chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was kinda sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was kinda sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    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 PAIN IN EXTREMITY (Arm was kinda sore). At the time of the report, PAIN IN EXTREMITY (Arm was kinda sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-101922 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Impaired work ability, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: difficult getting dressed and is unable to return to the sports that he enjoys; significant pain in the arm; loss of mobility; pain in joints, but it's related to my shoulder/searing joint pain; the pain was deep in the muscle and stabbing like; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (difficult getting dressed and is unable to return to the sports that he enjoys), PAIN IN EXTREMITY (significant pain in the arm), MOBILITY DECREASED (loss of mobility), ARTHRALGIA (pain in joints, but it's related to my shoulder/searing joint pain) and MYALGIA (the pain was deep in the muscle and stabbing like) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMPAIRED WORK ABILITY (difficult getting dressed and is unable to return to the sports that he enjoys), PAIN IN EXTREMITY (significant pain in the arm), MOBILITY DECREASED (loss of mobility), ARTHRALGIA (pain in joints, but it's related to my shoulder/searing joint pain) and MYALGIA (the pain was deep in the muscle and stabbing like). At the time of the report, IMPAIRED WORK ABILITY (difficult getting dressed and is unable to return to the sports that he enjoys), PAIN IN EXTREMITY (significant pain in the arm), MOBILITY DECREASED (loss of mobility), ARTHRALGIA (pain in joints, but it's related to my shoulder/searing joint pain) and MYALGIA (the pain was deep in the muscle and stabbing like) outcome was unknown.            No concomitant medication provided. No treatment medication provided.   This case was linked to MOD-2021-101905 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Reporters contact details were updated On 07-Jun-2021: New Events were added On 21-Jun-2021: FU email was added
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Apr-2021, the patient experienced COUGH (Dry cough). At the time of the report, COUGH (Dry cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided by reporter.   This case was linked to MOD21-084979, MOD21-085082, MOD21-085067 (E2B Linked Report).; Sender's Comments:  MOD21-084979:cross linked id MOD21-085082:cross linked id MOD21-085067:cross linked id
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke in 2015. Concurrent medical conditions included Wheelchair user.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was being treated with antibiotic and would consult HCP for advice when to reschedule second Moderna vaccine.  Concomitant medications were not reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (codeine and flobaxin).    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's next dose is scheduled for 14 May 2021.  No concomitant medications were reported No treatment information was provided
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Mood swings
Clinical narrative: Normal hormonal changes, such as moodiness; Menstrual cycle started 10 days early; Non-stopped menses; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle started 10 days early), HEAVY MENSTRUAL BLEEDING (Non-stopped menses) and MOOD SWINGS (Normal hormonal changes, such as moodiness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced MENSTRUAL DISORDER (Menstrual cycle started 10 days early) and HEAVY MENSTRUAL BLEEDING (Non-stopped menses). On an unknown date, the patient experienced MOOD SWINGS (Normal hormonal changes, such as moodiness). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle started 10 days early), HEAVY MENSTRUAL BLEEDING (Non-stopped menses) and MOOD SWINGS (Normal hormonal changes, such as moodiness) 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 medications were reported.  No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (Ear problem unsure if it is an infection or wax build-up) and DIZZINESS (She has dizziness when standing) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR DISCOMFORT (Ear problem unsure if it is an infection or wax build-up) and DIZZINESS (She has dizziness when standing). At the time of the report, EAR DISCOMFORT (Ear problem unsure if it is an infection or wax build-up) and DIZZINESS (She has dizziness when standing) outcome was unknown. Not Provided. No concomitant medications were reported. No laboratory details were  provided. No treatment medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Consumer states she was scheduled to receive the second dose of Moderna vaccine on Wednesday. She has an ear problem, unsure if it is an infection or wax build-up. She does have dizziness when standing.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair falling out in clumps; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair falling out in clumps) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alopecia (Taken steroid shots which helped in hair growth) in February 2020.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair falling out in clumps). At the time of the report, ALOPECIA (hair falling out in clumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-jun-2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient inadvertently received a dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently received a dose) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No treatment medication information were provided.     On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently received a dose). On 29-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient inadvertently received a dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment information were provided   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Possible NNI
