chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: rash in the back; Redness; itching; lower back,; arm soreness; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm soreness), RASH (rash in the back), ERYTHEMA (Redness), PRURITUS (itching) and RASH (lower back,) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary fibrosis, Acid reflux (oesophageal), Hypertension and Cholesterol. Concomitant products included TAMSULOSIN, PREDNISONE, PANTOPRAZOLE, MAGNESIUM, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 05-Mar-2021, the patient experienced RASH (rash in the back), ERYTHEMA (Redness), PRURITUS (itching) and RASH (lower back,). On 21-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, RASH (rash in the back), ERYTHEMA (Redness), PRURITUS (itching) and RASH (lower back,) 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Oral pain
Clinical narrative: Weakness; Aches; Left side of mouth where top and bottom meet has been sore; This spontaneous case was reported by a consumer and describes the occurrence of ORAL PAIN (Left side of mouth where top and bottom meet has been sore), ASTHENIA (Weakness) and MYALGIA (Aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-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 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ORAL PAIN (Left side of mouth where top and bottom meet has been sore). On 21-Mar-2021, the patient experienced ASTHENIA (Weakness) and MYALGIA (Aches). The patient was treated with PARACETAMOL (TYLENOL) for Ache and Weakness, at an unspecified dose and frequency. At the time of the report, ORAL PAIN (Left side of mouth where top and bottom meet has been sore) outcome was unknown and ASTHENIA (Weakness) and MYALGIA (Aches) had not resolved.            No concomitant medications were provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-036847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-MAY-2021 contains significant information: Added new treatment drug, new events "Aches"and "Weakness".
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Nausea
Clinical narrative: hip pain; slightly nauseated; muscle aches; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (hip pain), NAUSEA (slightly nauseated), MYALGIA (muscle aches), FATIGUE (fatigue) and ARTHRALGIA (joint pain) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (hip pain), NAUSEA (slightly nauseated), MYALGIA (muscle aches), FATIGUE (fatigue) and ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (hip pain), NAUSEA (slightly nauseated), MYALGIA (muscle aches), FATIGUE (fatigue) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Decreased appetite, Feeling abnormal, Headache, Insomnia
Clinical narrative: Headache; Back pain/Severe back  pain; Nausea; Excruciating and debilitating pain; 2 Sleepless night; Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night; Lost appetite; Vertigo; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FEELING ABNORMAL (Brain fog), PAIN (Excruciating and debilitating pain), INSOMNIA (2 Sleepless night) and MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Excruciating and debilitating pain), INSOMNIA (2 Sleepless night), MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night), DECREASED APPETITE (Lost appetite) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced BACK PAIN (Back pain/Severe back  pain). On 07-Mar-2021, the patient experienced HEADACHE (Headache). In March 2021, the patient experienced VERTIGO (Vertigo) and FEELING ABNORMAL (Brain fog). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, INSOMNIA (2 Sleepless night) had resolved. At the time of the report, VERTIGO (Vertigo), FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night), DECREASED APPETITE (Lost appetite), BACK PAIN (Back pain/Severe back  pain), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown and PAIN (Excruciating and debilitating pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up information received on 11 Mar 2021 contains Additional details regarding the events - cannot move arm and severe back pain. On 18-Mar-2021: Follow-up information received on 18 Mar 2021 contains no new information. On 03-May-2021: Follow-up information received on 03 May 2021 included non significant information. On 21-Jul-2021: Follow-up information received contains added events - brain for and vertigo
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Pain, Vertigo
Clinical narrative: Headache; Back pain/Severe back  pain; Nausea; Excruciating and debilitating pain; 2 Sleepless night; Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night; Lost appetite; Vertigo; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), FEELING ABNORMAL (Brain fog), PAIN (Excruciating and debilitating pain), INSOMNIA (2 Sleepless night) and MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (Excruciating and debilitating pain), INSOMNIA (2 Sleepless night), MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night), DECREASED APPETITE (Lost appetite) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced BACK PAIN (Back pain/Severe back  pain). On 07-Mar-2021, the patient experienced HEADACHE (Headache). In March 2021, the patient experienced VERTIGO (Vertigo) and FEELING ABNORMAL (Brain fog). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 06-Mar-2021, INSOMNIA (2 Sleepless night) had resolved. At the time of the report, VERTIGO (Vertigo), FEELING ABNORMAL (Brain fog), MOBILITY DECREASED (Unable to perform basic tasks/could not move her arm/can't tie her shoes or throw a blanket over herself, unable to take her clothes off at night), DECREASED APPETITE (Lost appetite), BACK PAIN (Back pain/Severe back  pain), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown and PAIN (Excruciating and debilitating pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up information received on 11 Mar 2021 contains Additional details regarding the events - cannot move arm and severe back pain. On 18-Mar-2021: Follow-up information received on 18 Mar 2021 contains no new information. On 03-May-2021: Follow-up information received on 03 May 2021 included non significant information. On 21-Jul-2021: Follow-up information received contains added events - brain for and vertigo
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Movement disorder, Myalgia
