chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.
Pt. states received 07/01/2021 and 07/02/2021 started experiencing dizziness, laid down with pulse of 176 and lowering. Called hospital to inform and recommended to be transported by ambulance. Admitted and diagnosed with palpations A-phib, and high enzymes. Cardiologist visited and recommended several prescriptions. Appt. with Cardiologist in the future. Has since recovered with continuing use of prescriptions.
Feeling ill for a week with decreased appetite and fatigue and R arm soreness that has been persisting for more than 2 weeks. Developed itching of palms then erythema to palms which remains present for more than 2 weeks. Attempting treat with NSAID and referral to dermatology.
Immediately after the shot, Pt. felt clammy,  had blurred vision and tingling of both hands, then lost consciousness.  Fell to floor, hit forehead, left knuckle and left knee.  Was assisted to supine position and symptoms improved.  (Admits to feeling anxious and not eating enough before the shot and feels that was related to her reaction.)   Left facility after observation, and got food before driving self home.  Reports soreness and stiff neck from fall injuries.  Reports soreness of injected arm and the same "clamminess and sweating" the following morning with fatigue, but without the tingling, lasting only a few hours, then resolved with no further sequelae.
Funny feeling in throat, followed 2 hours later by lower lip swelling.  Subsequent mild tongue swelling and upper lip swelling.
Patient called 5/5/18  and stated she was experiencing -fever 101 deg, joint pain, rash at injection site that was red, hot and hard. Patient called 5/6/2018 to follow up and stated - joints felt better, fever gone, rash was now larger but not as angry looking. Patient seems to be getting better at this point.
p/vax were administered pt became irritable w/long intervals of crying, pale complexion, dec appetite, inc sleep; pt afebrile sx for 4 days;
Patient said that the evening of the vaccine he had pain at injection site, achy arm and shivering. He said this lasted 3 days. He also said this occurred after the 1st shot in the series.
protein deposits in my liver; other side effects; This spontaneous case was reported by a consumer and describes the occurrence of PROTEIN TOTAL INCREASED (protein deposits in my liver) and VACCINATION COMPLICATION (other side effects) 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 PROTEIN TOTAL INCREASED (protein deposits in my liver) and VACCINATION COMPLICATION (other side effects). At the time of the report, PROTEIN TOTAL INCREASED (protein deposits in my liver) and VACCINATION COMPLICATION (other side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Became very ill once vaccine was completed, became hot, pounding headache, skin itchy and red splotches , blood pressure was elevated and throat started  getting tight
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 1:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 31.39.  Concomitant products were not provided.  On 14-FEB-2021, Excursion time was 09 AM, temperature was 32, 10 AM, temperature was 32, 11 AM, temperature was 32, 2 PM temperature was 35, 3 PM temperature was 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-FEB-2021, vial was moved to clinic on 13-JAN-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-MAR-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Patient vaccinated with Hepatitis A and Hepatitis B vaccines 15-20 seconds after vaccines administered patient fainted. Per guardian "patient  has always fainted after injections, I thought after his last shots in 2005 he'd be better". Patient observed and monitored, no injury occurred. Advised to go to nearest ER if any complications occur.
11:55 received report from Assistant Principal pt had fallen 11:58 am in clinic pt was alert x 1. She has no allergies per Emergency contact card and vaccination consent form. She was afebrile EMT was called at 12:05 due to her diminished mental status, she could not verbalize her last name or where she was. EMT arrived at 12:13, mom arrived at 12:15. She was escorted with EMT to the ER at 12:30 she had received a intranasal flu vaccine at 11:05/well tolerated/student walked back to class post vaccine observation/no distress.
Vaccine was administered Wednesday, 8/16/02. Dad stated that after vaccine was given, the pt had a red coloration to the area. That night, noticed swelling. Two days later, had swelling that traveled down to the knee. No treatment was given.
