chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: nose a little stuffy; throat a little sore; feeling tired; fever; chills; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nose a little stuffy), OROPHARYNGEAL PAIN (throat a little sore), FATIGUE (feeling tired), PYREXIA (fever) and CHILLS (chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-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 NASAL CONGESTION (nose a little stuffy), OROPHARYNGEAL PAIN (throat a little sore), FATIGUE (feeling tired), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches). On 06-Apr-2021, NASAL CONGESTION (nose a little stuffy) and OROPHARYNGEAL PAIN (throat a little sore) had resolved. At the time of the report, FATIGUE (feeling tired), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.            No treatment information was provided.  No concomitant medication was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-068508 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068508:CROSS LINKED WITH DOSE 1
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: red itchy spot; Swelling; red itchy spot; Sore arm; Tired; Slight headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (red itchy spot), HEADACHE (Slight headache), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease since 31-May-1999 and Penicillin allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.   On 05-Apr-2021, the patient received first 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) at an unspecified dose. On 05-Apr-2021, the patient experienced HEADACHE (Slight headache). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (red itchy spot), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (red itchy spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency. On 15-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (red itchy spot), HEADACHE (Slight headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (red itchy spot) outcome was unknown.            Treatment information included ice area for swelling.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-May-2021. Case was updated with additional events of vaccination site redness, itching and pruritus. Rechallenge information and causality for the event arm pain was updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: red itchy spot; Swelling; red itchy spot; Sore arm; Tired; Slight headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (red itchy spot), HEADACHE (Slight headache), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swelling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Crohn's disease since 31-May-1999 and Penicillin allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's disease.   On 05-Apr-2021, the patient received first 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) at an unspecified dose. On 05-Apr-2021, the patient experienced HEADACHE (Slight headache). On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (red itchy spot), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (red itchy spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency. On 15-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (red itchy spot), HEADACHE (Slight headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (red itchy spot) outcome was unknown.            Treatment information included ice area for swelling.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Additional information received on 18-May-2021. Case was updated with additional events of vaccination site redness, itching and pruritus. Rechallenge information and causality for the event arm pain was updated.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: hives; 6Feb2021, 10 days after receiving the 2nd dose of the Moderna Vaccine he developed a bad; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives) and RASH (6Feb2021, 10 days after receiving the 2nd dose of the Moderna Vaccine he developed a bad) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (amoxicillin). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced RASH (6Feb2021, 10 days after receiving the 2nd dose of the Moderna Vaccine he developed a bad). On an unknown date, the patient experienced URTICARIA (hives). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of 180 mg once a day; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of 20 mg twice a day and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 10 mg once a day. At the time of the report, URTICARIA (hives) had not resolved and RASH (6Feb2021, 10 days after receiving the 2nd dose of the Moderna Vaccine he developed a bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Maternal exposure during pregnancy, Myalgia, Pain in extremity
Clinical narrative: Sore arm; Flu like symptoms for 24 hours; Malaise; Body aches; Vaccinated in the third trimester; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated in the third trimester), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms for 24 hours), MALAISE (Malaise) and MYALGIA (Body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Mar-2021. On 10-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated in the third trimester). On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms for 24 hours), MALAISE (Malaise) and MYALGIA (Body aches). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. On 10-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccinated in the third trimester) had resolved. On 06-Feb-2021, PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms for 24 hours), MALAISE (Malaise) and MYALGIA (Body aches) had resolved.            On 10jan2021, post vaccination, the patient reported that she experienced symptoms of malaise, pain in extremity, flu like symptoms and myalgia  No treatment information was provided.  No concomitant medication was provided.  Internal review on 20jul2021 resulted in updates to pregnancy information   This case was linked to US-MODERNATX, INC.-MOD-2021-068503 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Internal review on 20jul2021 resulted in updates to pregnancy information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068503:dose 1
