chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: hand pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 13Jun2022 as dose number unknown, single (Lot number: FM7553) at the age of 7 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Jun2022, outcome "recovered" (13Jun2022), described as "hand pain"; HEADACHE (non-serious) with onset 13Jun2022, outcome "recovered" (13Jun2022). Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: This is the 1st case out of 2 cases. Call was transferred from RA. Concern, transferring agent stated, "I have a report for you, the caller was a patient (consumer) reporting an adverse event, she was also a Pharmacy tech, so she had medical knowledge, she had the Pfizer (Booster) COVID Vaccine Monday of this week and had a sore arm and hand pain for 2 to 3 days and now today she said, she feels like her right side of her face that somebody punched her and then her eye hurting a lot and her face is numb on the right side only. She said that this is the first Pfizer (Booster) shot (COVID Vaccine) that she got. Her (consumer) first vaccine (unspecified vaccine) was Johnson & Johnson. She was getting this (Pfizer COVID Vaccine) as a Booster, she also has a 7 year old daughter that she wants to report having a hand pain and headache for 2 days after this (Pfizer COVID Vaccine) Vaccine on Monday and that was all the information I have."  Consumer's administered Pfizer (Booster) COVID Vaccine LOT#, FM7553 (LOT# captured in the tab)." Patient had asthma." not took any treatment for the event, consumer stated, just my daughter has one Tylenol actually, not me. Vaccination anatomical site, consumer stated, "It is left." Pfizer COVID vaccination date and timing consumer stated, "It was 08Jun2022."   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive with antigen on 05Jun2022; Tested positive with antigen on 05Jun2022; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 11Jan2021 as dose 2, single (Lot number: EK9231), in left arm and on 30Aug2021 as dose 3 (booster), single (Lot number: EW0186) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Feb2022 as dose 4 (booster), single (Lot number: 070H21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seronegative rheumatoid arthritis" (unspecified if ongoing); "perennial allergic rhinitis" (unspecified if ongoing); "depression" (unspecified if ongoing); "Dose:4 Moderna/Dose:1, 2 and 3 Pfizer" (unspecified if ongoing), notes: Dose:4 Moderna/Dose:1, 2 and 3 Pfizer. Concomitant medication(s) included: METHOTREXATE, start date: Apr2020, stop date: 29May2022; LEXAPRO, start date: Feb2019, stop date: 15Jun2022; HUMIRA, start date: Jun2020, stop date: 14Jun2022; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: Jan1995, stop date: 15Jun2022; FOLIC ACID, start date: Apr2020, stop date: 15Jun2022. Past drug history included: Zosyn, reaction(s): "Known allergies: Zosyn", notes: Known allergies: Zosyn. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "Tested positive with antigen on 05Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive, notes: Tested positive with antigen on 5Jun2022; (11Jun2022) Negative, notes: Tested negative antigen on 11Jun2022; (15Jun2022) Positive, notes: positive antigen test 15Jun2022. Therapeutic measures were taken as a result of covid-19, vaccination failure.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 is possible.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: Jun2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022, outcome "not recovered" and all described as "Positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive; (Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Positive COVID test on 05Jun after sore throat starting on 04Jun2022 with headache, congestion, and fever. The patient was treated with Paxlovid from 05Jun2022 to 10Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Cough, Headache
Clinical narrative: Sore arm at injection site; aching across my back (from waist to neck); chills; headache; no energy to get up out of bed; no energy to get up out of bed; some coughing; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholestrol" (unspecified if ongoing), notes: other medical history: High Cholestrol; "low thkyroid" (unspecified if ongoing), notes: other medical history: low thkyroid; "acidic stomach" (unspecified if ongoing), notes: other medical history: acidic stomach. Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; PROTONIX [OMEPRAZOLE]. Past drug history included: Pseudoephedine for loss of breath, reaction(s): "Known Allergies: pseudoephedine", notes: known allergies: pseudoephedine-loss of breath. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 09Mar2021, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: not listed, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 11Feb2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "Sore arm at injection site"; BACK PAIN (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "aching across my back (from waist to neck)"; CHILLS (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering"; HEADACHE (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering"; LETHARGY (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "lethargic"; ASTHENIA (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Jun2022 at 01:00, outcome "recovering" and all described as "no energy to get up out of bed"; COUGH (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "some coughing". Therapeutic measures were taken as a result of vaccination site pain, back pain, chills, headache, asthenia, loss of personal independence in daily activities, cough, lethargy.  Reported Event: Sore arm at injection site, aching across her back (from waist to neck), chills, headache, no energy to get up out of bed, some coughing and lethargic. Consumer did not have any of these effects when she got other Booster Shots. Consumer took withheld Brand Pain Relief pill before bed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 15Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Loss of personal independence in daily activities, Vaccination site pain
Clinical narrative: Sore arm at injection site; aching across my back (from waist to neck); chills; headache; no energy to get up out of bed; no energy to get up out of bed; some coughing; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 10:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholestrol" (unspecified if ongoing), notes: other medical history: High Cholestrol; "low thkyroid" (unspecified if ongoing), notes: other medical history: low thkyroid; "acidic stomach" (unspecified if ongoing), notes: other medical history: acidic stomach. Concomitant medication(s) included: LEVOTHYROXINE; ATORVASTATIN; PROTONIX [OMEPRAZOLE]. Past drug history included: Pseudoephedine for loss of breath, reaction(s): "Known Allergies: pseudoephedine", notes: known allergies: pseudoephedine-loss of breath. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM), administration date: 09Mar2021, for Covid-19 Immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: not listed, Location of injection: Arm Left, Vaccine Administration Time: 01:30 PM), administration date: 11Feb2021, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "Sore arm at injection site"; BACK PAIN (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "aching across my back (from waist to neck)"; CHILLS (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering"; HEADACHE (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering"; LETHARGY (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "lethargic"; ASTHENIA (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Jun2022 at 01:00, outcome "recovering" and all described as "no energy to get up out of bed"; COUGH (non-serious) with onset 15Jun2022 at 01:00, outcome "recovering", described as "some coughing". Therapeutic measures were taken as a result of vaccination site pain, back pain, chills, headache, asthenia, loss of personal independence in daily activities, cough, lethargy.  Reported Event: Sore arm at injection site, aching across her back (from waist to neck), chills, headache, no energy to get up out of bed, some coughing and lethargic. Consumer did not have any of these effects when she got other Booster Shots. Consumer took withheld Brand Pain Relief pill before bed. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 15Jun2022.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL8982), on 05Feb2021 as dose 2, single (Lot number: EL9261) and on 21Nov2021 as dose 3 (booster), single (Lot number: EW0217) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 01Apr2022. 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 results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Addition information: Start date of treatment for COVID-19 was 24May2022. Stop date of treatment for COVID-19 was 29May2022. Known Allergies was none.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I started feeling covid symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022; I started feeling covid symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 at 16:00 as dose 3 (booster), single at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 01Jun2019, stop date: 16Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jun2022, outcome "unknown" and all described as "I started feeling covid symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative; (13Jun2022) Negative; (15Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient started feeling COVID symptoms of headache, body aches, fatigue, and nasal symptoms 06Jun2022. Was given Paxlovid due to her asthma history. Took Paxlovid 07Jun-11Jun. Symptoms went down. Was asymptomatic and almost negative 12Jun (small line on home test. Tested completely negative 13Jun with no symptoms. No symptoms at all 13Jun-14Jun. Woke up feeling sick 15Jun and tested postive. Feeling worse symptoms now into 16Jun- extreme fatigue, dizziness, heart palpitations, nauseous, painful body aches, fever, stuffy, shortness of breath. Symptoms are now worse than before Paxlovid.