chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-058846 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058846:Case for patient 2
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: sore arm; headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown, PYREXIA (fever) was resolving and CHILLS (chills) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sore arm; headache; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), HEADACHE (headache), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) outcome was unknown, PYREXIA (fever) was resolving and CHILLS (chills) and MYALGIA (body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Lymphadenopathy, Migraine, Neck pain
Clinical narrative: migraine; slightly swollen gland bellowthe ear; Worst eye migraine she ever had; Severe ocular migraine; Neck was hurting but mostly on the left side; Woke up in the middle of the night with lots of pain; pain in their head move to the eye; really really bad headache,mainly on the left side; Nose started running; Headache; Aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose started running), MIGRAINE (migraine), HEADACHE (Headache), PAIN IN EXTREMITY (Aches) and HEADACHE (really really bad headache,mainly on the left side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-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 05-Mar-2021, the patient experienced RHINORRHOEA (Nose started running), HEADACHE (Headache) and PAIN IN EXTREMITY (Aches). On 18-Mar-2021, the patient experienced HEADACHE (really really bad headache,mainly on the left side). On 23-Mar-2021, the patient experienced EYE PAIN (pain in their head move to the eye) and PAIN (Woke up in the middle of the night with lots of pain). On 24-Mar-2021, the patient experienced NECK PAIN (Neck was hurting but mostly on the left side). On an unknown date, the patient experienced MIGRAINE (migraine), LYMPHADENOPATHY (slightly swollen gland bellowthe ear), MIGRAINE (Worst eye migraine she ever had) and RETINAL MIGRAINE (Severe ocular migraine). At the time of the report, RHINORRHOEA (Nose started running), MIGRAINE (migraine), HEADACHE (Headache), PAIN IN EXTREMITY (Aches), HEADACHE (really really bad headache,mainly on the left side), LYMPHADENOPATHY (slightly swollen gland bellowthe ear), EYE PAIN (pain in their head move to the eye), MIGRAINE (Worst eye migraine she ever had), PAIN (Woke up in the middle of the night with lots of pain), NECK PAIN (Neck was hurting but mostly on the left side) and RETINAL MIGRAINE (Severe ocular migraine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included were thyroid medication and high blood pressure medication.  Treatment medication were Tylenol and ibuprofen.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD21-062595 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Retinal migraine, Rhinorrhoea
Clinical narrative: migraine; slightly swollen gland bellowthe ear; Worst eye migraine she ever had; Severe ocular migraine; Neck was hurting but mostly on the left side; Woke up in the middle of the night with lots of pain; pain in their head move to the eye; really really bad headache,mainly on the left side; Nose started running; Headache; Aches; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose started running), MIGRAINE (migraine), HEADACHE (Headache), PAIN IN EXTREMITY (Aches) and HEADACHE (really really bad headache,mainly on the left side) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-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 05-Mar-2021, the patient experienced RHINORRHOEA (Nose started running), HEADACHE (Headache) and PAIN IN EXTREMITY (Aches). On 18-Mar-2021, the patient experienced HEADACHE (really really bad headache,mainly on the left side). On 23-Mar-2021, the patient experienced EYE PAIN (pain in their head move to the eye) and PAIN (Woke up in the middle of the night with lots of pain). On 24-Mar-2021, the patient experienced NECK PAIN (Neck was hurting but mostly on the left side). On an unknown date, the patient experienced MIGRAINE (migraine), LYMPHADENOPATHY (slightly swollen gland bellowthe ear), MIGRAINE (Worst eye migraine she ever had) and RETINAL MIGRAINE (Severe ocular migraine). At the time of the report, RHINORRHOEA (Nose started running), MIGRAINE (migraine), HEADACHE (Headache), PAIN IN EXTREMITY (Aches), HEADACHE (really really bad headache,mainly on the left side), LYMPHADENOPATHY (slightly swollen gland bellowthe ear), EYE PAIN (pain in their head move to the eye), MIGRAINE (Worst eye migraine she ever had), PAIN (Woke up in the middle of the night with lots of pain), NECK PAIN (Neck was hurting but mostly on the left side) and RETINAL MIGRAINE (Severe ocular migraine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included were thyroid medication and high blood pressure medication.  Treatment medication were Tylenol and ibuprofen.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD21-062595 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 025J20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (07-09-2020: pregnancy end date. Live, full term birth.).   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 27-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 27-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Pregnancy test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided. Action taken with mRNA-1273  in response to events was not applicable.