chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Extreme Fatigue; Pain moved from one shoulder to the other, down her spine and tail bone; Red Flushing of the Face; Red Flushing of the Face; Severe Headache; Severe body ache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Red Flushing of the Face), ERYTHEMA (Red Flushing of the Face), HEADACHE (Severe Headache), MYALGIA (Severe body ache) and ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (never did a PCR test to confirm that in fact she had COVID-19 in 2020.) in 2020.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced FLUSHING (Red Flushing of the Face), ERYTHEMA (Red Flushing of the Face), HEADACHE (Severe Headache) and MYALGIA (Severe body ache). On 22-Jul-2021, the patient experienced ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone). On 24-Jul-2021, the patient experienced FATIGUE (Extreme Fatigue). The patient was treated with TYLENOL for Pain, at an unspecified dose and frequency. On 21-Jul-2021, FLUSHING (Red Flushing of the Face) and ERYTHEMA (Red Flushing of the Face) had resolved. At the time of the report, HEADACHE (Severe Headache), MYALGIA (Severe body ache), ARTHRALGIA (Pain moved from one shoulder to the other, down her spine and tail bone) and FATIGUE (Extreme Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. Two weeks after vaccination, the patient visited her doctor's office. The ARNP told her that some spike protein may have deposited into her joints, that is why she is having so much pain. Also the ARNP told her that because she had COVID-19 Disease early on, she had this reaction to the vaccine and experienced severe side effects. ARNP prescribed Anti-Inflammatory medication which helped with the pain. But the patient states that she is still aware the problem is there, even after taking the anti-inflammatory medication. Patient stated that she was very unhappy.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle twitching, Vaccination site erythema
Clinical narrative: some right arm and leg twitching; a small red patch by the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache) 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 MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache). At the time of the report, MUSCLE TWITCHING (some right arm and leg twitching), VACCINATION SITE ERYTHEMA (a small red patch by the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Lip swelling, Paraesthesia oral
Clinical narrative: Tongue had a tingling sensation; lips started to swell; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue had a tingling sensation) and LIP SWELLING (lips started to swell) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Itching. Concurrent medical conditions included Pollen allergy, Dust allergy, Mite allergy and Allergy to plants (Allergic to trees).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PARAESTHESIA ORAL (Tongue had a tingling sensation) and LIP SWELLING (lips started to swell). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 08-Mar-2021, PARAESTHESIA ORAL (Tongue had a tingling sensation) had resolved. At the time of the report, LIP SWELLING (lips started to swell) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood pressure measurement: unknown (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.. Patient was recommended to take second dose of vaccine by the allergist in facility with emergency room was reported.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) 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 ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (is now experiencing an adverse reaction which he does not know if it is related to the vaccine but he says it might help a lot of people) had not resolved.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.  Patient received the Moderna vaccine earlier this year, and was now experiencing an adverse reaction which he does not know if it was related to the vaccine but he says it might help a lot of people, he was currently in the hospital.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CEFIXIME (FLEXERIL [CEFIXIME]) for an unknown indication.    On 19-May-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 (Patient did not receive second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) had resolved.            No Treatment medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days have passed and patient did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed and patient did not get the second dose) had resolved.            No concomitant medication reported.  No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave patient her  second  dose early; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 001C21A) for COVID-19 vaccination.     No medical history was provided by reporter.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Gave  patient her  second  dose early) to be not applicable.    No Concomitant medications were provided. No treatment medications were provided.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: Off label Dosing; Off label Dosing to 16 year-old patient; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient) in a 16-year-old patient of an unknown 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 OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient). At the time of the report, OFF LABEL USE (Off label Dosing) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Off label Dosing to 16 year-old patient) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     No concomitant medication information was provided.  No treatment medication were provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Hurt to move the arm; Horrible aches in the right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm). On 16-Jun-2021, PAIN IN EXTREMITY (Hurt to move the arm) and MYALGIA (Horrible aches in the right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-259182 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Chills, Dizziness
