chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Nipple pain, Pain in extremity, Pyrexia
Clinical narrative: Nipples are very sore; My arm and armpits hurt; My arm and armpits hurt; High fevers all day; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (Nipples are very sore), PAIN IN EXTREMITY (My arm and armpits hurt), AXILLARY PAIN (My arm and armpits hurt) and PYREXIA (High fevers all day) 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 dosage form. On an unknown date, the patient experienced NIPPLE PAIN (Nipples are very sore), PAIN IN EXTREMITY (My arm and armpits hurt), AXILLARY PAIN (My arm and armpits hurt) and PYREXIA (High fevers all day). At the time of the report, NIPPLE PAIN (Nipples are very sore), PAIN IN EXTREMITY (My arm and armpits hurt), AXILLARY PAIN (My arm and armpits hurt) and PYREXIA (High fevers all day) outcome was unknown.            No concomitant medication information were provided. No treatment information were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Neck pain, Weight decreased
Clinical narrative: weight loss; Back pain; Neck pain; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (weight loss), BACK PAIN (Back pain) and NECK PAIN (Neck 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 05-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 WEIGHT DECREASED (weight loss), BACK PAIN (Back pain) and NECK PAIN (Neck pain). At the time of the report, WEIGHT DECREASED (weight loss), BACK PAIN (Back pain) and NECK PAIN (Neck pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Foreign body reaction, Vaccination complication
Clinical narrative: Filler reactions/Seen lots of filler reactions; Foreign body reactions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (Filler reactions/Seen lots of filler reactions) and FOREIGN BODY REACTION (Foreign body reactions) 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 VACCINATION COMPLICATION (Filler reactions/Seen lots of filler reactions) and FOREIGN BODY REACTION (Foreign body reactions). At the time of the report, VACCINATION COMPLICATION (Filler reactions/Seen lots of filler reactions) and FOREIGN BODY REACTION (Foreign body reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash macular, Urticaria
Clinical narrative: breaking out in hives all over his body; An area on his arm or leg will begin itching terribly; Turn red; A spot on arm would turn red and begin itching; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out in hives all over his body), PRURITUS (An area on his arm or leg will begin itching terribly), ERYTHEMA (Turn red) and RASH MACULAR (A spot on arm would turn red and begin itching) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stones since 07-Mar-2020. Concomitant products included LYSINE for Cold sores, VITAMIN B COMPLEX for Vitamin B complex supplementation.   On 26-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced URTICARIA (breaking out in hives all over his body). 28-Apr-2021, the patient experienced PRURITUS (An area on his arm or leg will begin itching terribly), ERYTHEMA (Turn red) and RASH MACULAR (A spot on arm would turn red and begin itching). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) on 08-Jun-2021 for Adverse event, at an unspecified dose and frequency and HYDROXYZINE (oral) on 08-Jun-2021 for Adverse event, at an unspecified dose and frequency. On 31-Jul-2021, URTICARIA (breaking out in hives all over his body), PRURITUS (An area on his arm or leg will begin itching terribly), ERYTHEMA (Turn red) and RASH MACULAR (A spot on arm would turn red and begin itching) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received on 05-AUG-2021 contains significant information Patient demographics, Treatment drug information was added and event added and outcome of event updated, reporters causality updated.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed Dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed Dose) in a 47-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 14-Apr-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 (Missed Dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed Dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: I received the first moderna vaccine in January then got Covid; I never received the second shot can I still get it; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I received the first moderna vaccine in January then got Covid) and PRODUCT DOSE OMISSION ISSUE (I never received the second shot can I still get it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I received the first moderna vaccine in January then got Covid) and PRODUCT DOSE OMISSION ISSUE (I never received the second shot can I still get it). At the time of the report, COVID-19 (I received the first moderna vaccine in January then got Covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I never received the second shot can I still get it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale) 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 PAIN (woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale). At the time of the report, PAIN (woke up with lots of pain on our side/pain was about a 7 on the 1-10 scale) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment information was not provided.    This case was linked to MOD21-120904 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Feel side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feel side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Feel side effects). At the time of the report, VACCINATION COMPLICATION (Feel side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain assessment
