chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VEIN INFLAMMATION IN NON VACCINATED ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced vein inflammation in non vaccinated arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vein inflammation in non vaccinated arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
anterior uveitis left and right eyes, treated with prednisolone acetate eye drops for ~5 months, symptoms resolved but began again after next COVID vaccine and continue
chills, fever, rigors, redness at site of reaction.  Fever for 48 hrs.  Redness longer lasting for days after injection
Information has been received from a radiology technician/vaccine coordinator referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. In October 2016 (reported as "between 06-OCT-2016 and 21-OCT-2016"), the unspecified numbers of patients were vaccinated with an improperly stored doses of ROTATEQ lot #M019708 exp. 25-OCT-2017, and M012495 exp. 09-OCT-2017 (dose and anatomical location were not reported), orally. No adverse effects were reported. Excursion details: Temperature/Time: -0.1 C for 8 hours and 15 minutes. No previous excursions. Data logger involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering.  Information about lot/batch number has been requested.
Right upper arm approximately 3cm x 3cm circular area surrounding injection site slightly erythematous, warm; no induration and no treatment.
rash that covered my entire body from scalp to the top of my feet/rash was small red spots; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm on 23Feb2021 15:30 (at the age of 24-year-old) as single for covid-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Concomitant medication included atorvastatin (MANUFACTURER UNKNOWN); estradiol (MANUFACTURER UNKNOWN); progesterone (MANUFACTURER UNKNOWN); colecalciferol (D3), all from unspecified date and unknown if ongoing. The patient previously received first dose of bnt162b2 on 02Feb2021 08:15 (lot number: EL3247) in the left arm for covid-19 immunisation. It was reported that five days following the vaccine, on 28Feb2021 at 08:00 patient developed a rash that covered her entire body from scalp to the top of her feet. The rash was small red spots. The event resulted in physician office visit. The patient was treated with unspecified steroids. The patient did not have covid prior to vaccination and was not tested for covid post vaccination. The patient had not recovered from rash that covered her entire body from scalp to the top of her feet /rash was small red spots at the time of the report.    No follow-up attempts are possible. No further information is expected.
4MAY93 4PM TC fro MD states mom brought pt in to office lt thigh red & swollen from knee to hip; unable to walk; t103 ax; recommends DT instead of DTP be given for further doses;
I am currently experiencing tingling and sharp pain in my upper and lower extremities. I went to my primary doctor who performed an MRI along with blood analysis. He referred me to a nerve specialist who scheduled a appointment run tests for another MRI of my lower extremities (nerve study) and spine for possible MS or auto-immune disease on 08/27/2021.
This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received Shingrix for prophylaxis. On 29th March 2018, the patient received the 1st dose of Shingrix. On 30th March 2018, 1 days after receiving Shingrix, the patient experienced general body pain, feeling abnormal and headache. On 31st March 2018, the outcome of the general body pain, feeling abnormal and headache were recovered/resolved. It was unknown if the reporter considered the general body pain, feeling abnormal and headache to be related to Shingrix. Additional details were provided as follows: The caller reported the case for her husband. The next day after vaccination at 12:00, the patient experienced body aches, headache and feeling out of sorts. The symptoms resolved after a day. For tolerance to next dose, refer case US2018GSK174512.
Unable to urinate after the injection with presentation next day to the Hospital ER on 12/19/2020. On evaluation, an in/out catheterization was required to empty the bladder with 1 liter output. She then was discharged home. She is a nurse and had to self catheterize once more prior to being able to urinate spontaneously. She is currently experiencing UTI symptoms of dysuria and urgency.
About 2 weeks after receiving first dose of pfizer vaccine, patient complains to headaches which lasted for a week and a strange leg pain lasted for 3 days.
doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The patient had received 2nd booster. No treatment medication was provided.
patient came to the pharmacy seeking TB test but technician misheard and entered in tdap. patient received tdap in error.
