chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Epistaxis, Nausea, Ocular discomfort, Pruritus
Clinical narrative: Felt confused, spacy, apathetic and out of sorts psychologicall; Flutters of light in the corners of eyes; Blood coming out of nose; Arm started itching; Nauseous/continues to feel nauseous every day; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Blood coming out of nose), CONFUSIONAL STATE (Felt confused, spacy, apathetic and out of sorts psychologicall), OCULAR DISCOMFORT (Flutters of light in the corners of eyes), PRURITUS (Arm started itching) and NAUSEA (Nauseous/continues to feel nauseous every day) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (Arm started itching) and NAUSEA (Nauseous/continues to feel nauseous every day). On 06-Apr-2021, the patient experienced EPISTAXIS (Blood coming out of nose). On an unknown date, the patient experienced CONFUSIONAL STATE (Felt confused, spacy, apathetic and out of sorts psychologicall) and OCULAR DISCOMFORT (Flutters of light in the corners of eyes). At the time of the report, EPISTAXIS (Blood coming out of nose), CONFUSIONAL STATE (Felt confused, spacy, apathetic and out of sorts psychologicall), OCULAR DISCOMFORT (Flutters of light in the corners of eyes), PRURITUS (Arm started itching) and NAUSEA (Nauseous/continues to feel nauseous every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm at the inejction site was slightly sore, swollen and reddish; arm at the inejction site was slightly sore, swollen and reddish; arm at the inejction site was slightly sore, swollen and reddish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE PAIN (arm at the inejction site was slightly sore, swollen and reddish), VACCINATION SITE SWELLING (arm at the inejction site was slightly sore, swollen and reddish) and VACCINATION SITE ERYTHEMA (arm at the inejction site was slightly sore, swollen and reddish) in a 77-year-old 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (arm at the inejction site was slightly sore, swollen and reddish), VACCINATION SITE SWELLING (arm at the inejction site was slightly sore, swollen and reddish) and VACCINATION SITE ERYTHEMA (arm at the inejction site was slightly sore, swollen and reddish). At the time of the report, VACCINATION SITE PAIN (arm at the inejction site was slightly sore, swollen and reddish) and VACCINATION SITE SWELLING (arm at the inejction site was slightly sore, swollen and reddish) outcome was unknown and VACCINATION SITE ERYTHEMA (arm at the inejction site was slightly sore, swollen and reddish) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information provided about any concomitant and treatment medications.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Photopsia
Clinical narrative: Visual flashes; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (Visual flashes) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PHOTOPSIA (Visual flashes). At the time of the report, PHOTOPSIA (Visual flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified     This case was linked to MOD-2021-069575 (E2B Linked Report).; Sender's Comments:  MOD-2021-069575:Wife case
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental exposure to product, Device connection issue, Underdose
Clinical narrative: needle breaking during administration of her second dose; Accidental exposure of skin to vaccine; The Dr who was administering the shot was unaware of how much of the vaccine went into her arm; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (needle breaking during administration of her second dose), ACCIDENTAL EXPOSURE TO PRODUCT (Accidental exposure of skin to vaccine) and UNDERDOSE (The Dr who was administering the shot was unaware of how much of the vaccine went into her arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination.     No medical history provided by the reporter. .  Concomitant products included AMLODIPINE, SIMVASTATIN, LEVOTHYROXINE and METFORMIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (needle breaking during administration of her second dose), ACCIDENTAL EXPOSURE TO PRODUCT (Accidental exposure of skin to vaccine) and UNDERDOSE (The Dr who was administering the shot was unaware of how much of the vaccine went into her arm). On 10-Mar-2021, ACCIDENTAL EXPOSURE TO PRODUCT (Accidental exposure of skin to vaccine) had resolved. At the time of the report, DEVICE CONNECTION ISSUE (needle breaking during administration of her second dose) and UNDERDOSE (The Dr who was administering the shot was unaware of how much of the vaccine went into her arm) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment received. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 6-Apr-2021 and contains non-significant information. Contact information updated. HCP information provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Pain in arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (Pain in arm). On 02-Apr-2021, MYALGIA (Pain in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medications  were not reported  Treatment was not specified   This case was linked to MOD21-071233 (E2B Linked Report). This case was linked to MOD-2021-069581 (Patient Link).; Sender's Comments:  MOD21-071233:wife's case