Clinical narrative: woke up with lots of pain on our side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (woke up with lots of pain on our side) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (woke up with lots of pain on our side). At the time of the report, PAIN (woke up with lots of pain on our side) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 7 (High) the pain was about a 7 on the 1-10 scale.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye irritation
Clinical narrative: eyes burn; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes burn) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical information was provided.     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 EYE IRRITATION (eyes burn). At the time of the report, EYE IRRITATION (eyes burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: he started to feel heart palpitations -palpitations and now he says they're worse; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (he started to feel heart palpitations -palpitations and now he says they're worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PALPITATIONS (he started to feel heart palpitations -palpitations and now he says they're worse). At the time of the report, PALPITATIONS (he started to feel heart palpitations -palpitations and now he says they're worse) had not resolved.            The concomitant medications was not reported. The treatment history was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Clear Liquid (Not Blood) ran down his arm after the Second Shot; Clear Liquid (Not Blood) ran down his arm after the Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) and DEVICE CONNECTION ISSUE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 013M20A) 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) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced UNDERDOSE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) and DEVICE CONNECTION ISSUE (Clear Liquid (Not Blood) ran down his arm after the Second Shot). On 12-Mar-2021, UNDERDOSE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) and DEVICE CONNECTION ISSUE (Clear Liquid (Not Blood) ran down his arm after the Second Shot) had resolved.            Patient stated that right after getting the second dose, a Clear Liquid (Not Blood) ran down his arm with a little bit of blood. The person who vaccinated him didn't say anything. But now he is wondering if he should get another shot with the Delta variant being around.  No relevant concomitant medication information provided.  No relevant treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Updated verbatim of the event.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Got heart issues about 1 week after got first; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Got heart issues about 1 week after got first) 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 CARDIAC DISORDER (Got heart issues about 1 week after got first). At the time of the report, CARDIAC DISORDER (Got heart issues about 1 week after got first) 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.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given the shot one week early to a patient/received 2nd Moderna dose at 21 days/ one week early; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the shot one week early to a patient/received 2nd Moderna dose at 21 days/ one week early) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the shot one week early to a patient/received 2nd Moderna dose at 21 days/ one week early). On 13-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Given the shot one week early to a patient/received 2nd Moderna dose at 21 days/ one week early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-Jul-2021 contains significant information. The second dose start date of the Moderna vaccine was added. The event was updated. On 20-Jul-2021: Follow-up received on 20-Jul-2021 contains significant information. The patient demographics (Patient's initials, DOB) were added. The start date and Lot no. of first and second Moderna vaccine was added. The expiry date of the second dose was added.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: headache; sore throat; Feverish; Rash; Redness; pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D28D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-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 HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash), ERYTHEMA (Redness) and PAIN (pain). At the time of the report, HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash), ERYTHEMA (Redness) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: headache; sore throat; Feverish; Rash; Redness; pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D28D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Jul-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 HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash), ERYTHEMA (Redness) and PAIN (pain). At the time of the report, HEADACHE (headache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Feverish), RASH (Rash), ERYTHEMA (Redness) and PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: No just a very hurt arm at injection site and its swollen a little; No just a very hurt arm at injection site and its swollen a little; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (No just a very hurt arm at injection site and its swollen a little) and VACCINATION SITE SWELLING (No just a very hurt arm at injection site and its swollen a little) 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 PAIN (No just a very hurt arm at injection site and its swollen a little) and VACCINATION SITE SWELLING (No just a very hurt arm at injection site and its swollen a little). At the time of the report, VACCINATION SITE PAIN (No just a very hurt arm at injection site and its swollen a little) and VACCINATION SITE SWELLING (No just a very hurt arm at injection site and its swollen a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        .