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Mar2021 at 09:45 as dose 1, single (Batch/Lot number: unknown), in left arm and on 17Apr2021 at 09:45 as dose 2, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 20Nov2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 06May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "VFib" (unspecified if ongoing); "SCA caused by vasospasm" (unspecified if ongoing); "vasospasm" (unspecified if ongoing). Concomitant medication(s) included: SUDAFED, start date: 25May2022, stop date: 06Jun2022; NORVASC, start date: 03Dec2019. Past drug history included: Known allergies: quinolones, reaction(s): "Known allergies: Quinolones". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical Course: Antiviral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 07Jun2022, Treatment stop date: 12Jun2022, Indication: Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2022 at 11:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 87 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Chills, Drug ineffective, Pain, Pyrexia
Clinical narrative: COVID-19; COVID-19; chills; fever; ache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4426070-00 (Agency).  A 60-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 03Mar2021 as dose 1, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; CHILLS (non-serious), outcome "recovered"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "ache". The action taken for adalimumab was unknown. Clinical information: It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter considered "covid-19", "chills", "fever" and "ache" related to BNT162b2. The reporter's causality for the event(s) covid-19", "chills", "fever" and "ache" with the suspect product(s) adalimumab (HUMIRA) was not provided at the time of this report. The reporter's causality for the event(s) covid-19", "chills", "fever" and "ache" with the suspect product(s) MODERNA COVID-19 VACCINE was possible at the time of this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: This is a spontaneous report received from noncontactable consumer or other non-HCP. A male patient received the 3rd dose (first booster) of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Vaccination history included the COVID-19 vaccine (primary immunization series complete; manufacturer unknown), for immunization. The patient had fatigue and pyrexia, with outcome of unknown. Pediatric male patient experienced fever and fatigue from COVID-19 vaccine booster. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: ADAMTS13 activity assay, Thrombotic thrombocytopenic purpura
Clinical narrative: immune-mediated thrombotic thrombocytopenic purpura (iTTP); This is a literature report for the following literature source(s).  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (medically significant, life threatening), 5 days after the suspect product(s) administration, outcome "recovered", described as "immune-mediated thrombotic thrombocytopenic purpura (iTTP)". The patient underwent the following laboratory tests and procedures: ADAMTS13 activity assay: less than 3; 97 %, notes: on day 142; ADAMTS13 activity assay: unknown results. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura.  Clinical course: Treatment included TPE, with a median of 7.5 (range 217).TPE sessions until sustained normalization of platelet counts (number not reported in three cases). Steroids were administered in 20/21 patients (not reported for one case).While four patients (19%) received no additional treatment, weekly rituximab (RTX) or daily caplacizumab was added in 43% (9/21) and 14% (3/21) of patients, respectively, and 5/21 (24%) patients received both.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Pain in extremity, Trigger finger
Clinical narrative: finger pain; trigger finger returned; trigger finger returned; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Tracheostomy", start date: 1971 (unspecified if ongoing); "Closure of hole from Trach", start date: 1980 (unspecified if ongoing); "c section", start date: 2000 (unspecified if ongoing); "Asthma" (unspecified if ongoing); "c section", start date: 2002 (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing); MONTELUKAST (ongoing); FLUTICASONE + SALMETEROL (ongoing). Vaccination history included: BNT162b2 (DOSE 1, Anatomical Site of injection: Left arm, Batch/Lot : EW0161, Administration time: 10 Am), administration date: 28Apr2021, when the patient was 50-year-old, for Covid-19 immunization, reaction(s): "Tingling in finger tips", "Trigger finger"; BNT162b2 (DOSE 2, Anatomical Site of injection: Left arm, Batch/Lot : EW0182, Administration time: 10 Am), administration date: 19May2021, when the patient was 50-year-old, for COVID-19 immunization, reaction(s): "Trigger finger in middle finger after second vaccine". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jun2022, outcome "not recovered", described as "finger pain"; TRIGGER FINGER (non-serious), DISEASE RECURRENCE (non-serious) all with onset Jun2022, outcome "not recovered" and all described as "trigger finger returned".  Clinical course: Fingers were tingling-day or two after shot began trigger finger-middle finger left hand-got worse went to Dr in Dec and got cortisone injection helped, but finger pain and trigger finger retrieved Jun2022.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy(light headed); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2022 at 11:00 as dose 1, single (Lot number: FK9894) at the age of 63 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 12Mar2022, outcome "recovered" (28Mar2022), described as "dizzy(light headed)".  Additional information: On 11Mar2022 at 10:00 am (pending clarification), the first dose of the Pfizer vaccine was administered in to patient's left arm. The morning of 12Mar2022 running thru 20Mar2022, the patient found himself very dizzy (light headed) for eight days. The dizzy feeling slowly began dissipating on 21Mar2022 until by the sixteenth day, the morning of 28Mar2022, it was gone.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong patient
Clinical narrative: Error: Wrong Patient-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site bruising, Injection site pain, Limb injury, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Confusional state, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: severe leg pain radiating from waist down her leg-Severe, Systemic: Flushed / Sweating-Mild
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Systemic: Abdominal Pain-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: severe leg pain radiating from waist down her leg-Severe, Systemic: Flushed / Sweating-Mild
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Fatigue, Hypertension, Lethargy
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypertension-Severe, Systemic: Weakness-Severe, Additional Details: wife came in and complained that patient was unable to get out of bed and that blood pressure has been elevated
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypertension-Severe, Systemic: Weakness-Severe, Additional Details: wife came in and complained that patient was unable to get out of bed and that blood pressure has been elevated
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Hypertension, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Additional Details: Patient complained of feeling slightly light headed and her throat felt like it was closing up and itchy. I gave her 25 mg (10 ml) of diphenhydramine 12.5 mg/5ml. She was counseled to look out for shortness of breath, wheezing, worsening of symptoms and to seek medical care immediately if needed.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Hypertension-Mild, Additional Details: Patient complained of feeling slightly light headed and her throat felt like it was closing up and itchy. I gave her 25 mg (10 ml) of diphenhydramine 12.5 mg/5ml. She was counseled to look out for shortness of breath, wheezing, worsening of symptoms and to seek medical care immediately if needed.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Heart rate increased, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: pt stated her vision was funny for brief time-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt stated vision was funny and that she felt a little funny. Heart rate was a little high. She stated that it passed and we gave her water. Did not want any other medical attention. Patient was fully concious, aware, responsive and coherent.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Musculoskeletal pain, Pain in extremity
Clinical narrative: Systemic: pain backside of thigh, butt area-Severe, Systemic: Weakness-Severe, Additional Details: Patient called on 6/13 and said she got Moderna shot on 5/31. Next morning felt extreme pain in backside of thigh/butt area. Dizziness. for several days. she is getting better but wanted us to send the info in case other patient were reacting to the shot like her
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chest pain, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: After 4 hours, pain in arm, swollen arm, hot to touch,  chest muscle pain (not heart related), joint pain moderate in hip, shoulders,  knees, hands.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Skin warm
Clinical narrative: After 4 hours, pain in arm, swollen arm, hot to touch,  chest muscle pain (not heart related), joint pain moderate in hip, shoulders,  knees, hands.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever 104.5, significant axillary lymph node on side of injection
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscular weakness
Clinical narrative: Sudden onset of chills, shivering to the point of knees nearly buckling. Was able to get in bed independently. Continued most of night. Totally recovered by 9 am next morning
