chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Joint swelling
Clinical narrative: swollen(joint); red (joint); This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swollen(joint)) and ERYTHEMA (red (joint)) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Jan-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 an unknown date, the patient experienced JOINT SWELLING (swollen(joint)) and ERYTHEMA (red (joint)). At the time of the report, JOINT SWELLING (swollen(joint)) and ERYTHEMA (red (joint)) outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: sniffles; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (sniffles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 RHINORRHOEA (sniffles). At the time of the report, RHINORRHOEA (sniffles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Illness, Limb discomfort, Pain
Clinical narrative: Sick; Felt shitty; Arm really sore; Tender; Couldn´t lift it; Fever of 101.7°F; Chills; Body aches; Couldn´t sleep on that side; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), FEELING ABNORMAL (Felt shitty), PAIN IN EXTREMITY (Arm really sore), TENDERNESS (Tender) and LIMB DISCOMFORT (Couldn´t lift it) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to Sulfas) and Hashimoto's disease. Concomitant products included MULTIVITAMINS & MINERALS PLUS LUTEIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Sick), FEELING ABNORMAL (Felt shitty), PAIN IN EXTREMITY (Arm really sore), TENDERNESS (Tender), LIMB DISCOMFORT (Couldn´t lift it), PYREXIA (Fever of 101.7°F), CHILLS (Chills), PAIN (Body aches) and LIMB DISCOMFORT (Couldn´t sleep on that side). On 16-Feb-2021, ILLNESS (Sick), FEELING ABNORMAL (Felt shitty), PAIN IN EXTREMITY (Arm really sore), TENDERNESS (Tender), LIMB DISCOMFORT (Couldn´t lift it), PYREXIA (Fever of 101.7°F), CHILLS (Chills), PAIN (Body aches) and LIMB DISCOMFORT (Couldn´t sleep on that side) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.7 Farad (High) 100.7 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Sick; Felt shitty; Arm really sore; Tender; Couldn´t lift it; Fever of 101.7°F; Chills; Body aches; Couldn´t sleep on that side; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick), FEELING ABNORMAL (Felt shitty), PAIN IN EXTREMITY (Arm really sore), TENDERNESS (Tender) and LIMB DISCOMFORT (Couldn´t lift it) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (allergic to Sulfas) and Hashimoto's disease. Concomitant products included MULTIVITAMINS & MINERALS PLUS LUTEIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Sick), FEELING ABNORMAL (Felt shitty), PAIN IN EXTREMITY (Arm really sore), TENDERNESS (Tender), LIMB DISCOMFORT (Couldn´t lift it), PYREXIA (Fever of 101.7°F), CHILLS (Chills), PAIN (Body aches) and LIMB DISCOMFORT (Couldn´t sleep on that side). On 16-Feb-2021, ILLNESS (Sick), FEELING ABNORMAL (Felt shitty), PAIN IN EXTREMITY (Arm really sore), TENDERNESS (Tender), LIMB DISCOMFORT (Couldn´t lift it), PYREXIA (Fever of 101.7°F), CHILLS (Chills), PAIN (Body aches) and LIMB DISCOMFORT (Couldn´t sleep on that side) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.7 Farad (High) 100.7 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest pain, Cough, Decreased appetite
Clinical narrative: blurred vision; Pounding in her chest; dizziness; weakness; lack of appetite; lung pain; chest pain; sweating; coughing; fever; tiredness; headache; Body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness) and DECREASED APPETITE (lack of appetite) in a female patient of an unknown age 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 in January 2021.    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 VISION BLURRED (blurred vision), PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness), DECREASED APPETITE (lack of appetite), PULMONARY PAIN (lung pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), COUGH (coughing), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (Body aches). At the time of the report, VISION BLURRED (blurred vision) had resolved and PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness), DECREASED APPETITE (lack of appetite), PULMONARY PAIN (lung pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), COUGH (coughing), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 104 degrees f High. On 08-Mar-2021, Heart rate increased: elevated pulse High. On 10-Mar-2021, Body temperature: 101 degrees f High.     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 relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: blurred vision; Pounding in her chest; dizziness; weakness; lack of appetite; lung pain; chest pain; sweating; coughing; fever; tiredness; headache; Body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness) and DECREASED APPETITE (lack of appetite) in a female patient of an unknown age 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 in January 2021.    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 VISION BLURRED (blurred vision), PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness), DECREASED APPETITE (lack of appetite), PULMONARY PAIN (lung pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), COUGH (coughing), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (Body aches). At the time of the report, VISION BLURRED (blurred vision) had resolved and PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness), DECREASED APPETITE (lack of appetite), PULMONARY PAIN (lung pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), COUGH (coughing), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 104 degrees f High. On 08-Mar-2021, Heart rate increased: elevated pulse High. On 10-Mar-2021, Body temperature: 101 degrees f High.     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 relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Palpitations, Pulmonary pain, Pyrexia, Vision blurred