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Axillary pain; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Axillary pain) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (Axillary pain). At the time of the report, AXILLARY PAIN (Axillary pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo like dizziness; Vertigo like dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Vertigo like dizziness) and VERTIGO (Vertigo like dizziness) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VERTIGO (Vertigo like dizziness). On an unknown date, the patient experienced DIZZINESS (Vertigo like dizziness). At the time of the report, DIZZINESS (Vertigo like dizziness) and VERTIGO (Vertigo like dizziness) outcome was unknown.      No treatment information was provided. No relevant concomitant medications reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine After First Dose of Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine After First Dose of Vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Osteoarthritis.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced MIGRAINE (Migraine After First Dose of Vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Headache, at a dose of UNK dosage form. On 05-Mar-2021, MIGRAINE (Migraine After First Dose of Vaccine) had resolved.            This case was linked to INC.-MOD-2021-069583 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-069583:CROSS LINKED WITH DOSE 2
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Swelling
Clinical narrative: redness; swollenness; warm feeling in the same arm.; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PAIN IN EXTREMITY (soreness in the arm), SWELLING (swollenness) and FEELING HOT (warm feeling in the same arm.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 02-Apr-2021, the patient experienced ERYTHEMA (redness), SWELLING (swollenness) and FEELING HOT (warm feeling in the same arm.). At the time of the report, ERYTHEMA (redness), SWELLING (swollenness) and FEELING HOT (warm feeling in the same arm.) outcome was unknown and PAIN IN EXTREMITY (soreness in the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Nasal congestion, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Slight sore throat; Congestion; Running nose; Coughing; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Slight sore throat), NASAL CONGESTION (Congestion), RHINORRHOEA (Running nose), COUGH (Coughing) and HEADACHE (Headaches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN and LANSOPRAZOLE (LANSPRO) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Slight sore throat), NASAL CONGESTION (Congestion), RHINORRHOEA (Running nose), COUGH (Coughing) and HEADACHE (Headaches). At the time of the report, OROPHARYNGEAL PAIN (Slight sore throat), NASAL CONGESTION (Congestion), RHINORRHOEA (Running nose), COUGH (Coughing) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: Pain in arm; Rash; Swollen; Itchy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), RASH (Rash), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B217) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMIN B COMPLEX (B COMPLEX (B50)) and VITAMIN D3 for an unknown indication.    On 29-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 PAIN IN EXTREMITY (Pain in arm), RASH (Rash), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), RASH (Rash), PERIPHERAL SWELLING (Swollen), PRURITUS (Itchy) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Patient does not want to share her email and does not have a fax. She provided Argus number On 09-Jul-2021: Non significant follow up
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine received after 6 weeks of 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine received after 6 weeks of 1st dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine received after 6 weeks of 1st dose). On 07-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccine received after 6 weeks of 1st dose) 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.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: Terrible pain in the arm; Cannot lift the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible pain in the arm) and HYPOKINESIA (Cannot lift the arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Terrible pain in the arm) and HYPOKINESIA (Cannot lift the arm). At the time of the report, PAIN IN EXTREMITY (Terrible pain in the arm) and HYPOKINESIA (Cannot lift the arm) outcome was unknown. 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 information was not provided.   This case was linked to MOD21-071279 (E2B Linked Report). This case was linked to MOD-2021-069571 (Patient Link).; Sender's Comments:  MOD21-071279:Husband's Case.