chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test negative
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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 13:00 as dose 1, single (Lot number: EN6200), in right arm, on 16Mar2021 at 13:00 as dose 2, single (Lot number: EN6206), in right arm and on 25Jan2022 at 18:00 as dose 3 (booster), single (Lot number: FJ5682) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (20Jun2022) Negative; (21Jun2022) Negative; (22Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, 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 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 at 13:00 as dose 1, single (Lot number: EN6200), in right arm, on 16Mar2021 at 13:00 as dose 2, single (Lot number: EN6206), in right arm and on 25Jan2022 at 18:00 as dose 3 (booster), single (Lot number: FJ5682) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (20Jun2022) Negative; (21Jun2022) Negative; (22Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Generalised oedema, Joint swelling, Peripheral swelling
Clinical narrative: Hair Loss; Backache; Nausea; Fever; Headache; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair Loss), BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VIT B12) for Vitamin supplementation.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches). On 01-Feb-2021, the patient experienced ALOPECIA (Hair Loss). The patient was treated with BIOTIN (oral) ongoing since an unknown date for Hair loss, at a dose of 500 microgram. On 16-Jan-2021, BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches) had resolved. At the time of the report, ALOPECIA (Hair Loss) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had never been diagnosed with/ tested positive for COVID-19 Indication for concomitant medication Vit B12 was reported as Energy Recent changes in condition status for Alopecia started on 01-Feb-2021 was reported as hair loss.   This case was linked to MOD-2022-584185, MOD-2022-596478 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Back pain, Headache, Myalgia, Nausea
Clinical narrative: Hair Loss; Backache; Nausea; Fever; Headache; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair Loss), BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VIT B12) for Vitamin supplementation.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches). On 01-Feb-2021, the patient experienced ALOPECIA (Hair Loss). The patient was treated with BIOTIN (oral) ongoing since an unknown date for Hair loss, at a dose of 500 microgram. On 16-Jan-2021, BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches) had resolved. At the time of the report, ALOPECIA (Hair Loss) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had never been diagnosed with/ tested positive for COVID-19 Indication for concomitant medication Vit B12 was reported as Energy Recent changes in condition status for Alopecia started on 01-Feb-2021 was reported as hair loss.   This case was linked to MOD-2022-584185, MOD-2022-596478 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Hair Loss; Backache; Nausea; Fever; Headache; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair Loss), BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VIT B12) for Vitamin supplementation.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches). On 01-Feb-2021, the patient experienced ALOPECIA (Hair Loss). The patient was treated with BIOTIN (oral) ongoing since an unknown date for Hair loss, at a dose of 500 microgram. On 16-Jan-2021, BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches) had resolved. At the time of the report, ALOPECIA (Hair Loss) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had never been diagnosed with/ tested positive for COVID-19 Indication for concomitant medication Vit B12 was reported as Energy Recent changes in condition status for Alopecia started on 01-Feb-2021 was reported as hair loss.   This case was linked to MOD-2022-584185, MOD-2022-596478 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Hair Loss; Backache; Nausea; Fever; Headache; Muscle aches; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Hair Loss), BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VIT B12) for Vitamin supplementation.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches). On 01-Feb-2021, the patient experienced ALOPECIA (Hair Loss). The patient was treated with BIOTIN (oral) ongoing since an unknown date for Hair loss, at a dose of 500 microgram. On 16-Jan-2021, BACK PAIN (Backache), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle aches) had resolved. At the time of the report, ALOPECIA (Hair Loss) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had never been diagnosed with/ tested positive for COVID-19 Indication for concomitant medication Vit B12 was reported as Energy Recent changes in condition status for Alopecia started on 01-Feb-2021 was reported as hair loss.   This case was linked to MOD-2022-584185, MOD-2022-596478 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Generalised oedema, Joint swelling, Peripheral swelling