Clinical narrative: Very very cold; Dont feel like moving; Chills; Aching; Nausea; Very very tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Mar-2021, the patient experienced FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching), NAUSEA (Nausea) and FATIGUE (Very very tired). At the time of the report, FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching), NAUSEA (Nausea) and FATIGUE (Very very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter details updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Very very cold; Dont feel like moving; Chills; Aching; Nausea; Very very tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Mar-2021, the patient experienced FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching), NAUSEA (Nausea) and FATIGUE (Very very tired). At the time of the report, FEELING COLD (Very very cold), MOVEMENT DISORDER (Dont feel like moving), CHILLS (Chills), MYALGIA (Aching), NAUSEA (Nausea) and FATIGUE (Very very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  No treatment medication was reported    Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Reporter details updated
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination site pain
Clinical narrative: Face swollen around the left eye; sore arm-left; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face swollen around the left eye) and VACCINATION SITE PAIN (sore arm-left) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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 04-Mar-2021, the patient experienced SWELLING FACE (Face swollen around the left eye) and VACCINATION SITE PAIN (sore arm-left). At the time of the report, SWELLING FACE (Face swollen around the left eye) and VACCINATION SITE PAIN (sore arm-left) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort, Muscular weakness
Clinical narrative: leg weakness; leg heaviness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (leg weakness), LIMB DISCOMFORT (leg heaviness) and FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.   On 20-Feb-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-Feb-2021, the patient experienced MUSCULAR WEAKNESS (leg weakness), LIMB DISCOMFORT (leg heaviness) and FATIGUE (tiredness). On 21-Feb-2021, MUSCULAR WEAKNESS (leg weakness), LIMB DISCOMFORT (leg heaviness) and FATIGUE (tiredness) had resolved.            Concomitant medication and treatment medication were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Red rash; Raised rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and RASH PAPULAR (Raised rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) and RASH PAPULAR (Raised rash). On 12-Feb-2021, RASH ERYTHEMATOUS (Red rash) and RASH PAPULAR (Raised rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  Patient was treated with an unspecified anti-itch cream.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Crying, Depression, Fatigue, Feeling abnormal
Clinical narrative: felt depressed; started crying and everything; it was really bad; weak; feels a little tired; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (felt depressed), CRYING (started crying and everything), FEELING ABNORMAL (it was really bad), ASTHENIA (weak) and FATIGUE (feels a little tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression, Crying, Tiredness and Weakness.    On 07-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (felt depressed), CRYING (started crying and everything), FEELING ABNORMAL (it was really bad), ASTHENIA (weak) and FATIGUE (feels a little tired). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency. At the time of the report, DEPRESSION (felt depressed), CRYING (started crying and everything), FEELING ABNORMAL (it was really bad), ASTHENIA (weak) and FATIGUE (feels a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Immune-mediated adverse reaction, Product administration error
Clinical narrative: Immune system type reactions; Vaccine dose from 2 vials; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine dose from 2 vials) and IMMUNE-MEDIATED ADVERSE REACTION (Immune system type reactions) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 30-Dec-2020, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine dose from 2 vials). On 28-Jan-2021, the patient experienced IMMUNE-MEDIATED ADVERSE REACTION (Immune system type reactions). On 28-Jan-2021, PRODUCT ADMINISTRATION ERROR (Vaccine dose from 2 vials) had resolved. At the time of the report, IMMUNE-MEDIATED ADVERSE REACTION (Immune system type reactions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  Treatment information was not provided.   This case was linked to MOD-2021-028537 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: No new information received. On 18-Mar-2021: Follow-up information included patient's age, gender and date of birth changed, dose and unit.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Abnormal weight gain, Asthenia, Pharyngeal swelling, Swelling
Clinical narrative: Swollen throat; Feels her body is swelling; No energy; Her stomach hurts every time she eats or drinks; Gaining weight even thought she is not eating; A spontaneous report was received from a consumer in the concerning a 65-year-old female patient who experienced swollen throat/MedDRA PT: pharyngeal swelling, no energy/MedDRA PT: asthenia, feels her body is swelling/MedDRA PT: swelling, stomach hurts every time she eats or drinks/MedDRA PT: abdominal pain upper and gaining weight even though she is not eating/MedDRA PT: abnormal weight gain after she was administered mRNA-1273 vaccine   The patient's medical history includes kidney transplant. Concomitant medications include (2) anti-rejection medications, high blood pressure medication, cholesterol med and vitamins NOS.  On 11-Feb-2021, five days prior to start of symptoms, this patient received their first planned dose of mRNA-1273 solution for injection (Lot/Batch number: 031l20a) in her right arm for prophylaxis of COVID-19 infection.   On 16-Feb-2021, this patient developed swollen throat and has experienced no energy, her stomach hurts every time she eats or drinks, is gaining weight even though she is not eating and feels her body is swelling. She was tested for covid-19 and for white blood cell count, results are pending. The patient is scheduled next week for her second dose and wonders if she should wait.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome for the events, swollen throat, no energy, feels her body is swelling, stomach hurts every time she eats or drinks,and gaining weight even though she is not eating were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Headache, Insomnia, Myalgia
