chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: redness in her shoulder blade and a under arm areas; Slightly raised rash on the left arm; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness in her shoulder blade and a under arm areas) and RASH (Slightly raised rash on the left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced RASH (Slightly raised rash on the left arm). On an unknown date, the patient experienced ERYTHEMA (redness in her shoulder blade and a under arm areas). At the time of the report, ERYTHEMA (redness in her shoulder blade and a under arm areas) and RASH (Slightly raised rash on the left arm) outcome was unknown.            Concomitant medications are not provided by the reporter. No treatment drugs are not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: having the flu like symptoms now; 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 INFLUENZA LIKE ILLNESS (having the flu like symptoms now) 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 second 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 2. On 30-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (having the flu like symptoms now). At the time of the report, INFLUENZA LIKE ILLNESS (having the flu like symptoms now) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm is really really sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm is really really sore) 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 29-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm is really really sore). At the time of the report, PAIN IN EXTREMITY (my arm is really really sore) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Severe joint pain; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe joint pain) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Severe joint pain) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Severe joint pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: He missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He missed 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A,) for COVID-19 vaccination.     No Medical History information was reported.    On 22-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 PRODUCT DOSE OMISSION ISSUE (He missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He missed 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Myalgia
Clinical narrative: got a little sick after my second shot that lasted a week or more; joints hurt; still achy; 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 ILLNESS (got a little sick after my second shot that lasted a week or more), ARTHRALGIA (joints hurt) and MYALGIA (still achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced ILLNESS (got a little sick after my second shot that lasted a week or more), ARTHRALGIA (joints hurt) and MYALGIA (still achy). At the time of the report, ILLNESS (got a little sick after my second shot that lasted a week or more), ARTHRALGIA (joints hurt) and MYALGIA (still achy) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: very sick; 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 MALAISE (very sick) 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 MALAISE (very sick). At the time of the report, MALAISE (very sick) 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.
Sex: U
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Told to wait 90 days for my 2nd 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 INTENTIONAL PRODUCT USE ISSUE (Told to wait 90 days for my 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Developed symptoms) on 05-Apr-2021.    On 07-Apr-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 INTENTIONAL PRODUCT USE ISSUE (Told to wait 90 days for my 2nd dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Told to wait 90 days for my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.  The patient received monoclonal antibody treatment on 16-APR-2021. The patient was told to wait 90 days for second dose.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site nodule
Clinical narrative: knot under my skin at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (knot under my skin at the injection site) 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 VACCINATION SITE NODULE (knot under my skin at the injection site). At the time of the report, VACCINATION SITE NODULE (knot under my skin at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I'm feeling really miserable today; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I'm feeling really miserable today) 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 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. On an unknown date, the patient experienced MALAISE (I'm feeling really miserable today). At the time of the report, MALAISE (I'm feeling really miserable today) outcome was unknown.            No concomitant medications were provided No treatment medications were provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Suspected COVID-19
Clinical narrative: COVID-19 symptoms; Body Ache; Headache; 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 SUSPECTED COVID-19 (COVID-19 symptoms), MYALGIA (Body Ache) and HEADACHE (Headache) 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 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID-19 symptoms), MYALGIA (Body Ache) and HEADACHE (Headache). At the time of the report, SUSPECTED COVID-19 (COVID-19 symptoms), MYALGIA (Body Ache) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: 13 year old son received the Moderna COVID-19 Vaccine instead of the Pfizer vaccine; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old son received the Moderna COVID-19 Vaccine instead of the Pfizer vaccine) and PYREXIA (slight fever) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old son received the Moderna COVID-19 Vaccine instead of the Pfizer vaccine) and PYREXIA (slight fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of 1 UNK. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old son received the Moderna COVID-19 Vaccine instead of the Pfizer vaccine) had resolved and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were taken by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Tired after the 2nd dose; Started feeling flu like; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Started feeling flu like) and FATIGUE (Tired after the 2nd 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 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Started feeling flu like). On an unknown date, the patient experienced FATIGUE (Tired after the 2nd dose). At the time of the report, INFLUENZA LIKE ILLNESS (Started feeling flu like) and FATIGUE (Tired after the 2nd dose) outcome was unknown.            No concomitant medication was reported.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizyness; 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 DIZZINESS (dizyness) 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 DIZZINESS (dizyness). At the time of the report, DIZZINESS (dizyness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient concomitant medication was not provided. Treatment information was not mentioned   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site warmth, Neck pain, Pain, Vaccination site erythema