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Apr-2021. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided          No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (pain in the arm), asthenia (weak) and fatigue (tired and exhausted) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006B21A) for COVID-19 immunization. No medical history reported. On Mar 23, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 23, 2021, patient experienced pain in extremity (pain in the arm), asthenia (weak) and fatigue (tired and exhausted). At the time of the report, pain in extremity (pain in the arm), asthenia (weak) and fatigue (tired and exhausted) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 8 days early for 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 days early for 2nd dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).   On 25-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 days early for 2nd dose). On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 days early for 2nd dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.  No concomitant medications were reported.  No treatment related information has been reported.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: 048A21A) with no associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on my stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on my stomach) 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 RASH (Rash on my stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on my stomach) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-058943 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Added follow up email received on 11-May-2021.(No information regarding the patient)
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: fatigue; joint pain; headaches; nausea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), ARTHRALGIA (joint pain), HEADACHE (headaches), NAUSEA (nausea) and DIARRHOEA (diarrhea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced FATIGUE (fatigue), ARTHRALGIA (joint pain), HEADACHE (headaches), NAUSEA (nausea) and DIARRHOEA (diarrhea). On 22-Mar-2021, FATIGUE (fatigue), ARTHRALGIA (joint pain), HEADACHE (headaches), NAUSEA (nausea) and DIARRHOEA (diarrhea) had resolved. Not Provided          Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; hives; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PRURITUS (itching) and URTICARIA (hives). At the time of the report, PRURITUS (itching) and URTICARIA (hives) outcome was unknown. Not Provided      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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: temperature keeps going up - 100.5° at the moment; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature keeps going up - 100.5° at the moment) and FATIGUE (FATIGUE) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (temperature keeps going up - 100.5° at the moment) and FATIGUE (FATIGUE). At the time of the report, PYREXIA (temperature keeps going up - 100.5° at the moment) and FATIGUE (FATIGUE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I am gettng another more itch my rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (I am gettng another more itch my rash) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (I am gettng another more itch my rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (I am gettng another more itch my rash) outcome was unknown. Not Provided          No concomitant medications were provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-058928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up information received on 11-MAY-2021 contains non-significant information: Patient stated no additional information to report.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weak; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 25-Mar-2021, the patient experienced ASTHENIA (weak). At the time of the report, ASTHENIA (weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling, Vaccination site swelling
Clinical narrative: Swelling in armpits and arms; Swelling of hands; Swelling in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in armpits and arms), PERIPHERAL SWELLING (Swelling of hands) and VACCINATION SITE SWELLING (Swelling in the injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No medical history information was reported .  Concomitant products included METFORMIN for an unknown indication.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced SWELLING (Swelling in armpits and arms), PERIPHERAL SWELLING (Swelling of hands) and VACCINATION SITE SWELLING (Swelling in the injection site). At the time of the report, SWELLING (Swelling in armpits and arms), PERIPHERAL SWELLING (Swelling of hands) and VACCINATION SITE SWELLING (Swelling in the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Swelling, redness, urticaria around the site; Swelling, redness, urticaria around the site; Swelling, redness, urticaria around the site; 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 VACCINATION SITE URTICARIA (Swelling, redness, urticaria around the site), VACCINATION SITE SWELLING (Swelling, redness, urticaria around the site) and VACCINATION SITE ERYTHEMA (Swelling, redness, urticaria around the site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Swelling, redness, urticaria around the site), VACCINATION SITE SWELLING (Swelling, redness, urticaria around the site) and VACCINATION SITE ERYTHEMA (Swelling, redness, urticaria around the site). At the time of the report, VACCINATION SITE URTICARIA (Swelling, redness, urticaria around the site), VACCINATION SITE SWELLING (Swelling, redness, urticaria around the site) and VACCINATION SITE ERYTHEMA (Swelling, redness, urticaria around the site) 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.   