chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Hypersensitivity, Peripheral swelling, Visual impairment
Clinical narrative: " bad reaction to the first injection of Moderna"; "left arm was swollen"; "Hot"; "I felt like the wind was taken out of me"; "Bedridden"; "Chills"; "Diarrhea"; "the most distressing part, my eyes is not what they were prior receiving the injection"; "I use glasses to read and another to watch tv.; "I had script, and never had to use"; "I didn't know vision could go."; "more energetic"; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me") and BEDRIDDEN ("Bedridden") in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A,031MZ0A,031MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included SARS (Had SARS in 2003). Concomitant products included BROMAZEPAM (LECTOPAM) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me"), BEDRIDDEN ("Bedridden"), CHILLS ("Chills"), DIARRHOEA ("Diarrhea"), EYE DISORDER ("the most distressing part, my eyes is not what they were prior receiving the injection"), EYE DISORDER ("I use glasses to read and another to watch tv.), FEELING ABNORMAL ("I had script, and never had to use"), VISUAL IMPAIRMENT ("I didn't know vision could go.") and ENERGY INCREASED ("more energetic"). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg,daily for 1 week. At the time of the report, HYPERSENSITIVITY (" bad reaction to the first injection of Moderna"), PERIPHERAL SWELLING ("left arm was swollen"), FEELING HOT ("Hot"), FEELING ABNORMAL ("I felt like the wind was taken out of me"), BEDRIDDEN ("Bedridden"), CHILLS ("Chills"), DIARRHOEA ("Diarrhea"), EYE DISORDER ("the most distressing part, my eyes is not what they were prior receiving the injection"), EYE DISORDER ("I use glasses to read and another to watch tv.), FEELING ABNORMAL ("I had script, and never had to use"), VISUAL IMPAIRMENT ("I didn't know vision could go.") and ENERGY INCREASED ("more energetic") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medication was Tylenol 500mg Included.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Pain, Tenderness
Clinical narrative: Felt cruddy; Body aches; Chills; Tiredness; Arm  tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt cruddy), PAIN (Body aches), CHILLS (Chills), FATIGUE (Tiredness) and TENDERNESS (Arm  tenderness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 17-Mar-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (Felt cruddy), PAIN (Body aches), CHILLS (Chills), FATIGUE (Tiredness) and TENDERNESS (Arm  tenderness). On 21-Mar-2021, ILLNESS (Felt cruddy), PAIN (Body aches), CHILLS (Chills), FATIGUE (Tiredness) and TENDERNESS (Arm  tenderness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking allergy shots. Patient wanted to know if she could take Ibuprofen or Tylenol.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Movement disorder, Myalgia
Clinical narrative: could not raise left arm; fluish; achy; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (could not raise left arm), INFLUENZA LIKE ILLNESS (fluish), MYALGIA (achy), FATIGUE (fatigue) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MOVEMENT DISORDER (could not raise left arm), INFLUENZA LIKE ILLNESS (fluish), MYALGIA (achy), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Mar-2021, MOVEMENT DISORDER (could not raise left arm), INFLUENZA LIKE ILLNESS (fluish), MYALGIA (achy), FATIGUE (fatigue) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   This case was linked to MOD-2021-225377 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Additional information received on 11-May-2021. Rechallenge details and events outcome was updated.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Oral pain, Paraesthesia
Clinical narrative: Swollen part in the mouth; Tingling part in the mouth; Hurts in small part of side in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (Swollen part in the mouth), PARAESTHESIA (Tingling part in the mouth) and ORAL PAIN (Hurts in small part of side in the mouth) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MOUTH SWELLING (Swollen part in the mouth), PARAESTHESIA (Tingling part in the mouth) and ORAL PAIN (Hurts in small part of side in the mouth). At the time of the report, MOUTH SWELLING (Swollen part in the mouth), PARAESTHESIA (Tingling part in the mouth) and ORAL PAIN (Hurts in small part of side in the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Patient had taken Diphenhydramine for the event.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Gait disturbance, Insomnia, Myalgia
Clinical narrative: Lose his strength; Difficulty sleeping due to pain; Difficult to walk and get out of bed; Very little appetite; Muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lose his strength), INSOMNIA (Difficulty sleeping due to pain), GAIT DISTURBANCE (Difficult to walk and get out of bed), DECREASED APPETITE (Very little appetite) and MYALGIA (Muscle aches and pains) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Drug resistance (Not responding to medicines or medicines making him sick.). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), PARACETAMOL (TYLENOL) and LOVASTATIN for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ASTHENIA (Lose his strength). 15-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping due to pain), GAIT DISTURBANCE (Difficult to walk and get out of bed), DECREASED APPETITE (Very little appetite) and MYALGIA (Muscle aches and pains). At the time of the report, ASTHENIA (Lose his strength), INSOMNIA (Difficulty sleeping due to pain), GAIT DISTURBANCE (Difficult to walk and get out of bed), DECREASED APPETITE (Very little appetite) and MYALGIA (Muscle aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .Concomitant medication including antifungal for toenail fungus was reported. Treatment using couple of shots that provided by the HCP that did not helped  was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure fluctuation, Blood pressure measurement, Chest pain, Cold sweat
