chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Rhinorrhoea, Sneezing
Clinical narrative: Not feeling so well; Runny noses; Doesn't have energies; Sneezes a lot; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling so well), RHINORRHOEA (Runny noses), ASTHENIA (Doesn't have energies), SNEEZING (Sneezes a lot) and HEADACHE (Head ache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling so well), RHINORRHOEA (Runny noses), ASTHENIA (Doesn't have energies), SNEEZING (Sneezes a lot) and HEADACHE (Head ache). At the time of the report, MALAISE (Not feeling so well), RHINORRHOEA (Runny noses), ASTHENIA (Doesn't have energies), SNEEZING (Sneezes a lot) and HEADACHE (Head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided.  No treatment medications was provided.   This case was linked to MOD-2021-294340 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Very mild shoulder pain (1st dose); This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Very mild shoulder pain (1st dose)) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid cancer (The patient had thyroid cancer 45 years ago.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (Very mild shoulder pain (1st dose)). On 11-Feb-2021, ARTHRALGIA (Very mild shoulder pain (1st dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-294416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up information was received include no new information.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Upset stomach; Inappropriate scheduled of vaccine administered; Severe fatigue; Headache; Severe muscle pain; Sore injection site left  arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered), FATIGUE (Severe fatigue), HEADACHE (Headache) and MYALGIA (Severe muscle pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21 and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered), FATIGUE (Severe fatigue), HEADACHE (Headache), MYALGIA (Severe muscle pain) and VACCINATION SITE PAIN (Sore injection site left  arm). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), FATIGUE (Severe fatigue), HEADACHE (Headache), MYALGIA (Severe muscle pain) and VACCINATION SITE PAIN (Sore injection site left  arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) had resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Upset stomach; Inappropriate scheduled of vaccine administered; Severe fatigue; Headache; Severe muscle pain; Sore injection site left  arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered), FATIGUE (Severe fatigue), HEADACHE (Headache) and MYALGIA (Severe muscle pain) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21 and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered), FATIGUE (Severe fatigue), HEADACHE (Headache), MYALGIA (Severe muscle pain) and VACCINATION SITE PAIN (Sore injection site left  arm). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), FATIGUE (Severe fatigue), HEADACHE (Headache), MYALGIA (Severe muscle pain) and VACCINATION SITE PAIN (Sore injection site left  arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate scheduled of vaccine administered) had resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swelled up like balloon/lips swollen like balloons/they were worse) and HEADACHE (really bad headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-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 LIP SWELLING (lips swelled up like balloon/lips swollen like balloons/they were worse) and HEADACHE (really bad headache). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Heartburn and Inflammation, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (lips swelled up like balloon/lips swollen like balloons/they were worse) and HEADACHE (really bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was referred to ER where she was treated in the emergency room on 22-august-2021.  Relevant concomitant medications were not provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint swelling, Mobility decreased
Clinical narrative: swelling of both wrists; difficult for him to make a fist; difficult for me to make a fist; headache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swelling of both wrists), MOBILITY DECREASED (difficult for him to make a fist), ARTHRALGIA (difficult for me to make a fist) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (Had been treated with prednisone.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (swelling of both wrists), MOBILITY DECREASED (difficult for him to make a fist), ARTHRALGIA (difficult for me to make a fist) and HEADACHE (headache). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 month. At the time of the report, JOINT SWELLING (swelling of both wrists), MOBILITY DECREASED (difficult for him to make a fist) and ARTHRALGIA (difficult for me to make a fist) was resolving and HEADACHE (headache) outcome was unknown.            Concomitant product was not provided by the reporter.   This case was linked to MOD-2021-294353 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Erythema, Fall, Hypokinesia, Wheezing
