chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain, Pain in extremity
Clinical narrative: On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Feb-2021, the patient experienced PAIN (Body Aches). On 21-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ARTHRALGIA (Right Knee joint hurting). At the time of the report, PAIN (Body Aches), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue) and ARTHRALGIA (Right Knee joint hurting) outcome was unknown.            No relevant concomitant medications were reported  no treatment product was reported  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Insomnia
Clinical narrative: not able to sleep that night.; discomfort in his chest; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not able to sleep that night.) and CHEST DISCOMFORT (discomfort in his chest) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Cancer of liver resectable. Concurrent medical conditions included Hypertension.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced INSOMNIA (not able to sleep that night.) and CHEST DISCOMFORT (discomfort in his chest). On 05-Mar-2021, INSOMNIA (not able to sleep that night.) and CHEST DISCOMFORT (discomfort in his chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: couldn't get out bed; headache; chills; achy all over; flu-like symptoms; lower back pain; started feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), FATIGUE (couldn't get out bed) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiac disorder.   On 08-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 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), HEADACHE (headache), CHILLS (chills) and MYALGIA (achy all over). On an unknown date, the patient experienced FATIGUE (couldn't get out bed). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), FATIGUE (couldn't get out bed), HEADACHE (headache), CHILLS (chills) and MYALGIA (achy all over) outcome was unknown.            No concomitant medication use was provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: couldn't get out bed; headache; chills; achy all over; flu-like symptoms; lower back pain; started feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), FATIGUE (couldn't get out bed) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cardiac disorder.   On 08-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 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), HEADACHE (headache), CHILLS (chills) and MYALGIA (achy all over). On an unknown date, the patient experienced FATIGUE (couldn't get out bed). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), BACK PAIN (lower back pain), FEELING ABNORMAL (started feeling bad), FATIGUE (couldn't get out bed), HEADACHE (headache), CHILLS (chills) and MYALGIA (achy all over) outcome was unknown.            No concomitant medication use was provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema
Clinical narrative: Black & Blue...at the injection site; red spots at inject site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Black & Blue...at the injection site) and VACCINATION SITE ERYTHEMA (red spots at inject site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 VACCINATION SITE BRUISING (Black & Blue...at the injection site) and VACCINATION SITE ERYTHEMA (red spots at inject site). At the time of the report, VACCINATION SITE BRUISING (Black & Blue..at the injection site) and VACCINATION SITE ERYTHEMA (red spots at inject site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter.  Treatment of events was reported as none.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood pressure measurement, Constipation, Dizziness, Feeling abnormal
Clinical narrative: constipation; Short term memory loss; Nausea; Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird; Throat started closing and tightening; Head feels foggy, loopy, funny when walking/brain fog; Dizzy; Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat started closing and tightening), FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog), DIZZINESS (Dizzy), HYPERTENSION (Hypertension) and CONSTIPATION (constipation) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy.    On 10-Mar-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat started closing and tightening), FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog), NAUSEA (Nausea) and HEADACHE (Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird). 10-Mar-2021, the patient experienced DIZZINESS (Dizzy) and HYPERTENSION (Hypertension). On an unknown date, the patient experienced CONSTIPATION (constipation) and AMNESIA (Short term memory loss). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK dosage form. At the time of the report, THROAT TIGHTNESS (Throat started closing and tightening), DIZZINESS (Dizzy), CONSTIPATION (constipation), AMNESIA (Short term memory loss), NAUSEA (Nausea) and HEADACHE (Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird) had not resolved and FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog) and HYPERTENSION (Hypertension) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2020, SARS-CoV-1 test: positive (Positive) positive. On 10-Mar-2021, Blood pressure measurement: 186/103 (High) elevated.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications also included Vitamins.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: Patient demographic details were updated, relevant history(food allergy)was added, added vaccine facility information and events ( Hypertension, dizziness, headache) On 10-Jun-2021: Lab data was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Nausea, SARS-CoV-1 test, Throat tightness
