chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels like there is something in it; Arm getting sore; 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 FEELING ABNORMAL (Feels like there is something in it) and PAIN IN EXTREMITY (Arm getting sore) 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 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 FEELING ABNORMAL (Feels like there is something in it) and PAIN IN EXTREMITY (Arm getting sore). At the time of the report, FEELING ABNORMAL (Feels like there is something in it) and PAIN IN EXTREMITY (Arm getting sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
weakness, bradycardia and hypotension, short of breath and a cough EKG demonstrates A. fib ,  given ceftriaxone and azithromycin.
Body aches; headache; fatigue; anxiety; confusion; restless legs; arm pain; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and did not receive any concomitant medications. The patient did not have any allergies to food, medicine and other products. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 10:15 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 06:00, the patient experienced body aches, headache, fatigue, anxiety, confusion, restless legs and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events body aches, headache, fatigue, anxiety, confusion, restless legs and arm pain was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a bachelor of science in nursing (nurse) refers to a 79-year-old female patient. The patient had drug reactions/allergies to penicillin and hydrochlorothiazide (manufacturer unknown). On 27-SEP-2012 the patient was vaccinated with, 0.5 millilitre (ml) PNEUMOVAX 23 (lot # reported as H13581 in validation process, expiration date 15-MAR-2014) (reported as 10 vials of 1) intramuscularly in her left arm. Concomitant medications included FLUOXETINE, ATENOLOL, LIPITOR, PROTONIX, SYNTHROID, MECLIZINE and TRANXENE. Nurse reported that the patient had severe local reactions. The patient came back to the office on 28-SEP-2012 (reported as next day) with erythema, mild swelling towards her bicep and warmth around injection site. Physician recommended TYLENOL and BENADRYL for symptomatic relief. No lab studies were performed. The outcome of the events were unknown at the time of this report. The patient sought medical attention at office visit. This is one of the several reports from the same source. Additional information has been requested.
Patient developed Bells Palsy. Left-sided facial palsy. Patient was in emergency room.  Possible reaction to Moderna Vaccine. 2. Patient states that after his Moderna vaccine 2/11/21 and 3/11/21 the left side of his face began to droop., better now but experiencing left eye tearing. He did see MD but due to insurance could not continue. He was prescribed doxycycline, it was thought it was an infection from his rosacea. He now has an appointment for his left eye.   19-year-old with history of hypothyroidism, obesity and rosacea who is here with his grandfather to get my opinion of Bell's palsy was related to COVID-19 vaccine.  Patient received moderna COVID-19 vaccine, 1st dose was February 11, 2021 and 2nd does was on March 11, 2021. On Mach 17, 2021 patient was seen at the Emergency Room for left-sided facial droop. Patient was diagnosed with Bell's palsy and was given prednisone and Valtrex. Most of the weakness a on left side of face has resolved, however he still complains of some puffiness on left side of face and watering of left eye.
Tingling of the arms / Intermittent tingling in the leg opposite of the left arm; Vomiting; Cold/shivers; Cold/shivers; This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5C29J, expiry date 25th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose was received on an unknown date, refer linked case US2020AMR255397).   On 22nd December 2020 16:15, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced tingling of extremity, vomiting, cold and shivers. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tingling of extremity, vomiting, cold and shivers were not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity, vomiting, cold and shivers to be related to Shingrix.  Additional details were provided as follows: The second dose of vaccine was administered day before the reporting date at 4:15pm at the pharmacy; which was given intramuscularly in the left deltoid. The patient had experienced tingling of the arms, vomiting, and intermittent tingling in the leg opposite of the left arm (where the injection was given) from the 2nd dose of the Shingrix vaccine.  The patient had also experienced colds/shivers. The reporter also stated that the patient did not experience swelling, shortness of breath, paralysis, or anything like that. The reporter consented to follow-up and provided contact information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR255397:Same reporter, same suspect, same patient, diferent dose (1st dose)
(L) arm red, edematous, body aches, low grade fever, nausea. To MD 10-25-10 tx with KEFLEX.
Arm pain right away.  May 22 sore throat. May 23 arm pain, lesser though, sore throat, fever,body aches, nausea, cough, congestion, extreme fatigue.
This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself that, A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that the patient had her second shot last Wednesday (03Mar), on 06Mar2021 (reported as today), she started feeling achy, her joints were aching, and she felt very tired. She wanted to know how long this will last. The outcome of events was unknown. There were not any unaddressed medical questions referred or forwarded to Medical Information. No Follow-up attempts are possible; information about batch/lot number cannot been obtained.
redness, sore - from the site area up to the lower arm, swelling and palpated some lumps on injection site. started - 1/24 - 2/1/2021
"positive" covid-19 after first covid 19 vaccine; "positive" covid-19 after first covid 19 vaccine; kidney function levels going down "blood work"; This is a spontaneous report from a contactable healthcare professional and a consumer. A 73-year-old male patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included psoriatic arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) from 29Oct2020 and ongoing for psoriatic arthritis. The patient reported new symptom of kidney function levels going down "blood work" so he was seeing a specialist. Specific results of tests not available. The patient reported he had recent "positive" covid-19 after first covid-19 vaccine with symptoms, lasted a few weeks. The patient recovered from "positive" covid-19 after first covid 19 vaccine on an unspecified date while outcome of other event was unknown.  Information on the lot/batch number has been requested.
