chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Myalgia
Clinical narrative: Diarrhea; stomach hurting; abdominal issues; arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), MYALGIA (arm is sore) and ABDOMINAL DISCOMFORT (abdominal issues) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Vitamins and FISH OIL for an unknown indication.    On 14-Jul-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 DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), MYALGIA (arm is sore) and ABDOMINAL DISCOMFORT (abdominal issues). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (stomach hurting), MYALGIA (arm is sore) and ABDOMINAL DISCOMFORT (abdominal issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: didn't receive the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Feeling abnormal, Nausea, Tinnitus
Clinical narrative: Very loud ringing noise in left ear; Fatigue; Felt slightly nauseated; Burning sensation when needle went in; Felt something funny was going on in his head; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation when needle went in), FEELING ABNORMAL (Felt something funny was going on in his head), TINNITUS (Very loud ringing noise in left ear), NAUSEA (Felt slightly nauseated) and FATIGUE (Fatigue) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified. Concomitant products included METFORMIN for Diabetes, LISINOPRIL for Heart disease, unspecified.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation when needle went in), FEELING ABNORMAL (Felt something funny was going on in his head) and NAUSEA (Felt slightly nauseated). On 02-Mar-2021, the patient experienced TINNITUS (Very loud ringing noise in left ear) and FATIGUE (Fatigue). At the time of the report, BURNING SENSATION (Burning sensation when needle went in), FEELING ABNORMAL (Felt something funny was going on in his head), TINNITUS (Very loud ringing noise in left ear), NAUSEA (Felt slightly nauseated) and FATIGUE (Fatigue) 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.   Treatment information was not provided.   This case was linked to MOD-2021-257876 (Patient Link).
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 3 months away from first dose and now scheduling the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 15-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose). On 15-Jul-2021, PRODUCT DOSE OMISSION ISSUE (More than 3 months away from first dose and now scheduling the second dose) had resolved.            No concomitant medications were provided. Treatment medications were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Somnolence, Vaccination complication
Clinical narrative: Had side effects for 10 days.; has no energy; feels "really down"/ feels like my "blood count is low"; hard to keep her eyes open; feeling tired / fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had side effects for 10 days.), ASTHENIA (has no energy), FEELING ABNORMAL (feels "really down"/ feels like my "blood count is low"), SOMNOLENCE (hard to keep her eyes open) and FATIGUE (feeling tired / fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-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 VACCINATION COMPLICATION (Had side effects for 10 days.), ASTHENIA (has no energy), FEELING ABNORMAL (feels "really down"/ feels like my "blood count is low"), SOMNOLENCE (hard to keep her eyes open) and FATIGUE (feeling tired / fatigued). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MULTIVITAMIN [VITAMINS NOS] at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Had side effects for 10 days.), ASTHENIA (has no energy), FEELING ABNORMAL (feels "really down"/ feels like my "blood count is low"), SOMNOLENCE (hard to keep her eyes open) and FATIGUE (feeling tired / fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15 Jul 2021 contains updated product information and new events added
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Eczema, Myalgia, Nausea
Clinical narrative: Eczema flare up worse after 2nd shot; condition aggravated; Sore arm/Arm sore to the touch/Arm sore when she rubs it; Still experiencing pain in left arm; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema flare up worse after 2nd shot), CONDITION AGGRAVATED (condition aggravated), MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm) and PYREXIA (Fever) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced ECZEMA (Eczema flare up worse after 2nd shot) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, ECZEMA (Eczema flare up worse after 2nd shot), CONDITION AGGRAVATED (condition aggravated), MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            No Concomitant medication was taken by the patient. No Treatment medication was taken by the patient. The patient's arm was sore when she rubbed and touched it .It was painful when she worked out.   This case was linked to MOD-2021-257906 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Eczema flare up worse after 2nd shot; condition aggravated; Sore arm/Arm sore to the touch/Arm sore when she rubs it; Still experiencing pain in left arm; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema flare up worse after 2nd shot), CONDITION AGGRAVATED (condition aggravated), MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm) and PYREXIA (Fever) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). On an unknown date, the patient experienced ECZEMA (Eczema flare up worse after 2nd shot) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, ECZEMA (Eczema flare up worse after 2nd shot), CONDITION AGGRAVATED (condition aggravated), MYALGIA (Sore arm/Arm sore to the touch/Arm sore when she rubs it), VACCINATION SITE PAIN (Still experiencing pain in left arm), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.            No Concomitant medication was taken by the patient. No Treatment medication was taken by the patient. The patient's arm was sore when she rubbed and touched it .It was painful when she worked out.   This case was linked to MOD-2021-257906 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Product administration error
