chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Temperature excursion occurred on 29Nov2022; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, 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 29-Nov-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 29-Nov-2022, temperature excursion occurred.  A total of 16 doses were administered in 6 days. 5 doses on 29-Nov-2022, 4 doses on 30-Nov-2022, 2 doses on 01-Dec-2022, 2 doses on 02-Dec-2022, 1 dose on 03-Dec-2022 and 2 doses on 05-Dec-2022.  No treatment medication was reported.  This case contains information for the 1st of 5 patients who received vaccine on 29-Nov-2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-687786, US-MODERNATX, INC.-MOD-2022-687788, US-MODERNATX, INC.-MOD-2022-687785, US-MODERNATX, INC.-MOD-2022-687787 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687786:Same reporter US-MODERNATX, INC.-MOD-2022-687788:Same reporter US-MODERNATX, INC.-MOD-2022-687785:Same reporter US-MODERNATX, INC.-MOD-2022-687787:Same reporter
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 2:46 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 2:46 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. No Treatment information was reported. The vaccine was stored in an ultra cold freezer at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Swelling in L arm at injection site. Pain and redness at site. Warm to the touch and hard. Reaction started about 2-3 hours after injection. Pt was seen in the office the next day for evaluation and treatment. Pt took OTC medication and used ice patches with improvement.
Incident occurred from possible inviable dose administered to patient. We tried to reach the patient 3 times but no answer
6cm x 4cm erythemic blanching macule with central induration noted 4 minutes after immunization, 4.5ml Benadryl given PO by MD.
Hives, swollen arm, heat around area and pain in arm, veins along left side of chest very visible, not visible along side where flu vacc. was given, severe diarrhea - no severe effects from flu vaccination - no treatment from clinic. I used Arnica rub - helped.
pt recvd vax;3 days later, sz for couple of days;stopped & start again;szs stopped about 1 mo ago;had 3rd dose on 14feb95, 3 days later, had an ear infect;
Flu vaccine to (L) deltoid 10/31/2013; within 24 hrs - red rash, swelling to size of egg, itching.
Insomnia, jitteriness, heart flutters, fatigue, brain fog, body aches, pain at the injection site, headache, stomach pain, nausea
Patient got home and arm was sore so took some Ibuprofen. Patient went to bed around 9.  Patient woke up today and felt completely wiped out, with no energy, nausea, loss of appetite, slight headache.  Arm still is sore but improving.  Patient has not contacted the pharmacy yet.     Patient received the Pneumonia vaccine in the same facility in mid-October; patient had no problems after the vaccine.
Patient was scheduled to come in on 11/7/2017 for shots (consent on file for both shots). Report pulled afternoon of 11/6/17, still showed Hep A and HPV (as well as flu) due. Patient absent on 11/7/17, rescheduled shots for 11/9/17. Reviewed report and consent, but did not run a report that day. Shots given to child (she did not mention going to the doctor or getting shots this week). After charting shots, ran new report and discovered shots given 3 days previously at doctor's office. Call made to both contact persons on contact information. Left message to call clinic. Notified supervisor and health department.
woke up w/rash on face & body;facial rash would come & go;no fever;17FEB98 seen by MD;rash not itching given med;
9/22: developed rash on low back; 9/23 headaches; 9/24 extremely hot, whole body shaky; 9/25 headaches; 9/27 10:30 pm extremely itchy, red bumps all over body.  Felt hot and shaky.  Took BENADRYL, itched for 2 hours, headache all nos.
got 50 mcg instead of 100 mcg; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (got 50 mcg instead of 100 mcg) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack (18 years ago), Sleep apnea (for 4 years), Hypothyroidism (for 4 years) and Ringing in ears (for 4 years). Concurrent medical conditions included Immunocompromised (his immune system is probably compromised,).   On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 50 microgram. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (got 50 mcg instead of 100 mcg). At the time of the report, ACCIDENTAL UNDERDOSE (got 50 mcg instead of 100 mcg) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported. Patient asked the local pharmacist who gave him third dose and pharmacist said patient can get a 4th dose, after 5 month which is on 2APR-2022. Patient reports no side effects.
vey sore arm; Headache; nausea; Dizzy for a minute,; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizzy for a minute,), PAIN IN EXTREMITY (vey sore arm), HEADACHE (Headache) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     no medical history reported.  The patient's past medical history included Influenza (Reaction to the flu shot). Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and PROBIOTICS FREEZE for an unknown indication, ANTIHISTAMINES and EPINEPHRINE (EPIPEN).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced DIZZINESS (Dizzy for a minute,). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (vey sore arm), HEADACHE (Headache) and NAUSEA (nausea). On 12-Feb-2021, DIZZINESS (Dizzy for a minute,) had resolved. On 13-Feb-2021, NAUSEA (nausea) had resolved. On 15-Feb-2021, PAIN IN EXTREMITY (vey sore arm) and HEADACHE (Headache) 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.   Treatment information not reported.Concomitant medication also include melatonin.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and nausea are consistent with the product safety profile
Patient diagnosed with COVID on January 9, 2021 after being exposed to family member that was under quarantine in the same household.  Admitted to the hospital and was discharged on January 14, 2021 with home hospice.  Patient passed away on January 18, 2021
Bradycardia with syncopal episodes and heart rate down to 26.  Patient's baseline heart rate typically 64. Patient required a pacemaker.
Presented with SOB and low grade fever.   Covid PNA. Fully vaccinated in May, reports exposed by her friend.  Treated with remdesivir,steroids and O2.  D/C home
gets sick every time he has one for about 24 hrs; His face turns red; fever; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 19-Oct-2020.  This case is linked to case 2020SA296404 (cluster).  This case involves a male patient of unknown age who got sick every time he has one for about 24 hours (Illness), his face turned red (Erythema) and fever (Pyrexia), while the patient received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that her husband got sick every time he has one for about 24 hours (Illness), his face turned red (Erythema) and fever (Pyrexia).   Action taken was not applicable.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown, at the time of reporting.  There will be no information about the batch number in this case.  The reporter assessed the causal relationship with suspect vaccine as related.
