chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer refers to a 70-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # R016640 and expiration date 28-JAN-2020) (dose, units and frequency unknown). On an unknown date the patient experienced redness, localized pain and swelling, hot to the touch and tenderness at site of Injection and low fever. The doctor gave the patient MEDROL and KEFLEX. The assistant reported that the patient was doing fine. Causality of the events was not reported.
FEELS WORSE; FEELING AWFUL; FEELING SICK; CHILLS; NAUSEA; HEADACHE; BODY ACHES; DID NOT SLEEP WELL; This spontaneous report received from a consumer concerned a female 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 was not reported, administered on 14-MAY-2021 13:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced body aches. On 14-MAY-2021, the subject experienced did not sleep well. On 14-MAY-2021, the subject experienced feeling sick. On 14-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced nausea. On 14-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced feels worse. On 15-MAY-2021, the subject experienced feeling awful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling sick, body aches, headache, nausea, chills, did not sleep well, and feels worse, and the outcome of feeling awful was not reported. This report was non-serious.
Patient is a  57 y.o. male with a history of testing testing diabetes, bronchitis, hypertension and recent COVID-19 infection presenting with worsening shortness of breath and fever at 102. Initially treated outpatient with antibiotics steroids without improvement.  Patient presented today with decreased oxygen saturations at 84% on 4L.  Reports dyspnea.  Reports fatigue.  Reports fever.  Denies nausea vomiting diarrhea.  Reports recently tested positive COVID-19 on August 31st.  Patient admitted to hospitalist service.  History was obtained from patient who seemed an accurate and reliable historian.  Significant other was present.  From Pulmonary/Critical Care Consult:  Patient is a  57 y.o. male who initially presented to the emergency department on 9/13/2021 with worsening respiratory status. Pt provides some information, majority of info provided by significant other that is at the bedside.    Pt was diagnosed with 8/31 with COVID 19 in the emergency department. He was sent home with home oxygen and managed by his fiance. His status waxed and waned. He presented back to the ED on 9/13 with increased dyspnea, increased fatigue, decreased oxygen saturation, and fever. Pt was then admitted to the pulmonary floor to the hospitalist services.    He remained on the pulmonary floor. He did require more supplemental oxygen and was eventually receiving maximum amounts of oxygen via heated high flow NC with a nonrebreather on top. He was also started on IV dexamethasone on admission. Decision was made to transfer the patient to the ICU for AVAPS.    Pt arrived to the ICU. He was placed on NIV. He did become anxious with application, so he was started on precedex. Pt is alert and oriented. His fiance is at bedside.    Hospital Course:  Patient was transferred to the ICU on 9/19/2021 due to worsening respiratory status and was transition to noninvasive ventilatory support.  He required a dexmedetomidine infusion for anxiety.  He further decompensated on 9/23/2021 and required intubation.  He suffered a spontaneous left pneumothorax and a chest tube was placed.  He required paralytic infusion as well.  He was initiated on broad-spectrum antibiotics while in the ICU for a possible secondary bacterial infection.  Unfortunately, the patient continued to decompensate despite maximal mechanical support.  On the evening of 9/26/2021, the patient's family mid determination to transition to comfort measures and terminal extubation.  Patient did succumb to his critical illness on the evening of 9/26/2021 at 1910 hr, may he rest in peace.   Disposition: Deceased; time of death 1910 hr, 9/26/2021
Hospital course: A 76-year-old female patient with history of multiple medical problems was vaccinated for COVID-19. She recently diagnosed with COVID-19 infection 9 days prior to presentation. She went to the emergency room because of worsening shortness of breath and chest pressure. Evaluation in the emergency room unremarkable (except for low oxygen with patient requiring 2 L of oxygen per nasal cannula). Upon admittance, she was placed on aggressive pulmonary toilet, bronchodilators, dexamethasone and antibiotics. She showed remarkable improvement and considered appropriate for discharge. She will follow-up with primary medical doctor in 7 to 14 days. She will return to emergency room for recurrent or worsening symptoms.
pt. reports itching to the neck & face.  pt. denies any difficulty swallowing / breathing and/or other s/s.   pt. declined staying at the vaccination site longer to be monitored.  advised to call 911 if symptoms worsen.  pt. verbalized understanding.
Pfizer 3/22/21, 4/12/21. Positive on 12/31/22
Pt devel severe & crippling pain in joints, fingers of both hands, toes, heels & instep of both feet; pain moves from one area to another & has incapacitated pt; walking regimen has ceased; site of inject very painful lt arm;
Child had probable chickenpox, approx 8-9 spots, low grade temp, lasting 4-5 days.