Clinical narrative: Chest Pain; Acid Reflux; Weakness; Severe pain under ribcage; Clammy; Warm; Large blood pressure variations going as high 203/98 at peak; Aching; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage) and COLD SWEAT (Clammy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure fluctuation (Patient had blood pressure instability issue . Patient had been "in and out" of the emergency room  in the past.).    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. On 20-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, CHEST PAIN (Chest Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 203/98 (High) Large blood pressure variations going as high 203/98 at peak.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Vitamins and supplements was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gastrooesophageal reflux disease, Headache, Musculoskeletal chest pain, Myalgia
Clinical narrative: Chest Pain; Acid Reflux; Weakness; Severe pain under ribcage; Clammy; Warm; Large blood pressure variations going as high 203/98 at peak; Aching; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage) and COLD SWEAT (Clammy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure fluctuation (Patient had blood pressure instability issue . Patient had been "in and out" of the emergency room  in the past.).    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. On 20-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, CHEST PAIN (Chest Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 203/98 (High) Large blood pressure variations going as high 203/98 at peak.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Vitamins and supplements was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Chest Pain; Acid Reflux; Weakness; Severe pain under ribcage; Clammy; Warm; Large blood pressure variations going as high 203/98 at peak; Aching; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage) and COLD SWEAT (Clammy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure fluctuation (Patient had blood pressure instability issue . Patient had been "in and out" of the emergency room  in the past.).    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. On 20-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, CHEST PAIN (Chest Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 203/98 (High) Large blood pressure variations going as high 203/98 at peak.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Vitamins and supplements was reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: Going from hot to cold; Fever; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Going from hot to cold), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced CHILLS (Chills). On 14-Mar-2021, the patient experienced NASOPHARYNGITIS (Going from hot to cold). 14-Mar-2021, the patient experienced PYREXIA (Fever). 14-Mar-2021, the patient experienced HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Going from hot to cold), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: Her arm was black and blue and swollen; Her arm was black and blue and swollen; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Her arm was black and blue and swollen) and PERIPHERAL SWELLING (Her arm was black and blue and swollen) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced SKIN DISCOLOURATION (Her arm was black and blue and swollen) and PERIPHERAL SWELLING (Her arm was black and blue and swollen). At the time of the report, SKIN DISCOLOURATION (Her arm was black and blue and swollen) and PERIPHERAL SWELLING (Her arm was black and blue and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Antibiotic was reported.  No treatment was reported in the source document.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: Really itchy; Feels fluidy like puffy inside arm; Arm has red square shape; Headache; Fever; Body aches; Very tired; Felt out of it; Felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm), FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE ERYTHEMA (Arm has red square shape) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer of bronchus stage IV (Stage 4 cancer).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Very tired). On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm has red square shape). On 22-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm) and VACCINATION SITE PRURITUS (Really itchy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 20-Mar-2021, FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE ERYTHEMA (Arm has red square shape) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.    This case was linked to MOD-2021-063795 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site erythema, Vaccination site oedema, Vaccination site pruritus
