chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea, Pain, Pain in extremity
Clinical narrative: My arm was sore after the injection; fever; nausia; headache; aches; ill with flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INFLUENZA LIKE ILLNESS (ill with flu-like symptoms), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever) and NAUSEA (nausia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (HIVES/URTICARIA) and Hay fever. Concurrent medical conditions included Contrast media allergy (injected die for venagram, developed rash/hives over entire body) since 1985.   On 01-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Apr-2021, the patient experienced PAIN (aches), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever), NAUSEA (nausia) and HEADACHE (headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (ill with flu-like symptoms). At the time of the report, PAIN (aches), INFLUENZA LIKE ILLNESS (ill with flu-like symptoms), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever), NAUSEA (nausia) and HEADACHE (headache) had resolved.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-040954 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: My arm was sore after the injection; fever; nausia; headache; aches; ill with flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), INFLUENZA LIKE ILLNESS (ill with flu-like symptoms), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever) and NAUSEA (nausia) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (HIVES/URTICARIA) and Hay fever. Concurrent medical conditions included Contrast media allergy (injected die for venagram, developed rash/hives over entire body) since 1985.   On 01-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 01-Apr-2021, the patient experienced PAIN (aches), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever), NAUSEA (nausia) and HEADACHE (headache). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (ill with flu-like symptoms). At the time of the report, PAIN (aches), INFLUENZA LIKE ILLNESS (ill with flu-like symptoms), PAIN IN EXTREMITY (My arm was sore after the injection), PYREXIA (fever), NAUSEA (nausia) and HEADACHE (headache) had resolved.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-040954 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Unspecific adverse event.; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Unspecific adverse event.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Unspecific adverse event.). At the time of the report, ADVERSE EVENT (Unspecific adverse event.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided. No Treatment Information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection spot itchy; injection spot to still be slightly red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection spot itchy) and VACCINATION SITE ERYTHEMA (injection spot to still be slightly red) 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 PRURITUS (injection spot itchy) and VACCINATION SITE ERYTHEMA (injection spot to still be slightly red). At the time of the report, VACCINATION SITE PRURITUS (injection spot itchy) and VACCINATION SITE ERYTHEMA (injection spot to still be slightly red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not reported.  Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Pulmonary pain
Clinical narrative: Painful right lung; Coughing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (Painful right lung) and COUGH (Coughing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (Painful right lung) and COUGH (Coughing). At the time of the report, PULMONARY PAIN (Painful right lung) and COUGH (Coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Persistent headache for the past week; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Persistent headache for the past week) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was provided.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Persistent headache for the past week). The patient was treated with IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (Persistent headache for the past week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had persistent headache for the past week since she was administered with first dose of vaccination. As she did not have her vaccination card so was unable to provide lot and expiration date.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Lymphadenopathy, Myalgia
Clinical narrative: Can't sleep at night; A lot of discomfort; All his joints hurt; Headaches; Lymph nodes are really swollen in his armpits and his groin area; Body pains like with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches) and LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer survivor) in 2017. Concurrent medical conditions included Reactive arthritis and Immune system disorder. Concomitant products included TRAMADOL and PREGABALIN (LYRICA) for an unknown indication.   On 14-Aug-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 14-Aug-2021, the patient experienced INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches), LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) and MYALGIA (Body pains like with the first dose). At the time of the report, INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches), LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) and MYALGIA (Body pains like with the first dose) outcome was unknown.            Patient couldn't remember all the concomitant medications.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-287392 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site discomfort