Clinical narrative: myalgia; migraine; first dose vaccine content in the syringe up to the plunger appeared "red"; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (myalgia), MIGRAINE (migraine) and PRODUCT ADMINISTRATION ERROR (first dose vaccine content in the syringe up to the plunger appeared "red") in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 048C21A) for COVID-19 vaccination.     Medical history was not provided. .    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-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 MYALGIA (myalgia), MIGRAINE (migraine) and PRODUCT ADMINISTRATION ERROR (first dose vaccine content in the syringe up to the plunger appeared "red"). The patient was treated with CANNABIS SATIVA (CBD COMPLEX) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (myalgia), MIGRAINE (migraine) and PRODUCT ADMINISTRATION ERROR (first dose vaccine content in the syringe up to the plunger appeared "red") outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Concomitant medication information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac murmur, Computerised tomogram, Dehydration, Nausea, Neuralgia
Clinical narrative: ringing in  ear; head spinning; heart murmur; pleural effusion; nerve pain; dehydration; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEURALGIA (nerve pain), DEHYDRATION (dehydration), VERTIGO (head spinning), CARDIAC MURMUR (heart murmur) and PLEURAL EFFUSION (pleural effusion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Heart disorder. Concomitant products included METFORMIN for Diabetes, LISINOPRIL for Heart disorder.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced NEURALGIA (nerve pain) and PLEURAL EFFUSION (pleural effusion). In 2021, the patient experienced DEHYDRATION (dehydration), NAUSEA (nausea) and VOMITING (vomiting). On 09-Jul-2021, the patient experienced VERTIGO (head spinning) and CARDIAC MURMUR (heart murmur). On an unknown date, the patient experienced TINNITUS (ringing in  ear). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date for Head spinning, at a dose of 1 dosage form; TRAMADOL ongoing since an unknown date for Nerve pain, at a dose of 1 dosage form; CELECOXIB for Muscle relaxant, at a dose of 1 dosage form; PREDNISONE for Nausea and Vomiting, at a dose of 1 dosage form and ONDANSETRON for Nausea and Vomiting, at a dose of 1 dosage form. At the time of the report, NEURALGIA (nerve pain), DEHYDRATION (dehydration), VERTIGO (head spinning), CARDIAC MURMUR (heart murmur), PLEURAL EFFUSION (pleural effusion), TINNITUS (ringing in  ear), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) fluid build up in chest.         Patient took prednisone for 4-5 days which causes nausea and vomiting. Patient undergone MRI scan.   This case was linked to MOD-2021-257861 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, Tinnitus, Vertigo, Vomiting
Clinical narrative: ringing in  ear; head spinning; heart murmur; pleural effusion; nerve pain; dehydration; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEURALGIA (nerve pain), DEHYDRATION (dehydration), VERTIGO (head spinning), CARDIAC MURMUR (heart murmur) and PLEURAL EFFUSION (pleural effusion) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Heart disorder. Concomitant products included METFORMIN for Diabetes, LISINOPRIL for Heart disorder.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced NEURALGIA (nerve pain) and PLEURAL EFFUSION (pleural effusion). In 2021, the patient experienced DEHYDRATION (dehydration), NAUSEA (nausea) and VOMITING (vomiting). On 09-Jul-2021, the patient experienced VERTIGO (head spinning) and CARDIAC MURMUR (heart murmur). On an unknown date, the patient experienced TINNITUS (ringing in  ear). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date for Head spinning, at a dose of 1 dosage form; TRAMADOL ongoing since an unknown date for Nerve pain, at a dose of 1 dosage form; CELECOXIB for Muscle relaxant, at a dose of 1 dosage form; PREDNISONE for Nausea and Vomiting, at a dose of 1 dosage form and ONDANSETRON for Nausea and Vomiting, at a dose of 1 dosage form. At the time of the report, NEURALGIA (nerve pain), DEHYDRATION (dehydration), VERTIGO (head spinning), CARDIAC MURMUR (heart murmur), PLEURAL EFFUSION (pleural effusion), TINNITUS (ringing in  ear), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) fluid build up in chest.         Patient took prednisone for 4-5 days which causes nausea and vomiting. Patient undergone MRI scan.   This case was linked to MOD-2021-257861 (Patient Link).