Clinical narrative: Really itchy; Feels fluidy like puffy inside arm; Arm has red square shape; Headache; Fever; Body aches; Very tired; Felt out of it; Felt sleepy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm), FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE ERYTHEMA (Arm has red square shape) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cancer of bronchus stage IV (Stage 4 cancer).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Very tired). On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm has red square shape). On 22-Mar-2021, the patient experienced VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm) and VACCINATION SITE PRURITUS (Really itchy). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 20-Mar-2021, FEELING ABNORMAL (Felt out of it), SOMNOLENCE (Felt sleepy), HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Very tired) had resolved. At the time of the report, VACCINATION SITE OEDEMA (Feels fluidy like puffy inside arm), VACCINATION SITE PRURITUS (Really itchy) and VACCINATION SITE ERYTHEMA (Arm has red square shape) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.    This case was linked to MOD-2021-063795 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (Patient on chemo since NOV2020.) in November 2020. Concurrent medical conditions included Hearing impaired (Hard of hearing).    On 28-Jan-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 PRURITUS (Itching all over the body). At the time of the report, PRURITUS (Itching all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-053350 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Joint swelling, Rash
Clinical narrative: Can barely walk now and has fell in shower since receiving vaccine; Can barely walk now and has fell in shower since receiving vaccine; Knees swollen and difficult to use; Whelps on face; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Knees swollen and difficult to use), GAIT DISTURBANCE (Can barely walk now and has fell in shower since receiving vaccine), FALL (Can barely walk now and has fell in shower since receiving vaccine) and RASH (Whelps on face) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0A8212A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease and Walker user (Used walker).   On 13-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 13-Mar-2021, the patient experienced RASH (Whelps on face). On 15-Mar-2021, the patient experienced JOINT SWELLING (Knees swollen and difficult to use). On 21-Mar-2021, the patient experienced GAIT DISTURBANCE (Can barely walk now and has fell in shower since receiving vaccine) and FALL (Can barely walk now and has fell in shower since receiving vaccine). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 15-Mar-2021, RASH (Whelps on face) had resolved. At the time of the report, JOINT SWELLING (Knees swollen and difficult to use) and GAIT DISTURBANCE (Can barely walk now and has fell in shower since receiving vaccine) had not resolved and FALL (Can barely walk now and has fell in shower since receiving vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash, Vaccination site swelling
Clinical narrative: Sore arm; Muscle was swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Muscle was swollen) and VACCINATION SITE RASH (Rash) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Muscle was swollen) and VACCINATION SITE RASH (Rash). The patient was treated with Physical therapy for Pain in extremity. On 02-Mar-2021, VACCINATION SITE SWELLING (Muscle was swollen) and VACCINATION SITE RASH (Rash) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had been doing physical therapy and daily exercises for sore arm but it has not helped.  No relevant concomitant medications were reported.   Treatment information was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Headache, Heart rate
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), DIARRHOEA (Diarrhoea), LETHARGY (Lethargic), ASTHENIA (Weakness) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced POLLAKIURIA (Frequent urination), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), LETHARGY (Lethargic) and ASTHENIA (Weakness). At the time of the report, POLLAKIURIA (Frequent urination), DIARRHOEA (Diarrhoea), LETHARGY (Lethargic), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Heart rate: elevated (High) Patient had elevated heart rate..         Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Pollakiuria, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Frequent urination), DIARRHOEA (Diarrhoea), LETHARGY (Lethargic), ASTHENIA (Weakness) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced POLLAKIURIA (Frequent urination), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 22-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea), LETHARGY (Lethargic) and ASTHENIA (Weakness). At the time of the report, POLLAKIURIA (Frequent urination), DIARRHOEA (Diarrhoea), LETHARGY (Lethargic), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Heart rate: elevated (High) Patient had elevated heart rate..         Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications were reported.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pustule, Rash pruritic
