chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Psychotic disorder
Clinical narrative: psychotic reaction a couple of days; redness, swelling, and pain around the injection site; redness, swelling, and pain around the injection site; redness, swelling, and pain around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER (psychotic reaction a couple of days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Plasma cell disorder.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (redness, swelling, and pain around the injection site), INJECTION SITE SWELLING (redness, swelling, and pain around the injection site) and INJECTION SITE PAIN (redness, swelling, and pain around the injection site). On an unknown date, the patient experienced PSYCHOTIC DISORDER (psychotic reaction a couple of days) (seriousness criterion hospitalization). At the time of the report, PSYCHOTIC DISORDER (psychotic reaction a couple of days) outcome was unknown and INJECTION SITE ERYTHEMA (redness, swelling, and pain around the injection site), INJECTION SITE SWELLING (redness, swelling, and pain around the injection site) and INJECTION SITE PAIN (redness, swelling, and pain around the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.  Company comment: This is a female patient who experienced psychotic disorder among other non-serious events after 1st dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Discharge summary is required for further assessment.; Sender's Comments: This is a female patient who experienced psychotic disorder among other non-serious events after 1st dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Discharge summary is required for further assessment.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever 99.9; 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 PYREXIA (fever 99.9) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (fever 99.9). At the time of the report, PYREXIA (fever 99.9) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Body temperature: 99.9 (High) fever 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Vomiting
Clinical narrative: her arm hurt immediately / pain from her arm upto her neck; feeling sicker than a dog; she started throwing up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (her arm hurt immediately / pain from her arm upto her neck), ILLNESS (feeling sicker than a dog) and VOMITING (she started throwing up) 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 31-Jan-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 (her arm hurt immediately / pain from her arm upto her neck), ILLNESS (feeling sicker than a dog) and VOMITING (she started throwing up). At the time of the report, PAIN (her arm hurt immediately / pain from her arm upto her neck), ILLNESS (feeling sicker than a dog) and VOMITING (she started throwing up) outcome was unknown. Not Provided          No Concomitant medications were reported. No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: does given to patient more than 6 hours after vial first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (does given to patient more than 6 hours after vial first punctured) 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 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (does given to patient more than 6 hours after vial first punctured). On 26-Feb-2021, EXPIRED PRODUCT ADMINISTERED (does given to patient more than 6 hours after vial first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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
Sex: U
Vaccine: COVID19
Symptoms: Rash, Skin discolouration
Clinical narrative: rash; it seems to be fading; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) and SKIN DISCOLOURATION (it seems to be fading) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash) and SKIN DISCOLOURATION (it seems to be fading). At the time of the report, RASH (rash) and SKIN DISCOLOURATION (it seems to be fading) outcome was unknown.            Treatment drug include Lotion. No concomitant drugs were provided
Sex: U
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction
Clinical narrative: Moderna Arm or covid arm and it is a harmless reaction; rash that comes 10 to 14 days after vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Moderna Arm or covid arm and it is a harmless reaction) and RASH (rash that comes 10 to 14 days after vaccination) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Moderna Arm or covid arm and it is a harmless reaction) and RASH (rash that comes 10 to 14 days after vaccination). At the time of the report, VACCINATION SITE REACTION (Moderna Arm or covid arm and it is a harmless reaction) and RASH (rash that comes 10 to 14 days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs and treatment medication information were provided. The reporter had seen pictures and videos of other patients who had the vaccine and had this reaction, but did not know exactly how many patients had it.   This case was linked to US-MODERNATX, INC.-MOD-2021-058178 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received , Containing Non Significant Information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058178:Case for another patient
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Kids arms are very sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Kids arms are very sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Kids arms are very sore). At the time of the report, VACCINATION SITE PAIN (Kids arms are very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 1st and 2nd dose on same day; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st and 2nd dose on same 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st and 2nd dose on same day). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st and 2nd dose on same day) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: headache; body aches; fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), MYALGIA (body aches) and FATIGUE (fatigue) 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 24-Mar-2021, the patient experienced HEADACHE (headache), MYALGIA (body aches) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), MYALGIA (body aches) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tired). At the time of the report, VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Dose dripped while administering the second dose; 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 UNDERDOSE (Dose dripped while administering the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 UNDERDOSE (Dose dripped while administering the second dose). At the time of the report, UNDERDOSE (Dose dripped while administering the second dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Frustration tolerance decreased, Insomnia, Loss of personal independence in daily activities, Tinnitus
