chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A and 041C21A) 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) (Intramuscular) 1 dosage form. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range). In 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna COVID-19 vaccine was given to 10 patients that was stored outside recommended storage conditions.
The first ulcer developed in March 2021.  It was thought to be venous stasis ulcers and treated periodically with antibiotics and steroids.  Since that time, he has had multiple recurrent sores develop.  The most recent episode began April 15, 2022.  He was seen in the emergency department at the Hospital on 05/08/2022 for pain.  He was treated with pain medication and sent home.  On 05/15/2022, he returned to the emergency department.  He had low sodium and was admitted to the hospital.  The doctors treated the low sodium, but did nothing to treat the ulcers stating he needed to see a rheumatologist in which they did not have on staff.  The diagnosis of vasculitis was given.  He was discharged on 05/20/2022.  On 05/25/2022 he had an appointment with the rheumatologist at the Hospital.  This doctor sent him to the emergency department where he was admitted.  There he was diagnosed with thrombotic vasculopathy.  He was discharged to a rehab facility on 06/15/2022.  He was released from rehab on 07/01/2022.  On 07/04/2022, he was readmitted for cellulitis.  He developed septicemia.  He was discharged on 07/11/2022.   On 07/13/2022, He was readmitted with cellulitis.  He was discharged 07/15/2022.
This spontaneous report as received from a pharmacy technician refers to a 2-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 12-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA001558:
Took Vivotif on days 1, 3, and 4; Spontaneous report received on 29JAN2020.  A nurse manager reported that a consumer "took Vivotif on days 1, 3, and 4" (PT: Inappropriate schedule of product administration) for immunisation. The consumer took first, second and third dose of Vivotif on 24JAN2020, 26JAN2020 and 27JAN2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doseson day 1, 3, and 4 (Inappropriate schedule of product administration) instead of taking on alternate days. The causality of inappropriate schedule of product administration is assessed as not applicable with Vivotif.; Sender's Comments: A consumer took Vivotif doseson day 1, 3, and 4 (Inappropriate schedule of product administration) instead of taking on alternate days. The causality of inappropriate schedule of product administration is assessed as not applicable with Vivotif.
fever, arthralgia,lymphadenopathy - Information has been received from a physician concerning her sister (nurse practitioner) who in early december 1994, was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  After two to three weeks, the patient developed a low grade fever, lymphadenopathy and arthralgia.  The physician reported that she feels the vaccine virus may have been transmitted to her (waes# 01033343) (also reported as transmission of rubella from this vaccinated individual).  No further detail were provide. On follow-up the physician reported that her sister developed lymphadenopathy, polyarthritis and low grade fever after vaccination. No further details were provided.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 48-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot#  FC3183), at the age of 48, in right deltoid, on Sep 4, 2021, at 08:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient experienced hyperhidrosis (sweats), felt hot (got really hot and is hot all the time), dizziness (kind of had like a dizzy feeling since these vaccines, still been able to go on, but feels weird in her head) and pain in extremity (underarm feels sore; knows it's normal with the swelling on the side where she got the vaccines), onset Sep 2021, with outcome of not recovered. Follow-up attempts completed. No further information expected.
Pt was given vaccine and shortly after experienced seizure activity, EMS was called and pt. was transported to ER.
Arm swollen size of golf ball - minor pain. Tired, lightheaded date of flu shot next day he was fine and exercised as usual.