Clinical narrative: Fever; Chills; Muscle Ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20R and 02LL20A) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for Vitamin supplementation.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache). On 13-Feb-2021, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) had resolved.            No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-596476, US-MODERNATX, INC.-MOD-2022-584185 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-596476:Dose 1 US-MODERNATX, INC.-MOD-2022-584185:Dose 3
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Back pain, Headache, Myalgia, Nausea
Clinical narrative: Fever; Chills; Muscle Ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20R and 02LL20A) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for Vitamin supplementation.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache). On 13-Feb-2021, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) had resolved.            No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-596476, US-MODERNATX, INC.-MOD-2022-584185 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-596476:Dose 1 US-MODERNATX, INC.-MOD-2022-584185:Dose 3
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Muscle Ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20R and 02LL20A) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for Vitamin supplementation.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache). On 13-Feb-2021, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) had resolved.            No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-596476, US-MODERNATX, INC.-MOD-2022-584185 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-596476:Dose 1 US-MODERNATX, INC.-MOD-2022-584185:Dose 3
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Muscle Ache; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20R and 02LL20A) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included CYANOCOBALAMIN (VITAMIN B-12) for Vitamin supplementation.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache). On 13-Feb-2021, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Muscle Ache) had resolved.            No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-596476, US-MODERNATX, INC.-MOD-2022-584185 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-596476:Dose 1 US-MODERNATX, INC.-MOD-2022-584185:Dose 3
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Hypoacusis, Magnetic resonance imaging head normal
Clinical narrative: SHL; lost complete hearing of the right ear; Began having right ear hearing problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: Heart disease. Concomitant medication(s) included: PLAVIX; CRESTOR; METOPROLOL. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization.  The following information was reported: HYPOACUSIS (disability) with onset 18May2022 at 14:00, outcome "not recovered", described as "Began having right ear hearing problem"; DEAFNESS (disability) with onset 18May2022 at 19:00, outcome "not recovered", described as "lost complete hearing of the right ear"; DEAFNESS NEUROSENSORY (disability, medically significant) with onset 23May2022, outcome "not recovered", described as "SHL". The events "shl", "lost complete hearing of the right ear" and "began having right ear hearing problem" required physician office visit. The patient underwent the following laboratory tests and procedures: Tested: (23May2022) SHL, notes: Tested and diagnosed as SHL; SARS-CoV-2 test: (20May2022) Negative, notes: COVID test type post vaccination: Nasal swab; (22May2022) Negative, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of deafness neurosensory, deafness, hypoacusis. Clinical Course:If other vaccine in four weeks was no. Other medications in two weeks  was multi vitamins. Treatment plan 3 injections of prednisone and oral two-week prednisone. If COVID prior vaccination was no. If COVID tested post vaccination was yes. COVID test type post vaccination was nasal swab, COVID test name post vaccination was rapid test, COVID test date: 20May2022, COVID test result: Negative. COVID test type post vaccination: Nasal Swab, COVID test name post vaccination: Rapid test, COVID test date: 22May2022, COVID test result: Negative. Known allergies was No. Device Date was 22Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Deafness neurosensory, Hypoacusis, Investigation, SARS-CoV-2 test
