chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: Headache; fatigue; vaccine exposure during pregnancy; Sore arm after second dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy), PAIN IN EXTREMITY (Sore arm after second dose), HEADACHE (Headache) and FATIGUE (fatigue) in a 30-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 12-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and PAIN IN EXTREMITY (Sore arm after second dose). On 13-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. On 13-Mar-2021, FATIGUE (fatigue) had resolved. On 14-Mar-2021, PAIN IN EXTREMITY (Sore arm after second dose) had resolved. On 15-Mar-2021, HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Oct-2020, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. On 11 Oct 2020 patient had positive pregnancy test. The estimated date of conception was 22 Sep 2020.    This case was linked to MOD-2021-048144, US-MODERNATX, INC.-MOD-2021-048144 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Haemorrhoids, Myalgia, Nasopharyngitis
Clinical narrative: Bloody discharge from rectum; achy body; weak stomach; head cold; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHOIDS (Bloody discharge from rectum), MYALGIA (achy body), ABDOMINAL PAIN UPPER (weak stomach) and NASOPHARYNGITIS (head cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced HAEMORRHOIDS (Bloody discharge from rectum), MYALGIA (achy body), ABDOMINAL PAIN UPPER (weak stomach) and NASOPHARYNGITIS (head cold). At the time of the report, HAEMORRHOIDS (Bloody discharge from rectum), MYALGIA (achy body), ABDOMINAL PAIN UPPER (weak stomach) and NASOPHARYNGITIS (head cold) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: got COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (got COVID) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), VITAMIN D NOS, VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (got COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (got COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient tested negative for COVID-19 on 14-Mar-2021. Other concomitant medication included high blood pressure medicines. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: short winded; cough; runny nose; sneezing; fever; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short winded), MALAISE (didn't feel well), COUGH (cough), RHINORRHOEA (runny nose) and SNEEZING (sneezing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (didn't feel well) and PYREXIA (fever). On 16-Mar-2021, the patient experienced COUGH (cough), RHINORRHOEA (runny nose) and SNEEZING (sneezing). On 17-Mar-2021, the patient experienced DYSPNOEA (short winded). On 17-Mar-2021, MALAISE (didn't feel well), COUGH (cough), RHINORRHOEA (runny nose), SNEEZING (sneezing) and PYREXIA (fever) had resolved. At the time of the report, DYSPNOEA (short winded) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: short winded; cough; runny nose; sneezing; fever; didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short winded), MALAISE (didn't feel well), COUGH (cough), RHINORRHOEA (runny nose) and SNEEZING (sneezing) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced MALAISE (didn't feel well) and PYREXIA (fever). On 16-Mar-2021, the patient experienced COUGH (cough), RHINORRHOEA (runny nose) and SNEEZING (sneezing). On 17-Mar-2021, the patient experienced DYSPNOEA (short winded). On 17-Mar-2021, MALAISE (didn't feel well), COUGH (cough), RHINORRHOEA (runny nose), SNEEZING (sneezing) and PYREXIA (fever) had resolved. At the time of the report, DYSPNOEA (short winded) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm to site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm to site of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm to site of injection). On 07-Mar-2021, VACCINATION SITE PAIN (Sore arm to site of injection) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information was  provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Bedridden, Chills, Disturbance in attention, Feeling abnormal
Clinical narrative: So Cold; Hazy,not clear; Feels like going to fall; Can't really concentrate; Chills; Felt like worst; Couldn't even get out of bed; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt like worst), BEDRIDDEN (Couldn't even get out of bed), NASOPHARYNGITIS (So Cold) and FEELING ABNORMAL (Hazy,not clear) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, the patient experienced HEADACHE (Headache). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like worst), BEDRIDDEN (Couldn't even get out of bed) and CHILLS (Chills). On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (So Cold), FEELING ABNORMAL (Hazy,not clear), BALANCE DISORDER (Feels like going to fall) and DISTURBANCE IN ATTENTION (Can't really concentrate). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at a dose of Extra Strength. On 12-Mar-2021, HEADACHE (Headache) had resolved. On 13-Mar-2021, FEELING ABNORMAL (Felt like worst) and BEDRIDDEN (Couldn't even get out of bed) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (So Cold), FEELING ABNORMAL (Hazy,not clear), BALANCE DISORDER (Feels like going to fall), DISTURBANCE IN ATTENTION (Can't really concentrate) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient describes pain as 8-10 normally. When he taken Acetaminophen it was decreased to 3-4 Concomitant product information includes High Blood Pressure Medication
