chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: wasn't feelin good; tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) and MALAISE (wasn't feelin good) 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 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced COVID-19 (tested positive for Covid). On an unknown date, the patient experienced MALAISE (wasn't feelin good). At the time of the report, COVID-19 (tested positive for Covid) and MALAISE (wasn't feelin good) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in jaw, Sinus pain
Clinical narrative: Her jaw hurt for 3 days; Her sinuses hurt for 3 days; The left side of her neck numbed up/ the left side of her face numbed up; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up), PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up). On 04-Aug-2021, the patient experienced PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days). On 04-Aug-2021, HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up) had resolved. In August 2021, PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: second on 15Apr2021 and third dose of the vaccine on 18Aug2021; third dose of the vaccine on 18Aug2021; gave patient their 3rd vaccine dose from the expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave patient their 3rd vaccine dose from the expired vial), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second on 15Apr2021 and third dose of the vaccine on 18Aug2021) and EXTRA DOSE ADMINISTERED (third dose of the vaccine on 18Aug2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included PREDNISONE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient their 3rd vaccine dose from the expired vial) and EXTRA DOSE ADMINISTERED (third dose of the vaccine on 18Aug2021). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second on 15Apr2021 and third dose of the vaccine on 18Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave patient their 3rd vaccine dose from the expired vial) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second on 15Apr2021 and third dose of the vaccine on 18Aug2021) and EXTRA DOSE ADMINISTERED (third dose of the vaccine on 18Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided by the reporter.  Patient received 3rd dose of vaccine on 18th Aug 2021 at 02:50 PM (Batch#: 088D21A) in the left arm. Vial has been dispose as of now confirmed by the pharmacist. Patient received second dose of vaccine on 15th April 2021 (Batch#: 036B21A)   This case was linked to MOD-2021-291158 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: One dose of the moderna on February 8 and did not receive my second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (One dose of the moderna on February 8 and did not receive my second 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 08-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 PRODUCT DOSE OMISSION ISSUE (One dose of the moderna on February 8 and did not receive my second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (One dose of the moderna on February 8 and did not receive my second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Influenza like illness, Mass
Clinical narrative: red in colour; knot that keeps getting bigger; hot to the touch; redness and swelling started at the injection site and grew from there; redness and swelling started at the injection site and grew from there; swelling of the left upper arm; fever; chills; flu-like symptoms; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (body aches) and ERYTHEMA (red in colour) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches). On 11-Aug-2021, the patient experienced ERYTHEMA (red in colour), MASS (knot that keeps getting bigger), FEELING HOT (hot to the touch), VACCINATION SITE ERYTHEMA (redness and swelling started at the injection site and grew from there), VACCINATION SITE SWELLING (redness and swelling started at the injection site and grew from there) and PERIPHERAL SWELLING (swelling of the left upper arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 10-Aug-2021, PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches) had resolved. At the time of the report, ERYTHEMA (red in colour), MASS (knot that keeps getting bigger), FEELING HOT (hot to the touch), VACCINATION SITE ERYTHEMA (redness and swelling started at the injection site and grew from there), VACCINATION SITE SWELLING (redness and swelling started at the injection site and grew from there) and PERIPHERAL SWELLING (swelling of the left upper arm) 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.   It was reported that  the patient was not on any concomitant medication. It was reported that the next day 11 Aug 2021after the vaccine was administered  the patient had swelling of the left upper arm, a knot that keeps getting bigger, it is hot to the touch, red in color, and measures 3x3. The patient described the redness and swelling started at the injection site and grew from there.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: red in colour; knot that keeps getting bigger; hot to the touch; redness and swelling started at the injection site and grew from there; redness and swelling started at the injection site and grew from there; swelling of the left upper arm; fever; chills; flu-like symptoms; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (body aches) and ERYTHEMA (red in colour) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches). On 11-Aug-2021, the patient experienced ERYTHEMA (red in colour), MASS (knot that keeps getting bigger), FEELING HOT (hot to the touch), VACCINATION SITE ERYTHEMA (redness and swelling started at the injection site and grew from there), VACCINATION SITE SWELLING (redness and swelling started at the injection site and grew from there) and PERIPHERAL SWELLING (swelling of the left upper arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 10-Aug-2021, PYREXIA (fever), CHILLS (chills), INFLUENZA LIKE ILLNESS (flu-like symptoms) and PAIN (body aches) had resolved. At the time of the report, ERYTHEMA (red in colour), MASS (knot that keeps getting bigger), FEELING HOT (hot to the touch), VACCINATION SITE ERYTHEMA (redness and swelling started at the injection site and grew from there), VACCINATION SITE SWELLING (redness and swelling started at the injection site and grew from there) and PERIPHERAL SWELLING (swelling of the left upper arm) 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.   It was reported that  the patient was not on any concomitant medication. It was reported that the next day 11 Aug 2021after the vaccine was administered  the patient had swelling of the left upper arm, a knot that keeps getting bigger, it is hot to the touch, red in color, and measures 3x3. The patient described the redness and swelling started at the injection site and grew from there.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Headache, Myalgia
