chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 03Apr2021 as dose 2, single (Lot number: EW0150), in left arm, on 20Oct2021 as dose 3 (booster), single (Lot number: FH0820), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Atherosclorotic" (unspecified if ongoing), notes: Atherosclorotic; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs; "quarternary salts" (unspecified if ongoing), notes: Known allergies: quarternary salts. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 included treatment with Paxlovid from 13Aug2022 to 18Aug2022.  Clinical course: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Rebounded symptoms -congestion, cough, sore throat, but no fever, within 3 days of initial symptom abatement  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Tested positive again after Paxlovid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2022 as dose 1, single (Lot number: 6022904), in left arm, on 17Mar2022 as dose 2, single (Lot number: 6022904), in left arm and in 2022 as dose 3 (booster), single (Lot number: EW0202) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "unknown", described as "Tested positive again after Paxlovid."; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, disease recurrence. Clinical course: The patient received Paxlovid treatment from 15Aug2022 to 19Aug2022.
Sex: F
Vaccine: COVID19, 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 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), 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 was not reported. Concomitant medication(s) included: METOPROLOL; SERTRALINE; PRAZOSIN; TRAZODONE; TORSEMIDE; ASPIRIN (E.C.). 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with Paxlovid (lot number: GC9416) on 23Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (002591). The reporter is the patient. A 73-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, 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: ALOPECIA (non-serious), outcome "unknown", described as "hair falling out". Additional information: Caller was not transferred to Pfizer Safety during in bound call patient stated, "I need financial assistance for Xeljanz for hair falling out after receiving your Pfizer vaccine." Patient is prescribed Xeljanz unspecified. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), in Oct2020 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Oct2017, stop date: 07Aug2022; LEVOTHYROXINE, start date: 03Nov2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "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.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) 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: RASH (non-serious), outcome "unknown", described as "I had experienced a rash on both arms". Additional information: Patient was unable to get a second dose of vaccine (Pfizer COVID-19 Vaccine); and stated did not get the shot, 21 days apart. Patient got first dose but it would be 26 days today. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Paxlovid start date: 13Aug2022; Pfizer / BioNTech / Paxlovid start date: 13Aug2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Pre-diabetes" (unspecified if ongoing), notes: Other medical history: Pre-diabetes; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN taken for hypertension; MAXIDENE taken for hypertension. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech / Paxlovid start date: 13Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive; (20Aug2022) Negative; (21Aug2022) Negative; (23Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received treatment for Covid-19 Paxlovid from 13Aug2022 to 17Aug2022 orally. Other medications the patient received within 2 weeks of vaccination was Losartan and Maxide for HTN Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: CCEC is required as it is a Spontaneous Serious case with medically confirmed events.Based on the information given in narrative, the causal relationship between the event vaccination failure and the suspect drug BNT162B2 cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN9269), in right arm and on 12Oct2021 as dose 3 (booster), single (Lot number: FE3590) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "obesity" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 01Jan2020, stop date: 07Aug2022; AMLODIPINE BESYLATE, start date: 01Jan2019, stop date: 07Aug2022; HYDROCHLOROTHIAZIDE, start date: 01Jan2019, stop date: 08Aug2022; TELMISARTAN, start date: 01Jan2019, stop date: 07Aug2022; EZETIMIBE, start date: 01Jan2021, stop date: 07Aug2022; B COMPLEX (B50), start date: 01Jan2020, stop date: 07Aug2022; VITAMIN D [VITAMIN D NOS], start date: 01Jan2019, stop date: 08Aug2022. The following information was reported: VACCINATION FAILURE (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: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown), 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. Past drug history included: Oxycodone, reaction(s): "Known allergies: oxycodone", notes: Known allergies: oxycodone, fentanyl; Fentanyl, reaction(s): "Known allergies: fentanyl", notes: Known allergies: oxycodone, fentanyl. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported that vaccine was received. Other medication in 2 weeks was unknown. Other medical history was none. Antiviral details was Product: COVID 19 Treatment, Brand was Paxlovid, treatment start date was 12Aug2022 and Treatment stop date was 17Aug2022, Lot number was ge4607, Indication was Treatment of COVID-19. Rebound symptoms on day 7 post Paxlovid. Never tested positive when started Paxlovid on day 2 of symptoms but the same as family member who did test positive for COVID three days earlier.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Vaccination failure
Clinical narrative: Pfizer / BioNTech / Treatment of COVID-19; Pfizer / BioNTech / Treatment of COVID-19; Rebound with symptoms after finishing full course of paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 01Feb2021 as dose 1, single (Lot number: En5318), in left arm, on 22Feb2021 as dose 2, single (Lot number: En6200), in left arm and on 03Jan2022 as dose 3 (booster), single (Lot number: Fl3198) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Adenomyosis" (unspecified if ongoing); "Known allergies: Foods" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; OMEPRAZOLE; VIT D [VITAMIN D NOS]; METFORMIN; IBUPROFEN. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 12Aug2022, outcome "recovering", described as "Rebound with symptoms after finishing full course of paxlovid"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech / Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: The patient received other medication in 2 weeks. Known allergies to foods. The patient received Paxlovid as a treatment for Covid-19 from 03Aug2022 to 07Aug2022. On 12Aug2022, rebound with symptoms after finishing full course of paxlovid.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2021 at 16:00 as dose 3 (booster), single (Lot number: F07218), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Mar2021 at 11:00 as dose 1, single (Lot number: 031A21A), in left arm and on 14Apr2021 at 14:00 as dose 2, single (Lot number: 038B21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. 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: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medication in 2weeks. Patient received antiviral treatment "paxlovid" from 14Aug2022 to 18Aug2022 for Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 64 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 had no known allergies. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (25Aug2022) Positive, notes: tested positive 25Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 11Aug2022 to 15Aug2022. Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Oct2021 as dose 3 (booster), single (Lot number: f48028) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 036a21a) and on 31Mar2021 as dose 2, single (Lot number: 038a21a) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE, start date: 02May2021; ADDERALL, start date: 04Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 22Aug2022, outcome "not recovered", described as "first positive test 11Aug; first negative test 16Aug, continued negative tested until 22Aug when I started testing positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2022) Positive, notes: first positive test; (16Aug2022) Negative, notes: first negative test; (22Aug2022) Positive, notes: until 22Aug when I started testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caught COVID. Symptom onset 09Aug, first positive test 11Aug; first negative test 16Aug, continued negative tested until 22Aug when I started testing positive again. Patient treated with Paxlovid, treatment start date was 11Aug2022 and stop date was 15Aug2022, Patient took other medication in two weeks. No known allergies.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Malaise
Clinical narrative: Bad reaction to vaccine; Following each vaccine I have felt worse than the one before; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2022-629305 (Moderna Vaccine Events).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "had Covid", start date: Oct2020 (unspecified if ongoing), notes: Oct20,lost son aged yrs to Hsptl Acquired Covid.this month caught Covid from my son when visit Hsptl. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, SINGLE), administration date: Jan2021, for Covid-19 Immunization; Covid-19 vaccine astrazeneca (DOSE 2, SINGLE), administration date: Apr2021, for Covid-19 Immunization.  The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Bad reaction to vaccine"; MALAISE (non-serious), outcome "unknown", described as "Following each vaccine I have felt worse than the one before".  Additional information: In Oct2020 I lost my son aged years to hospital acquired Covid. Also in this month I had Covid which I caught from my son when visiting him in hospital. In Jan2021 I received my 1st dose of (Manufacturer Name withheld) followed in April 2021 by the 2nd dose of (Manufacturer Name withheld). In Oct2021 I had a booster vaccine of Pfizer. In May2022 I had a booster of Moderna. My question is what is the same ingredient in all of these vaccines that make me so ill? following each vaccine I have felt worse than the one before. When I had the last vaccine Moderna I felt that ill that I don't think I will be having any more. I was delirious, replying to questions asked with totally irrelevant answers, when I came to I could not move my legs it was as though I was paralyzed for a good 2 or 3 minutes it was really scary. I also had the most awful headache and vomiting and was bed ridden for nearly a week. I wasn't as bad when I had actual Covid. I really don't think at I can go through this again when each dose is worse than the one before can you throw any light onto why this happens. Other people just seem to have a sore arm.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Skin hyperpigmentation
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Jun2022 as dose 4 (booster), single (Lot number: FJ4991) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6203; Expiration date: 30Jun2021), administration date: 20Feb2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EP6955; Expiration date: 30Jun2021), administration date: 13Mar2021, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FC3183), administration date: 25Sep2021, for COVID-19 Immunization. The following information was reported: SKIN HYPERPIGMENTATION (non-serious) with onset 25Jun2022, outcome "not recovered", described as "my upper lip got dark and still was hyperpigmentation". No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Emotional disorder, General physical health deterioration
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP), Program ID: (176890). A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "started having health issues"; EMOTIONAL DISORDER (non-serious), outcome "unknown", described as "have mixed emotions". Additional information: The patient reported that he was thinking what if he had any more health problems if he got the booster because he was healthy before he got the vaccine; after the vaccine he started having health problems, then he was wondering if he got the booster what he had more health problems, because to him the vaccine was unpredictable, also he was pretty healthy until he got the vaccine, then he started having health issues so he had mixed emotions with the situation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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) all with onset 15Aug2022, outcome "unknown" and all described as "COVID". Clinical information: Reporter was a physician. Have 10-year-old twin boys who are ex-31-week preemies her husband and her have vaccinated our family as soon as was available. We developed COVID for first time 15Aug2022 and now twins tested positive 17Aug2022. Was there any trial to allow them to t as me antiviral? The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Drug ineffective and the administration of the vaccine cannot be excluded.,Linked Report(s) : PFIZER INC-202201070692 same reporter/vaccine/AE, different patient; PFIZER INC-202201070693 same reporter/vaccine/AE, different patient; PFIZER INC-202201070694 same reporter/vaccine/AE, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (FIRST BOOSTER; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ILLNESS (non-serious) with onset Aug2022, outcome "not recovered", described as "sick". Additional information: Patient received second booster shot on an unknown date in Aug2022 and wanted to report that the patient had been sick going on five days. Patient was still sick. Event Awareness Date: 18Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Colitis ulcerative
