chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Photophobia, Product use issue, Productive cough, Pyrexia, Sneezing
Clinical narrative: Fever (up to 101F recorded); chills; wet cough; vomiting; sneezing; minor aches; sensitivity to sound/light; sensitivity to sound/light; Other vaccine same date product= Flu; Other vaccine same date product= Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE (Lot Number: FF8841)), administration date: 08Dec2021, when the patient was 31-year-old, for covid-19 immunization; BNT162b2 (DOSE 2, SINGLE (Lot Number: EN6199)), administration date: 11May2021, when the patient was 30-year-old, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE (Lot Number: EN6199)), administration date: 19Apr2021, when the patient was 30-year-old, for covid-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Nov2022, outcome "unknown" and all described as "Other vaccine same date product= Flu"; PYREXIA (non-serious) with onset 28Dec2022, outcome "recovering", described as "Fever (up to 101F recorded)"; CHILLS (non-serious) with onset 28Dec2022, outcome "recovering"; PAIN (non-serious) with onset 28Dec2022, outcome "recovering", described as "minor aches"; HYPERACUSIS (non-serious), PHOTOPHOBIA (non-serious) all with onset 28Dec2022, outcome "recovering" and all described as "sensitivity to sound/light"; SNEEZING (non-serious) with onset 28Dec2022, outcome "recovering"; VOMITING (non-serious) with onset 28Dec2022, outcome "recovering"; PRODUCTIVE COUGH (non-serious) with onset 28Dec2022, outcome "recovering", described as "wet cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, productive cough, vomiting, sneezing, pain, hyperacusis, photophobia.
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Vomiting
Clinical narrative: Fever (up to 101F recorded); chills; wet cough; vomiting; sneezing; minor aches; sensitivity to sound/light; sensitivity to sound/light; Other vaccine same date product= Flu; Other vaccine same date product= Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE (Lot Number: FF8841)), administration date: 08Dec2021, when the patient was 31-year-old, for covid-19 immunization; BNT162b2 (DOSE 2, SINGLE (Lot Number: EN6199)), administration date: 11May2021, when the patient was 30-year-old, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE (Lot Number: EN6199)), administration date: 19Apr2021, when the patient was 30-year-old, for covid-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Nov2022, outcome "unknown" and all described as "Other vaccine same date product= Flu"; PYREXIA (non-serious) with onset 28Dec2022, outcome "recovering", described as "Fever (up to 101F recorded)"; CHILLS (non-serious) with onset 28Dec2022, outcome "recovering"; PAIN (non-serious) with onset 28Dec2022, outcome "recovering", described as "minor aches"; HYPERACUSIS (non-serious), PHOTOPHOBIA (non-serious) all with onset 28Dec2022, outcome "recovering" and all described as "sensitivity to sound/light"; SNEEZING (non-serious) with onset 28Dec2022, outcome "recovering"; VOMITING (non-serious) with onset 28Dec2022, outcome "recovering"; PRODUCTIVE COUGH (non-serious) with onset 28Dec2022, outcome "recovering", described as "wet cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, productive cough, vomiting, sneezing, pain, hyperacusis, photophobia.
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Fever (up to 101F recorded); chills; wet cough; vomiting; sneezing; minor aches; sensitivity to sound/light; sensitivity to sound/light; Other vaccine same date product= Flu; Other vaccine same date product= Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 03Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 3 (BOOSTER), SINGLE (Lot Number: FF8841)), administration date: 08Dec2021, when the patient was 31-year-old, for covid-19 immunization; BNT162b2 (DOSE 2, SINGLE (Lot Number: EN6199)), administration date: 11May2021, when the patient was 30-year-old, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE (Lot Number: EN6199)), administration date: 19Apr2021, when the patient was 30-year-old, for covid-19 immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Nov2022, outcome "unknown" and all described as "Other vaccine same date product= Flu"; PYREXIA (non-serious) with onset 28Dec2022, outcome "recovering", described as "Fever (up to 101F recorded)"; CHILLS (non-serious) with onset 28Dec2022, outcome "recovering"; PAIN (non-serious) with onset 28Dec2022, outcome "recovering", described as "minor aches"; HYPERACUSIS (non-serious), PHOTOPHOBIA (non-serious) all with onset 28Dec2022, outcome "recovering" and all described as "sensitivity to sound/light"; SNEEZING (non-serious) with onset 28Dec2022, outcome "recovering"; VOMITING (non-serious) with onset 28Dec2022, outcome "recovering"; PRODUCTIVE COUGH (non-serious) with onset 28Dec2022, outcome "recovering", described as "wet cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, productive cough, vomiting, sneezing, pain, hyperacusis, photophobia.