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pain in extremity
Clinical narrative: So Cold; Hazy,not clear; Feels like going to fall; Can't really concentrate; Chills; Felt like worst; Couldn't even get out of bed; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt like worst), BEDRIDDEN (Couldn't even get out of bed), NASOPHARYNGITIS (So Cold) and FEELING ABNORMAL (Hazy,not clear) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, the patient experienced HEADACHE (Headache). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like worst), BEDRIDDEN (Couldn't even get out of bed) and CHILLS (Chills). On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (So Cold), FEELING ABNORMAL (Hazy,not clear), BALANCE DISORDER (Feels like going to fall) and DISTURBANCE IN ATTENTION (Can't really concentrate). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at a dose of Extra Strength. On 12-Mar-2021, HEADACHE (Headache) had resolved. On 13-Mar-2021, FEELING ABNORMAL (Felt like worst) and BEDRIDDEN (Couldn't even get out of bed) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (So Cold), FEELING ABNORMAL (Hazy,not clear), BALANCE DISORDER (Feels like going to fall), DISTURBANCE IN ATTENTION (Can't really concentrate) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient describes pain as 8-10 normally. When he taken Acetaminophen it was decreased to 3-4 Concomitant product information includes High Blood Pressure Medication
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave Moderna Covid-19 vaccine to a 16 and half years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna Covid-19 vaccine to a 16 and half years old) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter. No concomitant medication reported.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna Covid-19 vaccine to a 16 and half years old). On 17-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave Moderna Covid-19 vaccine to a 16 and half years old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 1/2 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Vaccination site rash
Clinical narrative: Bad chills; tired; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), CHILLS (Bad chills) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). On 06-Apr-2021, the patient experienced CHILLS (Bad chills) and FATIGUE (tired). At the time of the report, VACCINATION SITE RASH (rash at the injection site), CHILLS (Bad chills) and FATIGUE (tired) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications specified. No treatment medication information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Migraine, Pain in extremity, Pyrexia
Clinical narrative: arm hurt; fever of 104.4 F; chills; migraine; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PYREXIA (fever of 104.4 F), CHILLS (chills), MIGRAINE (migraine) and ARTHRALGIA (joint pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt), PYREXIA (fever of 104.4 F), CHILLS (chills), MIGRAINE (migraine) and ARTHRALGIA (joint pain). On 12-Mar-2021, PAIN IN EXTREMITY (arm hurt), PYREXIA (fever of 104.4 F), CHILLS (chills), MIGRAINE (migraine) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She took Tylenol for her symptoms. She spoke to her HCP to see if she should get the second dose. Her HCP advised her to call to see what the recommendation is.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pain in extremity, Pyrexia
Clinical narrative: felt cold; fever; nausea; arm sore and shooting to neck and elbow; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (felt cold), PAIN IN EXTREMITY (arm sore and shooting to neck and elbow), PYREXIA (fever) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore and shooting to neck and elbow). On 27-Feb-2021, the patient experienced NASOPHARYNGITIS (felt cold), PYREXIA (fever) and NAUSEA (nausea). On 02-Mar-2021, NASOPHARYNGITIS (felt cold), PAIN IN EXTREMITY (arm sore and shooting to neck and elbow) and PYREXIA (fever) had resolved. On 04-Mar-2021, NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided   This case was linked to MOD-2021-114223 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: swelling; pain at the injection site; 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 SWELLING (swelling) and VACCINATION SITE PAIN (pain at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, SWELLING (swelling) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Aches; Chills; Nausea; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Mar-2021, the patient experienced PAIN (Aches), CHILLS (Chills), NAUSEA (Nausea) and PYREXIA (Low grade fever). On 08-Mar-2021, PYREXIA (Low grade fever) had resolved. At the time of the report, PAIN (Aches), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatments were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Neck pain