At the beginning of September, she started a period where she experienced heavy bleeding with clots that continued for about three weeks, which is irregular/unusual for her.  She started her next period on 10/10/21 and is having heavy bleeding with cramping.  She was encouraged to complete vsafe reporting to the CDC, Counseled on use of over the counter pain medications and use of heating pad for cramping/pain.  Patient does not have a regular PCP and was encouraged to visit a local provider or local health care clinic for evaluation and possible treatment.  Patient had previously asked for consultation from another pharmacist for irregular bleeding issues but felt she was ignored.
My sugar has spiked; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6201), via an unspecified route of administration administered in arm right on 22Jan2021 (at the age of 75-years-old) as single dose for covid-19 immunisation. Medical history included diabetes for years, blood pressure/high blood pressure for years, cholesterol, and Afib (atrial fibrillation). Concomitant medications included amlodipine taken for blood pressure; losartan potassium taken for blood pressure; carvedilol (CARVIDIL) taken for high blood pressure (unsure how long she has been taking it); isosorbide taken for blood pressure; furosemide (20 mg) taken for water pill; rosuvastatin calcium (CRESTOR) taken for cholesterol; spironolactone taken for blood pressure; eicosapentaenoic acid ethyl ester (VASCEPA) taken for fish oil; apixaban (ELIQUIS) taken for Afib; insulin glargine (LANTUS) taken for diabetes; semaglutide (OZEMPIC) taken for diabetes. Consumer stated, she had the COVID Vaccine of Pfizer on the 22nd, 2 days ago and she had noticed her sugar has spiked in Jan2021. It was this possibly from the shot. Originally called to report that her blood sugars were spiking after taking the Pfizer Covid vaccine. It did not have any new events to report. Patient stated she (social media withheld) it and read that the Pfizer shot can trigger increased blood sugar, wanted to know if this was true. Patient stated she had been on all of her concomitant medications for a while. Treatment: Consumer stated she was taking semaglutide (OZEMPIC), 0.5 mg, once a week and she thought it was insulin glargine (LANTUS), '8 mg' once a day.
Heat from injection spot; Swollen painful armpit lump; Painful armpit lump; Tiredness; Pain and heat from injection spot.; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0193) via an unspecified route of administration on 09Jul2021 in the left arm (at an age of 31-year-old) as single dose for COVID-19 immunisation. Medical history included milk protein allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. On an unknown date in Jul2021, the patient experienced tiredness, pain and heat from injection spot and swollen painful armpit lump. 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, and emergency room/department or urgent care.  Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events tiredness, pain and heat from injection spot, Swollen painful armpit lump were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Rash appeared at injection site about 2 inch width 1.5 inch height. Rash is smooth red slightly raised and itchy. First noticed approximately 11 days after vaccine. Onset unknown.
I started with a cough the doctor gave me doxycycline before I knew I had a covid. On a wednesday I started coughing more and sneezing and it progressively getting worse So Sunday I went and I got tested for Covid and Monday it came back positive. On Wednesday I got monoclonal antibodies.
A report has been received from a Health Professional concerning, subject of unknown gender, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient received expired FLUMIST that were two days expired. Patient have reported no adverse effects. The patient experienced SIXTEN PATIENTS RECEIVED EXPIRED FLUMIST which started on 15-Jan-2014. The outcome of the event of SIXTEEN PATIENTS RECEIVED EXPIRED FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Patient needed 3 vaccines for paper work. After I gave the 2nd vaccination, she fainted for 3 to 5 seconds. Per pharmacy guideline, I called 911 and EMS/Fire Department came 5-10 minutes later. They checked her BP, O2 sat, and blood sugar. All were normal and she was responsive and alert. No other issues/symptoms were reported. On the VARS, she checked "No" on "Any history of fainting with Vaccines" but told the EMS/Fire Department that she had previous history of fainting. EMS/fire Department said she was okay to go home without further monitoring after their assessment. Will forward incident to pcp for followup.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 28-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 04-DEC-2015, the patient was administered (Oka/Merck) VARIVAX (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Dose Administration Error (Invalid Dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Dose Administration Error (Invalid Dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Dose Administration Error (Invalid Dose)). At the time of the report, INCORRECT DOSE ADMINISTERED (Dose Administration Error (Invalid Dose)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-106851, US-MODERNATX, INC.-MOD-2021-106777, US-MODERNATX, INC.-MOD-2021-106844 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-106851:crosslinked US-MODERNATX, INC.-MOD-2021-106777:crosslinked US-MODERNATX, INC.-MOD-2021-106844:crosslinked
This spontaneous report as received from a nurse refers to multiple patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX lot # M048203 for prophylaxis which had been stored incorrectly. It was stored at 6F to 14F for 74 hours and 22 minutes. There was no previous temperature excursion. This was reported due to a data logger. The diluent was stored properly (lot# not specified). No adverse effects were noted. Additional information has been requested.
Patient is experiencing pain in her shoulder/arm. She was seen by her doctor who diagnosed her with SIRVA and she is currently seeing a physical therapist.
