chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.         No concomitant and treatment medicine has been reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-079434 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079434:First Dose
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received the vaccine 5 minutes after her appointment; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Received the vaccine 5 minutes after her appointment) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Received the vaccine 5 minutes after her appointment). On 16-Apr-2021, PRODUCT STORAGE ERROR (Received the vaccine 5 minutes after her appointment) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment medications of the patient were not provided.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old received the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the vaccine). On 11-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old received the 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.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 52.0
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 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 26-Feb-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-079463 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079463:Dose 2
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia, Urticaria
Clinical narrative: Itching; Achy; Slight fever, 100 maybe; Hives from her wrist to her inner elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), PAIN (Achy), URTICARIA (Hives from her wrist to her inner elbow) and PYREXIA (Slight fever, 100 maybe) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PAIN (Achy) and PYREXIA (Slight fever, 100 maybe). On an unknown date, the patient experienced PRURITUS (Itching) and URTICARIA (Hives from her wrist to her inner elbow). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 24 hour during the day and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching) was resolving and PAIN (Achy), URTICARIA (Hives from her wrist to her inner elbow) and PYREXIA (Slight fever, 100 maybe) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Cough, Headache
Clinical narrative: covid-19; headache; chills; cough; mucus; all body pain; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all body pain), COUGH (cough), SECRETION DISCHARGE (mucus), COVID-19 (covid-19) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ARTHRALGIA (joint pain). On 09-Apr-2021, the patient experienced PAIN (all body pain) and PYREXIA (fever). On 10-Apr-2021, the patient experienced COUGH (cough), SECRETION DISCHARGE (mucus), HEADACHE (headache) and CHILLS (chills). On 11-Apr-2021, the patient experienced COVID-19 (covid-19). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN (all body pain), COUGH (cough), SECRETION DISCHARGE (mucus), COVID-19 (covid-19), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Secretion discharge
Clinical narrative: covid-19; headache; chills; cough; mucus; all body pain; fever; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (all body pain), COUGH (cough), SECRETION DISCHARGE (mucus), COVID-19 (covid-19) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetes.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced ARTHRALGIA (joint pain). On 09-Apr-2021, the patient experienced PAIN (all body pain) and PYREXIA (fever). On 10-Apr-2021, the patient experienced COUGH (cough), SECRETION DISCHARGE (mucus), HEADACHE (headache) and CHILLS (chills). On 11-Apr-2021, the patient experienced COVID-19 (covid-19). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PAIN (all body pain), COUGH (cough), SECRETION DISCHARGE (mucus), COVID-19 (covid-19), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (joint pain) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Illness, Insomnia
Clinical narrative: cannot sleep at night; really sick; fever; chills; headaches; constantly bad cough; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specified medical history was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-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 INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches) and COUGH (constantly bad cough). The patient was treated with DEXCHLORPHENIRAMINE MALEATE, HYOSCINE METHONITRATE, PSEUDOEPHEDRINE HYDROCHLORIDE (D-HIST D) at a dose of unknown; PARACETAMOL (TYLENOL) at a dose of unknown; VITAMIN D NOS at a dose of unknown and ASCORBIC ACID (VITAMIN C ACID) at an unspecified dose and frequency. At the time of the report, INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches) and COUGH (constantly bad cough) outcome was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: cannot sleep at night; really sick; fever; chills; headaches; constantly bad cough; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no specified medical history was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-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 INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches) and COUGH (constantly bad cough). The patient was treated with DEXCHLORPHENIRAMINE MALEATE, HYOSCINE METHONITRATE, PSEUDOEPHEDRINE HYDROCHLORIDE (D-HIST D) at a dose of unknown; PARACETAMOL (TYLENOL) at a dose of unknown; VITAMIN D NOS at a dose of unknown and ASCORBIC ACID (VITAMIN C ACID) at an unspecified dose and frequency. At the time of the report, INSOMNIA (cannot sleep at night), ILLNESS (really sick), PYREXIA (fever), CHILLS (chills), HEADACHE (headaches) and COUGH (constantly bad cough) outcome was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Pain, Vomiting
Clinical narrative: Stomach pain; Diarrhea; Body ache; Vomiting; Cold chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), VOMITING (Vomiting) and CHILLS (Cold chills) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body ache), VOMITING (Vomiting) and CHILLS (Cold chills). On 15-Apr-2021, the patient experienced DIARRHOEA (Diarrhea). On 16-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, PAIN (Body ache), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), VOMITING (Vomiting) and CHILLS (Cold chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hypersensitivity