Clinical narrative: Throat felt like burning; Body temperature raised; Dizzy; Loss of taste; Loss of smell; Chills are so strong felt they're killing patient; Body aches; Tired of speaking; Headache; Arm swelled a little; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled a little), THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy) and AGEUSIA (Loss of taste) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled a little). On 07-Aug-2021, the patient experienced THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache). On 30-Jul-2021, PERIPHERAL SWELLING (Arm swelled a little) had resolved. At the time of the report, THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter  No treatment medication were provided by the reporter
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Throat felt like burning; Body temperature raised; Dizzy; Loss of taste; Loss of smell; Chills are so strong felt they're killing patient; Body aches; Tired of speaking; Headache; Arm swelled a little; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled a little), THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy) and AGEUSIA (Loss of taste) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled a little). On 07-Aug-2021, the patient experienced THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache). On 30-Jul-2021, PERIPHERAL SWELLING (Arm swelled a little) had resolved. At the time of the report, THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter  No treatment medication were provided by the reporter
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Throat felt like burning; Body temperature raised; Dizzy; Loss of taste; Loss of smell; Chills are so strong felt they're killing patient; Body aches; Tired of speaking; Headache; Arm swelled a little; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled a little), THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy) and AGEUSIA (Loss of taste) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced PERIPHERAL SWELLING (Arm swelled a little). On 07-Aug-2021, the patient experienced THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache). On 30-Jul-2021, PERIPHERAL SWELLING (Arm swelled a little) had resolved. At the time of the report, THROAT IRRITATION (Throat felt like burning), PYREXIA (Body temperature raised), DIZZINESS (Dizzy), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), CHILLS (Chills are so strong felt they're killing patient), PAIN (Body aches), FATIGUE (Tired of speaking) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter  No treatment medication were provided by the reporter
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Feeling hot, Insomnia, Myalgia
Clinical narrative: Trouble sleeping; Felt it going through the left side of her body like a warm flow; Pain in her left hip; Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg; Pain under her arm, into her armpit; Pain spread in the left side of her back, described as nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) in a 31-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 13-Apr-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced NEURALGIA (Pain spread in the left side of her back, described as nerve pain). On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip), MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) and AXILLARY PAIN (Pain under her arm, into her armpit). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping). The patient was treated with Physical therapy (Massage unit) for Neuralgia and Physical therapy (Massage unit) for Myalgia. On 17-May-2021, FEELING HOT (Felt it going through the left side of her body like a warm flow) had resolved. On 31-May-2021, AXILLARY PAIN (Pain under her arm, into her armpit) had resolved. At the time of the report, NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) had not resolved.            Concomitant medication was not reported.  Treatment medication was not reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Trouble sleeping; Felt it going through the left side of her body like a warm flow; Pain in her left hip; Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg; Pain under her arm, into her armpit; Pain spread in the left side of her back, described as nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) in a 31-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 13-Apr-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced NEURALGIA (Pain spread in the left side of her back, described as nerve pain). On 17-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (Felt it going through the left side of her body like a warm flow), ARTHRALGIA (Pain in her left hip), MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) and AXILLARY PAIN (Pain under her arm, into her armpit). On an unknown date, the patient experienced INSOMNIA (Trouble sleeping). The patient was treated with Physical therapy (Massage unit) for Neuralgia and Physical therapy (Massage unit) for Myalgia. On 17-May-2021, FEELING HOT (Felt it going through the left side of her body like a warm flow) had resolved. On 31-May-2021, AXILLARY PAIN (Pain under her arm, into her armpit) had resolved. At the time of the report, NEURALGIA (Pain spread in the left side of her back, described as nerve pain), INSOMNIA (Trouble sleeping), ARTHRALGIA (Pain in her left hip) and MYALGIA (Excruciating pain in her left side/ Pain spread in the left side of her back, described as muscle pain/ Unable to move in bed without pain in her lower back and leg) had not resolved.            Concomitant medication was not reported.  Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Emphysema, Feeling abnormal