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Inflammation, Injected limb mobility decreased, Magnetic resonance imaging, Periarthritis
Clinical narrative: Pain in shoulders immediately after injections where pain made shoulders nonfunctionable so orthopedic surgeon initially diagnosed as 'frozen shoulder'.  Upon further testing, found inflammation throughout body.  Had xRay, MRI, cortizone shot, orthopedic surgeon, physical therapy, and now being treated by a rheumatologist for auto immune and inflammation.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Pain in shoulders immediately after injections where pain made shoulders nonfunctionable so orthopedic surgeon initially diagnosed as 'frozen shoulder'.  Upon further testing, found inflammation throughout body.  Had xRay, MRI, cortizone shot, orthopedic surgeon, physical therapy, and now being treated by a rheumatologist for auto immune and inflammation.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus that began about 4 hours after receiving the vaccine.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: Quarter sized lump under skin at injection site.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Ear discomfort, Headache, Injection site pain
Clinical narrative: Soreness at injection site. Nausea. Stomachache. Headache. Ear pressure. Sudden nasal discharge. Prolonged weakness.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rhinorrhoea
Clinical narrative: Soreness at injection site. Nausea. Stomachache. Headache. Ear pressure. Sudden nasal discharge. Prolonged weakness.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headache, nausea, 100.2F temperature
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Central venous catheterisation, Cerebrovascular accident, Condition aggravated, Dyspnoea
Clinical narrative: Had pic line installed for osteomyelitis and within a month on October 8, 2021 arm swelled up and doctor diagnosed  blood clothad formed in left arm and shoulder.  Sent home with prescription of Eliquois.  Next day, October 9, 2021 went back to  hospital and could not breath.  Was hospitalized for blood clots in lungs.  While in hospital had a celebral stroke.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Osteomyelitis, Peripheral swelling, Pulmonary thrombosis, Thrombosis
Clinical narrative: Had pic line installed for osteomyelitis and within a month on October 8, 2021 arm swelled up and doctor diagnosed  blood clothad formed in left arm and shoulder.  Sent home with prescription of Eliquois.  Next day, October 9, 2021 went back to  hospital and could not breath.  Was hospitalized for blood clots in lungs.  While in hospital had a celebral stroke.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site reaction, Nasopharyngitis, Pain in extremity
Clinical narrative: I had a cold around New Years and it reminded me I should get a COVID booster. Got my booster and it kicked my ass, I spent the next week mostly in bed feeling awful. Earlier this week (around 13th of June), I had recently gotten over another cold (made sure it wasn't COVID via home test) but my left arm has been sore since, and a strange sore has developed at the injection site.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Oedema peripheral, Pyrexia
Clinical narrative: Extreme fatigue beginning 7 hours post vaccination (booster #2). Fever, chills. Fatigue continued for 36 hours post vaccination. Armpit swollen & painful. Experienced similar symptoms post booster #1.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Extreme fatigue beginning 7 hours post vaccination (booster #2). Fever, chills. Fatigue continued for 36 hours post vaccination. Armpit swollen & painful. Experienced similar symptoms post booster #1.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Cough, Oropharyngeal pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: The adverse event was not related to the vaccines.  I tested positive for Covid-19 on April 26, 4 months after getting the Pfizer vaccine booster and flu shots.  Symptoms, including sore throat,  chest congestion and cough, started on April 22.  I had no fever or other symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Sensation of foreign body, Throat irritation
Clinical narrative: A few minutes after receiving her 4th dose of the Moderna Covid Vaccine the patient started complaining of a "lumpy/scratchy" feeling in the back of her throat that was very noticeable upon swallowing. She complained the sensation was getting worse and she was concerned for airway occlusion. Epi Auto-injector given to patient and EMS notified. EMS arrived within 6 min and transferred patient to nearby ER. Patient was alert and oriented upon EMS arrival and was verbalizing that the sensation had gotten better since receiving the EPI.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eyelid pain, Loss of personal independence in daily activities, Neuralgia, Ocular hyperaemia