Clinical narrative: SHL; lost complete hearing of the right ear; Began having right ear hearing problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: Heart disease. Concomitant medication(s) included: PLAVIX; CRESTOR; METOPROLOL. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, UNKNOWN MANUFACTURER), for COVID-19 Immunization.  The following information was reported: HYPOACUSIS (disability) with onset 18May2022 at 14:00, outcome "not recovered", described as "Began having right ear hearing problem"; DEAFNESS (disability) with onset 18May2022 at 19:00, outcome "not recovered", described as "lost complete hearing of the right ear"; DEAFNESS NEUROSENSORY (disability, medically significant) with onset 23May2022, outcome "not recovered", described as "SHL". The events "shl", "lost complete hearing of the right ear" and "began having right ear hearing problem" required physician office visit. The patient underwent the following laboratory tests and procedures: Tested: (23May2022) SHL, notes: Tested and diagnosed as SHL; SARS-CoV-2 test: (20May2022) Negative, notes: COVID test type post vaccination: Nasal swab; (22May2022) Negative, notes: COVID test type post vaccination: Nasal swab. Therapeutic measures were taken as a result of deafness neurosensory, deafness, hypoacusis. Clinical Course:If other vaccine in four weeks was no. Other medications in two weeks  was multi vitamins. Treatment plan 3 injections of prednisone and oral two-week prednisone. If COVID prior vaccination was no. If COVID tested post vaccination was yes. COVID test type post vaccination was nasal swab, COVID test name post vaccination was rapid test, COVID test date: 20May2022, COVID test result: Negative. COVID test type post vaccination: Nasal Swab, COVID test name post vaccination: Rapid test, COVID test date: 22May2022, COVID test result: Negative. Known allergies was No. Device Date was 22Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, FLUX, UNK, UNK, COVID19
Symptoms: Dermatitis atopic, Fatigue, Headache, Impaired driving ability, Interchange of vaccine products
Clinical narrative: quadriparesis; impaired driving ability; muscular weakness; tremor; headache; fatigue; moderna covid-19 vaccine and pfizer biontech covid-19 vaccine; PSP_DUPILUMAB_SAGLB.DUP.17.03.0229  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2020SA142197 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 13May2022 as dose numner unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Dec2017 as first dose (Batch/Lot number: unknown) and on 09Mar2020 (Batch/Lot number: unknown) for dermatitis atopic, localised infection. The patient's relevant medical history included: "lung capacity abnormal" (unspecified if ongoing), notes: The patients past medical history included lung capacity abnormal; "laryngitis" (unspecified if ongoing), notes: had a little bit of laryngitis due to air very dry; "memory issues" (unspecified if ongoing), notes: memory issues (which was not elaborated further); "Rash" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: TRIAMCINOLONE taken for rash; PIMECROLIMUS taken for rash; KETOCONAZOLE taken for rash, eczema; LAMISIL [TERBINAFINE HYDROCHLORIDE] taken for eczema; TYLENOL. Vaccination history included: Influenza vaccine, for immunization. The following information was reported: QUADRIPARESIS (medically significant), outcome "recovering"; IMPAIRED DRIVING ABILITY (medically significant), outcome "recovering"; MUSCULAR WEAKNESS (non-serious), outcome "recovering"; TREMOR (non-serious), outcome "recovering"; HEADACHE (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Weight: Unknown results, notes: Relevant laboratory test results included: Weight-on the unknown date unknown pounds. The action taken for dupilumab was unknown.  The reporter's assessment of the causal relationship of "quadriparesis", "impaired driving ability", "muscular weakness", "tremor", "headache", "fatigue" and "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, FLUX, UNK, UNK, COVID19
Symptoms: Localised infection, Quadriparesis, Somnolence, Tremor, Upper respiratory tract infection
Clinical narrative: quadriparesis; impaired driving ability; muscular weakness; tremor; headache; fatigue; moderna covid-19 vaccine and pfizer biontech covid-19 vaccine; PSP_DUPILUMAB_SAGLB.DUP.17.03.0229  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2020SA142197 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 13May2022 as dose numner unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Dec2017 as first dose (Batch/Lot number: unknown) and on 09Mar2020 (Batch/Lot number: unknown) for dermatitis atopic, localised infection. The patient's relevant medical history included: "lung capacity abnormal" (unspecified if ongoing), notes: The patients past medical history included lung capacity abnormal; "laryngitis" (unspecified if ongoing), notes: had a little bit of laryngitis due to air very dry; "memory issues" (unspecified if ongoing), notes: memory issues (which was not elaborated further); "Rash" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: TRIAMCINOLONE taken for rash; PIMECROLIMUS taken for rash; KETOCONAZOLE taken for rash, eczema; LAMISIL [TERBINAFINE HYDROCHLORIDE] taken for eczema; TYLENOL. Vaccination history included: Influenza vaccine, for immunization. The following information was reported: QUADRIPARESIS (medically significant), outcome "recovering"; IMPAIRED DRIVING ABILITY (medically significant), outcome "recovering"; MUSCULAR WEAKNESS (non-serious), outcome "recovering"; TREMOR (non-serious), outcome "recovering"; HEADACHE (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Weight: Unknown results, notes: Relevant laboratory test results included: Weight-on the unknown date unknown pounds. The action taken for dupilumab was unknown.  The reporter's assessment of the causal relationship of "quadriparesis", "impaired driving ability", "muscular weakness", "tremor", "headache", "fatigue" and "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, FLUX, UNK, UNK, COVID19
