chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I got I got both the Moderna Covid-19 shots. I had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (I got I got both the Moderna Covid-19 shots. I had a sore arm) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced PAIN IN EXTREMITY (I got I got both the Moderna Covid-19 shots. I had a sore arm). At the time of the report, PAIN IN EXTREMITY (I got I got both the Moderna Covid-19 shots. I had a sore arm) outcome was unknown.            No concomitant products were reported. No treatment information provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Complained of a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Complained of a headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002521A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Complained of a headache). At the time of the report, HEADACHE (Complained of a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment information was not provided.  First Moderna Covid-19 vaccine expiration date is not provided. Patient received the Moderna Covid-19 vaccine in her left arm shoulder deltoid muscle and received her vaccine at a Pharmacy. Patient provided permission for Safety to contact her.  Patient prefered to be contacted via telephone.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Vomiting
Clinical narrative: Heavy chest tightening; Experiencing vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Heavy chest tightening) and VOMITING (Experiencing vomiting) in an 18-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 CHEST DISCOMFORT (Heavy chest tightening) and VOMITING (Experiencing vomiting). At the time of the report, CHEST DISCOMFORT (Heavy chest tightening) and VOMITING (Experiencing vomiting) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since first 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.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate abnormal, Hunger
Clinical narrative: Dizziness; Weakness; Feels hungry; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness) and HUNGER (Feels hungry) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness) and HUNGER (Feels hungry). At the time of the report, DIZZINESS (Dizziness), ASTHENIA (Weakness) and HUNGER (Feels hungry) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Heart rate abnormal: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mobility decreased, Myalgia, Vomiting
Clinical narrative: hardly can get out of bed; strong body aches; headaches; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (hardly can get out of bed), MYALGIA (strong body aches), HEADACHE (headaches) and VOMITING (Vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced MOBILITY DECREASED (hardly can get out of bed), MYALGIA (strong body aches), HEADACHE (headaches) and VOMITING (Vomiting). At the time of the report, MOBILITY DECREASED (hardly can get out of bed), MYALGIA (strong body aches), HEADACHE (headaches) and VOMITING (Vomiting) outcome was unknown.            Concomitant medications were not reported.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Intermenstrual bleeding, Malaise, Muscle spasms
Clinical narrative: had my second shot and still not feel right including cramping and dizziness; had my second shot and still not feel right including cramping and dizziness; had my second shot and still not feel right including cramping and dizziness; still spotting; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (had my second shot and still not feel right including cramping and dizziness), DIZZINESS (had my second shot and still not feel right including cramping and dizziness), MALAISE (had my second shot and still not feel right including cramping and dizziness) and INTERMENSTRUAL BLEEDING (still spotting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 MUSCLE SPASMS (had my second shot and still not feel right including cramping and dizziness), DIZZINESS (had my second shot and still not feel right including cramping and dizziness), MALAISE (had my second shot and still not feel right including cramping and dizziness) and INTERMENSTRUAL BLEEDING (still spotting). At the time of the report, MUSCLE SPASMS (had my second shot and still not feel right including cramping and dizziness), DIZZINESS (had my second shot and still not feel right including cramping and dizziness) and INTERMENSTRUAL BLEEDING (still spotting) had not resolved and MALAISE (had my second shot and still not feel right including cramping and dizziness) outcome was unknown.            The concomitant medication was not reported. The treatment history was not reported.   This case was linked to (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Myalgia
Clinical narrative: Myalgia; chest pain; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced MYALGIA (Myalgia), CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath). At the time of the report, MYALGIA (Myalgia), CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Heart rate: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Heat on left arm Injection Site after second vaccine; Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine; Redness on left arm Injection Site after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat on left arm Injection Site after second vaccine), VACCINATION SITE SWELLING (Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine) and VACCINATION SITE ERYTHEMA (Redness on left arm Injection Site after second vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Heat on left arm Injection Site after second vaccine), VACCINATION SITE SWELLING (Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine) and VACCINATION SITE ERYTHEMA (Redness on left arm Injection Site after second vaccine). At the time of the report, VACCINATION SITE WARMTH (Heat on left arm Injection Site after second vaccine), VACCINATION SITE SWELLING (Swelling on left arm Injection Site after second vaccine/Knot on left arm Injection Site after second vaccine) and VACCINATION SITE ERYTHEMA (Redness on left arm Injection Site after second vaccine) outcome was unknown.            