chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 54-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Nurse did not have any information on the first dose.The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. Storage condition at the time of the excursion was refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit Vial moved from freezer to refrigerator on 3-MAR-2022. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) in a 59-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant product was provided by the reporter. No treatment medication was provided. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. The temperature excursions occurred on 4-MAR2-022, 5-MAR-2022, 7-MAR-2022, 8-MAR-2022, 9-MAR-2022, and 10-MAR-2022. It was reported that the vial was moved to refrigerator on 03-Mar-2022. Proposed desired use by date was reported to be on 16-Mar-2022.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   Nurse did not have information available on the first two doses. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. It was reported that the vial was moved to refrigerator on 03-Mar-2022. Proposed desired use by date was reported to be on 16-Mar-2022.  Patient received Moderna Covid-19 vaccine that had undergone multiple temperature excursions.  The Nurse reported no adverse reactions or side effects to the Moderna Covid-19 vaccine. The temperature excursions occurred on 4-MAR-2022, 5-MAR-2022, 7-MAR-2022, 8-MAR-2022, 8-MAR-2022, 9-MAR-2022, and 10-MAR-2022.  No treatment information was provided by the reporter.
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of Daptacel was administered, with no reported adverse event; Initial information received on 15-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves an unknown age female patient who received expired dose with no reported adverse event while receiving diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 14-Mar-2022, the patient received dose 0.5 ml once a day of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (strength: standard;  route, formulation, batch number: C5706AA, expiry date:11-Mar-2022) at left Deltoid administration site for Immunization.   On 14-Mar-2022 the patient developed a non-serious event as expired dose of daptacel was administered (expired product administered) (Latency: same day).  Action taken was not applicable.  Outcome was Unknown.   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 the guidelines. 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.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Painful respiration
Clinical narrative: -moderately severe heart/chest pain -painful breathing  Currently trying to rest, took ibuprofen
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza, Injection site pain
Clinical narrative: Flu symptoms including chills, fever, body aches, sore at injection site, swelling under left arm pit area started and lasted the following day.  Headache lasted 2 days.  Extremely tired lasted 2 days.  Took shot Friday at 1:00pm, Didn?t feel better til Monday 4:00am after taking 1 dose of Tylenol on Sunday at 7pm.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Flu symptoms including chills, fever, body aches, sore at injection site, swelling under left arm pit area started and lasted the following day.  Headache lasted 2 days.  Extremely tired lasted 2 days.  Took shot Friday at 1:00pm, Didn?t feel better til Monday 4:00am after taking 1 dose of Tylenol on Sunday at 7pm.
Age: 45.0
Sex: U
Vaccine: HPV9
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: missed the second dose in the vaccine series of GARD ASIL 9; the patient was 45 years old when the GARDASIL 9 vaccine series was started and turned 46 years old prior to receiving the second GARDASIL 9 shot; the patient was 45 years old when the GARDASIL 9 vaccine series was started and turned 46 years old prior to receiving the second GARDASIL 9 shot; No additional AE reported; This spontaneous report was received from a pharmacist referring to a 46-year-old patient of unknown agender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date in October 2021 (also reported as the date was not certain), at age of 45-year-old, the patient was vaccinated with the first daose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. The patient turned 46 years old prior to receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (circumstance or information capable of leading to medication error, product administered to patient of inappropriate age). On an unknown date, the patient missed the second dose in the vaccine series of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product dose omission issue). The patient still had not received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). At the time of reporting, the patient was 46-year-old. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information reported; ROTATEQ was administered after a supported temperature excursion; This spontaneous report was received from an other health care professional referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion with 49 Celsius degrees for 72 hours. There was no previous temperature excursion. On 24-FEB-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1742462, expiration date 19-SEP-2022; strength and dose were not reported) orally for prophylaxis (product storage error). No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA000194:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got the shot before I got it; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was thankful that he/she got the shingles shot before he/she got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not be possible as no contact details were available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Lymphadenopathy, Rash, Rash papular, Rash pruritic
Clinical narrative: gastrointestinal upset; swollen lymph node in her armpit, was the size of a golf ball.; red bumps on arm, hand, back, and waist/red bumps are now white; resembling a chickenpox rash; rash is now itchy; rash was painful; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal upset in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2, expiry date unknown) for prophylaxis.   On 9th March 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 9th March 2022, less than a day after receiving Shingrix, the patient experienced gastrointestinal upset and enlargement of lymph nodes. In March 2022, the patient experienced papular rash, vesicular rash, itchy rash and painful rash. On an unknown date, the outcome of the gastrointestinal upset and painful rash were recovered/resolved and the outcome of the enlargement of lymph nodes was recovering/resolving and the outcome of the papular rash, vesicular rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the gastrointestinal upset, enlargement of lymph nodes, papular rash, vesicular rash, itchy rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The case was self-reported by the patient. The patient received Shingrix in left deltoid. In that evening, after receiving Shingrix, patient developed unspecified GI upset (Gastrointestinal Upset) also developed a swollen lymph node in left armpit, the lymph node was the size of a golf ball. The swelling had decreased to the size of half a golf ball. The patient developed red bumps on left arm, left hand, back, and around waist. The patient further described the rash as resembling a chickenpox rash.  The rash was initially painful but was now itchy. The red bumps were now white. The reporter declined to provide her address or email address. The reporter stated her doctor already reported the adverse event (AE) to the FDA (Food and Drug Administration). Reporter abruptly ended the call. The reporter stated that follow up might be done via phone.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: gastrointestinal upset; swollen lymph node in her armpit, was the size of a golf ball.; red bumps on arm, hand, back, and waist/red bumps are now white; resembling a chickenpox rash; rash is now itchy; rash was painful; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal upset in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 2, expiry date unknown) for prophylaxis.   On 9th March 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 9th March 2022, less than a day after receiving Shingrix, the patient experienced gastrointestinal upset and enlargement of lymph nodes. In March 2022, the patient experienced papular rash, vesicular rash, itchy rash and painful rash. On an unknown date, the outcome of the gastrointestinal upset and painful rash were recovered/resolved and the outcome of the enlargement of lymph nodes was recovering/resolving and the outcome of the papular rash, vesicular rash and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the gastrointestinal upset, enlargement of lymph nodes, papular rash, vesicular rash, itchy rash and painful rash to be related to Shingrix.  Additional details were provided as follows: The case was self-reported by the patient. The patient received Shingrix in left deltoid. In that evening, after receiving Shingrix, patient developed unspecified GI upset (Gastrointestinal Upset) also developed a swollen lymph node in left armpit, the lymph node was the size of a golf ball. The swelling had decreased to the size of half a golf ball. The patient developed red bumps on left arm, left hand, back, and around waist. The patient further described the rash as resembling a chickenpox rash.  The rash was initially painful but was now itchy. The red bumps were now white. The reporter declined to provide her address or email address. The reporter stated her doctor already reported the adverse event (AE) to the FDA (Food and Drug Administration). Reporter abruptly ended the call. The reporter stated that follow up might be done via phone.
