chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Tachycardia, Tinnitus, Vaccination site pruritus
Clinical narrative: rapid heart rate; ears ringing; itchiness; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heart rate), TINNITUS (ears ringing), VACCINATION SITE PRURITUS (itchiness), HEADACHE (headache) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (rapid heart rate), TINNITUS (ears ringing), VACCINATION SITE PRURITUS (itchiness), HEADACHE (headache) and CHILLS (chills). The patient was treated with ALPRAZOLAM (XANAX) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, TACHYCARDIA (rapid heart rate), TINNITUS (ears ringing), VACCINATION SITE PRURITUS (itchiness), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            No relevant concomitant medications reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-033650 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Non-significant follow up added. Updated E-mail address.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033650:first dose
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Head cold; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Head cold) 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. Concomitant products included GUAIFENESIN (MUCINEX) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Apr-2021, the patient experienced NASOPHARYNGITIS (Head cold). At the time of the report, NASOPHARYNGITIS (Head cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included  guaifenesin (Mucinex).   This case was linked to MOD21-072032 (E2B Linked Report).; Sender's Comments:  MOD21-072032:
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches) 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 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body Aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain management, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body Aches) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up was received on 24 May 2021 included event outcome and treatment was updated.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Nausea
Clinical narrative: Joint pain; headache; nausea; vomiting; chills; body aches; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, the patient experienced ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches). At the time of the report, ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-071072, MOD-2021-071206 (E2B Linked Report).; Sender's Comments:  MOD-2021-071072:First dose of vaccine case MOD-2021-071206:Daughter Second dose case
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Joint pain; headache; nausea; vomiting; chills; body aches; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, the patient experienced ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches). At the time of the report, ARTHRALGIA (Joint pain), HEADACHE (headache), NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to MOD-2021-071072, MOD-2021-071206 (E2B Linked Report).; Sender's Comments:  MOD-2021-071072:First dose of vaccine case MOD-2021-071206:Daughter Second dose case
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: headache; Joint pain; Knee pain; Fatigue; Arm hurt; Pain on the injection site; Pain all the way down to her wrist; chills; fever; Breaks out sweat; Sick; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm hurt) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sjogren's syndrome. Concurrent medical conditions included Arthritis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE PAIN (Pain on the injection site), PAIN IN EXTREMITY (Pain all the way down to her wrist), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (Breaks out sweat), ILLNESS (Sick) and NAUSEA (Nauseated). At the time of the report, HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE PAIN (Pain on the injection site), PAIN IN EXTREMITY (Pain all the way down to her wrist), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (Breaks out sweat), ILLNESS (Sick) and NAUSEA (Nauseated) 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.   This case was linked to MOD21-072106, US-MODERNATX, INC.-MOD-2021-071096 (E2B Linked Report).; Sender's Comments:  MOD21-072106: US-MODERNATX, INC.-MOD-2021-071096:
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: headache; Joint pain; Knee pain; Fatigue; Arm hurt; Pain on the injection site; Pain all the way down to her wrist; chills; fever; Breaks out sweat; Sick; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PAIN IN EXTREMITY (Arm hurt) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sjogren's syndrome. Concurrent medical conditions included Arthritis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE PAIN (Pain on the injection site), PAIN IN EXTREMITY (Pain all the way down to her wrist), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (Breaks out sweat), ILLNESS (Sick) and NAUSEA (Nauseated). At the time of the report, HEADACHE (headache), ARTHRALGIA (Joint pain), ARTHRALGIA (Knee pain), FATIGUE (Fatigue), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE PAIN (Pain on the injection site), PAIN IN EXTREMITY (Pain all the way down to her wrist), CHILLS (chills), PYREXIA (fever), HYPERHIDROSIS (Breaks out sweat), ILLNESS (Sick) and NAUSEA (Nauseated) 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.   This case was linked to MOD21-072106, US-MODERNATX, INC.-MOD-2021-071096 (E2B Linked Report).; Sender's Comments:  MOD21-072106: US-MODERNATX, INC.-MOD-2021-071096:
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Got a cortisone injection for the arthritis on his knees between doses; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got a cortisone injection for the arthritis on his knees between doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got a cortisone injection for the arthritis on his knees between doses). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Got a cortisone injection for the arthritis on his knees between doses) 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 was not provided Treatment information was not provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: Cold, runny nose; Cold, runny nose; Bleeding from nose; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold, runny nose), RHINORRHOEA (Cold, runny nose), EPISTAXIS (Bleeding from nose), PYREXIA (Fever) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter  .     On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold, runny nose), RHINORRHOEA (Cold, runny nose), EPISTAXIS (Bleeding from nose), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with GUAIFENESIN (MUCINEX) ongoing since an unknown date at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold, runny nose), RHINORRHOEA (Cold, runny nose), EPISTAXIS (Bleeding from nose), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment medication reported included garlic.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Cough, Fatigue, Headache