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: follow-up received on 06-AUG-2021 contain No new information was provided. On 10-Aug-2021: follow-up received on 10-AUG-2021 contain No new information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. patient was given first and second dose of the Moderna COVID-19 vaccine 2 weeks/14days apart instead of the recommended window.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Chills; fever; Legs pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever) and PAIN IN EXTREMITY (Legs pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C021A and 051C021A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced CHILLS (Chills), PYREXIA (fever) and PAIN IN EXTREMITY (Legs pain). At the time of the report, CHILLS (Chills), PYREXIA (fever) and PAIN IN EXTREMITY (Legs pain) outcome was unknown.            No concomitant medications were reported. Treatment with Tylenol was provided by the patient to alleviate the symptoms experienced..   This case was linked to MOD-2021-257883 (Patient Link).; 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: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Myalgia; Arthralgia; Headache; Extreme fatigue; Low grade fever; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), HEADACHE (Headache), FATIGUE (Extreme fatigue) and PYREXIA (Low grade fever) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), HEADACHE (Headache), FATIGUE (Extreme fatigue) and PYREXIA (Low grade fever). On 17-Jan-2021, MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), HEADACHE (Headache), FATIGUE (Extreme fatigue) and PYREXIA (Low grade fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.   This case was linked to MOD-2021-257968 (Patient Link).
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Alopecia, Bone pain, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS, ALOPECIA, ABDOMINAL PAIN, BONE PAIN and HEADACHE in a 36-year-old patient of an unknown gender 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 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OESOPHAGITIS, ALOPECIA, ABDOMINAL PAIN, BONE PAIN, HEADACHE, FATIGUE and MYALGIA. At the time of the report, OESOPHAGITIS, ALOPECIA, ABDOMINAL PAIN, BONE PAIN, HEADACHE, FATIGUE  and MYALGIA  outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Translated document received contains translated dose related information and events .
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Oesophagitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGITIS, ALOPECIA, ABDOMINAL PAIN, BONE PAIN and HEADACHE in a 36-year-old patient of an unknown gender 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 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OESOPHAGITIS, ALOPECIA, ABDOMINAL PAIN, BONE PAIN, HEADACHE, FATIGUE and MYALGIA. At the time of the report, OESOPHAGITIS, ALOPECIA, ABDOMINAL PAIN, BONE PAIN, HEADACHE, FATIGUE  and MYALGIA  outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Translated document received contains translated dose related information and events .
