chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose yet past 42 days; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 42 days) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event (No medical history was reported.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 42 days). On 29-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet past 42 days) 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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling cold, Feeling hot, Hypersomnia
Clinical narrative: Was burning up; I slept early and throughout the night; Shivering; Felt very cold; Shaking; Had to turn on the heater; Felt extremely hot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot) and BURNING SENSATION (Was burning up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OLMESARTAN, ROSUVASTATIN, MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN E NOS], VITAMIN D [VITAMIN D NOS], CALCIUM, VITAMIN C [ASCORBIC ACID], GABAPENTIN and OMEPRAZOLE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (Sore arm). On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot) and CHILLS (Shivering). On 28-Mar-2021, the patient experienced HYPERSOMNIA (I slept early and throughout the night). On an unknown date, the patient experienced BURNING SENSATION (Was burning up). On 02-Mar-2021, MYALGIA (Sore arm) had resolved. On 29-Mar-2021, FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot), HYPERSOMNIA (I slept early and throughout the night) and CHILLS (Shivering) had resolved. At the time of the report, BURNING SENSATION (Was burning up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Tremor
Clinical narrative: Was burning up; I slept early and throughout the night; Shivering; Felt very cold; Shaking; Had to turn on the heater; Felt extremely hot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot) and BURNING SENSATION (Was burning up) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included OLMESARTAN, ROSUVASTATIN, MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN E NOS], VITAMIN D [VITAMIN D NOS], CALCIUM, VITAMIN C [ASCORBIC ACID], GABAPENTIN and OMEPRAZOLE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (Sore arm). On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot) and CHILLS (Shivering). On 28-Mar-2021, the patient experienced HYPERSOMNIA (I slept early and throughout the night). On an unknown date, the patient experienced BURNING SENSATION (Was burning up). On 02-Mar-2021, MYALGIA (Sore arm) had resolved. On 29-Mar-2021, FEELING COLD (Felt very cold), TREMOR (Shaking), FEELING COLD (Had to turn on the heater), FEELING HOT (Felt extremely hot), HYPERSOMNIA (I slept early and throughout the night) and CHILLS (Shivering) had resolved. At the time of the report, BURNING SENSATION (Was burning up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: itching on the back, left side of my neck; Hives/urticaria; redness; Rash on the back of patient's neck towards the left side; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on the back, left side of my neck), URTICARIA (Hives/urticaria), ERYTHEMA (redness) and RASH (Rash on the back of patient's neck towards the left side) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 007C21A) for COVID-19 vaccination.     The patient's past medical history included Depression on 01-Jan-2010. Concurrent medical conditions included Hypersensitivity reaction, Penicillin allergy (Since Childhood - Itching/Rash when taken.) and Sulfonamide allergy (Since Childhood - Itching/Rash when taken.). Concomitant products included CITALOPRAM from 01-Jan-2010 to an unknown date for Depression.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced RASH (Rash on the back of patient's neck towards the left side). On an unknown date, the patient experienced PRURITUS (itching on the back, left side of my neck), URTICARIA (Hives/urticaria) and ERYTHEMA (redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and HYDROCORTISONE from 24-Mar-2021 to 26-Mar-2021 for Rash, at a dose of 1 dosage form three times a day. At the time of the report, PRURITUS (itching on the back, left side of my neck), URTICARIA (Hives/urticaria), ERYTHEMA (redness) and RASH (Rash on the back of patient's neck towards the left side) had resolved.            The action taken with mRNA-1273 with the event was considered as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up information received contains significant information. Added medical history,outcome of the events and second dose taken.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose middle of January never got second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose middle of January never got second dose) 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose middle of January never got second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose middle of January never got second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lethargy, Pain, Pain in extremity
Clinical narrative: arm hurt; lethargic; achy; tired; felt weirded out that she drank coffee and went back to bed; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm hurt), LETHARGY (lethargic), PAIN (achy), FATIGUE (tired) and FEELING ABNORMAL (felt weirded out that she drank coffee and went back to bed) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included BIOTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and SACCHAROMYCES BOULARDII (FLORASTOR KIDS) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), LETHARGY (lethargic), PAIN (achy), FATIGUE (tired) and FEELING ABNORMAL (felt weirded out that she drank coffee and went back to bed). On 21-Feb-2021, PAIN IN EXTREMITY (arm hurt), LETHARGY (lethargic), PAIN (achy), FATIGUE (tired) and FEELING ABNORMAL (felt weirded out that she drank coffee and went back to bed) 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.   