Initial report received 19 February 2009 from a health care professional. A 31-year-old female patient with known allergies to Penicillin and Cephalosporins, had received an intramuscular right deltoid injection of ADACEL, lot number C3032AA, and an intramuscular left deltoid injection of TYPHIM VI, lot number B0424, and an intramuscular right deltoid injection HAVRIX (manufacturer Glaxosmithkline), lot number AHAVB275AA on 06 February 2009 and on the day of vaccination, she experienced pain radiating to her neck and down to her hand resulting in limited mobility. The patient was evaluated at a walk-in clinic (date not reported) and prescribed a sling. The patient was also evaluated by a chiropractor and acupuncturist (dates not reported). At the time of the report, her recovery status was unknown. No additional information was provided. Follow-up information was received 27 April 2009 from a health care professional who reported that they had no additional information to provide. The patient had returned to her home country and no forwarding address was left. Documents held by sender: None.
arm only got sore 4-5 hours; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 17Jan2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ongoing limb deformity, surgery from an unknown date and unknown if ongoing. On an unspecified date of Jan2021 patient reported that the first dose I didn't even know when the needle went in, the first one my arm only got sore 4-5 hours. The outcome of the event was recovered.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient notified clinic on 5/16/23 of complaints. Was examined on 5/16/23 and dx with bursitis. Given shoulder injection with kenalog and bupivacaine.
Had a hard time sleeping; Sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INSOMNIA (Had a hard time sleeping) and PAIN IN EXTREMITY (Sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Grapes). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 12-May-2021 to an unknown date for an unknown indication.   On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Mar-2021, the patient experienced INSOMNIA (Had a hard time sleeping) and PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, INSOMNIA (Had a hard time sleeping) and PAIN IN EXTREMITY (Sore arm) had resolved.      Treatment medications were not reported.   This case was linked to MOD-2021-015940 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Upon internal review on 28-Jan-2022, pregnancy details, assessment, batch number and event coding updated
I was diagnosed with severe preeclampsia at 37 weeks and 5 days pregnant and had an emergency induction that day. Baby's birth weight was 6 lb 1.5 oz.
Parent reported usual site swelling, erythema until 2/25/13 (evening) when "rash" noted on upper (R) back. Took to ER & then f/u with PCP. Dx with purpura, petechia (of unknown origin).
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Medical history was not reported. The reporter stated that M-M-R II underwent a temperature excursion. It was reported that on 21-NOV-2014 the patient was vaccinated with the improperly stored M-M-R II, 0.5 ml, subcutaneous injection, lot number J016232, expiration date 19-DEC-2015. Concomitant medication was not reported. No adverse effect was reported at the time of the report. This is one of several reports received from the same source. Additional information has been requested.
RN reported a child who was exposed to wildtype chicken pox devel shingles as a result of exposure to children that were recently vaccinated w/varicella;It was noted that MD was not convinced that the varicella vax was the cause
Involuntary movements, memory loss, cramps, auditory loss, vision and nervous system.
4 days after vaccination (on 5/18/21) she presented with right facial droopiness (unable to close right eye, unable to smile on right side etc) consistent with Bell's Palsy. Symptoms are (unsurprisingly) persistent now 3 days later
patient got 2nd dose of vaccine 2 weeks after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose of vaccine 2 weeks after 1st dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ARIPIPRAZOLE (ABILIFY), VITAMIN B12 [VITAMIN B12 NOS], IRON, IBUPROFEN, LISINOPRIL, PRAZOSIN, TOPIRAMATE, DULOXETINE HYDROCHLORIDE (CYMBALTA), MONTELUKAST SODIUM (SINGULAIR), DICLOFENAC, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), LIDOCAINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose of vaccine 2 weeks after 1st dose). On 13-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient got 2nd dose of vaccine 2 weeks after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication: Cordron ointment
More than 35 days for 2nd moderna dose; Patient given 0.25 mL for second dose, instead of 0.5 mL; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd moderna dose) and ACCIDENTAL UNDERDOSE (Patient given 0.25 mL for second dose, instead of 0.5 mL) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .25 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd moderna dose) and ACCIDENTAL UNDERDOSE (Patient given 0.25 mL for second dose, instead of 0.5 mL). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd moderna dose) and ACCIDENTAL UNDERDOSE (Patient given 0.25 mL for second dose, instead of 0.5 mL) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  The patient visited pharmacy for 2nd dose sometime last week from date of this report.  No treatment medications were reported.
[Janssen covid vaccine (J&J) use for COVID-19 under Emergency Use Authorization (EUA): pt vaccinated 4/10/21 with Janssen - J&J vaccine. tested positive on 8/20/2021. Received Regn-cov2 infusion on 8/25/2021. Currently hospitalized, on oxygen, remdesivir, dexamethasone