Age: 45.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1 dose on 12/20/2005, second on 6/26/2006; 1 dose on 12/20/2005, second on 6/26/2006; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 45-year-old male patient who received HAB (Twinrix) (batch number AHABB019BA, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 20th December 2005, Lot Number AHABB019BA).   On 26th June 2006, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 26th June 2006, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for 3rd dose. The pharmacist called and asked about a patient who received the first 2 doses of Twinrix over 15 years from the day of reporting. The pharmacist stated that the patient received the second dose later than the recommended interval (Schedule of 3 doses at 0, 1, and 6 months), which led to lengthening of vaccination schedule. Till the time of reporting the patient had not received their 3rd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six  patients received the vaccine in question) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) and EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. No concomitant medication were given. No treatment information were given. Date vial moved from freezer to refrigerator. 3-MAR-2022.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site erythema, Syncope
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure fluctuation, C-reactive protein increased, Cognitive disorder, Condition aggravated
Clinical narrative: Autoimmune flare lasting seven weeks. Unable to function for seven weeks.  Neuro: head pressure, blaring tinnitus,leg numb/heavy/spacticity, tingling extremities and face, cognitive dysfunction, extreme noise sensitivity,. Musculoskeletal: joint pain both hips, body aches,. Cardiac: blood pressure fluctuations to very low, low grade fevers 5 weeks after shot
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Hyperacusis, Hypoaesthesia, Limb discomfort, Mobility decreased
Clinical narrative: Autoimmune flare lasting seven weeks. Unable to function for seven weeks.  Neuro: head pressure, blaring tinnitus,leg numb/heavy/spacticity, tingling extremities and face, cognitive dysfunction, extreme noise sensitivity,. Musculoskeletal: joint pain both hips, body aches,. Cardiac: blood pressure fluctuations to very low, low grade fevers 5 weeks after shot
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse, Muscle spasticity, Pain, Paraesthesia, Pyrexia
Clinical narrative: Autoimmune flare lasting seven weeks. Unable to function for seven weeks.  Neuro: head pressure, blaring tinnitus,leg numb/heavy/spacticity, tingling extremities and face, cognitive dysfunction, extreme noise sensitivity,. Musculoskeletal: joint pain both hips, body aches,. Cardiac: blood pressure fluctuations to very low, low grade fevers 5 weeks after shot
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Autoimmune flare lasting seven weeks. Unable to function for seven weeks.  Neuro: head pressure, blaring tinnitus,leg numb/heavy/spacticity, tingling extremities and face, cognitive dysfunction, extreme noise sensitivity,. Musculoskeletal: joint pain both hips, body aches,. Cardiac: blood pressure fluctuations to very low, low grade fevers 5 weeks after shot
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Joint swelling, Pain in extremity, Rash, Rash erythematous, Rash papular
Clinical narrative: symptoms started 3/14/2022 ;she received 1 year vaccines 3/9/2022            daycare called and stated that she developed a "raised red rash" from her head to toe             it has been on her face, arms, legs, and diaper area            mom did notice some swelling around bilateral wrists and lower legs             mom denies any changes to diet, laundry detergent, or recent abx/medication use            it does not appear to itch her             mom has been giving her benadryl.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears that comes and goes. Never had this before the vaccine.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in the ears that comes and goes. Never had this before the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: 1 minute loss of consciousness with rapid return to normal. Vital signs monitored oriented x3 after event. Lungs clear Skin clear significant medical history listed of end-stage heart failure. (DNR & in hospice.) History of brief syncope in past. 16% E.F. hx of arahythmia cardiomyopathy Recent hospitalizations for CHF. Vitals 12:20, BP 118/58, P 90, Resp. 12 Pulse ox 96%. 12:25 BP 112/64, P 96, Resp. 12 Pulse ox 97%. BP 104/58 P 64 Resp. 12 Pulse ox 100%