Clinical narrative: blurred vision; Pounding in her chest; dizziness; weakness; lack of appetite; lung pain; chest pain; sweating; coughing; fever; tiredness; headache; Body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (blurred vision), PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness) and DECREASED APPETITE (lack of appetite) in a female patient of an unknown age 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 in January 2021.    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 VISION BLURRED (blurred vision), PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness), DECREASED APPETITE (lack of appetite), PULMONARY PAIN (lung pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), COUGH (coughing), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (Body aches). At the time of the report, VISION BLURRED (blurred vision) had resolved and PALPITATIONS (Pounding in her chest), DIZZINESS (dizziness), ASTHENIA (weakness), DECREASED APPETITE (lack of appetite), PULMONARY PAIN (lung pain), CHEST PAIN (chest pain), HYPERHIDROSIS (sweating), COUGH (coughing), PYREXIA (fever), FATIGUE (tiredness), HEADACHE (headache) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Body temperature: 104 degrees f High. On 08-Mar-2021, Heart rate increased: elevated pulse High. On 10-Mar-2021, Body temperature: 101 degrees f High.     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 relevant concomitant medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dry mouth, Heart rate, Hypertension, Nervousness
Clinical narrative: High blood pressure; Heart palpitations; Dehydrated; Nervousness; Shaky; Dry mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated) and NERVOUSNESS (Nervousness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated), NERVOUSNESS (Nervousness), TREMOR (Shaky) and DRY MOUTH (Dry mouth). The patient was treated with CLONIDINE on 27-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated), NERVOUSNESS (Nervousness), TREMOR (Shaky) and DRY MOUTH (Dry mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Event outcomes updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tremor
Clinical narrative: High blood pressure; Heart palpitations; Dehydrated; Nervousness; Shaky; Dry mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated) and NERVOUSNESS (Nervousness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METOPROLOL for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated), NERVOUSNESS (Nervousness), TREMOR (Shaky) and DRY MOUTH (Dry mouth). The patient was treated with CLONIDINE on 27-Feb-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERTENSION (High blood pressure), HEART RATE INCREASED (Increase heart rate), PALPITATIONS (Heart palpitations), DEHYDRATION (Dehydrated), NERVOUSNESS (Nervousness), TREMOR (Shaky) and DRY MOUTH (Dry mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Event outcomes updated.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: Didn't feel a pinch but instead felt most of her dose roll down her arm and into her arm.; Did not receive second dose and would like to know if can retake it; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Didn't feel a pinch but instead felt most of her dose roll down her arm and into her arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive second dose and would like to know if can retake it) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included LEVETIRACETAM, CALCIUM, BIOTIN, ESCITALOPRAM and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced UNDERDOSE (Didn't feel a pinch but instead felt most of her dose roll down her arm and into her arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive second dose and would like to know if can retake it). On 05-Feb-2021, UNDERDOSE (Didn't feel a pinch but instead felt most of her dose roll down her arm and into her arm.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive second dose and would like to know if can retake it) had resolved. Not Provided          Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had two doses of the Moderna vaccine a week apart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had two doses of the Moderna vaccine a week apart) 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, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had two doses of the Moderna vaccine a week apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had two doses of the Moderna vaccine a week apart) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Real bad chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Real bad chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (Real bad chills). At the time of the report, CHILLS (Real bad chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment has been taken by the patient.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Nausea, Oesophageal spasm, Pain in extremity
