chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Flatulence, Headache, Rhinorrhoea
Clinical narrative: unbelievable gas; runny nose; light headache; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (unbelievable gas), RHINORRHOEA (runny nose) and HEADACHE (light headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLATULENCE (unbelievable gas), RHINORRHOEA (runny nose) and HEADACHE (light headache). At the time of the report, FLATULENCE (unbelievable gas), RHINORRHOEA (runny nose) and HEADACHE (light headache) outcome was unknown. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided No concomitant medication was provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect) in a patient of an unknown age and 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect). At the time of the report, VACCINATION COMPLICATION (experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported No treatment was received by the patient   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the second dose within the recommended window; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose within the recommended window) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose within the recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose within the recommended window) 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.   No concomitant medications were reported. No treatment medications were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Inappropriate schedule of product administration, Oropharyngeal pain
Clinical narrative: Loss of taste; Loss of smell; sore throat; symptoms of COVID-19; suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose; Headache; fever; This spontaneous case was reported by a physician and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose) in a 50-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose), HEADACHE (Headache) and PYREXIA (fever). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose), HEADACHE (Headache) and PYREXIA (fever) 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.   No concomitant medications were reported. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Suspected COVID-19
Clinical narrative: Loss of taste; Loss of smell; sore throat; symptoms of COVID-19; suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose; Headache; fever; This spontaneous case was reported by a physician and describes the occurrence of AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose) in a 50-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.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose), HEADACHE (Headache) and PYREXIA (fever). At the time of the report, AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), OROPHARYNGEAL PAIN (sore throat), SUSPECTED COVID-19 (symptoms of COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (suppose to receive the second dose tomorrow, Will not have the lot numbers until she receives the second dose), HEADACHE (Headache) and PYREXIA (fever) 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.   No concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure systolic, Dizziness, Heart rate
Clinical narrative: Light headed/Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed/Dizziness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced DIZZINESS (Light headed/Dizziness). At the time of the report, DIZZINESS (Light headed/Dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, Blood pressure systolic (155-165): low (Low) 115-125 Systolic blood pressure dropping. On 23-Jul-2021, Heart rate: high (High) normal heartbeat is in upper 160 but now 185 to 190.         No concomitant medication were reported. No treatment medication was reported. Patient had several days of lightheaded and dizziness after the second dose of the vaccine. Patient had had no reaction after first dose. Patient was taking other medication.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Hyperhidrosis, Insomnia
Clinical narrative: week legs; arm also had red area; awake; sweeting; his feet were very cold; low grade fever/ he was too hot; light headache over eye; shivering/feeling chill; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting) and PERIPHERAL COLDNESS (his feet were very cold) in a 74-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.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting), PERIPHERAL COLDNESS (his feet were very cold), PYREXIA (low grade fever/ he was too hot), HEADACHE (light headache over eye) and CHILLS (shivering/feeling chill). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting), PERIPHERAL COLDNESS (his feet were very cold), PYREXIA (low grade fever/ he was too hot), HEADACHE (light headache over eye) and CHILLS (shivering/feeling chill) had resolved.            No Concomitant medications were provided   This case was linked to MOD-2021-049579, MOD-2021-266692, MOD-2021-049559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up contains Email address reported. On 18-Oct-2021: Followup received on 18-OCT-2021 considering NNI On 19-Oct-2021: Follow-up information received on 19-OCT-2021 ncluded no new information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness, Pyrexia
Clinical narrative: week legs; arm also had red area; awake; sweeting; his feet were very cold; low grade fever/ he was too hot; light headache over eye; shivering/feeling chill; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting) and PERIPHERAL COLDNESS (his feet were very cold) in a 74-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.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting), PERIPHERAL COLDNESS (his feet were very cold), PYREXIA (low grade fever/ he was too hot), HEADACHE (light headache over eye) and CHILLS (shivering/feeling chill). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (week legs), ERYTHEMA (arm also had red area), INSOMNIA (awake), HYPERHIDROSIS (sweeting), PERIPHERAL COLDNESS (his feet were very cold), PYREXIA (low grade fever/ he was too hot), HEADACHE (light headache over eye) and CHILLS (shivering/feeling chill) had resolved.            No Concomitant medications were provided   This case was linked to MOD-2021-049579, MOD-2021-266692, MOD-2021-049559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up contains Email address reported. On 18-Oct-2021: Followup received on 18-OCT-2021 considering NNI On 19-Oct-2021: Follow-up information received on 19-OCT-2021 ncluded no new information
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID-19 test after 1st dose of the Moderna Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive COVID-19 test after 1st dose of the Moderna Vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 16-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Positive COVID-19 test after 1st dose of the Moderna Vaccine). At the time of the report, COVID-19 (Positive COVID-19 test after 1st dose of the Moderna Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No specific side effects were reported with the positive virus test. No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccine adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccine adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Inappropriate schedule of product administration, Polymerase chain reaction, Pyrexia
Clinical narrative: 1st dose on 23 march 2nd dose on 29 april; Headache; Fever upto 101.5; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april), HEADACHE (Headache), PYREXIA (Fever upto 101.5) and VOMITING (Vomiting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035B21A and 04BA21A) for COVID-19 vaccination.     The patient's past medical history included Hospitalization from 23-Dec-2020 to 09-Jan-2021. Previously administered products included for Product used for unknown indication: Tdap vaccine; for COVID-19: remdesivir (for five days). Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) from 2017 to an unknown date for Anticoagulant therapy, VERAPAMIL for Blood pressure, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) from 2007 to an unknown date for Energy increased, FUROSEMIDE for Swelling of limb, LEVOTHYROXINE from 1965 to an unknown date for Thyroid disorder.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever upto 101.5) and VOMITING (Vomiting). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april). On 02-May-2021, PYREXIA (Fever upto 101.5) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, COVID-19: positive (Positive) Positive. On 23-Mar-2021, Pyrexia: 101.7 (High) 101.7 101.5. On 29-Apr-2021, Pyrexia: 101.5 (High) 101.5 deg c. On an unknown date, Polymerase chain reaction: positive (Positive) Positive.         No treatment medication information was given.   This case was linked to MOD-2021-064092 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 1st dose on 23 march 2nd dose on 29 april; Headache; Fever upto 101.5; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april), HEADACHE (Headache), PYREXIA (Fever upto 101.5) and VOMITING (Vomiting) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035B21A and 04BA21A) for COVID-19 vaccination.     The patient's past medical history included Hospitalization from 23-Dec-2020 to 09-Jan-2021. Previously administered products included for Product used for unknown indication: Tdap vaccine; for COVID-19: remdesivir (for five days). Concurrent medical conditions included Penicillin allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) from 2017 to an unknown date for Anticoagulant therapy, VERAPAMIL for Blood pressure, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) from 2007 to an unknown date for Energy increased, FUROSEMIDE for Swelling of limb, LEVOTHYROXINE from 1965 to an unknown date for Thyroid disorder.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever upto 101.5) and VOMITING (Vomiting). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april). On 02-May-2021, PYREXIA (Fever upto 101.5) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 23 march 2nd dose on 29 april), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, COVID-19: positive (Positive) Positive. On 23-Mar-2021, Pyrexia: 101.7 (High) 101.7 101.5. On 29-Apr-2021, Pyrexia: 101.5 (High) 101.5 deg c. On an unknown date, Polymerase chain reaction: positive (Positive) Positive.         No treatment medication information was given.   This case was linked to MOD-2021-064092 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Extremely weak; numbness in my legs, arms, face including my tongue; numbness in my legs, arms, face including my tongue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely weak), HYPOAESTHESIA ORAL (numbness in my legs, arms, face including my tongue) and HYPOAESTHESIA (numbness in my legs, arms, face including my tongue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Extremely weak), HYPOAESTHESIA ORAL (numbness in my legs, arms, face including my tongue) and HYPOAESTHESIA (numbness in my legs, arms, face including my tongue). At the time of the report, ASTHENIA (Extremely weak), HYPOAESTHESIA ORAL (numbness in my legs, arms, face including my tongue) and HYPOAESTHESIA (numbness in my legs, arms, face including my tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days has passed since first dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days has passed since first dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2021.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days has passed since first dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days has passed since first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired product administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine was administered from a vial that was first punctured and left at room temperature around 9:15am on 23Jul2021.This would far exceed both the allowed time at room temperature exposure and allowed time of a punctured vaccine vial) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine was administered from a vial that was first punctured and left at room temperature around 9:15am on 23Jul2021.This would far exceed both the allowed time at room temperature exposure and allowed time of a punctured vaccine vial). At the time of the report, PRODUCT STORAGE ERROR (vaccine was administered from a vial that was first punctured and left at room temperature around 9:15am on 23Jul2021.This would far exceed both the allowed time at room temperature exposure and allowed time of a punctured vaccine vial) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle tightness, Myalgia
Clinical narrative: Muscle tightness; numbness in both feet / still feels like circulation in both feet is not normal; sore left arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Muscle tightness), HYPOAESTHESIA (numbness in both feet / still feels like circulation in both feet is not normal) and MYALGIA (sore left arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 MUSCLE TIGHTNESS (Muscle tightness), HYPOAESTHESIA (numbness in both feet / still feels like circulation in both feet is not normal) and MYALGIA (sore left arm). At the time of the report, MUSCLE TIGHTNESS (Muscle tightness), HYPOAESTHESIA (numbness in both feet / still feels like circulation in both feet is not normal) and MYALGIA (sore left arm) outcome was unknown.            Patient had taken vaccine in march and April and still felt like circulation in both feet was not normal, along with sore left arm. No concomitants medications was reported. No treatments medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes). At the time of the report, PRURITUS (Extremely itching on both calfs/Extremely itching on upper thigh/Extremely itching on back/Extremely itching on arms sometimes) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue, Fear
Clinical narrative: Feels tense again now; Extremely weak (very weak)/Weakness/Wanting to lie down that lasted 24 hours; Tiredness; Cannot go due to fear of side effects/Terrorized to get 2nd dose; Extreme chills; Shaking/trembling; "All my body was stiff"; Not possible to stretch legs; Not possible to breath in and out/Not possible to calm down; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking/trembling), MUSCULOSKELETAL STIFFNESS ("All my body was stiff"), LIMB DISCOMFORT (Not possible to stretch legs), DYSPNOEA (Not possible to breath in and out/Not possible to calm down) and TENSION (Feels tense again now) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (between 13 and 15th) in December 2020. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ROSUVASTATIN for Hyperlipidemia, OLMESARTAN for Hypertension.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced TREMOR (Shaking/trembling), MUSCULOSKELETAL STIFFNESS ("All my body was stiff"), LIMB DISCOMFORT (Not possible to stretch legs) and DYSPNOEA (Not possible to breath in and out/Not possible to calm down). On an unknown date, the patient experienced TENSION (Feels tense again now), HEART RATE INCREASED (heartbeat was fast at times), ASTHENIA (Extremely weak (very weak)/Weakness/Wanting to lie down that lasted 24 hours), FATIGUE (Tiredness), FEAR (Cannot go due to fear of side effects/Terrorized to get 2nd dose) and CHILLS (Extreme chills). At the time of the report, TREMOR (Shaking/trembling), MUSCULOSKELETAL STIFFNESS ("All my body was stiff"), LIMB DISCOMFORT (Not possible to stretch legs), DYSPNOEA (Not possible to breath in and out/Not possible to calm down), TENSION (Feels tense again now), HEART RATE INCREASED (heartbeat was fast at times), ASTHENIA (Extremely weak (very weak)/Weakness/Wanting to lie down that lasted 24 hours), FATIGUE (Tiredness), FEAR (Cannot go due to fear of side effects/Terrorized to get 2nd dose) and CHILLS (Extreme chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not receive treatment for the adverse events.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Limb discomfort, Musculoskeletal stiffness, Tension, Tremor
