chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my elbow started swelling and the crease of the arm around; my elbow started swelling and the crease of the arm around; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Lot number: ER8734, Expiration Date: Jul2021) at the age of 63 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 26Mar2021, outcome "unknown" and all described as "my elbow started swelling and the crease of the arm around". The event "my elbow started swelling and the crease of the arm around" and "my elbow started swelling and the crease of the arm around" was evaluated at the physician office visit. Therapeutic measures were taken as a result of joint swelling, peripheral swelling. Additional information: The patient treatment was reported as Benadryl and Tylenol. The patient wanted to know if she should get the second dose since she was scheduled on 16Apr2021.   No follow-up attempts are possible. No further information is expected.
Moderna COVID?19 Vaccine. fever, chills, muscle and bone aches, weakness, fatigue, headache, nausea, fuzzy headedness
no ADE's.  Pt wasn't old enough to have received moderna.  Should have received Pfizer booster.
Flu-like symptoms; Stiffness; Mental fogginess; Fatigue; Headache; Body ache; This is a spontaneous report from a contactable company representative, the patient. A 64-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via unspecified route of administration in the left arm on 17Mar2021 at 09:30 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included fibromyalgia. The patient had no allergies to medications, food, or other products. Concomitant medications included bupropion (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN); both were taken for unknown indications from unspecified date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunisation. Prior to 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 17Mar2021 at 20:00, the patient experienced flu-like symptoms, fatigue, stiffness, body ache, headache and mental fogginess. 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 events. The clinical outcome of the events flu-like symptoms, stiffness, mental fogginess, fatigue, body ache and headache were resolved on an unknown date of Mar2021.  No follow-up attempts are needed. No further information is expected.
COVID-19; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported,1 total administered, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (Dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on an unspecified date in JUL-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 30-NOV-2022, the patient experienced covid-19 (Dose number in series 2) and it was reported as "Got my last booster in July. Got Covid 21 days ago. Lasted 21 days and I finally feel good. Would have been dead without the vaccines" (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid-19 on 21-DEC-2022. This report was non-serious. This report was associated with a product quality complaint 90000264256.
Skin is hot to touch And mildly itchy. Skin is also tender to touch.; Skin is hot to touch And mildly itchy. Skin is also tender to touch.; Skin is hot to touch And mildly itchy. Skin is also tender to touch.; This is a spontaneous report from a contactable other healthcare professional, reporting for herself. A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6202) via an unspecified route of administration in Arm left on 25Feb2021 10:45AM (at the age of 21-year-old) at single dose for COVID-19 immunisation. The patient was not pregnant and was not pregnant at the time of vaccination. Relevant medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 before vaccination and was not tested for COVID-19 post vaccination. On 25Jan2021 08:00PM skin was hot to touch and mildly itchy. Skin was also tender to touch. The events were non-serious, were not treated and had an unknown outcome.  No follow-up attempts are possible. No further information is expected.
Fatigue; 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix and Shingrix (1st and 2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue and extra dose administered. On an unknown date, the outcome of the fatigue and extra dose administered were unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient got a 3rd dose of Shingrix by mistake, which led to extra dose administered. The patient only had fatigue the following day. No other information was provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020172522:Same reporter
The patient experienced gradually increasing erythema, pain and itching at the injection site. The area is 3.5cm x 5cm.
He developed chest pain relatively soon after receiving 2nd dose of COVID vaccine.  The pain was sternal, sharp, constant, worse with breathing, non-radiating.  No fever, palpitations, SOB, or syncope.  On exam he had tenderness to palpation over sternal area of chest. I diagnosed him with chest wall pain but given his recent COVID-19 vaccination I did an ECG, CXR, and checked a Troponin I.  His ECG and CXR were normal but his Troponin I came back elevated at 3.  He returned to my office a few days later for repeat ECG and Troponin I, both of which were normal (Troponin I repeat was 0).  Additionally, his symptoms had fully resolved.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 03-JAN-2017, the patient was inoculated with ZOSTAVAX (dose, route of administration, site of administration and lot # were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the ZOSTAVAX vaccine, the patient suffered from focal weakness with a left sided facial droop and right sided gaze. The patient was diagnosed with an acute right middle cerebral artery infarction. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX vaccine, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the use of the ZOSTAVAX vaccine, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review, Acute right middle cerebral artery infarction was determined to be a medically significant event. Acute right middle cerebral artery infarction was considered to be disabling. Additional information has been requested.