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: inflammation in left knee and both elbows; joint pain went into knees; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation in left knee and both elbows) and ARTHRALGIA (joint pain went into knees) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 31-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 INFLAMMATION (inflammation in left knee and both elbows) and ARTHRALGIA (joint pain went into knees). At the time of the report, INFLAMMATION (inflammation in left knee and both elbows) and ARTHRALGIA (joint pain went into knees) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided. Treatment included anti-inflammatory medication for the inflammation she had put ice on the area.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Very Bad Migraine After Second Dose; Not Able to Sleep After Second Dose; Tender Skin on her Thighs and Right Arm After Second Dose; Out of Breath when Climbing Stairs After Second Dose; Hurting Neck and Shoulders After Second Dose; Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose; Chills on and off (Hot and Cold) After Second Dose; Joint Pain After Second Dose; Fatigue After Second Dose; Nauseous After Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose) and NECK PAIN (Hurting Neck and Shoulders After Second Dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Osteoarthritis.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose), NECK PAIN (Hurting Neck and Shoulders After Second Dose), DIARRHOEA (Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose), CHILLS (Chills on and off (Hot and Cold) After Second Dose), ARTHRALGIA (Joint Pain After Second Dose), FATIGUE (Fatigue After Second Dose) and NAUSEA (Nauseous After Second Dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of UNK dosage form. On 03-Apr-2021, MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), NECK PAIN (Hurting Neck and Shoulders After Second Dose), FATIGUE (Fatigue After Second Dose) and NAUSEA (Nauseous After Second Dose) had resolved. At the time of the report, TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose), DIARRHOEA (Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose), CHILLS (Chills on and off (Hot and Cold) After Second Dose) and ARTHRALGIA (Joint Pain After Second Dose) had not resolved.            No concomitants provided   This case was linked to US-MODERNATX, INC.-MOD-2021-069576 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069576:CROSS LINKED WITH DOSE 1
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Neck pain, Sleep disorder, Tenderness
Clinical narrative: Very Bad Migraine After Second Dose; Not Able to Sleep After Second Dose; Tender Skin on her Thighs and Right Arm After Second Dose; Out of Breath when Climbing Stairs After Second Dose; Hurting Neck and Shoulders After Second Dose; Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose; Chills on and off (Hot and Cold) After Second Dose; Joint Pain After Second Dose; Fatigue After Second Dose; Nauseous After Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose) and NECK PAIN (Hurting Neck and Shoulders After Second Dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Osteoarthritis.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose), NECK PAIN (Hurting Neck and Shoulders After Second Dose), DIARRHOEA (Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose), CHILLS (Chills on and off (Hot and Cold) After Second Dose), ARTHRALGIA (Joint Pain After Second Dose), FATIGUE (Fatigue After Second Dose) and NAUSEA (Nauseous After Second Dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of UNK dosage form. On 03-Apr-2021, MIGRAINE (Very Bad Migraine After Second Dose), SLEEP DISORDER (Not Able to Sleep After Second Dose), NECK PAIN (Hurting Neck and Shoulders After Second Dose), FATIGUE (Fatigue After Second Dose) and NAUSEA (Nauseous After Second Dose) had resolved. At the time of the report, TENDERNESS (Tender Skin on her Thighs and Right Arm After Second Dose), DYSPNOEA (Out of Breath when Climbing Stairs After Second Dose), DIARRHOEA (Going to the bathroom often (Pooping but Not Diarrhea) After Second Dose), CHILLS (Chills on and off (Hot and Cold) After Second Dose) and ARTHRALGIA (Joint Pain After Second Dose) had not resolved.            No concomitants provided   This case was linked to US-MODERNATX, INC.-MOD-2021-069576 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069576:CROSS LINKED WITH DOSE 1
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pyrexia, Retching
Clinical narrative: felt like i was hit by a truck; fever; dry heaves; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), RETCHING (dry heaves), CHILLS (chills), PYREXIA (fever) and FEELING ABNORMAL (felt like i was hit by a truck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (headache), RETCHING (dry heaves) and CHILLS (chills). On an unknown date, the patient experienced PYREXIA (fever) and FEELING ABNORMAL (felt like i was hit by a truck). At the time of the report, HEADACHE (headache), RETCHING (dry heaves), CHILLS (chills), PYREXIA (fever) and FEELING ABNORMAL (felt like i was hit by a truck) outcome was unknown. Not Provided