Clinical narrative: feel dizzy/dizzy; Headache; Chills; Sore left deltoid muscle; Fever 100.4 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight). At the time of the report, DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4 degrees Farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feel dizzy/dizzy; Headache; Chills; Sore left deltoid muscle; Fever 100.4 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight). At the time of the report, DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4 degrees Farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Experienced a hot; Covid arm; itchy; red spot/Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Experienced a hot), VACCINATION COMPLICATION (Covid arm), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red spot/Rash) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E27A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Experienced a hot), VACCINATION COMPLICATION (Covid arm), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red spot/Rash). At the time of the report, VACCINATION SITE WARMTH (Experienced a hot), VACCINATION COMPLICATION (Covid arm), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red spot/Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) tested positive for COVID.     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.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 child was erroneously given the first shot of the Moderna vaccine and now cannot get the 2nd shot) had resolved.            Concomitant product use was not provided.   Treatment information was not  provided. now the patient cannot get second dose.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Limb discomfort, Muscular weakness, Pyrexia, Swelling
Clinical narrative: side effects; Hand muscles are weak after second shot; Trouble holding things in his hands after second shot; Dropsy after second shot; Fever 101.7F unresponsive to Excedrin  after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), MUSCULAR WEAKNESS (Hand muscles are weak after second shot), LIMB DISCOMFORT (Trouble holding things in his hands after second shot), SWELLING (Dropsy after second shot) and PYREXIA (Fever 101.7F unresponsive to Excedrin  after second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 052C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced MUSCULAR WEAKNESS (Hand muscles are weak after second shot), LIMB DISCOMFORT (Trouble holding things in his hands after second shot), SWELLING (Dropsy after second shot) and PYREXIA (Fever 101.7F unresponsive to Excedrin  after second shot). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN EXTRA STRENGTH) for Fever, at a dose of Extra Strength. At the time of the report, VACCINATION COMPLICATION (side effects), MUSCULAR WEAKNESS (Hand muscles are weak after second shot), LIMB DISCOMFORT (Trouble holding things in his hands after second shot), SWELLING (Dropsy after second shot) and PYREXIA (Fever 101.7F unresponsive to Excedrin  after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7F.         No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-290928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: FU received on 18-AUG-2021 contains no new information
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; Hand muscles are weak after second shot; Trouble holding things in his hands after second shot; Dropsy after second shot; Fever 101.7F unresponsive to Excedrin  after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects), MUSCULAR WEAKNESS (Hand muscles are weak after second shot), LIMB DISCOMFORT (Trouble holding things in his hands after second shot), SWELLING (Dropsy after second shot) and PYREXIA (Fever 101.7F unresponsive to Excedrin  after second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 052C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced MUSCULAR WEAKNESS (Hand muscles are weak after second shot), LIMB DISCOMFORT (Trouble holding things in his hands after second shot), SWELLING (Dropsy after second shot) and PYREXIA (Fever 101.7F unresponsive to Excedrin  after second shot). On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN EXTRA STRENGTH) for Fever, at a dose of Extra Strength. At the time of the report, VACCINATION COMPLICATION (side effects), MUSCULAR WEAKNESS (Hand muscles are weak after second shot), LIMB DISCOMFORT (Trouble holding things in his hands after second shot), SWELLING (Dropsy after second shot) and PYREXIA (Fever 101.7F unresponsive to Excedrin  after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7F.         No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-290928 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: FU received on 18-AUG-2021 contains no new information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: developed rash on injection site 2 weeks later/She reports it as a covid arm.; sore left arm after 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm after 3 days) and VACCINATION SITE RASH (developed rash on injection site 2 weeks later/She reports it as a covid arm.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concomitant products included POTASSIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), CARVEDILOL (COREG) and LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PAIN IN EXTREMITY (sore left arm after 3 days). On 08-Aug-2021, the patient experienced VACCINATION SITE RASH (developed rash on injection site 2 weeks later/She reports it as a covid arm.). The patient was treated with CAMPHOR, MENTHOL (ICY HOT ADVANCED RELIEF [CAMPHOR;MENTHOL]) at an unspecified dose and frequency and LIDOCAINE (SALONPAS LIDOCAINE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore left arm after 3 days) and VACCINATION SITE RASH (developed rash on injection site 2 weeks later/She reports it as a covid arm.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Therapeutic response unexpected