Clinical narrative: felt like knife going through heart; felt like knife going through back; Nausea; arm was sore; pain on left side of jaw; esophageal spasm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt like knife going through heart), PAIN IN EXTREMITY (arm was sore), PAIN IN JAW (pain on left side of jaw), OESOPHAGEAL SPASM (esophageal spasm) and BACK PAIN (felt like knife going through back) in a 72-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.     Concurrent medical conditions included Morphea. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA), MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), LISINOPRIL, URSODEOXYCHOLIC ACID (ACTIGALL), GABAPENTIN, LORAZEPAM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN JAW (pain on left side of jaw) and OESOPHAGEAL SPASM (esophageal spasm). On 08-Feb-2021 at 6:30 PM, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Feb-2021, the patient experienced CHEST PAIN (felt like knife going through heart), BACK PAIN (felt like knife going through back) and NAUSEA (Nausea). On 08-Feb-2021, PAIN IN EXTREMITY (arm was sore), PAIN IN JAW (pain on left side of jaw) and OESOPHAGEAL SPASM (esophageal spasm) had resolved. On 11-Feb-2021, CHEST PAIN (felt like knife going through heart), BACK PAIN (felt like knife going through back) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the events has been provided at this time. The events were consistent with increased risk associated with elderly age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: felt like knife going through heart; felt like knife going through back; Nausea; arm was sore; pain on left side of jaw; esophageal spasm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (felt like knife going through heart), PAIN IN EXTREMITY (arm was sore), PAIN IN JAW (pain on left side of jaw), OESOPHAGEAL SPASM (esophageal spasm) and BACK PAIN (felt like knife going through back) in a 72-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.     Concurrent medical conditions included Morphea. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA), MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM), LISINOPRIL, URSODEOXYCHOLIC ACID (ACTIGALL), GABAPENTIN, LORAZEPAM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 08-Feb-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN JAW (pain on left side of jaw) and OESOPHAGEAL SPASM (esophageal spasm). On 08-Feb-2021 at 6:30 PM, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Feb-2021, the patient experienced CHEST PAIN (felt like knife going through heart), BACK PAIN (felt like knife going through back) and NAUSEA (Nausea). On 08-Feb-2021, PAIN IN EXTREMITY (arm was sore), PAIN IN JAW (pain on left side of jaw) and OESOPHAGEAL SPASM (esophageal spasm) had resolved. On 11-Feb-2021, CHEST PAIN (felt like knife going through heart), BACK PAIN (felt like knife going through back) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding the events has been provided at this time. The events were consistent with increased risk associated with elderly age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Feeling abnormal, Headache, Pain
Clinical narrative: head feels like it is splitting open; bedbound; developed a headache; sharp pains in temples; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head feels like it is splitting open), BEDRIDDEN (bedbound), HEADACHE (developed a headache) and PAIN (sharp pains in temples) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (head feels like it is splitting open), BEDRIDDEN (bedbound), HEADACHE (developed a headache) and PAIN (sharp pains in temples). The patient was treated with DIPHENHYDRAMINE CITRATE, PARACETAMOL (EXCEDRIN PM) for Adverse event, at an unspecified dose and frequency and HYDROCODONE for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (head feels like it is splitting open), BEDRIDDEN (bedbound), HEADACHE (developed a headache) and PAIN (sharp pains in temples) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site swelling; Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Neuropathy and Bacterial infection (Patient is taking antibiotic for small intestine bacterial overgrowth).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE PAIN (Injection site pain) 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 medication include medicine for blood pressure and neuropathy. Also an antibiotic for SIBO. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Feeling abnormal, Musculoskeletal chest pain, Pain
Clinical narrative: pain expanded to the left lung; growth pain around the body; pain moved to right hip; terrible pain in upper right side of the body; feeling "like somebody kicked the back"; pain expanded to the left rib; upper and lower stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (upper and lower stomach pain), PAIN IN EXTREMITY (terrible pain in upper right side of the body), FEELING ABNORMAL (feeling "like somebody kicked the back"), MUSCULOSKELETAL CHEST PAIN (pain expanded to the left rib) and PULMONARY PAIN (pain expanded to the left lung) in a 77-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.     The patient's past medical history included Shingles. Concurrent medical conditions included Rheumatoid arthritis and Hypertension. Concomitant products included CEFRADINE (VICODINE) for an unknown indication.    On 08-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 ABDOMINAL PAIN UPPER (upper and lower stomach pain). On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (terrible pain in upper right side of the body), FEELING ABNORMAL (feeling "like somebody kicked the back") and MUSCULOSKELETAL CHEST PAIN (pain expanded to the left rib). On 22-Feb-2021, the patient experienced PULMONARY PAIN (pain expanded to the left lung), PAIN (growth pain around the body) and ARTHRALGIA (pain moved to right hip). The patient was treated with MAGNESIUM OXIDE, POTASSIUM GLUCONATE, PYRIDOXINE HYDROCHLORIDE (POTASSIUM 167MG WITH MAGNESIUM & VITAMIN B6) at an unspecified dose and frequency and MAGNESIUM OXIDE, TOCOPHERYL ACETATE (MAGNESIUM + E-VITAMIN) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (upper and lower stomach pain), PAIN IN EXTREMITY (terrible pain in upper right side of the body), FEELING ABNORMAL (feeling "like somebody kicked the back"), MUSCULOSKELETAL CHEST PAIN (pain expanded to the left rib), PULMONARY PAIN (pain expanded to the left lung), PAIN (growth pain around the body) and ARTHRALGIA (pain moved to right hip) 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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary pain