Patient had Tdap injection 7/1/2022.  States he felt stabbing pain when he received injection.  That night he felt Ok.  Afterward he states he is unable to move his arm with associated numbness radiating down his arm.  Has improved but is still persistent.  Exam today shows decreased active ROM, able to get full ROM passively but great pain.  Pain with external rotation and weaker.  No swelling. No tenderness to palpation.  Patient prescribed Diclofenac 75 mg EC tablets.  Take 1 tablet 2 times daily with meals.
got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) in a 77-year-old patient of an unknown 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.; Sender's Comments: This case concerns a 77 year old patient with unknown gender  with no reported medical history , who experienced Non-serious unexpected event of Illness which occurred on an unknown date after vaccination with the 3rd dose ( booster dose )  of mRNA-1273  vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge is not applicable since the event was reported after the 3rd dose ( Booster dose ) , no additional doses will be given and also the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
About 3-4 weeks after getting the shingles vaccine I developed a blistery rash on scalp (and it continues) and an enlarged lymph node on back of neck. I have been going to dermo doctors several times and can't seem to clear up the rash.
Client called Public Health and reported that his arm was "hard' several days after his immunizations on 02/02/2011. He reported that the hard area was the size of "a golf ball". The client denied any redness or tenderness at the site. Ct is symptom free now. Ct reported symptoms lasted 2 days.
Noticed blisters underneath left breast on 7/23/2021. Pain in that area and in back. 7/30/2021 notice rash. Went to urgent care. Diagnosed with Shingles. Currently taking Valtrax.
Swollen at injection site; red at injection site; itchy welt at injection site; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient 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 08Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included dermatographia and sulfonamide allergy. Concomitant medications included evolcumab (REPATHA injection), rosuvastatin calcium (CRESTOR 20mg) for unknown indication from unknown date within two weeks of vaccine. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm on 20Mar2021 at 11:45 (at the age of 43-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. On 09Apr2021 at 08:00, the patient experienced swollen, red and itchy welt at injection site. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swollen, red and itchy welt was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
pt received first moderna covid vaccine and was seated in our observation areas and complained to friend that he felt uneasy and then fell to ground and began to seize.  Pt roommate states that this has happened to the patient before and has been seen by md however no clinical diagnosis of epilepsy was given nor is the patient being treated with any pharmaceuticals
Mother reports faint red, flat rash noted on both arms.  No blisters noted.  Used OTC cortisone cream to relieve mild itching, rash continues, but may be fading per mother.
Pt received PCV7 #2 at R thigh site on AM 4/18/05. Developed subjected fever 12 hrs later on 4/19. Temp 100 and fussy, 4/20 temp 101.7, 4/21 temp 102.6, no other symptoms.
shortly after receiving moderna had clamminess and dizziness. resolved after laying supine and receiving water
Patient presented 5 days after vaccination with pain/tenderness in upper left arm radiating to chest.  Later radiated to antecubital/forearm area along the vein tract. Redness was observed in the antecubital fossa. Imaging was performed and rest and heat was recommended. Following initial presentation and imaging, the patient presented again with no improvement in symptoms. Ibuprofen every 6-8 hours was recommended upon evaluating renal function.
Severe fatigue in the afternoon of the second day. Literally I could not keep my eyes open and I slept for 2 hours in the middle of the day. When I woke up I felt groggy and fatigued for the rest of the day.  The third day, I had severe muscle pain in my lower back, in an area of a previous injury but with no recent precipitating event. So far the pain has lasted for 2 days and has been everything from moderate to severe.
SORE ARM; FEVER; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. 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, start therapy date were not reported for prophylactic vaccination. 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, the subject experienced sore arm, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, fever, and fatigue. This report was non-serious.
pt recvd vax; exp irritability & devel 8 chicken pox lesions on face, back, neck & ears;to er a7 remained afebrile;
immediate: fever, shiver/chills, day 3-day 7: feeling foggy/dizzy
Nausea, lack of appetite, Gastroparesis - stomach emptying took 24 hours.   Symptoms persisted for 7 days.
Headache-muscle aches all over- fever of 102 Took Tylenol overnight was unable to sleep because pain from symptoms. Still going and the time is 9;30AM Sunday March 21st
Patient took off bandage on 20JUL2011 and noticed that part of the pustule came off and redness, induration, edema, and warm to touch.  Appears to be some infection.  Talked to Medical Doctor and Bactrim was given.
