chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna-Dose 1, Dose 2, Dose 3; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 17:00 as dose 5 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2021 at 16:00 as dose 1, single (Lot number: 025L20A), in left arm, on 20Feb2021 at 15:00 as dose 2, single (Lot number: 031L20A), in left arm and on 09Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 004f21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Known allergie: Shellfish" (unspecified if ongoing), notes: Known allergies : Shellfish; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs. Concomitant medication(s) included: METFORMIN ER, start date: 05Sep2022; LISINOPRIL, start date: 08Jun2009; VITAMIN C [ASCORBIC ACID], start date: 03Oct2022; VITAMIN D3, start date: 18Jun2007; VITAMIN B12 [CYANOCOBALAMIN], start date: 15Jun2020. Past drug history included: Iodine, reaction(s): "Known allergies :  Iodine", notes: Known allergies :  Iodine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22May2022 at 16:00, outcome "unknown", described as "Moderna-Dose 1, Dose 2, Dose 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Interchange of vaccine products, Drug ineffective and COVID-19 cannot be excluded for the suspect drug BNT162B2. the case will be reassessed once new information is available.
Age: 59.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 16:00 as dose 1, single (Lot number: EN6202), in right arm, on 26Mar2021 at 16:00 as dose 2, single (Lot number: ER8730), in right arm and on 28Feb2022 at 16:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 59 years, in right arm for covid-19 immunisation. The patient had no relevant medical history (no known allergies). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was not taken any other medications/products within 2 weeks of starting COVID-19 treatment. Previously the patient was taken COVID-19 Vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 treatment; COVID 19 treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), lot unknown reason: unable to locate or read the details as dose 3 (booster), single (Batch/Lot number: unknown) 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: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, Other medical history: None. If vaccine received: Yes. Concomitant medication(s) (Other medication in 2 weeks) included: TRI-SPRINTEC; FISH OIL; VIT B12; VIT D [COLECALCIFEROL]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product: COVID 19 treatment. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device date: 16Oct2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
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.  An 80-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing), notes: Known allergies: Gluten. The patient's concomitant medications were not reported. Past drug history included: Malarone, reaction(s): "Known allergies: Malarone"; Synthroid, reaction(s): "Known allergies: Synthroid". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Positive, notes: Positive COVID test 5 days after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received, other medication in 2 weeks was reported as no. Paxlovid was started on 03Oct2022 and stopped on 08Oct2022 for the treatment of COVID-19. Vaccine lot unknown reason: Misplaced/discarded  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 35.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2022) Negative; (14Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had received Paxlovid as a Treatment of COVID-19 from 05Oct2022 to 09Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID with mild symptoms of feel like a head cold, runny nose, and cough; tested positive for COVID with mild symptoms of feel like a head cold, runny nose, and cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), in left arm, on 23Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 10Dec2021 as dose 3 (booster), single (Lot number: 330308D), in left arm and on 01Aug2022 as dose 4 (booster), single (Lot number: FP7139) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Oct2022, outcome "recovering" and all described as "tested positive for COVID with mild symptoms of feel like a head cold, runny nose, and cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 67-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "high cholestrol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive, notes: Initial infection. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from contactable reporter(s) (Physician).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: MYOCARDITIS (medically significant), outcome "unknown".  Clinical course: Something happened soon as after got the COVID-Vaccine (COVID-19 Vaccine) and it was the mRNA Vaccine (Unspecified Vaccine). But it was not confirmed if it was Pfizer or Moderna. Reporter saw a patient that had myocarditis.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and myocarditis cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Pain
Clinical narrative: the worst pain I have ever had; my underarm lymph node swelled up to the size of a grapefruit; I felt like I was about to vomit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ2524) at the age of 50 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (3rd dose), administration date: 09Nov2021, when the patient was 49-year-old, for COVID-19 Immunization, reaction(s): "the worst pain I have ever had", "my underarm lymph node swelled up to the size of a grapefruit", "I felt like I was about to vomit"; Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 11Oct2022 at 16:00, outcome "recovered" (Oct2022), described as "I felt like I was about to vomit"; LYMPHADENOPATHY (non-serious) with onset 11Oct2022 at 16:00, outcome "recovered" (Oct2022), described as "my underarm lymph node swelled up to the size of a grapefruit"; PAIN (non-serious) with onset 11Oct2022 at 16:00, outcome "recovered" (Oct2022), described as "the worst pain I have ever had". Therapeutic measures were not taken as a result of pain, lymphadenopathy, nausea. The clinical course was reported as follows: with this shot (4th dose) and with the last booster I had on 09Nov2021 my underarm lymph node swelled up to the size of a grapefruit and was the worst pain I have ever had. I happen to have a high tolerance for pain but this came in constant waves for 48 hours and every time it hit a 10 in pain I felt like I was about to vomit. Follow-up attempts are completed. No further information is expected.