Clinical narrative: pain expanded to the left lung; growth pain around the body; pain moved to right hip; terrible pain in upper right side of the body; feeling "like somebody kicked the back"; pain expanded to the left rib; upper and lower stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (upper and lower stomach pain), PAIN IN EXTREMITY (terrible pain in upper right side of the body), FEELING ABNORMAL (feeling "like somebody kicked the back"), MUSCULOSKELETAL CHEST PAIN (pain expanded to the left rib) and PULMONARY PAIN (pain expanded to the left lung) in a 77-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.     The patient's past medical history included Shingles. Concurrent medical conditions included Rheumatoid arthritis and Hypertension. Concomitant products included CEFRADINE (VICODINE) for an unknown indication.    On 08-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 ABDOMINAL PAIN UPPER (upper and lower stomach pain). On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (terrible pain in upper right side of the body), FEELING ABNORMAL (feeling "like somebody kicked the back") and MUSCULOSKELETAL CHEST PAIN (pain expanded to the left rib). On 22-Feb-2021, the patient experienced PULMONARY PAIN (pain expanded to the left lung), PAIN (growth pain around the body) and ARTHRALGIA (pain moved to right hip). The patient was treated with MAGNESIUM OXIDE, POTASSIUM GLUCONATE, PYRIDOXINE HYDROCHLORIDE (POTASSIUM 167MG WITH MAGNESIUM & VITAMIN B6) at an unspecified dose and frequency and MAGNESIUM OXIDE, TOCOPHERYL ACETATE (MAGNESIUM + E-VITAMIN) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (upper and lower stomach pain), PAIN IN EXTREMITY (terrible pain in upper right side of the body), FEELING ABNORMAL (feeling "like somebody kicked the back"), MUSCULOSKELETAL CHEST PAIN (pain expanded to the left rib), PULMONARY PAIN (pain expanded to the left lung), PAIN (growth pain around the body) and ARTHRALGIA (pain moved to right hip) 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Decreased appetite, Dizziness
Clinical narrative: coughing; difficulty breathing; dizziness; weakness; loss of appitte; lost 5 pounds; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DECREASED APPETITE (loss of appitte), WEIGHT DECREASED (lost 5 pounds), COUGH (coughing) and DYSPNOEA (difficulty breathing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (muscle pain). On 01-Mar-2021, the patient experienced HEADACHE (headache). On 02-Mar-2021, the patient experienced ASTHENIA (weakness), DECREASED APPETITE (loss of appitte) and WEIGHT DECREASED (lost 5 pounds). On 03-Mar-2021, the patient experienced COUGH (coughing), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency; BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (muscle pain) had resolved. On 01-Mar-2021, HEADACHE (headache) had resolved. On 04-Mar-2021, ASTHENIA (weakness) had resolved. On 09-Mar-2021, WEIGHT DECREASED (lost 5 pounds) had resolved. In March 2021, DECREASED APPETITE (loss of appitte), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness) had resolved. At the time of the report, COUGH (coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Oxygen saturation: 88 (Low) 88. In March 2021, COVID-19: positive (Positive) positive.     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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Myalgia, Oxygen saturation, Weight decreased
Clinical narrative: coughing; difficulty breathing; dizziness; weakness; loss of appitte; lost 5 pounds; headache; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DECREASED APPETITE (loss of appitte), WEIGHT DECREASED (lost 5 pounds), COUGH (coughing) and DYSPNOEA (difficulty breathing) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (muscle pain). On 01-Mar-2021, the patient experienced HEADACHE (headache). On 02-Mar-2021, the patient experienced ASTHENIA (weakness), DECREASED APPETITE (loss of appitte) and WEIGHT DECREASED (lost 5 pounds). On 03-Mar-2021, the patient experienced COUGH (coughing), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness). The patient was treated with PARACETAMOL (TYLENOL A) for Adverse event, at an unspecified dose and frequency; BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. On 28-Feb-2021, MYALGIA (muscle pain) had resolved. On 01-Mar-2021, HEADACHE (headache) had resolved. On 04-Mar-2021, ASTHENIA (weakness) had resolved. On 09-Mar-2021, WEIGHT DECREASED (lost 5 pounds) had resolved. In March 2021, DECREASED APPETITE (loss of appitte), DYSPNOEA (difficulty breathing) and DIZZINESS (dizziness) had resolved. At the time of the report, COUGH (coughing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Oxygen saturation: 88 (Low) 88. In March 2021, COVID-19: positive (Positive) positive.     