Clinical narrative: Arm unbelievably painful; Aches and pains; Very weak, no strength, No energy to do anything; Cannot eat or drink.; Head and ears ringing.; Cannot sleep; Splitting headache; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was very weak, no strength; no energy to do anything(asthenia), head and ears ringing( tinnitus), splitting headache( headache), cannot sleep(insomnia), cannot eat or drink(decreased appetite), arm unbelievably painful (vaccination site pain), and aches and pains (myalgia).  The patient's medical history was not provided. Relevant current conditions included asthma, chronic obstructive pulmonary disease, heart problems, and osteoarthritis. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, patient had very weak, no strength, no energy to do anything, splitting headache, cannot eat or drink. The patient also had head and ears ringing, and cannot sleep. On an unknown date, the patient had arm unbelievably painful and aches and pains.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination site pain
Clinical narrative: Arm unbelievably painful; Aches and pains; Very weak, no strength, No energy to do anything; Cannot eat or drink.; Head and ears ringing.; Cannot sleep; Splitting headache; A spontaneous report was received from a consumer who was also a 77-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who was very weak, no strength; no energy to do anything(asthenia), head and ears ringing( tinnitus), splitting headache( headache), cannot sleep(insomnia), cannot eat or drink(decreased appetite), arm unbelievably painful (vaccination site pain), and aches and pains (myalgia).  The patient's medical history was not provided. Relevant current conditions included asthma, chronic obstructive pulmonary disease, heart problems, and osteoarthritis. No relevant concomitant medications were reported.  On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Mar 2021, patient had very weak, no strength, no energy to do anything, splitting headache, cannot eat or drink. The patient also had head and ears ringing, and cannot sleep. On an unknown date, the patient had arm unbelievably painful and aches and pains.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis allergic, Erythema, Feeling hot, Injection site mass, Injection site pruritus
Clinical narrative: Very red; slightly raised; hot to the touch; Covid arm; large rash; arm itching/itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PRURITUS (arm itching/itching). On 28-Feb-2021, the patient experienced ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash). At the time of the report, ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm), RASH (large rash) and INJECTION SITE PRURITUS (arm itching/itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Very red; slightly raised; hot to the touch; Covid arm; large rash; arm itching/itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INJECTION SITE PRURITUS (arm itching/itching). On 28-Feb-2021, the patient experienced ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm) and RASH (large rash). At the time of the report, ERYTHEMA (Very red), INJECTION SITE MASS (slightly raised), FEELING HOT (hot to the touch), DERMATITIS ALLERGIC (Covid arm), RASH (large rash) and INJECTION SITE PRURITUS (arm itching/itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.   Reporter did not allow further contact
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; Rash started on left arm on 07Mar2021, and today spread to both arms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01/A2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Mar-2021 for Itchy, at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy) and RASH (Rash started on left arm on 07Mar2021, and today spread to both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: Weak; Short of breath; Dizzy; Feels lousy; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy) and CHILLS (Chills) in a 72-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.     No Medical History information was reported.    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 (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-May-2021 included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Weak; Short of breath; Dizzy; Feels lousy; Chills; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy) and CHILLS (Chills) in a 72-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.     No Medical History information was reported.    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 (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, ASTHENIA (Weak), DYSPNOEA (Short of breath), DIZZINESS (Dizzy), MALAISE (Feels lousy), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information received on 03-May-2021 included no new information.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph node swelling; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph node swelling) 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 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 LYMPHADENOPATHY (lymph node swelling). At the time of the report, LYMPHADENOPATHY (lymph node swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment History was provided. Action taken with mRNA-1273 in response to the event was unknown
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body aches; Headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of MYALGIA (Body aches) and HEADACHE (Headaches) 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 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 MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.  Reporter states that his wife's friends had the second dose of the Moderna COVID-19 vaccine and experienced body aches and headaches.    Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Nausea
