had an allergic reaction where he had hives, a week after the 2nd booster dose. The patient stated that he started developing hives and it had been going on for 4 weeks now.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2022: Upon live follow-up reporter details (occupation, address and email address), patient details (DOB, gender, age and height), suspect drug dosing details and treatment medications were added. Reporter details (first name), patient details (initial (patient identifier)), details of concomitant medications, details of medical history and event details were updated. Event description was also updated.
Initial case received via search of scientific literature on 20 March 2012. The reporter for this case is the same as case numbers: 2012-03168, 2012-03170, 2012-03171, and 2012-03172. A 71-year-old male patient received an injection of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number unknown, route, site and date not reported) on a day reported as "between November 2010 and October 2012". The patient did not have any "clinical or laboratory evidence suggestive of any other precipitating conditions except the history of recent H1N1-influenza vaccination." One week after vaccination, the patient developed "perianal numbness, paresthesias in tongue, bilateral upper and lower extremities and oropharynx, and ataxia." The patient had "rapidly progressive ascending quadriparesis" with "reduced sensation of touch, pin-prick, temperature, and joint position in bilateral upper and lower extremities (worse distally)" after admission to hospital. "Motor strength rapidly worsened to very minimal movements of all four extremities over 12 hours (h) after admission; deep tendon reflexes (DTRs) diminished to 1+ throughout, worsened to areflexia. Bladder and bowel control, normal at admission, progressed to complete bowel incontinence and urinary retention." Laboratory test of cerebral spinal fluid (CSF) revealed abnormal results of Protein 82 mg/dl. Electrodiagnostic testing on Day 12 was normal, but on day 17: was "suggestive of Acute Inflammatory Demyelinating Polyradiculopathy (AIDP), (Absent F waves, A waves in all four limbs, absent sural and peroneal responses)." The patient had been diagnosed with Guillain-Barre syndrome and "acute motor sensory axonal neuropathy (AMSAN) and dysautonomia." The patient was hospitalized and treatment included intravenous Immunoglobulin "(IVIG) (0.4g/kg/day x 5days)." The patient experienced "improvement in motor strength, but unchanged sensory loss after first course of IVIG. A relapse two weeks later manifested as right facial palsy in addition to increasing limb weakness." During relapse on day 50, the patient developed "severe axonal sensorimotor polyneuropathy" and was treated with a repeated course of "IVIG (0.4g/kg/day x 5days)" after relapse. The patient showed significant improvement motor strength of arms, but still had sensory loss, with bowel incontinence and leg weakness improving very slowly. At eight months, he still had bowel incontinence and was not ambulatory. The patient's outcome was not recovered. Authors also indicated that even this patient had finding consistent with AMSAN, an atypical form of GBS, including perianal and oropharyngeal paresthesias, and bowel incontinence and urinary retention, this patient met level 1 diagnostic certainty criteria outlined by Brighton Collaboration Working group because of quadriparesis. Documents held by sender: None.
Moderna COVID 19 Vaccine EUA.  Vaccine administered to 16 year old, when only labeled for 18+
body weakness; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (body weakness) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (body weakness) and NAUSEA (nausea). At the time of the report, ASTHENIA (body weakness) and NAUSEA (nausea) outcome was unknown.            No information about the concomitants was provided.  No information about treatment medication was provided.
A report has been received from a Health Professional concerning a patient, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. Accidental administration of expired FLUMIST Quadrivalent to a patient was reported. The outcome of the event of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious.
Pt developed redness and swelling to right upper arm 24 hrs post receiving inj warm to touch. C/O slight pain and itching sensation. Advised to ice and give Motrin for pain.
Weakness, upon waking in the morning, weakness throughout the body and legs feeling like jelly. No energy. Lasts an hour or two, Fine again during the day till next morning.  Sometimes feeling weak again  in the evening.  Some days better than others.
Low grade fever 99 degrees F, worst stomach cramps, nausea and vomiting, headache, shoulders and neck ache, dizzy, started at about 7pm (vaccine admin 5:30PM).
States after flu injection 9/29/08, pt became feverish, aching all over, nauseated for a few days, also states he developed a huge cold sore on his nose.