Sudden drowsiness, fatigue and headache. Extreme thirst and dry mouth for more than 24 hours.
Within 24 hrs. of flu vaccination experienced more discomfort than usual. Over the course of winter discomfort gradually became pain, increasing over time, throbbing pain from shoulder to knuckles. Interruption of sleep, difficulty dressing, sensitive to cold. Applied heat for relief. Mentioned problem at every 3 mth. doctor visit. Sought advice from family surgeon who referred to orthopedic who diagnosed as adhesive capsulitis. Went under anesthesia 11-1-11 for shoulder manipulation. Therapy 3x daily for 2 months.
Redness; Swelling; Soreness; itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (itchy) and PAIN (Soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (itchy) and PAIN (Soreness). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), PRURITUS (itchy) and PAIN (Soreness) outcome was unknown.            Treatment information was not reported.
OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; DOUBLE STROKE; CANCER DIAGNOSIS; This solicited report received from a consumer via social media PPSCVM000196 Account concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received first and second dose of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, batch number, expiry was not reported) dose was not reported, administered on unspecified date for a covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first and second dose of covid-19 vaccine (unspecified manufacturer) (dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin, batch number, expiry date were not reported) dose was not reported, 1 total administered on unspecified date for a covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received fourth dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (unspecified manufacturer) (suspension for injection, route of admin, batch number, expiry date were not reported) dose was not reported, 1 total administered on unspecified date for covid-19 prophylaxis which was off label dosing frequency and revaccination with different covid-19 vaccine (dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in JUL-2023, the patient experienced double stroke, cancer diagnosis (dose number in series 3). The patient visited emergency room (ER).  The reporter stated that "Visited a friend who was rushed to ER last month double strokes and a cancer diagnosis (4x jabbed) ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the double stroke, cancer diagnosis, off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and double stroke, cancer diagnosis, off label dosing frequency, and revaccination with different covid-19 vaccine was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20230838087-Double stroke, Cancer diagnosis. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.
Loose stools (diarrhea), joint pain, throwing up, tiredness, weak, pain at site. Lasted 2 days.
Patient came to the clinic Saturday 9-14-13 with a left swollen arm, mother states he also had fever Wednesday night, Thursday and Friday. He had no fever Saturday when he arrived.
The patient experienced headaches for a month and a half after receiving her one dose Janssen vaccine. The headaches were more than 50% of days for a month and a half (estimated 70% of days) and moderate in severity.  This caused the patient to have two doctors visits during the month and a half experiencing the headaches. Prior to her Janssen COVID-19 vaccination, patient had had fewer than 10 headaches in her lifetime. These dispersed throughout her life and the frequency was not clumped. The patient also had a fever on day 5 after being vaccinated, which caused her to have to stay home from work. Common side effects for her age group also experienced on days 0-1: extreme fatigue and fever.
S/S started approx 16 hours after injection. It started with fatigue and headaches, by 1400 that same day I began to feel chills and the sensation of pressure on my chest grew. I'm currently writing this 48 hours after injection and still experiencing tiredness, muscle pain and slight chills.
Information has been received from a 68 year old female patient with "incurable lung disease", blockage in carotid artery and penicillin allergy who "a couple of years ago" was vaccinated subcutaneously with a 0.65 mL dose of ZOSTAVAX (Merck) (LOT# not reported). "Eight days ago", on approximately 26-AUG-2010 the patient experienced a very bad headache, sores in hairline and ear, and was diagnosed with shingles on 01-SEP-2010 by her dermatologist. The patient was in the emergency room all day Saturday (on 28-AUG-2010) for the pain in her head and was prescribed morphine (manufacturer unspecified) intravenously to stop the pain. On Sunday (29-AUG-2010), the pain came back. The patient also found out "2 days ago", on approximately 31-AUG-2010 the patient had had several mini strokes. MRI with and without contrast, ultrasound of Carotid Artery, MRA, EEG, blood tests were performed and results were not reported. At this time of reporting, the patient was not recovered. Follow-up information has been received via a Herpes Zoster Questionnaire which reported that the patient experienced herpes zoster on 01-SEP-2010 with vesicles erupting on the chin, left ear, and scalp. No direct fluorescent antibody was done. No specimen was collected for PCR. No photos were taken. On an unspecified date, the patient recovered from herpes zoster. No further information is available.