Clinical narrative: Feels tense again now; Extremely weak (very weak)/Weakness/Wanting to lie down that lasted 24 hours; Tiredness; Cannot go due to fear of side effects/Terrorized to get 2nd dose; Extreme chills; Shaking/trembling; "All my body was stiff"; Not possible to stretch legs; Not possible to breath in and out/Not possible to calm down; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking/trembling), MUSCULOSKELETAL STIFFNESS ("All my body was stiff"), LIMB DISCOMFORT (Not possible to stretch legs), DYSPNOEA (Not possible to breath in and out/Not possible to calm down) and TENSION (Feels tense again now) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (between 13 and 15th) in December 2020. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included ROSUVASTATIN for Hyperlipidemia, OLMESARTAN for Hypertension.    On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2021, the patient experienced TREMOR (Shaking/trembling), MUSCULOSKELETAL STIFFNESS ("All my body was stiff"), LIMB DISCOMFORT (Not possible to stretch legs) and DYSPNOEA (Not possible to breath in and out/Not possible to calm down). On an unknown date, the patient experienced TENSION (Feels tense again now), HEART RATE INCREASED (heartbeat was fast at times), ASTHENIA (Extremely weak (very weak)/Weakness/Wanting to lie down that lasted 24 hours), FATIGUE (Tiredness), FEAR (Cannot go due to fear of side effects/Terrorized to get 2nd dose) and CHILLS (Extreme chills). At the time of the report, TREMOR (Shaking/trembling), MUSCULOSKELETAL STIFFNESS ("All my body was stiff"), LIMB DISCOMFORT (Not possible to stretch legs), DYSPNOEA (Not possible to breath in and out/Not possible to calm down), TENSION (Feels tense again now), HEART RATE INCREASED (heartbeat was fast at times), ASTHENIA (Extremely weak (very weak)/Weakness/Wanting to lie down that lasted 24 hours), FATIGUE (Tiredness), FEAR (Cannot go due to fear of side effects/Terrorized to get 2nd dose) and CHILLS (Extreme chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not receive treatment for the adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Hypercoagulation, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: feel that the blood is thickness. In both feet; thickness of my feet; the hardening of my feet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPERCOAGULATION (feel that the blood is thickness. In both feet), PERIPHERAL SWELLING (thickness of my feet) and MUSCULOSKELETAL STIFFNESS (the hardening of my feet) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERCOAGULATION (feel that the blood is thickness. In both feet), PERIPHERAL SWELLING (thickness of my feet) and MUSCULOSKELETAL STIFFNESS (the hardening of my feet). At the time of the report, HYPERCOAGULATION (feel that the blood is thickness. In both feet), PERIPHERAL SWELLING (thickness of my feet) and MUSCULOSKELETAL STIFFNESS (the hardening of my feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder, Eye pain, Headache, Musculoskeletal stiffness, Pruritus
Clinical narrative: stiff back; im a very anxious person; on my eye which is sore; itchy; headache; hives behind her ear, on her eye, and from her wrist to her elbow.; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.), MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore) and PRURITUS (itchy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pneumonia (The Patient had been hospitalized for 3 months prior to receiving the vaccine for pneumonia.).    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore), PRURITUS (itchy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Stiff back, at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) (topical) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.), MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore), PRURITUS (itchy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: stiff back; im a very anxious person; on my eye which is sore; itchy; headache; hives behind her ear, on her eye, and from her wrist to her elbow.; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.), MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore) and PRURITUS (itchy) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pneumonia (The Patient had been hospitalized for 3 months prior to receiving the vaccine for pneumonia.).    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore), PRURITUS (itchy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Stiff back, at an unspecified dose and frequency and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) (topical) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives behind her ear, on her eye, and from her wrist to her elbow.), MUSCULOSKELETAL STIFFNESS (stiff back), ANXIETY DISORDER (im a very anxious person), EYE PAIN (on my eye which is sore), PRURITUS (itchy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.   Reporter did not allow further contact
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Exposure to SARS-CoV-2, Malaise, Myalgia