Patient is unable to move her right arm without considerable pain.  She states that at onset  she was unable to move the arm at all.  By friday approximately 36 hours post vaccination she has gained a few inches of mobility, but still has considerable pain from the vaccine and from movement.  She is able to bend at the elbow and move her wrist and fingers.
Breakthrough case admission after 3 vaccines Moderna 3/17/21 Lot# 030A21A;  Moderna 4/14/21 Lot# 043B21A;  Moderna 1/5/22 lot# 966H21A
MORNING AFTER VACCINATION, DEVELOPED VOMITING, DIARRHEA, HEADACHE, LOWER BACK PAIN, LEG PAIN, AND RASPY VOICE. WENT TO ER ON 1/21/21
This spontaneous report as received from a physician refers to a 23 years old female patient with allergic to shellfish and contrast used for MRI. The patient was vaccinated with dose 1 GARDASIL (lot # reported as 0475AE) in left arm on 04-SEP-2012 (dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The patient experienced a high fever, sweats and nausea for 3 days. The patient sought unspecified medical attention. The patient did not receive any treatment. At the time of report, the outcome was unknown. Additional information has been requested.
No tx as of today.  Sitting in office. Following up with PCP.  Symptoms itching, redness and swelling in hands knuckles and in between fingers, progressed to feet.
inability to raise arm past 60 degrees of elevation without significant pain. extreme tenderness to palpation around the glenohumeral joint, acromion process. tingling into the fingers of the ipsilateral hand with >2 minutes passive elevation range of motion work. pain and weakness in shoulder external rotation, elbow flexion, shoulder extension. swelling at glenohumeral joint. recalcitrant pain unaffected by Ibuprofen and ice.
No adverse effects reported; Patient received an improperly stored dose ofROTATEQ; This spontaneous report was received from the vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-OCT-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R026391, expiration date 09-JUL-2020, orally, for prophylaxis.      Temperature: (32.9F) Time frame: 3 hours 40 minutes Previous temperature excursion? NO Was call because of a "data logger"? YES  No adverse effects reported.
knot as big as her baby fingernail in the back of her head on the bone; Arm is swollen; Slight temperature; This spontaneous case was reported by a patient and describes the occurrence of SKIN INDURATION (knot as big as her baby fingernail in the back of her head on the bone), PERIPHERAL SWELLING (Arm is swollen) and BODY TEMPERATURE INCREASED (Slight temperature) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN INDURATION (knot as big as her baby fingernail in the back of her head on the bone), PERIPHERAL SWELLING (Arm is swollen) and BODY TEMPERATURE INCREASED (Slight temperature).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Fever to 102.3F and a seizure (generalized), lasting approx. 25 minutes with hypoxia (brief).
extremely strong menstrual cramping and bleeding; extremely strong menstrual cramping and bleeding; Throbbing pains in the side of head; Extremely cloudy in the head; Attention span is limited; Migraines longer than 4 days; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 06Apr2021 at 08:15 AM, at 21 years of age, (Batch/Lot Number: EW0150) as single dose for COVID-19 immunization. The patient had no relevant medical history. She was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was not pregnant. Concomitant medication included etonogestrel (NEXPLANON) 68 mg taken for an unspecified indication since an unknown date. On 07Apr2021 at 14:30 the patient experienced extremely strong menstrual cramping and bleeding, throbbing pains in the side of head, extremely cloudy in the head, attention span was limited and migraines longer than 4 days. The patient didn't receive any treatment. At the time of the report the reported events had not resolved yet.
Within five minutes of Typhoid and Anthrax No. one shot, I lost feeling returned in 12 hours. Some numbness lasted approximately 36 hours. Shots and numbness where both in left arm/ hand.
This spontaneous report as received from another health professional refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. It was reported that on 03-SEP-2013, GARDASIL went out of range as it was exposed to 31.2 F for 6 hours. On 17-SEP-2013, the patient was administered with this improperly stored GARDASIL (route of administration unknown) for an unknown indication. Lot number was reported as H021861 with an expiration date of 09-OCT-2015. No adverse effects were reported. No further information was provided. This is one of 16 reports from the same reporter. Additional information has been requested.
sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 11:00 (Lot number: EN6208) at the age of 62 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications patient received within 2 weeks of vaccination. No Prior to vaccination, the patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No Allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.