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: Severe dermatitis affecting both arms and anterior upper legs.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Diabetic ketoacidosis, Dialysis, Drug screen positive, Intensive care
Clinical narrative: Narrative: 52yo male pt was found down through his window in his apartment by office manager of the apartments who called police. Police arrived and called EMS. Pt was taken to hospital. Pt was diabetic and believed to have seized related to his diabetes. Also, pt tested positive for cocaine. Pt was admitted to hospital on 3/2/22 for medical complications (DKA) and placed in ICU. On 3/3/2022 pt was in ICU on a ventilator, on insulin drip, & received dialysis, also diagnosed with pneumonia (no mention of covid infection). Pt died on 3/8/ 2022 in hospital. Pt had received a covid vaccine on 6/29/2021 (JnJ). Likely this death is not related to the vaccine given pt in ICU with DKA & other medical complications.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Mechanical ventilation, Pneumonia, Seizure
Clinical narrative: Narrative: 52yo male pt was found down through his window in his apartment by office manager of the apartments who called police. Police arrived and called EMS. Pt was taken to hospital. Pt was diabetic and believed to have seized related to his diabetes. Also, pt tested positive for cocaine. Pt was admitted to hospital on 3/2/22 for medical complications (DKA) and placed in ICU. On 3/3/2022 pt was in ICU on a ventilator, on insulin drip, & received dialysis, also diagnosed with pneumonia (no mention of covid infection). Pt died on 3/8/ 2022 in hospital. Pt had received a covid vaccine on 6/29/2021 (JnJ). Likely this death is not related to the vaccine given pt in ICU with DKA & other medical complications.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product dispensing error
Clinical narrative: Narrative: This not an ADE or an ADR. Reporting a dispensing error with covid- 19 vaccine during inpatient admission of a 30 yo male admitted for evaluation. MD had ordered a booster dose (0.25ml) (dose #3) of covid vaccine (moderna) on 01/31/2022 at 19:33. On 2/1/22 at 09:57 Md cancelled the order. Nurse did not notice the order was cancelled and gave the vaccine on 2/1/22 at 17:20. Also the given was a full dose (0.5ml). Pt had previously received covid vaccines doses (Pfizer) on 4/5/21 & 4/26/21 at outside facility. Pt did not suffer any adverse reactions from receiving this vaccine in error.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative: Patient is 92 year old with multiple medical comordbidities (see below) PROBLEM LIST: *Urinary incontinenceSeen by Regulatory Authority  Parkinson's disease Allergic rhinitis Insomnia Complete faecal  incontinence Disorder of nail Dermatitis Contracture of knee joint Acquired iron Mild cognitive impairment Seen by palliative care service Chronic fatigue syndrome Skin cancer History of cataract extraction Thumb injury Stented coronary artery Aneurysm of popliteal artery Claudication Peripheral vascular disease Essential hypertension High chloesterol Hypothyroidism Osteporosis Chronic systolic heart failure Coronary arteriosclerosis Obstructive sleep apnea syndrome Vitamin D deficiency Atrial fibrillation H/O: vertebral fracture History of repair of musculotendinous cuff of shoulder Infection of phalanx of finger or thumb Malignant melamoma of skin of nose History of myocardial infarction  Disorder of prostate Gastroesophageal reflux disease Allergic arthritis History of hypotension Adjustment disorder with depressed mood Patient received COVID vaccine on 06/10/2021 and patient died on 03/11/2022 (cause unknown). Likely death is not related to vaccine due to patient's advanced age and comorbidities