Clinical narrative: I did not have a period in over a year, and the day after the first and second vaccination I had my period; More than 35 days between first and second shot; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     Concurrent medical conditions included Menstrual cycle abnormal. Concomitant products included TESTOSTERONE for Menses irregular, ESCITALOPRAM OXALATE (LEXAPRO) and ARIPIPRAZOLE (ABILIFY) for an unknown indication.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment information was reported.   This case was linked to MOD-2021-291011 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: I did not have a period in over a year, and the day after the first and second vaccination I had my period; More than 35 days between first and second shot; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I did not have a period in over a year, and the day after the first and second vaccination I had my period) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05392114 and 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), TESTOSTERONE and ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot). On 17-Aug-2021, the patient experienced MENSTRUAL DISORDER (I did not have a period in over a year, and the day after the first and second vaccination I had my period). On 16-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second shot) had resolved. At the time of the report, MENSTRUAL DISORDER (I did not have a period in over a year, and the day after the first and second vaccination I had my period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient says she takes testosterone as her body does not produce Estrogen and that she never has a period. treatment information was not provided   This case was linked to MOD-2021-291006 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Extra dose administered, Fatigue, Myalgia
Clinical narrative: Horrible severe fatigue; Multiple joint worse than what she normally experiences with her multiple sclerosis; Muscle pain worse than what she normally experiences with her multiple sclerosis; Extra dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered), FATIGUE (Horrible severe fatigue), ARTHRALGIA (Multiple joint worse than what she normally experiences with her multiple sclerosis) and MYALGIA (Muscle pain worse than what she normally experiences with her multiple sclerosis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 012M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis (diagnosed 6 years ago).   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On 18-Aug-2021, the patient experienced FATIGUE (Horrible severe fatigue), ARTHRALGIA (Multiple joint worse than what she normally experiences with her multiple sclerosis) and MYALGIA (Muscle pain worse than what she normally experiences with her multiple sclerosis). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved. At the time of the report, FATIGUE (Horrible severe fatigue), ARTHRALGIA (Multiple joint worse than what she normally experiences with her multiple sclerosis) and MYALGIA (Muscle pain worse than what she normally experiences with her multiple sclerosis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that about 24 hours after getting the booster shot, she had  horrible severe fatigue, multiple joint and muscle pain; worse than what she normally experiences with her multiple sclerosis. She also used Medical Marijuana gummies; but she was still having the symptoms. Her husband stated that she takes lots of other medication but did not provide them.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Pain in extremity
Clinical narrative: leg pain/that her left leg kept giving out on her; back pain; difficulty walking; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (leg pain/that her left leg kept giving out on her), BACK PAIN (back pain) and GAIT DISTURBANCE (difficulty walking) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052D21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, HYDROCHLOROTHIAZIDE and Nexium for an unknown indication.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PAIN IN EXTREMITY (leg pain/that her left leg kept giving out on her), BACK PAIN (back pain) and GAIT DISTURBANCE (difficulty walking). At the time of the report, PAIN IN EXTREMITY (leg pain/that her left leg kept giving out on her), BACK PAIN (back pain) and GAIT DISTURBANCE (difficulty walking) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment product information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Eyelid margin crusting, Fatigue, Headache, Lacrimation increased
Clinical narrative: eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning; eyes started  getting crusty and watery; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYELID MARGIN CRUSTING (eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning), LACRIMATION INCREASED (eyes started  getting crusty and watery), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included Peripheral neuropathy. Concurrent medical conditions included Sinus disorder NOS (Patient state that she takes cold medications for her sinus allergy.).    On 22-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 EYELID MARGIN CRUSTING (eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning), LACRIMATION INCREASED (eyes started  getting crusty and watery), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) for Headache, at an unspecified dose and frequency. At the time of the report, EYELID MARGIN CRUSTING (eyes started  getting crusty and watery/can barely open her  eyes or see for 30 minutes to 1  hour  in the morning) and LACRIMATION INCREASED (eyes started  getting crusty and watery) outcome was unknown and FATIGUE (fatigue) and HEADACHE (headache) had not resolved.            The  cold medications are concomitant medications.   This case was linked to MOD-2021-132097 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Severe flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Severe flu like symptoms) in a 55-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 (Patient stated that she got infected  with COVID-19) on 15-Dec-2020. Concurrent medical conditions included Breathing difficult (Patient had to go to a pulmonologist and a physical therapist to get better).    On 19-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 INFLUENZA LIKE ILLNESS (Severe flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Severe flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were provided  On an unspecified date Patient's primary care physician referred her to a  spine specialist, and they ordered her to get X-Ray and CT- Scan. Patient stated that her  spine doctor told her that her X-ray and CT-scan both were fine, and she might have arthritis. Patient went to physical therapist and acupuncture therapist but she has not felt any improvement.    This case was linked to MOD-2021-291122 (Patient Link).