administered vaccine to 14 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to 14 year old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059F71A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to 14 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered vaccine to 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
No adverse effects reported.; patient was vaccinated with improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a 12 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On 05-FEB-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R002509 with expiration date on 25-JAN-2020, dose, frequency, route of administration were not reported), The vaccine was reconstitute with properly store sterile diluent (dose, frequency, route of administration, lot number and expiration date were not reported).    Administered dose of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14.2 F) for 3 hours and 15 degrees Fahrenheit up to 46 degrees Fahrenheit (30.6 F) for 2 days, 16 hours and 15 minutes. There was a previous temperature excursion for 6 degrees Fahrenheit up to 14 degrees Fahrenheit (11.3 F) for 7 hours and 20 minutes. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1905USA000487: US-009507513-1905USA003150: US-009507513-1905USA003152:
TIGHTNESS IN CHEST; CHEST PAINS AROUND HEART AND THEN MOVED INTO LEFT ARM AND PAIN GOING UP TO NECK; TOUGH TO BREATH; WANTED TO TAKE OFF ALL OF HIS CLOTHES/UNCOMFORTABLE IN HIS CLOTHES AND HAD HIS PANTIES IN A TWIST; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JAN-2023, the patient experienced tightness in chest, chest pains around heart and then moved into left arm and pain going up to neck, tough to breath, and wanted to take off all of his clothes/uncomfortable in his clothes and had his panties in a twist. Treatment medications (dates unspecified) included: acetylsalicylic acid, ondansetron, morphine, and glyceryl trinitrate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tightness in chest, chest pains around heart and then moved into left arm and pain going up to neck, tough to breath and wanted to take off all of his clothes/uncomfortable in his clothes and had his panties in a twist was not reported. This report was non-serious.
Patient was vaccinated on 14MAR21 at 2000.  He returned to the vaccine room at 2130 complaining of nausea/vomiting, chills, warm face and increased heart rate (115-120).  Oxygen saturation was 98%, respirations 16.  Patient has a history of anxiety.  Patient was evaluated and monitored by our onsite registered nurse for approximately 20-30 minutes before going home.  He is to follow-up with our onsite nurse as needed.
MA did not double check the vaccine and thought she had Polio only. When MA got vaccine from refrigerator she only saw the IPV and did not notice DTap-IPV. MA is new and other MA was out on lunch.
Dose number 3; Redness and slight itching sensation / at the injection site; Redness and slight itching sensation / at the injection site; mild fever; sore throat; injection sight became very sensitive to the touch, a slight bump of the spot would hurt; injection sight became very sensitive to the touch, a slight bump of the spot would hurt; injection sight became very sensitive to the touch, a slight bump of the spot would hurt; the spot was hotter to the touch; has been roughly 4 days of it being itchy bed and swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: 33030BD) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergies: some types of bandage adhesive" (unspecified if ongoing), notes: Known allergies: some types of bandage adhesive. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), administration date: 26Apr2021, when the patient was 21 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 05Apr2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Dose number 3"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "Redness and slight itching sensation / at the injection site"; PYREXIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "mild fever"; OROPHARYNGEAL PAIN (non-serious) with onset 04Dec2021, outcome "not recovered", described as "sore throat"; VACCINATION SITE HYPERSENSITIVITY (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 04Dec2021, outcome "not recovered" and all described as "injection sight became very sensitive to the touch, a slight bump of the spot would hurt"; VACCINATION SITE WARMTH (non-serious) with onset 04Dec2021, outcome "not recovered", described as "the spot was hotter to the touch"; VACCINATION SITE SWELLING (non-serious) with onset 04Dec2021, outcome "not recovered", described as "has been roughly 4 days of it being itchy bed and swollen". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pruritus, pyrexia, oropharyngeal pain, vaccination site hypersensitivity, vaccination site mass, vaccination site pain, vaccination site warmth, vaccination site swelling. No follow-up attempts are possible. No further information is expected.  Additional information: 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 has not been tested for COVID-19.
Cellulitis, purulent drainage and tender left axillary left arm on day 8 of major reaction, responded to 4/5 days of Leuaquin on 7/6/04.
Nausea, fatigue, blurred vision, motion sickness, moody, heartburn, leg & feet pain (neuropathy). Migraines lasting up to 8 weeks, at times looks like I'm having a stroke.