Clinical narrative: Eye redness, pain - one eye (left) - it feels like a neurological pain !! This is the second time I report this side effect  I received the third dose (booster) June 15, 2022 and I have the same side effect ( that i reported previously) but less  severe ( red eye, moderate pain on the upper lid).   I had the same side effect (1 eye) after the 2nd dose (Sep 2021) and I went to an ophthalmologist (was not convinced it is a side effect  - although I'm a pharmacist and I can tell with confidence that was a side effect).  The pain was so severe that I couldn't even go out.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Lymph node pain, Pain in extremity, Somnolence
Clinical narrative: @24 hours = a sore left arm at the site of injection From 48 hours to 4 days = lymph nodes, left shoulder, left breast extraordinarily tender, mental fogginess,  and EXTREME sleepiness, which required multiple and IMMEDIATE naps throughout the day.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test normal, Chills, Electrocardiogram ambulatory normal, Fatigue, Headache
Clinical narrative: After the first dose, I had headaches that did not respond to medication (excedirin, Motrin or norco) that lasted for about 2 1/2 weeks. I also had deep fatigue that lasted for about the same amount of time. After the second dose, I had fever, chills, rigors & body aches That started around 9 PM same day and ended at 5 AM the next day. With a second dose I also had persistent headaches and deep fatigue for about three weeks. I started developing heart palpitations in June 2021. It started with multiple palpitations per hour for a couple of months and then they started to decrease.  They finally stopped in May 2022.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Palpitations, Pyrexia, Therapeutic product ineffective
Clinical narrative: After the first dose, I had headaches that did not respond to medication (excedirin, Motrin or norco) that lasted for about 2 1/2 weeks. I also had deep fatigue that lasted for about the same amount of time. After the second dose, I had fever, chills, rigors & body aches That started around 9 PM same day and ended at 5 AM the next day. With a second dose I also had persistent headaches and deep fatigue for about three weeks. I started developing heart palpitations in June 2021. It started with multiple palpitations per hour for a couple of months and then they started to decrease.  They finally stopped in May 2022.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt admit to hospital 6/12/22 and incidentally found to be COVID+. Pt previously received J&J vaccines on 6/15/21 & 11/4/21). O2 needs increased and started steroids on 6/15/22.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: The most recent third dose caused redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection which quickly spread to a welt 4inches by 3 inches and growing.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Injection site warmth, Urticaria
Clinical narrative: The most recent third dose caused redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection which quickly spread to a welt 4inches by 3 inches and growing.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vaccination site discomfort, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: The most recent third dose caused redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection which quickly spread to a welt 4inches by 3 inches and growing.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site warmth
Clinical narrative: The most recent third dose caused redness, swelling, warmth, hardness, itchiness and discomfort around the site of injection which quickly spread to a welt 4inches by 3 inches and growing.
Age: 28.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: The patient felt lightheaded & briefly blacked out 3-5 minutes after the injection. EMS was notified. Patient's vitals were examine by EMS after which patient elected not to be taken to the hospital. Patient returned home and will continue to monitor for improvement.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Pfizer 12+ vaccine dose administered to  8 year old client.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tenderness, Vomiting
Clinical narrative: Whole body hurts to the touch Fever Puking Headache  All started same day as vaccine about 5 hours after
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Periorbital swelling, Pruritus