Clinical narrative: Injection site burning hot to touch; Pain up to the neck; Stinging when receiving vaccination; Itchy; Red patch at injection site; Painful; Red patch at injection site; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (ESCITALOPRAM AL) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Red patch at injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (Red patch at injection site). The patient was treated with HYDROXYZINE at a dose of 25 mg and CYCLOBENZAPRINE at a dose of 10 mg. At the time of the report, INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy), HEADACHE (Headache), VACCINATION SITE RASH (Red patch at injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (Red patch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   About 3 days later, the patient noticed a red patch at the injection site that became itchy, painful, and also burned. She felt pain up to the neck and injection site was burning hot to touch. She reports stinging when receiving vaccination. Reported that doctor thinks it was injected to nerves.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Injection site burning hot to touch; Pain up to the neck; Stinging when receiving vaccination; Itchy; Red patch at injection site; Painful; Red patch at injection site; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ESCITALOPRAM OXALATE (ESCITALOPRAM AL) for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Red patch at injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (Red patch at injection site). The patient was treated with HYDROXYZINE at a dose of 25 mg and CYCLOBENZAPRINE at a dose of 10 mg. At the time of the report, INJECTION SITE WARMTH (Injection site burning hot to touch), NECK PAIN (Pain up to the neck), PAIN (Stinging when receiving vaccination), VACCINATION SITE PRURITUS (Itchy), HEADACHE (Headache), VACCINATION SITE RASH (Red patch at injection site), VACCINATION SITE PAIN (Painful) and VACCINATION SITE ERYTHEMA (Red patch at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   About 3 days later, the patient noticed a red patch at the injection site that became itchy, painful, and also burned. She felt pain up to the neck and injection site was burning hot to touch. She reports stinging when receiving vaccination. Reported that doctor thinks it was injected to nerves.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Cough, Neck pain, Pain
Clinical narrative: Still a band of pain under my breasts; Pain right arm; Pain upper back; Pain neck; Pain; Dry cough; Felt like throat was closing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck) 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 information was reported.   On 27-May-2021 at 12:00 PM, 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 27-May-2021, the patient experienced COUGH (Dry cough) and THROAT TIGHTNESS (Felt like throat was closing). On 28-May-2021 at 4:30 AM, the patient experienced PAIN (Pain). On an unknown date, the patient experienced BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck). On 27-May-2021, COUGH (Dry cough) and THROAT TIGHTNESS (Felt like throat was closing) had resolved. At the time of the report, PAIN (Pain), BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck) had not resolved.            Treatment provided include an unknown medication. Concomitant medication list was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Throat tightness
Clinical narrative: Still a band of pain under my breasts; Pain right arm; Pain upper back; Pain neck; Pain; Dry cough; Felt like throat was closing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck) 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 information was reported.   On 27-May-2021 at 12:00 PM, 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 27-May-2021, the patient experienced COUGH (Dry cough) and THROAT TIGHTNESS (Felt like throat was closing). On 28-May-2021 at 4:30 AM, the patient experienced PAIN (Pain). On an unknown date, the patient experienced BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck). On 27-May-2021, COUGH (Dry cough) and THROAT TIGHTNESS (Felt like throat was closing) had resolved. At the time of the report, PAIN (Pain), BREAST PAIN (Still a band of pain under my breasts), PAIN IN EXTREMITY (Pain right arm), BACK PAIN (Pain upper back) and NECK PAIN (Pain neck) had not resolved.            Treatment provided include an unknown medication. Concomitant medication list was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Facial spasm
Clinical narrative: facial tic/tics have slowed down to once a minute; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL SPASM (facial tic/tics have slowed down to once a minute) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.     On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL SPASM (facial tic/tics have slowed down to once a minute). At the time of the report, FACIAL SPASM (facial tic/tics have slowed down to once a minute) 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product, Wrong product administered
Clinical narrative: A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine; A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-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 28-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2). On 28-May-2021, WRONG PRODUCT ADMINISTERED (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2 doses of the Moderna Covid-19 Vaccine) and ACCIDENTAL EXPOSURE TO PRODUCT (A 3rd dose of Pfizer Covid-19 vaccine was mistakenly administer to a patient who already took 2) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.  Patient already received their 1st and 2nd dose of the Moderna Covid-19 vaccine. 2nd dose was given on 03 May 2021. Patient came into the Pharmacy today for their Shingles vaccine but mistakenly went into covid-19 vaccination room where they were administered the Pfizer Covid-19 vaccine.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient returned later than 14 days for the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient returned later than 14 days for the second dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient returned later than 14 days for the second dose). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient returned later than 14 days for the second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Head ache; 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 HEADACHE (Head ache) 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 HEADACHE (Head ache). At the time of the report, HEADACHE (Head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Forgot to take 2nd 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 INTENTIONAL PRODUCT USE ISSUE (Forgot to take 2nd vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 INTENTIONAL PRODUCT USE ISSUE (Forgot to take 2nd vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Forgot to take 2nd vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms, Musculoskeletal stiffness, Paraesthesia, Vaccination site pain
