chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included OMALIZUMAB (XOLAIR) for an unknown indication.    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 PRURITUS (itching). At the time of the report, PRURITUS (itching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment history was not reported. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Mobility decreased, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Severe and crippling arm pain; Could not lift arm; Chills; High fever; Still have occasional pain in arm at the injection site; Racing heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), PALPITATIONS (Racing heartbeat), CHILLS (Chills) and PYREXIA (High fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ASCORBIC ACID, ZINC (VITAMIN C + ZINC), COLECALCIFEROL (VITAMIN D 3), BIOTIN and VIVISCAL ADVANCED HAIR HEALTH for an unknown indication.   On 07-Mar-2021 at 11:00 AM, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021 at 10:00 PM, the patient experienced PALPITATIONS (Racing heartbeat). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), CHILLS (Chills), PYREXIA (High fever) and VACCINATION SITE PAIN (Still have occasional pain in arm at the injection site). At the time of the report, PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), CHILLS (Chills) and PYREXIA (High fever) outcome was unknown, PALPITATIONS (Racing heartbeat) had resolved with sequelae and VACCINATION SITE PAIN (Still have occasional pain in arm at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PALPITATIONS (Racing heartbeat) to be related. No further causality assessments were provided for PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), CHILLS (Chills), PYREXIA (High fever) and VACCINATION SITE PAIN (Still have occasional pain in arm at the injection site).    Treatment information was not reported.   This case was linked to MOD-2021-059920 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe and crippling arm pain; Could not lift arm; Chills; High fever; Still have occasional pain in arm at the injection site; Racing heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), PALPITATIONS (Racing heartbeat), CHILLS (Chills) and PYREXIA (High fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ASCORBIC ACID, ZINC (VITAMIN C + ZINC), COLECALCIFEROL (VITAMIN D 3), BIOTIN and VIVISCAL ADVANCED HAIR HEALTH for an unknown indication.   On 07-Mar-2021 at 11:00 AM, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021 at 10:00 PM, the patient experienced PALPITATIONS (Racing heartbeat). On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), CHILLS (Chills), PYREXIA (High fever) and VACCINATION SITE PAIN (Still have occasional pain in arm at the injection site). At the time of the report, PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), CHILLS (Chills) and PYREXIA (High fever) outcome was unknown, PALPITATIONS (Racing heartbeat) had resolved with sequelae and VACCINATION SITE PAIN (Still have occasional pain in arm at the injection site) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PALPITATIONS (Racing heartbeat) to be related. No further causality assessments were provided for PAIN IN EXTREMITY (Severe and crippling arm pain), MOBILITY DECREASED (Could not lift arm), CHILLS (Chills), PYREXIA (High fever) and VACCINATION SITE PAIN (Still have occasional pain in arm at the injection site).    Treatment information was not reported.   This case was linked to MOD-2021-059920 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis
Clinical narrative: sweating like she is going through menopause again/soaks the bed at night with sweating; felt tired/felt out of it; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating like she is going through menopause again/soaks the bed at night with sweating) and FATIGUE (felt tired/felt out of it) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPERHIDROSIS (sweating like she is going through menopause again/soaks the bed at night with sweating) and FATIGUE (felt tired/felt out of it). At the time of the report, HYPERHIDROSIS (sweating like she is going through menopause again/soaks the bed at night with sweating) and FATIGUE (felt tired/felt out of it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   No treatment information was provided.   No laboratory data was provided    MOD21-123471 is crosslinked to MOD21-123552   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: Sweating; 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 HYPERHIDROSIS (Sweating) 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 HYPERHIDROSIS (Sweating). At the time of the report, HYPERHIDROSIS (Sweating) 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.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: third vaccine dose given overseas; 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 EXTRA DOSE ADMINISTERED (third vaccine dose given overseas) 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 specified medical history has been 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 EXTRA DOSE ADMINISTERED (third vaccine dose given overseas). At the time of the report, EXTRA DOSE ADMINISTERED (third vaccine dose given overseas) had resolved.            No relevant concomitant medications were reported. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medications reported by investigator   This case was linked to MOD-2021-049404 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: intermittent swollen gland since vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of LYMPHADENOPATHY (intermittent swollen gland since vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LYMPHADENOPATHY (intermittent swollen gland since vaccination). At the time of the report, LYMPHADENOPATHY (intermittent swollen gland since vaccination) had resolved.        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 reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Illness, Somnolence
