chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12/17/21: malaise 12/18-12/25/21: progressing gray pallor, malaise, loss of appetite 12/26/21: mild shortness of breath, worsening color. Previous symptoms continued. 12/29/21: exam by PCP. Listened to patients lungs. Dx "bronchitis". No testing. No imaging. Rx Augmentin 875/125 2x/d.  Benzonatate 200mg 3x/d. No improvement. 1/2/22. About 7pm, patient too weak to stand, SOB. EMS called. O2Sat 70%. Rx O2, IV and steroid. Admitted via ED Hospital. Dx: blood clots lungs/legs; double pneumonia (type not specified). Negative for COVID 19; no fever, no evidence of infection. Rx oxygen(non-invasive ventilation: NIV), antibiotics, blood thinners and steroids. Response: O2Sat up to 94% on high flow oxygen.  1/3/22: admitted from ED to TCU. Central IV started. 1/3/22: second negative COVID-19 test. Cardiac arrhythmia due to "fluid on his heart". No prior history. Rx diuretics and anti-arrhythmic. Changed to anticoagulant (abdominal injections). Response: arrhythmia resolved in 24 hrs. No improvement in blood clots.  1/4/22:  Hematology consult-no origin of clots identified. Platelets reportedly normal.  1/5/22: third negative COVID-19 test. No fever, alert, oxygen NIV continues, O2 Sat mid-90's.  1/6/22: Hematology work-up negative for malignancy.  Cardiologist off record "these are COVID clots". 1/7/22: DAY 6 of hospitalization. FIRST positive COVID-19 test. Family told only possible Rx was Remdesivir because patient was already hospitalized. Began Remdesivir and cont'd anticoagulants, antibiotics and steroids.  1/8/22: transferred from TCU to ICU, breathing worsened. Patient more fatigued, mentally clear, clots unchanged.  O2 Sat in upper 80s on NIV at highest oxygen flow. 1/9/22: early afternoon: intubated, sedated, and placed on ventilator. High pressure of "12" required using "a gas" to expand his lungs. Able to follow simple commands. Cont'd anticoagulants, antibiotics and steroids.  1/10/22: "poor kidney function". CXR unchanged. Rx for elevated K+, no other change in medications. NG tube insertion attempt failed.  1/11/22: NG tube successfully inserted. Given liquid nutrition. Last day Remdesivir. Sedated, restrained, but follows commands. No other Rx changes. 1/12-1/15/22: Remains on ventilator, attempts to wean not successful. Unable to reduce oxygen requirements.  CXRs unchanged. Cont'd anticoagulants, antibiotics and steroids.  Rx plan: "try again to wean off ventilator in 3-5 days". 1/16/22: low grade fever. Rx: IV antibiotic changed.  1/17/22: port at neck identified as source of infection. Port line changed. Antibiotic continued; fever resolved.  1//18/22: clots persisting on maximum anticoagulants. CXR unchanged. Day 9 on ventilator.  Medical team advised tracheotomy, PEG and acute care rehab. Family requested DNR. 1/21/22. Patient unresponsive. Spouse observation: "the life went out of him".  1/22/22: Pneumonia and blood clots not responding to anticoagulants and kidneys failing. Family chose Comfort Care. 1/24/22: Life support withdrawn and patient died minutes after.
Tested positive on 11Jan2021; Tested positive on 11Jan2021; This is a spontaneous report from a contactable consumer (daughter reporter for her father). An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection lot no and expiry date not reported), via an unspecified route of administration on 28Dec2020 at a single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  Daughter calling on behalf of father, aged 88, who lives in assisted living received his first dose on 28Dec2020. However, patient tested positive on 11Jan2021, and was moved to a covid facility.  He is scheduled to receive his second dose on 18Jan2021. The daughter asked if her father could get the second covid vaccine after being sick. She also asked what if his father can't go back to his regular nursing home in time? Does he have to restart the vaccination schedule? The outcome of the events was unknown.  Information on lot/batch number has been requested.
On 6-22-2022, I took a home Covid19 test due to wanting to visit family members and I was surprised with positive results. I started having head congestion, cough, fatigue and body aches later that day. I called the doctors office on that same day and had a telehealth visit. The doctor prescribed Paxlovid and I began using my albuterol inhaler that I had at home. On 6-24-2022, I started having a low grade temp up to 99.4. On 6-25, I started having symptoms of UTI such as urinary frequency and pain so the doctor had me bring a urine sample on 6-27 and the doctor stated I had a UTI. I started feeling more normal on 6-27 am I feeling better now. I started antibiotics on 6-30 due to the UTI. I tested negative on 6-28 and 6-29. I am reporting my breakthru case of Covid.
Pain in arm and neck about 2 hours after injection. Headache fever and severe body aches 10 hours after injection. Headache loss of appetite and severe body pains and soreness over next day stuffy and runny nose. Feeling of sadness and hard to breathe day after injection.
pt seen in ER @ hosp;lt leg swollen, warm, & red; pt crying, lt let unable to move; pt given Advil
itching near injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was recovered/resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient experienced constant itching near injection site for 2 years. The follow-up would not possible, as no contact details were available.