Child less than 18 years of age was administered flublok by mistake. they experienced no major reaction and left the facility in the care of their parents
A nurse reported the occurrence of an injections site lump in a female of unspecified age who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. On 1/10/03, the subject received her first injection of Enerix B. Later that day, she developed a "hard lump: at the injection site that measured "three inches across." The lump resolved after approximately two weeks.
PATIENT had no adverse reaction after vaccine . HEALTHCARE is reporting to DH that this patient told us at the firehouse that he had NO vaccine, prior to us giving him the Moderna. CONTINOUS of number 18 corrected action in the future the patient will be check with internet through the link with verification with State ID or Driver License.
08/07/14 1620 TC from father c/o arm muscle that vaccinations in swelled and hot to touch. Parent denied all other s/s. RN/Adm 08-08-14/15 30 TC to parent to check on pt and PCP appt. Father states "Dr was uncertain type of reaction so gave him antibiotic OTC BENADRYL and methylprednisolone." RN 8-11-14/0900 TC to father states "swelling is down, no more pain and patient c/o itchiness. PCP evaluation Wed. It is better." 's
Information has been received from a physician concerning a patient who was vaccinated with the first dose of Gardasil.  Subsequently the patient experienced allergic reaction.  Unknown medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L048236, expiry date 31-MAR-2018, lot # L040458, expiry date 04-FEB-2018, lot # L045117, expiry date 06-OCT-2018, lot # L027733, expiry date 13-SEP-2017, (dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 0.2 degrees Celsius for 48 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
coughing; wheezing; This is a spontaneous report from a non-contactable consumer, patient's friend.   A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the covax and was coughing and wheezing. It was suggested that she get tested to rule out if she had the virus but this could also a side effect. It was reported that the patient did not have on a mask. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
18 hours after injection, muscle aches, headache, chills, and sore skin. Symptoms lasted 12 hours.
Information has been received through the Merck pregnancy registry for GARDASIL from a physician (also reported as medical assistant) concerning an 18 year old female with no pertinent medical history and no history of drug reactions or allergies who on 11-JUN-2008 was vaccinated with GARDASIL (dose unspecified). Concomitant therapy included birth control pills (unspecified). Subsequently, the patient reported a positive home urine pregnancy test. The patient's last menstrual period was the last week in May 2008 (dates unspecified). However, the patient had menstrual spotting from 24-JUn-2008 to 25-JUN-2008. No other adverse symptoms or treatment reported. The reporter is the patient's gynecologist and the patient received the GARDASIL elsewhere. The estimated delivery date is 02-MAR-2009. The patient sought medical attention with a telephone call. Additional information has been requested.
Severe rash within 24 hours of injection. Rash continues as of this date. Patient seen by 4 doctors. Latest dermatologist said PREVNAR 13. Triamcinolone acetonide cream prescribed 10/7. Itching subsided. Rash continues to appear.
After the initial swelling and redness had gone away, on the 8th day after receiving the vaccine, the area where the shot was given became red and swollen and itchy.  Over the next three days the redness moved down my arm, covering an area of 6 inches and nearly all the way around my arm.  The arm was stiff and painful and hot to the touch.  On Monday,  1/25/21, I contacted my primary care doctor.
This spontaneous report as received from a registered nurse refers to a 21 year old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 03-FEB-2014 the "healthy" patient was vaccinated with second dose of VARIVAX (Merck) lot # J008229, Expiration Date 12-JUL-2015, 0.5 ml once, subcutaneously "in forearm". There was no concomitant medication. On 03-FEB-2014, the patient experienced local reaction. Nurse stated VARIVAX (Merck) dose showed "a little bubbling" and did not feel the dose was intradermal. Nurse stated for treatment that patient received ice and the arm was elevated. Nurse stated she watched patient for half hour at which time the injection site looked red from the ice so nurse stated "I put hydrocortisone on it and sent her home with ice." Nurse stated patient later was advised to use BENADRYL and ibuprofen for any discomfort. The outcome of the event was unknown.