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Cough, Fatigue, Headache, Illness
Clinical narrative: severe cough; couch ridden; pulled back muscle; down for the count; headache; extreme fatigue; swollen feet; left shoulder where she received the vaccine has been hurting; This spontaneous case was reported by an other and describes the occurrence of COUGH (severe cough), BEDRIDDEN (couch ridden), MUSCLE STRAIN (pulled back muscle), ILLNESS (down for the count) and PERIPHERAL SWELLING (swollen feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endometrial cancer. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 25-Mar-2021 to an unknown date and PEMBROLIZUMAB (KEYTRUDA) for Endometrial cancer.   On 15-Apr-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) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced VACCINATION SITE PAIN (left shoulder where she received the vaccine has been hurting). On 08-Jul-2021, the patient experienced PERIPHERAL SWELLING (swollen feet). On an unknown date, the patient experienced COUGH (severe cough), BEDRIDDEN (couch ridden), MUSCLE STRAIN (pulled back muscle), ILLNESS (down for the count), HEADACHE (headache) and FATIGUE (extreme fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) for Vaccination site pain, at an unspecified dose and frequency and GABAPENTIN for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, COUGH (severe cough), BEDRIDDEN (couch ridden), MUSCLE STRAIN (pulled back muscle), ILLNESS (down for the count), PERIPHERAL SWELLING (swollen feet), HEADACHE (headache), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (left shoulder where she received the vaccine has been hurting) outcome was unknown.            The patient has increased and new lung nodules and new lesions on her liver per PT scan. Patient was awaiting x-ray results to confirm that the arm was not broken.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: The additional information document received with Lab information is added On 03-Jun-2021: EISAI confirms document receipt, ESAI case ID number provided On 04-Jun-2021: NNI On 03-Aug-2021: New events added.
Sex: F
Vaccine: COVID19
Symptoms: Muscle strain, Peripheral swelling, Vaccination site pain
Clinical narrative: severe cough; couch ridden; pulled back muscle; down for the count; headache; extreme fatigue; swollen feet; left shoulder where she received the vaccine has been hurting; This spontaneous case was reported by an other and describes the occurrence of COUGH (severe cough), BEDRIDDEN (couch ridden), MUSCLE STRAIN (pulled back muscle), ILLNESS (down for the count) and PERIPHERAL SWELLING (swollen feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Endometrial cancer. Concomitant products included LENVATINIB MESILATE (LENVIMA) from 25-Mar-2021 to an unknown date and PEMBROLIZUMAB (KEYTRUDA) for Endometrial cancer.   On 15-Apr-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) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced VACCINATION SITE PAIN (left shoulder where she received the vaccine has been hurting). On 08-Jul-2021, the patient experienced PERIPHERAL SWELLING (swollen feet). On an unknown date, the patient experienced COUGH (severe cough), BEDRIDDEN (couch ridden), MUSCLE STRAIN (pulled back muscle), ILLNESS (down for the count), HEADACHE (headache) and FATIGUE (extreme fatigue). The patient was treated with NAPROXEN SODIUM (ALEVE) for Vaccination site pain, at an unspecified dose and frequency and GABAPENTIN for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, COUGH (severe cough), BEDRIDDEN (couch ridden), MUSCLE STRAIN (pulled back muscle), ILLNESS (down for the count), PERIPHERAL SWELLING (swollen feet), HEADACHE (headache), FATIGUE (extreme fatigue) and VACCINATION SITE PAIN (left shoulder where she received the vaccine has been hurting) outcome was unknown.            The patient has increased and new lung nodules and new lesions on her liver per PT scan. Patient was awaiting x-ray results to confirm that the arm was not broken.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: The additional information document received with Lab information is added On 03-Jun-2021: EISAI confirms document receipt, ESAI case ID number provided On 04-Jun-2021: NNI On 03-Aug-2021: New events added.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Condition aggravated, Dizziness, Headache, Migraine