Sex: U
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Affecting people's hearing ability; 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 HYPOACUSIS (Affecting people's hearing ability) 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 HYPOACUSIS (Affecting people's hearing ability). At the time of the report, HYPOACUSIS (Affecting people's hearing ability) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (patient had a reaction) and product dose omission issue (longer than month since first dose) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (patient had a reaction) and product dose omission issue (longer than month since first dose). At the time of the report, vaccination complication (patient had a reaction) outcome: unknown. Product dose omission issue (longer than month since first dose): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Chills, Dysphagia, Feeling abnormal, Headache
Clinical narrative: Extremely agitated today; Feels like crap; Headache; Muscle pain; Chills; Fever (internal); Pain on injection site; Difficulty swallowing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing), AGITATION (Extremely agitated today), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis and Cystic fibrosis. Concurrent medical conditions included Iodine allergy, Penicillin allergy and Allergy to chemicals (Sulfate). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Anxiety, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and CLONAZEPAM for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSPHAGIA (Difficulty swallowing), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever (internal)) and VACCINATION SITE PAIN (Pain on injection site). On 18-Jul-2021, the patient experienced AGITATION (Extremely agitated today). At the time of the report, DYSPHAGIA (Difficulty swallowing), AGITATION (Extremely agitated today), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever (internal)) and VACCINATION SITE PAIN (Pain on injection site) 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 treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: Extremely agitated today; Feels like crap; Headache; Muscle pain; Chills; Fever (internal); Pain on injection site; Difficulty swallowing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing), AGITATION (Extremely agitated today), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hepatitis and Cystic fibrosis. Concurrent medical conditions included Iodine allergy, Penicillin allergy and Allergy to chemicals (Sulfate). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Anxiety, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and CLONAZEPAM for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced DYSPHAGIA (Difficulty swallowing), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever (internal)) and VACCINATION SITE PAIN (Pain on injection site). On 18-Jul-2021, the patient experienced AGITATION (Extremely agitated today). At the time of the report, DYSPHAGIA (Difficulty swallowing), AGITATION (Extremely agitated today), FEELING ABNORMAL (Feels like crap), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), PYREXIA (Fever (internal)) and VACCINATION SITE PAIN (Pain on injection site) 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 treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: COVID positive after fully vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID positive after fully vaccinated) 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 SARS-COV-2 TEST POSITIVE (COVID positive after fully vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID positive after fully vaccinated) 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.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt like i was going to die; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like i was going to die) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt like i was going to die). At the time of the report, FEELING ABNORMAL (felt like i was going to die) outcome was unknown.            No concomitant medications provided. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: I can't keep my balance/ I can't go back to work; 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 BALANCE DISORDER (I can't keep my balance/ I can't go back to work) 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 BALANCE DISORDER (I can't keep my balance/ I can't go back to work). At the time of the report, BALANCE DISORDER (I can't keep my balance/ I can't go back to work) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up document contains Non significant information
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm swell; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm swell). At the time of the report, PERIPHERAL SWELLING (Arm swell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Heart rate, Myalgia, Pyrexia
Clinical narrative: Fever; Allergy to vaccine; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ALLERGY TO VACCINE (Allergy to vaccine) and MYALGIA (Body aches) 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 PYREXIA (Fever), ALLERGY TO VACCINE (Allergy to vaccine) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), ALLERGY TO VACCINE (Allergy to vaccine) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 97-102 (High) 97-102 per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided.; 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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: experiencing itching at my injection site as if it were a mosquito bite that wont subside; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (experiencing itching at my injection site as if it were a mosquito bite that wont subside) 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 (experiencing itching at my injection site as if it were a mosquito bite that wont subside). At the time of the report, VACCINATION SITE PRURITUS (experiencing itching at my injection site as if it were a mosquito bite that wont subside) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; 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 EXPIRED PRODUCT ADMINISTERED (expired vaccine used) 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) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information not provided.  Treatment information not provided.  Per Moderna CMC Lot analysis, regarding doses administered on 13Jul2021 from lot# 006B21A and 10Jul2021 from lot# 009C21A: Moderna cannot guarantee patients received full protection against the COVID-19 Virus.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: follow up received with No new information. The causality for Regulatory Authority was corrected from initial version from Possible to Not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: vaccine cause an ear ache; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (vaccine cause an ear 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 EAR PAIN (vaccine cause an ear ache). At the time of the report, EAR PAIN (vaccine cause an ear ache) 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: Pruritus, Urticaria