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. 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) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia, Magnetic resonance imaging head, Malaise, Nausea
Clinical narrative: dizzy; Feeling sick; vertigo; Difficulty in standing; vestibular neuritis; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ) and VESTIBULAR NEURONITIS (vestibular neuritis) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B2NA and 001B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE for Sleep disorder, VITAMIN C [ASCORBIC ACID], LYSINE, MULTIVITAMINS [VITAMINS NOS], LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), ASPIRIN [ACETYLSALICYLIC ACID], BIOTIN, FAMOTIDINE, MELOXICAM, TELMISARTAN (MICARDIS), ESCITALOPRAM, ROSUVASTATIN, METHOCARBAMOL (ROBAXIN), METFORMIN and OXYCODONE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (dizzy), MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ), VESTIBULAR NEURONITIS (vestibular neuritis) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy) and NAUSEA (Nausea) had not resolved and MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ) and VESTIBULAR NEURONITIS (vestibular neuritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: abnormal (abnormal) Vestibular neuritis.         Patient was prescribed to took meclizine , but declined to take. Patient was taking stool softener 100 milligram as concomitant medication.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo, Vestibular neuronitis
Clinical narrative: dizzy; Feeling sick; vertigo; Difficulty in standing; vestibular neuritis; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ) and VESTIBULAR NEURONITIS (vestibular neuritis) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B2NA and 001B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE for Sleep disorder, VITAMIN C [ASCORBIC ACID], LYSINE, MULTIVITAMINS [VITAMINS NOS], LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), ASPIRIN [ACETYLSALICYLIC ACID], BIOTIN, FAMOTIDINE, MELOXICAM, TELMISARTAN (MICARDIS), ESCITALOPRAM, ROSUVASTATIN, METHOCARBAMOL (ROBAXIN), METFORMIN and OXYCODONE for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (dizzy), MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ), VESTIBULAR NEURONITIS (vestibular neuritis) and NAUSEA (Nausea). At the time of the report, DIZZINESS (dizzy) and NAUSEA (Nausea) had not resolved and MALAISE (Feeling sick), VERTIGO ( vertigo), DYSSTASIA (Difficulty in standing ) and VESTIBULAR NEURONITIS (vestibular neuritis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: abnormal (abnormal) Vestibular neuritis.         Patient was prescribed to took meclizine , but declined to take. Patient was taking stool softener 100 milligram as concomitant medication.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema aggravated; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema aggravated) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     The patient's past medical history included Eczema.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema aggravated). At the time of the report, ECZEMA (Eczema aggravated) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant drugs were reported. No treatment medications were reported.   This case was linked to MOD-2021-257906 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 20april2021 and the second dose on 14july2021.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20april2021 and the second dose on 14july2021.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036c4a and 042B21a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20april2021 and the second dose on 14july2021.). On 14-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20april2021 and the second dose on 14july2021.) had resolved.            No concomitant medications was reported Treatment information was not provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose of the vaccine given 17Apr2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given 17Apr2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 205A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given 17Apr2021). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine given 17Apr2021) 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.   The concomitant medications were not reported.  The treatment information was not provided
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ). On 15-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications was reported.  Treatment information was not provided. Second dose administered 21 days after the first dose to patient.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received as a 2nd dose a vaccine from a vial that was first punctured more than 2 days before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and  treatment medications were provided.  patient  received a vaccine accidentally, the vial had been first punctured on 09 or 10-jul-2021, it was open 1 or 2 days already, then it was put back on the fridge, and it was administered as a 2nd dose to a patient on 13-Jul-2021.  only 1 vial affected, it was not discarded and was sent again to the refrigerator, it looked normal, clear. He doesn't remember the exact temperature   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: follow up document is received it does not contain any new information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, Cough