10 minutes post vaccine, pt became pale w c/o nausea and weakness. Vomited once and felt better. Does have a hx of OCD, tremors, and MVP. C/O bilateral lower arm numbness. EMS arrived and after EKG status improved and pt decided not to transport to the ED.  25 minutes total time to recover
NAUSEA; POUNDING HEADACHE; BODY ACHES; SLIGHT FEVER
Systemic: Unusual heavy nose bleeding -Medium, Additional Details: Patient wife called pharmacy 5/6/21, reporting heavy nose bleeding starting 5/5 and continuing until today. RPh on duty instructed to have pt seek medical attention
This spontaneous report was received from a physician and refers to a 12 month old patient (gender was not reported). The patient's pertinent medical history or drug allergies/drug reactions were not reported. On 23-OCT-2015, the patient was vaccinated with the first dose of M-M-R II (lot number, expiration date, dose and route of administration were not reported) and with the first dose of PROQUAD (Merck) (lot number, expiration date, dose and route of administration were not reported) (overdose). There was no concomitant medication reported and no adverse effect were reported. Additional information has been requested.
Pt developed swollen lymph nodes in neck and bilateral axilla, fever, body aches, and fever with Tmax 100.4.  Also states she had visual hallucinations, "wild" dreams, and seemed "incoherent" when talking with her husband. All symptoms have resolved but still has swollen lymph nodes in neck that wax and wane. Also c/o right side ear pain and right side sore throat x 2 days. Right side ear pain started on 1/24/21, 5 days after vaccine.
Rt arm swelled, became hot & red. Sat. night arm hurt, Sun. developed full blown arm reaction. Tx w/ Cipro for 10 days.
Shingles. My doctor said he has had a number of patients getting Shingles 2-4 days after getting shot. Some first shot some second shot.
The vaccine created an inflammatory response in my right knee and hip where I have a previous injury.  My injuries were not bothering me until the 3rd dose of the vaccine.  Since then, I have experienced pain and swelling in both. The pain is constant now.   I had an MRI of the knee and hip, which showed multiple problems in the knee.  The orthopedic surgeon gave me two cortisone shots in my knee and one in my hip.  The hip pain is under control now, but the knee pain is the same.  I am having arthroscopic surgery on my right knee on May the 10th.
has a lot of red welts and hives; itching like crazy; This is a spontaneous report from a contactable consumer (patient) reporting for herself.  A 74-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection) via unknown route of administration at left arm on 10Mar2021 (lot number: EN6205) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine first dose of bnt162b2 (COMIRNATY, Solution for injection) via unknown route of administration at left arm on 17Feb2021 (lot number: 2L9267) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that, the patient experienced itching like crazy on Mar2021 and has a lot of red welts and hives began late in the afternoon on 11Mar2021 and was worse. Clinical course of events include; she had the 2nd shot on Tuesday and then clarifies later in the call the 2nd dose was administered on 10Mar2021. stated that she thinks she has had a pretty good reaction to it and she did not really start feeling any symptoms until maybe very late in the day on either Tuesday or early Wednesday and the symptoms are that she is itching like crazy and has a lot of red welts and hives.  stated that the itching began either very late on 10Mar2021 or in the early hours of 11Mar2021 and states god yes the itching is ongoing and is much worse than when it began.states the red welts and hives began late in the afternoon on 11Mar2021 and are ongoing and worse. The adverse events did not resulted in emergency room and physician office. The patient was not hospitalized. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
I started on the eleventh of October 2022 being sick on October the fourteenth 2022 a COVID-19 showed a positive result I still feel pretty crappy and my wind or stamina are still very low especially my breathing as I cannot do much at all without taking a deep breath.
Arm became sore to the touch at site of injection and in the muscle at my shoulder/bicep muscle at the site of injection; Arm became sore to the touch at site of injection and in the muscle at my shoulder/bicep muscle at the site of injection; had pain if the site was barely touched and also in lifting my arm; This is a spontaneous report from a contactable consumer (patient).  This 36-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3248), via an unspecified route of administration in the right arm, on 28Jan2021 at 07:30 (at the age of 36-year-old) at single dose for COVID-19 immunisation, administered at . Relevant medical history included allergy to NSAIDS. Relevant concomitant medications bupropion hydrochloride (WELLBUTRIN), cetirizine hydrochloride (ZYRTEC) and probiotics. No other vaccine was received in four weeks. On 28Jan2021 (at 10:00), her arm became sore to the touch at site of injection and in the muscle at her shoulder/bicep muscle at the site of injection and just below on her bicep. During the evening and overnight she had pain if the site was barely touched and also in lifting her arm during housework. Today, (day after vaccine), the injection site was still sore to the touch but she have more mobility in her shoulder/bicep. Nothing unbearable and she still look forward to the second dose. The patient was not treated for the events.  Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.
This spontaneous report was received from an office manager referring to a 2-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 24-JAN-2019, the patient was vaccinated with a dose of VARIVAX (lot # R020652 and expiration date 18-JUL-2020), subcutaneously for prophylaxis. The administered dose experienced a temperature excursion of -2.3 degree Celsius for 1 hour. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1901USA010637: US-009507513-1901USA010788: US-009507513-1901USA010789.