chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary imaging procedure abnormal; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY IMAGING PROCEDURE ABNORMAL (Pulmonary imaging procedure abnormal) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 039A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Smoker (11 years ago).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY IMAGING PROCEDURE ABNORMAL (Pulmonary imaging procedure abnormal). At the time of the report, PULMONARY IMAGING PROCEDURE ABNORMAL (Pulmonary imaging procedure abnormal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Computerised tomogram: abnormal (abnormal) Results were not concerning but were kind of abnormality.         No concomitant medications were reported. No treatment information was reported.  Patient stated that the nurse informed lung CT was not concerning then but it has kind of abnormality.
Lost sense of taste of smell; Lost sense of taste of smell; This is a spontaneous report from contactable male consumer reported for himself received from a Pfizer-sponsored program.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced lost sense of taste of smell. Outcome of the events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
ITCHING; GOLF BALL SIZE SWELLING AT INJECTION SITE ABOUT 6 HOURS AFTER THE VACCINATION; PAIN; ABOUT 3 HOURS  AFTER THE VACCINATION LOW GRADE FEVER  AND TEMPERATURE; REDNESS; This spontaneous report received from a patient concerned a 28 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, and other pre-existing medical conditions included no illness or surgery to report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 12:00 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for drug used for unknown indication. On 08-MAR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 12-MAR-2021, the subject experienced itching. On 12-MAR-2021, the subject experienced golf ball size swelling at injection site about 6 hours after the vaccination. On 12-MAR-2021, the subject experienced pain. On 12-MAR-2021, the subject experienced about 3 hours after the vaccination low grade fever and temperature. On 12-MAR-2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itching, and redness, and had not recovered from golf ball size swelling at injection site about 6 hours after the vaccination, pain, and about 3 hours after the vaccination low grade fever and temperature. This report was non-serious.
Pt apparently fell off exam table after vaccines given, and hit face/head. No loss of consciousness. Pt observed 20 min, discharged home. Went to ER that night for memory loss, CT negative. Exam normal.
Working on Thursday 10/12/2022, patient 2:45 pm face felt hot turned red, arms torso and face became  hot and itchy. red and hot non raised. went home took 2 benadryl 3 ibuprofen. today, 10/13/22 had red spots still, went to MD
Aches; Soreness around shot; Fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A male patient of unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 05Apr2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 06Apr2021, the patient experienced soreness around shot (vaccination site pain), fever, aches and headache. 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 soreness around shot (vaccination site pain), fever, aches and headache were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient states she had a rash on chest, palms on hands and stomach. She had swelling in the hands. She said it started the day after receiving the vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Sleep Apnea" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Morbid Obesity" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient reported positive COVID antigen test seven days after completing five day Paxlovid regimen. He was currently experiencing mild COVID symptoms, no other medical attention / treatment sought at this time. Plan was to use OTC medication to treat symptoms and isolate 5 days at this time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with improperly stored GARDASIL (lot# K016966, expiration date 10-MAY-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Exacerbation of left, lateral, leg lesion appeared two days after vaccation. Generalized Vaccinia vs Autoinoculation
(R) upper arm swelling, lymph node enlargement (R) axillary region, reported 3-24-14, 4-7-14 symptoms minimal.
I got my 2nd shot around 10am.  My arm started to feel sore within 1-2 hours.  At 7pm I started to feel pain in upper left back area with breathing. At 9pm I was in bed and started to have chest tightness and pain with breathing. Both arms and hands started to go numb and tingling. I got to ER around midnight and all testing was negative.  I was hooked up to IV fluids which seemed to calm the chest pain and numbness. I got home around 3am and went to sleep.  By 7am I was having sore muscles and body aches. I was fatigued and having chills.  I was also running a low grade fever.   I continue on like this for 24 hours.  The next 24 hours I was fatigued.  By day 3 I felt like I was getting back to normal.