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Slight headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. No treatment medication was reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Got half the dose, medicine dripped down the arm; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Got half the dose, medicine dripped down the arm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 07-Apr-2021, the patient experienced ACCIDENTAL UNDERDOSE (Got half the dose, medicine dripped down the arm). On 07-Apr-2021, ACCIDENTAL UNDERDOSE (Got half the dose, medicine dripped down the arm) had resolved.        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 relevant concomitant medications were reported.   No treatment information was provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Extreme pain in arm and part of back; Extreme pain in arm and part of back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Extreme pain in arm and part of back) and BACK PAIN (Extreme pain in arm and part of back) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Extreme pain in arm and part of back) and BACK PAIN (Extreme pain in arm and part of back). At the time of the report, PAIN IN EXTREMITY (Extreme pain in arm and part of back) and BACK PAIN (Extreme pain in arm and part of back) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that it was just a little pain and that he was fine. No concomitant medications were provided  by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: TCR Added. Event outcome updated. Consent for further FU was declined by reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypoaesthesia, Paraesthesia, Swelling
Clinical narrative: Intense eye swelling; Cheeks tingling; Cheek swollen; Cheeks numb; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Intense eye swelling), PARAESTHESIA (Cheeks tingling), SWELLING (Cheek swollen) and HYPOAESTHESIA (Cheeks numb) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 EYE SWELLING (Intense eye swelling), PARAESTHESIA (Cheeks tingling), SWELLING (Cheek swollen) and HYPOAESTHESIA (Cheeks numb). At the time of the report, EYE SWELLING (Intense eye swelling), PARAESTHESIA (Cheeks tingling), SWELLING (Cheek swollen) and HYPOAESTHESIA (Cheeks numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported. Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information was received on 21-May-2021 contains information regarding reporter mail address.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: Brain fog; Shortness of breath; Sweats; Swelling and pain at the injection site; Swelling and pain at the injection site; Swollen lymph nodes in neck,armpit; Fatigue; Headache; Fever; Chills; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site) and VACCINATION SITE PAIN (Swelling and pain at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site), VACCINATION SITE PAIN (Swelling and pain at the injection site), LYMPHADENOPATHY (Swollen lymph nodes in neck,armpit), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site), VACCINATION SITE PAIN (Swelling and pain at the injection site), LYMPHADENOPATHY (Swollen lymph nodes in neck,armpit), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No Concomitant product use was reported.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Brain fog; Shortness of breath; Sweats; Swelling and pain at the injection site; Swelling and pain at the injection site; Swollen lymph nodes in neck,armpit; Fatigue; Headache; Fever; Chills; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site) and VACCINATION SITE PAIN (Swelling and pain at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site), VACCINATION SITE PAIN (Swelling and pain at the injection site), LYMPHADENOPATHY (Swollen lymph nodes in neck,armpit), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site), VACCINATION SITE PAIN (Swelling and pain at the injection site), LYMPHADENOPATHY (Swollen lymph nodes in neck,armpit), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No Concomitant product use was reported.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Brain fog; Shortness of breath; Sweats; Swelling and pain at the injection site; Swelling and pain at the injection site; Swollen lymph nodes in neck,armpit; Fatigue; Headache; Fever; Chills; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site) and VACCINATION SITE PAIN (Swelling and pain at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site), VACCINATION SITE PAIN (Swelling and pain at the injection site), LYMPHADENOPATHY (Swollen lymph nodes in neck,armpit), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Brain fog), DYSPNOEA (Shortness of breath), HYPERHIDROSIS (Sweats), VACCINATION SITE SWELLING (Swelling and pain at the injection site), VACCINATION SITE PAIN (Swelling and pain at the injection site), LYMPHADENOPATHY (Swollen lymph nodes in neck,armpit), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No Concomitant product use was reported.  No treatment information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lip swelling, Oral discomfort, Paraesthesia oral
