chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Contusion, Erythema, Vaccination site erythema
Clinical narrative: couple of red dots in his right arm; having this defined bruise that kept showing up on his arm; has a red dot on his left arm where he received the vaccine. It is almost where his forearm is, where the forearm meets the upper arm; sharp stomach pain; pain in right shoulder blade (pain scale 3); This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (sharp stomach pain), ERYTHEMA (couple of red dots in his right arm), CONTUSION (having this defined bruise that kept showing up on his arm), ARTHRALGIA (pain in right shoulder blade (pain scale 3)) and VACCINATION SITE ERYTHEMA (has a red dot on his left arm where he received the vaccine. It is almost where his forearm is, where the forearm meets the upper arm) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy. Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ABDOMINAL PAIN UPPER (sharp stomach pain) and ARTHRALGIA (pain in right shoulder blade (pain scale 3)). On an unknown date, the patient experienced ERYTHEMA (couple of red dots in his right arm), CONTUSION (having this defined bruise that kept showing up on his arm) and VACCINATION SITE ERYTHEMA (has a red dot on his left arm where he received the vaccine. It is almost where his forearm is, where the forearm meets the upper arm). At the time of the report, ABDOMINAL PAIN UPPER (sharp stomach pain), CONTUSION (having this defined bruise that kept showing up on his arm) and ARTHRALGIA (pain in right shoulder blade (pain scale 3)) outcome was unknown and ERYTHEMA (couple of red dots in his right arm) and VACCINATION SITE ERYTHEMA (has a red dot on his left arm where he received the vaccine. It is almost where his forearm is, where the forearm meets the upper arm) had not resolved.            Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Event information and concomitant medication were updated.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm still red and swollen after 4 days; Arm still red and swollen after 4 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm still red and swollen after 4 days) and PERIPHERAL SWELLING (Arm still red and swollen after 4 days) 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 ERYTHEMA (Arm still red and swollen after 4 days) and PERIPHERAL SWELLING (Arm still red and swollen after 4 days). At the time of the report, ERYTHEMA (Arm still red and swollen after 4 days) and PERIPHERAL SWELLING (Arm still red and swollen after 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Injection site rash, Pain, Pyrexia
Clinical narrative: Flu like symptoms; Ache; Rash around injection site; Feverish; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Ache), INJECTION SITE RASH (Rash around injection site), PYREXIA (Feverish) and FATIGUE (Tired) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-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 an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Ache), INJECTION SITE RASH (Rash around injection site), PYREXIA (Feverish) and FATIGUE (Tired). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Ache), INJECTION SITE RASH (Rash around injection site), PYREXIA (Feverish) and FATIGUE (Tired) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported   This case was linked to MOD-2021-138588 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: New events(Flu like symptoms, pain and Rash at injection site) were added, patient age updated
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Peripheral swelling, Yellow skin
Clinical narrative: my legs stared to swell a out four day's later; Skin has a yellow tint to it/yellow tint all over my body; Pains in my back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my legs stared to swell a out four day's later), YELLOW SKIN (Skin has a yellow tint to it/yellow tint all over my body) and BACK PAIN (Pains in my back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (my legs stared to swell a out four day's later), YELLOW SKIN (Skin has a yellow tint to it/yellow tint all over my body) and BACK PAIN (Pains in my back). At the time of the report, PERIPHERAL SWELLING (my legs stared to swell a out four day's later), YELLOW SKIN (Skin has a yellow tint to it/yellow tint all over my body) and BACK PAIN (Pains in my back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Pain on her arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain on her arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 022C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for COVID-19.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (Pain on her arm). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) at a dose of 1 dosage form. On 23-Apr-2021, MYALGIA (Pain on her arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (sore arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had myalgia (sore arm). At the time of the report, myalgia (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness, Oropharyngeal discomfort
Clinical narrative: Itchy at times; a red rash; I have a rash almost in my whole arm; I felt like I had the flu all day; achy; arm was very tender; arm was very swollen; I feel like there is something in there; Lot of phlegm in my throat; feverish; I was really tired; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen) and FEELING ABNORMAL (I feel like there is something in there) in a 70-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 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (I was really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 31-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm) and PYREXIA (feverish). On an unknown date, the patient experienced PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm), PYREXIA (feverish), FATIGUE (I was really tired), PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash) outcome was unknown.            The concomitant medication include Cholesterol pill 20 mg. The other treatment medication was Anti itch cream to stop the rash on leg and arm.   This case was linked to MOD-2021-019620 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up information was received: Itching and red rash were added