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Body temperature, Chills, Hyperacusis, Off label use, Pain
Clinical narrative: Clinitest Rapid COVID-19 Antigen Self-Test positive; Clinitest Rapid COVID-19 Antigen Self-Test positive; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: EN6199), on 11May2021 as dose 2, single (Lot number: EN6199) and on 08Dec2021 as dose 3 (booster), single (Lot number: FF8841) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "Clinitest Rapid COVID-19 Antigen Self-Test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300002490 Same reporter/patient/drug; different AE;
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Photophobia, Product use issue, Productive cough, Pyrexia, Sneezing
Clinical narrative: Clinitest Rapid COVID-19 Antigen Self-Test positive; Clinitest Rapid COVID-19 Antigen Self-Test positive; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: EN6199), on 11May2021 as dose 2, single (Lot number: EN6199) and on 08Dec2021 as dose 3 (booster), single (Lot number: FF8841) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "Clinitest Rapid COVID-19 Antigen Self-Test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300002490 Same reporter/patient/drug; different AE;
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Vomiting
Clinical narrative: Clinitest Rapid COVID-19 Antigen Self-Test positive; Clinitest Rapid COVID-19 Antigen Self-Test positive; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: EN6199), on 11May2021 as dose 2, single (Lot number: EN6199) and on 08Dec2021 as dose 3 (booster), single (Lot number: FF8841) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "Clinitest Rapid COVID-19 Antigen Self-Test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300002490 Same reporter/patient/drug; different AE;
Age: 32.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Clinitest Rapid COVID-19 Antigen Self-Test positive; Clinitest Rapid COVID-19 Antigen Self-Test positive; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 32 years for COVID-19 immunisation; BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: EN6199), on 11May2021 as dose 2, single (Lot number: EN6199) and on 08Dec2021 as dose 3 (booster), single (Lot number: FF8841) for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2022, outcome "unknown" and all described as "Clinitest Rapid COVID-19 Antigen Self-Test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300002490 Same reporter/patient/drug; different AE;
Age: 55.0
Sex: M
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9703) at the age of 55 years, in right 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 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 Dec2022, 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 has not received any other medication in 2 weeks.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Pfizer / BioNTech/Modedrna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 82 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Apr2022 as dose 4 (booster), single (Lot number: 048L21A) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostrate cancer" (unspecified if ongoing); "Non Hodgkin lymphoma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sodium pentothal, reaction(s): "Allergy: sodium pentothal". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2022, outcome "unknown", described as "Pfizer / BioNTech/Modedrna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment for Covid-19. The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as no. The patient previously receive a COVID-19 Vaccine was reported as yes. Reported Event were Sore throat, runny nose, tired eyes. Went to a hospital for pre-op testing and was tested for COVID-19 and was found to be positive. Slightly tired.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: a lot of sleeping; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tromethamine, reaction(s): "gets very ill". Vaccination history included: Bnt162b2 (DOSE 1, lot# FJ8762.), for COVID-19 Immunization, reaction(s): "she had seizure". The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "a lot of sleeping". Additional information: The reporter stated that s she was going for her pre-registration last month for the vaccination, she saw tromethamine listed as part of the bivalent vaccine. The patient got very ill if she received tromethamine orally or through IV. The reporter wanted to know if there was a way to trace if the Pfizer vaccine they had contained tromethamine as they were able to "tolerate it". The information will help her decide if they should get the bivalent vaccine.  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) : PFIZER INC-202201402857 same patient/drug, different dose/event;
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 12:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 14:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 at 14:30 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Oct2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Apr2022 at 14:45 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "splenectomy" (unspecified if ongoing); "pancreatic removal" (unspecified if ongoing); "Brest cancer" (unspecified if ongoing). Concomitant medication(s) included: INSULIN GLARGINE, start date: 30Jan2020. Past drug history included: Codeine, reaction(s): "known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, 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: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Headache, Pyrexia
