chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071431, US-MODERNATX, INC.-MOD-2021-071492 (E2B Linked Report). This case was linked to MOD-2021-052937, MOD-2021-052928 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071492: US-MODERNATX, INC.-MOD-2021-071431:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030m20a and 031a21a) for COVID-19 vaccination.     The patient's past medical history included Eczema (Patient had eczema in his childhood but it went away The eczema came back when the patient was given "several shots" 50 years ago.). Concomitant products included OMEPRAZOLE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ECZEMA (Eczema). At the time of the report, ECZEMA (Eczema) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included a cream to help with the itchiness and a steroid shot 1 hour after the second dose.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness at the injection site; Swelling at the injection site; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.            No relevant concomitant medications were reported.   No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not applicable.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tingling in my tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling in my tongue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (tetanus).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling in my tongue). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 26-Feb-2021 at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Feb-2021 at an unspecified dose and frequency and IBUPROFEN on 26-Feb-2021 at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (tingling in my tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tachycardia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Fast heart beat; Fluttering; Redness near the injection site; Itching near the injection site; Swelling near the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Fast heart beat), PALPITATIONS (Fluttering), VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Swelling near the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced TACHYCARDIA (Fast heart beat), PALPITATIONS (Fluttering), VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Swelling near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Fast heart beat), PALPITATIONS (Fluttering), VACCINATION SITE ERYTHEMA (Redness near the injection site), VACCINATION SITE PRURITUS (Itching near the injection site) and VACCINATION SITE SWELLING (Swelling near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Dec-2020 and the estimated date of delivery was 14-Sep-2021. On 06-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 06-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Concomitant medication includes Thyroid medicine. No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding mother received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breastfeeding mother received vaccine) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 22-Mar-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding mother received vaccine). On 22-Mar-2021, EXPOSURE VIA BREAST MILK (Breastfeeding mother received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient states that he noticed it was only drawn up to 0.1ml, the staff says it was drawn up to 0.5ml; A spontaneous report was received from a pharmacist ,concerning a 64-year-old, male patient , who received Moderna's COVID-19 vaccine(mRNA-1273) and patient states that he noticed it was only drawn up to 0.1ml,staff says it was drawn up to 0.5ml.  The patient's medical history was not reported. Concomitant medication reported was not reported.  On 21 Feb 2021, patient received their first of two planned doses of mRNA-1273(Lot/batch: unknown) vaccine through unknown route of administration, for prophylaxis of COVID-19 infection.  On 22 Mar 2021, patient received their second of two planned doses of mRNA-1273(Lot/batch:031A21A) vaccine through unknown route of administration, in the left arm, for prophylaxis of COVID-19 infection.  On 22 Mar 2021, the patient experienced event that he noticed it was only drawn up to 0.1ml , the staff says it was drawn up to 0.5ml. Treatment information was not reported.  Action taken with mRNA-1273 in response to the events was not applicable.  The event patient noticed it was only drawn up to 0.1ml, the staff says it was drawn up to 0.5ml was considered resolved on 22 Mar 2021.; Reporter's Comments: This report refers to a case of accidental under dose for mRNA-1273 with no associated AEs.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Tinnitus
Clinical narrative: Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now; Joint pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now) and ARTHRALGIA (Joint pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dental implant user (Patient stated that she had dental implants after she received the vaccine).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now) and ARTHRALGIA (Joint pain). At the time of the report, TINNITUS (Humming/buzz in my ear - kind of like tinnitus - becoming more dominant now) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.  No relevant concomitant medications were reported.   Patient thought the humming sound was due to the dental implant but her oral surgeon told her it was due to vaccine, a rare side effect.  Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oedema peripheral, Pain, Rash, Rash erythematous