Clinical narrative: heartburn; nauseous; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DYSPEPSIA (heartburn) and NAUSEA (nauseous) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A21A) 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 08-Mar-2021, the patient experienced DYSPEPSIA (heartburn) and NAUSEA (nauseous). At the time of the report, DYSPEPSIA (heartburn) and NAUSEA (nauseous) 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 included, medications for depression, were reported.  Treatment information included, a pill for the heartburn but they forgot taking it for the last three days so they think it may be the cause.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Some sore arm; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy). At the time of the report, PAIN IN EXTREMITY (Some sore arm) and PAIN (Achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information mentioned.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: pretty severe pain throughout entire body; pain at injection site; injection site was feverish/fever 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fever and Pain.    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 PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5). At the time of the report, PAIN (pretty severe pain throughout entire body), INJECTION SITE PAIN (pain at injection site) and PYREXIA (injection site was feverish/fever 101.5) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported included Back pain medication.  Treatment detail also included Tylenol Extra Strength for fever and pain.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: outbreak of shingles; A spontaneous report was received from a consumer (patient's wife) concerning a 73-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced outbreak of shingles.  The patient's medical history included shingles episodes.  Concomitant medications included multiple unknown medications.  On 5 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011A21A) intramuscularly for prophylaxis of COVID-19 infection. On the same day immediately following administration of the vaccine patient experienced an outbreak of shingles. The outbreaks occurred in the locations where patient had previously experienced shingles episodes.  Treatment details included Valtrex (valaciclovir) and cream for shingles.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of event(s), outbreak of shingles was unknown.  The reporter did not provide the assessment for the event, outbreak of shingles.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Pain
Clinical narrative: cold with rigors; body ache; chills; tired; rigors; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors). At the time of the report, NASOPHARYNGITIS (cold with rigors), PAIN (body ache), CHILLS (chills), FATIGUE (tired) and CHILLS (rigors) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant product usage were not reported by the reporter. Treatment included some tonic water with quinine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Lip swelling, Rash, Swollen tongue
Clinical narrative: Rash on the body , arms and legs ,that goes away but returns on other places of the body; Skipped the second dose; Tongue swelling; Lips are swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling), RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling), RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose). At the time of the report, SWOLLEN TONGUE (Tongue swelling), LIP SWELLING (Lips are swelling) and INCOMPLETE COURSE OF VACCINATION (Skipped the second dose) outcome was unknown and RASH (Rash on the body , arms and legs ,that goes away but returns on other places of the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Hardness at injection site; Redness at injection site; Swelling at injection site; Hot area at injection site; extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE DISCOMFORT (Hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE PAIN (Hot area at injection site) and INJECTION SITE PRURITUS (extremely itchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma since 1970. Concurrent medical conditions included Hypertension since 2000. Concomitant products included LISINOPRIL, METOPROLOL SUCCINATE (METOPROLOL succ ER), ATORVASTATIN CALCIUM and PROBIOTIC 30 BILLION for an unknown indication.    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 INJECTION SITE DISCOMFORT (Hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE PAIN (Hot area at injection site) and INJECTION SITE PRURITUS (extremely itchy). At the time of the report, INJECTION SITE DISCOMFORT (Hardness at injection site), INJECTION SITE ERYTHEMA (Redness at injection site), INJECTION SITE SWELLING (Swelling at injection site), INJECTION SITE PAIN (Hot area at injection site) and INJECTION SITE PRURITUS (extremely itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: follow up received on 12-may-2021,patient demographics updated, concomitent medication added, medical history updated
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Vaccine leaked out entirely from the syringe; Vaccine leaked out entirely from the syringe; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) 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 05-Mar-2021, the patient experienced UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe). At the time of the report, UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered UNDERDOSE (Vaccine leaked out entirely from the syringe) and DEVICE CONNECTION ISSUE (Vaccine leaked out entirely from the syringe) to be not applicable.    This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 026A12A  with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: NNI On 17-Jul-2021: Follow up received and it contains no new information.; Sender's Comments: This report refers to a case of vaccine underdose and syringe connection issue for mRNA-1273, lot # 026A12A  with no associated AEs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Diarrhoea, Lymphadenopathy
Clinical narrative: stomach cramps; diarrhea; lower back pain; constant nausea; lymph node under left armpit swollen; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea) and LYMPHADENOPATHY (lymph node under left armpit swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea), LYMPHADENOPATHY (lymph node under left armpit swollen), CHILLS (chills) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps), DIARRHOEA (diarrhea), BACK PAIN (lower back pain), NAUSEA (constant nausea), LYMPHADENOPATHY (lymph node under left armpit swollen), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.