Intense itching sensation and pins/needles sensation throughout body, sensation will be in one spot (ie. lower calf for several minutes then stop and an hour later on head). Pt also experienced blisters on inner elbows. Pt stating itches so intensely, she will bleed from itching.
pt called in 10 days post-vaccination to report her right arm injection site is red, warm to touch and itching, pt denies edema or red streaks, denies fever, pt advised to contact PCP is site s/s worsen or if patient develops a fever or site worsens, aware verbalized understanding- jrw
Initial and follow-up information has been received from a licensed practical nurse concerning a 46 year old female officer manager with seasonal allergies who in 05-NOV-2007 was vaccinated with a first dose of PNEUMOVAX 23. On 01-OCT-2007 at 11:30 the patient was vaccinated subcutaneously into the left arm with a second dose of PNEUMOVAX 23 (Lot #657525/0554U). There was no concomitant medication. On 01-OCT-2007 the patient developed itching right immediately after vaccination with PNEUMOVAX 23. Subsequently the patient developed a large area localized reaction with redness, warmth, swelling, pain and fever. The pain went to the patient's underarm. Unspecified antibiotics was to be prescribed. There were no laboratory or diagnostic tests performed. On 08-OCT-2007 the patient recovered from localized reaction and fever. The patient was recovering from itching. Additional information is not expected.
36-48 hours post vax, the pt went to the doctor and presented with swelling of her left arm. It was markedly swollen from her elbow to her shoulder approximately twice the size of the right arm. The pt also had localized erythema and induration at the injection site. Treatment included topical hydrocortisone cream, diphenhydramine, and Amoxicillin. The most recent information received on 5/15/00 reported the symptoms resolved within 5 days. When she went to her doctor, she did not appear to be clinically ill and was afebrile. She was later hospitalized for viral-syndrome which reported as a non-event.
The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 9399001) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-366988, MOD-2021-367774 (Patient Link).
a couple days after the second shot his arm swelled up; After his whole upper torso swelled up; has no strength in his arm; pain in his muscl; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) in a 62-year-old male adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) , while the parent received the product for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the adult was diagnosed with PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up) (seriousness criterion hospitalization), SWELLING (After his whole upper torso swelled up) (seriousness criterion hospitalization), ASTHENIA (has no strength in his arm) (seriousness criterion hospitalization) and MYALGIA (pain in his muscl) (seriousness criterion hospitalization). The patient was hospitalized on sometime in 2021 due to ASTHENIA, MYALGIA, PERIPHERAL SWELLING and SWELLING. At the time of the report, PERIPHERAL SWELLING (a couple days after the second shot his arm swelled up), SWELLING (After his whole upper torso swelled up), ASTHENIA (has no strength in his arm) and MYALGIA (pain in his muscl) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had been in the hospital for a week due to symptoms. couple days after the second shot his arm swelled up and then after his whole upper torso swelled up. The patient had no strength in his arm and pain in his muscle. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site pain) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 30-Apr-2022, the patient experienced VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided. Treatment information was not provided.
I had some sort of reaction.  I was glad to get the shot and was not nervous about getting the shot. 5 minutes after the shot I felt something cold go down my left arm from my shoulder to my hand.  A minute or two after that both my hands went numb, then both my arms went numb.  I asked others around me if anyone felt anything and everyone else was fine.  A minute or two after that both my legs went numb. I started to black out but made it to a chair before this happened,  I drank some cold water and felt awake about 5 minutes later.  30 minutes after that i felt comfortable enough to walk.  For the rest of the day i felt like i was legally drunk and felt lots of pins and needles on the back of my hands and feet. I did not feel dizzy or nauseous at that time. i also felt a lot of pressure on the inside of my skin all over my body. I've never felt anything like that and it was a bit uncomfortable.  The next day i was too dizzy to walk without becoming very nauseous.  I still had pins and needles on my feet. i had chills as well which i guess is a good sign.  my appetite was fine. i felt clear-headed as well.  Two days after the shot i felt slightly dizzy and by the third day i felt fine except for minor muscle cramps all over my body.  For the three days after the shot i also had some pretty strong forearm and calf muscle cramps and my arms (biceps and triceps) felt pumped up like i just had a great arm workout, but they weren't swollen at all.