Clinical narrative: Neck hurts; Didn't feel well; Nauseated; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck hurts), MALAISE (Didn't feel well), NAUSEA (Nauseated) and FATIGUE (Fatigued) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. No concomitant medication reported.    On 21-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 NECK PAIN (Neck hurts), MALAISE (Didn't feel well), NAUSEA (Nauseated) and FATIGUE (Fatigued). At the time of the report, NECK PAIN (Neck hurts), MALAISE (Didn't feel well), NAUSEA (Nauseated) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chills, Electrocardiogram, Fatigue
Clinical narrative: Weakness/loss of energy; Chills; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness/loss of energy), CHILLS (Chills) and FATIGUE (Exhaustion) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 016M20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), ESCITALOPRAM OXALATE (LEXAPRO) and FISH OIL (OMEGA 3 FISH OIL [FISH OIL]) for an unknown indication.   On 10-Mar-2001, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness/loss of energy), CHILLS (Chills) and FATIGUE (Exhaustion). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness/loss of energy), CHILLS (Chills) and FATIGUE (Exhaustion) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: inconclusive (Inconclusive) Blood work was fine. On an unknown date, Electrocardiogram: inconclusive (Inconclusive) EKG was fine.         Other concomitant products include Vitamins. Action taken with mRNA-1273 in response to the events is not applicable
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Lost Sense of taste; Lost Sense of Smell; Bad Headache; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost Sense of taste), ANOSMIA (Lost Sense of Smell), HEADACHE (Bad Headache) and FATIGUE (Fatigued) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Bad Headache) and FATIGUE (Fatigued). On an unknown date, the patient experienced AGEUSIA (Lost Sense of taste) and ANOSMIA (Lost Sense of Smell). At the time of the report, AGEUSIA (Lost Sense of taste), ANOSMIA (Lost Sense of Smell), HEADACHE (Bad Headache) and FATIGUE (Fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: (Positive) Covid19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: soreness; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (tired) 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 No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (soreness) and FATIGUE (tired). At the time of the report, PAIN (soreness) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant list  Treatment was Not provided
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Insomnia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site - Swollen, red and very itch; injection site - Swollen, red and very itchy; injection site - Swollen, red and very itchy; Injection site redness; she could not sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (she could not sleep last night), VACCINATION SITE SWELLING (injection site - Swollen, red and very itch), VACCINATION SITE ERYTHEMA (injection site - Swollen, red and very itchy), VACCINATION SITE PRURITUS (injection site - Swollen, red and very itchy) and INJECTION SITE ERYTHEMA (Injection site redness) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INSOMNIA (she could not sleep last night). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site - Swollen, red and very itch), VACCINATION SITE ERYTHEMA (injection site - Swollen, red and very itchy), VACCINATION SITE PRURITUS (injection site - Swollen, red and very itchy) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INSOMNIA (she could not sleep last night), VACCINATION SITE SWELLING (injection site - Swollen, red and very itch), VACCINATION SITE ERYTHEMA (injection site - Swollen, red and very itchy), VACCINATION SITE PRURITUS (injection site - Swollen, red and very itchy) and INJECTION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concurrent medical conditions included Diabetes.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Little sore arm). At the time of the report, VACCINATION SITE PAIN (Little sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-049855 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049855:Crosslinked with dose 2
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pruritus, Vaccination site nodule
Clinical narrative: Itching; Red knot at the injection site; The shot was given in her biceps in the wrong location; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The shot was given in her biceps in the wrong location), PRURITUS (Itching) and VACCINATION SITE NODULE (Red knot at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The shot was given in her biceps in the wrong location) and VACCINATION SITE NODULE (Red knot at the injection site). On 18-Mar-2021, the patient experienced PRURITUS (Itching). On 10-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (The shot was given in her biceps in the wrong location) had resolved. At the time of the report, PRURITUS (Itching) and VACCINATION SITE NODULE (Red knot at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes Alcohol calmed it down. Concomitant product information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Pain, Pain in extremity