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site vesicles
Clinical narrative: Itchy; Blister spot where she was injected/ half inch long skinny blister; 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 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (Blister spot where she was injected/ half inch long skinny blister) and VACCINATION SITE PRURITUS (Itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, VITAMIN C [ASCORBIC ACID] and VITAMIN B NOS for an unknown indication.    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 VACCINATION SITE VESICLES (Blister spot where she was injected/ half inch long skinny blister). On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). At the time of the report, VACCINATION SITE VESICLES (Blister spot where she was injected/ half inch long skinny blister) and VACCINATION SITE PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Cough, Dysphonia
Clinical narrative: I had head congestion; chest congestion; couldn't breathe; was hoarse; sweating; trouble sleeping; cough; my taste was a little off; my smell was a little off; fever; nausea; very tired; chills; My throat was itchy/My throat was scratchy; My throat was sore; slight headache; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion) and DYSPNOEA (couldn't breathe) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). On 02-Apr-2021, the patient experienced THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), HEADACHE (slight headache), VACCINATION SITE PAIN (arm was sore at the injection site), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided. Patient had  2nd shot a month later and there is no reaction.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains significant information. updated outcome of events and second dose information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Head discomfort, Headache, Hyperhidrosis
Clinical narrative: I had head congestion; chest congestion; couldn't breathe; was hoarse; sweating; trouble sleeping; cough; my taste was a little off; my smell was a little off; fever; nausea; very tired; chills; My throat was itchy/My throat was scratchy; My throat was sore; slight headache; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion) and DYSPNOEA (couldn't breathe) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). On 02-Apr-2021, the patient experienced THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), HEADACHE (slight headache), VACCINATION SITE PAIN (arm was sore at the injection site), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided. Patient had  2nd shot a month later and there is no reaction.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains significant information. updated outcome of events and second dose information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: I had head congestion; chest congestion; couldn't breathe; was hoarse; sweating; trouble sleeping; cough; my taste was a little off; my smell was a little off; fever; nausea; very tired; chills; My throat was itchy/My throat was scratchy; My throat was sore; slight headache; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion) and DYSPNOEA (couldn't breathe) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). On 02-Apr-2021, the patient experienced THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), HEADACHE (slight headache), VACCINATION SITE PAIN (arm was sore at the injection site), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided. Patient had  2nd shot a month later and there is no reaction.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains significant information. updated outcome of events and second dose information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site pain
Clinical narrative: I had head congestion; chest congestion; couldn't breathe; was hoarse; sweating; trouble sleeping; cough; my taste was a little off; my smell was a little off; fever; nausea; very tired; chills; My throat was itchy/My throat was scratchy; My throat was sore; slight headache; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion) and DYSPNOEA (couldn't breathe) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore at the injection site). On 02-Apr-2021, the patient experienced THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, THROAT IRRITATION (My throat was itchy/My throat was scratchy), OROPHARYNGEAL PAIN (My throat was sore), HEAD DISCOMFORT (I had head congestion), RESPIRATORY TRACT CONGESTION (chest congestion), DYSPNOEA (couldn't breathe), DYSPHONIA (was hoarse), HYPERHIDROSIS (sweating), INSOMNIA (trouble sleeping), COUGH (cough), AGEUSIA (my taste was a little off), ANOSMIA (my smell was a little off), HEADACHE (slight headache), VACCINATION SITE PAIN (arm was sore at the injection site), PYREXIA (fever), NAUSEA (nausea), FATIGUE (very tired) and CHILLS (chills) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication was not provided. Patient had  2nd shot a month later and there is no reaction.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information received on 15-JUL-2021 contains significant information. updated outcome of events and second dose information.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cold sweat, Erythema, Feeling abnormal, Headache
