chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extreme pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Extreme pain). At the time of the report, PAIN (Extreme pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unidentified side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Unidentified side effect) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unidentified side effect). At the time of the report, VACCINATION COMPLICATION (Unidentified side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd shot past 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd shot past 42 days) 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 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd shot past 42 days). On 17-May-2021, PRODUCT DOSE OMISSION ISSUE (2nd shot past 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I have not gotten the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not gotten the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 immunisation. No Medical History information was reported. On 26-Feb-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 (I have not gotten the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not gotten the second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I have not gotten the second shot) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have not gotten the second shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Dizziness, Dysphonia
Clinical narrative: Hoarse; lost her voice; Felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Hoarse), APHONIA (lost her voice) and DIZZINESS (Felt dizzy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced DYSPHONIA (Hoarse), APHONIA (lost her voice) and DIZZINESS (Felt dizzy). At the time of the report, DYSPHONIA (Hoarse), APHONIA (lost her voice) and DIZZINESS (Felt dizzy) outcome was unknown.            No concomitant medication was reported.  Patient had experienced events after second dose.  No treatment medication was reported.  Action taken with the mRNA-1273 vaccine in response to the events was not applicable.   This case was linked to MOD-2021-142069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18 May 2021 had no new information regarding first dose.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: Shortness of breath; Nerve pain; Stomach upset; Sweating; Chills; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), NEURALGIA (Nerve pain), ABDOMINAL DISCOMFORT (Stomach upset), HYPERHIDROSIS (Sweating) and CHILLS (Chills) in a 36-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 was provided by the reporter.  Concomitant products included CITALOPRAM and BUSPIRONE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Other) 1 dosage form. On 01-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue). On 02-May-2021, the patient experienced NEURALGIA (Nerve pain). On 13-May-2021, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) for Fatigue, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), NEURALGIA (Nerve pain), ABDOMINAL DISCOMFORT (Stomach upset), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Other) was unknown.       Treatment medication also included nausea pill.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Shortness of breath; Nerve pain; Stomach upset; Sweating; Chills; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), NEURALGIA (Nerve pain), ABDOMINAL DISCOMFORT (Stomach upset), HYPERHIDROSIS (Sweating) and CHILLS (Chills) in a 36-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 was provided by the reporter.  Concomitant products included CITALOPRAM and BUSPIRONE for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Other) 1 dosage form. On 01-May-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue). On 02-May-2021, the patient experienced NEURALGIA (Nerve pain). On 13-May-2021, the patient experienced DYSPNOEA (Shortness of breath). The patient was treated with PARACETAMOL (TYLENOL) for Fatigue, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), NEURALGIA (Nerve pain), ABDOMINAL DISCOMFORT (Stomach upset), HYPERHIDROSIS (Sweating), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Other) was unknown.       Treatment medication also included nausea pill.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Bad shaking; Hot; Felt dry/ Weird mouth feel; Couldn't get warm; White tongue; Body was burning; Dizzy; Diarrhea; Vomit; Tired/ Tired most of the day; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm) and TONGUE DISCOLOURATION (White tongue) in a 56-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.     Concomitant products included METOPROLOL and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm), TONGUE DISCOLOURATION (White tongue), BURNING SENSATION (Body was burning), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), VOMITING (Vomit), FATIGUE (Tired/ Tired most of the day), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm), TONGUE DISCOLOURATION (White tongue), BURNING SENSATION (Body was burning), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), VOMITING (Vomit), FATIGUE (Tired/ Tired most of the day), MYALGIA (Body aches) and PYREXIA (Fever) had not resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had bad shaking, hot, couldn't get warm, body was burning, dizzy, tired, vomit, tired most of the day, felt dry, diarrhea, white tongue, weird mouth feel, body aches, and fever. It was reported that those symptoms were active. Concomitant medications and treatment drugs were  not reported.   This case was linked to MOD-2021-142364 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Myalgia, Pyrexia, Tongue discolouration
Clinical narrative: Bad shaking; Hot; Felt dry/ Weird mouth feel; Couldn't get warm; White tongue; Body was burning; Dizzy; Diarrhea; Vomit; Tired/ Tired most of the day; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm) and TONGUE DISCOLOURATION (White tongue) in a 56-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.     Concomitant products included METOPROLOL and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm), TONGUE DISCOLOURATION (White tongue), BURNING SENSATION (Body was burning), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), VOMITING (Vomit), FATIGUE (Tired/ Tired most of the day), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm), TONGUE DISCOLOURATION (White tongue), BURNING SENSATION (Body was burning), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), VOMITING (Vomit), FATIGUE (Tired/ Tired most of the day), MYALGIA (Body aches) and PYREXIA (Fever) had not resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had bad shaking, hot, couldn't get warm, body was burning, dizzy, tired, vomit, tired most of the day, felt dry, diarrhea, white tongue, weird mouth feel, body aches, and fever. It was reported that those symptoms were active. Concomitant medications and treatment drugs were  not reported.   This case was linked to MOD-2021-142364 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vomiting
Clinical narrative: Bad shaking; Hot; Felt dry/ Weird mouth feel; Couldn't get warm; White tongue; Body was burning; Dizzy; Diarrhea; Vomit; Tired/ Tired most of the day; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm) and TONGUE DISCOLOURATION (White tongue) in a 56-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.     Concomitant products included METOPROLOL and ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS) for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm), TONGUE DISCOLOURATION (White tongue), BURNING SENSATION (Body was burning), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), VOMITING (Vomit), FATIGUE (Tired/ Tired most of the day), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, TREMOR (Bad shaking), FEELING HOT (Hot), FEELING ABNORMAL (Felt dry/ Weird mouth feel), FEELING COLD (Couldn't get warm), TONGUE DISCOLOURATION (White tongue), BURNING SENSATION (Body was burning), DIZZINESS (Dizzy), DIARRHOEA (Diarrhea), VOMITING (Vomit), FATIGUE (Tired/ Tired most of the day), MYALGIA (Body aches) and PYREXIA (Fever) had not resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had bad shaking, hot, couldn't get warm, body was burning, dizzy, tired, vomit, tired most of the day, felt dry, diarrhea, white tongue, weird mouth feel, body aches, and fever. It was reported that those symptoms were active. Concomitant medications and treatment drugs were  not reported.   This case was linked to MOD-2021-142364 (Patient Link).