Clinical narrative: extremely dizzy; Not able to stand up unless she was grabbing some furniture; Swing motion that is taking different nodes of reaction; Headache; Received second dose 11 days after the first dose; Same symptoms of the first dose (chills, body ache, arm was sore); Same symptoms of the first dose (chills, body ache, arm was sore); Same symptoms of the first dose (chills, body ache, arm was sore); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (extremely dizzy), GAIT INABILITY (Not able to stand up unless she was grabbing some furniture), MOTION SICKNESS (Swing motion that is taking different nodes of reaction), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 11 days after the first dose) and PAIN (Same symptoms of the first dose (chills, body ache, arm was sore)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer, Allergy to antibiotic (Amoxicillin), Drug allergy and Vertigo. Concomitant products included CARFILZOMIB (KYPROLIS) for Cancer, POTASSIUM, CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 11 days after the first dose), PAIN (Same symptoms of the first dose (chills, body ache, arm was sore)), PAIN IN EXTREMITY (Same symptoms of the first dose (chills, body ache, arm was sore)) and CHILLS (Same symptoms of the first dose (chills, body ache, arm was sore)). On 15-Mar-2021, the patient experienced DIZZINESS (extremely dizzy), GAIT INABILITY (Not able to stand up unless she was grabbing some furniture), MOTION SICKNESS (Swing motion that is taking different nodes of reaction) and HEADACHE (Headache). On 13-Mar-2021, PAIN (Same symptoms of the first dose (chills, body ache, arm was sore)), PAIN IN EXTREMITY (Same symptoms of the first dose (chills, body ache, arm was sore)) and CHILLS (Same symptoms of the first dose (chills, body ache, arm was sore)) had resolved. At the time of the report, DIZZINESS (extremely dizzy), GAIT INABILITY (Not able to stand up unless she was grabbing some furniture), MOTION SICKNESS (Swing motion that is taking different nodes of reaction), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 11 days after the first dose) and HEADACHE (Headache) outcome was unknown. Not Provided          Patient's concomitant medication also included Celexa for cancer.   Patient had a shutter shoulder on right arm and hence took the vaccine on left arm. No treatment information was provided.   This case was linked to MOD-2021-049908 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Hyperhidrosis, Nausea, Vaccination site pain
Clinical narrative: kept breaking up during the night on full body sweats; had one weird heart beat just one time; very very nauseated; whole upper arm including the injection site was in pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (kept breaking up during the night on full body sweats), HEART RATE ABNORMAL (had one weird heart beat just one time), NAUSEA (very very nauseated) and VACCINATION SITE PAIN (whole upper arm including the injection site was in pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included TIMOLOL for Glaucoma, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid therapy.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HYPERHIDROSIS (kept breaking up during the night on full body sweats), HEART RATE ABNORMAL (had one weird heart beat just one time), NAUSEA (very very nauseated) and VACCINATION SITE PAIN (whole upper arm including the injection site was in pain). On 18-Mar-2021, HYPERHIDROSIS (kept breaking up during the night on full body sweats), HEART RATE ABNORMAL (had one weird heart beat just one time) and NAUSEA (very very nauseated) had resolved. At the time of the report, VACCINATION SITE PAIN (whole upper arm including the injection site was in pain) had not 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.   Other concomitant medication included high blood pressure pill.   No treatment information was provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.   Concurrent medical conditions included Morning sickness.  No medical history was provided by reporter.  No concomitant medication reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Oct-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information and concomitant medications were not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea, Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: injection site itched/Weird; Red rash! Right underneath the injection site; Little sick; Sore Arm; Nauseous; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ILLNESS (Little sick), VACCINATION SITE PRURITUS (injection site itched/Weird), VACCINATION SITE RASH (Red rash! Right underneath the injection site) and NAUSEA (Nauseous) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy (Honey), Fibromyalgia since 2003 and Pollen allergy. Concomitant products included CHLORPHENIRAMINE MALEATE from an unknown date to 10-Mar-2021 for Pollen allergy.    