Clinical narrative: very dry nose; sometimes had red hands; cold sweat; inflammation at the injection site palm-size; red, very hot (injection site); red, very hot (injection site); rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin); felt very bad; stomach pain; sore arm; itches; numb fingers in her hand; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose) and ERYTHEMA (sometimes had red hands) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand) and HEADACHE (headache). On 27-Mar-2021 at 2:30 PM, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 30-Mar-2021, the patient experienced RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)). On an unknown date, the patient experienced NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), ABDOMINAL PAIN UPPER (stomach pain), FEELING ABNORMAL (felt very bad), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)) outcome was unknown and RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cream Sheffield and ice.   Patient clarify that she was born on March 2 1937, but her birthday card says she was born on Feb 2 1937.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 06 Apr 2021 in which event verbatim was updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nasal dryness, Pain in extremity, Pruritus, Rash
Clinical narrative: very dry nose; sometimes had red hands; cold sweat; inflammation at the injection site palm-size; red, very hot (injection site); red, very hot (injection site); rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin); felt very bad; stomach pain; sore arm; itches; numb fingers in her hand; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose) and ERYTHEMA (sometimes had red hands) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand) and HEADACHE (headache). On 27-Mar-2021 at 2:30 PM, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 30-Mar-2021, the patient experienced RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)). On an unknown date, the patient experienced NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), ABDOMINAL PAIN UPPER (stomach pain), FEELING ABNORMAL (felt very bad), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)) outcome was unknown and RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cream Sheffield and ice.   Patient clarify that she was born on March 2 1937, but her birthday card says she was born on Feb 2 1937.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 06 Apr 2021 in which event verbatim was updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
Clinical narrative: very dry nose; sometimes had red hands; cold sweat; inflammation at the injection site palm-size; red, very hot (injection site); red, very hot (injection site); rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin); felt very bad; stomach pain; sore arm; itches; numb fingers in her hand; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose) and ERYTHEMA (sometimes had red hands) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand) and HEADACHE (headache). On 27-Mar-2021 at 2:30 PM, the patient experienced ABDOMINAL PAIN UPPER (stomach pain). On 29-Mar-2021, the patient experienced FEELING ABNORMAL (felt very bad). On 30-Mar-2021, the patient experienced RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)). On an unknown date, the patient experienced NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itches), HYPOAESTHESIA (numb fingers in her hand), NASAL DRYNESS (very dry nose), ERYTHEMA (sometimes had red hands), ABDOMINAL PAIN UPPER (stomach pain), FEELING ABNORMAL (felt very bad), COLD SWEAT (cold sweat), VACCINATION SITE INFLAMMATION (inflammation at the injection site palm-size), VACCINATION SITE WARMTH (red, very hot (injection site)), HEADACHE (headache) and VACCINATION SITE ERYTHEMA (red, very hot (injection site)) outcome was unknown and RASH (rash on her right hand/under her right armpit/rash size of 1 coin/ rash the size of a quarter (a 25 coin)) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included cream Sheffield and ice.   Patient clarify that she was born on March 2 1937, but her birthday card says she was born on Feb 2 1937.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow up information was received on 06 Apr 2021 in which event verbatim was updated.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Pain in extremity
Clinical narrative: Missed Dose; Covid-19; No smell; Sneezing; No Taste; Chills; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), PRODUCT DOSE OMISSION ISSUE (Missed Dose), PAIN IN EXTREMITY (Arm was sore), ANOSMIA (No smell) and SNEEZING (Sneezing) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 30-Mar-2021, the patient experienced COVID-19 (Covid-19), ANOSMIA (No smell), SNEEZING (Sneezing), AGEUSIA (No Taste) and CHILLS (Chills). On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Dose). On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed Dose) had resolved. At the time of the report, COVID-19 (Covid-19), PAIN IN EXTREMITY (Arm was sore), ANOSMIA (No smell), SNEEZING (Sneezing), AGEUSIA (No Taste) and CHILLS (Chills) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Sneezing
Clinical narrative: Missed Dose; Covid-19; No smell; Sneezing; No Taste; Chills; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), PRODUCT DOSE OMISSION ISSUE (Missed Dose), PAIN IN EXTREMITY (Arm was sore), ANOSMIA (No smell) and SNEEZING (Sneezing) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 30-Mar-2021, the patient experienced COVID-19 (Covid-19), ANOSMIA (No smell), SNEEZING (Sneezing), AGEUSIA (No Taste) and CHILLS (Chills). On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Dose). On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed Dose) had resolved. At the time of the report, COVID-19 (Covid-19), PAIN IN EXTREMITY (Arm was sore), ANOSMIA (No smell), SNEEZING (Sneezing), AGEUSIA (No Taste) and CHILLS (Chills) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Nasopharyngitis, Underdose, Vaccination site pain