Moderna COVID-19 vaccine EUA. Arm of injection sore and swollen. Lymph nodes under arm of injection site have swollen large and hard. It is extremely uncomfortable and painful. Fever of 102.4.
Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a 26-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Hospitalized 5/7/22-5/17/22 Fall, confusion, weakness, tachycardia, afib, rib fx, myocarditis,
Sore; patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; Swelling; patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Sore), FEELING ABNORMAL (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), SWELLING (Swelling) and NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) in a 5-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore), FEELING ABNORMAL (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), SWELLING (Swelling) and NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN (Sore), FEELING ABNORMAL (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), SWELLING (Swelling) and NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   This case was linked to MOD-2023-749212 (Patient Link).   Reporter did not allow further contact
Period was 3 days late; Causing cramps both front and lower back for at least 7 days / Period finally started and still cramping; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 12:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included high BP (blood pressure) and allergy to sulfa drugs. Concomitant medications included labetalol (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 13:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 16:30, the patient's period was 3 days late which was causing cramps, both front and lower back for at least seven days. Then the period finally started and was still cramping. The patient reported that none of which was normal for her. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events period was 3 days late which was causing cramps both front and lower back/ period finally started and still cramping was not resolved at the time of the report.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Rash & UrticariaPruritus telephone nurse visit. advised to ice site, take OTC apap PRN and OTC antihistamines  for itching.
Exactly one week of receiving the first dose of the Moderna vaccine, my arm swelled at the injection site to a 2-3 inch lump. The site was itchy, sore and warm to the touch. (When I had initially gotten my shot, the site swelled and was sore, but those symptoms went away.) I took Benadryl and applied an ice pack to mitigate the symptoms.
Information has been received from a physician concerning a female patient who was vaccinated with a dose of MMR II. It was reported that the patient stated she has a history of febrile seizure after receiving childhood vaccines. The physician was not sure which vaccines but believes "MMR was one of the vaccines." Subsequently, the patient recovered. No product quality complaint was involved. Upon internal review, febrile seizures was considered to be an other important medical event. Additional information is not expected.
Patient was seen at Facility 10 minutes after his Pfizer  immunization.  He had wooziness, and hyperventilation with a breathing rate of  40.  He was transferred by wheelchair to a stretcher.  Initial Vitals:  BP  128/68, O2 sat 96% on 2 liters O2, pulse 68; veteran was diaphoretic, with clear  lungs.  He did not recall he had an immunization, and was uncertain of his own  age.  He did report he was on metformin for DMII.  911 was called. He was  transported to Hospital ER by EMTs.
Patient developed Pityriasis Rubra Pilaris after second dose of COVID-19 vaccine.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working on a compliance improvement plan and has been reinstated vaccination privileges.
Patient's arm swelled at the site of the injection. Patient called on call provider at 5:30 PM and sent him a photo. Patient's arm was swelling above the Band-Aid and down his arm. No ecchymosis or erythema noted on his arm.
> Day one 9 /3 - sore arm at injection site approximately 6 hours after injection > Day one 9/3 - watery diarrhea, two bouts, approximately 10 hours after injection > Day two 9/4 - general fatigue and body aches, no arm pain or diarrhea  > Day three 9/5 - light rash on chest, some fatigue and body aches, no arm pain or diarrhea
Right after the vaccination I was told to sit down for 15minutes and almost immediately I had a metallic taste in my mouth and then I started having a headache. I the pharmacists and they asked me stay longer and drank some water. I felt headache lasted 20mins and metallic taste in my mouth lasted less than an hour. It did not last very long.
This report was identified from a line listing obtained on request by the company from the FDA under the Freedom of Information Act. A patient experienced an extremely bad reaction to a second shot of VARIVAX vaccine (Merck). This was originally reported by a physician. No further information is available.