Clinical narrative: constipation; Short term memory loss; Nausea; Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird; Throat started closing and tightening; Head feels foggy, loopy, funny when walking/brain fog; Dizzy; Hypertension; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat started closing and tightening), FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog), DIZZINESS (Dizzy), HYPERTENSION (Hypertension) and CONSTIPATION (constipation) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy.    On 10-Mar-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat started closing and tightening), FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog), NAUSEA (Nausea) and HEADACHE (Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird). 10-Mar-2021, the patient experienced DIZZINESS (Dizzy) and HYPERTENSION (Hypertension). On an unknown date, the patient experienced CONSTIPATION (constipation) and AMNESIA (Short term memory loss). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form and FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of UNK dosage form. At the time of the report, THROAT TIGHTNESS (Throat started closing and tightening), DIZZINESS (Dizzy), CONSTIPATION (constipation), AMNESIA (Short term memory loss), NAUSEA (Nausea) and HEADACHE (Headaches/head felt like it was going to burst/Frontal headaches/Head felt very weird) had not resolved and FEELING ABNORMAL (Head feels foggy, loopy, funny when walking/brain fog) and HYPERTENSION (Hypertension) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2020, SARS-CoV-1 test: positive (Positive) positive. On 10-Mar-2021, Blood pressure measurement: 186/103 (High) elevated.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications also included Vitamins.   Most recent FOLLOW-UP information incorporated above includes: On 03-Apr-2021: Patient demographic details were updated, relevant history(food allergy)was added, added vaccine facility information and events ( Hypertension, dizziness, headache) On 10-Jun-2021: Lab data was added.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dyspnoea, Headache, Pyrexia
Clinical narrative: Breathlessness; Diarrhea; Feeling very weak; Headache; Running a high fever for 2 nights; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathlessness), DIARRHOEA (Diarrhea), ASTHENIA (Feeling very weak), HEADACHE (Headache) and PYREXIA (Running a high fever for 2 nights) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-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) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (Breathlessness), DIARRHOEA (Diarrhea), ASTHENIA (Feeling very weak), HEADACHE (Headache) and PYREXIA (Running a high fever for 2 nights). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. In March 2021, PYREXIA (Running a high fever for 2 nights) had resolved. At the time of the report, DYSPNOEA (Breathlessness), DIARRHOEA (Diarrhea), ASTHENIA (Feeling very weak) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperatue: 104.7 f (High) 104.7 F, 103 f (High) 103 F and 100.4 f (High) 100.4 F.         Concomitant products used were not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip began to hurt; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip began to hurt) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 015M2OA) for COVID-19 vaccination.     Concurrent medical conditions included Pain in hip. Concomitant products included MELOXICAM for Pain in hip.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (hip began to hurt). At the time of the report, ARTHRALGIA (hip began to hurt) outcome was unknown.            Treatment medication was not reported
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Rash, 2 by 3 inches; arm red at the injection site; really itchy, 2 by 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (arm red at the injection site), INJECTION SITE PRURITUS (really itchy, 2 by 3 inches) and INJECTION SITE RASH (Rash, 2 by 3 inches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE and LISINOPRIL for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (arm red at the injection site) and INJECTION SITE PRURITUS (really itchy, 2 by 3 inches). On 15-Mar-2021, the patient experienced INJECTION SITE RASH (Rash, 2 by 3 inches). At the time of the report, INJECTION SITE ERYTHEMA (arm red at the injection site), INJECTION SITE PRURITUS (really itchy, 2 by 3 inches) and INJECTION SITE RASH (Rash, 2 by 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment of events was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Discomfort, Pain in extremity