Treatment information not provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Dizzy became worst; Weak became worst; Not able to do anything and could not drive car; pain moved to his left arm soon after the vaccination became worst\  pain in left leg; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy became worst), ASTHENIA (Weak became worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to do anything and could not drive car) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination became worst\  pain in left leg) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 212A21A and 012A20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (Dizzy became worst), ASTHENIA (Weak became worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to do anything and could not drive car) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination became worst\  pain in left leg). At the time of the report, DIZZINESS (Dizzy became worst), ASTHENIA (Weak became worst), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Not able to do anything and could not drive car) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination became worst\  pain in left leg) had not resolved. Not Provided          Treatment information not provided.  Concomitant medications were not provided.  The symptoms became worst after the second shot.  In followup patient stated that the event-Still having excruciating pain in left leg and also stated that  Wrecked a car since getting the vaccine.   This case was linked to -MODERNATX, INC.-MOD-2021-060819 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received contains significant information, updated  I-narrative.; Sender's Comments:  -MODERNATX, INC.-MOD-2021-060819:dose 1
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Swelling, Vaccination site erythema, Vaccination site reaction
Clinical narrative: small little raised area; welts surrounding the injection site site; covid arm; bright red; warm; sore arm; painful feeling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (small little raised area), VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling) and VACCINATION SITE URTICARIA (welts surrounding the injection site site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE ERYTHEMA (bright red). On 25-Mar-2021, the patient experienced SWELLING (small little raised area) and VACCINATION SITE URTICARIA (welts surrounding the injection site site). At the time of the report, SWELLING (small little raised area), VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling), VACCINATION SITE URTICARIA (welts surrounding the injection site site), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: small little raised area; welts surrounding the injection site site; covid arm; bright red; warm; sore arm; painful feeling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (small little raised area), VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling) and VACCINATION SITE URTICARIA (welts surrounding the injection site site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 23-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE ERYTHEMA (bright red). On 25-Mar-2021, the patient experienced SWELLING (small little raised area) and VACCINATION SITE URTICARIA (welts surrounding the injection site site). At the time of the report, SWELLING (small little raised area), VACCINATION SITE WARMTH (warm), PAIN IN EXTREMITY (sore arm), PAIN (painful feeling), VACCINATION SITE URTICARIA (welts surrounding the injection site site), VACCINATION SITE REACTION (covid arm) and VACCINATION SITE ERYTHEMA (bright red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: No specific follow-up information recorded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: sore arm; pain in thigh; body pains; extreme fatigue; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in thigh), PAIN (body pains), FATIGUE (extreme fatigue) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included AMOXYCILLIN [AMOXICILLIN] for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in thigh), PAIN (body pains), FATIGUE (extreme fatigue), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (body pains), FATIGUE (extreme fatigue), VOMITING (vomiting) and PYREXIA (fever) had resolved and PAIN IN EXTREMITY (pain in thigh) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         Concomitant medications taken by the patient also included an inhaler.     This case was linked to US-MODERNATX, INC.-MOD-2021-060747 (E2B Linked Report). This case was linked to MOD-2021-060747 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Followup received on 19-JUL-2021 contains no significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060747:Case for first dose
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: sore arm; pain in thigh; body pains; extreme fatigue; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in thigh), PAIN (body pains), FATIGUE (extreme fatigue) and VOMITING (vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concomitant products included AMOXYCILLIN [AMOXICILLIN] for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN IN EXTREMITY (pain in thigh), PAIN (body pains), FATIGUE (extreme fatigue), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (body pains), FATIGUE (extreme fatigue), VOMITING (vomiting) and PYREXIA (fever) had resolved and PAIN IN EXTREMITY (pain in thigh) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 antibody test: positive (Positive) Positive.         Concomitant medications taken by the patient also included an inhaler.     This case was linked to US-MODERNATX, INC.-MOD-2021-060747 (E2B Linked Report). This case was linked to MOD-2021-060747 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Followup received on 19-JUL-2021 contains no significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060747:Case for first dose
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received the first Moderna vaccine at age 17; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first Moderna vaccine at age 17) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first Moderna vaccine at age 17). On 27-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the first Moderna vaccine at age 17) 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 medications were reported. No treatment related information has been reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number 019A21A) with no associated AEs reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dysarthria, Hypokinesia, Malaise, Pain in extremity
