chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP gave 6 shots of vaccine on 05-OCT-2021 morning that expired on 01-OCT-2021. Initially that vial was stored in the refrigerator on 27Sep2021. Concomitant medications were not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Young girl died from the Moderna vaccine after her second dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Young girl died from the Moderna vaccine after her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not provided.  Treatment information was not provided.  Company comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of death. The event occurred on an unknown date after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of death. The event occurred on an unknown date after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The cause of death was not reported. It is unknown if an autopsy was performed.    The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Report adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Report adverse event) 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 ADVERSE EVENT (Report adverse event). At the time of the report, ADVERSE EVENT (Report adverse event) 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 drug details were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Vaccination site reaction
Clinical narrative: Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site; covid hands; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site) and VACCINATION SITE REACTION (covid hands) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     The patient's past medical history included Eczema.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced ECZEMA (Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site) and VACCINATION SITE REACTION (covid hands). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, ECZEMA (Exacerbated her eczema- weird bumps on her hands and her skin began to peel/the peeling has brought her hands down to the 3rd or 4th layer of skin./she has had a purple band around her arm at the height of the vaccination site) and VACCINATION SITE REACTION (covid hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient tried multiple different lotions and creams for her hands, eczema medication and psoriasis medication.   No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered the Moderna COVID 19 vaccine after 30-day Use By Date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID 19 vaccine after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID 19 vaccine after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the Moderna COVID 19 vaccine after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided    Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Added contact information
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: couldn't walk upstairs; continuing muscle and joint pain in lower back; hurting in arm; severe muscle pain to the point it hurt to lay down; the joint and muscle pain lasted for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't walk upstairs), BACK PAIN (continuing muscle and joint pain in lower back), PAIN IN EXTREMITY (hurting in arm), MYALGIA (severe muscle pain to the point it hurt to lay down) and ARTHRALGIA (the joint and muscle pain lasted for 2 days) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced MYALGIA (severe muscle pain to the point it hurt to lay down) and ARTHRALGIA (the joint and muscle pain lasted for 2 days). On 29-Dec-2020, the patient experienced GAIT DISTURBANCE (couldn't walk upstairs), BACK PAIN (continuing muscle and joint pain in lower back) and PAIN IN EXTREMITY (hurting in arm). At the time of the report, GAIT DISTURBANCE (couldn't walk upstairs), BACK PAIN (continuing muscle and joint pain in lower back), PAIN IN EXTREMITY (hurting in arm), MYALGIA (severe muscle pain to the point it hurt to lay down) and ARTHRALGIA (the joint and muscle pain lasted for 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-343058 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscular weakness, Pain in extremity, Tremor
Clinical narrative: Shaking/her whole body shook; Legs would not work/ hard to get her legs to work; Mild arm ache; Shivers; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking/her whole body shook), MUSCULAR WEAKNESS (Legs would not work/ hard to get her legs to work), PAIN IN EXTREMITY (Mild arm ache) and CHILLS (Shivers) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking/her whole body shook), MUSCULAR WEAKNESS (Legs would not work/ hard to get her legs to work), PAIN IN EXTREMITY (Mild arm ache) and CHILLS (Shivers). At the time of the report, TREMOR (Shaking/her whole body shook), MUSCULAR WEAKNESS (Legs would not work/ hard to get her legs to work), PAIN IN EXTREMITY (Mild arm ache) and CHILLS (Shivers) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.    This case was linked to MOD-2021-010360, MOD-2021-245521 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Skin discolouration, Urticaria
Clinical narrative: The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them; Her forearm looked like it was frosted white/her right forearm started turning white; Her right arm itched like her skin was going to come off; She had a fever; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them), SKIN DISCOLOURATION (Her forearm looked like it was frosted white/her right forearm started turning white), PRURITUS (Her right arm itched like her skin was going to come off) and PYREXIA (She had a fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046CZ11A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced URTICARIA (The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them), SKIN DISCOLOURATION (Her forearm looked like it was frosted white/her right forearm started turning white), PRURITUS (Her right arm itched like her skin was going to come off) and PYREXIA (She had a fever). On 01-Oct-2021, URTICARIA (The middle of her right forearm started turning white with white welts. The Welts looked like mosquito bites with fluid in them), SKIN DISCOLOURATION (Her forearm looked like it was frosted white/her right forearm started turning white), PRURITUS (Her right arm itched like her skin was going to come off) and PYREXIA (She had a fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Everything lasted for about an hour and a half and then her arm went back to normal again.  No concomitant medication was provided.  No treatment medication was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: shortness of breath; bruise where got the shot; arm felt a little swollen; rash on stomach on the left side/ size of hand, swirly dark red; feeling itchy-like/face itching/ still itching on her face; arm is bright red; sore for a few days; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE BRUISING (bruise where got the shot), PERIPHERAL SWELLING (arm felt a little swollen), RASH ERYTHEMATOUS (rash on my stomach on the left side/ size of your hand, swirly dark red) and PRURITUS (feeling itchy-like/face itching/ still itching on her face) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (allergy to sulfur), Allergy to chemicals (allergy to sodium) and Allergy (allergy to red dye).    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE BRUISING (bruise where got the shot), PERIPHERAL SWELLING (arm felt a little swollen), RASH ERYTHEMATOUS (rash on my stomach on the left side/ size of your hand, swirly dark red), PRURITUS (feeling itchy-like/face itching/ still itching on her face), ERYTHEMA (arm is bright red) and PAIN IN EXTREMITY (sore for a few days). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (shortness of breath), PERIPHERAL SWELLING (arm felt a little swollen), RASH ERYTHEMATOUS (rash on my stomach on the left side/ size of your hand, swirly dark red), PRURITUS (feeling itchy-like/face itching/ still itching on her face), ERYTHEMA (arm is bright red) and PAIN IN EXTREMITY (sore for a few days) outcome was unknown and VACCINATION SITE BRUISING (bruise where got the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was provided i.e., patient applied ice pack on her face. She put an ice pack on her stomach.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site bruising