Clinical narrative: COVID-arm lasting for a week; tightness in her chest (lasted 3 days); Throat ticklish; Cough; Felt like asthma attack; Slight Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in her chest (lasted 3 days)), THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack) and HEADACHE (Slight Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction. Concurrent medical conditions included Type II diabetes mellitus, Asthma and Drug allergy. Concomitant products included IRBESARTAN (AVAPRO), BUDESONIDE (RHINOCORT ALLERGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), EPINEPHRINE (EPIPEN), AMLODIPINE BESILATE, ATENOLOL (AMORIL AT), SODIUM CHLORIDE (SALINE SPRAY), ADENOSINE (TRICOR [ADENOSINE]), PARACETAMOL (TYLENOL), SALBUTAMOL SULFATE (INHALERIN) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHEST DISCOMFORT (tightness in her chest (lasted 3 days)), THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack), HEADACHE (Slight Headache) and FATIGUE (Fatigue). On 27-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID-arm lasting for a week). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, CHEST DISCOMFORT (tightness in her chest (lasted 3 days)) had resolved. On 07-Apr-2021, VACCINATION SITE REACTION (COVID-arm lasting for a week) had resolved. At the time of the report, THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack), HEADACHE (Slight Headache) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not seek medical attention but reported treating events with Asthma inhaler and Tylenol.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site reaction
Clinical narrative: COVID-arm lasting for a week; tightness in her chest (lasted 3 days); Throat ticklish; Cough; Felt like asthma attack; Slight Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in her chest (lasted 3 days)), THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack) and HEADACHE (Slight Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction. Concurrent medical conditions included Type II diabetes mellitus, Asthma and Drug allergy. Concomitant products included IRBESARTAN (AVAPRO), BUDESONIDE (RHINOCORT ALLERGY), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), EPINEPHRINE (EPIPEN), AMLODIPINE BESILATE, ATENOLOL (AMORIL AT), SODIUM CHLORIDE (SALINE SPRAY), ADENOSINE (TRICOR [ADENOSINE]), PARACETAMOL (TYLENOL), SALBUTAMOL SULFATE (INHALERIN) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHEST DISCOMFORT (tightness in her chest (lasted 3 days)), THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack), HEADACHE (Slight Headache) and FATIGUE (Fatigue). On 27-Mar-2021, the patient experienced VACCINATION SITE REACTION (COVID-arm lasting for a week). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 20-Mar-2021, CHEST DISCOMFORT (tightness in her chest (lasted 3 days)) had resolved. On 07-Apr-2021, VACCINATION SITE REACTION (COVID-arm lasting for a week) had resolved. At the time of the report, THROAT IRRITATION (Throat ticklish), COUGH (Cough), ASTHMA (Felt like asthma attack), HEADACHE (Slight Headache) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not seek medical attention but reported treating events with Asthma inhaler and Tylenol.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Sleep disorder, Vaccination site pain, Vaccination site warmth
Clinical narrative: pain in the arm of the injection; The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨; it disturb my sleeping; axillary pain; A lymph node on the left side of her neck, it is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (it disturb my sleeping), VACCINATION SITE WARMTH (The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨), LYMPHADENOPATHY (A lymph node on the left side of her neck, it is swollen), AXILLARY PAIN (axillary pain) and VACCINATION SITE PAIN (pain in the arm of the injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroiditis.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced LYMPHADENOPATHY (A lymph node on the left side of her neck, it is swollen). On 06-Apr-2021, the patient experienced SLEEP DISORDER (it disturb my sleeping) and AXILLARY PAIN (axillary pain). On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (it disturb my sleeping), VACCINATION SITE WARMTH (The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨), LYMPHADENOPATHY (A lymph node on the left side of her neck, it is swollen), AXILLARY PAIN (axillary pain) and VACCINATION SITE PAIN (pain in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Night sweats, Pain, Pyrexia
Clinical narrative: Pain; fever; chills; night sweats; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PYREXIA (fever), CHILLS (chills), NIGHT SWEATS (night sweats) and PAIN (Aches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, MELOXICAM, BENAZEPRIL, FLUOXETINE and BACLOFEN for an unknown indication.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Pain), PYREXIA (fever), CHILLS (chills), NIGHT SWEATS (night sweats) and PAIN (Aches). At the time of the report, PAIN (Pain), PYREXIA (fever), CHILLS (chills), NIGHT SWEATS (night sweats) and PAIN (Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Pyrexia: 99.6 (High) fever of 99.6 and 102.2 (High) fever was 102.2.         The treatment medication was Tylenol. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 13-Mar-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. Not Provided          Concomitant product use was not provided by the reporter.  The patient received her first Moderna Covid-19 vaccination in early February and reported no adverse reactions.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD21-072277 (E2B Linked Report).; Sender's Comments:  MOD21-072277:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Burning; Itching; Rash on her back, legs, and arm; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), PRURITUS (Itching) and RASH (Rash on her back, legs, and arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning), PRURITUS (Itching) and RASH (Rash on her back, legs, and arm). At the time of the report, BURNING SENSATION (Burning), PRURITUS (Itching) and RASH (Rash on her back, legs, and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Patient stated the reaction was getting better on her legs but was still there and she was experiencing the most discomfort in her back.   Treatment for the event included an antibiotic cream and a product that helps prevent drying of the skin.