Clinical narrative: Feel really sick; Couldn't talk for a week; Can barely move; Diarrhea; Pain in arm and legs; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel really sick), DYSARTHRIA (Couldn't talk for a week), HYPOKINESIA (Can barely move), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm and legs) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MALAISE (Feel really sick), DYSARTHRIA (Couldn't talk for a week), HYPOKINESIA (Can barely move), DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Pain in arm and legs). On 20-Mar-2021, DYSARTHRIA (Couldn't talk for a week) and DIARRHOEA (Diarrhea) had resolved. At the time of the report, MALAISE (Feel really sick), HYPOKINESIA (Can barely move) and PAIN IN EXTREMITY (Pain in arm and legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included as Cold medicine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus
Clinical narrative: red right arm; warm right arm; itchy right arm; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red right arm), FEELING HOT (warm right arm), PRURITUS (itchy right arm) and PAIN IN EXTREMITY (sore right arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (itchy right arm) and PAIN IN EXTREMITY (sore right arm). On 28-Mar-2021, the patient experienced ERYTHEMA (red right arm) and FEELING HOT (warm right arm). At the time of the report, ERYTHEMA (red right arm), FEELING HOT (warm right arm), PRURITUS (itchy right arm) and PAIN IN EXTREMITY (sore right arm) outcome was unknown.        No concomitant medications were reported. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Extreme diarrhea episodes; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme diarrhea episodes) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DIARRHOEA (Extreme diarrhea episodes). At the time of the report, DIARRHOEA (Extreme diarrhea episodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pruritus
Clinical narrative: arthralgia; joint pain; headache; fatigue; sore arm; felt a little icky; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (felt a little icky), ARTHRALGIA (arthralgia), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PRURITUS (felt a little icky). On 23-Mar-2021, the patient experienced ARTHRALGIA (arthralgia), ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PRURITUS (felt a little icky), ARTHRALGIA (arthralgia), ARTHRALGIA (joint pain), HEADACHE (headache), FATIGUE (fatigue) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Pain
Clinical narrative: Pain; Redness; chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), ERYTHEMA (Redness), CHILLS (chills) and FATIGUE (Tiredness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (Pain), ERYTHEMA (Redness), CHILLS (chills) and FATIGUE (Tiredness). On 27-Mar-2021, PAIN (Pain) and ERYTHEMA (Redness) had resolved. On 28-Mar-2021, CHILLS (chills) had resolved. At the time of the report, FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no concomitant medication reported. There was no relevant treatment medication reported.    It took about two and a half weeks for the reactions to settle down especially the tiredness. Had the 2nd dose without any issues.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR received on 07-JUL-2021 - updated event outcome.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Flushing, Hypoaesthesia, Pyrexia
Clinical narrative: face and tongue went numb; got flushed; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (face and tongue went numb), FLUSHING (got flushed), PYREXIA (fever) and CHILLS (chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced HYPOAESTHESIA (face and tongue went numb), FLUSHING (got flushed), PYREXIA (fever) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (face and tongue went numb), FLUSHING (got flushed), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: Pain was limited to lower back; Aches pain all over body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches pain all over body) and BACK PAIN (Pain was limited to lower back) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN (Aches pain all over body). On 29-Mar-2021, the patient experienced BACK PAIN (Pain was limited to lower back). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, PAIN (Aches pain all over body) and BACK PAIN (Pain was limited to lower back) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Duodenogastric reflux, Headache, Hyperhidrosis
Clinical narrative: profuse sweating; diarrhea; bile; severe abdominal pain; headache; violent vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain) and HEADACHE (headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Mar-2021, the patient experienced HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain), HEADACHE (headache) and VOMITING (violent vomiting). At the time of the report, HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain), HEADACHE (headache) and VOMITING (violent vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetic medica Treatment patient in ED for 3-4 hrs. patient stated she received fluids, haldol, and other meds she didn't know. She felt better after her ED visit and had no further symptoms.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: profuse sweating; diarrhea; bile; severe abdominal pain; headache; violent vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain) and HEADACHE (headache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 25-Mar-2021, the patient experienced HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain), HEADACHE (headache) and VOMITING (violent vomiting). At the time of the report, HYPERHIDROSIS (profuse sweating), DIARRHOEA (diarrhea), DUODENOGASTRIC REFLUX (bile), ABDOMINAL PAIN (severe abdominal pain), HEADACHE (headache) and VOMITING (violent vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetic medica Treatment patient in ED for 3-4 hrs. patient stated she received fluids, haldol, and other meds she didn't know. She felt better after her ED visit and had no further symptoms.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: pain is aggravating; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) and PAIN (pain is aggravating) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On an unknown date, the patient experienced PAIN (pain is aggravating). On 28-Feb-2021, PAIN IN EXTREMITY (soreness in the arm) had resolved. At the time of the report, PAIN (pain is aggravating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not Applicable