Currently ongoing, starting approx. 12 hours after second dose: Nausea, severe chills, severe arthralgia, severe myalgia, low fever (100.0 F). Currently ongoing, starting approx. 24 hours after second dose: What is listed above, fever (101.1 F), and diarrhea.  I can keep water down and some food. Ibuprofen helps mute the symptoms but does not mask them well enough for comfort. Losing sleep and drying to stay hydrated.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient had no further vaccination history. The patient's other concurrent condition, medical history and concomitant therapy were not reported. On an unknown date (reported as "prior to school"), the patient was vaccinated with (Wistar RA 27-3) M-M-R II (dose, strength, route, lot# and expiration date unknown) for vaccination for school. The patient also vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (dose, strength, route, lot# and expiration date unknown) for vaccination for school. On an unknown date, the patient had "medium titers" after receiving the vaccines. The outcome for "medium titer" was unknown. The reporter considered medium titers to be related with the suspect vaccines.
Prior to vaccination, Client was clinical evaluated and clinically cleared by medical consultant, to receive vaccine.  Vaccine administered and 2 minutes later client states "I don't feel well".  Paramedic assessed, monitored and client eventually cleared to go home.
Fever developed and peaked after 36 hours. Arthralgias presented on day 2 with peak fever of 104 by history. Rash developed on Day 3. Fever resolved by day four, rash persisted on day 4- morbiliform chest, back, sparing neck, face, extremities.
After receiving the shot in the left arm, I began feeling numbness/weakness in my left arm, left side of chest and entire left leg, the next day.   I can not distinguish warm or cold objects with my left hand, by feeling. My left leg is weaker and numb/tingling including my foot.  Day 2 was headaches and body aches and tired.
This is a spontaneous report from a contactable consumer (patient's wife). A 80-years-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on Apr2021 as dose 2, single (at the age of 80-years-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunisation and two days later came down with a rash that went back and forth on his arm and back, once the rash got worse, he went to the emergency room (ER) and they said it was shingles, patient had a lot of pain and gets tired easily and never did before, he goes outside to work in the yard and gets very tired. On Apr2021, patient received his second dose 10 weeks after his first dose. On Apr2021, patient gets tired really easily and his balance was not what it used to be. Patient stated that when he works hard with his right arm with a wheelbarrow it seems to flare up and in the 90 degree heat it did the same thing and asks what he can do to get rid of this. Patient stated he had been to 12 or 14 doctors and none of them knew crap. On Apr2021, from the base of his neck down to his right arm and thumb and forefinger and his arm was like a piece of leather. Patient asked if Pfizer could give information to his physician, when patient got the covid shot and got shingles that was still there but was not contagious after a week and had all this pain and had shots and medicine. Patient wife asked how long will this last. The outcome of all the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Right-sided facial and head pain that start on the  02/252021 patient  saw a provider on 03/02/2021.  patient reports shingles outbreak Per Pharmacist at the hospital.
Fever up to 100.4; Headache; Chills; Muscle pains; This is a spontaneous report from a contactable physician (patient). A 57-year-old male patient was received first dose BNT162B2 (reported "Active Drug substance names: COVID 19", lot number: EJ1685), via unspecified route of administration at left arm on 18Dec2020 05:15 PM at single dose for COVID-19 immunization. Medical history included hyperlipidaemia and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes), No known allergies. There are no other medications in two weeks and no other vaccine in four weeks. Patient experienced fever up to 100.4, headache, chills, muscle pains on 19Dec2020 12:00 PM (20Dec2020 00:00). the most recent COVID-19 vaccine was administered in Hospital. Since the vaccination, the patient has not been tested for COVID-19 (COVID was not tested post vaccination). Treatment for the event included paracetamol (TYLENOL). Patient was recovered from the events. It was reported as non-serious. No results in death, life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.  Pfizer is a marketing authorization holder of COVID 19 vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID 19 vaccine has submitted the same report to the regulatory authorities.
extreme fussiness & swelling rt thigh & t100.8 R; crying x 3 hrs; no neuro findings;
Initial information received on 11-October-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 71 years old patient who had bruising, hot to the touch and swelling, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 10-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ037AA and expiry date: 12-May-2019) via intramuscular route in the left arm. On an unknown date, following the vaccination the patient experienced bruising, sensation of warmth and swelling. (Other relevant tests included no lab data). Final diagnosis was swelling, hot to the touch and bruising. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.