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Death, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Narrative:  84 y/o male presented to ER on 1/22/22 with progressive dyspnea with intermittent chest pain for a week and a half. Treated with dexamethasone only as other COVID treatments were contraindicated. Patient died on 1/25/22. PMH includes DM, hyperlipidemia, ischemic heart disease, s/p coronary bypass, COPD, HTN, obesity, CKD and CHF.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Cellulitis, Clostridium difficile infection, Diarrhoea
Clinical narrative: Narrative: 73 y/o old male presented to ER on 01/27/22 with N/V, diarrhea, fever, and weakness. Recently d/c on antibiotics for cellulitis. COVID positive. Treated with remdesivir and dexamethasone. Hospital course complicated with C. Diff infection and hypersmolar hyponatremia. Discharged 02/5/22. PMH includes HTN, morbid obesity, hyperlipidemia, BPH, atrial flutter, overactive bladder, osteoarthritis, and skin basal cell carcinoma.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperosmolar state, Hyponatraemia, Nausea, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative: 73 y/o old male presented to ER on 01/27/22 with N/V, diarrhea, fever, and weakness. Recently d/c on antibiotics for cellulitis. COVID positive. Treated with remdesivir and dexamethasone. Hospital course complicated with C. Diff infection and hypersmolar hyponatremia. Discharged 02/5/22. PMH includes HTN, morbid obesity, hyperlipidemia, BPH, atrial flutter, overactive bladder, osteoarthritis, and skin basal cell carcinoma.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Narrative: 73 y/o old male presented to ER on 01/27/22 with N/V, diarrhea, fever, and weakness. Recently d/c on antibiotics for cellulitis. COVID positive. Treated with remdesivir and dexamethasone. Hospital course complicated with C. Diff infection and hypersmolar hyponatremia. Discharged 02/5/22. PMH includes HTN, morbid obesity, hyperlipidemia, BPH, atrial flutter, overactive bladder, osteoarthritis, and skin basal cell carcinoma.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Cough, Exposure to SARS-CoV-2, Fatigue
Clinical narrative: Narrative: 76 y/o male presented to ER on 1/8/22 with cough, congestion, and extreme fatigue and weakness. Close contact had COVID. Treated with remdesivir and dexamethasone. Discharged 1/24/22. PMH of a fib, CVA, HTN, OSA, and CAD.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Narrative: 76 y/o male presented to ER on 1/8/22 with cough, congestion, and extreme fatigue and weakness. Close contact had COVID. Treated with remdesivir and dexamethasone. Discharged 1/24/22. PMH of a fib, CVA, HTN, OSA, and CAD.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Angioplasty, Anticoagulant therapy, Aortic thrombosis, Deep vein thrombosis, Fibrin D dimer decreased
Clinical narrative: Narrative: 61 y/o male presented to ER on 1/2/22. Received the COVID-19 (JANSSEN), VECTOR-NR, RS* vaccine on 11/30/21 and presented to the ED on 1/2/22 with worsening LLE pain. CTA revealed pulmonary emboli, extensive aortic thrombus, L renal infarct, common iliac stenosis, CFA/SFA/profunda occlusion on the left. LE duplex 1/4 with multiple b/l DVTs. Patient also had a new thrombocytopenia with PLTs of 61 and D-dimer of 13.62. Hem/Onc was consulted and patient was transitioned from a heparin drip to an argatroban drip and received 2 doses of IVIG for possible Thrombosis with Thrombocytopenia Syndrome (TTS) related to the COVID-19 vaccine. He underwent thrombectomy of left iliac, CFA, SFA, profunda and patch angioplasty on 1/14/22 HIT panel has resulted and is positive and patient appears to meet the 5 criteria for definitive diagnosis of TTS. Definitive Diagnosis (must meet all five criteria) per Hematology: - COVID vaccine 4 to 42 days prior to symptom onset - Any venous or arterial thrombosis (often cerebral or abdominal) - Thrombocytopenia (platelet count < 150 x 109/L) - Positive PF4 "HIT" (heparin- induced thrombocytopenia) ELISA - Markedly elevated D-dimer (> 4 times upper limit of normal) Discharged on 1/19/22 on apixaban. PMH includes HTN, GERD, depression, RLS, and lung nodules
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Heparin-induced thrombocytopenia test, Heparin-induced thrombocytopenia test positive, Iliac artery stenosis, Immunoglobulin therapy