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Itchy at times; a red rash; I have a rash almost in my whole arm; I felt like I had the flu all day; achy; arm was very tender; arm was very swollen; I feel like there is something in there; Lot of phlegm in my throat; feverish; I was really tired; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen) and FEELING ABNORMAL (I feel like there is something in there) in a 70-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 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (I was really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 31-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm) and PYREXIA (feverish). On an unknown date, the patient experienced PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm), PYREXIA (feverish), FATIGUE (I was really tired), PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash) outcome was unknown.            The concomitant medication include Cholesterol pill 20 mg. The other treatment medication was Anti itch cream to stop the rash on leg and arm.   This case was linked to MOD-2021-019620 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up information was received: Itching and red rash were added
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Itchy at times; a red rash; I have a rash almost in my whole arm; I felt like I had the flu all day; achy; arm was very tender; arm was very swollen; I feel like there is something in there; Lot of phlegm in my throat; feverish; I was really tired; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen) and FEELING ABNORMAL (I feel like there is something in there) in a 70-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 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (I was really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 31-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm) and PYREXIA (feverish). On an unknown date, the patient experienced PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm), PYREXIA (feverish), FATIGUE (I was really tired), PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash) outcome was unknown.            The concomitant medication include Cholesterol pill 20 mg. The other treatment medication was Anti itch cream to stop the rash on leg and arm.   This case was linked to MOD-2021-019620 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up information was received: Itching and red rash were added
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: Diabetes with reading 7.4; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes with reading 7.4) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A20A) for COVID-19 vaccination.     No Medical history was reported by the reporter.  Concomitant products included PAROXETINE, ROSUVASTATIN CALCIUM (CRESTOR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and LATANOPROST for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIABETES MELLITUS (Diabetes with reading 7.4). At the time of the report, DIABETES MELLITUS (Diabetes with reading 7.4) outcome was unknown.            Treatment information was not provided.  Additional information included that the patient was diagnosed with Diabetes with the reading 7.4 and the doctor prescribed to check her diet until the next office visit which was scheduled in June.  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.
Sex: M
Vaccine: COVID19
Symptoms: Depressed mood, Discomfort, Fatigue, Pain
Clinical narrative: body discomfort; "feeling down"; Pain; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body discomfort), DEPRESSED MOOD ("feeling down"), PAIN (Pain) and FATIGUE (tiredness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (body discomfort), DEPRESSED MOOD ("feeling down"), PAIN (Pain) and FATIGUE (tiredness). At the time of the report, DISCOMFORT (body discomfort), DEPRESSED MOOD ("feeling down"), PAIN (Pain) and FATIGUE (tiredness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant and treatment medication were provided.   This case was linked to MOD-2021-195316, MOD-2021-195316, MOD-2021-195316, MOD-2021-195316 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Patient's initials and gender updated.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: got vaccine yesterday, pain in upper leg; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (got vaccine yesterday, pain in upper leg) 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 PAIN IN EXTREMITY (got vaccine yesterday, pain in upper leg). At the time of the report, PAIN IN EXTREMITY (got vaccine yesterday, pain in upper leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurry vision; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision) 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 VISION BLURRED (Blurry vision). At the time of the report, VISION BLURRED (Blurry vision) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: experiencing joint pain in my elbowd; experiencing muscle pain in my elbowd; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (experiencing joint pain in my elbowd) and MYALGIA (experiencing muscle pain in my elbowd) 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 ARTHRALGIA (experiencing joint pain in my elbowd) and MYALGIA (experiencing muscle pain in my elbowd). At the time of the report, ARTHRALGIA (experiencing joint pain in my elbowd) and MYALGIA (experiencing muscle pain in my elbowd) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Myalgia, Palpitations, Paraesthesia