started a very light menstrual period that lasted about 5-6 days; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9261) via an unspecified route of administration, administered in arm left on 22Jan2021 at 07:30 (at the age of 56-year-old) as SINGLE DOSE and dose second via an unspecified route of administration on 11Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included High risk smoldering multiple myeloma, autoimmune- psoriatic arthritis. The patient had no known allergies. Concomitant medications in two weeks included trazodone (TRAZODONE), sertraline (SERTRALINE) and topiramate (TOPIRAMATE). On 01Feb2021, the patient experienced started a very light menstrual period that lasted about 5-6 days.Patient stated that she started having periods again and her periods stopped around Nov2019, due to menopause. About 2 weeks later, she took first vaccination and a very light menstrual period started that lasted about 5-6 days. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the event was unknown.
This case was reported by a physician and described patient who did not respond to Pediarix for prophylaxis.  The patient's medical history included acute bronchitis, allergic rhinitis and reactive airway disease.  On 05 February, 14 April 2003, and 13 June 2003, patient received three doses of Pediarix immunization  series.  On 10 October 2005, two years after vaccination with Pediarix, a hepatitis B surface antibody titer was negative.  On 05 February 2003, the patient was also vaccinated with Prevnar.  On 14 April 2003, the subject was also vaccinated with Prevnar and PedvaxHIB.  On 13 June 2003, the subject was also vaccinated with Prevnar.  In the reporting physician's opinion, the event was possibly related to vaccination with Pediarix; however, the physician also noted the event could have been associated with the subject's medical history/concurrent illness and/or a lack of effect.
The patient had joint pain ,body ache ,headache,swelling at the injection site and around it and it felt like a rock at the injection site. he said that he never had these adverse events before and that was the first time he is experiencing these side effects. he forgot to tell the pharmacist that he got a flu shot back in January 2020
This spontaneous report as received from a registered nurse refers to a 12 year old patient of unknown gender. On 07-OCT-2014, the patient was vaccinated with a dose of PROQUAD (Merck) lot # K008579, expiration date 13-DEC-2015, (dose, dose number, route and frequency were not reported) that was exposed to 19.5 F for 9 hours (supported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Patient's right arm was swollen and tender from the site of injection all the way down to the elbow.  Redness associated with swelling.
joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; joint and leg pain, beyond stiffness, elbow and knee pain; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 13Mar2021 16:00 (lot number: ERJ6207) at the age of 56 years old as 2nd dose, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient had no known allergies. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 14Feb2021 19:00 (lot number: EN6201) at the age of 56 years old as 1st dose, single for COVID-19 immunisation. The patient didn't have COVID prior to vaccination. Since the vaccination the patient hadn't been tested for COVID. The patient didn't receive other vaccines in four weeks. On 14Mar2021 14:00 (the following day after the second dose), the patient had continued joint and leg pain, beyond stiffness, elbow and knee pain. No treatment was received by the patient. The patient thought that the symptoms would go away and assumed a few days is no usual but had persisted. The patient then mentioned that at the evening of 14Mar2021, the joint pain became more evident. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Body aches, pain; pain and swelling at injection site; pain and swelling at injection site; HSV2 outbreaks; This is a spontaneous report from a nurse (patient herself). A 48-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as COVID 19 vaccine, brand Pfizer), second dose in left arm on 13Jan2021 (lot EL1283) and first dose in right arm on 23Dec2020 09:15 (lot EK5730), via an unspecified route of administration at single dose, for Covid-19 immunisation. Medical history was none. No any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included colecalciferol (VITAMIN D). On 15Jan2021 20:00, she had body aches, pain and swelling at injection site and HSV2 outbreaks with both doses. First was more severe than the second and took longer to heal. No treatment was given. The outcome of events was recovered.
103+ fever, headache, joint pain, trouble breathing, Had sever case of covid 19 3/9/2020
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 12-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L000454 with exp. 06-JAN-2017, (route were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
8/17/02 localized swelling from top of L deltoid to ~ 1" above elbow. Blisters (about 15 total) lat-mid section of L deltoid. "No fever-no pain." Localized sxs persistent 8/19/02. 8/22 sxs almost resolved. 9/9/02 localized swelling totally resolved.