Hives- onset AM 6/26/08 (spreading from arms to torso and later to legs)
Information has been received from a physician concerning a patient (age and gender not reported) who was vaccinated on an unspecified date with a dose of MMR II (lot # not reported). Immediately upon receiving the vaccination, the patient developed a hard knot just above the injection site (also reported as a knot above administration site). On follow up information, the same physician reported that 2 weeks after the dose, on 05Mar03, the pt developed redness, induration, swelling and tenderness at measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) site. The pt recovered from these events. THe physician also reported that a pt was vaccinated with varicella virus vaccine live and experienced a rash. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. On unknown dates over an unspecified period of time, the patients were vaccinated with an improperly stored dose of MMR II with lot number L041457 and expiration date of 22-OCT-2017 (strength, route of administration and dose were not reported) for prophylaxis, which was stored between 32 Fahrenheit degrees (°F) to 35°F for 15 hours and 30 minutes. There was previous temperature excursion. However, the temperature excursions were not detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA006606: US-009507513-1705USA010439.
No other AE reported; Medical assistant reports administration of an improperly stored dose of ROTATEQ; This spontaneous report has been received from a medical assistant referring to a 8 weeks old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported.  On 08-NOV-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ),  lot # 1821791, expiration date 26-JUL-2022, 2 milliliter for prophylaxis (route was not reported) (product storage error). No other adverse event reported. There was no previous temperature excursion. The improperly stored temperature and duration as follows: 34.7 Fahrenheit for 0 hours 25 minutes and 0 seconds; 35.4 Fahrenheit for 5 hours 0 minutes and 0 seconds; 35.6 Fahrenheit for 3 hours 20 minutes and 0 seconds;  35.9 Fahrenheit for 0 hours 25 minutes and 0 seconds; 35.7 Fahrenheit for 0 hours 25 minutes and 0 seconds; 35.2 Fahrenheit for 3 hours 20 minutes and 0 seconds; 33.8 Fahrenheit for 18 hours 20 minutes and 0 ; 32.1 Fahrenheit for 23 hours 45 minutes and 0 seconds; 32.5 Fahrenheit for 9 hours 35 minutes and 0 seconds.
On 1/24/99, the pt developed an injection site reaction characterized by redness and tenderness. She was seen by the physician who suggested that she apply warm compresses to the area. On 1/27/99, she developed an area of redness the size of an egg distal to the original site. She was seen again by the physician who noted the area to be hot and red. He dxed cellulitis and prescribed Keflex, bacitracin ointment, and wound care.
approx 4hr p/vax pt told the reporter could not move the injected arm;pt declined to be seen by the MD;by 6PM that day pt stated was much better & could move the arm;pain @ the inj site;
Several hours after injections, she developed pain posterior neck. Reports she has had mild, intermittent sore throat for several days. When she awoke the next day, she had sore throat, pain had extended to anterior neck, ears felt congested, and felt "fuzzy headed."
COVID-19; This spontaneous report received from a health care professional (patient) concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total, administered on left arm on 08-APR-2021 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 APR-2021, about 10 day after vaccination the patient had covid-19, patient did not have an exact date. Patient had a test done at a site that went up her nostril, and got a positive result 2-3 days later. Patient said just standard test, but did not remember what kind. Patient had a monoclonal infusion towards end of the month of April-2021, the next week after she got the positive covid result, but had no exact date. She went to the hospital and got the infusion there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000211941.; Sender's Comments: V0: 20220126052-COVID-19 VACCINE AD26.COV2.S- Covid-19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fatigue; Acid reflux (esophageal); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced FATIGUE (Fatigue) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)). At the time of the report, FATIGUE (Fatigue) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Severe headache with pain radiating down the back of her neck.  Change in mental status, pale, chills and some shortness of breath.   Sent to ER for further evaluation
My arm was sore (inj site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore (inj site)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore (inj site)). At the time of the report, VACCINATION SITE PAIN (My arm was sore (inj site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Pt developed a flushed feeling, numbness in hands and palpitations(heart racing) several minutes after injection. Symptoms slowly subsided after 20-30 minutes of observation. HR: 100, SBP: 150, SP02: 99. EMS services/hospital evaluation was offered and pt declined. She elected to go home with her husband as the driver with a plan to self monitor at home.
Within 24 hrs of vaccine swelling in arm pit which increased in size and sensitivity over the course of 2 days, approximate size of a lemon. Swelling and sensitivity then decreased over a course of 2 days; Within 24 hrs of vaccine swelling in arm pit which increased in size and sensitivity over the course of 2 days, approximate size of a lemon. Swelling and sensitivity then decreased over a course of 2 days; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Other medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GP6955 6121) via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 02:00, within 24 hours of vaccine, the patient experienced swelling in arm pit which increased in size and sensitivity over the course of two days, approximate size of a lemon. Swelling and sensitivity then decreased over a course of two days. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events within 24 hours of vaccine, experienced swelling in arm pit which increased in size and sensitivity over the course of two days, approximate size of a lemon; swelling and sensitivity then decreased over a course of two days was resolved on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cerebral infarction, unspecified mechanism (163.9).  Ischemic Stroke:  patient without risk factors, new Left CRAO (Central Retinal Arterial Occlusion) and also small R superior parietal punctate ischemic infarct on MR, c/f central embolic process, rapid stroke f/u from ED.  Loss of vision in left eye.