Clinical narrative: mentally frustrating; stuffy ear and can't sleep at night/didn't sleep for days; interfered with my daily activities; pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse; experiencing in right stuffy ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse), EAR CONGESTION (experiencing in right stuffy ear), FRUSTRATION TOLERANCE DECREASED (mentally frustrating), INSOMNIA (stuffy ear and can't sleep at night/didn't sleep for days) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (interfered with my daily activities) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 30-Oct-1997 and Tinnitus. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 30-Oct-1997 to an unknown date for Hypothyroidism, ATORVASTATIN for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced EAR CONGESTION (experiencing in right stuffy ear). On 09-Apr-2021, the patient experienced TINNITUS (pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse). On an unknown date, the patient experienced FRUSTRATION TOLERANCE DECREASED (mentally frustrating), INSOMNIA (stuffy ear and can't sleep at night/didn't sleep for days) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (interfered with my daily activities). At the time of the report, TINNITUS (pulsing sound and ringing in ear/tinnitus(ringing in the ears)and pulsing tinnitus about 9-10 days/Tinnitus got worse) was resolving, EAR CONGESTION (experiencing in right stuffy ear) and FRUSTRATION TOLERANCE DECREASED (mentally frustrating) outcome was unknown and INSOMNIA (stuffy ear and can't sleep at night/didn't sleep for days) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (interfered with my daily activities) had not resolved.        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 details were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received on 07-sep 2021 second event of ear congestion  and  action taken updated from unknown to no change. only one event of tinnitus aggravated coded with onset date of 09-Apr-2021a nd outcome recovering.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Swelling face
Clinical narrative: swelling on their cheek; chills; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling on their cheek), CHILLS (chills) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). On 21-Apr-2021, the patient experienced SWELLING FACE (swelling on their cheek). At the time of the report, SWELLING FACE (swelling on their cheek), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided  No treatment medication were provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) 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 FATIGUE (Felt tired). At the time of the report, FATIGUE (Felt tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypervolaemia, Pyrexia
Clinical narrative: fluid overload; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever) and FLUID OVERLOAD (fluid overload) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and FLUID OVERLOAD (fluid overload). At the time of the report, PYREXIA (Fever) and FLUID OVERLOAD (fluid overload) outcome was unknown. Not Provided      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. The treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: severe tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (severe tinnitus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (severe tinnitus). At the time of the report, TINNITUS (severe tinnitus) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD21-087878, MOD21-082910 (E2B Linked Report).; Sender's Comments:  MOD21-087878: MOD21-082910:
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Weird taste in mouth; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 22-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Weird taste in mouth) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Weird taste in mouth). At the time of the report, DYSGEUSIA (Weird taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       No concomitant and treatment medication
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body aches) 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) at an unspecified dose. 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 MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.            The patient was asking if the patient could take pain relivers with the second dose of Moderna. The patient was having some body aches.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (Shingles) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 HERPES ZOSTER (Shingles). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Shingles, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown. Not Provided      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 product use was provided by the reporter.  Treatment medication included taking Valtrex for the past 7 days.  The patient was currently scabbed over and scheduled for his second dose on Saturday. He should have 1-2 days left of his Valtrex treatment at the time of vaccination.   This case was linked to US-MODERNATX, INC.-MOD-2021-025136 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-025136:Cross linked case
Sex: U
Vaccine: COVID19
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: terrible cough; body aches; 100 degree fever; 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 COUGH (terrible cough), MYALGIA (body aches) and PYREXIA (100 degree fever) 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 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (terrible cough), MYALGIA (body aches) and PYREXIA (100 degree fever). At the time of the report, COUGH (terrible cough), MYALGIA (body aches) and PYREXIA (100 degree fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm at the site of the vaccination; Inflammation at the site of the vaccination; Redness at the site of the vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at the site of the vaccination), VACCINATION SITE SWELLING (Inflammation at the site of the vaccination) and VACCINATION SITE ERYTHEMA (Redness at the site of the vaccination) 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 WARMTH (Warm at the site of the vaccination), VACCINATION SITE SWELLING (Inflammation at the site of the vaccination) and VACCINATION SITE ERYTHEMA (Redness at the site of the vaccination). At the time of the report, VACCINATION SITE WARMTH (Warm at the site of the vaccination), VACCINATION SITE SWELLING (Inflammation at the site of the vaccination) and VACCINATION SITE ERYTHEMA (Redness at the site of the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had redness and warm raised area around the injection nine days after the vaccine shot was noted.  No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: slight numbness in my left cheek-same side as injection; 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 HYPOAESTHESIA (slight numbness in my left cheek-same side as injection) 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 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced HYPOAESTHESIA (slight numbness in my left cheek-same side as injection). At the time of the report, HYPOAESTHESIA (slight numbness in my left cheek-same side as injection) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding) in an elderly female patient 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding) had resolved.            No Concomitant medications were reported No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Arm is very swollen; 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 PERIPHERAL SWELLING (Arm is very swollen) 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 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm is very swollen). At the time of the report, PERIPHERAL SWELLING (Arm is very swollen) outcome was unknown.            No concomitant medication was reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (Hair loss). At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Having fever after moderna 2nd dose and not reducing; 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 PYREXIA (Having fever after moderna 2nd dose and not reducing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Having fever after moderna 2nd dose and not reducing). At the time of the report, PYREXIA (Having fever after moderna 2nd dose and not reducing) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Malaise, Secretion discharge