Clinical narrative: lips tingling; lips swollen especially her lower lip; lips burning; tired and sluggish; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips tingling), LIP SWELLING (lips swollen especially her lower lip), ORAL DISCOMFORT (lips burning) and FATIGUE (tired and sluggish) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008b21a and 029a21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (AUROVELA 24 FE) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PARAESTHESIA ORAL (lips tingling), LIP SWELLING (lips swollen especially her lower lip), ORAL DISCOMFORT (lips burning) and FATIGUE (tired and sluggish). On 03-Apr-2021, FATIGUE (tired and sluggish) had resolved. On 07-Apr-2021, ORAL DISCOMFORT (lips burning) had resolved. At the time of the report, PARAESTHESIA ORAL (lips tingling) and LIP SWELLING (lips swollen especially her lower lip) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-069615 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069615:Dose 1
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Injection site rash, Pain
Clinical narrative: She experiencedrash at the injection site; She experienced flu like symptoms; She experienced body aches; She experienced headache; She experienced chills; She experienced fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills) and PYREXIA (She experienced fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills) and PYREXIA (She experienced fever). On 07-Apr-2021, the patient experienced INJECTION SITE RASH (She experiencedrash at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills), PYREXIA (She experienced fever) and INJECTION SITE RASH (She experiencedrash at the injection site) outcome was unknown. Not Provided          Concomitant product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up  received on 08-July-2021 and Reporter email address provided. On 12-Jul-2021: Follow-up received on 12-JUL-2021 and contains non significant information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She experiencedrash at the injection site; She experienced flu like symptoms; She experienced body aches; She experienced headache; She experienced chills; She experienced fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills) and PYREXIA (She experienced fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills) and PYREXIA (She experienced fever). On 07-Apr-2021, the patient experienced INJECTION SITE RASH (She experiencedrash at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (She experienced flu like symptoms), PAIN (She experienced body aches), HEADACHE (She experienced headache), CHILLS (She experienced chills), PYREXIA (She experienced fever) and INJECTION SITE RASH (She experiencedrash at the injection site) outcome was unknown. Not Provided          Concomitant product information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up  received on 08-July-2021 and Reporter email address provided. On 12-Jul-2021: Follow-up received on 12-JUL-2021 and contains non significant information
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chills, Dyspnoea, Feeling of body temperature change, Inappropriate schedule of product administration
Clinical narrative: Anxiety; Shortness of breath; Shaking; Feeling hot and cold; Inappropriate schedule of vaccine administered; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), DYSPNOEA (Shortness of breath), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac disorder and Aortic aneurysm (surgery for aortic aneurism).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ANXIETY (Anxiety) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). 30-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ANXIETY (Anxiety), DYSPNOEA (Shortness of breath), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Relevant concomitant medications included, Blood pressure medications, cholesterol medications and Nebulizers  were reported.   Treatment medications included cold compress.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Anxiety; Shortness of breath; Shaking; Feeling hot and cold; Inappropriate schedule of vaccine administered; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), DYSPNOEA (Shortness of breath), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac disorder and Aortic aneurysm (surgery for aortic aneurism).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ANXIETY (Anxiety) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). 30-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ANXIETY (Anxiety), DYSPNOEA (Shortness of breath), TREMOR (Shaking), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Relevant concomitant medications included, Blood pressure medications, cholesterol medications and Nebulizers  were reported.   Treatment medications included cold compress.