Clinical narrative: painful; shingles-like feeling; red; the ones by my ankles are getting big; very itchy; They were red; they're starting to turn purple; they started popping up all over legs, arms, bottoms of my feet, palms of my hands, face, lower back/ about 25 of them on each hand and foot/ more on my hands and feet than anywhere else; raised bumps on her fingers on the left hand/ they started popping up all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PAPULAR (raised bumps on her fingers on the left hand/ they started popping up all over), PAIN (painful), HERPES ZOSTER (shingles-like feeling), RASH ERYTHEMATOUS (red) and OEDEMA PERIPHERAL (the ones by my ankles are getting big) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox (Patient had chickenpox at the age of 6.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH PAPULAR (raised bumps on her fingers on the left hand/ they started popping up all over). On 21-Mar-2021, the patient experienced RASH (they started popping up all over legs, arms, bottoms of my feet, palms of my hands, face, lower back/ about 25 of them on each hand and foot/ more on my hands and feet than anywhere else). On 22-Mar-2021, the patient experienced SKIN DISCOLOURATION (They were red; they're starting to turn purple). On an unknown date, the patient experienced PAIN (painful), HERPES ZOSTER (shingles-like feeling), RASH ERYTHEMATOUS (red), OEDEMA PERIPHERAL (the ones by my ankles are getting big) and RASH PRURITIC (very itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and NAPROXEN at a dose of 1 dosage form. At the time of the report, RASH PAPULAR (raised bumps on her fingers on the left hand/ they started popping up all over), PAIN (painful), HERPES ZOSTER (shingles-like feeling), RASH ERYTHEMATOUS (red), OEDEMA PERIPHERAL (the ones by my ankles are getting big), SKIN DISCOLOURATION (They were red; they're starting to turn purple), RASH PRURITIC (very itchy) and RASH (they started popping up all over legs, arms, bottoms of my feet, palms of my hands, face, lower back/ about 25 of them on each hand and foot/ more on my hands and feet than anywhere else) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.   The ones by her ankles are getting big, but she's not sure if it's from her shoes rubbing on them.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic, Skin discolouration
Clinical narrative: painful; shingles-like feeling; red; the ones by my ankles are getting big; very itchy; They were red; they're starting to turn purple; they started popping up all over legs, arms, bottoms of my feet, palms of my hands, face, lower back/ about 25 of them on each hand and foot/ more on my hands and feet than anywhere else; raised bumps on her fingers on the left hand/ they started popping up all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PAPULAR (raised bumps on her fingers on the left hand/ they started popping up all over), PAIN (painful), HERPES ZOSTER (shingles-like feeling), RASH ERYTHEMATOUS (red) and OEDEMA PERIPHERAL (the ones by my ankles are getting big) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chickenpox (Patient had chickenpox at the age of 6.).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH PAPULAR (raised bumps on her fingers on the left hand/ they started popping up all over). On 21-Mar-2021, the patient experienced RASH (they started popping up all over legs, arms, bottoms of my feet, palms of my hands, face, lower back/ about 25 of them on each hand and foot/ more on my hands and feet than anywhere else). On 22-Mar-2021, the patient experienced SKIN DISCOLOURATION (They were red; they're starting to turn purple). On an unknown date, the patient experienced PAIN (painful), HERPES ZOSTER (shingles-like feeling), RASH ERYTHEMATOUS (red), OEDEMA PERIPHERAL (the ones by my ankles are getting big) and RASH PRURITIC (very itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and NAPROXEN at a dose of 1 dosage form. At the time of the report, RASH PAPULAR (raised bumps on her fingers on the left hand/ they started popping up all over), PAIN (painful), HERPES ZOSTER (shingles-like feeling), RASH ERYTHEMATOUS (red), OEDEMA PERIPHERAL (the ones by my ankles are getting big), SKIN DISCOLOURATION (They were red; they're starting to turn purple), RASH PRURITIC (very itchy) and RASH (they started popping up all over legs, arms, bottoms of my feet, palms of my hands, face, lower back/ about 25 of them on each hand and foot/ more on my hands and feet than anywhere else) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported.   The ones by her ankles are getting big, but she's not sure if it's from her shoes rubbing on them.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Extra dose administered, Palpitations
Clinical narrative: palpitations; heaviness in his heart.; patient received his third dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (palpitations), CHEST DISCOMFORT (heaviness in his heart.) and EXTRA DOSE ADMINISTERED (patient received his third dose of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Brain disorder NOS and Memory impairment.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PALPITATIONS (palpitations), CHEST DISCOMFORT (heaviness in his heart.) and EXTRA DOSE ADMINISTERED (patient received his third dose of the vaccine). On 17-Mar-2021, PALPITATIONS (palpitations), CHEST DISCOMFORT (heaviness in his heart.) and EXTRA DOSE ADMINISTERED (patient received his third dose of the vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   An ambulance was called and an EKG was taken but the caller has no information on its results. The patient was able to keep up a conversation throughout this situation. Eventually, his feelings resolved and he was stable and released from the vaccination site. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Slept for three to four days after second shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for three to four days after second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (Slept for three to four days after second shot). At the time of the report, HYPERSOMNIA (Slept for three to four days after second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 012M20A.) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown. Not Provided          Concomitant medications were not reported. Treatment information were not provided.  Action taken with mRNA-1273 in response to the event was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   This case was linked to MOD21-059005 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Lymphadenopathy, Pain, Swelling, Vaccination site pain