Clinical narrative: Sore arm; Cold like symptoms; concerned he did not receive the full dose; felt some vaccine ran down his arm to the end of his elbow; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (concerned he did not receive the full dose), DEVICE CONNECTION ISSUE (felt some vaccine ran down his arm to the end of his elbow), VACCINATION SITE PAIN (Sore arm) and NASOPHARYNGITIS (Cold like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced UNDERDOSE (concerned he did not receive the full dose) and DEVICE CONNECTION ISSUE (felt some vaccine ran down his arm to the end of his elbow). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and NASOPHARYNGITIS (Cold like symptoms). On 06-Apr-2021, UNDERDOSE (concerned he did not receive the full dose) and DEVICE CONNECTION ISSUE (felt some vaccine ran down his arm to the end of his elbow) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) and NASOPHARYNGITIS (Cold like symptoms) outcome was unknown. Not Provided          No concomitant medications were provided by reporter. Treatment medications were not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on 26 Jun 2021 and contains significant information Additional events reported (Sore arm and cold like symptoms).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Fever; body ache; a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm), PYREXIA (fever) and MYALGIA (body ache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation.  No Medical History information was reported.  On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (a sore arm), PYREXIA (fever) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Mar-2021, PAIN IN EXTREMITY (a sore arm), PYREXIA (fever) and MYALGIA (body ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068507 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever 100 Fahrenheit) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.  Concurrent medical conditions included Diabetes and Blood pressure.  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) and PYREXIA (Fever 100 Fahrenheit). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever 100 Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications of the patient were not provided. No concomitant medications of the patient were provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea , 7 days after receiving the second dose; Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose; Chills , 7 days after receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea , 7 days after receiving the second dose), PYREXIA (Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose) and CHILLS (Chills , 7 days after receiving the second dose) in a 74-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 06-Apr-2021, the patient experienced DIARRHOEA (Diarrhea , 7 days after receiving the second dose), PYREXIA (Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose) and CHILLS (Chills , 7 days after receiving the second dose). At the time of the report, DIARRHOEA (Diarrhea , 7 days after receiving the second dose), PYREXIA (Fever (103° F , and now is 99.1°F) , 7 days after receiving the second dose) and CHILLS (Chills , 7 days after receiving the second dose) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy (from the neck down) and Handicap. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    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 (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) (Intramuscular) was unknown.       Concomitant medications include pain medication.  pain medication prescribed for neuropathy.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up information include:Reporter details updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: Never went back to take the second dose of vaccine; Tested positive for Covid-19; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore arm), SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) and PRODUCT DOSE OMISSION ISSUE (Never went back to take the second dose of vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, METOPROLOL and PANTOPRAZOLE for Reflux esophagitis, MONTELUKAST for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 28-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never went back to take the second dose of vaccine). At the time of the report, VACCINATION SITE PAIN (Sore arm) and SARS-COV-2 TEST POSITIVE (Tested positive for Covid-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never went back to take the second dose of vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive Tested Positive For Covid-19.     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.   Other Concomitant Product includes Allergy Shot.Had question if her mother-in-law can still take the second dose and when can she take the second dose.bTreatment Information was not provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Rash pruritic
Clinical narrative: rash is mildly itchy; rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms; arm was sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for a couple of days), RASH PRURITIC (rash is mildly itchy) and RASH (rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028a21a) for COVID-19 vaccination.     Concomitant products included LOSARTAN, AMLODIPINE, LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for a couple of days). On 01-Apr-2021, the patient experienced RASH PRURITIC (rash is mildly itchy) and RASH (rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms). On 29-Mar-2021, PAIN IN EXTREMITY (arm was sore for a couple of days) had resolved. At the time of the report, RASH PRURITIC (rash is mildly itchy) and RASH (rash with a bump with small bumps around it on arms and legs/rash on middle of his forearm/ bumps on both legs and both arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Off label dosing frequency; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Off label dosing frequency) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Off label dosing frequency). At the time of the report, OFF LABEL USE (Off label dosing frequency) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.