Concomitant medication were not reported. Treatment medication were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is extremely sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is extremely sore). At the time of the report, PAIN IN EXTREMITY (Arm is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: unpunctured sitting at room temperature > 24 hours; The unpunctured vial was placed at room temperature yesterday at 3:58 pm and was administered this morning; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (unpunctured sitting at room temperature > 24 hours) and EXPIRED PRODUCT ADMINISTERED (The unpunctured vial was placed at room temperature yesterday at 3:58 pm and was administered this morning) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (unpunctured sitting at room temperature > 24 hours) and EXPIRED PRODUCT ADMINISTERED (The unpunctured vial was placed at room temperature yesterday at 3:58 pm and was administered this morning). At the time of the report, PRODUCT STORAGE ERROR (unpunctured sitting at room temperature > 24 hours) and EXPIRED PRODUCT ADMINISTERED (The unpunctured vial was placed at room temperature yesterday at 3:58 pm and was administered this morning) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant history was not reported.  The treatment details  was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Vaccination site pain
Clinical narrative: infection in her arm below the injection site; soreness at injection site/pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection in her arm below the injection site) and VACCINATION SITE PAIN (soreness at injection site/pain at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site/pain at the injection site). On 24-Apr-2021, the patient experienced INFECTION (infection in her arm below the injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 30-Apr-2021, INFECTION (infection in her arm below the injection site) had resolved. At the time of the report, VACCINATION SITE PAIN (soreness at injection site/pain at the injection site) outcome was unknown.            Concomitant medications were not reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-293234 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Generalised oedema, Swelling, Vaccination site pain
Clinical narrative: My body has edema; My body has swelling/swelling in her body; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED OEDEMA (My body has edema), SWELLING (My body has swelling/swelling in her body) and VACCINATION SITE PAIN (Sore arm) 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.    In March 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 GENERALISED OEDEMA (My body has edema), SWELLING (My body has swelling/swelling in her body) and VACCINATION SITE PAIN (Sore arm). At the time of the report, GENERALISED OEDEMA (My body has edema), SWELLING (My body has swelling/swelling in her body) and VACCINATION SITE PAIN (Sore arm) had not resolved.            The concomitant medications were not reported.  The treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: A little sick in the night; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (A little sick in the night) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (A little sick in the night). At the time of the report, ILLNESS (A little sick in the night) 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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021 at 8:25 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally gave 2 patients a second dose from vials that were expired past the 12 hours mark this morning 21Aug2021 at 8:25am (vial was open since yesterday 20Aug2021, punctured at 1:35pm)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal
Clinical narrative: 5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE ABNORMAL (5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm). At the time of the report, HEART RATE ABNORMAL (5 days after receiving my 1st Moderna covid 19 vaccine my heart bate began flucuating from as low as 55 bpm and as high as100 bpm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (abnormal) heart bate began fluctuating from as low as 55 bpm and as high as100 bpm..     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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: neighbor who is "lady down the hall, we are both very sick she has been for 7 months"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (neighbor who is "lady down the hall, we are both very sick she has been for 7 months") in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (neighbor who is "lady down the hall, we are both very sick she has been for 7 months"). At the time of the report, VACCINATION COMPLICATION (neighbor who is "lady down the hall, we are both very sick she has been for 7 months") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was provided. No Treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), HEADACHE (Headaches) and NAUSEA (Nausea) 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 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo), HEADACHE (Headaches) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Facial discomfort, Hypoaesthesia, Hypoaesthesia oral, Limb discomfort, Mouth swelling
Clinical narrative: Left side of her face felt uncomfortable; Left arm felt uncomfortable; Left side of mouth felt uncomfortable; Swelling on left side of face; Numbness on left side of face; Swelling on left side of mouth; Numbness on left side of mouth; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face) and HYPOAESTHESIA (Numbness on left side of face) in a 63-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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face), HYPOAESTHESIA (Numbness on left side of face), MOUTH SWELLING (Swelling on left side of mouth) and HYPOAESTHESIA ORAL (Numbness on left side of mouth). At the time of the report, FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face), HYPOAESTHESIA (Numbness on left side of face), MOUTH SWELLING (Swelling on left side of mouth) and HYPOAESTHESIA ORAL (Numbness on left side of mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Swelling face