Clinical narrative: shortness of breath; bruise where got the shot; arm felt a little swollen; rash on stomach on the left side/ size of hand, swirly dark red; feeling itchy-like/face itching/ still itching on her face; arm is bright red; sore for a few days; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), VACCINATION SITE BRUISING (bruise where got the shot), PERIPHERAL SWELLING (arm felt a little swollen), RASH ERYTHEMATOUS (rash on my stomach on the left side/ size of your hand, swirly dark red) and PRURITUS (feeling itchy-like/face itching/ still itching on her face) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (allergy to sulfur), Allergy to chemicals (allergy to sodium) and Allergy (allergy to red dye).    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), VACCINATION SITE BRUISING (bruise where got the shot), PERIPHERAL SWELLING (arm felt a little swollen), RASH ERYTHEMATOUS (rash on my stomach on the left side/ size of your hand, swirly dark red), PRURITUS (feeling itchy-like/face itching/ still itching on her face), ERYTHEMA (arm is bright red) and PAIN IN EXTREMITY (sore for a few days). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy, at a dose of UNK dosage form. At the time of the report, DYSPNOEA (shortness of breath), PERIPHERAL SWELLING (arm felt a little swollen), RASH ERYTHEMATOUS (rash on my stomach on the left side/ size of your hand, swirly dark red), PRURITUS (feeling itchy-like/face itching/ still itching on her face), ERYTHEMA (arm is bright red) and PAIN IN EXTREMITY (sore for a few days) outcome was unknown and VACCINATION SITE BRUISING (bruise where got the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was provided i.e., patient applied ice pack on her face. She put an ice pack on her stomach.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of illness and inappropriate schedule of product administration in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In May 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness and inappropriate schedule of product administration. At the time of the report, illness outcome: unknown and inappropriate schedule of product administration: resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (tired) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history provided. Concomitant products included vitamins (NOS) for an unknown indication. On Aug 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 7, 2021, patient experienced fatigue (tired). In August 2021, fatigue (tired): resolved. No treatment information provided. Reportedly,  patient didn't take any medications for the symptoms. She didn't go to the doctor as a result of her symptoms. This case linked to MOD-2021-343037 (patient link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) had not resolved.            No treatment information provided.   This case was linked to MOD-2021-343023 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: receiving dose from an expired Moderna COVID19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: Abdominal pain; Groin pain; Tingling in left forearm, thumb; Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet; Bothered to walk; Motor dysfunction NOS; Extremely fatigued; Arthritic pain in tops of feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet) and GAIT DISTURBANCE (Bothered to walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet), GAIT DISTURBANCE (Bothered to walk), MOTOR DYSFUNCTION (Motor dysfunction NOS), FATIGUE (Extremely fatigued) and ARTHRALGIA (Arthritic pain in tops of feet). At the time of the report, ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet), GAIT DISTURBANCE (Bothered to walk), MOTOR DYSFUNCTION (Motor dysfunction NOS), FATIGUE (Extremely fatigued) and ARTHRALGIA (Arthritic pain in tops of feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment details were reported.   This case was linked to MOD-2021-266628 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Motor dysfunction, Paraesthesia
Clinical narrative: Abdominal pain; Groin pain; Tingling in left forearm, thumb; Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet; Bothered to walk; Motor dysfunction NOS; Extremely fatigued; Arthritic pain in tops of feet; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Oct-2021 and was forwarded to Moderna on 04-Oct-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet) and GAIT DISTURBANCE (Bothered to walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet), GAIT DISTURBANCE (Bothered to walk), MOTOR DYSFUNCTION (Motor dysfunction NOS), FATIGUE (Extremely fatigued) and ARTHRALGIA (Arthritic pain in tops of feet). At the time of the report, ABDOMINAL PAIN (Abdominal pain), GROIN PAIN (Groin pain), PARAESTHESIA (Tingling in left forearm, thumb), FEELING ABNORMAL (Don't feel normal anymore/feels like someone has crushed the bones in the tops of feet), GAIT DISTURBANCE (Bothered to walk), MOTOR DYSFUNCTION (Motor dysfunction NOS), FATIGUE (Extremely fatigued) and ARTHRALGIA (Arthritic pain in tops of feet) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment details were reported.   This case was linked to MOD-2021-266628 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for 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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: little bit of arm pain; stiff neck pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of arm pain) and MUSCULOSKELETAL STIFFNESS (stiff neck pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE and THYROID (ARMOUR THYROID) for an unknown indication.    On 09-Mar-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 PAIN IN EXTREMITY (little bit of arm pain) and MUSCULOSKELETAL STIFFNESS (stiff neck pain). At the time of the report, PAIN IN EXTREMITY (little bit of arm pain) and MUSCULOSKELETAL STIFFNESS (stiff neck pain) 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 Treatment medications are Reported.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Heart rate abnormal
Clinical narrative: issues with heart rate; issues with blood pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure). At the time of the report, HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure) 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 products were reported. No Treatment medication were reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Insomnia