Clinical narrative: 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-163-4471639-00. A 63-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 11628483), subcutaneous for colitis ulcerative; prednisone (PREDNISONE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COLITIS ULCERATIVE (medically significant), outcome "recovering", described as "Colitis ulcerative aggravated"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "recovering". The action taken for adalimumab and prednisone was unknown. The reporter's assessment of the causal relationship of "colitis ulcerative aggravated" and "chronic obstructive pulmonary disease" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events "colitis ulcerative aggravated" and "chronic obstructive pulmonary disease".
Age: 56.0
Sex: M
Vaccine: PNC20, TDAP
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: PT GOT FEVER, CHILLS, BODY PAIN NORMAL AFTER VACCINES SYMPTOMS BUT PT RECEIVED IT TWICE BY ERROR IN 3 MONTHS DURATION
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Alanine aminotransferase normal, Aspartate aminotransferase normal, Biliary dilatation, Bilirubin conjugated increased
Clinical narrative: Discharge Summary MD (Physician) ? ? Hospitalist Physician Discharge Summary   Patient ID: 74 y.o.    Admit Date:  7/5/2022   Discharge Date: 7/9/22   Principal Dx/ Final Dx: Bacteremia due to Klebsiella pneumoniae   Relevant Inpt Dx: Principal Problem:   Bacteremia due to Klebsiella pneumoniae Active Problems:   Type 2 diabetes mellitus, with long-term current use of insulin   Fever   Benign essential HTN   H/O Whipple procedure   Abnormal CT of the abdomen   Sepsis   AKI (acute kidney injury)   COVID-19 virus infection       HPI:   Hospital Course:   This 74 year old man was admitted with klebsiella bacteremia.  He has pancreatic cancer and had past whipple.  He presented with chills.  Blood cultures grew klebsiella.  He was treated with iv antibiotics and did well.  Repeat cultures show clearing of blood.  He will complete antibiotics orally based on sensitivities.     CT did show abnormalities felt due to surgery.  There was also concern for recurrence of malignancy.  He has talked with his surgeon by phone and will follow up with facility in near future.     He did test positive for covid but did not require any treatment  Notes    Component Ref Range & Units 01:10  T BILIRUBIN 0.2 - 1.0 mg/dL 2.8 High   D BILIRUBIN 0.0 - 0.2 mg/dL 1.7 High   Albumin 3.2 - 5.0 g/dL 2.6 Low   ALT (SGPT) 10 - 60 [iU]/L 28  AST 10 - 42 [iU]/L 24  ALP 42 - 121 [iU]/L 330 High   PROTEIN TOTAL 6.1 - 7.8 g/dL 5.0 Low          MPRESSION:  From CT scan 1.  Postoperative changes from Whipple procedure secondary to pancreatic carcinoma.  There has been interval development of marked intra hepatic biliary ductal dilation extending to the main left and right intrahepatic ducts near the level of the of the choledochojejunostomy.  Although the there is relative density change in the porta hepatis this may simply be secondary to partial volume averaging with the adjacent bowel loop in the porta hepatis.  No more definitive masses identified.  Differential would remain benign stricture related to the choledochojejunostomy versus malignant obstruction.  Would consider follow-up MRI of the abdomen without and with IV contrast and MRCP for further evaluation. 2.  Multiple new small non calcified nodules in the lingula and left lower lobe suspicious for metastatic disease in this patient with history of pancreatic carcinoma.       Consults:   IP CONSULT TO HOSPITALIST       Disposition:  home   Discharge Condition:  fair
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood albumin decreased, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood culture positive, COVID-19
Clinical narrative: Discharge Summary MD (Physician) ? ? Hospitalist Physician Discharge Summary   Patient ID: 74 y.o.    Admit Date:  7/5/2022   Discharge Date: 7/9/22   Principal Dx/ Final Dx: Bacteremia due to Klebsiella pneumoniae   Relevant Inpt Dx: Principal Problem:   Bacteremia due to Klebsiella pneumoniae Active Problems:   Type 2 diabetes mellitus, with long-term current use of insulin   Fever   Benign essential HTN   H/O Whipple procedure   Abnormal CT of the abdomen   Sepsis   AKI (acute kidney injury)   COVID-19 virus infection       HPI:   Hospital Course:   This 74 year old man was admitted with klebsiella bacteremia.  He has pancreatic cancer and had past whipple.  He presented with chills.  Blood cultures grew klebsiella.  He was treated with iv antibiotics and did well.  Repeat cultures show clearing of blood.  He will complete antibiotics orally based on sensitivities.     CT did show abnormalities felt due to surgery.  There was also concern for recurrence of malignancy.  He has talked with his surgeon by phone and will follow up with facility in near future.     