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3 patients may get 3rd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 patients may get 3rd dose) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 patients may get 3rd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3 patients may get 3rd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medication provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Instead of drawing 0.5 ml dosage from the vial she drew 0.4 ml each time; 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 UNDERDOSE (Instead of drawing 0.5 ml dosage from the vial she drew 0.4 ml each time) 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) .4 milliliter. On an unknown date, the patient experienced UNDERDOSE (Instead of drawing 0.5 ml dosage from the vial she drew 0.4 ml each time). At the time of the report, UNDERDOSE (Instead of drawing 0.5 ml dosage from the vial she drew 0.4 ml each time) had resolved. Not Provided      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 medication were provided  Treatment medication was not provided
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Myalgia
Clinical narrative: a lot of diarrhea; can't keep anything down; body aches/body pains; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (a lot of diarrhea), FEELING ABNORMAL (can't keep anything down) and MYALGIA (body aches/body pains) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced DIARRHOEA (a lot of diarrhea), FEELING ABNORMAL (can't keep anything down) and MYALGIA (body aches/body pains). At the time of the report, DIARRHOEA (a lot of diarrhea), FEELING ABNORMAL (can't keep anything down) and MYALGIA (body aches/body pains) outcome was unknown.        No concomitant medication information was Reported No treatment medication information was Reported Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD21-091481 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: follow-up Information recived on 18-JUN-2021 contains non Significant Information; Sender's Comments:  MOD21-091481:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Shortness of breath; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness) in an 85-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness). At the time of the report, DYSPNOEA (Shortness of breath) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 32-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 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2021 at 1:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Heart rate: fast heart rate (High) Fast heart rate. Action taken with mRNA-1273 in response to the event was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches after first shot on and off for a couple of days. Started within 30 minutes after first shot.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches after first shot on and off for a couple of days. Started within 30 minutes after first shot.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HEADACHE (Headaches after first shot on and off for a couple of days. Started within 30 minutes after first shot.). The patient was treated with IBUPROFEN (ADVIL HEADACHE & MIGRAINE) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches after first shot on and off for a couple of days. Started within 30 minutes after first shot.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication include Medication for Thyroid everyday.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of the vaccine to be scheduled more than 36 days after the first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine to be scheduled more than 36 days after the first dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNKNOWN) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine to be scheduled more than 36 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of the vaccine to be scheduled more than 36 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment drug information provided. No concomitant drug information provided.   Reporter did not allow further contact
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Interchange of vaccine products
Clinical narrative: patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm; patient received first dose of Pfizer covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm) and INTERCHANGE OF VACCINE PRODUCTS (patient received first dose of Pfizer covid-19 vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INCORRECT DOSE ADMINISTERED (patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm) and INTERCHANGE OF VACCINE PRODUCTS (patient received first dose of Pfizer covid-19 vaccine). At the time of the report, INCORRECT DOSE ADMINISTERED (patient received first dose of Pfizer covid-19 vaccinegiven second dose of Moderna Covid-19 vaccine today in left arm) and INTERCHANGE OF VACCINE PRODUCTS (patient received first dose of Pfizer covid-19 vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment information was provided  no concomitant medication were reported
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: "little sore arm"; "slight headache"; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA ("little sore arm") and HEADACHE ("slight headache") in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025C21A) 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-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-May-2021, the patient experienced MYALGIA ("little sore arm") and HEADACHE ("slight headache"). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 17-May-2021, MYALGIA ("little sore arm") and HEADACHE ("slight headache") had resolved.            No concomitant medication was provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: right arm soreness; left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm soreness) and PAIN IN EXTREMITY (right arm soreness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (left arm soreness). On 18-May-2021, the patient experienced PAIN IN EXTREMITY (right arm soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Apr-2021, PAIN IN EXTREMITY (left arm soreness) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (right arm soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.   This case was linked to MOD-2021-142107 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Dizziness, Erythema
Clinical narrative: dizziness; weakness; fatigue; muscle pain; nausea; stomach ache; loose bowl movements; arm hurting at injection site; red arm; tender arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), VACCINATION SITE PAIN (arm hurting at injection site), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Nausea, Tenderness