Clinical narrative: Can't sleep at night; A lot of discomfort; All his joints hurt; Headaches; Lymph nodes are really swollen in his armpits and his groin area; Body pains like with the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches) and LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cancer (Cancer survivor) in 2017. Concurrent medical conditions included Reactive arthritis and Immune system disorder. Concomitant products included TRAMADOL and PREGABALIN (LYRICA) for an unknown indication.   On 14-Aug-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 14-Aug-2021, the patient experienced INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches), LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) and MYALGIA (Body pains like with the first dose). At the time of the report, INSOMNIA (Can't sleep at night), VACCINATION SITE DISCOMFORT (A lot of discomfort), ARTHRALGIA (All his joints hurt), HEADACHE (Headaches), LYMPHADENOPATHY (Lymph nodes are really swollen in his armpits and his groin area) and MYALGIA (Body pains like with the first dose) outcome was unknown.            Patient couldn't remember all the concomitant medications.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-287392 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: Missed 2nd dose; Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine) and PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). On 10-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine received by an underage patient/Consumer under 18 years old got 1st dose of the vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not reported.  Treatment information was not provided by the reporter.  The patient denied 2nd dose of the vaccine and did not received the 2nd dose.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Reporter Address details updated. Patient demographics was updated. Suspect product Batch/Lot number was updated.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the second dose of the vaccine more than 36 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days after the first dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042021A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days after the first dose). On 02-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the vaccine more than 36 days after the first dose) had resolved.            No concomitant medications were reported.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Pruritus, Rash
Clinical narrative: arm was hot; arm was itching; arm was red; arm was swollen; Arm was rashy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm was hot), PRURITUS (arm was itching), ERYTHEMA (arm was red), PERIPHERAL SWELLING (arm was swollen) and RASH (Arm was rashy) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced FEELING HOT (arm was hot), PRURITUS (arm was itching), ERYTHEMA (arm was red), PERIPHERAL SWELLING (arm was swollen) and RASH (Arm was rashy). The patient was treated with HYDROCORTISONE (HYDROCORTICONE) for Adverse event, at a dose of 1 dosage form. On 16-Aug-2021, PERIPHERAL SWELLING (arm was swollen) had resolved. At the time of the report, FEELING HOT (arm was hot), PRURITUS (arm was itching) and RASH (Arm was rashy) outcome was unknown and ERYTHEMA (arm was red) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by  the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient got their first vaccine in January2021 & still not received second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got their first vaccine in January2021 & still not received second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got their first vaccine in January2021 & still not received second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient got their first vaccine in January2021 & still not received second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I experienced every side effect possible; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I experienced every side effect possible) 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 VACCINATION COMPLICATION (I experienced every side effect possible). At the time of the report, VACCINATION COMPLICATION (I experienced every side effect possible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and ASTHENIA (Weakness) 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 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment medication was not provided. The patient considered the events Dizziness and Weakness might related to the BP.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis/plaques were on my elbows/legs; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis/plaques were on my elbows/legs) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to all OTC cough medications), Allergy to arthropod bite (fire ant bites.) and Psoriasis (Psoriasis for as long as he can remember - certainly back as far as 1970s or 80 s, perhaps more. Usually treated with tropical steroids, to little effect.).   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (psoriasis/plaques were on my elbows/legs). At the time of the report, PSORIASIS (psoriasis/plaques were on my elbows/legs) was resolving.            concomitant medication include tropical steroids for psoriasis  No treatment medication information was provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Cough, Fatigue, Myalgia
Clinical narrative: Sore arm; wants to sleep all the time/sleepiness; a little nasal stuffed up; a little coughing; lost her taste; joint pain; Muscle ache/all these aching; Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste) and ARTHRALGIA (joint pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient history information was provided.  Concomitant products included MIRTAZAPINE (REMERON), LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Aug-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 (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste), ARTHRALGIA (joint pain), MYALGIA (Muscle ache/all these aching), FATIGUE (Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores) and PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN for Muscle ache and Fatigue, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste), ARTHRALGIA (joint pain), MYALGIA (Muscle ache/all these aching), FATIGUE (Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores) and PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Somnolence
Clinical narrative: Sore arm; wants to sleep all the time/sleepiness; a little nasal stuffed up; a little coughing; lost her taste; joint pain; Muscle ache/all these aching; Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste) and ARTHRALGIA (joint pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No patient history information was provided.  Concomitant products included MIRTAZAPINE (REMERON), LISINOPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 08-Aug-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 (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste), ARTHRALGIA (joint pain), MYALGIA (Muscle ache/all these aching), FATIGUE (Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores) and PAIN IN EXTREMITY (Sore arm). The patient was treated with IBUPROFEN for Muscle ache and Fatigue, at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (wants to sleep all the time/sleepiness), NASAL CONGESTION (a little nasal stuffed up), COUGH (a little coughing), AGEUSIA (lost her taste), ARTHRALGIA (joint pain), MYALGIA (Muscle ache/all these aching), FATIGUE (Real fatigue/"very very tired"/tiredness/tired all the time/has to lie down after doing some chores) and PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Felt tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and FATIGUE (Felt tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L204 and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Anxiety, Arthritis and Heart block NOS (Left Ventricle Blockage in the heart.). Concomitant products included ALPRAZOLAM for Anxiety, AMLODIPINE BESILATE (NORVASC) for Hypertension.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced MYALGIA (Sore arm). On 20-Jan-2021, the patient experienced FATIGUE (Felt tired). At the time of the report, MYALGIA (Sore arm) had resolved and FATIGUE (Felt tired) outcome was unknown.      Treatment medication was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-287599 (Patient Link).   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise
Clinical narrative: I was weak all over/I didn't want to get out of bed; Malaise; Headache; This case was received via United Kingdom MHRA (Reference number: MOD21-131145) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (I was weak all over/I didn't want to get out of bed), MALAISE (Malaise) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Arm discomfort (a metal rod in the left humorous), Knee replacement (Both knees replaced) and Hip replacement (Left hip replacement). Concurrent medical conditions included Arthritis (Severe arthritis), Scoliosis and Stenosis.   On 13-Feb-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 15-Feb-2021, the patient experienced ASTHENIA (I was weak all over/I didn't want to get out of bed), MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, ASTHENIA (I was weak all over/I didn't want to get out of bed), MALAISE (Malaise) and HEADACHE (Headache) had resolved.            No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  The events lasted for 4 to 5 hours, came and went away for the patient.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Felt really tired) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Felt really tired). At the time of the report, PYREXIA (Fever) and FATIGUE (Felt really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: got a third 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 EXTRA DOSE ADMINISTERED (got a third 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 third 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 1 dosage form and 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 EXTRA DOSE ADMINISTERED (got a third dose). At the time of the report, EXTRA DOSE ADMINISTERED (got a third dose) outcome was unknown.            No concomitant medications were reported. Treatment medications were not provided by reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported. Patient has it every day to varying degrees and It's more prominent when the patient is idle.   This case was linked to MOD-2021-287685 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Gastrointestinal disorder, Vaccination complication
Clinical narrative: she got the 2nd shot and it got worse for her; I have read a whole bunch of stuff about gastro issues; people have experienced bloating; lady had same symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she got the 2nd shot and it got worse for her), ABDOMINAL DISCOMFORT (I have read a whole bunch of stuff about gastro issues), ABDOMINAL DISTENSION (people have experienced bloating) and GASTROINTESTINAL DISORDER (lady had same symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (she got the 2nd shot and it got worse for her), ABDOMINAL DISCOMFORT (I have read a whole bunch of stuff about gastro issues), ABDOMINAL DISTENSION (people have experienced bloating) and GASTROINTESTINAL DISORDER (lady had same symptoms). At the time of the report, VACCINATION COMPLICATION (she got the 2nd shot and it got worse for her), ABDOMINAL DISCOMFORT (I have read a whole bunch of stuff about gastro issues), ABDOMINAL DISTENSION (people have experienced bloating) and GASTROINTESTINAL DISORDER (lady had same symptoms) outcome was unknown.            No concomitant medications was reported.  No treatment medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: recently got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (recently got Covid) 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 COVID-19 (recently got Covid). At the time of the report, COVID-19 (recently got Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medications reported.   Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: He had tinnitus after the 1st shot which got a little worse after the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (He had tinnitus after the 1st shot which got a little worse after the 2nd shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (He had tinnitus after the 1st shot which got a little worse after the 2nd shot). At the time of the report, TINNITUS (He had tinnitus after the 1st shot which got a little worse after the 2nd shot) outcome was unknown.            no concomitant medications were reported treatment information was not provided. Patient has tinnitus every day to varying degrees.  It's more prominent when he's idle and it's quiet and less noticeable when he's busy or in conversation.   This case was linked to MOD-2021-287633 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Vaccine Interaction 1st dose Moderna 2nd dose Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Vaccine Interaction 1st dose Moderna 2nd dose Pfizer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Vaccine Interaction 1st dose Moderna 2nd dose Pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Vaccine Interaction 1st dose Moderna 2nd dose Pfizer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Urticaria