Clinical narrative: fever; rash/hives on her neck; injection site very swollen; injection site red; fatigue; headache; muscle pain; joint pain; chills; hives on her neck; ITCHY; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever) and RASH (rash/hives on her neck) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) 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 considered HYPERSENSITIVITY (Hypersensitivity reaction) to be related. No further causality assessments were provided for URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills).     No  concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received and contains patient demographics,AE not yet resolved On 01-Jul-2021: follow up received and contains patient demographics ,product details and event outcome as unknown
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Myalgia, Pruritus, Pyrexia
Clinical narrative: fever; rash/hives on her neck; injection site very swollen; injection site red; fatigue; headache; muscle pain; joint pain; chills; hives on her neck; ITCHY; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever) and RASH (rash/hives on her neck) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) 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 considered HYPERSENSITIVITY (Hypersensitivity reaction) to be related. No further causality assessments were provided for URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills).     No  concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received and contains patient demographics,AE not yet resolved On 01-Jul-2021: follow up received and contains patient demographics ,product details and event outcome as unknown
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: fever; rash/hives on her neck; injection site very swollen; injection site red; fatigue; headache; muscle pain; joint pain; chills; hives on her neck; ITCHY; Hypersensitivity reaction; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever) and RASH (rash/hives on her neck) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On an unknown date, the patient experienced URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills) 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 considered HYPERSENSITIVITY (Hypersensitivity reaction) to be related. No further causality assessments were provided for URTICARIA (hives on her neck), PRURITUS (ITCHY), PYREXIA (fever), RASH (rash/hives on her neck), INJECTION SITE SWELLING (injection site very swollen), INJECTION SITE ERYTHEMA (injection site red), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and CHILLS (chills).     No  concomitant medications were provided. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received and contains patient demographics,AE not yet resolved On 01-Jul-2021: follow up received and contains patient demographics ,product details and event outcome as unknown
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Induration, Lethargy, Papule
Clinical narrative: Arm felt like a brick; Unable to focus; tingling sensation; Rash on arm; Headache; Lethargic; a little bump; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PAPULE (a little bump), INDURATION (Arm felt like a brick), DISTURBANCE IN ATTENTION (Unable to focus) and PARAESTHESIA (tingling sensation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Drug allergy (Pencillin allergy), Food allergy (soy food), Iodine allergy, Latex allergy and Seafood allergy. Concomitant products included GABAPENTIN for Back pain, ZOLPIDEM for Insomnia.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced LETHARGY (Lethargic), PAPULE (a little bump), RASH (Rash on arm) and HEADACHE (Headache). On 05-Apr-2021, the patient experienced PARAESTHESIA (tingling sensation). On an unknown date, the patient experienced INDURATION (Arm felt like a brick) and DISTURBANCE IN ATTENTION (Unable to focus). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 12-Mar-2021, PAPULE (a little bump) had resolved. On 15-Mar-2021, LETHARGY (Lethargic), INDURATION (Arm felt like a brick), DISTURBANCE IN ATTENTION (Unable to focus), RASH (Rash on arm) and HEADACHE (Headache) had resolved. On 08-Apr-2021, PARAESTHESIA (tingling sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-079483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-May-2021, added Concomitant medications, event outcome and.treatment details were updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Rash
Clinical narrative: Arm felt like a brick; Unable to focus; tingling sensation; Rash on arm; Headache; Lethargic; a little bump; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), PAPULE (a little bump), INDURATION (Arm felt like a brick), DISTURBANCE IN ATTENTION (Unable to focus) and PARAESTHESIA (tingling sensation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Drug allergy (Pencillin allergy), Food allergy (soy food), Iodine allergy, Latex allergy and Seafood allergy. Concomitant products included GABAPENTIN for Back pain, ZOLPIDEM for Insomnia.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced LETHARGY (Lethargic), PAPULE (a little bump), RASH (Rash on arm) and HEADACHE (Headache). On 05-Apr-2021, the patient experienced PARAESTHESIA (tingling sensation). On an unknown date, the patient experienced INDURATION (Arm felt like a brick) and DISTURBANCE IN ATTENTION (Unable to focus). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 12-Mar-2021, PAPULE (a little bump) had resolved. On 15-Mar-2021, LETHARGY (Lethargic), INDURATION (Arm felt like a brick), DISTURBANCE IN ATTENTION (Unable to focus), RASH (Rash on arm) and HEADACHE (Headache) had resolved. On 08-Apr-2021, PARAESTHESIA (tingling sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-079483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-May-2021, added Concomitant medications, event outcome and.treatment details were updated