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Today, she started with sharp pain underneath her rib on the right side(same side as injection site); Patient had sore arm next day after recieving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Today, she started with sharp pain underneath her rib on the right side(same side as injection site)) and PAIN IN EXTREMITY (Patient had sore arm next day after recieving 1st dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included POTASSIUM and VITAMINS NOS for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Patient had sore arm next day after recieving 1st dose). On 08-Apr-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Today, she started with sharp pain underneath her rib on the right side(same side as injection site)). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Today, she started with sharp pain underneath her rib on the right side(same side as injection site)) and PAIN IN EXTREMITY (Patient had sore arm next day after recieving 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include unknown blood pressure medication.   Patient only rested and did not took any treatment medications.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-JUL-2021, Outcome of the updated. Patient stated that she is doing fine now and did not took any medication but only rest.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Tremor
Clinical narrative: lot leg and arm weakness; very very shaking not like shaking chills but shaking like muscle weakness; This spontaneous case was reported by a health care professional and describes the occurrence of MUSCULAR WEAKNESS (lot leg and arm weakness) and TREMOR (very very shaking not like shaking chills but shaking like muscle weakness) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-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 02-Apr-2021, the patient experienced MUSCULAR WEAKNESS (lot leg and arm weakness) and TREMOR (very very shaking not like shaking chills but shaking like muscle weakness). The patient was treated with HYDROCORTISONE at a dose of 1 dosage form. At the time of the report, MUSCULAR WEAKNESS (lot leg and arm weakness) and TREMOR (very very shaking not like shaking chills but shaking like muscle weakness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site it was pink; Little bit bulging out, of swollen up; Soreness only when she presses it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site it was pink), VACCINATION SITE SWELLING (Little bit bulging out, of swollen up) and VACCINATION SITE PAIN (Soreness only when she presses it) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site it was pink), VACCINATION SITE SWELLING (Little bit bulging out, of swollen up) and VACCINATION SITE PAIN (Soreness only when she presses it). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site it was pink), VACCINATION SITE SWELLING (Little bit bulging out, of swollen up) and VACCINATION SITE PAIN (Soreness only when she presses it) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received the first dose on 8mar21 by accident; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose on 8mar21 by accident) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose on 8mar21 by accident). On 08-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first dose on 8mar21 by accident) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter.  The patient was denied the second dose because she was under 18 years of age.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up received- the follow up report states that when patient when to receive the second dose of vaccination, the patient's mother got to know that her daughter received wrong vaccine(moderna)  instead of Pfizer vaccine. Reporter called Moderna and they suggested her to contact the Pfizer but danaid and  the locality of patient contains only the moderna vaccine which they could not give.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: Weakness all over the body; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Weakness all over the body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 07-Apr-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 08-Apr-2021, the patient experienced ASTHENIA (Weakness all over the body). At the time of the report, ASTHENIA (Weakness all over the body) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and the temporal relationship between the product use and the start date of the event a causal relationship cannot be excluded.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and the temporal relationship between the product use and the start date of the event a causal relationship cannot be excluded.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received 1 dose of Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1 dose of Moderna COVID19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1 dose of Moderna COVID19 vaccine). On 06-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient received 1 dose of Moderna COVID19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Feeling abnormal, Mobility decreased
Clinical narrative: Pain in her arm; Feeling very bad; She cant get up; Stabs all over the body; Dizziness; Diarrhea on and off; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body) and DIZZINESS (Dizziness) 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 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea on and off), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body), DIARRHOEA (Diarrhea on and off), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved and DIZZINESS (Dizziness) had not resolved. Not Provided          No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain
Clinical narrative: Pain in her arm; Feeling very bad; She cant get up; Stabs all over the body; Dizziness; Diarrhea on and off; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body) and DIZZINESS (Dizziness) 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 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea on and off), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Pain in her arm), FEELING ABNORMAL (Feeling very bad), MOBILITY DECREASED (She cant get up), MYALGIA (Stabs all over the body), DIARRHOEA (Diarrhea on and off), NAUSEA (Nausea) and FATIGUE (Fatigue) had resolved and DIZZINESS (Dizziness) had not resolved. Not Provided          No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Generalized body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized body pain) in a 55-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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (Generalized body pain). At the time of the report, PAIN (Generalized body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided. Treatment information not provided.