Clinical narrative: Left worsen day by day; Dizzy; Some migraines; Lost control and put my head down"; Random duration two hours headaches; Slight dizziness; Arm pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost control and put my head down"), DIZZINESS (Slight dizziness), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy) and MIGRAINE (Some migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DIZZINESS (Slight dizziness), PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced BALANCE DISORDER (Lost control and put my head down"), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy), MIGRAINE (Some migraines) and HEADACHE (Random duration two hours headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MINERALS NOS, VITAMINS NOS (CENTRUM BALANCE) at an unspecified dose and frequency. On 19-Apr-2021, DIZZINESS (Slight dizziness) and HEADACHE (Headache) had resolved. On 21-Apr-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, BALANCE DISORDER (Lost control and put my head down"), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy), MIGRAINE (Some migraines) and HEADACHE (Random duration two hours headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left worsen day by day; Dizzy; Some migraines; Lost control and put my head down"; Random duration two hours headaches; Slight dizziness; Arm pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Lost control and put my head down"), DIZZINESS (Slight dizziness), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy) and MIGRAINE (Some migraines) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced DIZZINESS (Slight dizziness), PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache). On 22-Apr-2021, the patient experienced BALANCE DISORDER (Lost control and put my head down"), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy), MIGRAINE (Some migraines) and HEADACHE (Random duration two hours headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MINERALS NOS, VITAMINS NOS (CENTRUM BALANCE) at an unspecified dose and frequency. On 19-Apr-2021, DIZZINESS (Slight dizziness) and HEADACHE (Headache) had resolved. On 21-Apr-2021, PAIN IN EXTREMITY (Arm pain) had resolved. At the time of the report, BALANCE DISORDER (Lost control and put my head down"), CONDITION AGGRAVATED (Left worsen day by day), DIZZINESS (Dizzy), MIGRAINE (Some migraines) and HEADACHE (Random duration two hours headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site pain, Injection site swelling
Clinical narrative: arm was sore; sore and swelling underneath the armpit near the breast area pain on left side; sore and swelling underneath the armpit near the breast area pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm was sore), INJECTION SITE SWELLING (sore and swelling underneath the armpit near the breast area pain on left side) and AXILLARY PAIN (sore and swelling underneath the armpit near the breast area pain) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CITALOPRAM and LOSARTAN for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced INJECTION SITE PAIN (arm was sore), INJECTION SITE SWELLING (sore and swelling underneath the armpit near the breast area pain on left side) and AXILLARY PAIN (sore and swelling underneath the armpit near the breast area pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (arm was sore), INJECTION SITE SWELLING (sore and swelling underneath the armpit near the breast area pain on left side) and AXILLARY PAIN (sore and swelling underneath the armpit near the breast area pain) had resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Gait disturbance, Headache, Herpes zoster
Clinical narrative: Diagnosed with Shingles; Rash on left buttock; Fatigue; Headache; Nausea; Difficult to walk because of the pain; intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot; Problem sitting down because of the pain on her left buttock; Blister on left buttock; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock) and HERPES ZOSTER (Diagnosed with Shingles) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Pollen allergy and Allergy to molds. Concomitant products included METFORMIN, VITAMIN D3, CETIRIZINE HYDROCHLORIDE (ZYRTEC R), FLUOXETINE HYDROCHLORIDE (PROZAC), ATORVASTATIN, LISINOPRIL, FISH OIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and LEVOTHYROXINE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock), RASH (Rash on left buttock), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 30-Apr-2021, the patient experienced HERPES ZOSTER (Diagnosed with Shingles). At the time of the report, GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock), HERPES ZOSTER (Diagnosed with Shingles), RASH (Rash on left buttock), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity, Rash
Clinical narrative: Diagnosed with Shingles; Rash on left buttock; Fatigue; Headache; Nausea; Difficult to walk because of the pain; intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot; Problem sitting down because of the pain on her left buttock; Blister on left buttock; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock) and HERPES ZOSTER (Diagnosed with Shingles) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy, Pollen allergy and Allergy to molds. Concomitant products included METFORMIN, VITAMIN D3, CETIRIZINE HYDROCHLORIDE (ZYRTEC R), FLUOXETINE HYDROCHLORIDE (PROZAC), ATORVASTATIN, LISINOPRIL, FISH OIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and LEVOTHYROXINE for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock), RASH (Rash on left buttock), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 30-Apr-2021, the patient experienced HERPES ZOSTER (Diagnosed with Shingles). At the time of the report, GAIT DISTURBANCE (Difficult to walk because of the pain), PAIN IN EXTREMITY (intense sharp pain (pain scale of 7) on her buttocks that runs all the way down to her left leg, behind her left knee then on her left foot), MUSCULOSKELETAL PAIN (Problem sitting down because of the pain on her left buttock), BLISTER (Blister on left buttock), HERPES ZOSTER (Diagnosed with Shingles), RASH (Rash on left buttock), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 06-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved. Not Provided          Patient reported that she was taking concomitant medication.  