Clinical narrative: mark on the arm with sides of a quarter with pus/pus bump; Itchy rash on buttock / rash on the top of the buttocks; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on buttock / rash on the top of the buttocks) and PUSTULE (mark on the arm with sides of a quarter with pus/pus bump) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Herpes infection.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on buttock / rash on the top of the buttocks). On 25-Mar-2021, the patient experienced PUSTULE (mark on the arm with sides of a quarter with pus/pus bump). At the time of the report, RASH PRURITIC (Itchy rash on buttock / rash on the top of the buttocks) and PUSTULE (mark on the arm with sides of a quarter with pus/pus bump) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  The patient states that she was given antibiotics to treat the rash with pus on her arm and states that this event as resolved as per her follow up on 1-Jul-21.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Source doc appended On 01-Jul-2021: Significant followup appended, pictures of arm were emailed. On 24-Jul-2021: Non-significant follow-up received.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Mobility decreased
Clinical narrative: Severe Back Pain; Unable to stand from sitting position; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe Back Pain) and MOBILITY DECREASED (Unable to stand from sitting position) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2114) for COVID-19 vaccination.     The patient's past medical history included Back injury (3 years ago patients  back was injured).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced BACK PAIN (Severe Back Pain) and MOBILITY DECREASED (Unable to stand from sitting position). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Severe Back Pain) and MOBILITY DECREASED (Unable to stand from sitting position) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported.  No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Breast feeding, Vision blurred
Clinical narrative: Breastfeeding; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) and BREAST FEEDING (Breastfeeding) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported for the patient.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), MULTIVITAMINS;MINERALS, VITAMIN D [VITAMIN D NOS] and FOLIC ACID (FOLATE) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VISION BLURRED (Blurred vision). On an unknown date, the patient experienced BREAST FEEDING (Breastfeeding). At the time of the report, VISION BLURRED (Blurred vision) had not resolved and BREAST FEEDING (Breastfeeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient only notice the blurred vision when she was looking at her computer screen. She worked from home. Patient was breastfeeding. Patient took Tylenol and Ibuprofen to help with the symptoms. The symptoms was ongoing at the time of the call.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypokinesia, Nausea, Pain in extremity
Clinical narrative: arm pain; couldn't move; joint pain; nausea; headache; pain in knee and elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), HYPOKINESIA (couldn't move), ARTHRALGIA (joint pain), NAUSEA (nausea) and HEADACHE (headache) in a 72-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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), HYPOKINESIA (couldn't move), ARTHRALGIA (joint pain), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (pain in knee and elbow). On 21-Mar-2021, HYPOKINESIA (couldn't move), ARTHRALGIA (joint pain), NAUSEA (nausea), HEADACHE (headache) and ARTHRALGIA (pain in knee and elbow) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Pyrexia, Tremor
Clinical narrative: Shaking; Could not eat; Dizziness, lightheadedness; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), DECREASED APPETITE (Could not eat), DIZZINESS (Dizziness, lightheadedness) and PYREXIA (Fever of 102F) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 immunisation.     Concomitant products included INSULIN for COVID-19 vaccination, METFORMIN, PIOGLITAZONE and PRAVASTATIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced TREMOR (Shaking), DECREASED APPETITE (Could not eat), DIZZINESS (Dizziness, lightheadedness) and PYREXIA (Fever of 102F). At the time of the report, TREMOR (Shaking), DECREASED APPETITE (Could not eat), DIZZINESS (Dizziness, lightheadedness) and PYREXIA (Fever of 102F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Consumer declined further follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain in her left shoulder/sore shoulder; A spontaneous report was received from a consumer concerning an 80 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced joint pain in her left shoulder/sore shoulder/arthralgia  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number:  Batch number not provided) on 4 Feb 2021 and the patient received their second of two planned doses of mRNA-1273 (Batch number: Batch number not provided) on 11 Mar 2021, approximately one day prior to the onset of the symptoms, via an unknown route in the left arm for prophylaxis of COVID-19 infection.  On 12 Mar 2021, the patient experienced joint pain in her left shoulder/sore shoulder.  On an unspecified date patient was treated with prednisone and tramadol.  No relevant laboratory details were included.  Action taken with mRNA-1273 in response to the events was not applicable.    The outcomes of the events joint pain in her left shoulder/sore shoulder was not recovered.; Reporter'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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bed rest, Headache, Hyperhidrosis, Muscle spasms