Clinical narrative: chest pain; headache; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FJ8762) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tromethamine, reaction(s): "GI bleeding", notes: She and her mom have a reaction to tromethamine. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "For me, I had chest pain"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "fever". Relevant laboratory tests and procedures are available in the appropriate section.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Pyrexia
Clinical narrative: Chest pain; Headache; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female 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. Past drug history included: Tromethamine, reaction(s): "GI bleeding". Vaccination history included: Bnt162b2 (Dose: 1 lot number FJ8762), for COVID-19 immunization, reaction(s): "Chest pain", "headache", "fever". The following information was reported: CHEST PAIN (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Additional information: The patient was going for her pre-registration last month for the vaccination, she saw tromethamine listed as part of the bivalent vaccine. She and her mom have a reaction to tromethamine. "If I take tromethamine orally, I'll have GI bleeding. For her (mom), she gets very ill whether she gets it orally or through IV". They both had Pfizer vaccines each time because "Moderna had tromethamine as ingredient from the very beginning." They had a mild reaction to the previous Pfizer vaccine they had. LOT#FJ8762. Caller wants to know if there is a way to trace if the Pfizer vaccine they had contained tromethamine as they were able to "tolerate it". The information will help her decide if they should get the bivalent vaccine. For me, I had chest pain, headache, fever for my vaccines".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
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.  A 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), 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), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: other medical history: Hypothyroidism; "post-menopausal" (unspecified if ongoing), notes: other medical history:post-menopausal. Concomitant medication(s) included: SYNTHROID; IMVEXXY. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (31Dec2022) Positive, notes: retested on 31Dec2022 and had a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19. 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: 68.0
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.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 at 09:00 as dose 5 (booster), single (Lot number: Gj2524) at the age of 68 years, in right 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, single (Batch/Lot number: unknown) and as dose 4, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "IV contrast allergy" (unspecified if ongoing), notes: Known allergies: IV contrast; "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: STELARA taken for Crohn's disease. The patient also took multiple unspecified medications as concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Negative; (Dec2022) Negative; (Dec2022) Positive; (Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19: complete 10 doses of PAXLOVID from 18Dec2022 to 23Dec2022.
Age: 72.0
Sex: F
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 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Jun2022 at 17:00 as dose 4 (booster), single (Lot number: FN2908), in left arm and on 17Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Feb2021 at 10:00 as dose 1, single (Lot number: EL9265), in left arm, on 23Feb2021 at 10:00 as dose 2, single (Lot number: EN6198), in left arm and on 13Oct2021 at 15:00 as dose 3 (booster), single (Lot number: FF8841), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing), notes: sulfa drugs; "penicillin" (unspecified if ongoing), notes: penicillin; "latex" (unspecified if ongoing), notes: latex. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 36.0
Sex: F
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 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Aug2021 as dose 1, single (Lot number: EW0167) and on 04Sep2021 as dose 2, single (Lot number: FC3182) at the age of 36 years for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures (Paxlovid) were taken as a result of vaccination failure, covid-19. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19, 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 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Dec2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: Tested negative for two days after the completion of Paxlovid; Positive, notes: after completion my symptoms have returned and I have tested positive again; Negative, notes: Tested negative for two days after the completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Tested negative for two days after the completion of Paxlovid and felt better now the fourth day after completion my symptoms have returned, and I have tested positive again. Patient received vaccine. It was unknown if patient received any other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 25 years 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: "3rd time with covid", start date: Apr2020 (unspecified if ongoing), notes: 3rd time with covid. Had pneumonia the 1st time I had covid in Apr2020; "Latex allergy" (unspecified if ongoing); "Pneumonia", start date: Apr2020 (unspecified if ongoing), notes: 3rd time with covid. Had pneumonia the 1st time I had covid in Apr2020. There were no concomitant medications. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin". 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, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had not received other medication in 2 weeks. Patient received anti-viral drug Paxlovid (Lot number: GC7458) from Dec2022 for the treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Pfizer Dose 3 14Nov2021, Moderna Dose 2 01Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 at 10:30 as dose 5 (booster), single (Lot number: GH9703) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Nov2021 at 10:30 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 14Jun2022 at 10:30 as dose 4 (booster), single (Lot number: LP4554), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Feb2021 at 10:30 as dose 1, single (Lot number: 022M20A), in left arm and on 01Apr2021 at 10:30 as dose 2, single (Lot number: 020B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 14Nov2021, outcome "unknown", described as "Pfizer Dose 3 14Nov2021, Moderna Dose 2 01Apr2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (29Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Tendonitis
Clinical narrative: Developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations; Developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: en6198) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. The following information was reported: BURSITIS (disability), TENDONITIS (disability) all with onset 2021, outcome "not recovered" and all described as "Developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations". The event "developed right shoulder tendinitis/bursitis to right arm after first 2 vaccinations" required physician office visit. Therapeutic measures were taken as a result of tendonitis, bursitis (Cortisone shots, prednisone).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Tendonitis
Clinical narrative: Developed right shoulder tendinitis; bursitis to right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: ew0170) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: en6198, Location of injection: Arm Right), administration date: 10Apr2021, when the patient was 59-year-old, for Covid-19 immunization, reaction(s): "developed right shoulder tendinitis", "bursitis to right arm". Patient had no known drug allergies. The following information was reported: TENDONITIS (disability) with onset 01Jul2021, outcome "not recovered", described as "Developed right shoulder tendinitis"; BURSITIS (disability) with onset 01Jul2021, outcome "not recovered", described as "bursitis to right arm". The events "developed right shoulder tendinitis" and "bursitis to right arm" required physician office visit. Therapeutic measures were taken as a result of tendonitis, bursitis (Cortisone shots, prednisone).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Bursitis, Polymyalgia rheumatica, Rheumatoid arthritis, Tendonitis
Clinical narrative: developed an inflammatory arthritis/PMR/RA post vaccination; developed an inflammatory arthritis/PMR/RA post vaccination; developed tendinitis/bursitis to left arm after booster; developed tendinitis/bursitis to left arm after booster; developed an inflammatory arthritis/PMR/RA post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID test positive", start date: 27Jul2022, stop date: 27Jul2022, notes: covid test type post vaccination: Nasal Swab; covid test name post vaccination: Abbott test. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: en6198, Location of injection: Arm Right), administration date: 10Apr2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "bursitis", "tendinitis", "covid-19"; BNT162b2 (Dose 2, single, Batch/Lot No: ew0170, Location of injection: Arm Right), administration date: 03May2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "covid-19", "tendinitis", "bursitis". The patient has no known drug allergies. The following information was reported: ARTHRITIS (disability), POLYMYALGIA RHEUMATICA (disability, medically significant), RHEUMATOID ARTHRITIS (disability, medically significant ) all with onset 2021, outcome "not recovered" and all described as "developed an inflammatory arthritis/PMR/RA post vaccination"; BURSITIS (disability), TENDONITIS (disability) all with onset 2021, outcome "not recovered" and all described as "developed tendinitis/bursitis to left arm after booster". The events "developed tendinitis/bursitis to left arm after booster" and "developed an inflammatory arthritis/pmr/ra post vaccination" required physician office visit. Therapeutic measures were taken as a result of bursitis, tendonitis, arthritis, polymyalgia rheumatica, rheumatoid arthritis and included cortisone shots and prednisone.