Clinical narrative: unusual pain high up in her back; pain moved over to left arm; little discomfort; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (unusual pain high up in her back), PAIN IN EXTREMITY (pain moved over to left arm) and DISCOMFORT (little discomfort) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (unusual pain high up in her back), PAIN IN EXTREMITY (pain moved over to left arm) and DISCOMFORT (little discomfort). The patient was treated with ACETYLSALICYLIC ACID (ST. JOSEPH ASPIRIN) at a dose of 1 dosage form. At the time of the report, BACK PAIN (unusual pain high up in her back), PAIN IN EXTREMITY (pain moved over to left arm) and DISCOMFORT (little discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was administered.   This case was linked to MOD-2021-044777 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: injection site has rash like hives that is red but raised; injection site has rash like hives that is red but raised; tired; could not eat; woke up twice soak and wet last night; nauseated; fever of 102.4; slight headache; later intensified and it felt like her head was going to explode; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and HEADACHE (slight headache; later intensified and it felt like her head was going to explode) in a 67-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.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (fever of 102.4). On 14-Mar-2021, the patient experienced DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night) and NAUSEA (nauseated). On 15-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and FATIGUE (tired). At the time of the report, DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches), NAUSEA (nauseated), PYREXIA (fever of 102.4) and FATIGUE (tired) was resolving and VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised) and VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 102.4 (High) high.         Concomitant medications were not provided by the reporter.  On 14MAR2021 the patient took an acetaminophen to alleviate the symptoms, but it did not really work. The following day, she took acetaminophen every 4 hours.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Nausea, Pyrexia, Vaccination site erythema
Clinical narrative: injection site has rash like hives that is red but raised; injection site has rash like hives that is red but raised; tired; could not eat; woke up twice soak and wet last night; nauseated; fever of 102.4; slight headache; later intensified and it felt like her head was going to explode; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and HEADACHE (slight headache; later intensified and it felt like her head was going to explode) in a 67-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.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (fever of 102.4). On 14-Mar-2021, the patient experienced DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night) and NAUSEA (nauseated). On 15-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and FATIGUE (tired). At the time of the report, DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches), NAUSEA (nauseated), PYREXIA (fever of 102.4) and FATIGUE (tired) was resolving and VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised) and VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 102.4 (High) high.         Concomitant medications were not provided by the reporter.  On 14MAR2021 the patient took an acetaminophen to alleviate the symptoms, but it did not really work. The following day, she took acetaminophen every 4 hours.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: injection site has rash like hives that is red but raised; injection site has rash like hives that is red but raised; tired; could not eat; woke up twice soak and wet last night; nauseated; fever of 102.4; slight headache; later intensified and it felt like her head was going to explode; chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and HEADACHE (slight headache; later intensified and it felt like her head was going to explode) in a 67-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.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches) and PYREXIA (fever of 102.4). On 14-Mar-2021, the patient experienced DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night) and NAUSEA (nauseated). On 15-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised), VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) and FATIGUE (tired). At the time of the report, DECREASED APPETITE (could not eat), HYPERHIDROSIS (woke up twice soak and wet last night), HEADACHE (slight headache; later intensified and it felt like her head was going to explode), CHILLS (chills), MYALGIA (Body aches), NAUSEA (nauseated), PYREXIA (fever of 102.4) and FATIGUE (tired) was resolving and VACCINATION SITE URTICARIA (injection site has rash like hives that is red but raised) and VACCINATION SITE ERYTHEMA (injection site has rash like hives that is red but raised) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 102.4 (High) high.         Concomitant medications were not provided by the reporter.  On 14MAR2021 the patient took an acetaminophen to alleviate the symptoms, but it did not really work. The following day, she took acetaminophen every 4 hours.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site mass, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: The vaccine went interstitial or subcutaneous instead of going into the muscle; Warmth at the injection sitte; Big large lumps at the injection site; Itching at the injection site; Swelling at the injection site; Very sore at the injection site; A spontaneous report was received from a consumer concerning for herself, a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine went interstitial or subcutaneous instead of going into the muscle/ Incorrect route of product administration with the following events of warmth at the injection site/ Vaccination site warmth, Big large lumps at the injection site/ Vaccination site mass, Itching at the injection site/ Vaccination site pruritus, Swelling at the injection site/ Vaccination site swelling, Very sore at the injection site/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On Saturday 13Mar2021 about 9:40 am, patient received second dose of two planed doses of mRNA-1273 (lot/batch: Unknown) via Intramuscular at Right arm for prophylaxis of COVID-19 infection.  