Age: 26.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 26 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing), notes: Seasonal allergies; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Oct2022) Positive, notes: Completed Paxlovid regimen at 10AM Friday 14Oct2022 but still testing positive for COVID-19 24 hours later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details was product COVID 19 Treatment, brand was Paxlovid, treatment start date was 09Oct2022 and stop date was14Oct2022,indication was 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: 56.0
Sex: M
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 contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 as dose 1, single (Lot number: EB8737), in left arm, on 26Apr2021 as dose 2, single (Lot number: EW0172), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Adrenal Hyperplasia" (unspecified if ongoing). Concomitant medication(s) included: FLUDROCORTISONE, start date: 01Sep2021; HYDROCORTISONE, start date: 01Feb2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: our last booster was about 6 months ago, but we both had covid in September; our last booster was about 6 months ago, but we both had covid in September; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), SUSPECTED COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "our last booster was about 6 months ago, but we both had covid in September".   Clinical course: Caller was a consumer asking about the Pfizer Covid19 vaccine, explained our last booster was about 6 months ago, but they both had covid in September. They both were high-risk. Agent: E-transmit, AE for contracting covid after receiving all booster doses of vaccine. Caller stated she thought they probably had the Omicron variant of the virus. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), more than equal to 12 years - 15/15 mcg per dos.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201232922 Same reporter/drug/event, different Patient;
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Drug ineffective
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 71-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Jan2021 as dose 1, single (Lot number: 012L20A), in right arm, on 02Feb2021 as dose 2, single (Lot number: 010M20A), in left arm, on 24Aug2021 as dose 3 (booster), single (Lot number: 04021A), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: 002M12A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: AVAPRO, start date: Jan2017; CRESTOR, start date: Jan2017, stop date: 01Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information included: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: long haul COVID symptoms; long haul COVID symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "long haul COVID symptoms".  Clinical information: Consumer reporting for friends who are women in their 30-40s are abnormally thin and they are both experiencing long haul covid symptoms after being vaccinated. They are both so petite, they may need a child size dosage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200083726 same reporter/vaccine/event, different patients.;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech-Dose 1, Dose 2/Moderna-Dose 3, Dose 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: En6203), in left arm and on 22Mar2021 as dose 2, single (Lot number: Ep7534) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Dec2021 as dose 3 (booster), single (Lot number: 037c21a), in left arm and on 24May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "known allergies: fish" (unspecified if ongoing). Concomitant medication(s) included: TESTOSTERONE, start date: 16Aug2016; VALSARTAN. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 11Dec2021, outcome "unknown", described as "Pfizer / BioNTech-Dose 1, Dose 2/Moderna-Dose 3, Dose 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: Not available/provided to reporter at the time of report completion) at the age of 29 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nuvigil, reaction(s): "Drug allergy"; Provigil, reaction(s): "Drug allergy".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment drug from 04Oct2022 to 09Oct2022.  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: Lupus; "Fibromyalgia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nsaids, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment and previously received a COVID-19 Vaccine.  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 known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, 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) from product quality group. The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: Em9810), in left arm, on 12Mar2021 as dose 2, single (Lot number: En6208), in left arm, on 12Oct2021 as dose 3 (booster), single (Lot number: Ew0196), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: Fk9729) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "slight thyroid issue" (unspecified if ongoing); "known allergies:Quinolones" (unspecified if ongoing). Concomitant medication(s) included: LIVALO, start date: 01Jan2018, stop date: 22Sep2022; LOSARTAN, stop date: 22Sep2022; LEVOTHYROXINE, stop date: 22Sep2022; EZETIMIBE, stop date: 22Sep2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Positive, notes: Diagnosed 21Sep; Body temperature: (Sep2022) I had 101-102 fever each afternoon for about 3-4, notes: days. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 22Sep2022 to 26Sep2022. Clinical course: Adverse event was diagnosed on 21Sep. First bout, I had 101-102 fever each afternoon for about 3-4 days, and night sweats, fatigue. The patient received any other medication in two weeks.
Age: 61.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 at 12:00 as dose 1, single (Lot number: EN6203), in left arm, on 20Mar2021 at 12:00 as dose 2, single (Lot number: ER2613), in left arm, on 21Oct2021 at 12:00 as dose 3 (booster), single (Lot number: 3014SBA), in left arm and on 05May2022 at 12:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BRCA-1" (unspecified if ongoing), notes: BRCA-1; "MAC lung disease" (unspecified if ongoing), notes: MAC lung disease. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Oct2022) Positive; (10Oct2022) Negative; (12Oct2022) Positive; (15Oct2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and the patient got Paxlovid treatment initiated on 02Oct and finished last doses on 06Oct.  Clinical Course: The patient had no known allergies. It was reported that the patient received vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 43 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 09Apr2021 as dose 2, single (Lot number: ER8729), in right arm and on 27Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Apr2022 as dose 4 (booster), single (Lot number: 0E4J214), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Epileptic" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Apr2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that, it was unknown if patient was taking any other medications/products within 2 weeks of starting covid-19 treatment. The patient previously received a COVID-19 Vaccine. No known allergies. The patient received Paxlovid (route: oral) for the treatment of COVID-19 from 01Oct2022 to 06Oct2022. 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 known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2.