Concomitant medication was not reported. Treatment medication was not reported.  It was first thought as cellulitis, but it was a local reaction.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18-Jun-2021 as the outcome of all events has been updated as recovered.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Cough, Fatigue
Clinical narrative: Stuffy nose; Runny nose; Cough; Sore throat; Swelling at injection site; Redness at injection site; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Tenderness and swelling of lymph nodes; Pain; Tenderness and swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose) and COUGH (Cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes). On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes) outcome was unknown and NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Nasal congestion, Oropharyngeal pain
Clinical narrative: Stuffy nose; Runny nose; Cough; Sore throat; Swelling at injection site; Redness at injection site; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Tenderness and swelling of lymph nodes; Pain; Tenderness and swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose) and COUGH (Cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes). On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes) outcome was unknown and NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rhinorrhoea, Tenderness, Vaccination site erythema
Clinical narrative: Stuffy nose; Runny nose; Cough; Sore throat; Swelling at injection site; Redness at injection site; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Tenderness and swelling of lymph nodes; Pain; Tenderness and swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose) and COUGH (Cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes). On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes) outcome was unknown and NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Stuffy nose; Runny nose; Cough; Sore throat; Swelling at injection site; Redness at injection site; Fatigue; Headache; Muscle pain; Joint pain; Chills; Fever; Tenderness and swelling of lymph nodes; Pain; Tenderness and swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose) and COUGH (Cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes). On an unknown date, the patient experienced NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PAIN (Pain), TENDERNESS (Tenderness and swelling of lymph nodes), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), CHILLS (Chills), PYREXIA (Fever) and LYMPHADENOPATHY (Tenderness and swelling of lymph nodes) outcome was unknown and NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.     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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Achy; My joints were bothering me; Pain at the spot where I got vaccinated; Little bit of red at the spot/red spot has gotten bigger; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Achy), ARTHRALGIA (My joints were bothering me), VACCINATION SITE PAIN (Pain at the spot where I got vaccinated) and VACCINATION SITE ERYTHEMA (Little bit of red at the spot/red spot has gotten bigger) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Surgery in my right arm.). Concomitant products included IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) for Surgery, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (Achy), ARTHRALGIA (My joints were bothering me), VACCINATION SITE PAIN (Pain at the spot where I got vaccinated) and VACCINATION SITE ERYTHEMA (Little bit of red at the spot/red spot has gotten bigger). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Achy), ARTHRALGIA (My joints were bothering me), VACCINATION SITE PAIN (Pain at the spot where I got vaccinated) and VACCINATION SITE ERYTHEMA (Little bit of red at the spot/red spot has gotten bigger) 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.   The patient reported that she used a cold cloth on the site.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: "a lot of fatigue"; "severe joint pain"; "fever"; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ("a lot of fatigue"), ARTHRALGIA ("severe joint pain") and PYREXIA ("fever") in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic lymphocytic leukemia (exposed to Agent Orange spray during the war).   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Mar-2021, the patient experienced FATIGUE ("a lot of fatigue"), ARTHRALGIA ("severe joint pain") and PYREXIA ("fever"). On 22-Mar-2021, FATIGUE ("a lot of fatigue"), ARTHRALGIA ("severe joint pain") and PYREXIA ("fever") had resolved.            no concomitant medications reported. no treatment details reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Rash