Clinical narrative: Coughing up mucus; This is not a good feeling; Coughing all through the night; Been sick with headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-May-2021 and was forwarded to Moderna on 24-May-2021.    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 SECRETION DISCHARGE (Coughing up mucus), MALAISE (This is not a good feeling), COUGH (Coughing all through the night) and HEADACHE (Been sick with headache) 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 27-Apr-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 SECRETION DISCHARGE (Coughing up mucus), MALAISE (This is not a good feeling), COUGH (Coughing all through the night) and HEADACHE (Been sick with headache). At the time of the report, SECRETION DISCHARGE (Coughing up mucus), MALAISE (This is not a good feeling), COUGH (Coughing all through the night) and HEADACHE (Been sick with headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medication was provided.  No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Tachycardia; Fever; 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 TACHYCARDIA (Tachycardia) and PYREXIA (Fever) 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 TACHYCARDIA (Tachycardia) and PYREXIA (Fever). At the time of the report, TACHYCARDIA (Tachycardia) and PYREXIA (Fever) 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up received and contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Chills, Limb discomfort, Myalgia, Nausea
Clinical narrative: Arm hurts moderate bad; 'm having bad body aches; Feel nauseated; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills). At the time of the report, LIMB DISCOMFORT (Arm hurts moderate bad), MYALGIA ('m having bad body aches), NAUSEA (Feel nauseated) and CHILLS (Chills) 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.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness). At the time of the report, HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: high blood pressure; lightheadedness; 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 HYPERTENSION (high blood pressure) and DIZZINESS (lightheadedness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (high blood pressure) and DIZZINESS (lightheadedness). At the time of the report, HYPERTENSION (high blood pressure) and DIZZINESS (lightheadedness) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; 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 CHEST PAIN (Chest pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: my head feels like it will explode; 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 HEAD DISCOMFORT (my head feels like it will explode) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (my head feels like it will explode). At the time of the report, HEAD DISCOMFORT (my head feels like it will explode) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: arm patient got the shot feel hot; 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 FEELING HOT (arm patient got the shot feel hot) 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 FEELING HOT (arm patient got the shot feel hot). At the time of the report, FEELING HOT (arm patient got the shot feel hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information  was provided. No Concomitant medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Having headaches for the past couple days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Having headaches for the past couple 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 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. In May 2021, the patient experienced HEADACHE (Having headaches for the past couple days). At the time of the report, HEADACHE (Having headaches for the past couple days) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia since 10-Oct-2020. Concomitant products included IRON from 01-Jan-2021 to an unknown date for Anemia.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021 at 12:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).). At the time of the report, PYREXIA (fever/Fever was recoccuring for 24hrs everytime tylenol wore off(every 6hrs).) had resolved.            No Treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heartbeat after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat after vaccination) 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 HEART RATE INCREASED (fast heartbeat after vaccination). At the time of the report, HEART RATE INCREASED (fast heartbeat after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants , treatments are provided
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Night sweats
Clinical narrative: Night sweats; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue). On 05-Jun-2021, NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product details was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-245689 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information received on 12-JUL-2021 included no new information. On 07-Sep-2021: Follow-up Information received contains No New Information
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injection site erythema, Pruritus, Vaccination site induration, Vaccination site reaction
Clinical narrative: covid arm; Left arm which was hard in between elbow and shoulder; Amr was pink; Sore left armpit; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink), AXILLARY PAIN (Sore left armpit) and PRURITUS (itchy) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myeloid leukemia. Concomitant products included ASCORBIC ACID (VITAMIN C ACID) and DASATINIB MONOHYDRATE (SPRYCEL) for an unknown indication.    On 11-May-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 REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink), AXILLARY PAIN (Sore left armpit) and PRURITUS (itchy). The patient was treated with IBUPROFEN (oral) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (covid arm), INDURATION (Left arm which was hard in between elbow and shoulder), ERYTHEMA (Amr was pink) and AXILLARY PAIN (Sore left armpit) outcome was unknown and PRURITUS (itchy) had resolved.        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.   This case was linked to MOD-2021-253150 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2021: contact details of reporter, treatment medication, new events were added