Clinical narrative: Breathing problems that got progressively worse; Emphysema; diagnosed as having emphysema/ It was as bad; Like having elephants sitting on your chest or needing a ventolator to help breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing problems that got progressively worse), EMPHYSEMA (Emphysema), FEELING ABNORMAL (diagnosed as having emphysema/ It was as bad) and CHEST DISCOMFORT (Like having elephants sitting on your chest or needing a ventolator to help breath) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 DYSPNOEA (Breathing problems that got progressively worse), EMPHYSEMA (Emphysema), FEELING ABNORMAL (diagnosed as having emphysema/ It was as bad) and CHEST DISCOMFORT (Like having elephants sitting on your chest or needing a ventolator to help breath). At the time of the report, DYSPNOEA (Breathing problems that got progressively worse), EMPHYSEMA (Emphysema), FEELING ABNORMAL (diagnosed as having emphysema/ It was as bad) and CHEST DISCOMFORT (Like having elephants sitting on your chest or needing a ventolator to help breath) outcome was unknown.            Concomitant product information was not provided. Treatment information was provided but not specified.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hot flush, Mobility decreased, Peripheral swelling
Clinical narrative: Swelling in feet jaw and left hand; Hot flashes; spots on hands and feet; Feels like cant process thoughts; Shortness of breath; Dizziness; Could not lift head or  move; fever temperature 103; shaking like tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking like tremors), PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet) and THOUGHT BLOCKING (Feels like cant process thoughts) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003E21A and 003E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced TREMOR (shaking like tremors) and PYREXIA (fever temperature 103). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet), THOUGHT BLOCKING (Feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness) and MOBILITY DECREASED (Could not lift head or  move). The patient was treated with ALBUTEROL [SALBUTAMOL] for Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, TREMOR (shaking like tremors), PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet), THOUGHT BLOCKING (Feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness), MOBILITY DECREASED (Could not lift head or  move) and PYREXIA (fever temperature 103) outcome was unknown.      No concomitant medication were provided by the reporter   This case was linked to MOD-2021-285303 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin discolouration, Thought blocking, Tremor
Clinical narrative: Swelling in feet jaw and left hand; Hot flashes; spots on hands and feet; Feels like cant process thoughts; Shortness of breath; Dizziness; Could not lift head or  move; fever temperature 103; shaking like tremors; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking like tremors), PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet) and THOUGHT BLOCKING (Feels like cant process thoughts) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003E21A and 003E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced TREMOR (shaking like tremors) and PYREXIA (fever temperature 103). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet), THOUGHT BLOCKING (Feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness) and MOBILITY DECREASED (Could not lift head or  move). The patient was treated with ALBUTEROL [SALBUTAMOL] for Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, TREMOR (shaking like tremors), PERIPHERAL SWELLING (Swelling in feet jaw and left hand), HOT FLUSH (Hot flashes), SKIN DISCOLOURATION (spots on hands and feet), THOUGHT BLOCKING (Feels like cant process thoughts), DYSPNOEA (Shortness of breath), DIZZINESS (Dizziness), MOBILITY DECREASED (Could not lift head or  move) and PYREXIA (fever temperature 103) outcome was unknown.      No concomitant medication were provided by the reporter   This case was linked to MOD-2021-285303 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: felt bad; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and FATIGUE (fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad) and FATIGUE (fatigue). At the time of the report, FEELING ABNORMAL (felt bad) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not provided. Treatment information was provided.   This case was linked to MOD-2021-285588 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: Given vaccine after sitting out punctured for a day.; Given another dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: a patient who received the 1st dose on 21Jul21, she came today with the shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (a patient who received the 1st dose on 21Jul21, she came today with the shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Significant Follow up: Patient race and ethnicity are updated, Route of administration, lot no, anatomical location were updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Product dose omission issue