Clinical narrative: discomfort while sleeping; pain - pain level 3 on a pain scale of 1-10; small bump on his head; swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear; arm is sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head), VACCINATION SITE PAIN (arm is sore at the injection site) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is sore at the injection site). On 21-Mar-2021, the patient experienced INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear). At the time of the report, INSOMNIA (discomfort while sleeping), PAIN (pain - pain level 3 on a pain scale of 1-10), SWELLING (small bump on his head), VACCINATION SITE PAIN (arm is sore at the injection site) and LYMPHADENOPATHY (swelling of the lymph node on the right side of the head/swelling of the lymph node all the way back to the top of the right ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: hard and red spot on her arm around the site of injection; only achy the first night after receiving the injection but not anymore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection) and VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.). On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection). On 12-Mar-2021, VACCINATION SITE PAIN (only achy the first night after receiving the injection but not anymore.) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (hard and red spot on her arm around the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: temperature that went up to 102; headaches; very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102). At the time of the report, HEADACHE (headaches), FATIGUE (very fatigued) and PYREXIA (temperature that went up to 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Temperature went up to 102.         No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: updated contact information (mail, address)and new event
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Rash
Clinical narrative: Rash on her face / Rash on her neck; Lot of chills; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), RASH (Rash on her face / Rash on her neck) and CHILLS (Lot of chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Pain). On 20-Mar-2021, the patient experienced CHILLS (Lot of chills). On 21-Mar-2021, the patient experienced RASH (Rash on her face / Rash on her neck). At the time of the report, PAIN (Pain), RASH (Rash on her face / Rash on her neck) and CHILLS (Lot of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-053016 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Eye irritation, Headache, Peripheral swelling, Swelling face
Clinical narrative: Later experienced shortness; Swollen face; Swollen arms; Teeth ache; Burning eyes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache) and EYE IRRITATION (Burning eyes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache), EYE IRRITATION (Burning eyes) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache), EYE IRRITATION (Burning eyes) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not administered. Treatment for the event was not taken.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Later experienced shortness; Swollen face; Swollen arms; Teeth ache; Burning eyes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache) and EYE IRRITATION (Burning eyes) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache), EYE IRRITATION (Burning eyes) and HEADACHE (Headache). At the time of the report, DYSPNOEA (Later experienced shortness), SWELLING FACE (Swollen face), PERIPHERAL SWELLING (Swollen arms), TOOTHACHE (Teeth ache), EYE IRRITATION (Burning eyes) and HEADACHE (Headache) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not administered. Treatment for the event was not taken.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Taste disorder
Clinical narrative: Patient stated that she has experienced the vaccine working from her upper arm, into her face,; patient said that she can taste the vaccine; Having issues with feeling in face; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (Patient stated that she has experienced the vaccine working from her upper arm, into her face,), TASTE DISORDER (patient said that she can taste the vaccine) and HYPOAESTHESIA (Having issues with feeling in face) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Patient stated that she has experienced the vaccine working from her upper arm, into her face,), TASTE DISORDER (patient said that she can taste the vaccine) and HYPOAESTHESIA (Having issues with feeling in face). At the time of the report, FEELING ABNORMAL (Patient stated that she has experienced the vaccine working from her upper arm, into her face,) and TASTE DISORDER (patient said that she can taste the vaccine) outcome was unknown and HYPOAESTHESIA (Having issues with feeling in face) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient reported that she has not received any treatment.   This case was linked to US-MODERNATX, INC.-MOD-2021-053108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053108:Crosslinked for Dose 2