Clinical narrative: rom Providers On: A child was given COVID vaccine and had left the clinic area. Patient/family did not wait full 15 minutes. The mother noticed unilateral periorbital swelling and came back upstairs with the child and went to registration to report this. We administered Diphenhydramine but we discovered that we do not have any Famotidine or Cimetidine. We ended up calling the ED, administering Epinephrine per their guidance and awaited EMS transport. Was transported to ED.   From ED: Got Pfizer COVID vaccine at today. About 15 minutes afterward developed swelling of right eye and whole body itchiness. Was given benadryl about 30-45 min after vaccine dose for these symptoms. She was then observed. Epi given at about 1753 and she was subsequently brought to ED by EMS for further management. No breathing issues. No swelling of lips, tongue, mouth. No rash noted on body. No vomiting. She is otherwise healthy. Takes no medications. No food allergies or other known allergies. No recent fevers, rhinorrhea, cough, abdominal pain, dysuria, diarrhea. Currently feeling well. Did get lidocaine under arm prior to vaccine injection. Family wondering if she could have touched the lidocaine and then touched her thigh. Had eye redness and itchiness with swelling initially.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Acne, Anxiety, Colonoscopy
Clinical narrative: nausea, constipation, bloating, brain fog, dizziness, numbness, tingling, muscle pain, foot pain, rectal bleeding, headaches, swollen/watery eyes, swollen lymph nodes, abdominal pain, insomnia, fatigue, shaky, trouble urinating, acne, splotches on skin, anxiety, sound sensitivity, reduced appetite, weight loss
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Decreased appetite, Dizziness, Dysuria, Endoscopy
Clinical narrative: nausea, constipation, bloating, brain fog, dizziness, numbness, tingling, muscle pain, foot pain, rectal bleeding, headaches, swollen/watery eyes, swollen lymph nodes, abdominal pain, insomnia, fatigue, shaky, trouble urinating, acne, splotches on skin, anxiety, sound sensitivity, reduced appetite, weight loss
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Feeling abnormal, Headache, Hyperacusis
Clinical narrative: nausea, constipation, bloating, brain fog, dizziness, numbness, tingling, muscle pain, foot pain, rectal bleeding, headaches, swollen/watery eyes, swollen lymph nodes, abdominal pain, insomnia, fatigue, shaky, trouble urinating, acne, splotches on skin, anxiety, sound sensitivity, reduced appetite, weight loss
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Insomnia, Laboratory test, Lacrimation increased, Lymphadenopathy
Clinical narrative: nausea, constipation, bloating, brain fog, dizziness, numbness, tingling, muscle pain, foot pain, rectal bleeding, headaches, swollen/watery eyes, swollen lymph nodes, abdominal pain, insomnia, fatigue, shaky, trouble urinating, acne, splotches on skin, anxiety, sound sensitivity, reduced appetite, weight loss
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Paraesthesia, Rash macular
Clinical narrative: nausea, constipation, bloating, brain fog, dizziness, numbness, tingling, muscle pain, foot pain, rectal bleeding, headaches, swollen/watery eyes, swollen lymph nodes, abdominal pain, insomnia, fatigue, shaky, trouble urinating, acne, splotches on skin, anxiety, sound sensitivity, reduced appetite, weight loss
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage, SARS-CoV-2 antibody test, Tremor, Weight decreased
Clinical narrative: nausea, constipation, bloating, brain fog, dizziness, numbness, tingling, muscle pain, foot pain, rectal bleeding, headaches, swollen/watery eyes, swollen lymph nodes, abdominal pain, insomnia, fatigue, shaky, trouble urinating, acne, splotches on skin, anxiety, sound sensitivity, reduced appetite, weight loss
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri cyst, Aortic arteriosclerosis, Cardiomegaly, Computerised tomogram abdomen abnormal, Dizziness
Clinical narrative: patient states she felt dizzy on day of shot, then now with portal vein clot in June 2022
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Endometrial thickening, Portal vein thrombosis, Scan with contrast abnormal
Clinical narrative: patient states she felt dizzy on day of shot, then now with portal vein clot in June 2022
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Hot flush, Hyperhidrosis, Nausea
Clinical narrative: Patient nausea, heat flashes, sweating, shortness of breath, diarrhea, neck soreness, fainting
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Syncope
Clinical narrative: Patient nausea, heat flashes, sweating, shortness of breath, diarrhea, neck soreness, fainting
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt admit to hospital with COVID 6/15/22 (1st positive test on 6/13/22 - given molnupiravir OP). Pt previously received 3 doses Moderna on 1/22/21, 2/19/21, 12/28/21.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Anticoagulant therapy, Computerised tomogram thorax abnormal, Deep vein thrombosis, Echocardiogram normal
Clinical narrative: Puffing, swelling and redness of left sub-clavical area. DVT detected via ultrasound Started IV heparin, then transitioned to oral Eliquis. Stayed in hospital 2 days.  Venous embolism and thrombosis of subclavian vein, left (CMS/HCC)   Internal jugular (IJ) vein thromboembolism, acute (CMS/HCC)   AKI (acute kidney injury) (CMS/HCC)   Pericardial effusion