Headache, Myalgia, Fever, nausea, malaise, fatigue
pt recv vax 8AUG96 & 14AUG96 pt bumped head & devel a fist sized bruise;lab eval on 16AUG96 revealed a platelet count of 4000 w/nl hgb & hct & sl low WBC count of 3.5;adm to hosp for presumed ITP;dx aplastic anemia;
No effects from day of vaccination until this morning. Woke up with light congestion and possible low fever. Injection site had been absolutely fine and was sore, almost 3? diameter, pink and hard.  It is now after 5:30 and symptoms are dissipated.  I reported every day on the CDC vsafe website and then today website said follow up was complete.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown demographics. The patients current conditions or medical history were not reported. On an unknown date, between January-February 2014, the patients were vaccinated with 28 doses (unspecified) of VAQTA (dose and route were not reported) lot #s: H010659 expiry 01-MAR-2015; H012669 expiry 17-APR-2015; H019104 expiry 19-JUL-2015; J000366 expiry 22-AUG-2015; J005713 expiry 25-OCT-2015 that had been stored in January 2014 (starting 16-JAN-2014) at 30 F minimum for a total of 112 hours. No adverse effect reported. This is one of several reports from the same source: 1403USA000542, 1403USA001589, 1403USA001588, 1402USA001586. Additional information has been requested.
right bundle branch block; sinus pressure; fatigue; headaches; infection to toes; This report is received from Pfizer Sponsored Program. This is a spontaneous report from a contactable other HCP. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Mar2021 as unknown, single for covid-19 immunisation; tofacitinib citrate (XELJANZ, Strength: 5 mg), oral from 02Mar2021 (Batch/Lot number was not reported) to Mar2021, at 5 mg, 2x/day and oral from Mar2021 (Batch/Lot number was not reported) and ongoing, at 5 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient stated one week after starting XELJANZ infection reported to toes (on Mar2021) and ordered "foot soaks" patient states since then there has been improvements with the infection md aware, no further information provided. 14Mar2021 patient reports going to emergency room after COVID vaccine, states she was diagnosed with a right bundle branch block (on Mar2021) and Doctor of Medicine (MD) was aware. No further information provided. The patient reported sinus pressure, fatigue, and headaches (on Mar2021) since start of therapy and on-going. The MD was aware. No further information provided. She was sensitive to medication, her doctor said to take one 5mg tablet daily then she will re-evaluate how she was doing before she takes two 5mg tablets per day. The MD was aware. Outcome Attributed to Adverse Event: Other serious (Important Medical Events). The action taken in response to the events for tofacitinib citrate was dose reduced. The outcome of the event right bundle branch block was unknown. The outcome of the events sinus pressure, fatigue, headaches was not recovered and outcome of the event infection to toes was recovering.   No follow up attempts are possible. Information about lot/batch number cannot been obtained.; Sender's Comments: The events were considered intercurrent conditions and unrelated to suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) and Tofacitinib citrate.
Pt c/o swollen upper arm with redness. Could not move arm. Pt said she ran 102 degrees F temperature. Did not mention going to MD. Pt is a RN.
Mild pink rash oval shaped under injection site on upper left arm. Not hot. Not swollen. Not painful. A little itchy first two days. Lasted 2 weeks.
Numb, tingling hand on left arm, numb throat, roof of mouth and top lip.  Administered liquid Benadryl.  Stayed at site for observation.  Symptoms subsided within 45 minutes.
Patient experienced itching at injection site about 20 minutes after vaccination. About 1 hour after vaccine he experienced hives. Has never had an allergic reaction to flu shot before. Patient took two Benadryl and symptoms resolved
Information has been received from a physician concerning an over 65 year old female patient who on approximately 23-SEP-2010, "within last two weeks", was vaccinated with her first dose of PNEUMOVAX 23 (Lot # not reported). On an unspecified date the patient had "swelling of arm at injection site from PNEUMOVAX 23 therapy." No lab diagnostics studies performed. At the time of reporting, the patient's swelling of arm at the injection site was recovering. The patient did not seek medical attention. No further information is available.