Clinical narrative: confused; face and hands felt a little tingly; heart was racing; chills; fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), PARAESTHESIA (face and hands felt a little tingly), PALPITATIONS (heart was racing), CHILLS (chills) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CANNABIDIOL (CBD OIL) for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (arm was sore). On 22-May-2021, the patient experienced CONFUSIONAL STATE (confused), PARAESTHESIA (face and hands felt a little tingly) and PALPITATIONS (heart was racing). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; Bed rest (Bed rest) for Confusional state; Bed rest (Bed rest) for Paraesthesia; Bed rest (Bed rest) for Palpitations; Bed rest (Bed rest) for Chills; Bed rest (Bed rest) for Pyrexia and Bed rest (Bed rest) for Myalgia. On 22-May-2021, CONFUSIONAL STATE (confused), PARAESTHESIA (face and hands felt a little tingly), PALPITATIONS (heart was racing), CHILLS (chills), PYREXIA (fever) and MYALGIA (arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: confused; face and hands felt a little tingly; heart was racing; chills; fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (confused), PARAESTHESIA (face and hands felt a little tingly), PALPITATIONS (heart was racing), CHILLS (chills) and PYREXIA (fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CANNABIDIOL (CBD OIL) for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (arm was sore). On 22-May-2021, the patient experienced CONFUSIONAL STATE (confused), PARAESTHESIA (face and hands felt a little tingly) and PALPITATIONS (heart was racing). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; Bed rest (Bed rest) for Confusional state; Bed rest (Bed rest) for Paraesthesia; Bed rest (Bed rest) for Palpitations; Bed rest (Bed rest) for Chills; Bed rest (Bed rest) for Pyrexia and Bed rest (Bed rest) for Myalgia. On 22-May-2021, CONFUSIONAL STATE (confused), PARAESTHESIA (face and hands felt a little tingly), PALPITATIONS (heart was racing), CHILLS (chills), PYREXIA (fever) and MYALGIA (arm was sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Somnolence
Clinical narrative: Tiredness and sleepiness throw the day; Nomness(numbness) on the  right side of the body, head , neck , shoulders, hip and leg; Tiredness and sleepiness throw the day; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Tiredness and sleepiness throw the day), HYPOAESTHESIA (Nomness(numbness) on the  right side of the body, head , neck , shoulders, hip and leg), FATIGUE (Tiredness and sleepiness throw the day) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Tiredness and sleepiness throw the day), HYPOAESTHESIA (Nomness(numbness) on the  right side of the body, head , neck , shoulders, hip and leg), FATIGUE (Tiredness and sleepiness throw the day) and HEADACHE (Headaches). At the time of the report, SOMNOLENCE (Tiredness and sleepiness throw the day), HYPOAESTHESIA (Nomness(numbness) on the  right side of the body, head , neck , shoulders, hip and leg), FATIGUE (Tiredness and sleepiness throw the day) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: three fingers of my left hand went numb and the same happened with two toes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (three fingers of my left hand went numb and the same happened with two toes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HYPOAESTHESIA (three fingers of my left hand went numb and the same happened with two toes). On 01-May-2021, HYPOAESTHESIA (three fingers of my left hand went numb and the same happened with two toes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Medication for bipolarity for an unknown indication. No treatment medication provided 1st dose - Expiration date: not provided 2nd dose - Expiration date: not provided. Case crosslinked with case number MOD21-104844
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Axillary pain, Insomnia, Limb discomfort, Pain
Clinical narrative: sleeplessness; generalized aching; leg discomfort; axillary pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (sleeplessness), PAIN (generalized aching), LIMB DISCOMFORT (leg discomfort) and AXILLARY PAIN (axillary pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    No Medical History information was reported.   On 17-Feb-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 80 mg. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced AXILLARY PAIN (axillary pain). On 26-May-2021, the patient experienced INSOMNIA (sleeplessness), PAIN (generalized aching) and LIMB DISCOMFORT (leg discomfort). At the time of the report, INSOMNIA (sleeplessness), PAIN (generalized aching), LIMB DISCOMFORT (leg discomfort) and AXILLARY PAIN (axillary pain) was resolving.        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.   Daily dose of co suspect humira is on day 1 80 mg,1 in 1 once and on Day 8 40 mg,1 in 1 once was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: hand and fingers are having a throbbing pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand and fingers are having a throbbing pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (hand and fingers are having a throbbing pain). At the time of the report, PAIN IN EXTREMITY (hand and fingers are having a throbbing pain) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Migraine, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (Migraine), INTERMENSTRUAL BLEEDING (Spotting) and PYREXIA (Very mild fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced MIGRAINE (Migraine). On 30-Apr-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting) and PYREXIA (Very mild fever). On 30-Apr-2021, MIGRAINE (Migraine) outcome was unknown. On 01-May-2021, INTERMENSTRUAL BLEEDING (Spotting) and PYREXIA (Very mild fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. Treatment provided was Aspirin and Motrin. The patient took first shot on 28Apr2021 and second shot on 28May2021. A day after the shot had migraine for a day. Very mild fever and spotting for 2 days. A day after the second shot had 104F fever and spotting for two and a half days. Also had aches and chills for two days. Lot# 049C21A (second shot)
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Took the first dose and did not had 2nd dose in 28-day window period and its now past 60 days) had resolved.        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.   Concomitant product use was not provided. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: FU received  - No adverse event occured
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Arm still feels like the needle is still in; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm still feels like the needle is still in) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm still feels like the needle is still in). At the time of the report, LIMB DISCOMFORT (Arm still feels like the needle is still in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Mobility decreased, Peripheral swelling, Skin tightness