This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 17-AUG-2016, the patient was vaccinated intramuscularly with 0.5 ml dose of expired PNEUMOVAX 23 (lot# K021881, expiration date 30-JUL-2016. No adverse effects were reported. No further information was given. Additional information has been requested.
Full body rash (arms, legs, abdomen, chest, back, and face)-red, fluid filled, itchy; headache; fevers over 102.
This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th March 2020 in left deltoid(0.5 ml, intramuscular), batch number K9R97, expiry date 15th November 2021). On an unknown date, the patient received 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 details were provided as follows: The reporter was the patient. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter called to ask about the efficacy of getting the second dose later then 6 months past the second dose and if should get the second dose. The reporter did not consent to follow up. This case was linked with case US2021254899, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021254899:same reporter.
Rash started then turned into hives on the neck the rash moved to her hands, then her feet.  now it is on her back rash is on fire
(L) thigh - 11 cm x 15 cm , warm, tender, over area.
This spontaneous report as received from a medical assistant refers to 10 unspecified patients. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with a dose of GARDASIL (dose, route, lot number and expiration date not reported) that were improperly stored, exposed to seven temperature excursions over two months for a maximum of 55 F for a total of 48 hours. No adverse effects reported. This is one of several cases from the same source. Additional information has been requested.
G40.909 EPILEPSY, UNSPECIFIED 3/23/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE I63.512 ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY 3/23/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE T78.40XA ALLERGIC REACTION, INIT 3/9/2023 LEFT CAROTID ARTERY STENOSIS    INTRAOPERATIVE STROKE, COMPLICATING NONCARDIAC PROCEDURE
Sudden appendicitis. CT showed enlarged appendix.  Fever. Had my appendix removed. Post appendectomy, I suffered from Ilus, day two.
approx 1hr p/vax pt hosp & dx w/pneumonia, congestive heart failure, & r/o myocardial infarction;addtl info recv 12DEC96 indicated that sputum cult was pos for strep pneumoniae;
Caught during Bariatric surgery.  No symptoms beforehand. Oxygen levels crashed on table. Labs show increased WBC over 10-14 hr period. Pneumonia like  symptoms, wasn?t confirmed by IMDrs or tests, chest X-ray showed enlarged heart (mild)
Patient had tenderness and edema under the arm and surrounding the injection site. Robust take - purulence and edema approximately 24 mm, thickness of approximately 1 mm. Patient reported fever of 101 degrees approximately 6 days following the injection. Patient did not have a fever at the time of reporting, vital signs were normal. Patient denied pericarditis symptoms.
This 42 year old male was referred to VHC for clearance to continue with Rabies vaccination. He received first Rabies vaccine (Novartis lot #534011A) on 4/28/2014 along with YF booster (SP lot #UH669A). The next morning (24 hour later) he awoke with his face feeling puffy and swollen, L>R eyelid swelling and cheek swelling. He also had a prickly heat like rash described as multiple single red dots in band formation across his chest over breast region that extended from axilla to axilla (but did not include the axilla). His left deltoid had a red raised area over both the rabies and yellow fever site both about 3-5cm (per pt) he called a hive. He contacted medical personnel as he was on leave and was advised to take BENADRYL. He used BENADRYL for 2 days with resolution of swelling and rash on day 3. His site reaction persisted for total of 6 days with full resolution. He advised the site swelling was similar to reactions he had to bee stings in past. He denied any shortness of breath, chest pain, difficulty swallowing, lip/tongue swelling, eye/nasal drainage, visual disturbance, weakness, paresthesia or any new detergents, deodorants, food, travel, clothing, lotions, et al.
Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023; No adverse event; Vaccines past the expiration date and administered them to 3 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients), PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines past the expiration date and administered them to 3 adult patients) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator on 21-Jun-2023 and administered on 28-Jul-2023).    Concomitant medication was not reported. Date the vial was initially stored in the refrigerator on 21-Jun-2023. Use by date of vial was 21-Jul-2023. The dose was administered after 30-day Use By Date. Vial did not undergo any temperature excursions. Treatment medication was not reported.  This case was for the 3rd patient out of 3 adult patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735312 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735312:Master case/Patient 1