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Face looked sunburnt red for about 20 minutes; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Face looked sunburnt red for about 20 minutes) 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 (No recorded medical history).   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ERYTHEMA (Face looked sunburnt red for about 20 minutes). On 06-Apr-2021, ERYTHEMA (Face looked sunburnt red for about 20 minutes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071175 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non-significant follow-up. Event duration has been changed.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Paraesthesia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Localized reactions swelling; Localized reactions redness; flu like symptoms; then tingling in other arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Localized reactions swelling), VACCINATION SITE ERYTHEMA (Localized reactions redness), INFLUENZA LIKE ILLNESS (flu like symptoms) and PARAESTHESIA (then tingling in other arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) and SIMVASTATIN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Localized reactions swelling), VACCINATION SITE ERYTHEMA (Localized reactions redness), INFLUENZA LIKE ILLNESS (flu like symptoms) and PARAESTHESIA (then tingling in other arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Localized reactions swelling), VACCINATION SITE ERYTHEMA (Localized reactions redness), INFLUENZA LIKE ILLNESS (flu like symptoms) and PARAESTHESIA (then tingling in other arm) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   This case was linked to MOD-2021-071114 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. No medical history was provided by the reporter.  On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced BACK PAIN (Back pain). The patient was treated with ACETAMINOPHEN from 07-Apr-2021 to 08-Apr-2021 at a dose of 1 dosage form. At the time of the report, BACK PAIN (Back pain) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. concomitant medication include Vitamin D Drops takes every day (OTC medication).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling of relaxation
Clinical narrative: feels better; still felt tired; felt like a wet dishrag; feeling tired, arms tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF RELAXATION (feels better), ASTHENIA (felt like a wet dishrag), FATIGUE (feeling tired, arms tired) and FATIGUE (still felt tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced ASTHENIA (felt like a wet dishrag) and FATIGUE (feeling tired, arms tired). On 06-Apr-2021, the patient experienced FATIGUE (still felt tired). On 08-Apr-2021, the patient experienced FEELING OF RELAXATION (feels better). At the time of the report, FEELING OF RELAXATION (feels better), ASTHENIA (felt like a wet dishrag), FATIGUE (feeling tired, arms tired) and FATIGUE (still felt tired) had resolved.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable  Patient reported they are fine now, further follow up is not required.  Patient denied further follow up.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: follow up received on 10 may 2021 stated that Patient reported they are fine now, further follow up is not required..
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: flu like symptoms; wiped out feeling; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021. The most recent information was received on 06-Apr-2021 and was forwarded to Moderna on 17-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING ABNORMAL (wiped out feeling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING ABNORMAL (wiped out feeling). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and FEELING ABNORMAL (wiped out feeling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant product details were not provided   This case was linked to MOD-2021-068383 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Significant: event outcome updated. Patient says she is fine
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided. No concomitant medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart alternation and Liver disorder. Concomitant products included Ursadiol, Generic Synthroid, and Metoprolol for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE PAIN outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.   This case was linked to MOD21-072324. This case was linked to MOD-2021-071272. Sender's Comments: MOD21-072324.