On 13Mar2021, the patient stated that the second dose was administered on saturday into her right dominant arm, the flesh of her arm was collected or squeezed up between the thumb and fingers of the person who administered it, instead of having the skin of that injection site area lying flat during the injection. She believes that the vaccine went interstitial or subcutaneous instead of going into the muscle. Within 3 hours of arriving back home after the administration of the vaccine, her arm was sore at the injection site, so she took a Tylenol. By about 9 pm that Saturday evening of 13Mar2021, she woke up after sleeping to find that her arm was very sore, and she also had itching, warmth, swelling, and big large lumps at the injection site. She described the lumps to her family as being "almost as big as my head". All symptoms are ongoing as of today 15Mar2021, though her arm is not as warm but was still warm.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event the vaccine went interstitial or subcutaneous instead of going into the muscle was recovered on 13Mar2021, at the time of this report. The outcome for the events itching at the injection site, warmth at the injection site, big large lumps at the injection site, swelling at the injection site, very sore at the injection site were not recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with  of vaccination site warmth, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, and Vaccination site pain reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: The vaccine went interstitial or subcutaneous instead of going into the muscle; Warmth at the injection sitte; Big large lumps at the injection site; Itching at the injection site; Swelling at the injection site; Very sore at the injection site; A spontaneous report was received from a consumer concerning for herself, a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine went interstitial or subcutaneous instead of going into the muscle/ Incorrect route of product administration with the following events of warmth at the injection site/ Vaccination site warmth, Big large lumps at the injection site/ Vaccination site mass, Itching at the injection site/ Vaccination site pruritus, Swelling at the injection site/ Vaccination site swelling, Very sore at the injection site/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On Saturday 13Mar2021 about 9:40 am, patient received second dose of two planed doses of mRNA-1273 (lot/batch: Unknown) via Intramuscular at Right arm for prophylaxis of COVID-19 infection.  On 13Mar2021, the patient stated that the second dose was administered on saturday into her right dominant arm, the flesh of her arm was collected or squeezed up between the thumb and fingers of the person who administered it, instead of having the skin of that injection site area lying flat during the injection. She believes that the vaccine went interstitial or subcutaneous instead of going into the muscle. Within 3 hours of arriving back home after the administration of the vaccine, her arm was sore at the injection site, so she took a Tylenol. By about 9 pm that Saturday evening of 13Mar2021, she woke up after sleeping to find that her arm was very sore, and she also had itching, warmth, swelling, and big large lumps at the injection site. She described the lumps to her family as being "almost as big as my head". All symptoms are ongoing as of today 15Mar2021, though her arm is not as warm but was still warm.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event the vaccine went interstitial or subcutaneous instead of going into the muscle was recovered on 13Mar2021, at the time of this report. The outcome for the events itching at the injection site, warmth at the injection site, big large lumps at the injection site, swelling at the injection site, very sore at the injection site were not recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with  of vaccination site warmth, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, and Vaccination site pain reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in a 79-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) 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 medications were provided by the reporter.  Treatment of the event included gabapentin.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Pyrexia
Clinical narrative: Freezing; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FEELING COLD (Freezing), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FEELING COLD (Freezing), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 102.5 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 15th March 2021 contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: 2nd vaccine received 3 inches lower on arm than 1st vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (2nd vaccine received 3 inches lower on arm than 1st vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (2nd vaccine received 3 inches lower on arm than 1st vaccine). On 14-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (2nd vaccine received 3 inches lower on arm than 1st vaccine) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable Patient took Acetaminophen before and after vaccination   This case was linked to MOD-2021-044692 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Headache, Swelling, Varicose vein