Clinical narrative: My arm is red; having arthritis in the arms and legs; I couldn't get up from the bed, my legs and arms couldn't move; feeling a little whizzy; I fall in my family room and couldn't get up; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (feeling a little whizzy), HYPOKINESIA (I couldn't get up from the bed, my legs and arms couldn't move), ERYTHEMA (My arm is red), FALL (I fall in my family room and couldn't get up) and ARTHRITIS (having arthritis in the arms and legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included HYDROXYCARBAMIDE (HYDROXYUREA), PRAVASTATIN, DOXEPIN and LEVOTHYROXINE for an unknown indication.    On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced WHEEZING (feeling a little whizzy) and FALL (I fall in my family room and couldn't get up). On 22-Aug-2021, the patient experienced HYPOKINESIA (I couldn't get up from the bed, my legs and arms couldn't move). On an unknown date, the patient experienced ERYTHEMA (My arm is red) and ARTHRITIS (having arthritis in the arms and legs). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, WHEEZING (feeling a little whizzy), HYPOKINESIA (I couldn't get up from the bed, my legs and arms couldn't move), ERYTHEMA (My arm is red), FALL (I fall in my family room and couldn't get up) and ARTHRITIS (having arthritis in the arms and legs) outcome was unknown.            Patient was taking an unspecified medication for arthritis.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: muscle cramps in her both feet/left leg had horrible cramp up to her calf which lasted almost 5 minutes; left arm was very sore for a day; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps in her both feet/left leg had horrible cramp up to her calf which lasted almost 5 minutes) and MYALGIA (left arm was very sore for a day) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ATORVASTATIN, LEVOTHYROXINE and OLMESARTAN for an unknown indication.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced MUSCLE SPASMS (muscle cramps in her both feet/left leg had horrible cramp up to her calf which lasted almost 5 minutes) and MYALGIA (left arm was very sore for a day). At the time of the report, MUSCLE SPASMS (muscle cramps in her both feet/left leg had horrible cramp up to her calf which lasted almost 5 minutes) and MYALGIA (left arm was very sore for a day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided by the reporter
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia
Clinical narrative: Weak  left Arm after second vaccine; Sore left Arm after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weak  left Arm after second vaccine) and MYALGIA (Sore left Arm after second vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 030M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced MUSCULAR WEAKNESS (Weak  left Arm after second vaccine) and MYALGIA (Sore left Arm after second vaccine). At the time of the report, MUSCULAR WEAKNESS (Weak  left Arm after second vaccine) and MYALGIA (Sore left Arm after second vaccine) outcome was unknown.            No concomitant medications were provided by reporter. No treatment details were provided by reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Allergic reaction; Received his booster, third shot; Feels like he is "sick with the flu"; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like he is "sick with the flu"), HYPERSENSITIVITY (Allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his booster, third shot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like he is "sick with the flu"). 17-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his booster, third shot). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like he is "sick with the flu"), HYPERSENSITIVITY (Allergic reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received his booster, third shot) outcome was unknown.            No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Tinnitus
Clinical narrative: Buzzing in my head like when I have a fever; Very mild shoulder pain again (2nd dose); This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Buzzing in my head like when I have a fever) and ARTHRALGIA (Very mild shoulder pain again (2nd dose)) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid cancer (Thyroid cancer 45 years ago.).   On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced TINNITUS (Buzzing in my head like when I have a fever) and ARTHRALGIA (Very mild shoulder pain again (2nd dose)). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 18-Mar-2021, TINNITUS (Buzzing in my head like when I have a fever) and ARTHRALGIA (Very mild shoulder pain again (2nd dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.   This case was linked to MOD-2021-294380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Non-significant follow up received.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus was exacerbated after the first dose, got tinnitus in left ear/Had tinnitus generally but has been exacerbated after the vaccine/Still pretty intense; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus was exacerbated after the first dose, got tinnitus in left ear/Had tinnitus generally but has been exacerbated after the vaccine/Still pretty intense) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 045B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Tinnitus was exacerbated after the first dose, got tinnitus in left ear/Had tinnitus generally but has been exacerbated after the vaccine/Still pretty intense). At the time of the report, TINNITUS (Tinnitus was exacerbated after the first dose, got tinnitus in left ear/Had tinnitus generally but has been exacerbated after the vaccine/Still pretty intense) had not resolved.            No concomitant products were reported.  The patient reported that about three days after the first dose of the vaccine her tinnitus got worse only in left ear. She had tinnitus generally but has been exacerbated after the vaccine. She saw health care professional and was told this should go away after three months and it had not, it was still pretty intense.  No treatment information provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Fatigue, Feeling abnormal, Oral herpes
Clinical narrative: Started not felling good; Blisters on face; Cold sores/Fever bilisters; Redness legs/Redness feet; Swelling legs/Swelling feet; Achy; Tired; Felt feverish, but no fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet) and PERIPHERAL SWELLING (Swelling legs/Swelling feet) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (Achy), FATIGUE (Tired) and PYREXIA (Felt feverish, but no fever). On 21-Aug-2021, the patient experienced FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet) and PERIPHERAL SWELLING (Swelling legs/Swelling feet). The patient was treated with IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet), PERIPHERAL SWELLING (Swelling legs/Swelling feet), PAIN (Achy), FATIGUE (Tired) and PYREXIA (Felt feverish, but no fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include steroid and anti-viral medication.  Concomitant medication was not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia
Clinical narrative: Started not felling good; Blisters on face; Cold sores/Fever bilisters; Redness legs/Redness feet; Swelling legs/Swelling feet; Achy; Tired; Felt feverish, but no fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet) and PERIPHERAL SWELLING (Swelling legs/Swelling feet) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced PAIN (Achy), FATIGUE (Tired) and PYREXIA (Felt feverish, but no fever). On 21-Aug-2021, the patient experienced FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet) and PERIPHERAL SWELLING (Swelling legs/Swelling feet). The patient was treated with IBUPROFEN (MOTRIN IB) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Started not felling good), BLISTER (Blisters on face), ORAL HERPES (Cold sores/Fever bilisters), ERYTHEMA (Redness legs/Redness feet), PERIPHERAL SWELLING (Swelling legs/Swelling feet), PAIN (Achy), FATIGUE (Tired) and PYREXIA (Felt feverish, but no fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include steroid and anti-viral medication.  Concomitant medication was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Felt weak; Achy legs; Felt a little short of breath; Felt lightheaded; Headache/head hurt; Sore left arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded) and HEADACHE (Headache/head hurt) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CLOZAPINE and ALPRAZOLAM (ALPLAX) for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded), HEADACHE (Headache/head hurt), MYALGIA (Sore left arm) and FATIGUE (Felt tired). At the time of the report, ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded), HEADACHE (Headache/head hurt), MYALGIA (Sore left arm) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported Patient was scheduled to get the second dose on 27Aug2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Felt weak; Achy legs; Felt a little short of breath; Felt lightheaded; Headache/head hurt; Sore left arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded) and HEADACHE (Headache/head hurt) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CLOZAPINE and ALPRAZOLAM (ALPLAX) for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded), HEADACHE (Headache/head hurt), MYALGIA (Sore left arm) and FATIGUE (Felt tired). At the time of the report, ASTHENIA (Felt weak), PAIN IN EXTREMITY (Achy legs), DYSPNOEA (Felt a little short of breath), DIZZINESS (Felt lightheaded), HEADACHE (Headache/head hurt), MYALGIA (Sore left arm) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported Patient was scheduled to get the second dose on 27Aug2021.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nervous system disorder, Pruritus, Rash
Clinical narrative: COVID arm; it's itchy; blurry vision; feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy; it's affecting his neurological; a big rash on his arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy) and NERVOUS SYSTEM DISORDER (it's affecting his neurological) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Received the monoclonal antibody drip treatment) in March 2021.    On 11-Aug-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 VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy), NERVOUS SYSTEM DISORDER (it's affecting his neurological), RASH (a big rash on his arm) and FATIGUE (tiredness). At the time of the report, VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy), NERVOUS SYSTEM DISORDER (it's affecting his neurological), RASH (a big rash on his arm) and FATIGUE (tiredness) 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.   No concomitant medication was reported.                   No treatment medication was reported.   This case was linked to MOD-2021-294319 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vision blurred
Clinical narrative: COVID arm; it's itchy; blurry vision; feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy; it's affecting his neurological; a big rash on his arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy) and NERVOUS SYSTEM DISORDER (it's affecting his neurological) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Received the monoclonal antibody drip treatment) in March 2021.    On 11-Aug-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 VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy), NERVOUS SYSTEM DISORDER (it's affecting his neurological), RASH (a big rash on his arm) and FATIGUE (tiredness). At the time of the report, VACCINATION COMPLICATION (COVID arm), PRURITUS (it's itchy), VISION BLURRED (blurry vision), FEELING ABNORMAL (feeling of weirdness in husband's calves/his calves feel different / brain fog / not feeling normal/it's driving him crazy), NERVOUS SYSTEM DISORDER (it's affecting his neurological), RASH (a big rash on his arm) and FATIGUE (tiredness) 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.   No concomitant medication was reported.                   No treatment medication was reported.   This case was linked to MOD-2021-294319 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It's been more than 36 days since caller received the first dose of the vaccine and still does not have the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been more than 36 days since caller received the first dose of the vaccine and still does not have the second) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been more than 36 days since caller received the first dose of the vaccine and still does not have the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It's been more than 36 days since caller received the first dose of the vaccine and still does not have the second) outcome was unknown.            Patient got a surgery scheduled after the first dose. Her doctor advised not to take the second dose at the time.  No concomitant medications were reported.  No treatment information was provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Mobility decreased, Musculoskeletal discomfort, Shoulder injury related to vaccine administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (the second dose caused SIRVA), ASTHENIA (loss of strength), MOBILITY DECREASED (drastically reduced range of motion), MUSCULOSKELETAL DISCOMFORT (how to get his shoulder back to where it used to be) and ARTHRALGIA (pain) in a 67-year-old male patient 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 Blood pressure abnormal. Concomitant products included LOSARTAN and ATORVASTATIN for Blood pressure abnormal.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (SIRVA is an improperly placed vaccination, instead of it going into the muscle, it went into his joint, the fluid filled sac around the joint.). In 2021, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (the second dose caused SIRVA), ASTHENIA (loss of strength), MOBILITY DECREASED (drastically reduced range of motion), MUSCULOSKELETAL DISCOMFORT (how to get his shoulder back to where it used to be) and ARTHRALGIA (pain). On 04-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (SIRVA is an improperly placed vaccination, instead of it going into the muscle, it went into his joint, the fluid filled sac around the joint.) had resolved. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (the second dose caused SIRVA), ASTHENIA (loss of strength), MOBILITY DECREASED (drastically reduced range of motion), MUSCULOSKELETAL DISCOMFORT (how to get his shoulder back to where it used to be) and ARTHRALGIA (pain) outcome was unknown.            The treatment history was not provided. Patient sent for MRI scan on a unknown date in which the results are inconclusive.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (the second dose caused SIRVA), ASTHENIA (loss of strength), MOBILITY DECREASED (drastically reduced range of motion), MUSCULOSKELETAL DISCOMFORT (how to get his shoulder back to where it used to be) and ARTHRALGIA (pain) in a 67-year-old male patient 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 Blood pressure abnormal. Concomitant products included LOSARTAN and ATORVASTATIN for Blood pressure abnormal.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-articular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (SIRVA is an improperly placed vaccination, instead of it going into the muscle, it went into his joint, the fluid filled sac around the joint.). In 2021, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (the second dose caused SIRVA), ASTHENIA (loss of strength), MOBILITY DECREASED (drastically reduced range of motion), MUSCULOSKELETAL DISCOMFORT (how to get his shoulder back to where it used to be) and ARTHRALGIA (pain). On 04-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (SIRVA is an improperly placed vaccination, instead of it going into the muscle, it went into his joint, the fluid filled sac around the joint.) had resolved. At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (the second dose caused SIRVA), ASTHENIA (loss of strength), MOBILITY DECREASED (drastically reduced range of motion), MUSCULOSKELETAL DISCOMFORT (how to get his shoulder back to where it used to be) and ARTHRALGIA (pain) outcome was unknown.            The treatment history was not provided. Patient sent for MRI scan on a unknown date in which the results are inconclusive.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site erythema
Clinical narrative: A round red patch at the injection site; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (A round red patch at the injection site) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy ) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gestational diabetes. Concomitant products included INSULIN for Gestational diabetes, IRON for Iron supplementation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Oct-2020 and the estimated date of delivery was 30-Aug-2021. On 06-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy ). On 12-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (A round red patch at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fortieth week of the pregnancy.  On 06-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy ) had resolved. On 13-Aug-2021, VACCINATION SITE ERYTHEMA (A round red patch at the injection 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 also includes nighty insulin, Novolin for gestational diabetes.  Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Rash pruritic, Skin warm
Clinical narrative: Itcy,rash; Rash got worse , almost all his back and legs; Warm  to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itcy,rash), CONDITION AGGRAVATED (Rash got worse , almost all his back and legs) and SKIN WARM (Warm  to the touch) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included SERTRALINE, ATORVASTATIN, OLANZAPINE, CLONIDINE HYDROCHLORIDE (CLONIDINE [CLONIDINE HYDROCHLORIDE]) and CARVEDILOL for an unknown indication.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced RASH PRURITIC (Itcy,rash), CONDITION AGGRAVATED (Rash got worse , almost all his back and legs) and SKIN WARM (Warm  to the touch). The patient was treated with ECONAZOLE NITRATE (topical) at a dose of 1 percent and FLUOCINONIDE (FLUCINONIDE) at a dose of 0.5 percent. At the time of the report, RASH PRURITIC (Itcy,rash) had not resolved and CONDITION AGGRAVATED (Rash got worse , almost all his back and legs) and SKIN WARM (Warm  to the touch) outcome was unknown.            Patient took the supplements as a concomitant.   This case was linked to MOD-2021-294479 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Wrong schedule
Clinical narrative: Extended time since first dose; shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) and WRONG SCHEDULE (Extended time since first dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced WRONG SCHEDULE (Extended time since first dose). At the time of the report, HERPES ZOSTER (shingles) and WRONG SCHEDULE (Extended time since first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported being treated with antivirals for 10 days. Patient took vitamins daily.It was unknown if patient received second dose.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was reported No concomitant medications were provided by the reporter. The caller stated that she will have her sister call moderna if she did receive moderna vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Cold urticaria, Dizziness, Feeling abnormal
Clinical narrative: Faint; Spinal pain; Arthritis; Freezing rash around mouth; Dizzy; Feeling of shock happening; Sweating; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), SPINAL PAIN (Spinal pain), ARTHRITIS (Arthritis), COLD URTICARIA (Freezing rash around mouth), DIZZINESS (Dizzy), FEELING ABNORMAL (Feeling of shock happening), HYPERHIDROSIS (Sweating) and PAIN IN EXTREMITY (Sore arm). In June 2021, SYNCOPE (Faint), SPINAL PAIN (Spinal pain), ARTHRITIS (Arthritis), COLD URTICARIA (Freezing rash around mouth), DIZZINESS (Dizzy), FEELING ABNORMAL (Feeling of shock happening), HYPERHIDROSIS (Sweating) and PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 96 (Low) low. On 27-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The concomitant medications were not reported. The treatment information was not provided.  Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-294546 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain in extremity, SARS-CoV-2 test, Spinal pain, Syncope
Clinical narrative: Faint; Spinal pain; Arthritis; Freezing rash around mouth; Dizzy; Feeling of shock happening; Sweating; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), SPINAL PAIN (Spinal pain), ARTHRITIS (Arthritis), COLD URTICARIA (Freezing rash around mouth), DIZZINESS (Dizzy), FEELING ABNORMAL (Feeling of shock happening), HYPERHIDROSIS (Sweating) and PAIN IN EXTREMITY (Sore arm). In June 2021, SYNCOPE (Faint), SPINAL PAIN (Spinal pain), ARTHRITIS (Arthritis), COLD URTICARIA (Freezing rash around mouth), DIZZINESS (Dizzy), FEELING ABNORMAL (Feeling of shock happening), HYPERHIDROSIS (Sweating) and PAIN IN EXTREMITY (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Body temperature: 96 (Low) low. On 27-May-2021, SARS-CoV-2 test: negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The concomitant medications were not reported. The treatment information was not provided.  Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-294546 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue after 1st and 2nd dose; Headaches after 1st and 2nd dose; Soreness at injection site after 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 1st and 2nd dose), HEADACHE (Headaches after 1st and 2nd dose) and VACCINATION SITE PAIN (Soreness at injection site after 1st and 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included CALCIUM for COVID-19 vaccination, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S), GABAPENTIN and ESZOPICLONE (LUNESTA) for an unknown indication.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue after 1st and 2nd dose), HEADACHE (Headaches after 1st and 2nd dose) and VACCINATION SITE PAIN (Soreness at injection site after 1st and 2nd dose). At the time of the report, FATIGUE (Fatigue after 1st and 2nd dose), HEADACHE (Headaches after 1st and 2nd dose) and VACCINATION SITE PAIN (Soreness at injection site after 1st and 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. The patient was on multivitamin/calcium   This case was linked to MOD-2021-294485, MOD-2021-294441 (Patient Link).