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Congestive heart failure. Concomitant products included DIGOXIN and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.            No treatment medications were provided.  The patient experienced dizziness, she states the whole room spins only when she is going to bed at night, but the dizziness is not there in the morning.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: blotchy now going down to her wrist; Arm was warm at injection site; Circled her arm above elbow going down; hard at the injection site; Arm was itchy at injection site; arm was red at  injection site; arm hurt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (blotchy now going down to her wrist), VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site) and VACCINATION SITE PRURITUS (Arm was itchy at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR) and ATORVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm hurt at injection site). On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PRURITUS (Arm was itchy at injection site) and VACCINATION SITE ERYTHEMA (arm was red at  injection site). On 22-Mar-2021, the patient experienced RASH MACULAR (blotchy now going down to her wrist). At the time of the report, RASH MACULAR (blotchy now going down to her wrist), VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PRURITUS (Arm was itchy at injection site), VACCINATION SITE PAIN (arm hurt at injection site) and VACCINATION SITE ERYTHEMA (arm was red at  injection site) had resolved.            Concomitant product also included Iron supplement.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Event outcome updated
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction, Vaccination site warmth
Clinical narrative: blotchy now going down to her wrist; Arm was warm at injection site; Circled her arm above elbow going down; hard at the injection site; Arm was itchy at injection site; arm was red at  injection site; arm hurt at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (blotchy now going down to her wrist), VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site) and VACCINATION SITE PRURITUS (Arm was itchy at injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR) and ATORVASTATIN for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm hurt at injection site). On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PRURITUS (Arm was itchy at injection site) and VACCINATION SITE ERYTHEMA (arm was red at  injection site). On 22-Mar-2021, the patient experienced RASH MACULAR (blotchy now going down to her wrist). At the time of the report, RASH MACULAR (blotchy now going down to her wrist), VACCINATION SITE WARMTH (Arm was warm at injection site), VACCINATION SITE REACTION (Circled her arm above elbow going down), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE PRURITUS (Arm was itchy at injection site), VACCINATION SITE PAIN (arm hurt at injection site) and VACCINATION SITE ERYTHEMA (arm was red at  injection site) had resolved.            Concomitant product also included Iron supplement.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Event outcome updated
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Malaise, SARS-CoV-2 test
Clinical narrative: Not feeling well; sinus or seasonal allergies; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), HYPERSENSITIVITY (sinus or seasonal allergies) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced HEADACHE (Headache). On 22-Mar-2021, the patient experienced MALAISE (Not feeling well) and HYPERSENSITIVITY (sinus or seasonal allergies). On 24-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, MALAISE (Not feeling well) and HYPERSENSITIVITY (sinus or seasonal allergies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: other (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        The concomitant medications and treatment details were not provided. Treatment information was not provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Middle ear effusion, Vaccination site pain
Clinical narrative: Fluid in the ear; Soreness in the arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIDDLE EAR EFFUSION (Fluid in the ear), VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No relevant Medical history Reported.  Concurrent medical conditions included Fluid in middle ear. Concomitant products included LISINOPRIL, CHLORTHALIDONE and SIMVASTATIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced MIDDLE EAR EFFUSION (Fluid in the ear), VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache). At the time of the report, MIDDLE EAR EFFUSION (Fluid in the ear) had not resolved and VACCINATION SITE PAIN (Soreness in the arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dental disorder NOS.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment Medication were provided. The patient enquired that if he could take Antibiotic for his dental treatment.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ATORVASTATIN, METOPROLOL, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LISINOPRIL, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ANASTROZOLE for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the deadline for her second dose) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2021-053134.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: Didn't get the second dose before the 37 day mark; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Didn't get the second dose before the 37 day mark) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment Medications and concomitant medications were provided.  The patient got an email from the health department stating that they scheduled her for the Pfizer vaccine.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Swelling
Clinical narrative: Swelling behand the ear; Swelling of the neck; This spontaneous case was reported by a consumer and describes the occurrence of EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck). At the time of the report, EAR SWELLING (Swelling behand the ear) and SWELLING (Swelling of the neck) had not resolved.            No concomitant medication details were provided. No Treatment Medication was available.  The action taken with mRNA-1273 in response to the event was not applicable.