chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Influenza like illness
Clinical narrative: shortness of breath; pain in my body like I was having the flu; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) and INFLUENZA LIKE ILLNESS (pain in my body like I was having the flu) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Cholesterol.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) and INFLUENZA LIKE ILLNESS (pain in my body like I was having the flu). At the time of the report, DYSPNOEA (shortness of breath) and INFLUENZA LIKE ILLNESS (pain in my body like I was having the flu) outcome was unknown.        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 medications included blood pressure medications and cholesterol medications.  Treatment includes tylenol
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine; 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 VACCINATION SITE REACTION (Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine). At the time of the report, VACCINATION SITE REACTION (Covid arm/ I had Covid arm 3 times  last time was on May 10th, 8 weeks after the last vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported , No treatment medication was reported .
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Gait disturbance
Clinical narrative: cant walk; can't stand/cant set up; 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 GAIT DISTURBANCE (cant walk) and DYSSTASIA (can't stand/cant set up) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (cant walk) and DYSSTASIA (can't stand/cant set up). At the time of the report, GAIT DISTURBANCE (cant walk) and DYSSTASIA (can't stand/cant set up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Granuloma annulare
Clinical narrative: strange pimple on their left thigh; Granuloma Annulare; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (Granuloma Annulare) and ACNE (strange pimple on their left thigh) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced GRANULOMA ANNULARE (Granuloma Annulare). On an unknown date, the patient experienced ACNE (strange pimple on their left thigh). At the time of the report, GRANULOMA ANNULARE (Granuloma Annulare) and ACNE (strange pimple on their left thigh) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Treatment Information was not provided by the reporter.   This case was linked to MOD-2021-182108 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Exceeded the 30 day refrigeration limit; Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) and PRODUCT STORAGE ERROR (Exceeded the 30 day refrigeration limit) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Exceeded the 30 day refrigeration limit). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) and PRODUCT STORAGE ERROR (Exceeded the 30 day refrigeration limit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant product use was provided by the reporter.  No treatment medication was provided.  The vials were placed in the refrigerator on 21-Apr2-021 and stayed in the same location until their administration date on 25-May-2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Fatigue, Headache, Pain in extremity
Clinical narrative: my back hurts; pain in my legs; my bones hurt; my head hurts a lot; I get very tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (my back hurts), PAIN IN EXTREMITY (pain in my legs), BONE PAIN (my bones hurt), HEADACHE (my head hurts a lot) and FATIGUE (I get very tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced BACK PAIN (my back hurts), PAIN IN EXTREMITY (pain in my legs), BONE PAIN (my bones hurt), HEADACHE (my head hurts a lot) and FATIGUE (I get very tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BACK PAIN (my back hurts), PAIN IN EXTREMITY (pain in my legs), BONE PAIN (my bones hurt), HEADACHE (my head hurts a lot) and FATIGUE (I get very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications included medication for cholesterol  and Medication for blood pressure, not specified.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Email response received On 11-Jun-2021: Translation received on 29-JUN-2021 and does not contain any new information.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: good size swelling on my arm; the swelling on the arm iches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (good size swelling on my arm) and PRURITUS (the swelling on the arm iches) 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 was provided by the reporter.     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 PERIPHERAL SWELLING (good size swelling on my arm) and PRURITUS (the swelling on the arm iches). At the time of the report, PERIPHERAL SWELLING (good size swelling on my arm) and PRURITUS (the swelling on the arm iches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: I received the Moderna vaccine and had several side effect from it; mild chest pains in the middle of my chest; fatigue; headache; body ache; chills; 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 VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (body ache) in a patient of an unknown age and gender 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 was provided by the reporter.    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 VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I received the Moderna vaccine and had several side effect from it; mild chest pains in the middle of my chest; fatigue; headache; body ache; chills; 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 VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache) and MYALGIA (body ache) in a patient of an unknown age and gender 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 was provided by the reporter.    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 VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (I received the Moderna vaccine and had several side effect from it), CHEST PAIN (mild chest pains in the middle of my chest), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (body ache) and CHILLS (chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment medication was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Peripheral swelling