He did test positive for covid but did not require any treatment  Notes    Component Ref Range & Units 01:10  T BILIRUBIN 0.2 - 1.0 mg/dL 2.8 High   D BILIRUBIN 0.0 - 0.2 mg/dL 1.7 High   Albumin 3.2 - 5.0 g/dL 2.6 Low   ALT (SGPT) 10 - 60 [iU]/L 28  AST 10 - 42 [iU]/L 24  ALP 42 - 121 [iU]/L 330 High   PROTEIN TOTAL 6.1 - 7.8 g/dL 5.0 Low          MPRESSION:  From CT scan 1.  Postoperative changes from Whipple procedure secondary to pancreatic carcinoma.  There has been interval development of marked intra hepatic biliary ductal dilation extending to the main left and right intrahepatic ducts near the level of the of the choledochojejunostomy.  Although the there is relative density change in the porta hepatis this may simply be secondary to partial volume averaging with the adjacent bowel loop in the porta hepatis.  No more definitive masses identified.  Differential would remain benign stricture related to the choledochojejunostomy versus malignant obstruction.  Would consider follow-up MRI of the abdomen without and with IV contrast and MRCP for further evaluation. 2.  Multiple new small non calcified nodules in the lingula and left lower lobe suspicious for metastatic disease in this patient with history of pancreatic carcinoma.       Consults:   IP CONSULT TO HOSPITALIST       Disposition:  home   Discharge Condition:  fair
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Choledochoenterostomy, Computerised tomogram abdomen abnormal, Essential hypertension, Insulin-requiring type 2 diabetes mellitus, Klebsiella bacteraemia
Clinical narrative: Discharge Summary MD (Physician) ? ? Hospitalist Physician Discharge Summary   Patient ID: 74 y.o.    Admit Date:  7/5/2022   Discharge Date: 7/9/22   Principal Dx/ Final Dx: Bacteremia due to Klebsiella pneumoniae   Relevant Inpt Dx: Principal Problem:   Bacteremia due to Klebsiella pneumoniae Active Problems:   Type 2 diabetes mellitus, with long-term current use of insulin   Fever   Benign essential HTN   H/O Whipple procedure   Abnormal CT of the abdomen   Sepsis   AKI (acute kidney injury)   COVID-19 virus infection       HPI:   Hospital Course:   This 74 year old man was admitted with klebsiella bacteremia.  He has pancreatic cancer and had past whipple.  He presented with chills.  Blood cultures grew klebsiella.  He was treated with iv antibiotics and did well.  Repeat cultures show clearing of blood.  He will complete antibiotics orally based on sensitivities.     CT did show abnormalities felt due to surgery.  There was also concern for recurrence of malignancy.  He has talked with his surgeon by phone and will follow up with facility in near future.     He did test positive for covid but did not require any treatment  Notes    Component Ref Range & Units 01:10  T BILIRUBIN 0.2 - 1.0 mg/dL 2.8 High   D BILIRUBIN 0.0 - 0.2 mg/dL 1.7 High   Albumin 3.2 - 5.0 g/dL 2.6 Low   ALT (SGPT) 10 - 60 [iU]/L 28  AST 10 - 42 [iU]/L 24  ALP 42 - 121 [iU]/L 330 High   PROTEIN TOTAL 6.1 - 7.8 g/dL 5.0 Low          MPRESSION:  From CT scan 1.  Postoperative changes from Whipple procedure secondary to pancreatic carcinoma.  There has been interval development of marked intra hepatic biliary ductal dilation extending to the main left and right intrahepatic ducts near the level of the of the choledochojejunostomy.  Although the there is relative density change in the porta hepatis this may simply be secondary to partial volume averaging with the adjacent bowel loop in the porta hepatis.  No more definitive masses identified.  Differential would remain benign stricture related to the choledochojejunostomy versus malignant obstruction.  Would consider follow-up MRI of the abdomen without and with IV contrast and MRCP for further evaluation. 2.  Multiple new small non calcified nodules in the lingula and left lower lobe suspicious for metastatic disease in this patient with history of pancreatic carcinoma.       Consults:   IP CONSULT TO HOSPITALIST       Disposition:  home   Discharge Condition:  fair
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic carcinoma, Pancreaticoduodenectomy, Protein total decreased, Pulmonary mass, Pyrexia