Clinical narrative: Next day the rash came back; Covid arm; that went to my upper arm; After several days, I got a bad rash on lower arm; chills; Super tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Super tired), CHILLS (chills), RASH (Next day the rash came back), RASH (Covid arm) and RASH (that went to my upper arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 025J20A and Lot# 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Super tired), CHILLS (chills), RASH (Next day the rash came back), RASH (Covid arm), RASH (that went to my upper arm) and RASH (After several days, I got a bad rash on lower arm). At the time of the report, FATIGUE (Super tired), CHILLS (chills), RASH (Next day the rash came back), RASH (Covid arm), RASH (that went to my upper arm) and RASH (After several days, I got a bad rash on lower arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment drugs taken for rash : Tylenol, Benadryl, "AND" ointment.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Bowel movement irregularity, Constipation, Feeling abnormal, Flatulence
Clinical narrative: Bowel movement; Sore arm; Gas pain; Tremendous constipation; Bloated; Pain; Making me miserable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated) and PAIN (Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included ATENOLOL, LISINOPRIL, POTASSIUM, WARFARIN, PRIMIDONE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 07-Feb-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 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated), PAIN (Pain) and FEELING ABNORMAL (Making me miserable). On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (Bowel movement). At the time of the report, PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated), PAIN (Pain), FEELING ABNORMAL (Making me miserable) and BOWEL MOVEMENT IRREGULARITY (Bowel movement) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products also included Thyroid medications No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up Received on 06-AUG-2021 and no new information was provided and the consent denied for follow-up
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Bowel movement; Sore arm; Gas pain; Tremendous constipation; Bloated; Pain; Making me miserable; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated) and PAIN (Pain) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included ATENOLOL, LISINOPRIL, POTASSIUM, WARFARIN, PRIMIDONE and HYDROCHLOROTHIAZIDE for an unknown indication.   On 07-Feb-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 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated), PAIN (Pain) and FEELING ABNORMAL (Making me miserable). On an unknown date, the patient experienced BOWEL MOVEMENT IRREGULARITY (Bowel movement). At the time of the report, PAIN IN EXTREMITY (Sore arm), FLATULENCE (Gas pain), CONSTIPATION (Tremendous constipation), ABDOMINAL DISTENSION (Bloated), PAIN (Pain), FEELING ABNORMAL (Making me miserable) and BOWEL MOVEMENT IRREGULARITY (Bowel movement) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products also included Thyroid medications No treatment medication included.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up Received on 06-AUG-2021 and no new information was provided and the consent denied for follow-up
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Tinnitus
Clinical narrative: Pulsing in both ears still occuring; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and TINNITUS (Pulsing in both ears still occuring) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath). On 18-Mar-2021, the patient experienced TINNITUS (Pulsing in both ears still occuring). At the time of the report, DYSPNOEA (Shortness of breath) had resolved and TINNITUS (Pulsing in both ears still occuring) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Nausea
Clinical narrative: Joint Pain; Nausea; Severe headache; Tender arm; This spontaneous case was reported by a nurse and describes the occurrence of ARTHRALGIA (Joint Pain), MYALGIA (Tender arm), NAUSEA (Nausea) and HEADACHE (Severe headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced MYALGIA (Tender arm). On 22-Mar-2021, the patient experienced ARTHRALGIA (Joint Pain), NAUSEA (Nausea) and HEADACHE (Severe headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (Joint Pain), MYALGIA (Tender arm), NAUSEA (Nausea) and HEADACHE (Severe headache) outcome was unknown. 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 was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Head discomfort, Headache
Clinical narrative: pressure on the chest; weight on the head; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (pressure on the chest), HEAD DISCOMFORT (weight on the head) and HEADACHE (Terrible headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CHEST DISCOMFORT (pressure on the chest), HEAD DISCOMFORT (weight on the head) and HEADACHE (Terrible headache). On 25-Mar-2021, CHEST DISCOMFORT (pressure on the chest) had resolved. At the time of the report, HEAD DISCOMFORT (weight on the head) and HEADACHE (Terrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.