chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain on her arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her arm) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on her arm). At the time of the report, PAIN IN EXTREMITY (Pain on her arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: light headedness; really tired; could not move; really weird surges; brain fog; dizziness; head chills; cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), HYPOKINESIA (could not move), ADVERSE EVENT (really weird surges), DIZZINESS (light headedness) and FEELING ABNORMAL (brain fog) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0300A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), FEELING ABNORMAL (brain fog), DIZZINESS (dizziness) and CHILLS (head chills). On 24-Mar-2021, the patient experienced HYPOKINESIA (could not move) and ADVERSE EVENT (really weird surges). On 25-Mar-2021, the patient experienced DIZZINESS (light headedness) and FATIGUE (really tired). The patient was treated with LORATADINE (ALAVERT) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Mar-2021, NASOPHARYNGITIS (cold) and CHILLS (head chills) had resolved. On 24-Mar-2021, HYPOKINESIA (could not move) and ADVERSE EVENT (really weird surges) had resolved. On 25-Mar-2021, DIZZINESS (light headedness) and FATIGUE (really tired) had resolved. At the time of the report, FEELING ABNORMAL (brain fog) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Nasopharyngitis
Clinical narrative: light headedness; really tired; could not move; really weird surges; brain fog; dizziness; head chills; cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), HYPOKINESIA (could not move), ADVERSE EVENT (really weird surges), DIZZINESS (light headedness) and FEELING ABNORMAL (brain fog) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0300A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.     On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced NASOPHARYNGITIS (cold), FEELING ABNORMAL (brain fog), DIZZINESS (dizziness) and CHILLS (head chills). On 24-Mar-2021, the patient experienced HYPOKINESIA (could not move) and ADVERSE EVENT (really weird surges). On 25-Mar-2021, the patient experienced DIZZINESS (light headedness) and FATIGUE (really tired). The patient was treated with LORATADINE (ALAVERT) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Mar-2021, NASOPHARYNGITIS (cold) and CHILLS (head chills) had resolved. On 24-Mar-2021, HYPOKINESIA (could not move) and ADVERSE EVENT (really weird surges) had resolved. On 25-Mar-2021, DIZZINESS (light headedness) and FATIGUE (really tired) had resolved. At the time of the report, FEELING ABNORMAL (brain fog) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Dizziness, Head discomfort, Nausea, Vertigo
Clinical narrative: dizziness; light headedness; couldn't hold her head up; the runs and its highlighter yellow; vertigo; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIZZINESS (light headedness), HEAD DISCOMFORT (couldn't hold her head up), CHROMATURIA (the runs and its highlighter yellow) and VERTIGO (vertigo) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo.    On 12-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 DIZZINESS (dizziness), DIZZINESS (light headedness), HEAD DISCOMFORT (couldn't hold her head up), CHROMATURIA (the runs and its highlighter yellow), VERTIGO (vertigo) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), DIZZINESS (light headedness), HEAD DISCOMFORT (couldn't hold her head up), CHROMATURIA (the runs and its highlighter yellow), VERTIGO (vertigo) and NAUSEA (nausea) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant  information was  provided. Treatment include A vertigo medication Mentions she had something similar occur in 2019 after a trip she went on.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site swelling
Clinical narrative: left arm occasionally painful; Rash; Injection site raised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm occasionally painful), RASH (Rash) and VACCINATION SITE SWELLING (Injection site raised) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (left arm occasionally painful), RASH (Rash) and VACCINATION SITE SWELLING (Injection site raised). At the time of the report, PAIN IN EXTREMITY (left arm occasionally painful), RASH (Rash) and VACCINATION SITE SWELLING (Injection site raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Allergy Medicine. No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-059847 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059847:cross_link report
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pyrexia, Vaccination site vesicles
Clinical narrative: really cold; a little clear liquid filled blister where he got the vaccine; fever; shivering a lot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (really cold), VACCINATION SITE VESICLES (a little clear liquid filled blister where he got the vaccine), PYREXIA (fever) and CHILLS (shivering a lot) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m20a) for COVID-19 vaccination.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced NASOPHARYNGITIS (really cold), VACCINATION SITE VESICLES (a little clear liquid filled blister where he got the vaccine), PYREXIA (fever) and CHILLS (shivering a lot). The patient was treated with PARACETAMOL (TYLENOL) on 26-Mar-2021 for Fever, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (really cold), VACCINATION SITE VESICLES (a little clear liquid filled blister where he got the vaccine), PYREXIA (fever) and CHILLS (shivering a lot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication information was provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Food poisoning
Clinical narrative: intense pain on his stomach; felt like he had food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (intense pain on his stomach) and FOOD POISONING (felt like he had food poisoning) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031L20A) for COVID-19 vaccination.     No medical history was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (intense pain on his stomach) and FOOD POISONING (felt like he had food poisoning). At the time of the report, ABDOMINAL PAIN UPPER (intense pain on his stomach) and FOOD POISONING (felt like he had food poisoning) outcome was unknown.            Concomitant product use was provided by the reporter Statin for cholesterol and unknown for blood pressure. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swollen tongue, Vaccination site erythema, Vaccination site rash, Vaccination site reaction
Clinical narrative: Hot; Rash on arm; Swollen; Red; Rash; Tongue is swollen/Tongue swelled a week after vaccination; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), RASH (Rash) and VACCINATION SITE RASH (Rash on arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Loss of memory (bad memory and is getting worse).    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 SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination), VACCINATION SITE REACTION (Covid arm) and RASH (Rash). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash on arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination) was resolving, VACCINATION SITE REACTION (Covid arm) and RASH (Rash) had resolved and VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash on arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medication provided. Treatment medication includes Benadryl and  Arnica.  The patient lost 10 pounds and stated that her tongue was so big that it hurt to talk. The patient discovered Arnica later which was a homeopathic medicine that worked within 15 minutes after taking it.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up information received included ne events and treatment information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot; Rash on arm; Swollen; Red; Rash; Tongue is swollen/Tongue swelled a week after vaccination; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination), VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), RASH (Rash) and VACCINATION SITE RASH (Rash on arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Loss of memory (bad memory and is getting worse).    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 SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination), VACCINATION SITE REACTION (Covid arm) and RASH (Rash). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash on arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWOLLEN TONGUE (Tongue is swollen/Tongue swelled a week after vaccination) was resolving, VACCINATION SITE REACTION (Covid arm) and RASH (Rash) had resolved and VACCINATION SITE WARMTH (Hot), VACCINATION SITE RASH (Rash on arm), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no relevant concomitant medication provided. Treatment medication includes Benadryl and  Arnica.  The patient lost 10 pounds and stated that her tongue was so big that it hurt to talk. The patient discovered Arnica later which was a homeopathic medicine that worked within 15 minutes after taking it.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: follow up information received included ne events and treatment information.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pruritus, Paraesthesia oral, Rash, Swelling face, Tachycardia
Clinical narrative: rash on her face and chin; face was puffy; lips are tingly; lips are itchy; she feels that she has a fast heart beat.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on her face and chin), SWELLING FACE (face was puffy), PARAESTHESIA ORAL (lips are tingly), LIP PRURITUS (lips are itchy) and TACHYCARDIA (she feels that she has a fast heart beat.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for an unknown indication.     Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), GABAPENTIN and Rovaxin for an unknown indication.   On 25-Mar-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 25-Mar-2021, the patient experienced RASH (rash on her face and chin), SWELLING FACE (face was puffy), PARAESTHESIA ORAL (lips are tingly), LIP PRURITUS (lips are itchy) and TACHYCARDIA (she feels that she has a fast heart beat.). At the time of the report, RASH (rash on her face and chin), SWELLING FACE (face was puffy), PARAESTHESIA ORAL (lips are tingly), LIP PRURITUS (lips are itchy) and TACHYCARDIA (she feels that she has a fast heart beat.) outcome was unknown.            The patient did not receive any treatment.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12 May  2021 contain information: No new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia, Paraesthesia oral