Clinical narrative: she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine; metallic taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in her mouth) and PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DYSGEUSIA (metallic taste in her mouth). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine). At the time of the report, DYSGEUSIA (metallic taste in her mouth) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  No treatment medications were provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: started experiencing the same pain after being under the sun on the same day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (started experiencing the same pain after being under the sun on the same day) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (started experiencing the same pain after being under the sun on the same day). At the time of the report, PAIN (started experiencing the same pain after being under the sun on the same day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E121A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included BUDESONIDE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose). On 11-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Feeling hot, Gait inability, Hypertension
Clinical narrative: her body was on fire; foggy brain; she was so numb; could not walk; she threw up and it lasted for probably 7 hours; her neurological function went down; Her blood pressure was really high 150/90; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), HYPERTENSION (Her blood pressure was really high 150/90) and NERVOUS SYSTEM DISORDER (her neurological function went down) in a 33-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.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced HYPERTENSION (Her blood pressure was really high 150/90). On 01-Aug-2021, the patient experienced NERVOUS SYSTEM DISORDER (her neurological function went down). On an unknown date, the patient experienced FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), GAIT INABILITY (could not walk) and VOMITING (she threw up and it lasted for probably 7 hours). At the time of the report, FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), HYPERTENSION (Her blood pressure was really high 150/90), NERVOUS SYSTEM DISORDER (her neurological function went down) and GAIT INABILITY (could not walk) outcome was unknown and VOMITING (she threw up and it lasted for probably 7 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Blood pressure measurement: 150/90 mmhg (High) 150/90 mmHg.         No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-285548 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervous system disorder, Vomiting
Clinical narrative: her body was on fire; foggy brain; she was so numb; could not walk; she threw up and it lasted for probably 7 hours; her neurological function went down; Her blood pressure was really high 150/90; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), HYPERTENSION (Her blood pressure was really high 150/90) and NERVOUS SYSTEM DISORDER (her neurological function went down) in a 33-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.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced HYPERTENSION (Her blood pressure was really high 150/90). On 01-Aug-2021, the patient experienced NERVOUS SYSTEM DISORDER (her neurological function went down). On an unknown date, the patient experienced FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), GAIT INABILITY (could not walk) and VOMITING (she threw up and it lasted for probably 7 hours). At the time of the report, FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), HYPERTENSION (Her blood pressure was really high 150/90), NERVOUS SYSTEM DISORDER (her neurological function went down) and GAIT INABILITY (could not walk) outcome was unknown and VOMITING (she threw up and it lasted for probably 7 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Blood pressure measurement: 150/90 mmhg (High) 150/90 mmHg.         No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-285548 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication product use was not provided by the reporter.  Vial may had been move from the freezer to the refrigerator on 02-Aug-2021. Vial did not undergo any previous temperature excursions. Total amount of time the vial was exposed to room temperature range (46° to 77° F). No treatment information was provided.   This case was linked to MOD-2021-285140, MOD-2021-285144, MOD-2021-285214, MOD-2021-285623, MOD-2021-285659 (E2B Linked Report).; Sender's Comments:  MOD-2021-285140:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285144:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285214:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285623:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285659:6 patients received expired Moderna COVID-19 vaccine
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, Fatigue, SARS-CoV-2 test, Sinus congestion
Clinical narrative: Lack of efficacy; congested in his sinus area; a little fatigue; contracted asymptomatic COVID; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (contracted asymptomatic COVID), DRUG INEFFECTIVE (Lack of efficacy), SINUS CONGESTION (congested in his sinus area) and FATIGUE (a little fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VIT D [VITAMIN D NOS], ASCORBIC ACID (VIT C) and ZINC for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced ASYMPTOMATIC COVID-19 (contracted asymptomatic COVID). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy), SINUS CONGESTION (congested in his sinus area) and FATIGUE (a little fatigue). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASYMPTOMATIC COVID-19 (contracted asymptomatic COVID), DRUG INEFFECTIVE (Lack of efficacy), SINUS CONGESTION (congested in his sinus area) and FATIGUE (a little fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive took 3 minute and positive (Positive) Positive took 4 minute.