Clinical narrative: Left arm redness; Left arm swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Left arm redness), PERIPHERAL SWELLING (Left arm swelling) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and D07B21A) for COVID-19 vaccination.     Concomitant products included INSULIN DEGLUDEC (TRESIBA), METOPROLOL, ISOSORBIDE MONONITRATE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, LOSARTAN and WARFARIN for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced ERYTHEMA (Left arm redness), PERIPHERAL SWELLING (Left arm swelling) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Left arm redness), PERIPHERAL SWELLING (Left arm swelling) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose received on day 57; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 57) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 048C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included QUINAPRIL HYDROCHLORIDE (ACCUPRIL), METOPROLOL, METFORMIN, HYDROCHLOROTHIAZIDE (HCTZ), ROSUVASTATIN and OMEPRAZOLE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 57). On 26-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose received on day 57) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received second dose on the 57th day from dose 1. Action taken with mRNA-1273 in response to the events was not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: follow up was received on 9-Jun-2021, contained no new information.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach pain/stomach has been killing me; 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 ABDOMINAL PAIN UPPER (stomach pain/stomach has been killing me) 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 ABDOMINAL PAIN UPPER (stomach pain/stomach has been killing me). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain/stomach has been killing me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm for a couple of days (left); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm for a couple of days (left)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 010M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MESALAZINE (MESALAMINE) for Ulcerative colitis.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm for a couple of days (left)). On 02-Mar-2021, VACCINATION SITE PAIN (Sore arm for a couple of days (left)) outcome was unknown.            No treatment medication was provided.   The patient had no side effects after taking first dose.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chest pain, Headache, Lymphadenopathy
Clinical narrative: Just slept; My arm was swollen for a month; Lymph nodes were swollen; Felt Congested; Got rash all over my body; Got hives; Still having aches in back \ The pain has moved to lower back; Having pain in upper chest; Stomach hurts; Have body aches \ Have muscle aches \ Still having aches in arm; Had headaches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested) and RASH (Got rash all over my body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy and Dust allergy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14-jun-2021, Reporter information was updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Peripheral swelling, Rash, Somnolence
Clinical narrative: Just slept; My arm was swollen for a month; Lymph nodes were swollen; Felt Congested; Got rash all over my body; Got hives; Still having aches in back \ The pain has moved to lower back; Having pain in upper chest; Stomach hurts; Have body aches \ Have muscle aches \ Still having aches in arm; Had headaches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested) and RASH (Got rash all over my body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy and Dust allergy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14-jun-2021, Reporter information was updated
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Just slept; My arm was swollen for a month; Lymph nodes were swollen; Felt Congested; Got rash all over my body; Got hives; Still having aches in back \ The pain has moved to lower back; Having pain in upper chest; Stomach hurts; Have body aches \ Have muscle aches \ Still having aches in arm; Had headaches; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested) and RASH (Got rash all over my body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pollen allergy and Dust allergy.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at a dose of 1 dosage form. At the time of the report, SOMNOLENCE (Just slept), PERIPHERAL SWELLING (My arm was swollen for a month), LYMPHADENOPATHY (Lymph nodes were swollen), MALAISE (Felt Congested), RASH (Got rash all over my body), URTICARIA (Got hives), BACK PAIN (Still having aches in back \ The pain has moved to lower back), CHEST PAIN (Having pain in upper chest), ABDOMINAL PAIN UPPER (Stomach hurts), MYALGIA (Have body aches \ Have muscle aches \ Still having aches in arm) and HEADACHE (Had headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14-jun-2021, Reporter information was updated
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain
Clinical narrative: shooting pain in the middle of my back; shooting pain radiating downwards; 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 BACK PAIN (shooting pain in the middle of my back) and PAIN (shooting pain radiating downwards) 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 BACK PAIN (shooting pain in the middle of my back) and PAIN (shooting pain radiating downwards). At the time of the report, BACK PAIN (shooting pain in the middle of my back) and PAIN (shooting pain radiating downwards) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: My side affects from first dose is really bad.; 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 ADVERSE EVENT (My side affects from first dose is really bad.) 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 ADVERSE EVENT (My side affects from first dose is really bad.). At the time of the report, ADVERSE EVENT (My side affects from first dose is really bad.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: major increase in hair loss, very large quantities; 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 ALOPECIA (major increase in hair loss, very large quantities) 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 ALOPECIA (major increase in hair loss, very large quantities). At the time of the report, ALOPECIA (major increase in hair loss, very large quantities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare
Clinical narrative: Granuloma Annulare; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (Granuloma Annulare) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced GRANULOMA ANNULARE (Granuloma Annulare). At the time of the report, GRANULOMA ANNULARE (Granuloma Annulare) outcome was unknown.            The patient developed Granuloma annulare that has been diagnosed by their dermatologist. The exact timetable of this condition is not fully known by the patient, but the rash is currently up their left leg, stomach, some of the right leg, and part of their front side. The patient believes it may have started as a strange pimple on their left thigh sometime after the first dose of the vaccine. After the second dose, the patient noticed this skin condition was more prominent. The patient has had screws put into their leg, so they are not entirely sure if the rash is related to the vaccine.   This case was linked to MOD-2021-181993 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up document was added with no new information
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Fatigue, Pain in extremity