Clinical narrative: after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk; after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) and PRURITUS (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) 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 dosage form. On an unknown date, the patient experienced URTICARIA (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) and PRURITUS (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk). At the time of the report, URTICARIA (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) and PRURITUS (after the second shot can you develop inching and hive that looks like bumps on legs and arms also on the nexk) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Gout, Insomnia, Malaise, Pyrexia
Clinical narrative: Gout flares; diarrhea; sleeping twice his normal; feeling unwell/sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout flares), DIARRHOEA (diarrhea), INSOMNIA (sleeping twice his normal), MALAISE (feeling unwell/sick) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (Gout flares), DIARRHOEA (diarrhea), INSOMNIA (sleeping twice his normal), MALAISE (feeling unwell/sick) and PYREXIA (Fever). At the time of the report, GOUT (Gout flares), DIARRHOEA (diarrhea), INSOMNIA (sleeping twice his normal), MALAISE (feeling unwell/sick) and PYREXIA (Fever) outcome was unknown. Not Provided          The patient's concomitant medications were not reported.   It was reported that the patient was seen by his primary care physician (PCP) and nothing was found.   No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: Injection site is still red and warm to the touch; Injection site is still red and warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site is still red and warm to the touch) and VACCINATION SITE WARMTH (Injection site is still red and warm to the touch) 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 SITE ERYTHEMA (Injection site is still red and warm to the touch) and VACCINATION SITE WARMTH (Injection site is still red and warm to the touch). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site is still red and warm to the touch) and VACCINATION SITE WARMTH (Injection site is still red and warm to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I had my second dose after 47 days; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my second dose after 47 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my second dose after 47 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had my second dose after 47 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment information were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: a sore arm at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (a sore arm at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergies to medications, food.), Penicillin allergy and Sulfonamide allergy. Concomitant products included LISINOPRIL for Hypertension, HYDROCHLOROTHIAZIDE, METFORMIN HCL and ANASTROZOLE (ANASTRAZOLE DENK) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (a sore arm at injection site). At the time of the report, VACCINATION SITE PAIN (a sore arm at injection site) outcome was unknown. Not provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Test-Rapid antigen.     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.   Treatment medication was not provided   This case was linked to MOD-2021-051513 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) 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 Sinus pressure and Cough (The patient had sinus pressure and slight cough a few days before vaccination.).    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 ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Influenza, Peripheral swelling, Rash
Clinical narrative: Flu; Arms swelled up; Hairs started to shed off; Rashes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), PERIPHERAL SWELLING (Arms swelled up), ALOPECIA (Hairs started to shed off) and RASH (Rashes) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced INFLUENZA (Flu), PERIPHERAL SWELLING (Arms swelled up), ALOPECIA (Hairs started to shed off) and RASH (Rashes). At the time of the report, INFLUENZA (Flu), PERIPHERAL SWELLING (Arms swelled up) and RASH (Rashes) had resolved and ALOPECIA (Hairs started to shed off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Insomnia, Pain in extremity, Vaccination site erythema, Vaccination site induration
Clinical narrative: Hot to the touch (little bit of a temperature) at both injection sites; First shot missed the muscle; Tight at both injection sites; Red at both injection sites; Puffy at both injection sites; Sore at injection site; Sleepless night for a week; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleepless night for a week), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle) and VACCINATION SITE INDURATION (Tight at both injection sites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On an unknown date, the patient experienced INSOMNIA (Sleepless night for a week), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle), VACCINATION SITE INDURATION (Tight at both injection sites), VACCINATION SITE ERYTHEMA (Red at both injection sites), VACCINATION SITE SWELLING (Puffy at both injection sites) and VACCINATION SITE PAIN (Sore at injection site). On 09-Mar-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, INSOMNIA (Sleepless night for a week), VACCINATION SITE WARMTH (Hot to the touch (little bit of a temperature) at both injection sites), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (First shot missed the muscle), VACCINATION SITE INDURATION (Tight at both injection sites), VACCINATION SITE ERYTHEMA (Red at both injection sites), VACCINATION SITE SWELLING (Puffy at both injection sites) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-259384 (Patient Link).