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: developed an inflammatory arthritis/PMR/RA post vaccination; developed an inflammatory arthritis/PMR/RA post vaccination; developed tendinitis/bursitis to left arm after booster; developed tendinitis/bursitis to left arm after booster; developed an inflammatory arthritis/PMR/RA post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID test positive", start date: 27Jul2022, stop date: 27Jul2022, notes: covid test type post vaccination: Nasal Swab; covid test name post vaccination: Abbott test. Concomitant medication(s) included: SYNTHROID. Vaccination history included: BNT162b2 (Dose 1, single, Batch/Lot No: en6198, Location of injection: Arm Right), administration date: 10Apr2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "bursitis", "tendinitis", "covid-19"; BNT162b2 (Dose 2, single, Batch/Lot No: ew0170, Location of injection: Arm Right), administration date: 03May2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "covid-19", "tendinitis", "bursitis". The patient has no known drug allergies. The following information was reported: ARTHRITIS (disability), POLYMYALGIA RHEUMATICA (disability, medically significant), RHEUMATOID ARTHRITIS (disability, medically significant ) all with onset 2021, outcome "not recovered" and all described as "developed an inflammatory arthritis/PMR/RA post vaccination"; BURSITIS (disability), TENDONITIS (disability) all with onset 2021, outcome "not recovered" and all described as "developed tendinitis/bursitis to left arm after booster". The events "developed tendinitis/bursitis to left arm after booster" and "developed an inflammatory arthritis/pmr/ra post vaccination" required physician office visit. Therapeutic measures were taken as a result of bursitis, tendonitis, arthritis, polymyalgia rheumatica, rheumatoid arthritis and included cortisone shots and prednisone.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthritis, Bursitis, Polymyalgia rheumatica, Rheumatoid arthritis, Tendonitis
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: en6198), in right arm, on 03May2021 as dose 2, single (Lot number: ew0170), in right arm and on 18Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: Nasal Swab.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Since the vaccination, has the patient been tested for COVID-19?:Yes; Since the vaccination, has the patient been tested for COVID-19?:Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: en6198), in right arm, on 03May2021 as dose 2, single (Lot number: ew0170), in right arm and on 18Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jul2022, outcome "unknown" and all described as "Since the vaccination, has the patient been tested for COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jul2022) Positive, notes: Nasal Swab.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Lacrimation increased, Photophobia, Vision blurred, Visual impairment
Clinical narrative: his vision in his left eye is now minimal; his left eye watering uncontrollably; his left eye hurt really bad/His sight in his right eye hurts his left eye; It was very blurry and can't make out much; light hurts more than anything; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 40-year-old male patient received BNT162b2 (COMIRNATY), on 30Dec2022 at 13:15 as dose 1, single (Lot number: Fr2587) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Copd" (unspecified if ongoing); "Hepatitis C" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VISION BLURRED (disability) with onset 30Dec2022, outcome "not recovered", described as "It was very blurry and can't make out much"; EYE PAIN (disability) with onset 30Dec2022, outcome "not recovered", described as "his left eye hurt really bad/His sight in his right eye hurts his left eye"; LACRIMATION INCREASED (disability) with onset 30Dec2022, outcome "not recovered", described as "his left eye watering uncontrollably"; VISUAL IMPAIRMENT (disability) with onset 30Dec2022, outcome "not recovered", described as "his vision in his left eye is now minimal"; PHOTOPHOBIA (disability) with onset 30Dec2022, outcome "not recovered", described as "light hurts more than anything". The events "his vision in his left eye is now minimal", "his left eye watering uncontrollably", "his left eye hurt really bad/his sight in his right eye hurts his left eye", "it was very blurry and can't make out much" and "light hurts more than anything" required emergency room visit. Therapeutic measures were not taken as a result of visual impairment, lacrimation increased, eye pain, vision blurred, photophobia. Clinical course details: 5 minutes after the shot was given, his left eye hurt really bad and watering uncontrollably, and has been like that since his vision in his left eye is now minimal. It was very blurry and can't make out much. He had a 20/20 vision prior to this and light hurts more than anything. His sight in his right eye hurts his left eye. The patient has no known allergies. The patient has not been test post vaccination for covid. The patient has not had covid prior to vaccination.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid diagnosed by home test 06Dec; Covid diagnosed by home test 06Dec; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 3 (booster), single (Lot number: C-H902) at the age of 79 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 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 06Dec2022, outcome "unknown" and all described as "Covid diagnosed by home test 06Dec". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Dec2022) Positive, notes: Covid diagnosed by home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 (paxlovid).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Minor COPD" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN, stop date: 20Dec2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.