Clinical narrative: Diarrhea; Hives; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), URTICARIA (Hives) and FATIGUE (Fatigue) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939893) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Codeine).    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced DIARRHOEA (Diarrhea), URTICARIA (Hives) and FATIGUE (Fatigue). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), URTICARIA (Hives) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. No lab data provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: An I take Tylenol for the pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (An I take Tylenol for the pain) 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 (An I take Tylenol for the pain). At the time of the report, PAIN (An I take Tylenol for the pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter  No Treatment  information were provided by the reporter   Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.; the arm there is very hard; arm is quite swollen there; is in a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.), VACCINATION SITE INDURATION (the arm there is very hard), VACCINATION SITE SWELLING (arm is quite swollen there) and VACCINATION SITE PAIN (is in a lot of pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANXIETY (worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.), VACCINATION SITE INDURATION (the arm there is very hard), VACCINATION SITE SWELLING (arm is quite swollen there) and VACCINATION SITE PAIN (is in a lot of pain). At the time of the report, ANXIETY (worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.), VACCINATION SITE INDURATION (the arm there is very hard), VACCINATION SITE SWELLING (arm is quite swollen there) and VACCINATION SITE PAIN (is in a lot of pain) outcome was unknown.            No concomitant medication listed.  No treatment information reported.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: First dose Pfizer, second dose Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (First dose Pfizer, second dose Moderna) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (First dose Pfizer, second dose Moderna). On 17-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (First dose Pfizer, second dose Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist is asking if patient can receive another shot of Moderna vaccine and complete the series or if he's good with both doses he has already received. Pharmacist doesn't know where did patient receive his doses Patient's not immunocompromised as for Pharmacist's knowledge  No concomitant medication was provided  Treatment medication was not provided by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Heart rate increased
Clinical narrative: Rapid heart beat after the first shot; Not sure if it was anxiety after the first shot; 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 HEART RATE INCREASED (Rapid heart beat after the first shot) and ANXIETY (Not sure if it was anxiety after the first shot) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEART RATE INCREASED (Rapid heart beat after the first shot) and ANXIETY (Not sure if it was anxiety after the first shot). In 2021, HEART RATE INCREASED (Rapid heart beat after the first shot) and ANXIETY (Not sure if it was anxiety after the first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment provided. Patient states that she is terrified of getting the second dose.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin mass, Vaccination site rash
Clinical narrative: spreading/it went from a raised bump to a flat, rash kind of thing; it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing; I had a rash at the injection site  that looked like a burnt mark; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing), RASH (spreading/it went from a raised bump to a flat, rash kind of thing) and VACCINATION SITE RASH (I had a rash at the injection site  that looked like a burnt mark) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history has been reported.  Concomitant products included METFORMIN, LOSARTAN, METOPROLOL and ATORVASTATIN for an unknown indication.   On 20-Apr-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 22-Apr-2021, the patient experienced VACCINATION SITE RASH (I had a rash at the injection site  that looked like a burnt mark). On 23-Apr-2021, the patient experienced SKIN MASS (it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing). On an unknown date, the patient experienced RASH (spreading/it went from a raised bump to a flat, rash kind of thing). On 24-Apr-2021, VACCINATION SITE RASH (I had a rash at the injection site  that looked like a burnt mark) had resolved. At the time of the report, SKIN MASS (it was right above the ring finger/the bump started to flatten out/it went from a raised bump to a flat, rash kind of thing) and RASH (spreading/it went from a raised bump to a flat, rash kind of thing) outcome was unknown.            Treatment drug not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Had fever of 100-101 for over 48 hours after getting 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Had fever of 100-101 for over 48 hours after getting 1st shot) 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 PYREXIA (Had fever of 100-101 for over 48 hours after getting 1st shot). At the time of the report, PYREXIA (Had fever of 100-101 for over 48 hours after getting 1st shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) fever of 100-101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Palpitations, Vaccination complication
Clinical narrative: Worried; Palpitation; Strong side effects; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), VACCINATION COMPLICATION (Strong side effects) and ANXIETY (Worried) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing impaired.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects). On 31-Jul-2021, the patient experienced ANXIETY (Worried). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects) was resolving and ANXIETY (Worried) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.