Clinical narrative: Swelling went up into right thigh area; Swelling in right knee area; Skin was tighter around knee; Couldn't bend right knee like before; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in right knee area), SKIN TIGHTNESS (Skin was tighter around knee), MOBILITY DECREASED (Couldn't bend right knee like before) and PERIPHERAL SWELLING (Swelling went up into right thigh area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011A21A) for COVID-19 vaccination.     The patient's past medical history included Knee surgery NOS (In 1978 patient had surgery of the right knee and then post-operation had infection in the area) in 1978 and Physical therapy.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced JOINT SWELLING (Swelling in right knee area), SKIN TIGHTNESS (Skin was tighter around knee) and MOBILITY DECREASED (Couldn't bend right knee like before). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling went up into right thigh area). In March 2021, JOINT SWELLING (Swelling in right knee area), SKIN TIGHTNESS (Skin was tighter around knee) and MOBILITY DECREASED (Couldn't bend right knee like before) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling went up into right thigh area) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case was linked to MOD-2021-195800.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: why does a magnet stick to my arm where the shot was administered?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (why does a magnet stick to my arm where the shot was administered?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (why does a magnet stick to my arm where the shot was administered?). At the time of the report, VACCINATION SITE REACTION (why does a magnet stick to my arm where the shot was administered?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Mobility decreased, Musculoskeletal stiffness, Swelling
Clinical narrative: Muscoskeletal Stiffness; Swelling; Mobility Decreased; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscoskeletal Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Mobility Decreased) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscoskeletal Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Mobility Decreased). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscoskeletal Stiffness), SWELLING (Swelling) and MOBILITY DECREASED (Mobility Decreased) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: Hurt feet; Hurt neck; Hurt in shoulder, knee , ankle; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Hurt feet), NECK PAIN (Hurt neck) and ARTHRALGIA (Hurt in shoulder, knee , ankle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 032B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis and Stomach discomfort. Concomitant products included SULFASALAZINE and HYDROXYCHLOROQUINE for Rheumatoid arthritis.   In 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a day. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced PAIN IN EXTREMITY (Hurt feet), NECK PAIN (Hurt neck) and ARTHRALGIA (Hurt in shoulder, knee , ankle). At the time of the report, PAIN IN EXTREMITY (Hurt feet), NECK PAIN (Hurt neck) and ARTHRALGIA (Hurt in shoulder, knee , ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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.   The patient is a Non smoker and abstains from Alcohol
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: injection site brusing; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE BRUISING (injection site brusing) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection, emulsion for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult CROHN'S  DISEASe).   In 2015, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE BRUISING (injection site brusing). At the time of the report, INJECTION SITE BRUISING (injection site brusing) had resolved.            no treatment products included
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Generalized Aching; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Generalized Aching), CHILLS (chills) and PYREXIA (fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN (Generalized Aching), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN (Generalized Aching), CHILLS (chills) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Joint swelling, Pain in extremity
Clinical narrative: It did not swell up not much like in 1st dose; Whole right thigh area was painful; feels not recovered completely, lasted longer, still having some pain; whole right thigh area was painful along with right knee; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (It did not swell up not much like in 1st dose), PAIN IN EXTREMITY (Whole right thigh area was painful), CONDITION AGGRAVATED (feels not recovered completely, lasted longer, still having some pain) and ARTHRALGIA (whole right thigh area was painful along with right knee) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 0011A21A) for COVID-19 vaccination.     The patient's past medical history included Post procedural infection (With unspecified complications) in 1978 and Knee operation (Right knee operation.) in 1978.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced JOINT SWELLING (It did not swell up not much like in 1st dose), PAIN IN EXTREMITY (Whole right thigh area was painful), CONDITION AGGRAVATED (feels not recovered completely, lasted longer, still having some pain) and ARTHRALGIA (whole right thigh area was painful along with right knee). The patient was treated with Physical therapy for Joint swelling; Physical therapy for Pain in extremity; Physical therapy for Condition aggravated and Physical therapy for Arthralgia. In April 2021, JOINT SWELLING (It did not swell up not much like in 1st dose), PAIN IN EXTREMITY (Whole right thigh area was painful) and ARTHRALGIA (whole right thigh area was painful along with right knee) was resolving. At the time of the report, CONDITION AGGRAVATED (feels not recovered completely, lasted longer, still having some pain) was resolving.            Concomitant product use was not reported.   No additional treatment information was reported.   This case was linked to MOD-2021-195642 (Patient Link).