Symptoms: Weight
Clinical narrative: quadriparesis; impaired driving ability; muscular weakness; tremor; headache; fatigue; moderna covid-19 vaccine and pfizer biontech covid-19 vaccine; PSP_DUPILUMAB_SAGLB.DUP.17.03.0229  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2020SA142197 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 13May2022 as dose numner unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Dec2017 as first dose (Batch/Lot number: unknown) and on 09Mar2020 (Batch/Lot number: unknown) for dermatitis atopic, localised infection. The patient's relevant medical history included: "lung capacity abnormal" (unspecified if ongoing), notes: The patients past medical history included lung capacity abnormal; "laryngitis" (unspecified if ongoing), notes: had a little bit of laryngitis due to air very dry; "memory issues" (unspecified if ongoing), notes: memory issues (which was not elaborated further); "Rash" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: TRIAMCINOLONE taken for rash; PIMECROLIMUS taken for rash; KETOCONAZOLE taken for rash, eczema; LAMISIL [TERBINAFINE HYDROCHLORIDE] taken for eczema; TYLENOL. Vaccination history included: Influenza vaccine, for immunization. The following information was reported: QUADRIPARESIS (medically significant), outcome "recovering"; IMPAIRED DRIVING ABILITY (medically significant), outcome "recovering"; MUSCULAR WEAKNESS (non-serious), outcome "recovering"; TREMOR (non-serious), outcome "recovering"; HEADACHE (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Weight: Unknown results, notes: Relevant laboratory test results included: Weight-on the unknown date unknown pounds. The action taken for dupilumab was unknown.  The reporter's assessment of the causal relationship of "quadriparesis", "impaired driving ability", "muscular weakness", "tremor", "headache", "fatigue" and "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, FLUX, UNK, UNK, COVID19
Symptoms: Fatigue, Headache, Impaired driving ability, Interchange of vaccine products, Muscular weakness
Clinical narrative: quadriparesis; impaired driving ability; muscular weakness; tremor; headache; fatigue; moderna covid-19 vaccine and pfizer biontech covid-19 vaccine; PSP_DUPILUMAB_SAGLB.DUP.17.03.0229  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2020SA142197 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 13May2022 as dose numner unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Dec2017 as first dose (Batch/Lot number: unknown) and on 09Mar2020 (Batch/Lot number: unknown) for dermatitis atopic, localised infection. The patient's relevant medical history included: "lung capacity abnormal" (unspecified if ongoing), notes: The patients past medical history included lung capacity abnormal; "laryngitis" (unspecified if ongoing), notes: had a little bit of laryngitis due to air very dry; "memory issues" (unspecified if ongoing), notes: memory issues (which was not elaborated further); "Rash" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: TRIAMCINOLONE taken for rash; PIMECROLIMUS taken for rash; KETOCONAZOLE taken for rash, eczema; LAMISIL [TERBINAFINE HYDROCHLORIDE] taken for eczema; TYLENOL. Vaccination history included: Influenza vaccine, for immunization. The following information was reported: QUADRIPARESIS (medically significant), outcome "recovering"; IMPAIRED DRIVING ABILITY (medically significant), outcome "recovering"; MUSCULAR WEAKNESS (non-serious), outcome "recovering"; TREMOR (non-serious), outcome "recovering"; HEADACHE (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Weight: Unknown results, notes: Relevant laboratory test results included: Weight-on the unknown date unknown pounds. The action taken for dupilumab was unknown.  The reporter's assessment of the causal relationship of "quadriparesis", "impaired driving ability", "muscular weakness", "tremor", "headache", "fatigue" and "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Sex: F
Vaccine: COVID19, COVID19, FLUX, UNK, UNK, COVID19
Symptoms: Quadriparesis, Tremor, Weight