Clinical narrative: tingling at tip of her tongue; tingling at fingertips - both hands; Hot spots inside of elbow - both elbows; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (tingling at tip of her tongue), PARAESTHESIA (tingling at fingertips - both hands) and FEELING HOT (Hot spots inside of elbow - both elbows) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling at tip of her tongue), PARAESTHESIA (tingling at fingertips - both hands) and FEELING HOT (Hot spots inside of elbow - both elbows). At the time of the report, PARAESTHESIA ORAL (tingling at tip of her tongue), PARAESTHESIA (tingling at fingertips - both hands) and FEELING HOT (Hot spots inside of elbow - both elbows) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. No treatment details  were provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Confusional state, Disorientation, Eye contusion, Inappropriate schedule of product administration
Clinical narrative: More than 36 days after the first dose and second dose was not given.; black eye on right side; Pain in right arm; Foggy mind; Scratching right eyebrow; feel disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (feel disoriented), EYE CONTUSION (black eye on right side), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind) and SEBORRHOEIC DERMATITIS (Scratching right eyebrow) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DISORIENTATION (feel disoriented), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind) and SEBORRHOEIC DERMATITIS (Scratching right eyebrow). On 02-Feb-2021, the patient experienced EYE CONTUSION (black eye on right side). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose and second dose was not given.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (feel disoriented), EYE CONTUSION (black eye on right side), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind), SEBORRHOEIC DERMATITIS (Scratching right eyebrow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose and second dose was not given.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were, Cholesterol Medicine and Diuretics.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Seborrhoeic dermatitis
Clinical narrative: More than 36 days after the first dose and second dose was not given.; black eye on right side; Pain in right arm; Foggy mind; Scratching right eyebrow; feel disoriented; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (feel disoriented), EYE CONTUSION (black eye on right side), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind) and SEBORRHOEIC DERMATITIS (Scratching right eyebrow) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hyperlipidemia.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DISORIENTATION (feel disoriented), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind) and SEBORRHOEIC DERMATITIS (Scratching right eyebrow). On 02-Feb-2021, the patient experienced EYE CONTUSION (black eye on right side). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose and second dose was not given.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISORIENTATION (feel disoriented), EYE CONTUSION (black eye on right side), PAIN IN EXTREMITY (Pain in right arm), CONFUSIONAL STATE (Foggy mind), SEBORRHOEIC DERMATITIS (Scratching right eyebrow) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose and second dose was not given.) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications reported were, Cholesterol Medicine and Diuretics.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Extrasystoles, Heart rate, Heart rate increased, Insomnia
Clinical narrative: EKG showed "sinus arrhythmia"; Heart "was skipping beats"; Heart was pounding; It was uncomfortable; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable), INSOMNIA (Could not sleep) and SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia") in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable) and INSOMNIA (Could not sleep). On 05-Mar-2021, the patient experienced SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia"). At the time of the report, EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable) and INSOMNIA (Could not sleep) outcome was unknown and SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus arrhythmia
Clinical narrative: EKG showed "sinus arrhythmia"; Heart "was skipping beats"; Heart was pounding; It was uncomfortable; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable), INSOMNIA (Could not sleep) and SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia") in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable) and INSOMNIA (Could not sleep). On 05-Mar-2021, the patient experienced SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia"). At the time of the report, EXTRASYSTOLES (Heart "was skipping beats"), HEART RATE INCREASED (Heart was pounding), DISCOMFORT (It was uncomfortable) and INSOMNIA (Could not sleep) outcome was unknown and SINUS ARRHYTHMIA (EKG showed "sinus arrhythmia") had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist drew up doses last night and stored in fridge; administered 6 of 10 doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist drew up doses last night and stored in fridge; administered 6 of 10 doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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 EXPIRED PRODUCT ADMINISTERED (Pharmacist drew up doses last night and stored in fridge; administered 6 of 10 doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist drew up doses last night and stored in fridge; administered 6 of 10 doses) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  No concomitant medications were reported  No treatment information was provided.; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: Not Provided)  with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchies; pricklies; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchies) and RASH (pricklies) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 PRURITUS (itchies) and RASH (pricklies). At the time of the report, PRURITUS (itchies) and RASH (pricklies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Chills, Headache, Hypokinesia, Myalgia
