chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; 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 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: Gl0446), in left arm 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 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 Feb2023, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 21Feb2023 to 26Feb2023.
Age: 69.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-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 (Lot number: GH9703) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EL9266), on 19Mar2021 as dose 2, single (Lot number: EN6198), in left arm, on 17Sep2021 as dose 3 (booster), single (Lot number: EW0169), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillan, Erythrmycin, Ceclor, codiene; "mild asthma" (unspecified if ongoing); "had breast cancer 7 years ago" (unspecified if ongoing), notes: breast cancer 7 years ago; "high blood pressure" (unspecified if ongoing), notes: Other medical history: diabetes, high blood pressure, mild asthma, had breast cancer 7 years ago. Concomitant medication(s) included: METFORMIN, start date: 07Feb2002, stop date: 04Mar2023; ATORVASTATIN, stop date: 16Feb2023. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Penicillin, Erythromycin, Ceclor, codeine; Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Penicillin, Erythromycin, Ceclor, codeine; Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Penicillin, Erythromycin, Ceclor, codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 15Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: I also still was testing positive for Covid using an at home test; (04Mar2023) Positive, notes: today I again tested positive for Covid. Therapeutic measures were taken as a result of vaccination failure, covid-19: Treatment with Paxlovid.
Age: 49.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 49 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: "Diabetes mellitus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19: Treatment with Paxlovid.  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.
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 5 (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), 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: "Coronary artery disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: antigen 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: treatment with Paxlovid.
Age: 69.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 02:00 as dose 5 (booster), single (Lot number: C-J5352) at the age of 69 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: "Rheumatoid arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: 3 days after 5 day Paxlovid treatment and testing covid free; (2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19: Treatment with Paxlovid.
Age: 60.0
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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FJ1620), 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 had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP),.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches". Additional information: The reporter said he talked to 200 people who have a headache from that booster shot. 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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP)  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches". Additional information: The reporter said he talked to 200 people who have a headache from that booster shot. 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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:   A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  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-PV202300034302 Same reporter/ drug/ event for different patients;
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter. A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.;
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID on December 21, 2022
Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Inflammation
Clinical narrative: Patient reported their arm was red and inflamed.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a non-contactable reporter  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: his is a spontaneous report received from a non-contactable reporter NT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches".  Additional information: The reporter said he talked to 200 people who have a headaches from that booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Illness, Polymyalgia rheumatica
Clinical narrative: Polymyalgia rheumatica; decline in health; sick more or less; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 55-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: EW0161) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot number: ER2613), administration date: 30Mar2021, for Covid-19 Immunization, reaction(s): "Polymyalgia rheumatica", "decline in health". The following information was reported: ILLNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "sick more or less"; POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown"; GENERAL PHYSICAL HEALTH DETERIORATION (non-serious), outcome "unknown", described as "decline in health". Therapeutic measures were taken as a result of polymyalgia rheumatica and included treatment with prednisone since Apr2022. Clinical course: The patient need to get into a vaccine study. She have been sick more or less since Apr2021. Patient was still sick. The patient see a relationship between the vaccine and decline in health. She have never been diagnosed with COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300043708 same patient, different vaccine dose number/event;
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shot, got shingles anyway/Suspected vaccination failure; Got Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient's friend via interactive digital media. The patient did a shingles vaccine and he got shingles anyway. The reporter stated that his doctor told him 51 percent who got shingles vaccine got shingles anyway. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule ,time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR034659, reported by same reporter, for different patient.; Sender's Comments:  US-GSK-US2023AMR034659:Same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headaches". Additional information: The reporter said he talked to 200 people who have a headache from that booster shot. 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-202300086344 Same reporter/ drug/ event for different patients;