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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Arm started being hot; Arm started being hard; Arm started itching; Arm started being red; Arm started aching and painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Arm started being hot), VACCINATION SITE INDURATION (Arm started being hard), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Arm started being red) and VACCINATION SITE PAIN (Arm started aching and painful) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Arm started being hot), VACCINATION SITE INDURATION (Arm started being hard), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Arm started being red) and VACCINATION SITE PAIN (Arm started aching and painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Arm started being hot), VACCINATION SITE INDURATION (Arm started being hard), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE ERYTHEMA (Arm started being red) and VACCINATION SITE PAIN (Arm started aching and painful) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. The patient's doctor told her to put a warm compress on the arm.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain in extremity, Pruritus, Somnolence, Vaccination site rash
Clinical narrative: delayed onset injection site reaction; sleeping a lot more than normal; feeling groggy upon waking up; soreness on arm (left arm from the first shot); Itchiness; rashes on arm below injection site for 8 to 9 days (from first shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up), PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)) and PRURITUS (Itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Shingle shot in December 2020.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced PRURITUS (Itchiness) and VACCINATION SITE RASH (rashes on arm below injection site for 8 to 9 days (from first shot)). On an unknown date, the patient experienced VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up) and PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)). On 04-Mar-2021, VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up), PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)), PRURITUS (Itchiness) and VACCINATION SITE RASH (rashes on arm below injection site for 8 to 9 days (from first shot)) had resolved.            Treatment information were not provided.   Received  first vaccine Feb 20 and experienced oval shaped rash and itchiness 1.5 to 2 inches below the injection site on Feb 28th and she also mention rashes disappeared and sleeping a lot more than normal and feeling groggy upon walking up.   This case was linked to US-MODERNATX, INC.-MOD-2021-110250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded. On 05-May-2021: significant changes updated On 12-May-2021: Dose two information and after dose two events updated ( fatigue and tiredness ).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: delayed onset injection site reaction; sleeping a lot more than normal; feeling groggy upon waking up; soreness on arm (left arm from the first shot); Itchiness; rashes on arm below injection site for 8 to 9 days (from first shot); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up), PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)) and PRURITUS (Itchiness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Vaccination: Shingle shot in December 2020.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced PRURITUS (Itchiness) and VACCINATION SITE RASH (rashes on arm below injection site for 8 to 9 days (from first shot)). On an unknown date, the patient experienced VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up) and PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)). On 04-Mar-2021, VACCINATION SITE REACTION (delayed onset injection site reaction), HYPERSOMNIA (sleeping a lot more than normal), SOMNOLENCE (feeling groggy upon waking up), PAIN IN EXTREMITY (soreness on arm (left arm from the first shot)), PRURITUS (Itchiness) and VACCINATION SITE RASH (rashes on arm below injection site for 8 to 9 days (from first shot)) had resolved.            Treatment information were not provided.   Received  first vaccine Feb 20 and experienced oval shaped rash and itchiness 1.5 to 2 inches below the injection site on Feb 28th and she also mention rashes disappeared and sleeping a lot more than normal and feeling groggy upon walking up.   This case was linked to US-MODERNATX, INC.-MOD-2021-110250 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded. On 05-May-2021: significant changes updated On 12-May-2021: Dose two information and after dose two events updated ( fatigue and tiredness ).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed window for second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PAIN (Epidural shot for (chronic pain)).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed window for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-039278 (Patient Link).; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Unknown) with no associated AEs.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013620A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Under Chemotherapy). Concomitant products included CYCLOPHOSPHAMIDE, DOXORUBICIN HYDROCHLORIDE, PREDNISONE, RITUXIMAB, VINCRISTINE SULFATE (R CHOP) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 17-Jan-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea
Clinical narrative: nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, HYDROCHLOROTHIAZIDE, AMLODIPINE and OMEPRAZOLE for an unknown indication.    On 02-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 DIARRHOEA (diarrhea). On 09-Mar-2021, the patient experienced NAUSEA (nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) at an unspecified dose and frequency. On 09-Mar-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-039192 (Patient Link).