Clinical narrative: Bruise; Swelling; Veins popping; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise), SWELLING (Swelling), VARICOSE VEIN (Veins popping), CHILLS (Chills) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Bruise), SWELLING (Swelling), VARICOSE VEIN (Veins popping), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CONTUSION (Bruise), SWELLING (Swelling), VARICOSE VEIN (Veins popping), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (soreness). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes) and MYALGIA (soreness) outcome was unknown.            Treatment of the events included ibuprofen.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Myalgia, Nausea
Clinical narrative: Couldn't sleep; Aching; Fever; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID-19 and was hospitalized in OCT 2020) in October 2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said that she is on a lot of medications concomitantly. No other details were provided. Treatment Took tylenol and zofran to treat symptoms
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Couldn't sleep; Aching; Fever; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Had COVID-19 and was hospitalized in OCT 2020) in October 2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, INSOMNIA (Couldn't sleep), MYALGIA (Aching), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said that she is on a lot of medications concomitantly. No other details were provided. Treatment Took tylenol and zofran to treat symptoms
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Peripheral swelling
Clinical narrative: Left leg swollen from knee down; Harder for her to move; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left leg swollen from knee down) and HYPOKINESIA (Harder for her to move) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 PERIPHERAL SWELLING (Left leg swollen from knee down) and HYPOKINESIA (Harder for her to move). The patient was treated with PARACETAMOL (TYLENOL) from March 2021 to March 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Left leg swollen from knee down) and HYPOKINESIA (Harder for her to move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that the patient experienced swelling on her left leg which moved to the back of the knee. It was soft and not painful to touch. The patient reported having difficulty moving the knees and legs.   The patient was treated with Tylenol and generic ointment.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received is non-significant. Reporter contact details updated.
Age: 80.0
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 an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Product dose omission issue, Vaccination site vesicles
Clinical narrative: Patient is past the 42 day window; Blisters could be a bug bites; Bubble blisters on the arm of the injection one inch in diameter; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE VESICLES (Bubble blisters on the arm of the injection one inch in diameter), PRODUCT DOSE OMISSION ISSUE (Patient is past the 42 day window) and ARTHROPOD BITE (Blisters could be a bug bites) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE VESICLES (Bubble blisters on the arm of the injection one inch in diameter) and ARTHROPOD BITE (Blisters could be a bug bites). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is past the 42 day window). At the time of the report, VACCINATION SITE VESICLES (Bubble blisters on the arm of the injection one inch in diameter) and ARTHROPOD BITE (Blisters could be a bug bites) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient is past the 42 day window) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that the patient has not received the second dose as she is waiting for blisters to heal and is past the 42-day window.   No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Myalgia, Pyrexia, Somnolence
Clinical narrative: On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced ASTHENIA (Loss of energy), SOMNOLENCE (feeling sleepy), PYREXIA (fever), CHILLS (chills) and MYALGIA (soreness; aches). On 07-Mar-2021, ASTHENIA (Loss of energy), SOMNOLENCE (feeling sleepy), PYREXIA (fever), CHILLS (chills) and MYALGIA (soreness; aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Lip swelling, Product dose omission issue
Clinical narrative: Anxious to get 2nd dose; Not received 2nd dose yet; Swelling of the lips; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling of the lips), ANXIETY (Anxious to get 2nd dose) and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced LIP SWELLING (Swelling of the lips). On an unknown date, the patient experienced ANXIETY (Anxious to get 2nd dose) and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet). On 18-Feb-2021, LIP SWELLING (Swelling of the lips) had resolved. At the time of the report, ANXIETY (Anxious to get 2nd dose) and PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose yet) 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.   Concomitant medications were not provided. Treatment information was not provided. Patient doctor had put patient on hold from taking the 2nd dose.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information received contains significant information. Added events anxiety and dose omission.