Clinical narrative: Narrative: 61 y/o male presented to ER on 1/2/22. Received the COVID-19 (JANSSEN), VECTOR-NR, RS* vaccine on 11/30/21 and presented to the ED on 1/2/22 with worsening LLE pain. CTA revealed pulmonary emboli, extensive aortic thrombus, L renal infarct, common iliac stenosis, CFA/SFA/profunda occlusion on the left. LE duplex 1/4 with multiple b/l DVTs. Patient also had a new thrombocytopenia with PLTs of 61 and D-dimer of 13.62. Hem/Onc was consulted and patient was transitioned from a heparin drip to an argatroban drip and received 2 doses of IVIG for possible Thrombosis with Thrombocytopenia Syndrome (TTS) related to the COVID-19 vaccine. He underwent thrombectomy of left iliac, CFA, SFA, profunda and patch angioplasty on 1/14/22 HIT panel has resulted and is positive and patient appears to meet the 5 criteria for definitive diagnosis of TTS. Definitive Diagnosis (must meet all five criteria) per Hematology: - COVID vaccine 4 to 42 days prior to symptom onset - Any venous or arterial thrombosis (often cerebral or abdominal) - Thrombocytopenia (platelet count < 150 x 109/L) - Positive PF4 "HIT" (heparin- induced thrombocytopenia) ELISA - Markedly elevated D-dimer (> 4 times upper limit of normal) Discharged on 1/19/22 on apixaban. PMH includes HTN, GERD, depression, RLS, and lung nodules
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral artery occlusion, Platelet count decreased, Pulmonary embolism, Renal infarct
Clinical narrative: Narrative: 61 y/o male presented to ER on 1/2/22. Received the COVID-19 (JANSSEN), VECTOR-NR, RS* vaccine on 11/30/21 and presented to the ED on 1/2/22 with worsening LLE pain. CTA revealed pulmonary emboli, extensive aortic thrombus, L renal infarct, common iliac stenosis, CFA/SFA/profunda occlusion on the left. LE duplex 1/4 with multiple b/l DVTs. Patient also had a new thrombocytopenia with PLTs of 61 and D-dimer of 13.62. Hem/Onc was consulted and patient was transitioned from a heparin drip to an argatroban drip and received 2 doses of IVIG for possible Thrombosis with Thrombocytopenia Syndrome (TTS) related to the COVID-19 vaccine. He underwent thrombectomy of left iliac, CFA, SFA, profunda and patch angioplasty on 1/14/22 HIT panel has resulted and is positive and patient appears to meet the 5 criteria for definitive diagnosis of TTS. Definitive Diagnosis (must meet all five criteria) per Hematology: - COVID vaccine 4 to 42 days prior to symptom onset - Any venous or arterial thrombosis (often cerebral or abdominal) - Thrombocytopenia (platelet count < 150 x 109/L) - Positive PF4 "HIT" (heparin- induced thrombocytopenia) ELISA - Markedly elevated D-dimer (> 4 times upper limit of normal) Discharged on 1/19/22 on apixaban. PMH includes HTN, GERD, depression, RLS, and lung nodules
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombectomy, Thrombocytopenia, Thrombosis, Thrombosis with thrombocytopenia syndrome
Clinical narrative: Narrative: 61 y/o male presented to ER on 1/2/22. Received the COVID-19 (JANSSEN), VECTOR-NR, RS* vaccine on 11/30/21 and presented to the ED on 1/2/22 with worsening LLE pain. CTA revealed pulmonary emboli, extensive aortic thrombus, L renal infarct, common iliac stenosis, CFA/SFA/profunda occlusion on the left. LE duplex 1/4 with multiple b/l DVTs. Patient also had a new thrombocytopenia with PLTs of 61 and D-dimer of 13.62. Hem/Onc was consulted and patient was transitioned from a heparin drip to an argatroban drip and received 2 doses of IVIG for possible Thrombosis with Thrombocytopenia Syndrome (TTS) related to the COVID-19 vaccine. He underwent thrombectomy of left iliac, CFA, SFA, profunda and patch angioplasty on 1/14/22 HIT panel has resulted and is positive and patient appears to meet the 5 criteria for definitive diagnosis of TTS. Definitive Diagnosis (must meet all five criteria) per Hematology: - COVID vaccine 4 to 42 days prior to symptom onset - Any venous or arterial thrombosis (often cerebral or abdominal) - Thrombocytopenia (platelet count < 150 x 109/L) - Positive PF4 "HIT" (heparin- induced thrombocytopenia) ELISA - Markedly elevated D-dimer (> 4 times upper limit of normal) Discharged on 1/19/22 on apixaban. PMH includes HTN, GERD, depression, RLS, and lung nodules