Clinical narrative: Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19; Unanticipated cycle menstruation; Green sputum; Complete lost of taste; Complete lost of smell; Sinusitis; Cough; high fever of 103.5 °F; Profound headache; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19), MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste) and ANOSMIA (Complete lost of smell) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included INFLIXIMAB (REMICADE) for Ulcerative colitis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste), ANOSMIA (Complete lost of smell), SINUSITIS (Sinusitis), COUGH (Cough) and HEADACHE (Profound headache). 08-Jul-2021, the patient experienced PYREXIA (high fever of 103.5 °F). On 11-Jul-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19). On 11-Jul-2021, COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19) had resolved. At the time of the report, MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste), ANOSMIA (Complete lost of smell), SINUSITIS (Sinusitis), COUGH (Cough), PYREXIA (high fever of 103.5 °F) and HEADACHE (Profound headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 103.5 (High) 103.5 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was tested via PCR (nasal swab) in the hospital. An extra nasal swab was made for genomic testing. On 12-Jul-2021, the patient received monoclonal antibody therapy for severe COVID-19. Patient was treated as an out-patient so was not hospitalized.  When the patient was vaccinated, it had been over 8 weeks since the patient last received the Remicade infusions.   This case was linked to MOD-2021-257972 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstruation irregular, Pyrexia, Sinusitis, Sputum discoloured
Clinical narrative: Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19; Unanticipated cycle menstruation; Green sputum; Complete lost of taste; Complete lost of smell; Sinusitis; Cough; high fever of 103.5 °F; Profound headache; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19), MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste) and ANOSMIA (Complete lost of smell) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included INFLIXIMAB (REMICADE) for Ulcerative colitis.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste), ANOSMIA (Complete lost of smell), SINUSITIS (Sinusitis), COUGH (Cough) and HEADACHE (Profound headache). 08-Jul-2021, the patient experienced PYREXIA (high fever of 103.5 °F). On 11-Jul-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19). On 11-Jul-2021, COVID-19 (Diagnosed with COVID-19 after 3 days of escalating symptoms/breakthrough COVID-19) had resolved. At the time of the report, MENSTRUATION IRREGULAR (Unanticipated cycle menstruation), SPUTUM DISCOLOURED (Green sputum), AGEUSIA (Complete lost of taste), ANOSMIA (Complete lost of smell), SINUSITIS (Sinusitis), COUGH (Cough), PYREXIA (high fever of 103.5 °F) and HEADACHE (Profound headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Body temperature: 103.5 (High) 103.5 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was tested via PCR (nasal swab) in the hospital. An extra nasal swab was made for genomic testing. On 12-Jul-2021, the patient received monoclonal antibody therapy for severe COVID-19. Patient was treated as an out-patient so was not hospitalized.  When the patient was vaccinated, it had been over 8 weeks since the patient last received the Remicade infusions.   This case was linked to MOD-2021-257972 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache, Myalgia, Product storage error
Clinical narrative: arm soreness; headache; chills; dose was given on the 34th day after the vial was thawed; dose was given on the 34th day after the vial was thawed; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed), PRODUCT STORAGE ERROR (dose was given on the 34th day after the vial was thawed), MYALGIA (arm soreness), HEADACHE (headache) and CHILLS (chills) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-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 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed) and PRODUCT STORAGE ERROR (dose was given on the 34th day after the vial was thawed). On an unknown date, the patient experienced MYALGIA (arm soreness), HEADACHE (headache) and CHILLS (chills). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (dose was given on the 34th day after the vial was thawed) and PRODUCT STORAGE ERROR (dose was given on the 34th day after the vial was thawed) had resolved. At the time of the report, MYALGIA (arm soreness), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. First dose was given 28 days prior.   Most recent FOLLOW-UP information incorporated above includes: On 07-Aug-2021: Non-significant follow up- Contact details added
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache
Clinical narrative: headache; sick to stomach; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and ABDOMINAL DISCOMFORT (sick to stomach) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.     On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced HEADACHE (headache) and ABDOMINAL DISCOMFORT (sick to stomach). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) and ABDOMINAL DISCOMFORT (sick to stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller didn't wished to get second dose. Concomitant product use was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: Sore arm; Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). In March 2021, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: Weakness; Fatigue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), FATIGUE (Fatigue) and MYALGIA (Sore Arm) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ASTHENIA (Weakness), FATIGUE (Fatigue) and MYALGIA (Sore Arm). On 25-Apr-2021, ASTHENIA (Weakness), FATIGUE (Fatigue) and MYALGIA (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-257969 (Patient Link).