Age: 75.0
Sex: M
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 75-year-old male patient received BNT162b2, on 24Sep2021 as dose 3 (booster), single (Lot number: 301308A), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: FN2g0B) at the age of 75 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: COVID-19 Treatment (Treatment of COVID-19) with Paxlovid treatment start date on 01Oct2022 to treatment stop date on 05Oct2022.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 13Feb2021 as dose 2, single (Lot number: EL9267), in right arm and on 09Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Macular Degeneration" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2009, stop date: 27Sep2022; AREDS 2 PLUS MULTI VITAMIN, start date: Jan2018; VITAMIN D3, start date: 01Jan2019.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". 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.  Clinical course: The patient received Paxlovid for COVID 19 Treatment from 28Sep2022 to 03Oct2022. Other medication received in 2 weeks. Known allergies: None known.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: he's sick from the vaccine (two doses); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, 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, SINGLE), for Covid-19 immunisation, reaction(s): "he's sick from the vaccine (two doses)". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "he's sick from the vaccine (two doses)".  Additional information: Caller mentioned that he was sick from the vaccine (two doses) and would never take the booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200083941 same patient/drug/event, different dose.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Malaise
Clinical narrative: got very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "got very ill".  Additional information: Reporter's friend took the covid shot and the flu shot together and got very ill after doing that.  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: Blood glucose, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4483525-00. A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure study/not in control", start date: 2020 (ongoing); "Moderate to Severe Chronic Plaque Psoriasis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA subcutaneous taken for psoriasis. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 01Jul2022, outcome "unknown", COVID-19 (medically significant) with onset 01Jul2022, outcome "recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: Blood glucose: (2022) Unknown Results; SARS-CoV-2 test: (01Jul2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; dizzy like vertigo; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication included: ELIQUIS. Vaccination history included: BNT162b2 (Dose 1, ), administration date: 13Mar2021, when the patient was 61-year-old, for Covid-19 Immunization; BNT162b2 (Dose 2, ), administration date: 31Jul2021, when the patient was 61-year-old, for Covid-19 Immunization; Bnt162b2 (Dose 3), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 13Oct2022, outcome "unknown"; VERTIGO (non-serious) with onset Oct2022, outcome "unknown", described as "dizzy like vertigo".  Course of the event: After she got the booster yesterday she sat down for 15 minutes and then she went home and was dizzy and she laid down and got up and still dizzy and eventually went away and woke up to got the bathroom and was really dizzy like vertigo and when she woke up at 8 and had subsided a little and she went downstairs and she had to take her time and was a little dizzy.  Caller said dizzy was not listed in the side effects and said nothing about dizziness.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201236069 same patient, different drug, different event;
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Post-acute COVID-19 syndrome, Suspected COVID-19
Clinical narrative: have had Covid 3x + long hauler symptoms; have had Covid 3x + long hauler symptoms; have had Covid 3x + long hauler symptoms; have had Covid 3x + long hauler symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: Private. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: "Endometriosis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "inflammation issues" (unspecified if ongoing); "had Covid 3x" (unspecified if ongoing), notes: Covid 3x Positive long hauler symptoms. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown" and all described as "have had Covid 3x + long hauler symptoms".  Clinical course: The reporter reported about have pre-existing conditions, including Endometriosis, Fibromyalgia, Psoriasis, and a number of inflammation issues, and have had Covid 3x Positive long hauler symptoms. This far, your boosters were the only thing that gave relief.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Illness, Renal function test, Renal function test abnormal, Suspected COVID-19
Clinical narrative: Sick; COVID; COVID; Kidney number was high; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4252170-00.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1158135) at 40 mg (40 mg (citrate free)), subcutaneous for psoriatic arthropathy. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARBIDOPA + LEVODOPA. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID"; RENAL FUNCTION TEST ABNORMAL (non-serious) with onset 2022, outcome "unknown", described as "Kidney number was high"; ILLNESS (non-serious), outcome "unknown", described as "Sick". The patient underwent the following laboratory tests and procedures: Renal function test: (2022) High, notes: Kidney numbers [Renal function test], 2022, High; (unspecified date) Abnormal. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Events of Sick, and non-serious leakage when administers Humira shot, COVID, and Kidney number was high with Single Dose Pen, Adalimumab Solution for Injection. In Dec 2021, the patient had hip replacement. He got the COVID booster and got COVID after getting booster. Alternative Etiology for COVID with Adalimumab Solution for Injection: Event more likely related to SARS CoV-2 pandemic outbreak for tis elderly patient with psoriatic arthritis. Event more likely related to SARS CoV-2 pandemic outbreak for tis elderly patient with psoriatic arthritis. Change History: On 10 Oct 2022, Received updates for events. Pfizer COVID-19 vaccine was updated as suspect. Assessment results of event Hip replacement was updated as No reasonable possibility. Lab test was updated.  The reporter considered "covid" related to BNT162b2. The reporter's assessment of the causal relationship of "sick" and "kidney number was high" 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the limited available data events drug ineffective and suspected covid-19 are possibly related to the suspect BNT162B2 and other events illness and renal function test abnormal are not related to suspect.