Clinical narrative: dizziness; weakness; fatigue; muscle pain; nausea; stomach ache; loose bowl movements; arm hurting at injection site; red arm; tender arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), VACCINATION SITE PAIN (arm hurting at injection site), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: dizziness; weakness; fatigue; muscle pain; nausea; stomach ache; loose bowl movements; arm hurting at injection site; red arm; tender arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), VACCINATION SITE PAIN (arm hurting at injection site), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), FATIGUE (fatigue), MYALGIA (muscle pain), NAUSEA (nausea), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (loose bowl movements), ERYTHEMA (red arm), TENDERNESS (tender arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection site itching; Vaccination site rash; injection site redness; Respiratory issue; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (Respiratory issue), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (injection site redness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C21A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included FLUCONAZOLE for Antifungal treatment.   On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced RESPIRATORY DISORDER (Respiratory issue). On 17-May-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (injection site redness). In May 2021, RESPIRATORY DISORDER (Respiratory issue) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (injection site redness) outcome was unknown.            Patient has not taken any medication for the symptoms.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches after second shot, started within an hour after shot.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headaches after second shot, started within an hour after shot.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 13-Apr-2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (Headaches after second shot, started within an hour after shot.) outcome was unknown. She had headache everyday since getting the dose. Concomitant medication included Thyroid everyday.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose 3 weeks apart from first one; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 3 weeks apart from first one) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 3 weeks apart from first one). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 3 weeks apart from first one) 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.   Concomitant medication list was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Vaccination complication
Clinical narrative: broad out MIS symptoms; Bad reaction after first dose; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (broad out MIS symptoms) and VACCINATION COMPLICATION (Bad reaction after first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-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 NERVOUS SYSTEM DISORDER (broad out MIS symptoms) and VACCINATION COMPLICATION (Bad reaction after first dose). At the time of the report, NERVOUS SYSTEM DISORDER (broad out MIS symptoms) and VACCINATION COMPLICATION (Bad reaction after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was told by her neurologist not to take second dose of Moderna vaccine , which will be  schedule on 9June2021. So the patient want to cancel her second appointment for Moderna dose. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Other patients stated they had diarrhea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (Other patients stated they had diarrhea). At the time of the report, DIARRHEA (Other patients stated they had diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported. Event outcome was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Severe allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Severe allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    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 ALLERGY TO VACCINE (Severe allergic reaction). At the time of the report, ALLERGY TO VACCINE (Severe allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin mass
Clinical narrative: Lump after day 9; redness after day 9; This spontaneous case was reported by a health care professional and describes the occurrence of SKIN MASS (Lump after day 9) and ERYTHEMA (redness after day 9) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 SKIN MASS (Lump after day 9) and ERYTHEMA (redness after day 9). At the time of the report, SKIN MASS (Lump after day 9) and ERYTHEMA (redness after day 9) 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.   Limited information was provided by the reporter.  No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD21-091386, MOD21-020814, MOD21-090979 (E2B Linked Report). This case was linked to MOD-2021-027244 (Patient Link).; Sender's Comments:  MOD21-091386: MOD21-020814: MOD21-090979:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Little headache; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Little headache) and VACCINATION SITE PAIN (Arm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo. Concomitant products included MECLIZINE [MECLOZINE] for an unknown indication.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced HEADACHE (Little headache) and VACCINATION SITE PAIN (Arm pain). On 08-May-2021, HEADACHE (Little headache) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm pain) had resolved.            Treatment for the events was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-080005 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional information received on 09-Jun-2021 contains no new information. On 09-Jun-2021: Additional information received on 09-Jun-2021 as correct email was provided. On 09-Jun-2021: Additional information received on 09-Jun-2021 as non significant follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Vomiting
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), DIARRHEA (Diarrhea), DIZZINESS (Some dizziness) and VOMITING (Vomiting) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. Medical history was not provided. Concomitant products included METFORMIN and GLYBURIDE for an unknown indication. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), DIZZINESS (Some dizziness) and VOMITING (Vomiting). On 13-May-2021, ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), DIZZINESS (Some dizziness) and VOMITING (Vomiting) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Patient missed the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient missed the second dose of the vaccine) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient missed the second dose of the vaccine). On 06-May-2021, INTENTIONAL PRODUCT USE ISSUE (Patient missed the second dose of the vaccine) had resolved.            Second dose was scheduled on 06 May 2021, and patient wanted to re-schedule the second dose.   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Apr-2021, PAIN IN EXTREMITY (pain in arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.   This case was linked to MOD-2021-142026 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: arm is red; swollen; hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), PERIPHERAL SWELLING (swollen) and FEELING HOT (hot to touch) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced ERYTHEMA (arm is red), PERIPHERAL SWELLING (swollen) and FEELING HOT (hot to touch). At the time of the report, ERYTHEMA (arm is red), PERIPHERAL SWELLING (swollen) and FEELING HOT (hot to touch) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided.