chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: he woke up feeling a choking sensation; dyspnea; neck pain; falling asleep; increased secretions; Injection Site Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), NECK PAIN (neck pain), SOMNOLENCE (falling asleep) and INCREASED BRONCHIAL SECRETION (increased secretions) in a 56-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.     The patient's past medical history included Lung upper lobectomy (s/p left upper lobectomy). Previously administered products included for Neck pain: cortisone (spinal injection). Past adverse reactions to the above products included No adverse event with cortisone. Concurrent medical conditions included COPD and Lung cancer (lung cancer of unknown cell type).    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, the patient experienced CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), NECK PAIN (neck pain), SOMNOLENCE (falling asleep), INCREASED BRONCHIAL SECRETION (increased secretions) and INJECTION SITE PAIN (Injection Site Pain). The patient was treated with OXYCODONE at a dose of 1 dosage form; HYDROCODONE at a dose of 1 dosage form; LORAZEPAM at a dose of 1 dosage form and OXYGEN at a dose of 1 dosage form. At the time of the report, CHOKING SENSATION (he woke up feeling a choking sensation), DYSPNOEA (dyspnea), SOMNOLENCE (falling asleep) and INCREASED BRONCHIAL SECRETION (increased secretions) had resolved and NECK PAIN (neck pain) and INJECTION SITE PAIN (Injection Site Pain) outcome was unknown.            No concomitant medication was reported. Treatment medication included IV rehydration. Patient drank vodka with cranberry juice of unknown amount. Patient received O2 by nasal cannula.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia
Clinical narrative: felt like foggy / as soon as I took the shot I knew i got something; arm hurt immediately; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like foggy / as soon as I took the shot I knew i got something) and MYALGIA (arm hurt immediately) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like foggy / as soon as I took the shot I knew i got something) and MYALGIA (arm hurt immediately). At the time of the report, FEELING ABNORMAL (felt like foggy / as soon as I took the shot I knew i got something) and MYALGIA (arm hurt immediately) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided No treatment medications were provided   This case was linked to MOD-2021-236437 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Dizziness, Eye swelling, Feeling abnormal, Headache
Clinical narrative: DIZZINESS; Brain fog; right eye Swelling; watery eyes; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DIZZINESS), FEELING ABNORMAL (Brain fog), EYE SWELLING (right eye Swelling), LACRIMATION INCREASED (watery eyes) and PYREXIA (Low grade fever) in an adult 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 provided.  Concomitant products included SEMAGLUTIDE (OZEMPIC) for an unknown indication.   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 DIZZINESS (DIZZINESS), FEELING ABNORMAL (Brain fog), EYE SWELLING (right eye Swelling), LACRIMATION INCREASED (watery eyes), PYREXIA (Low grade fever) and HEADACHE (Headache). At the time of the report, DIZZINESS (DIZZINESS), FEELING ABNORMAL (Brain fog), EYE SWELLING (right eye Swelling), LACRIMATION INCREASED (watery eyes), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) Blood sugar high, since the vaccine injection.         No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pyrexia
Clinical narrative: DIZZINESS; Brain fog; right eye Swelling; watery eyes; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DIZZINESS), FEELING ABNORMAL (Brain fog), EYE SWELLING (right eye Swelling), LACRIMATION INCREASED (watery eyes) and PYREXIA (Low grade fever) in an adult 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 provided.  Concomitant products included SEMAGLUTIDE (OZEMPIC) for an unknown indication.   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 DIZZINESS (DIZZINESS), FEELING ABNORMAL (Brain fog), EYE SWELLING (right eye Swelling), LACRIMATION INCREASED (watery eyes), PYREXIA (Low grade fever) and HEADACHE (Headache). At the time of the report, DIZZINESS (DIZZINESS), FEELING ABNORMAL (Brain fog), EYE SWELLING (right eye Swelling), LACRIMATION INCREASED (watery eyes), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) Blood sugar high, since the vaccine injection.         No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Ear pain, Illness, Musculoskeletal stiffness, Myalgia
Clinical narrative: arm hurt /  achy; stiff arm/stiff ear; got a fever; sometimes couldn't even sip water; no energy; still feel sick; Ear achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water) and ASTHENIA (no energy) 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.     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 MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water), ASTHENIA (no energy), ILLNESS (still feel sick) and EAR PAIN (Ear achy). At the time of the report, MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water), ASTHENIA (no energy), ILLNESS (still feel sick) and EAR PAIN (Ear achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter. No concomitant information was provided by the reporter.    This case was linked to MOD-2021-236380 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pyrexia
Clinical narrative: arm hurt /  achy; stiff arm/stiff ear; got a fever; sometimes couldn't even sip water; no energy; still feel sick; Ear achy; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water) and ASTHENIA (no energy) 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.     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 MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water), ASTHENIA (no energy), ILLNESS (still feel sick) and EAR PAIN (Ear achy). At the time of the report, MYALGIA (arm hurt /  achy), MUSCULOSKELETAL STIFFNESS (stiff arm/stiff ear), PYREXIA (got a fever), OROPHARYNGEAL DISCOMFORT (sometimes couldn't even sip water), ASTHENIA (no energy), ILLNESS (still feel sick) and EAR PAIN (Ear achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter. No concomitant information was provided by the reporter.    This case was linked to MOD-2021-236380 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: The patient has not received the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient has not received the 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient has not received the 2nd 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 medications were provided. No treatment details were reported.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chronic obstructive pulmonary disease, Feeding disorder, Oxygen saturation, Productive cough
Clinical narrative: 2nd shot worse with coughing/mucus buildup; inability to eat; Went from very active to very inactive and rapid decline; COPD; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). At the time of the report, PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 99 (Inconclusive) 99. On an unknown date, Weight decreased: decreased (Low) lost lot of weight.         Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.  Patient have been in Hospice care. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-236373 (Patient Link).
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: 2nd shot worse with coughing/mucus buildup; inability to eat; Went from very active to very inactive and rapid decline; COPD; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). At the time of the report, PRODUCTIVE COUGH (2nd shot worse with coughing/mucus buildup), FEEDING DISORDER (inability to eat), ASTHENIA (Went from very active to very inactive and rapid decline) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 99 (Inconclusive) 99. On an unknown date, Weight decreased: decreased (Low) lost lot of weight.         Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.  Patient have been in Hospice care. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-236373 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by reporter.   This case was linked to MOD-2021-236555, MOD-2021-236569, MOD-2021-236580, MOD-2021-239232 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches) and CHILLS (Chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PAIN (Aches) and CHILLS (Chills). At the time of the report, PAIN (Aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided  No treatment medications were provided   This case was linked to MOD-2021-236539, MOD-2021-236569, MOD-2021-236580, MOD-2021-236580, MOD-2021-236539, MOD-2021-239232 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Gait disturbance, Nasopharyngitis, Pain in extremity, Rash
Clinical narrative: Difficulty in walking; pain in arm; Back pain; Rash; Cold; Drug effect incomplete; This spontaneous case was reported by a physician and describes the occurrence of GAIT DISTURBANCE (Difficulty in walking), PAIN IN EXTREMITY (pain in arm), BACK PAIN (Back pain), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and NASOPHARYNGITIS (Cold) in a 77-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.    Co-suspect product included non-company product ADALIMUMAB injection for Rheumatoid arthritis.    There was no reported medical history.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (Subcutaneous) 1 dosage form. On 30-Apr-2021, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete). On 22-Jun-2021, the patient experienced NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty in walking), PAIN IN EXTREMITY (pain in arm), BACK PAIN (Back pain) and RASH (Rash). At the time of the report, GAIT DISTURBANCE (Difficulty in walking) and BACK PAIN (Back pain) had resolved and PAIN IN EXTREMITY (pain in arm), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), NASOPHARYNGITIS (Cold) and RASH (Rash) had not 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 product use was not provided by the reporter. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: C
Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Therapeutic product effect incomplete
Clinical narrative: Difficulty in walking; pain in arm; Back pain; Rash; Cold; Drug effect incomplete; This spontaneous case was reported by a physician and describes the occurrence of GAIT DISTURBANCE (Difficulty in walking), PAIN IN EXTREMITY (pain in arm), BACK PAIN (Back pain), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete) and NASOPHARYNGITIS (Cold) in a 77-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.    Co-suspect product included non-company product ADALIMUMAB injection for Rheumatoid arthritis.    There was no reported medical history.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (Subcutaneous) 1 dosage form. On 30-Apr-2021, the patient experienced THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete). On 22-Jun-2021, the patient experienced NASOPHARYNGITIS (Cold). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty in walking), PAIN IN EXTREMITY (pain in arm), BACK PAIN (Back pain) and RASH (Rash). At the time of the report, GAIT DISTURBANCE (Difficulty in walking) and BACK PAIN (Back pain) had resolved and PAIN IN EXTREMITY (pain in arm), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), NASOPHARYNGITIS (Cold) and RASH (Rash) had not 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 product use was not provided by the reporter. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: C
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Aches; Chills; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (Aches) and CHILLS (Chills) 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.    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, the patient experienced PAIN (Aches) and CHILLS (Chills). At the time of the report, PAIN (Aches) and CHILLS (Chills) outcome was unknown.            No concomitant medications were used. No treatment medications were used.    This case was linked to MOD-2021-236539, MOD-2021-236555, MOD-2021-236580, MOD-2021-236580, MOD-2021-236539, MOD-2021-239232 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Vomiting
Clinical narrative: Aches; Vomiting; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches), VOMITING (Vomiting) and CHILLS (Chills) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 PAIN (Aches), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, PAIN (Aches), VOMITING (Vomiting) and CHILLS (Chills) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-236539, MOD-2021-236555, MOD-2021-236569, MOD-2021-239232 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling cold, Feeling hot, Paraesthesia, Pruritus
Clinical narrative: tingling feeling on different part of body, head , and feet; swollen all over body, knees, and elbows; red and itchy skin; red and itchy skin; feeling cold internally; hot externally; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin) and FEELING COLD (feeling cold internally) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-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 01-Mar-2021, the patient experienced PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin), FEELING COLD (feeling cold internally) and FEELING HOT (hot externally). At the time of the report, PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin), FEELING COLD (feeling cold internally) and FEELING HOT (hot externally) had resolved. Not Provided          The patient reported that her reactions to the second vaccine were much like the first. The caller reported three separate episodes of these set of symptoms occurring on 01Mar2021, an unknown date, and again on 22Apr2021. After the onset of symptoms she stated that they lasted 1.5 hours.  No concomitant medication information provided. No treatment information was given. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-021416, MOD-2021-025546 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: tingling feeling on different part of body, head , and feet; swollen all over body, knees, and elbows; red and itchy skin; red and itchy skin; feeling cold internally; hot externally; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin) and FEELING COLD (feeling cold internally) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Feb-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 01-Mar-2021, the patient experienced PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin), FEELING COLD (feeling cold internally) and FEELING HOT (hot externally). At the time of the report, PARAESTHESIA (tingling feeling on different part of body, head , and feet), SWELLING (swollen all over body, knees, and elbows), ERYTHEMA (red and itchy skin), PRURITUS (red and itchy skin), FEELING COLD (feeling cold internally) and FEELING HOT (hot externally) had resolved. Not Provided          The patient reported that her reactions to the second vaccine were much like the first. The caller reported three separate episodes of these set of symptoms occurring on 01Mar2021, an unknown date, and again on 22Apr2021. After the onset of symptoms she stated that they lasted 1.5 hours.  No concomitant medication information provided. No treatment information was given. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-021416, MOD-2021-025546 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: had joint pain for 6 weeks and he still has it; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (had joint pain for 6 weeks and he still has it) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On an unknown date, the patient experienced ARTHRALGIA (had joint pain for 6 weeks and he still has it). At the time of the report, ARTHRALGIA (had joint pain for 6 weeks and he still has it) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. The medical history was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: down and out straight; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (down and out straight) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (down and out straight). At the time of the report, ADVERSE EVENT (down and out straight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-236647 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: down and out straight; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (down and out straight) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ADVERSE EVENT (down and out straight). At the time of the report, ADVERSE EVENT (down and out straight) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-236634 (Patient Link).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID-19 Virus test Positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 Virus test Positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 Virus test Positive). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 Virus test Positive) outcome was unknown.            No ongoing treatments provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: caller's wife has a cold but is scheduled for her second dose today; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (caller's wife has a cold but is scheduled for her second dose today) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (caller's wife has a cold but is scheduled for her second dose today). At the time of the report, NASOPHARYNGITIS (caller's wife has a cold but is scheduled for her second dose today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient wife has scheduled for her second dose and wanted to know if she can still receive her second dose of Moderna as she has cold. When agent asked about further information to file AE caller became angry and did not provide any information about it. Caller denied consent for safety follow up.  No treatment drugs were reported. No concomitant drugs were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Pain, Sensitive skin
Clinical narrative: very sensitive skin starting at her belly button going around; few days later she started having pain; after her second dose she felt a little tired; felt cold; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (very sensitive skin starting at her belly button going around), FEELING COLD (felt cold), PAIN (few days later she started having pain) and FATIGUE (after her second dose she felt a little tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced FEELING COLD (felt cold) and FATIGUE (after her second dose she felt a little tired). On 05-May-2021, the patient experienced SENSITIVE SKIN (very sensitive skin starting at her belly button going around) and PAIN (few days later she started having pain). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 04-May-2021, FEELING COLD (felt cold) and FATIGUE (after her second dose she felt a little tired) had resolved. At the time of the report, SENSITIVE SKIN (very sensitive skin starting at her belly button going around) and PAIN (few days later she started having pain) outcome was unknown.            No concomitant medication was reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Pain
Clinical narrative: Sick for six weeks with joint with all kinds of pain; all kinds of pain; joint with all kinds of pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for six weeks with joint with all kinds of pain), PAIN (all kinds of pain) and ARTHRALGIA (joint with all kinds of pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for six weeks with joint with all kinds of pain), PAIN (all kinds of pain) and ARTHRALGIA (joint with all kinds of pain). At the time of the report, ILLNESS (Sick for six weeks with joint with all kinds of pain), PAIN (all kinds of pain) and ARTHRALGIA (joint with all kinds of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided. Patient stated that he had taken Pfizer Biontech COVID -19 vaccine and experienced Adverse events for Pfizer vaccine.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: TCR  form received and it contains No New Information
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear pain, Fatigue, Headache, Lacrimation increased
Clinical narrative: Fatigue; short of breath; body ache; headache pressure; red watering eyes; sharp ear pain; Runny nose; red watering eyes/poor circulation; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), DYSPNOEA (short of breath) and LACRIMATION INCREASED (red watering eyes) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049Cz1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), LACRIMATION INCREASED (red watering eyes) and HEADACHE (headache pressure). On 23-Jun-2021, the patient experienced MYALGIA (body ache). On 24-Jun-2021, the patient experienced DYSPNOEA (short of breath). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) from 22-Jun-2021 to 23-Jun-2021 at a dose of UNK, bid. On 22-Jun-2021, HEADACHE (headache pressure) had resolved. At the time of the report, EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), DYSPNOEA (short of breath), LACRIMATION INCREASED (red watering eyes), MYALGIA (body ache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication  was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Ocular hyperaemia, Rhinorrhoea
Clinical narrative: Fatigue; short of breath; body ache; headache pressure; red watering eyes; sharp ear pain; Runny nose; red watering eyes/poor circulation; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), DYSPNOEA (short of breath) and LACRIMATION INCREASED (red watering eyes) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049Cz1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), LACRIMATION INCREASED (red watering eyes) and HEADACHE (headache pressure). On 23-Jun-2021, the patient experienced MYALGIA (body ache). On 24-Jun-2021, the patient experienced DYSPNOEA (short of breath). On an unknown date, the patient experienced FATIGUE (Fatigue). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) from 22-Jun-2021 to 23-Jun-2021 at a dose of UNK, bid. On 22-Jun-2021, HEADACHE (headache pressure) had resolved. At the time of the report, EAR PAIN (sharp ear pain), RHINORRHOEA (Runny nose), OCULAR HYPERAEMIA (red watering eyes/poor circulation), DYSPNOEA (short of breath), LACRIMATION INCREASED (red watering eyes), MYALGIA (body ache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication  was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Magnet gets stock at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Magnet gets stock at the vaccination site) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Magnet gets stock at the vaccination site). At the time of the report, VACCINATION SITE REACTION (Magnet gets stock at the vaccination site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MODERNATX, INC.-MOD-2021-225861, MODERNATX, INC.-MOD-2021-225944, MODERNATX, INC.-MOD-2021-225807 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-225861:Same reporter MODERNATX, INC.-MOD-2021-225944:Same reporter MODERNATX, INC.-MOD-2021-225807:Same reporter
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: stiff neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck) and HEADACHE (headache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder.    On 25-Jun-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 MUSCULOSKELETAL STIFFNESS (stiff neck) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) had not resolved and HEADACHE (headache) had resolved.            No Treatment was provided  No concomitant medication was provided   This case was linked to MOD-2021-044827, MOD-2021-044827 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J2014) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of 600 mg. On 25-Dec-2020, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported.    This case was linked to MOD-2021-013927 (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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleepy; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and FATIGUE (Very tired) 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 11-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and FATIGUE (Very tired). At the time of the report, SOMNOLENCE (sleepy) and FATIGUE (Very tired) outcome was unknown.            No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-008796 (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 event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: Dizzy; Weakness; Arm still hurts; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weakness) and PAIN IN EXTREMITY (Arm still hurts) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031BZ1B and 011AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy, Latex allergy, Penicillin allergy, Allergy to antibiotic, Lupus syndrome, Blood pressure high and Diabetes. Concomitant products included AMLODIPINE BESYLATE, ATORVASTATIN, HYDROCHLOROTHIAZIDE and LOSARTAN for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weakness) and PAIN IN EXTREMITY (Arm still hurts). At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weakness) and PAIN IN EXTREMITY (Arm still hurts) had not resolved.            No treatment medication was provided by reporter.    This case was linked to MOD-2021-038708 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Tiredness; Headache; Body aches; Sore at injection site; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore at injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnant.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-Aug-2020 and the estimated date of delivery was 30-Apr-2021. On an unknown date, the patient experienced FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore at injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Body aches) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.            Patient  have not been able to note if there is any change to her period she is not menstruating and still 7 weeks  postpartum..  No negative effect has been noted with patient's recently born child. The baby was born after the first dose and 4 days before the second dose.  No concomitant medication reported. No treatment information reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-068456 (Patient Link).