Clinical narrative: Left side of her face felt uncomfortable; Left arm felt uncomfortable; Left side of mouth felt uncomfortable; Swelling on left side of face; Numbness on left side of face; Swelling on left side of mouth; Numbness on left side of mouth; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face) and HYPOAESTHESIA (Numbness on left side of face) in a 63-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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face), HYPOAESTHESIA (Numbness on left side of face), MOUTH SWELLING (Swelling on left side of mouth) and HYPOAESTHESIA ORAL (Numbness on left side of mouth). At the time of the report, FACIAL DISCOMFORT (Left side of her face felt uncomfortable), LIMB DISCOMFORT (Left arm felt uncomfortable), ORAL DISCOMFORT (Left side of mouth felt uncomfortable), SWELLING FACE (Swelling on left side of face), HYPOAESTHESIA (Numbness on left side of face), MOUTH SWELLING (Swelling on left side of mouth) and HYPOAESTHESIA ORAL (Numbness on left side of mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Insomnia, Pain, Pain in extremity
Clinical narrative: breathing very hard; could not even go to sleep; arm was also hurting; It was very sore that night; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breathing very hard), INSOMNIA (could not even go to sleep), PAIN IN EXTREMITY (arm was also hurting) and PAIN (It was very sore that night) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, the patient experienced DYSPNOEA (breathing very hard), INSOMNIA (could not even go to sleep), PAIN IN EXTREMITY (arm was also hurting) and PAIN (It was very sore that night). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, DYSPNOEA (breathing very hard), INSOMNIA (could not even go to sleep), PAIN IN EXTREMITY (arm was also hurting) and PAIN (It was very sore that night) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, Heart rate: increased (High) Increased. On an unknown date, Heart rate: high (High) High (Rapid heart beat during day time).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient felt heart beating was very fast and breathing very hard. It lasted for a while and patient could not even go to sleep. The next night was better. Previous day, patient had rapid heartbeat during the day. Patient never had any trouble with rapid heartbeat or breathing. It was very sore that night (same day of first vaccination), and for a couple of days it continued.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered Higher dose (1 ml) -than-authorized dose (0.5 Ml); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (administered Higher dose (1 ml) -than-authorized dose (0.5 Ml)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered Higher dose (1 ml) -than-authorized dose (0.5 Ml)). At the time of the report, ACCIDENTAL OVERDOSE (administered Higher dose (1 ml) -than-authorized dose (0.5 Ml)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller also  stated that  it was their first  dose of a series for 4  out  of 5  patients involved,  and it was  the second dose of a series  for 1  patient and stated that no side effects have been reported from the patients involved.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-293191, MOD-2021-292849, MOD-2021-293520, MOD-2021-292850 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (had a tender left arm/Tender left injection site arm) and FATIGUE (patient was tired the next day after second moderna vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (had a tender left arm/Tender left injection site arm) and FATIGUE (patient was tired the next day after second moderna vaccine). At the time of the report, VACCINATION SITE PAIN (had a tender left arm/Tender left injection site arm) and FATIGUE (patient was tired the next day after second moderna vaccine) outcome was unknown.            Concomitant medication not provided by reporter. Treatment information not provided by reporter.   This case was linked to MOD-2021-293330, MOD-2021-293338 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tender left injection site arm; patient was tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tender left injection site arm ) and FATIGUE (patient was tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 011A21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Tender left injection site arm ) and FATIGUE (patient was tired). At the time of the report, PAIN IN EXTREMITY (Tender left injection site arm ) and FATIGUE (patient was tired) outcome was unknown.            Concomitant medication not provided by reporter. Treatment information not provided by reporter.   This case was linked to MOD-2021-293330, MOD-2021-293337 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing). At the time of the report, COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient asking  Is coughing a side effect . No concomitant medications were provided by reporter. No treatment details were provided by reporter.  Denied to be followed by safety
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dysphonia
Clinical narrative: DYSPHONIA/voice was weak; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (DYSPHONIA/voice was weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product EDARAVONE (RADICAVA) injection for Amyotrophic lateral sclerosis.    Concurrent medical conditions included Amyotrophic lateral sclerosis since August 2021 and Wheelchair user.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started EDARAVONE (RADICAVA) (unknown route) at an unspecified dose. On 10-Mar-2021, the patient experienced DYSPHONIA (DYSPHONIA/voice was weak). At the time of the report, DYSPHONIA (DYSPHONIA/voice was weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment drugs were not provided   This case was linked to (Patient Link).   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Vaccination site discolouration, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Her muscles are still swollen 3-4 inches to the side; It broke out into a rash; Arm is still swelling; Very itchy/3 inches down from the shot site of the upper left arm; The shot location has turned kind of greenish at the injection site; It has gotten very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE RASH (It broke out into a rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE SWELLING (Arm is still swelling). On an unknown date, the patient experienced MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side) and VACCINATION SITE RASH (It broke out into a rash). At the time of the report, VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE RASH (It broke out into a rash) outcome was unknown and MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side) and VACCINATION SITE SWELLING (Arm is still swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   On 22Aug2021, patient pressed the vaccination site to feel what was going on, just touched it and aggravated it more.