Clinical narrative: Woke up sweating on Sunday morning; Spent most of the day in bed on Saturday; headache; muscle cramps in upper leg; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps in upper leg), ABDOMINAL PAIN UPPER (Stomach pain), BED REST (Spent most of the day in bed on Saturday), HYPERHIDROSIS (Woke up sweating on Sunday morning) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCLE SPASMS (muscle cramps in upper leg), ABDOMINAL PAIN UPPER (Stomach pain) and HEADACHE (headache). On 20-Mar-2021, the patient experienced BED REST (Spent most of the day in bed on Saturday). On 21-Mar-2021, the patient experienced HYPERHIDROSIS (Woke up sweating on Sunday morning). On 21-Mar-2021, MUSCLE SPASMS (muscle cramps in upper leg), ABDOMINAL PAIN UPPER (Stomach pain), BED REST (Spent most of the day in bed on Saturday), HYPERHIDROSIS (Woke up sweating on Sunday morning) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details pertained to the events were provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache
Clinical narrative: Feeling cold; Shaky; Dull headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Feeling cold), CHILLS (Shaky) and HEADACHE (Dull headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and ASA for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced FEELING COLD (Feeling cold), CHILLS (Shaky) and HEADACHE (Dull headache). At the time of the report, FEELING COLD (Feeling cold), CHILLS (Shaky) and HEADACHE (Dull headache) outcome was unknown. Not Provided          Concomitant medication included blood pressure medication.  Treatment medication included Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-116559 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Email address added. Newconcomitant medication (ASA) added. Action taken changed from Unknown to Not applicable.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Product dose omission issue
Clinical narrative: missed 2nd dose, and now its more than 42 days; Flu like symptoms; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed 2nd dose, and now its more than 42 days) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 02-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed 2nd dose, and now its more than 42 days). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 02-Mar-2021, PRODUCT DOSE OMISSION ISSUE (missed 2nd dose, and now its more than 42 days) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) 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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Updated information included date of birth of the patient, date of the 1st dose of the drug is given on 12-02-2021, batch number, anatomical location, new event Flu like symptoms,concomitant medications and  treatment medication.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: injection site redness; injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Food allergy, Dust allergy, Pollen allergy, Fruit allergy and Fruit allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling). At the time of the report, VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is also allergic to hay and pine.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up Information received  contains No New Information. On 15-Jul-2021: follow up received and medical history were added.Event dates and patient initial updated. Treatment details were added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial pain, Illness, Speech disorder, Swelling face
Clinical narrative: swelling of the left side of her face to the eye; electrical pain on the face that did not allow her to talk or eat; electrical pain on the face that did not allow her to talk or eat; very sick; felt really dizzy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of the left side of her face to the eye), FACIAL PAIN (electrical pain on the face that did not allow her to talk or eat), SPEECH DISORDER (electrical pain on the face that did not allow her to talk or eat), ILLNESS (very sick) and DIZZINESS (felt really dizzy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (DYE ALLERGY) and Trigeminal neuralgia.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced DIZZINESS (felt really dizzy). On an unknown date, the patient experienced SWELLING FACE (swelling of the left side of her face to the eye), FACIAL PAIN (electrical pain on the face that did not allow her to talk or eat), SPEECH DISORDER (electrical pain on the face that did not allow her to talk or eat) and ILLNESS (very sick). At the time of the report, SWELLING FACE (swelling of the left side of her face to the eye), FACIAL PAIN (electrical pain on the face that did not allow her to talk or eat), SPEECH DISORDER (electrical pain on the face that did not allow her to talk or eat) and ILLNESS (very sick) had not resolved and DIZZINESS (felt really dizzy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.