Safety Officer called to vaccinator table. Client just recently vaccinated.  Vaccinator noticed that the date of vaccination on card and spreadsheet did not match date on database.  Spreadsheet and vaccine card said 2/25/21 for 2nd dose. Registered by staff with incorrect year.  Database date for 2nd dose Pfizer reads 2/25/22 - 1 year difference. Client confirmed that she was vaccinated earlier this year.  Vaccinator on 2/25/22 wrote incorrect year on client?s card.  Client notified of error, assured of safety of vaccine. Gave information on when/when not to return.
2-3 hr after vac., developed shaky rigors, Temp 99.5, BP 140/81, Pulse 120. Arm pain, shakes, body shakes. Treated w/ZOFRAN, BENADRYL, IVF.
sore arm; This is a spontaneous report from a contactable nurse (patient). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 19Dec2020 for COVID-19 immunization. Medical history included asthma; hypertension; acid reflux; food allergies; known allergies to peanut, shell fish, IVP dye, penicillin and tree nuts. Patient also had known allergies to erythromycin and ceftriaxone (ROCEPHIN). Concomitant medication was not reported. There was no other vaccine in four weeks. On the first dose of 19Dec2020 just a sore arm (date unspecified). The outcome of event was unknown.   Information on lot/batch no. has been requested.
Patient developed swelling and redness of right arm after receiving GARDASIL vaccine. 4 cm x 6 cm. Advised to take prednisone 3-5 days, MOTRIN for swelling as well.
Central retinal vein occlusion right eye with cystoid macular edema right eye, requiring anti-VEGF intravitreal injections.
pt recvd vax 130PM; pt states that w/in 15 to 20 mins felt weak & drowsy went to sleep & when awoke about 8 hrs later face, lips, & jaws were swollen & could hardly stand; took DPH; denies having any difficulty breathing;
Redness, soreness, unable to lift arm (Lt.), red, splotches in chest area, Rt. arm and down Rt. side. Low Potassium Level at ER.
I had the pneumovax 23 PFS INJ at Pharmacy. On Tuesday May 7th, Wednesday my arm was sore as usual when I have had vacinations in the past, by that evening my arm became very sore , a felt very tired and ached all over. I took tylenol and slept ok the next morning I could hardly move my arm, it was swollen and hot and red, my arm pit had a very swollen lump . I contacted my doctor went in at 10 AM she said I had a skin infection, cellulitis, she prescribed an antibiotic, Cephalexin. I spent the next 2 days not able to do much, very painful and frightening experience. I am finishing the antibiotic today hoping it will take care of the infection. I am very alarmed to have such a severe reaction to a "safe" preventative medicine. The Pharmacist was very careful cleaned my arm very thourouly before the injection. I hope this does not happen to everyone.
Occlusion of right vertebral artery, stroke.  Symptoms began the morning of October 16, went to hospital via ambulance, discharged to home on the 18th, though medical team wanted in patient rehab. Now homebound with severely compromised mobility, right sided weakness, pain , balance issues
patient received 2nd dose of Pfizer vaccine on 11/9/21, which was to close to the initial dose given on 10/26/21
weakness; fever; fatigue; chill; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chill) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chill). At the time of the report, ASTHENIA (weakness), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Information has been received from a health professional concerning a patient, in grades 3-5, who was vaccinated with a dose of varicella virus vaccine live. Recently, since November 2005, the patient experienced a chickenpox outbreak. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 04-DEC-2013, the patient was vaccinated with the first dose of GARDASIL (dose, Lot# and route of administration was not reported). On 14-AUG-2014, the patient was vaccinated with the second dose of GARDASIL (dose, Lot# and route of administration was not reported) which was late according to the reporter. No symptoms were reported. Additional information has been requested.
Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 months old female patient who received ADACEL instead of DAPTACEL, while she received vaccines DAPTACEL and ADACEL. The patient's past medical treatment included DTAP. The patient's past medical history, vaccination(s) and family history were not provided. On 06-Aug-2018, the patient received a fourth 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5979AA, expiry date-13-Jun-2020 via intramuscular route in the right thigh instead of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route. It was a case of actual medication due to wrong vaccine administered. (Other relevant tests included No lab test). Final diagnosis was patient was administered ADACEL instead of DAPTACEL. No reportable adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
5-10 minutes after receiving vaccines, she became pale, felt warm & weak. She was given a cool cloth, water & a lollipop. She did not actually have syncope, only near-syncope. Observed longer.