Patient reported that after receiving the first dose of vaccine, she had lump in her neck which still persisted. Treatment medication included antibiotics. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-100485 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Minor rash on her arms, hand, legs, neck, back and torso) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced RASH (Minor rash on her arms, hand, legs, neck, back and torso). The patient was treated with HYDROCORTISONE (topical) for Rash, at an unspecified dose and frequency and ACRIVASTINE (BENADRYL ALLERGY RELIEF) (oral) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Minor rash on her arms, hand, legs, neck, back and torso) 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.   No concomitant medications were provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral vascular disorder
Clinical narrative: Pain in her legs; Lot of vascularity; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her legs), PERIPHERAL VASCULAR DISORDER (Lot of vascularity) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Leg pain (Patient stated that she usually has leg pains before the vaccine, doesn't have pain while moving the gastrocnemius and the vascularity reduces when getting the leg up.).    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in her legs), PERIPHERAL VASCULAR DISORDER (Lot of vascularity) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Pain in her legs), PERIPHERAL VASCULAR DISORDER (Lot of vascularity) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: administered to people after being store in the refrigerator for 30 days after being taken out of the freezer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT STORAGE ERROR (administered to people after being store in the refrigerator for 30 days after being taken out of the freezer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered to people after being store in the refrigerator for 30 days after being taken out of the freezer). At the time of the report, PRODUCT STORAGE ERROR (administered to people after being store in the refrigerator for 30 days after being taken out of the freezer) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia
Clinical narrative: Heart rate increased; Upper body ache/Lower body ache; Headache; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (increased heart rate), MYALGIA (Upper body ache/Lower body ache) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chemotherapy. Concomitant products included OLAPARIB (LYNPARZA) for Chemotherapy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced HEART RATE INCREASED (increased heart rate), MYALGIA (Upper body ache/Lower body ache) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (increased heart rate), MYALGIA (Upper body ache/Lower body ache) and HEADACHE (headache) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 3-JUN-2021,contains no newinformation.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Rash
Clinical narrative: form of dermatitis; skin rash on the neck, back and the forearms; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (form of dermatitis) and RASH (skin rash on the neck, back and the forearms) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 013L20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS], PRAVASTATIN and PLANTAGO OVATA (METAMUCIL FIBRE THERAPY) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced RASH (skin rash on the neck, back and the forearms). On 01-Apr-2021, the patient experienced DERMATITIS (form of dermatitis). The patient was treated with TRIAMCINOLONE for Itching, at an unspecified dose and frequency. At the time of the report, DERMATITIS (form of dermatitis) and RASH (skin rash on the neck, back and the forearms) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101951 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Neuralgia, Thirst
Clinical narrative: Bitterness in mouth; Nerve pain down left fingers; Nerve pain down right fingers; Extremely thirsty; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bitterness in mouth), THIRST (Extremely thirsty), NEURALGIA (Nerve pain down right fingers) and NEURALGIA (Nerve pain down left fingers) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 062B20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced THIRST (Extremely thirsty). On 19-Mar-2021, the patient experienced NEURALGIA (Nerve pain down right fingers). On 16-Apr-2021, the patient experienced NEURALGIA (Nerve pain down left fingers). On 26-Apr-2021, the patient experienced DYSGEUSIA (Bitterness in mouth). At the time of the report, DYSGEUSIA (Bitterness in mouth), THIRST (Extremely thirsty), NEURALGIA (Nerve pain down right fingers) and NEURALGIA (Nerve pain down left fingers) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   This case was linked to MOD-2021-100619 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm after the injection) 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 VACCINATION SITE PAIN (sore arm after the injection). At the time of the report, VACCINATION SITE PAIN (sore arm after the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided   This case was linked to MOD-2021-039044 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Suspected COVID-19