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 pneumonia, Computerised tomogram thorax abnormal, Cough, Dyspnoea, Febrile neutropenia
Clinical narrative: Narrative:  70 y/o male presented to ER  on 1/18/22 with cough and SOB. Presented with leukocytopenia and thrombocytopenia. Elevated inflammatory markers with CT noting pneumonia. Neutropenic fever and sepsis possibly secondary to bilateral COVID-19 pneumonia-oxygen saturation decreased to 89% on ambulation on admission, Treated with dexamethasone. Discharged 1/24/2022. PMH of HTN, myelodysplastic syndrome, CML, RA, AND CKD.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker increased, Leukopenia, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Narrative:  70 y/o male presented to ER  on 1/18/22 with cough and SOB. Presented with leukocytopenia and thrombocytopenia. Elevated inflammatory markers with CT noting pneumonia. Neutropenic fever and sepsis possibly secondary to bilateral COVID-19 pneumonia-oxygen saturation decreased to 89% on ambulation on admission, Treated with dexamethasone. Discharged 1/24/2022. PMH of HTN, myelodysplastic syndrome, CML, RA, AND CKD.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sepsis, Thrombocytopenia
Clinical narrative: Narrative:  70 y/o male presented to ER  on 1/18/22 with cough and SOB. Presented with leukocytopenia and thrombocytopenia. Elevated inflammatory markers with CT noting pneumonia. Neutropenic fever and sepsis possibly secondary to bilateral COVID-19 pneumonia-oxygen saturation decreased to 89% on ambulation on admission, Treated with dexamethasone. Discharged 1/24/2022. PMH of HTN, myelodysplastic syndrome, CML, RA, AND CKD.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea, Hypotension, Hypoxia
Clinical narrative: Narrative: 58 y/o female presented to ER on 1/15/2022 with hypoxia and reports of SOB, productive cough, and right side chest pain, Admitted to hospital for higher O2 requirements and possible CPAP. Pt became hypotensive requiring pressor support, found to have strep pneumonia bacteremia, which was treated with antibiotics. COVID infection treated with dexamethasone and remdesivir. Discharged 1/27/2022. PMH includes COPD, HTN, hyperlipidemia, OSA, and osteoporosis.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia streptococcal, Productive cough, SARS-CoV-2 test positive, Streptococcal bacteraemia
Clinical narrative: Narrative: 58 y/o female presented to ER on 1/15/2022 with hypoxia and reports of SOB, productive cough, and right side chest pain, Admitted to hospital for higher O2 requirements and possible CPAP. Pt became hypotensive requiring pressor support, found to have strep pneumonia bacteremia, which was treated with antibiotics. COVID infection treated with dexamethasone and remdesivir. Discharged 1/27/2022. PMH includes COPD, HTN, hyperlipidemia, OSA, and osteoporosis.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Parkinsonism
Clinical narrative: Narrative:  Developed an Atypical Parkinson's Syndrome within one month after receiving 3rd dose (booster) Moderna COVID vaccine without other explanation for development of sub acute Atypical Parkinson's Syndrome.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Cough, Dyspnoea, Exposure to SARS-CoV-2
Clinical narrative: Narrative: 91 y/o male present to ER on 1/16/22 reporting of worsening cough, dyspnea and weakness. Close contact recently had COVID. Admitted due Covid infection and elevate troponin. Treated with remdesivir and dexamethasone. Complications during admission included suspected CPAP, sepsis, thrombocytosis and lactic acidosis. Discharge on 1/24/2022. PMH includes, SVT, CAD, and Afib.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lactic acidosis, Positive airway pressure therapy, SARS-CoV-2 test positive, Sepsis, Thrombocytosis
Clinical narrative: Narrative: 91 y/o male present to ER on 1/16/22 reporting of worsening cough, dyspnea and weakness. Close contact recently had COVID. Admitted due Covid infection and elevate troponin. Treated with remdesivir and dexamethasone. Complications during admission included suspected CPAP, sepsis, thrombocytosis and lactic acidosis. Discharge on 1/24/2022. PMH includes, SVT, CAD, and Afib.