pt recvd vax; clammy, pallor, red rash at inject site;DPH given w/immediate fading of rash;seen twice by MD;
This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (blister), SKIN DISCOLOURATION (discoloration of arm), PAIN (Pain), ERYTHEMA (Area was reddish) and CONTUSION (Area was "bruise" like) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 014F21A) for COVID-19 vaccination.No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PAIN (Pain), ERYTHEMA (Area was reddish) and CONTUSION (Area was "bruise" like). On 05-Sep-2021, the patient experienced BLISTER (blister) and SKIN DISCOLOURATION (discoloration of arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BLISTER (blister), SKIN DISCOLOURATION (discoloration of arm), PAIN (Pain), ERYTHEMA (Area was reddish) and CONTUSION (Area was "bruise" like) outcome was unknown.No Concomitant informations were reported.Most recent FOLLOW-UP information incorporated above includes:On 07-Sep-2021: Patient date of birth added, vaccination information , date and details added, events added.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild
Case number PHEH2015US002911, is an initial spontaneous report from a health care professional received on 06 Feb 2015. This report refers to a 24-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with a dose of FLUVIRIN (batch number: 1412801) at a dose of 0.5 ml intramuscularly on 30 Jan 2015. It was reported that the FLUVIRIN MDV dose administered to the patient reached temperature to 34 Fahrenheit for 15 hours. No adverse events were reported following the maladministration.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69-year-old male patient received BNT162b2 (BNT162B2), on 31Jan2021 as dose 1, single (Batch/Lot number: unknown), on 23Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hepatic steatosis" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE oral; PANTOPRAZOLE oral; ROSUVASTATIN oral, start date: 11May2022; LOSARTAN oral. Past drug history included: No, reaction(s): "Allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events Drug ineffective and Covid 19 cannot be completely excluded.
mom called & stated pt has been crying for 3+ hr & has a knot;instructed to call MD;21MAY97 called mom-stated recommended dose of APAP was not given until pt devel fever;pt given APAP & crying ceased;
Pt experienced 15 cm, indurated, round, red, non-tender, warm swelling of anterolateral thigh.
moderate resting ischemia of the right lower extremity and subsequent CT angiogram showed a near occlusive lesion in his proximal superficial femoral artery as well as some likely tibial arterial occlusion. There was no significant underlying atherosclerosis and this appeared to be embolic. He is admitted for further therapy. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
The pt had a fever of 102 degrees F. Took extra strength tylenol. Gait unsteady so he was taken to the ER which they gave him more tylenol and some fluids. Temp went down to 99 degrees and then he was released.
I feel that I had adverse events: my arm was swollen and a bump on the site of injection. It was very painful to even move it. I was fatigued aching all over and suffered two days with a very sore arm
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No other medications the patient received within 2 weeks of vaccination. I had bad rebound symptoms 4 days after taking Paxlovid and also started testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug BNT162b2  to all the reported events cannot be completely excluded based on temporal association and known drug safety profile
Under age based on EUA for Moderna. Pediatrician recommended vaccination and patient's mother made decision to vaccinate 16 year 6 month old daughter with both Moderna doses.
Refridgeration excursions identified; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Allergies to medications, food and other products were reported as not applicable. It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.     On 15-Sep-2022 at 4:13 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Sep-2022 at 4:13 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient).    No concomitant medication was reported.  Refrigeration excursions was identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation.  Vaccines stored in refrigerator underwent several temperature excursions going back to Aug-2022.  Patient received vaccine in deltoid. Product dose/ volume was reported as 0.5.  No adverse reactions reported for the patient.  No treatment medication was reported.
Right upper arm with redness/pain/swelling over majority of arm 1st day after injection. 2nd day swelling down to 6-7 cm, pain/tender. 3rd day swelling mild, local, not red, still tender mildly.
Erythema, induration, soft tissue swelling, tenderness involving upper arm. Augmentin 875 mg BID x 10d. Ibuprophen 800 mg q 8 hours. Vicodin 1-2 po q 4-6 hours cold compress. PRN pain.
The night of the 8th of march I slept fine, however the night of the 9th,10th, 11th,and 12th were total insomnia hence very tired and sleepy during the day specially in the evening, the 13th I slept fairly well and by the 14Th, I finally slept great.
Pt said she had body aches/joint pain, fatigue, 2 inch area around the injection site was hot and swollen, she took 2 Benadryls which seem to help. I advised her to take Claritin during day and Benadryl at night and NSAID for pain to see if improvement. I told her to trace perimeter of the swollen area to see if improvement, if yes then continue, if not or if pt develops fever or feels worse then to seek immediate medical advice
After a few hours, pain at vaccination site. Not very painful, though.   Sore and red throat on the left side. Shot was given in my left arm.
Soreness at injection site/ chills on 1st day .  36 hours after shot, my face/ lips swelled and chills. Took Benadryl(1).  24 hours later, swelling returned in left side of face and mouth, weakness in left arm/fingers of left hand, chills. Took 1 Benadryl.  Continued symptoms and 24-36 hours later broke out in hives on trunk (stomach & back), both arms, and both legs.  Took Benadryl.  From that time to present, I continue to break out in hives, have chills, developed a burning sensation in left leg/upper back of thigh with tingling sensation in my left foot.  I continue to take a Benadryl as needed.  It has been 12 days since the injection.