Clinical narrative: Really, really, really bad lower abdominal cramps right over where the uterus is; Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm; Really, really tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (Really, really, really bad lower abdominal cramps right over where the uterus is), PAIN IN EXTREMITY (Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm) and FATIGUE (Really, really tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     no medical history was reported.  Concurrent medical conditions included Complex regional pain syndrome. Concomitant products included IBUPROFEN for Complex regional pain syndrome, ASCORBIC ACID (VIT C) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced ABDOMINAL PAIN LOWER (Really, really, really bad lower abdominal cramps right over where the uterus is), PAIN IN EXTREMITY (Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm) and FATIGUE (Really, really tired). The patient was treated with IBUPROFEN at a dose of 800 mg every four hours. At the time of the report, ABDOMINAL PAIN LOWER (Really, really, really bad lower abdominal cramps right over where the uterus is) was resolving and PAIN IN EXTREMITY (Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm) and FATIGUE (Really, really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID after first dose; 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 COVID-19 (COVID after first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 COVID-19 (COVID after first dose). At the time of the report, COVID-19 (COVID after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received doses from vials that had exceeded the 30 day refrigeration limit; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received doses from vials that had exceeded the 30 day refrigeration limit) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  Action taken with mRNA-1273 in response to the event was Not Applicable  The vials were placed in the refrigerator on 21-Apr-2021 and stayed in the same location until their administration date on 25-May-2021.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 RASH (Rash) 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder Hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder Hurting) in a 60-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 13-Apr-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 ARTHRALGIA (Shoulder Hurting). At the time of the report, ARTHRALGIA (Shoulder Hurting) outcome was unknown.            No concomitant medications were reported. Treatment medication included Muscle relaxer, moist heat pad.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects of the vaccine; 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 VACCINATION COMPLICATION (side effects of the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects of the vaccine). At the time of the report, VACCINATION COMPLICATION (side effects of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Sore throat; 46 days gap between first and second dose vaccine; Dont feel like eating and drinking; Flu like symptoms; Chills; Fever; Tiredness; Little bit nausea; Joint pains; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days gap between first and second dose vaccine), DECREASED APPETITE (Dont feel like eating and drinking), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-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 OROPHARYNGEAL PAIN (Sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days gap between first and second dose vaccine), DECREASED APPETITE (Dont feel like eating and drinking), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), NAUSEA (Little bit nausea) and ARTHRALGIA (Joint pains). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Dont feel like eating and drinking), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), NAUSEA (Little bit nausea) and ARTHRALGIA (Joint pains) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days gap between first and second dose vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient called her doctor and nurse and was told that if the symptoms are worse call them back. The patient didnt take any medications. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; 46 days gap between first and second dose vaccine; Dont feel like eating and drinking; Flu like symptoms; Chills; Fever; Tiredness; Little bit nausea; Joint pains; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days gap between first and second dose vaccine), DECREASED APPETITE (Dont feel like eating and drinking), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-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 OROPHARYNGEAL PAIN (Sore throat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days gap between first and second dose vaccine), DECREASED APPETITE (Dont feel like eating and drinking), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), NAUSEA (Little bit nausea) and ARTHRALGIA (Joint pains). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DECREASED APPETITE (Dont feel like eating and drinking), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Tiredness), NAUSEA (Little bit nausea) and ARTHRALGIA (Joint pains) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (46 days gap between first and second dose vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. The patient called her doctor and nurse and was told that if the symptoms are worse call them back. The patient didnt take any medications. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste in my mouth; 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 DYSGEUSIA (Metal taste in my mouth) 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 DYSGEUSIA (Metal taste in my mouth). At the time of the report, DYSGEUSIA (Metal taste in my mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Nausea
Clinical narrative: chills wash over off and on; nauseous; feel sick and it goes away but comes back off and on; 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 CHILLS (chills wash over off and on), NAUSEA (nauseous) and MALAISE (feel sick and it goes away but comes back off and on) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (chills wash over off and on), NAUSEA (nauseous) and MALAISE (feel sick and it goes away but comes back off and on).            Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Head discomfort, Hyperhidrosis, Loss of consciousness, Musculoskeletal discomfort
Clinical narrative: passed out on the floor; sweat; discomfort; Head is in discomfort; neck is in discomfort; very nauseous; sore at the site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the floor), HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included MAGNESIUM and COLECALCIFEROL, MENAQUINONE (D3 +K2) for an unknown indication.   On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the floor), HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort). On an unknown date, the patient experienced NAUSEA (very nauseous) and VACCINATION SITE PAIN (sore at the site). On 02-Jun-2021, HYPERHIDROSIS (sweat), DISCOMFORT (discomfort), HEAD DISCOMFORT (Head is in discomfort) and MUSCULOSKELETAL DISCOMFORT (neck is in discomfort) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out on the floor), NAUSEA (very nauseous) and VACCINATION SITE PAIN (sore at the site) had resolved.            The patient reported that neck and head discomfort could be due to the way of lying in the bed. The patient mentioned that there was no  problems with the first dose. Patient had no treatment, just drinking water and been lying on the floor because it was cold.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23/7/21: events outcome added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.