Clinical narrative: Discharge Summary MD (Physician) ? ? Hospitalist Physician Discharge Summary   Patient ID: 74 y.o.    Admit Date:  7/5/2022   Discharge Date: 7/9/22   Principal Dx/ Final Dx: Bacteremia due to Klebsiella pneumoniae   Relevant Inpt Dx: Principal Problem:   Bacteremia due to Klebsiella pneumoniae Active Problems:   Type 2 diabetes mellitus, with long-term current use of insulin   Fever   Benign essential HTN   H/O Whipple procedure   Abnormal CT of the abdomen   Sepsis   AKI (acute kidney injury)   COVID-19 virus infection       HPI:   Hospital Course:   This 74 year old man was admitted with klebsiella bacteremia.  He has pancreatic cancer and had past whipple.  He presented with chills.  Blood cultures grew klebsiella.  He was treated with iv antibiotics and did well.  Repeat cultures show clearing of blood.  He will complete antibiotics orally based on sensitivities.     CT did show abnormalities felt due to surgery.  There was also concern for recurrence of malignancy.  He has talked with his surgeon by phone and will follow up with facility in near future.     He did test positive for covid but did not require any treatment  Notes    Component Ref Range & Units 01:10  T BILIRUBIN 0.2 - 1.0 mg/dL 2.8 High   D BILIRUBIN 0.0 - 0.2 mg/dL 1.7 High   Albumin 3.2 - 5.0 g/dL 2.6 Low   ALT (SGPT) 10 - 60 [iU]/L 28  AST 10 - 42 [iU]/L 24  ALP 42 - 121 [iU]/L 330 High   PROTEIN TOTAL 6.1 - 7.8 g/dL 5.0 Low          MPRESSION:  From CT scan 1.  Postoperative changes from Whipple procedure secondary to pancreatic carcinoma.  There has been interval development of marked intra hepatic biliary ductal dilation extending to the main left and right intrahepatic ducts near the level of the of the choledochojejunostomy.  Although the there is relative density change in the porta hepatis this may simply be secondary to partial volume averaging with the adjacent bowel loop in the porta hepatis.  No more definitive masses identified.  Differential would remain benign stricture related to the choledochojejunostomy versus malignant obstruction.  Would consider follow-up MRI of the abdomen without and with IV contrast and MRCP for further evaluation. 2.  Multiple new small non calcified nodules in the lingula and left lower lobe suspicious for metastatic disease in this patient with history of pancreatic carcinoma.       Consults:   IP CONSULT TO HOSPITALIST       Disposition:  home   Discharge Condition:  fair
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis
Clinical narrative: Discharge Summary MD (Physician) ? ? Hospitalist Physician Discharge Summary   Patient ID: 74 y.o.    Admit Date:  7/5/2022   Discharge Date: 7/9/22   Principal Dx/ Final Dx: Bacteremia due to Klebsiella pneumoniae   Relevant Inpt Dx: Principal Problem:   Bacteremia due to Klebsiella pneumoniae Active Problems:   Type 2 diabetes mellitus, with long-term current use of insulin   Fever   Benign essential HTN   H/O Whipple procedure   Abnormal CT of the abdomen   Sepsis   AKI (acute kidney injury)   COVID-19 virus infection       HPI:   Hospital Course:   This 74 year old man was admitted with klebsiella bacteremia.  He has pancreatic cancer and had past whipple.  He presented with chills.  Blood cultures grew klebsiella.  He was treated with iv antibiotics and did well.  Repeat cultures show clearing of blood.  He will complete antibiotics orally based on sensitivities.     CT did show abnormalities felt due to surgery.  There was also concern for recurrence of malignancy.  He has talked with his surgeon by phone and will follow up with facility in near future.     He did test positive for covid but did not require any treatment  Notes    Component Ref Range & Units 01:10  T BILIRUBIN 0.2 - 1.0 mg/dL 2.8 High   D BILIRUBIN 0.0 - 0.2 mg/dL 1.7 High   Albumin 3.2 - 5.0 g/dL 2.6 Low   ALT (SGPT) 10 - 60 [iU]/L 28  AST 10 - 42 [iU]/L 24  ALP 42 - 121 [iU]/L 330 High   PROTEIN TOTAL 6.1 - 7.8 g/dL 5.0 Low          MPRESSION:  From CT scan 1.  Postoperative changes from Whipple procedure secondary to pancreatic carcinoma.  There has been interval development of marked intra hepatic biliary ductal dilation extending to the main left and right intrahepatic ducts near the level of the of the choledochojejunostomy.  Although the there is relative density change in the porta hepatis this may simply be secondary to partial volume averaging with the adjacent bowel loop in the porta hepatis.  No more definitive masses identified.  Differential would remain benign stricture related to the choledochojejunostomy versus malignant obstruction.  Would consider follow-up MRI of the abdomen without and with IV contrast and MRCP for further evaluation. 2.  Multiple new small non calcified nodules in the lingula and left lower lobe suspicious for metastatic disease in this patient with history of pancreatic carcinoma.       Consults:   IP CONSULT TO HOSPITALIST       Disposition:  home   Discharge Condition:  fair
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Pyrexia