On 12-Mar-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NAUSEA (Nauseous). On 12-Mar-2021 at 3:00 AM, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 14-Mar-2021, the patient experienced ILLNESS (Little sick). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itched/Weird) and VACCINATION SITE RASH (Red rash! Right underneath the injection site). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ILLNESS (Little sick), VACCINATION SITE PRURITUS (injection site itched/Weird), VACCINATION SITE RASH (Red rash! Right underneath the injection site) and NAUSEA (Nauseous) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076590 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: Patient's age, New event added. On 16-May-2021: Completed ADR received with additional AE information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076590:Second dose case
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Throat tightness
Clinical narrative: experienced tightness in the throat  for about 10 seconds within 1 minute after administration; experienced dizziness for about 10 seconds within 1 minute after administration.; This spontaneous case was reported by an other and describes the occurrence of   in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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 was reported. No treatment medication was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took dose too early-16 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took dose too early-16 days) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took dose too early-16 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Took dose too early-16 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant drugs were given No Treatment medication was added  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Reporter details, patient details and second dose details were updated.; Reporter's Comments: INAPPROPRIATE SCHEDULING OF DRUG..TOOK DOSE 16 DAYS EARLY
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Sore arm; injection site is very warm; Its like someone injected her with warm water; Headaches; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE WARMTH (injection site is very warm), FEELING HOT (Its like someone injected her with warm water), HEADACHE (Headaches) and INJECTION SITE SWELLING (Swollen injection site) outcome was unknown.            The patient took the second dose of the mRNA-1273, hence action taken with the vaccine in response to the events was not applicable.   No concomitant medication was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pain
Clinical narrative: red blotch seems to be getting bigger; little pain on the injection site, right upper arm had pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotch seems to be getting bigger) and VACCINATION SITE PAIN (little pain on the injection site, right upper arm had pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (little pain on the injection site, right upper arm had pain). On 18-Mar-2021, the patient experienced RASH MACULAR (red blotch seems to be getting bigger). At the time of the report, RASH MACULAR (red blotch seems to be getting bigger) and VACCINATION SITE PAIN (little pain on the injection site, right upper arm had pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No comcomitant medications were provided. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction to the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction to the moderna 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.    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 ADVERSE REACTION (adverse reaction to the moderna vaccine). At the time of the report, ADVERSE REACTION (adverse reaction to the moderna vaccine) 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. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Minimal sore on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Minimal sore on the 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Minimal sore on the arm). At the time of the report, PAIN IN EXTREMITY (Minimal sore on the arm) outcome was unknown.            Concomitant medication was not provided by the reporter.  Treatment medication was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Terrible headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and HEADACHE (Terrible headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). On 19-Mar-2021, the patient experienced HEADACHE (Terrible headache). At the time of the report, FATIGUE (Tired) and HEADACHE (Terrible headache) outcome was unknown. Not Provided          Concomitant product information was not provided. Had a terrible headache after using Fluticasone propionate.(Aller-flo). During the follow up Patient said he had both shots and is "happy with it."   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information received on 24 May 2021 does not contain any new information.