Clinical narrative: felt so sick; she felt horrible; weak; had stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt so sick), FEELING ABNORMAL (she felt horrible), ASTHENIA (weak) and SOMNOLENCE (had stayed in bed) in a 67-year-old female patient 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, the patient experienced ILLNESS (felt so sick), FEELING ABNORMAL (she felt horrible), ASTHENIA (weak) and SOMNOLENCE (had stayed in bed). At the time of the report, ILLNESS (felt so sick), FEELING ABNORMAL (she felt horrible) and ASTHENIA (weak) had resolved and SOMNOLENCE (had stayed in bed) had not resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-051748, MOD-2021-051748 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient's email address was updated.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Palpitations, Product dose omission issue, Pruritus, Urticaria
Clinical narrative: Hives on the arm of injection\Hives on the opposite arm of injection\hives on left leg; Did not receive the 2nd dose between day 25-35 of the 1st dose; Heart started flip flopping; Hives was red; Hives itched bad; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose between day 25-35 of the 1st dose), PALPITATIONS (Heart started flip flopping), URTICARIA (Hives on the arm of injection\Hives on the opposite arm of injection\hives on left leg), ERYTHEMA (Hives was red) and PRURITUS (Hives itched bad) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose between day 25-35 of the 1st dose) and PALPITATIONS (Heart started flip flopping). On 26-Feb-2021, the patient experienced URTICARIA (Hives on the arm of injection\Hives on the opposite arm of injection\hives on left leg). On an unknown date, the patient experienced ERYTHEMA (Hives was red) and PRURITUS (Hives itched bad). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive the 2nd dose between day 25-35 of the 1st dose), PALPITATIONS (Heart started flip flopping), URTICARIA (Hives on the arm of injection\Hives on the opposite arm of injection\hives on left leg), ERYTHEMA (Hives was red) and PRURITUS (Hives itched bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: Did not receive second dose; She states that a few days later, she had ringing in her ears (still have it).; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (She states that a few days later, she had ringing in her ears (still have it).) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced TINNITUS (She states that a few days later, she had ringing in her ears (still have it).). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive second dose). At the time of the report, TINNITUS (She states that a few days later, she had ringing in her ears (still have it).) and PRODUCT DOSE OMISSION ISSUE (Did not receive second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-123779 (Linked Report).; Sender's Comments:  MOD21-123779:
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: people who had ringing in their ears as well; 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 TINNITUS (people who had ringing in their ears as well) 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 TINNITUS (people who had ringing in their ears as well). At the time of the report, TINNITUS (people who had ringing in their ears as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment information was reported   This case was linked to MOD21-123774 (E2B Linked Report).; Sender's Comments:  MOD21-123774:
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis
Clinical narrative: felt faint; Has been breaking out in sweats; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Has been breaking out in sweats) and DIZZINESS (felt faint) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, the patient experienced HYPERHIDROSIS (Has been breaking out in sweats). On 25-Jul-2021, the patient experienced DIZZINESS (felt faint). At the time of the report, HYPERHIDROSIS (Has been breaking out in sweats) and DIZZINESS (felt faint) 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 provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow up received: contains no new information about husbands case.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information were reported by the reporter.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Product dose omission issue, Pyrexia
Clinical narrative: Headache; Fever; Body Aches; 1st dose of the vaccine 19Mar2021, no 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body Aches) and PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine 19Mar2021, no 2nd dose yet) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine 19Mar2021, no 2nd dose yet). On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body Aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. On 26-Jul-2021, PRODUCT DOSE OMISSION ISSUE (1st dose of the vaccine 19Mar2021, no 2nd dose yet) had resolved. At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Updated events.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: His skin went grey for a time; Stayed in bed three days; Had to crawl because he could not stand up his feet; feet and ankles were burning; His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle; sore feet/ his feet started hurting; His feet started hurting and he could barely walk; Joint pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting), GAIT DISTURBANCE (His feet started hurting and he could barely walk), SKIN DISCOLOURATION (His skin went grey for a time) and MOBILITY DECREASED (Stayed in bed three days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced ARTHRALGIA (Joint pain) and FATIGUE (Tiredness). On 15-Jul-2021, the patient experienced JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting) and GAIT DISTURBANCE (His feet started hurting and he could barely walk). On an unknown date, the patient experienced SKIN DISCOLOURATION (His skin went grey for a time), MOBILITY DECREASED (Stayed in bed three days), DYSSTASIA (Had to crawl because he could not stand up his feet) and BURNING SENSATION (feet and ankles were burning). The patient was treated with NAPROXEN SODIUM (ALEVE) for Joint pain, Knee swelling and Sore feet, at a dose of 1 dosage form. On 14-Jul-2021, ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) had resolved. At the time of the report, JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting), GAIT DISTURBANCE (His feet started hurting and he could barely walk), SKIN DISCOLOURATION (His skin went grey for a time), MOBILITY DECREASED (Stayed in bed three days), DYSSTASIA (Had to crawl because he could not stand up his feet) and BURNING SENSATION (feet and ankles were burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Mobility decreased, Pain in extremity, Skin discolouration