Clinical narrative: couldnt move; symptoms were "just really bad!"; sight headache that gradually worsened; chills; muscles aches; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills) and MYALGIA (muscles aches) in a 59-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.     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 26-Mar-2021, the patient experienced HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills), MYALGIA (muscles aches), PYREXIA (fever) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills), MYALGIA (muscles aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: couldnt move; symptoms were "just really bad!"; sight headache that gradually worsened; chills; muscles aches; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills) and MYALGIA (muscles aches) in a 59-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.     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 26-Mar-2021, the patient experienced HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills), MYALGIA (muscles aches), PYREXIA (fever) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (couldnt move), ADVERSE EVENT (symptoms were "just really bad!"), HEADACHE (sight headache that gradually worsened), CHILLS (chills), MYALGIA (muscles aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Cyst, Myalgia, Rash, Vaccination site reaction
Clinical narrative: Couple of cysts on the arm and underarm area; Rash showing up a week later /Rash is the size of a baseball; muscle soreness; Minor reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Minor reactions), CYST (Couple of cysts on the arm and underarm area), RASH (Rash showing up a week later /Rash is the size of a baseball) and MYALGIA (muscle soreness) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE REACTION (Minor reactions) and MYALGIA (muscle soreness). On 25-Mar-2021, the patient experienced CYST (Couple of cysts on the arm and underarm area) and RASH (Rash showing up a week later /Rash is the size of a baseball). At the time of the report, VACCINATION SITE REACTION (Minor reactions), CYST (Couple of cysts on the arm and underarm area), RASH (Rash showing up a week later /Rash is the size of a baseball) and MYALGIA (muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported Patient didn't receive any treatment
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Movement disorder, Myalgia, Pyrexia
Clinical narrative: Couldn't move; fever; muscle ache; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (Couldn't move), PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (Headache) and CHILLS (chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced MOVEMENT DISORDER (Couldn't move), PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (Headache) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOVEMENT DISORDER (Couldn't move), PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (Headache) and CHILLS (chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Pain in extremity
Clinical narrative: Dizzy; flu like symptoms; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN IN EXTREMITY (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN IN EXTREMITY (sore arm). At the time of the report, DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (flu like symptoms) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Chills, Headache, Hypokinesia, Myalgia
Clinical narrative: symptoms were "just really bad!"; couldn't move; sight headache that actually worsened; chills; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (symptoms were "just really bad!"), HYPOKINESIA (couldn't move), HEADACHE (sight headache that actually worsened), CHILLS (chills) and PYREXIA (fever) in a 59-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.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ADVERSE EVENT (symptoms were "just really bad!"), HYPOKINESIA (couldn't move), HEADACHE (sight headache that actually worsened), CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (symptoms were "just really bad!"), HYPOKINESIA (couldn't move), HEADACHE (sight headache that actually worsened), CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: symptoms were "just really bad!"; couldn't move; sight headache that actually worsened; chills; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (symptoms were "just really bad!"), HYPOKINESIA (couldn't move), HEADACHE (sight headache that actually worsened), CHILLS (chills) and PYREXIA (fever) in a 59-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.     