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: benign lesion removed from the leg; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID. The reporter is the patient.  A 68-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "handicap"; "Disability"; "chicken pox", notes: in inner ear; "don't hear well out", notes: right ear. The patient's concomitant medications were not reported. The following information was reported: SKIN LESION (medically significant), outcome "unknown", described as "benign lesion removed from the leg". Therapeutic measures were taken as a result of skin lesion. Additional information: patient stated, can't always hear. It's can't, it's hard to speak when the patient don't hear well out of the right ear. Patient sent a note up to the Neurologist and knows patient is handicap. Patient got vaccine and boosters in Jan or Feb when it first came out and developed a problem. Patient reported something, like a benign lesion removed from the leg. The surgical assistant said patient was going to give an (inaudible) injection and patient has watched as the assistant numb her leg up.  The patient did not specify which vaccine they received. Pfizer-BioNTech COVID-19 Vaccine is being reported out of an abundance of caution.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the temporal relationship, the association between the event "benign lesion removed from the leg" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Muscular tension dysphonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jul2022 as dose 4 (booster), single (Lot number: F107135) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ANASTROZOLE. Vaccination history included: BNT162b2 (dose 1, lot number=EN6207, vaccine location=Right arm), administration date: 12Mar2021, when the patient was 64-year-old, for COVID-19 Immunization; BNT162b2 (dose 2, lot number=ER8734,, vaccine location=Right arm), administration date: 02Apr2021, when the patient was 64-year-old, for COVID-19 Immunization; BNT162b2 (dose 3, lot number=FF2589, vaccine location=Left arm), administration date: 11Oct2021, when the patient was 65-year-old, for COVID-19 Immunization. The patient had no other vaccine in four weeks. The following information was reported: DYSPHONIA (disability) with onset 01Aug2022, outcome "not recovered", described as "Muscular tension dysphonia". The event "muscular tension dysphonia" required physician office visit. Therapeutic measures were not taken as a result of dysphonia.
Sex: U
Vaccine: FLU4
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA057309 and 2023SA057733.   This case involves Adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered DAPTACEL 5 days after the expiration date with no reported adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 19-month-old male patient to whom administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] 5 days after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Prophylactic vaccination.  On 03-Mar-2023, the patient received dose 4 at 0.5ml total of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength: standard) (lot number: C5816AA, expiry date: 26-Feb-2023) via intramuscular route in the left thigh for Immunization and on the same day to the patient administered daptacel 5 days after the expiration date with no reported adverse event (expired product administered).  It was reported, Caller requesting information on DAPTACEL. Wanting to know if the dose needs to be repeated.   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shots, got shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 01-Mar-2023 Reporter's Comment: This case was reported by patient via interactive digital media. The patient had the Shingles shots and still got shingles after. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Was vaccinated, got them on one hip/ Suspected vaccination failure; Got them on one hip, had them on face; They sting; They burn; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, stinging and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, stinging and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, stinging and burning sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter comment: This case was reported by a patient via interactive digital media. The patient was vaccinated and got them on one hip. The patient still think she/ he had them before on her/his face, they sting and burn. The patient doctor stated that she would prescribe Lyrica if it continues. The patient said he/ she will live with it, because she/ he don't want Lyrica.  The patient doctor stated you can get them again.  The patient stated that great prayers for those who are going through this too. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Mild
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Encephalopathy, Pneumonia, Pneumonia aspiration
Clinical narrative: acute hypoxic respiratory failure, COVID-19 infection, Possible aspiration pneumonia versus community-acquired pneumonia, acute encephalopathy
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory viral panel, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: acute hypoxic respiratory failure, COVID-19 infection, Possible aspiration pneumonia versus community-acquired pneumonia, acute encephalopathy
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Vaccinated-contracted COVID
Age: 91.0
Sex: F
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: vaccinated-got covid
Age: 91.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Got covid-vax'd
Age: 66.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Vaccinated, got covid
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthritis
Clinical narrative: I did not have an adverse reaction to the vaccine. I developed symptoms of arthritis in January 2023. I went to my doctor in February 2023 and diagnosed with inflammatory arthritis.  As of today, I am working with my doctor to find a medication that will help with the inflammation.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Headache, Infection
Clinical narrative: I experienced a breakthrough case of COVID-19 with sneezing, headaches, sore throat, sore ears, fever and chills, body aches, congestion and coughing.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: I experienced a breakthrough case of COVID-19 with sneezing, headaches, sore throat, sore ears, fever and chills, body aches, congestion and coughing.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: I experienced a breakthrough case of COVID-19 with sneezing, headaches, sore throat, sore ears, fever and chills, body aches, congestion and coughing.
Age: 35.0
Sex: M
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: Got COVID-vax'd