Pain in arm; Shakiness; Feeling out of sorts; 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 PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts) 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 PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts). At the time of the report, PAIN IN EXTREMITY (Pain in arm), TREMOR (Shakiness) and FEELING ABNORMAL (Feeling out of sorts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
limited medical records received on this pt; pt in ED for cough and SOB; COVID pneumonia; DNR status; per medical records and death certificate, pt died in the hospital of COVID
Resumption of joint swelling (dormant for two years) two hours following FLUCELVAX QUAD vaccination.
Menveo only diluent administration; Menveo only diluent administration; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, only diluent of Menveo administrated to the patient. The reporter stated that a mispaired extra dose of Menveo lyophilized powder was found. The reporter stated that, the patient might have received a dose of diluent only but it might have been that a diluent vial broke and it was not reported by staff, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The healthcare professional did not collect information about patients or vaccines that may be administered incorrectly. The reporter consent to follow up was not gathered. This case has been linked to US2021250237, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021250237:Same reporter
Swollen lymph nodes on the left side; Little bumps on his face had worsened; This is a spontaneous report from a contactable consumer (patient's friend). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 08Apr2021 (afternoon), as first dose, single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had his first vaccine on 08Apr2021, and he is scheduled for his second dose this Thursday (29Apr2021) and told his friend he has swollen lymph nodes still; it started late (15Apr2021). They are on the left side, the same side as the patient got the shot on. The patient had swollen lymph nodes, and he has little bumps on his face on 15Apr2021 for which he had been using diphenhydramine hydrochloride (BENADRYL) cream as treatment. Little bumps on the patient's face had worsened. According to what the patient's friend was reading on the Pfizer site, that can happen but usually only starts within a few days of the vaccine. The patient's friend was asking, if the patient still has these, if he should still take the second vaccine on Thursday. The patient had not recovered from the events.  Information about lot or batch number for the suspect product will be requested in follow-up attempts.
Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date; Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 031H21A, 011M20A and 011M20A) for COVID-19 prophylaxis.     It was unknown if patient had Allergies to medications, food and other products and it was unknown if patient was ever diagnosed or tested positive for COVID-19 and Acute illness at the time of vaccination and up to one month before was provided as unknown and it was unknown if patient had any Chronic or long standing health conditions.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 04-Dec-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 8:48 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 17-May-2022, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022). On 19-May-2022 at 8:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if patient took any Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was reported as unknown.  The event did not cause patient to seek medical care There were no other potential causes reported. Patient did not experience any similar events in the past.   This case was linked to MOD-2022-585601 (Patient Link).
first dose 2020, has not received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th November 2020 in right arm with batch number E49YT and expiry date 25th March 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-Jul-2022 Reporter's comment: The pharmacist reported at the time of the reporting, the patient has not yet received the 2nd dose. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Developed bilateral erythromelalgia on the palms of hands. Extreme redness, tingling and pain. Initial reaction 4 days after the shot was extremely painful. Touched base with Immediate Care Clinic immediately after reaction and was told likely from the vaccine and to give it a few weeks. I was seeing my dermatologist anyway about 4 weeks post 2nd shot and she confirmed that I definitely had redness on my palms. She said to give it two more weeks and then she'd prescribe a steroid cream. I touched base with my primary care doctor when I was 6 wks out from shot and I was still having this reaction. She had me see a rheumatologist to see if I had an underlying autoimmune disorder that we didn't know about and that was what got triggered by vaccine. The rheumatologist did an autoimmune workup and nothing was found. She is the one that used the term erythromelagia and suggested that if the pain was not tolerable when the tingling happened that I could see a neurologist. The reaction still happens. It is primarily associated with heat, physical activity/manipulations with my hands or with stress. I never had this before and came on so suddenly on the morning of the 4th day after my shot.
itching, inflammation, redness, rash mainly at underwear borders but also in eyes/eyelids.