Clinical narrative: (2 week after vaccination ) (Right arm) tingling which runs down into the ring and pinky fingers; (2 week after vaccination ) (Right arm) numbness; (2 week after vaccination ) (Right arm) muscle spasms; (2 week after vaccination ) (Right arm) stiffness; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection site), PARAESTHESIA ((2 week after vaccination ) (Right arm) tingling which runs down into the ring and pinky fingers), HYPOAESTHESIA ((2 week after vaccination ) (Right arm) numbness), MUSCLE SPASMS ((2 week after vaccination ) (Right arm) muscle spasms) and MUSCULOSKELETAL STIFFNESS ((2 week after vaccination ) (Right arm) stiffness) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection site). On 20-May-2021, the patient experienced PARAESTHESIA ((2 week after vaccination ) (Right arm) tingling which runs down into the ring and pinky fingers), HYPOAESTHESIA ((2 week after vaccination ) (Right arm) numbness), MUSCLE SPASMS ((2 week after vaccination ) (Right arm) muscle spasms) and MUSCULOSKELETAL STIFFNESS ((2 week after vaccination ) (Right arm) stiffness). At the time of the report, VACCINATION SITE PAIN (Soreness at injection site), PARAESTHESIA ((2 week after vaccination ) (Right arm) tingling which runs down into the ring and pinky fingers), HYPOAESTHESIA ((2 week after vaccination ) (Right arm) numbness), MUSCLE SPASMS ((2 week after vaccination ) (Right arm) muscle spasms) and MUSCULOSKELETAL STIFFNESS ((2 week after vaccination ) (Right arm) stiffness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history not provided.  Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Fevers; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fevers) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fevers). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fevers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Skin mass, Vaccination site mass
Clinical narrative: Have a lump in my arm from the shot; Have a small bump in my arm we're I got the 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 SKIN MASS (Have a lump in my arm from the shot) and VACCINATION SITE MASS (Have a small bump in my arm we're I got the 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (Have a lump in my arm from the shot) and VACCINATION SITE MASS (Have a small bump in my arm we're I got the shot). At the time of the report, SKIN MASS (Have a lump in my arm from the shot) and VACCINATION SITE MASS (Have a small bump in my arm we're I got the shot) outcome was unknown.            No concomitant medications were reported Treatment medications were  not reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Pain at shoulder down to forarm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain at shoulder down to forarm) 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) dosage form. On an unknown date, the patient experienced ARTHRALGIA (Pain at shoulder down to forarm). At the time of the report, ARTHRALGIA (Pain at shoulder down to forarm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       AE submitted. no concomitant medications and treatment medications are provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) 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 CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: migraine; I'm sore all over; 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 MIGRAINE (migraine) and MYALGIA (I'm sore all over) 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) dosage form. On an unknown date, the patient experienced MIGRAINE (migraine) and MYALGIA (I'm sore all over). At the time of the report, MIGRAINE (migraine) and MYALGIA (I'm sore all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. No treatment was reported.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slight arm pain at injection site) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Slight arm pain at injection site). At the time of the report, VACCINATION SITE PAIN (Slight arm pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain on my right side of my body; 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 MYALGIA (pain on my right side of my body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced MYALGIA (pain on my right side of my body). At the time of the report, MYALGIA (pain on my right side of my body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed 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 PRODUCT DOSE OMISSION ISSUE (missed 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medication were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Myalgia
Clinical narrative: Can barley get it up above the head; Arm still sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Can barley get it up above the head) and MYALGIA (Arm still sore) 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 LIMB DISCOMFORT (Can barley get it up above the head) and MYALGIA (Arm still sore). At the time of the report, LIMB DISCOMFORT (Can barley get it up above the head) and MYALGIA (Arm still sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drug was provided. No concomitant drugs provided.  Action taken with respect to product mRNA-1273 was  not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; 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 AGEUSIA (Loss of taste) 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 AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; 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 INFLUENZA (Flu) 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 INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Product dose omission in error
Clinical narrative: she did not have any side effects but got scared from what she heard from other people; patient did not receive the second dose of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ANXIETY (she did not have any side effects but got scared from what she heard from other people) and PRODUCT DOSE OMISSION IN ERROR (patient did not receive the second dose of the vaccine) 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 12-Feb-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 ANXIETY (she did not have any side effects but got scared from what she heard from other people) and PRODUCT DOSE OMISSION IN ERROR (patient did not receive the second dose of the vaccine). At the time of the report, ANXIETY (she did not have any side effects but got scared from what she heard from other people) and PRODUCT DOSE OMISSION IN ERROR (patient did not receive the second dose of the vaccine) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: vaccination site reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (vaccination site reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (vaccination site reaction). At the time of the report, VACCINATION SITE REACTION (vaccination site reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data provided by reporter. No concomitant medication provided by reporter. No treatment medication provided by reporter.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Disturbance in attention, Feeling abnormal, Pruritus, Rash
Clinical narrative: Foggy feeling in head; Concentration impaired; Rash over arms; Itchy; Taste loss; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash over arms), PRURITUS (Itchy), AGEUSIA (Taste loss), FEELING ABNORMAL (Foggy feeling in head) and DISTURBANCE IN ATTENTION (Concentration impaired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Hysterectomy. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication.   On 29-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 06-May-2021, the patient experienced RASH (Rash over arms), PRURITUS (Itchy) and AGEUSIA (Taste loss). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head) and DISTURBANCE IN ATTENTION (Concentration impaired). At the time of the report, RASH (Rash over arms), PRURITUS (Itchy), AGEUSIA (Taste loss), FEELING ABNORMAL (Foggy feeling in head) and DISTURBANCE IN ATTENTION (Concentration impaired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Cortisone cream, Calamine lotion and Benadryl for itching.  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.; 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.