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: only received one dose of the moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received one dose of the moderna vaccine) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Feeling abnormal, Heart rate increased, Pyrexia
Clinical narrative: Chills; A high heart rate, sitting still it was 125 bpm; Had cold chills; He was not feeling good,he felt bad all day; Had 102 fever which then went normal,102 fever,101.5 fever; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (A high heart rate, sitting still it was 125 bpm), FEELING ABNORMAL (He was not feeling good,he felt bad all day), CHILLS (Had cold chills), ARTHRALGIA (Sore shoulder) and PYREXIA (Had 102 fever which then went normal,102 fever,101.5 fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced ARTHRALGIA (Sore shoulder). On 16-Aug-2021, the patient experienced FEELING ABNORMAL (He was not feeling good,he felt bad all day) and PYREXIA (Had 102 fever which then went normal,102 fever,101.5 fever). On 17-Aug-2021, the patient experienced HEART RATE INCREASED (A high heart rate, sitting still it was 125 bpm) and CHILLS (Had cold chills). On 18-Aug-2021, the patient experienced CHILLS (Chills). At the time of the report, HEART RATE INCREASED (A high heart rate, sitting still it was 125 bpm), FEELING ABNORMAL (He was not feeling good,he felt bad all day), CHILLS (Had cold chills), ARTHRALGIA (Sore shoulder), PYREXIA (Had 102 fever which then went normal,102 fever,101.5 fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old got the first Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the first Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the first Moderna vaccine). On 11-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old got the first Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Very hot to the touch; Very red around injection site; Swollen at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Very hot to the touch), VACCINATION SITE ERYTHEMA (Very red around injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A and 027D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Very hot to the touch), VACCINATION SITE ERYTHEMA (Very red around injection site) and VACCINATION SITE SWELLING (Swollen at the injection site). At the time of the report, VACCINATION SITE WARMTH (Very hot to the touch), VACCINATION SITE ERYTHEMA (Very red around injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: high (High) Running high temperature, two lines over 102.         No concomitant medications were reported.  The patient kept ice on vaccination site as her Pharmacist recommended to do.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Off label use
Clinical narrative: gave patient a dose from an expired vial; gave patient their 3rd vaccine dose; Extra dose adminstered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial), OFF LABEL USE (gave patient their 3rd vaccine dose) and EXTRA DOSE ADMINISTERED (Extra dose adminstered) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Kidney disorder (Kidney issues.).    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial), OFF LABEL USE (gave patient their 3rd vaccine dose) and EXTRA DOSE ADMINISTERED (Extra dose adminstered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial), OFF LABEL USE (gave patient their 3rd vaccine dose) and EXTRA DOSE ADMINISTERED (Extra dose adminstered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Her injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her injection site arm was sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Her injection site arm was sore). At the time of the report, PAIN IN EXTREMITY (Her injection site arm was sore) outcome was unknown.            No concomitant medication was reported. The Partial date of birth was provided as13 May, year was declined. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-291045, MOD-2021-291120 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: My arm was sore; I had a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm was sore) and PYREXIA (I had a fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm was sore) and PYREXIA (I had a fever). At the time of the report, PAIN IN EXTREMITY (My arm was sore) and PYREXIA (I had a fever) outcome was unknown.            No concomitant medications were reported.  The patient had first 2 injections of moderna Covid-19 vaccine on an unknown date in Feb-2021 which went well. Patient received third dose on 13-Aug-2021 and experienced a  sore arm  and tiredness. Patient was scheduled for another dose, the 2nd one (Booster), which he wanted to get the scheduled 4th dose.  Treatment information was not provided.   This case was linked to MOD-2021-291170 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it ) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced MYALGIA (hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it ). At the time of the report, MYALGIA (hurts/problems with her arm/couldn't lift it all the way up/couldn't sleep on it/couldn't move it ) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.