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Her muscles are still swollen 3-4 inches to the side; It broke out into a rash; Arm is still swelling; Very itchy/3 inches down from the shot site of the upper left arm; The shot location has turned kind of greenish at the injection site; It has gotten very hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE RASH (It broke out into a rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE SWELLING (Arm is still swelling). On an unknown date, the patient experienced MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side) and VACCINATION SITE RASH (It broke out into a rash). At the time of the report, VACCINATION SITE DISCOLOURATION (The shot location has turned kind of greenish at the injection site), VACCINATION SITE WARMTH (It has gotten very hot), VACCINATION SITE PRURITUS (Very itchy/3 inches down from the shot site of the upper left arm) and VACCINATION SITE RASH (It broke out into a rash) outcome was unknown and MUSCLE SWELLING (Her muscles are still swollen 3-4 inches to the side) and VACCINATION SITE SWELLING (Arm is still swelling) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   On 22Aug2021, patient pressed the vaccination site to feel what was going on, just touched it and aggravated it more.  No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disorientation, Illness, Pyrexia
Clinical narrative: Saturday Morning experienced disorientation like dizziness; real bad vision as well last Saturday Morning; Yesterday patient  was still sick on the couch all day until around 6-7o'clock; Fever 103F; Chills; Violently shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violently shaking), DISORIENTATION (Saturday Morning experienced disorientation like dizziness), VISION BLURRED (real bad vision as well last Saturday Morning), ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock) and PYREXIA (Fever 103F) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS and SIMVASTATIN for an unknown indication.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced TREMOR (Violently shaking), PYREXIA (Fever 103F) and CHILLS (Chills). On 20-Aug-2021, the patient experienced ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock). On 21-Aug-2021, the patient experienced DISORIENTATION (Saturday Morning experienced disorientation like dizziness) and VISION BLURRED (real bad vision as well last Saturday Morning). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Violently shaking), DISORIENTATION (Saturday Morning experienced disorientation like dizziness), VISION BLURRED (real bad vision as well last Saturday Morning) and CHILLS (Chills) had not resolved, ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock) outcome was unknown and PYREXIA (Fever 103F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature: 103 (High) had fever at 103 F all night.         Patient was advised to take Tylenol and hydrate.   This case was linked to MOD-2021-293388 (Patient Link).
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: Saturday Morning experienced disorientation like dizziness; real bad vision as well last Saturday Morning; Yesterday patient  was still sick on the couch all day until around 6-7o'clock; Fever 103F; Chills; Violently shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violently shaking), DISORIENTATION (Saturday Morning experienced disorientation like dizziness), VISION BLURRED (real bad vision as well last Saturday Morning), ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock) and PYREXIA (Fever 103F) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MULTIVITAMIN [VITAMINS NOS], ASCORBIC ACID (VITAMIN C ACID), VITAMIN D NOS and SIMVASTATIN for an unknown indication.   On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced TREMOR (Violently shaking), PYREXIA (Fever 103F) and CHILLS (Chills). On 20-Aug-2021, the patient experienced ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock). On 21-Aug-2021, the patient experienced DISORIENTATION (Saturday Morning experienced disorientation like dizziness) and VISION BLURRED (real bad vision as well last Saturday Morning). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (Violently shaking), DISORIENTATION (Saturday Morning experienced disorientation like dizziness), VISION BLURRED (real bad vision as well last Saturday Morning) and CHILLS (Chills) had not resolved, ILLNESS (Yesterday patient  was still sick on the couch all day until around 6-7o'clock) outcome was unknown and PYREXIA (Fever 103F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, Body temperature: 103 (High) had fever at 103 F all night.         Patient was advised to take Tylenol and hydrate.   This case was linked to MOD-2021-293388 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fear, Vaccination complication
Clinical narrative: Dizziness; Afraid to drive; Experienced some issues with the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), FEAR (Afraid to drive) and VACCINATION COMPLICATION (Experienced some issues with the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), FEAR (Afraid to drive) and VACCINATION COMPLICATION (Experienced some issues with the vaccine). At the time of the report, DIZZINESS (Dizziness), FEAR (Afraid to drive) and VACCINATION COMPLICATION (Experienced some issues with the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Terrible ringing in her right ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Terrible ringing in her right ear) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Terrible ringing in her right ear). At the time of the report, TINNITUS (Terrible ringing in her right ear) outcome was unknown.            Treatment medication was  not reported. Relevant concomitant medications were not reported.   Reporter did not allow further contact