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Narrative: 91 y/o male present to ER on 1/16/22 reporting of worsening cough, dyspnea and weakness. Close contact recently had COVID. Admitted due Covid infection and elevate troponin. Treated with remdesivir and dexamethasone. Complications during admission included suspected CPAP, sepsis, thrombocytosis and lactic acidosis. Discharge on 1/24/2022. PMH includes, SVT, CAD, and Afib.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Hypersensitivity, Immunisation reaction, Pruritus
Clinical narrative: Client advises she had her first Covid 19 Vaccine on 3/16/21. On 3/19/21 Client woke up approx 2am "very itchy, like something crawling all over me, literally". States she went to the bathroom and states she had "all these red spots forming that looked like mosquito bites". States it progressed over time spreading all over her body from face to thighs. States she was living in a group home at the time and they thought it was just related to mosquito bites at first but no one in the house had any bites-states the house is "very clean". Client decided to go on Monday the 22nd to clinic in the city to seek treatment Dr diagnosed client with "allergic reaction to covid vaccine". States the Dr also stated "that means the vaccine is working" but advised her to speak with nurse if she can receive second vaccine as scheduled. Patient advises she is feeling better but not fully recovered at this time. I advised patient that she should not receive second vaccine r/t dx allergic reaction to Covid vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Productive cough
Clinical narrative: Narrative:  64 y/o male presented to ER on 1/16 with progressive shortness of breath over 3 - 4 days and productive sputum. Home nebulizers not improving symptoms. Dx with COVID infection, admitted and treated with IV remdesivir 01/16- 01/20/2022, dexamethasone (1/16 - 1/17) which was changed to methylprednisolone (better effect for associated COPD exacerbation) tapering dose. Discharged on 1/20/2022/ PMH of TIA, pulmonary embolism, hypertension, hyperlipidemia coronary disease status post graft, and on 2 L home O2 for COPD.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative:  64 y/o male presented to ER on 1/16 with progressive shortness of breath over 3 - 4 days and productive sputum. Home nebulizers not improving symptoms. Dx with COVID infection, admitted and treated with IV remdesivir 01/16- 01/20/2022, dexamethasone (1/16 - 1/17) which was changed to methylprednisolone (better effect for associated COPD exacerbation) tapering dose. Discharged on 1/20/2022/ PMH of TIA, pulmonary embolism, hypertension, hyperlipidemia coronary disease status post graft, and on 2 L home O2 for COPD.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Narrative:  75 year old male who presented to ED on 12/30/21 with complaints of SOB, cough, chills, and fatigue. PMH includes COPD (pt on 4 L oxygen at baseline), arrhythmia, and DM. Tested positive for COVID-19 and was admitted for treatment. Treated with remdesivir and dexamethasoone and discharged on 1/1/22 with no new medications for home use. Presented back to ED on 1/4/22 for complaints of new and increasing SOB and O2 in mid 70s on 4L O2. Treated with dexamethasone again. Discharged on 1/7/22 back on baseline supplemental oxygen needs and home dexamethasone.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Narrative:  75 year old male who presented to ED on 12/30/21 with complaints of SOB, cough, chills, and fatigue. PMH includes COPD (pt on 4 L oxygen at baseline), arrhythmia, and DM. Tested positive for COVID-19 and was admitted for treatment. Treated with remdesivir and dexamethasoone and discharged on 1/1/22 with no new medications for home use. Presented back to ED on 1/4/22 for complaints of new and increasing SOB and O2 in mid 70s on 4L O2. Treated with dexamethasone again. Discharged on 1/7/22 back on baseline supplemental oxygen needs and home dexamethasone.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, COVID-19, Chromaturia, Computerised tomogram thorax abnormal, Confusional state
Clinical narrative: Narrative: 75 y/o male with dementia presented to ER on 1/25/22 with weakness, falls, and worsening confusion. Increased cough and congestion. Darker urine and dry heaves but no vomiting earlier in the day. Tested positive for COVID. Treated with remdesivir and dexamethasone. Patient died on 2/3/2022. Cause of death likely due to progression of COVID vs treatment medications. PMH of hypertension, dementia, diabetes, atrial fibrillation on apixaban, aortic dissection, and hyperlipidemia.