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive from covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive from covid-19) in a female 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 reported medical history).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced COVID-19 (Tested positive from covid-19). The patient was treated with Immunotherapy (Monoclonal antibodies) for COVID-19. At the time of the report, COVID-19 (Tested positive from covid-19) 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 product use was not provided by the reporter.  Patient  has to wait 90 days before being able to get second dose.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Lymph node haemorrhage, Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen/dark red lymph node in right groin area that bleed when touched; Swollen lymph node in right groin area; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE HAEMORRHAGE (swollen/dark red lymph node in right groin area that bleed when touched), VACCINATION SITE PAIN (soreness at injection site) and LYMPHADENOPATHY (Swollen lymph node in right groin area) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). On 14-Apr-2021, the patient experienced LYMPH NODE HAEMORRHAGE (swollen/dark red lymph node in right groin area that bleed when touched) and LYMPHADENOPATHY (Swollen lymph node in right groin area). On 26-Mar-2021, VACCINATION SITE PAIN (soreness at injection site) had resolved. At the time of the report, LYMPH NODE HAEMORRHAGE (swollen/dark red lymph node in right groin area that bleed when touched) and LYMPHADENOPATHY (Swollen lymph node in right groin area) had not resolved.            No concomitant medications were provided.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-079449 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079449:Dose 1
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain, Pyrexia
Clinical narrative: Lower back pain radiating tothe testicle area; Body Aches; Fever; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain radiating tothe testicle area), PAIN (Body Aches), PYREXIA (Fever) and MYALGIA (Myalgia) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PAIN (Body Aches), PYREXIA (Fever) and MYALGIA (Myalgia). On 14-Apr-2021, the patient experienced BACK PAIN (Lower back pain radiating tothe testicle area). At the time of the report, BACK PAIN (Lower back pain radiating tothe testicle area), PAIN (Body Aches), PYREXIA (Fever) and MYALGIA (Myalgia) outcome was unknown.            patient was treated with Advil.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Therapeutic response unexpected
Clinical narrative: Status Dermatitis has cleared up after the vaccine; Fatigue after first dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Status Dermatitis has cleared up after the vaccine) and FATIGUE (Fatigue after first dose of vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Stasis dermatitis (since last fall, red rash type on legs plus peeling of the skin.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FATIGUE (Fatigue after first dose of vaccination). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Status Dermatitis has cleared up after the vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Status Dermatitis has cleared up after the vaccine) and FATIGUE (Fatigue after first dose of vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided. No treatment medication details were provided. Status Dermatitis has cleared up after the vaccine first dose.   This case was linked to MOD-2021-079474 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information received included no significant information updated. On 30-Apr-2021: Follow up received included no new significant information updated. On 25-May-2021: Follow up information received included no new significant information. On 03-Jun-2021: Follow up received included no new significant information updated. On 27-Jul-2021: Follow up received included no new significant information.; Sender's Comments:  MOD-2021-079474:Second dose of vaccine case.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: more serious reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (more serious reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (more serious reaction). At the time of the report, VACCINATION COMPLICATION (more serious reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Localised infection, Pruritus, Urticaria
Clinical narrative: eye was all swollen; Arm feels like its infected; feels hot to touch; arm has a hard knot; it is all red; Still feeling fatigue; hives on her rear end; skin felt itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her rear end), EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), VACCINATION SITE WARMTH (feels hot to touch) and PRURITUS (skin felt itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRAMADOL, DULOXETINE and ALPRAZOLAM for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced URTICARIA (hives on her rear end) and PRURITUS (skin felt itchy). On an unknown date, the patient experienced EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), VACCINATION SITE WARMTH (feels hot to touch), VACCINATION SITE INDURATION (arm has a hard knot), VACCINATION SITE ERYTHEMA (it is all red) and FATIGUE (Still feeling fatigue). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on her rear end), EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), PRURITUS (skin felt itchy) and VACCINATION SITE ERYTHEMA (it is all red) outcome was unknown and VACCINATION SITE WARMTH (feels hot to touch), VACCINATION SITE INDURATION (arm has a hard knot) and FATIGUE (Still feeling fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: eye was all swollen; Arm feels like its infected; feels hot to touch; arm has a hard knot; it is all red; Still feeling fatigue; hives on her rear end; skin felt itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her rear end), EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), VACCINATION SITE WARMTH (feels hot to touch) and PRURITUS (skin felt itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included TRAMADOL, DULOXETINE and ALPRAZOLAM for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced URTICARIA (hives on her rear end) and PRURITUS (skin felt itchy). On an unknown date, the patient experienced EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), VACCINATION SITE WARMTH (feels hot to touch), VACCINATION SITE INDURATION (arm has a hard knot), VACCINATION SITE ERYTHEMA (it is all red) and FATIGUE (Still feeling fatigue). The patient was treated with LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on her rear end), EYE SWELLING (eye was all swollen), LOCALISED INFECTION (Arm feels like its infected), PRURITUS (skin felt itchy) and VACCINATION SITE ERYTHEMA (it is all red) outcome was unknown and VACCINATION SITE WARMTH (feels hot to touch), VACCINATION SITE INDURATION (arm has a hard knot) and FATIGUE (Still feeling fatigue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Condition aggravated, Headache, Nausea, Rash pruritic