Clinical narrative: Dizziness; Muscle aches; Headache; I felt like a Mini Covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (I felt like a Mini Covid), DIZZINESS (Dizziness), MYALGIA (Muscle aches) and HEADACHE (Headache) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced SUSPECTED COVID-19 (I felt like a Mini Covid). On 03-May-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA (Muscle aches) and HEADACHE (Headache). At the time of the report, SUSPECTED COVID-19 (I felt like a Mini Covid), DIZZINESS (Dizziness), MYALGIA (Muscle aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dermatitis, Pruritus, Skin test
Clinical narrative: my dermatologist diagnosed me with a form of dermatitis; triamcinolone for itching; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (my dermatologist diagnosed me with a form of dermatitis) and PRURITUS (triamcinolone for itching) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) for an unknown indication.    No medical history was reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] and PRAVASTATIN for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-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 started PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]) (unknown route) at an unspecified dose. On 01-Apr-2021, the patient experienced DERMATITIS (my dermatologist diagnosed me with a form of dermatitis) and PRURITUS (triamcinolone for itching). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, DERMATITIS (my dermatologist diagnosed me with a form of dermatitis) and PRURITUS (triamcinolone for itching) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Skin test: Negative.         This case was linked to MOD-2021-101946 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: No antibodies after both doses; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (No antibodies after both doses) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (No antibodies after both doses). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (No antibodies after both doses) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: other (Negative) No antibodies after both doses.         No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Chills, Disorientation, Dizziness
Clinical narrative: stomach ache; disoriented; dizzy; very itchy arm lasted for quite; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and ABDOMINAL PAIN UPPER (stomach ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), DISORIENTATION (disoriented) and DIZZINESS (dizzy). At the time of the report, PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), DISORIENTATION (disoriented) and DIZZINESS (dizzy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, COVID-19: negative negative (Negative) negative.         no concomitant medication given no treatment provided   This case was linked to MOD21-046612, MOD21-036754, US-MODERNATX, INC.-MOD-2021-022796 (E2B Linked Report).; Sender's Comments:  MOD21-046612: MOD21-036754:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pruritus
Clinical narrative: stomach ache; disoriented; dizzy; very itchy arm lasted for quite; chills; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache) and ABDOMINAL PAIN UPPER (stomach ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), DISORIENTATION (disoriented) and DIZZINESS (dizzy). At the time of the report, PRURITUS (very itchy arm lasted for quite), CHILLS (chills), NAUSEA (nausea), HEADACHE (headache), ABDOMINAL PAIN UPPER (stomach ache), DISORIENTATION (disoriented) and DIZZINESS (dizzy) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, COVID-19: negative negative (Negative) negative.         no concomitant medication given no treatment provided   This case was linked to MOD21-046612, MOD21-036754, US-MODERNATX, INC.-MOD-2021-022796 (E2B Linked Report).; Sender's Comments:  MOD21-046612: MOD21-036754:
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Nasopharyngitis
Clinical narrative: cold; chills; This spontaneous case was reported by a  and describes the occurrence of NASOPHARYNGITIS (cold) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) 1. On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and CHILLS (chills). At the time of the report, NASOPHARYNGITIS (cold) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Ocular discomfort
Clinical narrative: began to feel pressure on and around her eyes; chills; headaches; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (began to feel pressure on and around her eyes), CHILLS (chills) and HEADACHE (headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Influenza vaccine.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced CHILLS (chills) and HEADACHE (headaches). On 10-Apr-2021, the patient experienced OCULAR DISCOMFORT (began to feel pressure on and around her eyes). At the time of the report, OCULAR DISCOMFORT (began to feel pressure on and around her eyes), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.             .   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021, No significant information was received.