Clinical narrative: Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye; can not sleep; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (High blood pressure) and Diabetes. Concomitant products included METFORMIN for an unknown indication.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) (seriousness criterion medically significant) and INSOMNIA (can not sleep). The patient was treated with PREDNISONE on 04-Oct-2021 for Adverse event, at an unspecified dose and frequency and VALACICLOVIR on 04-Oct-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) and INSOMNIA (can not sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included statins, high blood pressure medication and another diabetes oral medication. Treatment medications also included some eye ointment, an eye patch at night to keep the eye shut, and some eye drops for daytime.  Patient reported that he went to the ER yesterday as he wanted to rule out a stroke. There he was diagnosed with Bell's Palsy. He reported that he could not eat, could not drink, could not smile and could not close his left eye.  Company comment: This case concerns a 58 year-old male patient with history of diabetes, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. Because diabetes is a risk factor for the event, the patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58 year-old male patient with history of diabetes, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. Because diabetes is a risk factor for the event, the patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 3rd dose administered to non-immunocompromised individual; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (3rd dose administered to non-immunocompromised individual) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced OFF LABEL USE (3rd dose administered to non-immunocompromised individual). On 05-Oct-2021, OFF LABEL USE (3rd dose administered to non-immunocompromised individual) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Caller was not willing to report adverse event. Caller stated a 3rd dose was administered to an non-eligible consumer.  Concomitant medication use was unknown Treatment information was unknown
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: Hot right arm injection site; Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot) 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 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Patient stated that after first vaccine she said that the injection site at the right arm felt like there was a hard lump that has got softer the last fewdays and felt like a big knot and it is hot.. It was reported that Manufacturer date of suspect drug was Apr2021, Lot number and expiration date of suspect drug was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: left abdominal pain/symptom; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (left abdominal pain/symptom) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (left abdominal pain/symptom). At the time of the report, ABDOMINAL PAIN (left abdominal pain/symptom) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Insomnia
Clinical narrative: can not sleep; Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced INSOMNIA (can not sleep). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy) and INSOMNIA (can not sleep) outcome was unknown.            No concomitant medications were reported. Patient was also treated with eye ointment, an eye patch at night to keep the eye shut, and some eye drops for daytime.  Reported that Patient went to the ER because they developed facial paralysis affecting the left side and wanted to rule out a stroke.   Reported that There patient were diagnosed with Bell's Palsy and can not eat and can not drink, can not smile, can not sleep, can not close their left eye.  Company comment: This case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts) in a 33-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Shellfish allergy.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts) had not resolved.        The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown.       No concomitant medication details was provided.  Patient was trying applying ice, heat pad. The medication and remedies was not subsiding the pain.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site discolouration
Clinical narrative: Airport security monitor showed human figure on vaccination site twice at different airports; Missed second dose intentionally; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLORATION (Airport security monitor showed human figure on vaccination site twice at different airports) and PRODUCT DOSE OMISSION ISSUE (Missed second dose intentionally) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE DISCOLORATION (Airport security monitor showed human figure on vaccination site twice at different airports) and PRODUCT DOSE OMISSION ISSUE (Missed second dose intentionally). In September 2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose intentionally) had resolved. At the time of the report, VACCINATION SITE DISCOLORATION (Airport security monitor showed human figure on vaccination site twice at different airports) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness; tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness) and FATIGUE (tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 408D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced MYALGIA (he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness) and FATIGUE (tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her). At the time of the report, MYALGIA (he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness) and FATIGUE (tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were  provided by the reporter No Treatment information was provided by the reporter   This case was linked to MOD-2021-342936 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  Patient didn't experienced Adverse Events  Date the vial was initially stored in the refrigerator: 27-SEP-2021.  No Treatment information was reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: 2nd dose received more than 5 months after the second; different COVID-19 vaccine for 1st and 2nd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (different COVID-19 vaccine for 1st and 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 5 months after the second) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD on 25-Mar-2021.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (different COVID-19 vaccine for 1st and 2nd dose). On 03-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 5 months after the second). On 03-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (different COVID-19 vaccine for 1st and 2nd dose) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 5 months after the second) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided. No treatment medication was provided. First dose lot number includes 1805031 and expiration date includes 31-DEC-2069 Patient had stated that No adverse events are experienced.