Clinical narrative: quadriparesis; impaired driving ability; muscular weakness; tremor; headache; fatigue; moderna covid-19 vaccine and pfizer biontech covid-19 vaccine; PSP_DUPILUMAB_SAGLB.DUP.17.03.0229  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2020SA142197 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 13May2022 as dose numner unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), in Dec2017 as first dose (Batch/Lot number: unknown) and on 09Mar2020 (Batch/Lot number: unknown) for dermatitis atopic, localised infection. The patient's relevant medical history included: "lung capacity abnormal" (unspecified if ongoing), notes: The patients past medical history included lung capacity abnormal; "laryngitis" (unspecified if ongoing), notes: had a little bit of laryngitis due to air very dry; "memory issues" (unspecified if ongoing), notes: memory issues (which was not elaborated further); "Rash" (unspecified if ongoing); "Eczema" (unspecified if ongoing). Concomitant medication(s) included: TRIAMCINOLONE taken for rash; PIMECROLIMUS taken for rash; KETOCONAZOLE taken for rash, eczema; LAMISIL [TERBINAFINE HYDROCHLORIDE] taken for eczema; TYLENOL. Vaccination history included: Influenza vaccine, for immunization. The following information was reported: QUADRIPARESIS (medically significant), outcome "recovering"; IMPAIRED DRIVING ABILITY (medically significant), outcome "recovering"; MUSCULAR WEAKNESS (non-serious), outcome "recovering"; TREMOR (non-serious), outcome "recovering"; HEADACHE (non-serious), outcome "recovering"; FATIGUE (non-serious), outcome "recovering"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine". The patient underwent the following laboratory tests and procedures: Weight: Unknown results, notes: Relevant laboratory test results included: Weight-on the unknown date unknown pounds. The action taken for dupilumab was unknown.  The reporter's assessment of the causal relationship of "quadriparesis", "impaired driving ability", "muscular weakness", "tremor", "headache", "fatigue" and "moderna covid-19 vaccine and pfizer biontech covid-19 vaccine" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Tested positive for COVID-19; experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19), HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies. Patient had no history of Myocarditis/pericarditis.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. The patient had not taken any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was not hospitalized due to COVID-19.  Company comment: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to MOD-2022-593007, MOD-2022-593014, MOD-2022-592989 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Chest discomfort, Chest pain, Electrocardiogram, Fatigue
Clinical narrative: Tested positive for COVID-19; experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19), HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies. Patient had no history of Myocarditis/pericarditis.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. The patient had not taken any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was not hospitalized due to COVID-19.  Company comment: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to MOD-2022-593007, MOD-2022-593014, MOD-2022-592989 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Mechanical urticaria, Muscle spasms, Pruritus, Pyrexia
Clinical narrative: Tested positive for COVID-19; experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19), HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies. Patient had no history of Myocarditis/pericarditis.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. The patient had not taken any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was not hospitalized due to COVID-19.  Company comment: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to MOD-2022-593007, MOD-2022-593014, MOD-2022-592989 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Urticaria, X-ray
Clinical narrative: Tested positive for COVID-19; experienced headache, lasting 24hrs; experienced fever, lasting 24hrs; experienced tired, lasting 24hrs; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive for COVID-19), HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies. Patient had no history of Myocarditis/pericarditis.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs). The patient was treated with ACETAMINOPHEN at a dose of 500 milligram. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and HEADACHE (experienced headache, lasting 24hrs), PYREXIA (experienced fever, lasting 24hrs) and FATIGUE (experienced tired, lasting 24hrs) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. The patient had not taken any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient was not hospitalized due to COVID-19.  Company comment: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.   This case was linked to MOD-2022-593007, MOD-2022-593014, MOD-2022-592989 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 25-year-old female patient with no previous medical history reported, who experienced the non-serious unexpected AESI of COVID-19 (reported as Tested positive for COVID-19). The event occurred 8 months and 17 days after the second dose of mRNA-1273. Exact period of time between doses 1 and 2 of mRNA-1273 was not reported. The patient was not hospitalized due to COVID-19. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.