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14-JUL-2021: Contains Non-significant information
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Primary cough headache, Rhinorrhoea
Clinical narrative: Coughing; Nose running; Hurts head when I cough; Tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), RHINORRHOEA (Nose running), PRIMARY COUGH HEADACHE (Hurts head when I cough) and FATIGUE (Tired) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), RHINORRHOEA (Nose running), PRIMARY COUGH HEADACHE (Hurts head when I cough) and FATIGUE (Tired). At the time of the report, COUGH (Coughing), RHINORRHOEA (Nose running), PRIMARY COUGH HEADACHE (Hurts head when I cough) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Hight Blood Sugar; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Hight Blood Sugar) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arm discomfort. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE, TELMISARTAN, METFORMIN, METOPROLOL TARTRATE and TRAMADOL for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (Hight Blood Sugar). At the time of the report, BLOOD GLUCOSE INCREASED (Hight Blood Sugar) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood glucose: 206 (High) Blood sugar was 206. On an unknown date, Blood glucose: 95 (normal) 95 Normal, 98 (normal) 98 Normal, 105 (normal) 105 Normal and unknown (High) Blood sugar was high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: dizzy; very weak not able to do anything, very weak; pain moved to his left arm soon after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (very weak not able to do anything, very weak) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (very weak not able to do anything, very weak) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination). At the time of the report, DIZZINESS (dizzy), ASTHENIA (very weak not able to do anything, very weak) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported..  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060798:dose 2
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion
Clinical narrative: headache; lots of congestion; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (lots of congestion) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NASAL CONGESTION (lots of congestion) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (lots of congestion) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Headache, Nausea
Clinical narrative: COVID-19; Diarrhea; Cough; Headache; Fever of 99 F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NAUSEA (Nausea), DIARRHOEA (Diarrhea), COUGH (Cough) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included INSULIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99 F). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and COUGH (Cough). On 16-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), NAUSEA (Nausea), DIARRHOEA (Diarrhea), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever of 99 F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included cholesterol and high blood pressure medication. No treatment information were informed.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; Diarrhea; Cough; Headache; Fever of 99 F; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), NAUSEA (Nausea), DIARRHOEA (Diarrhea), COUGH (Cough) and HEADACHE (Headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history was provided by reporter.  Concomitant products included INSULIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever of 99 F). On 14-Mar-2021, the patient experienced DIARRHOEA (Diarrhea) and COUGH (Cough). On 16-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19), NAUSEA (Nausea), DIARRHOEA (Diarrhea), COUGH (Cough), HEADACHE (Headache) and PYREXIA (Fever of 99 F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included cholesterol and high blood pressure medication. No treatment information were informed.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Product dose omission issue
Clinical narrative: did not receive my second dose; Headache; Fatigue; Diarrhea; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ASTHENIA (Weakness), PRODUCT DOSE OMISSION ISSUE (did not receive my second dose), HEADACHE (Headache) and FATIGUE (Fatigue) in a 63-year-old female patient who received mRNA-1273 (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), ASTHENIA (Weakness), HEADACHE (Headache) and FATIGUE (Fatigue). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive my second dose). On 25-Feb-2021, DIARRHOEA (Diarrhea) had resolved. On 08-Mar-2021, ASTHENIA (Weakness) and HEADACHE (Headache) had resolved. On 25-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive my second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment medication was not provided
Age: 75.0
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 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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.   No treatment medication was provided   This case was linked to US-MODERNATX, INC.-MOD-2021-125312 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-125312:First dose case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain
Clinical narrative: achy pain; hard for me to walk; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy pain), MOBILITY DECREASED (hard for me to walk) and ARTHRALGIA (joint pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIHYDROCODEINE PHOSPHATE (HYDROCODEINE) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy pain), MOBILITY DECREASED (hard for me to walk) and ARTHRALGIA (joint pain). At the time of the report, PAIN (achy pain), MOBILITY DECREASED (hard for me to walk) and ARTHRALGIA (joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.