Clinical narrative: Admitted to hospital 7/3/22 was admitted with fever.  He had covid.  He was seen by ID,  He was treated with remdesivir.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose: 1), for Covid-19 immunization; Bnt162b2 (Dose: 2), for Covid-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "never had AFib until receive the 2 shots and booster". Clinical course: Patient stated know 4 friends of mine that we all four never had AFib until receive the 2 shots and booster. Patient scheduled for an abolition surgery on 20Sep2022 and 2 of patient friend have already under gone this procedure. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Albumin globulin ratio, Anaemia, Angiogram pulmonary, Anion gap
Clinical narrative: Patient:Age:65 y.o.  Admit Date:  7/5/2022 Discharge Date:  7/14/2022      Principal Diagnoses:  Principal Problem:   Pneumonia due to infectious organism Active Problems:   Acute metabolic encephalopathy   ESRD (end stage renal disease)   COVID-19   Tick bite   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin     Discharge Diagnosis:  Bilateral PNA, Myroides bacteremia, COVID 19, ARF with ATN, HTN, elevated D.dimer. Anemia. Dm2,    Hospital Course:  The patient was admitted with the above. She was treated with 5 days of remdesivir. She was also treated with cefepime for PNA. Blood cultures came back positive for Myroides species. TEE was negative for endocarditis. Her tunneled Dialysis catheter was removed and she had a line holiday. The catheter was replaced and she did well with HD. She was weaned down to 2 liters of oxygen before discharge. She was swtiched to merrem for the blood cultures and was to complete 10 days total of abx. She had 3 days left at the time of discharge. She was debilitated so was sent to emcompas for further treatment.    Consults to: Nephrology, ID, vascular surgery.    Significant Diagnostic Studies:  CT head, CT abdomen, CTA chest, 2D echo,     Procedure(s): Tunneled Catheter exchange, TEE.    Disposition: LTAC.    Discharge Condition:  fair
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Bacteraemia, Bacterial test negative, Base excess increased, Basophil count decreased
Clinical narrative: Patient:Age:65 y.o.  Admit Date:  7/5/2022 Discharge Date:  7/14/2022      Principal Diagnoses:  Principal Problem:   Pneumonia due to infectious organism Active Problems:   Acute metabolic encephalopathy   ESRD (end stage renal disease)   COVID-19   Tick bite   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin     Discharge Diagnosis:  Bilateral PNA, Myroides bacteremia, COVID 19, ARF with ATN, HTN, elevated D.dimer. Anemia. Dm2,    Hospital Course:  The patient was admitted with the above. She was treated with 5 days of remdesivir. She was also treated with cefepime for PNA. Blood cultures came back positive for Myroides species. TEE was negative for endocarditis. Her tunneled Dialysis catheter was removed and she had a line holiday. The catheter was replaced and she did well with HD. She was weaned down to 2 liters of oxygen before discharge. She was swtiched to merrem for the blood cultures and was to complete 10 days total of abx. She had 3 days left at the time of discharge. She was debilitated so was sent to emcompas for further treatment.    Consults to: Nephrology, ID, vascular surgery.    Significant Diagnostic Studies:  CT head, CT abdomen, CTA chest, 2D echo,     Procedure(s): Tunneled Catheter exchange, TEE.    Disposition: LTAC.    Discharge Condition:  fair
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Basophil percentage decreased, Bilirubin urine, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bicarbonate increased
Clinical narrative: Patient:Age:65 y.o.  Admit Date:  7/5/2022 Discharge Date:  7/14/2022      Principal Diagnoses:  Principal Problem:   Pneumonia due to infectious organism Active Problems:   Acute metabolic encephalopathy   ESRD (end stage renal disease)   COVID-19   Tick bite   Type 2 diabetes mellitus with hyperglycemia, without long-term current use of insulin     Discharge Diagnosis:  Bilateral PNA, Myroides bacteremia, COVID 19, ARF with ATN, HTN, elevated D.dimer. Anemia. Dm2,    Hospital Course:  The patient was admitted with the above. She was treated with 5 days of remdesivir. She was also treated with cefepime for PNA. Blood cultures came back positive for Myroides species. TEE was negative for endocarditis. Her tunneled Dialysis catheter was removed and she had a line holiday. The catheter was replaced and she did well with HD. She was weaned down to 2 liters of oxygen before discharge. She was swtiched to merrem for the blood cultures and was to complete 10 days total of abx. She had 3 days left at the time of discharge. She was debilitated so was sent to emcompas for further treatment.    Consults to: Nephrology, ID, vascular surgery.    Significant Diagnostic Studies:  CT head, CT abdomen, CTA chest, 2D echo,     Procedure(s): Tunneled Catheter exchange, TEE.    Disposition: LTAC.    Discharge Condition:  fair