Clinical narrative: exposed to COVID-19, got sick but does not test positive; typical symptoms post vaccination; chills; body aches/aches; Feel sick; non-productive cough; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Feel sick), COUGH (non-productive cough), EXPOSURE TO SARS-COV-2 (exposed to COVID-19, got sick but does not test positive), VACCINATION COMPLICATION (typical symptoms post vaccination) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced MALAISE (Feel sick), COUGH (non-productive cough), CHILLS (chills) and MYALGIA (body aches/aches). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to COVID-19, got sick but does not test positive) and VACCINATION COMPLICATION (typical symptoms post vaccination). At the time of the report, MALAISE (Feel sick), COUGH (non-productive cough), EXPOSURE TO SARS-COV-2 (exposed to COVID-19, got sick but does not test positive), VACCINATION COMPLICATION (typical symptoms post vaccination), CHILLS (chills) and MYALGIA (body aches/aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Reportedly, the patient's respiratory panel looked at 14-16 panels including, flu A, flu B, RSV, Corona virus, etc. and he was negative for all test. The patient had also  taken 3 antigen tests and those were all negative as well.  Treatment information was not provided.     This case was linked to MOD-2021-268351 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: exposed to COVID-19, got sick but does not test positive; typical symptoms post vaccination; chills; body aches/aches; Feel sick; non-productive cough; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Feel sick), COUGH (non-productive cough), EXPOSURE TO SARS-COV-2 (exposed to COVID-19, got sick but does not test positive), VACCINATION COMPLICATION (typical symptoms post vaccination) and CHILLS (chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced MALAISE (Feel sick), COUGH (non-productive cough), CHILLS (chills) and MYALGIA (body aches/aches). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to COVID-19, got sick but does not test positive) and VACCINATION COMPLICATION (typical symptoms post vaccination). At the time of the report, MALAISE (Feel sick), COUGH (non-productive cough), EXPOSURE TO SARS-COV-2 (exposed to COVID-19, got sick but does not test positive), VACCINATION COMPLICATION (typical symptoms post vaccination), CHILLS (chills) and MYALGIA (body aches/aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Reportedly, the patient's respiratory panel looked at 14-16 panels including, flu A, flu B, RSV, Corona virus, etc. and he was negative for all test. The patient had also  taken 3 antigen tests and those were all negative as well.  Treatment information was not provided.     This case was linked to MOD-2021-268351 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Tinnitus
Clinical narrative: Tinnitus; Fuzzy head; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus), FEELING ABNORMAL (Fuzzy head), HEADACHE (Headache) and FATIGUE (Tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 24M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-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 TINNITUS (Tinnitus), FEELING ABNORMAL (Fuzzy head), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, TINNITUS (Tinnitus), FEELING ABNORMAL (Fuzzy head), HEADACHE (Headache) and FATIGUE (Tired) had not resolved.            No relevant concomitant medications was reported.  Treatment information included antihistamine.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered greater than 12 hours after initial vial puncture; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours after initial vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Product dose omission issue, Pruritus, Swelling face
Clinical narrative: Has not gotten the second dose; swollen face; Severe pain behind her eyes; Itching from head to toe including the bottoms of her feet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose), SWELLING FACE (swollen face), EYE PAIN (Severe pain behind her eyes) and PRURITUS (Itching from head to toe including the bottoms of her feet) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (Itching from head to toe including the bottoms of her feet). On 27-Jan-2021, the patient experienced SWELLING FACE (swollen face) and EYE PAIN (Severe pain behind her eyes). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose). On 27-Jan-2021, PRURITUS (Itching from head to toe including the bottoms of her feet) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not gotten the second dose) had resolved and SWELLING FACE (swollen face) and EYE PAIN (Severe pain behind her eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Faeces discoloured, Hepatic function abnormal, Peripheral swelling
Clinical narrative: low Liver function; light tan poop; Swollen Legs and feet; Swollen Legs and feet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC FUNCTION ABNORMAL (low Liver function), FAECES DISCOLOURED (light tan poop), the first episode of PERIPHERAL SWELLING (Swollen Legs and feet) and the second episode of PERIPHERAL SWELLING (Swollen Legs and feet) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEPATIC FUNCTION ABNORMAL (low Liver function), FAECES DISCOLOURED (light tan poop), the first episode of PERIPHERAL SWELLING (Swollen Legs and feet) and the second episode of PERIPHERAL SWELLING (Swollen Legs and feet). At the time of the report, HEPATIC FUNCTION ABNORMAL (low Liver function), FAECES DISCOLOURED (light tan poop) and the last episode of PERIPHERAL SWELLING (Swollen Legs and feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.  Company comment: Very limited information regarding these events has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.