Clinical narrative: complaints related to Chrone's disease have increased after vaccine.; GI complaints after vaccination.; headache on and off; nausea; rash all over body  itchy; redness at injection site; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (complaints related to Crone's disease have increased after vaccine), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site) and HEADACHE (headache on and off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease (No reported Medical history).    On 27-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 CONDITION AGGRAVATED (complaints related to Crone's disease have increased after vaccine.), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site), HEADACHE (headache on and off) and NAUSEA (nausea). At the time of the report, CONDITION AGGRAVATED (complaints related to Chrone's disease have increased after vaccine.), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site), HEADACHE (headache on and off) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient asked about delayed reactions and if she can go for the second dose of vaccine? Concomitant drug information was not provided.  Treatment information was not provided. Gave consent for safety team to follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: complaints related to Chrone's disease have increased after vaccine.; GI complaints after vaccination.; headache on and off; nausea; rash all over body  itchy; redness at injection site; This spontaneous case was reported by a patient and describes the occurrence of CONDITION AGGRAVATED (complaints related to Crone's disease have increased after vaccine), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site) and HEADACHE (headache on and off) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease (No reported Medical history).    On 27-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 CONDITION AGGRAVATED (complaints related to Crone's disease have increased after vaccine.), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site), HEADACHE (headache on and off) and NAUSEA (nausea). At the time of the report, CONDITION AGGRAVATED (complaints related to Chrone's disease have increased after vaccine.), ABDOMINAL DISCOMFORT (GI complaints after vaccination.), RASH PRURITIC (rash all over body  itchy), VACCINATION SITE ERYTHEMA (redness at injection site), HEADACHE (headache on and off) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient asked about delayed reactions and if she can go for the second dose of vaccine? Concomitant drug information was not provided.  Treatment information was not provided. Gave consent for safety team to follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: schedualed for second dsoe 55 days from the first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (schedualed for second dsoe 55 days from the first dose) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (schedualed for second dsoe 55 days from the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (schedualed for second dsoe 55 days from the first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: sore in the arm (left arm where the shot was given); hard (bump on the injection site); bump on the injection site; vaccination site itching; there is also a bit of rashes in the area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore in the arm (left arm where the shot was given)), VACCINATION SITE INDURATION (hard (bump on the injection site)), VACCINATION SITE SWELLING (bump on the injection site), VACCINATION SITE PRURITUS (vaccination site itching) and RASH (there is also a bit of rashes in the area) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-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 IN EXTREMITY (sore in the arm (left arm where the shot was given)), VACCINATION SITE INDURATION (hard (bump on the injection site)), VACCINATION SITE SWELLING (bump on the injection site), VACCINATION SITE PRURITUS (vaccination site itching) and RASH (there is also a bit of rashes in the area). At the time of the report, PAIN IN EXTREMITY (sore in the arm (left arm where the shot was given)), VACCINATION SITE INDURATION (hard (bump on the injection site)), VACCINATION SITE SWELLING (bump on the injection site), VACCINATION SITE PRURITUS (vaccination site itching) and RASH (there is also a bit of rashes in the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment details include, cream and diphenhydramine for itchiness.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Hypoaesthesia, Muscle twitching, Nervousness
Clinical narrative: Nervous; Trembling of fingers; Twitching of left arm; Right hand numb; Congestion in chest; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb) and CHEST DISCOMFORT (Congestion in chest) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb), CHEST DISCOMFORT (Congestion in chest) and HEADACHE (Slight Headache). At the time of the report, NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb), CHEST DISCOMFORT (Congestion in chest) and HEADACHE (Slight Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included some cough formula. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Nervous; Trembling of fingers; Twitching of left arm; Right hand numb; Congestion in chest; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb) and CHEST DISCOMFORT (Congestion in chest) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-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 NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb), CHEST DISCOMFORT (Congestion in chest) and HEADACHE (Slight Headache). At the time of the report, NERVOUSNESS (Nervous), TREMOR (Trembling of fingers), MUSCLE TWITCHING (Twitching of left arm), HYPOAESTHESIA (Right hand numb), CHEST DISCOMFORT (Congestion in chest) and HEADACHE (Slight Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included some cough formula. No treatment information was provided.