3/11/2021-- received dose of Pfizer vaccine. Soon after vaccination, had B/L anterior rib pain that he could not otherwise explain. No trauma, dyspnea, dizziness, fever, headache, N/V, falls, personal or family history of blood clots or autoimmune disease, recent smoking (quit 38 yrs ago), prolonged immobility or travel, history of bleeding, red/hot joints, known cancer, or cough/hemoptysis (and patient has outpatient medical follow-up including preventive measures like screening colonoscopy). 4/19/2021-- B/L rib pain got worse with new scant hemoptysis. Went to Urgent Care and diagnosed with "pneumonia"-- prescribed azithromycin, Augmentin; of which he took 2 doses the next two days. Due to persistent symptoms, he presented to the ER 4/21/2021 and was found to have B/L segmental and subsegmental PE's without R heart strain. He had a mild troponin elevation in the setting of known vascular disease. He was not hypoxemic or hemodynamically unstable. No residual DVT noted on imaging. He was transitioned to Eliquis on was discharged home after 1 day (4/22/2021) with outpatient follow-up with outpatient physicians (plus hematology referral) for pending hypercoaguable workup. His medications were adjusted accordingly (e.g. ASA dose decreased given his new DOAC use).
07Jan83 pt vax;  15Jan83 devel high fever & exp convulsion.  At age 9 pt seen by MD for hypersensitivity.
Mid-to-late afternoon: progressive mild soreness in left arm Early evening: chills, fatigue, moderate soreness in left arm Evening: temperature increase of 3.8 degrees (96.7 to 100.5) over the course of an hour, moderate fatigue, moderate body aches, chills, severe soreness in left arm (unable to raise past shoulder, moderate pain with any movement). Took two ibuprofen.
Shoulder articular/muscular pain, at one time the pain diffused to the hands and then stopped, continuing just in the shoulder. Then it diffused to the neck and continue until this date.
Arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     The patient's past medical history included Spasm of muscle.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm is sore). At the time of the report, VACCINATION SITE PAIN (Arm is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter.treatment details not included.
No adverse events reported at the time.  Patient was administered the same vaccination twice (PCV 13) reportedly on different legs.
Fever, Headache, Muscle aches - 6/13/2022 at 12:30am
Mild Swelling and pain at injection site Mild joint pain Fatigue Rested most of the day. Took ibuprofen Note: I had very mild head cold day of vaccine
Information has been received from a consumer concerning her daughter, a female patient who was vaccinated with the first dose of Gardasil. Subsequently the patient "broke out in hives after initial dose." It is unknown if the patient recovered. The patient sought unspecified medical attention. Additional information is not expected.
Pt recvd vax 16JAN92 & 2 days late fussy, lethargic, unable to walk, fever 104.8; Taken to hosp x 4 days; dx cerebellum ataxia; returned to hosp 5th day dx pneumonia;
Patient is a 71 years old male patient of local MD with history of COPD, CAD s/p numerous stents and PCI, PVD s/p stenting of L leg, HTN, TIA, PAF, chronic pain disorder, and HLD presented to a local Hospital with shortness of breath Admitted with Acute Hypoxic Respiratory failure,COVID-19 infection and Acute exacerbation of COPD CXR: Prominent bilateral infrahilar interstitial lung markings with scattered peribronchial cuffing.  This suggests small airways disease such as bronchitis/bronchiolitis or pneumonitis.  Patient responded to treatment with dexamethasone subsequently discharged on prednisone taper on baseline oxygen requirements   Discharge Diagnoses:   Acute Hypoxic Respiratory failure. COVID-19 infection Acute exacerbation of COPD Peripheral vascular disease s/p stenting CAD s/p numerous stent Essential HTN Pulmonary hypertension Obesity; BMI 37.33. Hypophosphatemia ___________________________________________________________________________