Clinical narrative: His skin went grey for a time; Stayed in bed three days; Had to crawl because he could not stand up his feet; feet and ankles were burning; His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle; sore feet/ his feet started hurting; His feet started hurting and he could barely walk; Joint pain; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting), GAIT DISTURBANCE (His feet started hurting and he could barely walk), SKIN DISCOLOURATION (His skin went grey for a time) and MOBILITY DECREASED (Stayed in bed three days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced ARTHRALGIA (Joint pain) and FATIGUE (Tiredness). On 15-Jul-2021, the patient experienced JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting) and GAIT DISTURBANCE (His feet started hurting and he could barely walk). On an unknown date, the patient experienced SKIN DISCOLOURATION (His skin went grey for a time), MOBILITY DECREASED (Stayed in bed three days), DYSSTASIA (Had to crawl because he could not stand up his feet) and BURNING SENSATION (feet and ankles were burning). The patient was treated with NAPROXEN SODIUM (ALEVE) for Joint pain, Knee swelling and Sore feet, at a dose of 1 dosage form. On 14-Jul-2021, ARTHRALGIA (Joint pain) and FATIGUE (Tiredness) had resolved. At the time of the report, JOINT SWELLING (His knee was swollen/ He felt like he was turning the corner when his knee started to swell along with his shin and he noticed his skin turned grey/he was nowhaving some swelling in his right ankle), PAIN IN EXTREMITY (sore feet/ his feet started hurting), GAIT DISTURBANCE (His feet started hurting and he could barely walk), SKIN DISCOLOURATION (His skin went grey for a time), MOBILITY DECREASED (Stayed in bed three days), DYSSTASIA (Had to crawl because he could not stand up his feet) and BURNING SENSATION (feet and ankles were burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose was given 23 days after first one; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 23 days after first one) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 23 days after first one). On 27-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given 23 days after first one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 70-year-old female patient 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) had resolved.       Concomitant medication not reported. No treatment information provided. Thinks it is the delta variant given as event.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received her 1st dose of the Moderna vaccine over 92 days ago (14APR2021)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received: reporter contact details updated
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pharyngeal swelling, Pyrexia
Clinical narrative: Throat swelling; pain in whole body; Ever since i got vacited im feelin high fever; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), MYALGIA (pain in whole body) and PYREXIA (Ever since i got vacited im feelin high fever) 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 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), MYALGIA (pain in whole body) and PYREXIA (Ever since i got vacited im feelin high fever). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), MYALGIA (pain in whole body) and PYREXIA (Ever since i got vacited im feelin high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  It was reported that the patient already had consulted physician and he gave some medicines. After using those medicines it was better for sometime but again the patient was feeling same side effects.  Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Product dose omission issue
Clinical narrative: numbness from the top of her head to the tips of her toes; haven't gotten the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numbness from the top of her head to the tips of her toes) and PRODUCT DOSE OMISSION ISSUE (haven't gotten the second dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness from the top of her head to the tips of her toes) and PRODUCT DOSE OMISSION ISSUE (haven't gotten the second dose). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form. At the time of the report, HYPOAESTHESIA (numbness from the top of her head to the tips of her toes) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (haven't gotten the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a seventeen-year-old patient received first dose of Moderna Covid-19 vaccine on 24Jul2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a seventeen-year-old patient received first dose of Moderna Covid-19 vaccine on 24Jul2021) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a seventeen-year-old patient received first dose of Moderna Covid-19 vaccine on 24Jul2021). On 24-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a seventeen-year-old patient received first dose of Moderna Covid-19 vaccine on 24Jul2021) 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 medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Fever; Fatigue; Chills; muscle aches and body aches; site pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (muscle aches and body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy, Breathing difficult (Only needed inhalers once in a while. Now I use them much more often.), Arrhythmia, Blood pressure abnormal, Heart disorder and Asthma. Concomitant products included METOPROLOL for Arrhythmia, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, QUINAPRIL for Blood pressure abnormal, ROSUVASTATIN for Heart disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (muscle aches and body aches) and VACCINATION SITE PAIN (site pain). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (muscle aches and body aches) and VACCINATION SITE PAIN (site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 102 (High) 102 and 102-104 (High) 102.         No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Headache; Fever; Fatigue; Chills; muscle aches and body aches; site pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills) and MYALGIA (muscle aches and body aches) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19. Concurrent medical conditions included Drug allergy, Breathing difficult (Only needed inhalers once in a while. Now I use them much more often.), Arrhythmia, Blood pressure abnormal, Heart disorder and Asthma. Concomitant products included METOPROLOL for Arrhythmia, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, QUINAPRIL for Blood pressure abnormal, ROSUVASTATIN for Heart disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (muscle aches and body aches) and VACCINATION SITE PAIN (site pain). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), MYALGIA (muscle aches and body aches) and VACCINATION SITE PAIN (site pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 102 (High) 102 and 102-104 (High) 102.         No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid pain, Eyelids pruritus, Swelling of eyelid
Clinical narrative: Left eyelid itched; Left eyelid hurt; Left eyelid swollen; This spontaneous case was reported by a consumer and describes the occurrence of EYELIDS PRURITUS (Left eyelid itched), EYELID PAIN (Left eyelid hurt) and SWELLING OF EYELID (Left eyelid swollen) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced EYELIDS PRURITUS (Left eyelid itched), EYELID PAIN (Left eyelid hurt) and SWELLING OF EYELID (Left eyelid swollen). At the time of the report, EYELIDS PRURITUS (Left eyelid itched), EYELID PAIN (Left eyelid hurt) and SWELLING OF EYELID (Left eyelid swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment medications were reported Patient reported that symptoms were lasted for 24 hours.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin mass
Clinical narrative: Bump; Arm swelled; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled) and SKIN MASS (Bump) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 025L20A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PERIPHERAL SWELLING (Arm swelled). On an unknown date, the patient experienced SKIN MASS (Bump). At the time of the report, PERIPHERAL SWELLING (Arm swelled) outcome was unknown and SKIN MASS (Bump) had not resolved.            Concomitantly the patient was taking unspecified medication for his heart disease (unspecified).  No treatment information was provided by the reporter.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling
Clinical narrative: Right Knee is extremely swollen; Difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right Knee is extremely swollen) and GAIT DISTURBANCE (Difficulty walking) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Down's syndrome.   On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced JOINT SWELLING (Right Knee is extremely swollen) and GAIT DISTURBANCE (Difficulty walking). The patient was treated with DICLOFENAC at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (Right Knee is extremely swollen) and GAIT DISTURBANCE (Difficulty walking) outcome was unknown.            Concomitant product details was not provided by the reporter. Action taken in response to mRNA-1273 was not applicable
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Vaccine Exposure Via Breast Milk; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Vaccine Exposure Via Breast Milk) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029AZIA) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Gestational Diabetes.  The mother's past medical history included Gestational diabetes. Concurrent medical conditions included Latex allergy.    MEDICAL HISTORY (Patient): No medical history was provided by the reporter.  Concomitant product exposures included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and MAGNESIUM OXIDE for an unknown indication.    On 02-Mar-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on 04-Sep-2020 and the estimated date of delivery was 11-Jun-2021. On 02-Mar-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Vaccine Exposure Via Breast Milk). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy. The vaginal delivery occurred on 04-Jun-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Delivered NOS. On 02-Mar-2021, EXPOSURE VIA BREAST MILK (Vaccine Exposure Via Breast Milk) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   The mother taken Red Raspberry Leaf Tea (2x daily) and 1 shot Apple Cider vinegar( 1x daily) at the time of conception and during pregnancy.  Upon internal review on 03-Nov-2021, fetal outcome captured as delivered NOS   This case was linked to MOD-2021-032275, MOD-2021-032276 (Parent-Child Link).   See case MOD-2021-032276,MOD-2021-032275 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Non-Significant Follow up-Email attached
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Expired dose of the vaccine was administered on 26JUL2021 as 2nd doses. The lot number for the vaccine was 053C21A (expiration date on vial 09Nov2021). The date the vial was moved from freezer to refrigerator was 24Jun2021. The date the vial expired was 23Jul2021. The administration of the doses was 3 days after the vial expired.   This case was linked to MOD-2021-277219 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm where it was put into the muscle of her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm where it was put into the muscle of her right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 SITE PAIN (sore arm where it was put into the muscle of her right arm). At the time of the report, VACCINATION SITE PAIN (sore arm where it was put into the muscle of her right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia, Pruritus, Pruritus, Unevaluable event
Clinical narrative: Metal objects sticking to her, paper clips and iPhone stuck to her chest as well; Arm started itching; Tingling in her fingers; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Metal objects sticking to her, paper clips and iPhone stuck to her chest as well), PRURITUS (Arm started itching) and PARAESTHESIA (Tingling in her fingers) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION COMPLICATION (Metal objects sticking to her, paper clips and iPhone stuck to her chest as well), PRURITUS (Arm started itching) and PARAESTHESIA (Tingling in her fingers). At the time of the report, VACCINATION COMPLICATION (Metal objects sticking to her, paper clips and iPhone stuck to her chest as well) outcome was unknown and PRURITUS (Arm started itching) and PARAESTHESIA (Tingling in her fingers) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she was not on any concomitant medications. Treatment medications were unknown.