No medical history was reported.     On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced ADVERSE EVENT (symptoms were "just really bad!"), HYPOKINESIA (couldn't move), HEADACHE (sight headache that actually worsened), CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (symptoms were "just really bad!"), HYPOKINESIA (couldn't move), HEADACHE (sight headache that actually worsened), CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little body ache very very little like when you get the flu shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a little body ache very very little like when you get the flu shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement. Concurrent medical conditions included Hypertension. Concomitant products included NAPROXEN SODIUM (ALEVE) for Pain, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 25-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 (a little body ache very very little like when you get the flu shot). At the time of the report, PAIN (a little body ache very very little like when you get the flu shot) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medications also include, blood pressure medication and water pill.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache; chills; muscle ache; joint ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache), ARTHRALGIA (joint ache) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 immunisation.     No medical history was reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache), ARTHRALGIA (joint ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache), ARTHRALGIA (joint ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Injection site swelling, Pain in extremity, Sinusitis
Clinical narrative: allergies; slight headache for a few weeks; left arm injection site still remains slightly raised; sinus infection; sore right arm for a few weeks; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection), PAIN IN EXTREMITY (sore right arm for a few weeks), HYPERSENSITIVITY (allergies), HEADACHE (slight headache for a few weeks) and INJECTION SITE SWELLING (left arm injection site still remains slightly raised) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced SINUSITIS (sinus infection), PAIN IN EXTREMITY (sore right arm for a few weeks), HEADACHE (slight headache for a few weeks) and INJECTION SITE SWELLING (left arm injection site still remains slightly raised). On 26-Mar-2021, the patient experienced HYPERSENSITIVITY (allergies). At the time of the report, SINUSITIS (sinus infection), PAIN IN EXTREMITY (sore right arm for a few weeks), HYPERSENSITIVITY (allergies), HEADACHE (slight headache for a few weeks) and INJECTION SITE SWELLING (left arm injection site still remains slightly raised) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant medications include Allergy Medicine. No Treatment information was  provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-059825 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059825:cross_link report
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Feeling hot, Hyperglycaemia, Hyperhidrosis, Tremor
Clinical narrative: High blood sugar after the vaccine; Sweating; Shaky; Hot feeling; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (High blood sugar after the vaccine), HYPERHIDROSIS (Sweating), TREMOR (Shaky) and FEELING HOT (Hot feeling) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DULAGLUTIDE (TRULICITY), GLIPIZIDE and METFORMIN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HYPERGLYCAEMIA (High blood sugar after the vaccine), HYPERHIDROSIS (Sweating), TREMOR (Shaky) and FEELING HOT (Hot feeling). The patient was treated with DULAGLUTIDE (TRULICITY) at a dose of once a week; GLIPIZIDE at a dose of 10 mg twice a day and METFORMIN at a dose of 1000 mg twice a day. At the time of the report, HYPERGLYCAEMIA (High blood sugar after the vaccine) had not resolved and HYPERHIDROSIS (Sweating), TREMOR (Shaky) and FEELING HOT (Hot feeling) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Blood glucose increased: 292 (High) Blood sugar 292 and 201 (High) Blood sugar 201. On 24-Mar-2021, Blood glucose increased: 234 (High) Blood sugar 234. On an unknown date, Blood glucose increased: 151 (High) Blood sugar 151 and 357 (High) Blood sugar 357.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site pain, Peripheral swelling, Swelling
Clinical narrative: swollen; red; ally swollen in her arm.It looks like it is 6 inches long and 3 inches wide; sore arm at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen), ERYTHEMA (red), PERIPHERAL SWELLING (ally swollen in her arm.It looks like it is 6 inches long and 3 inches wide) and INJECTION SITE PAIN (sore arm at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced SWELLING (swollen), ERYTHEMA (red), PERIPHERAL SWELLING (ally swollen in her arm.It looks like it is 6 inches long and 3 inches wide) and INJECTION SITE PAIN (sore arm at the injection site). At the time of the report, SWELLING (swollen), ERYTHEMA (red), PERIPHERAL SWELLING (ally swollen in her arm.It looks like it is 6 inches long and 3 inches wide) and INJECTION SITE PAIN (sore arm at the injection site) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided. No Treatment information was  provided.    Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Vaccination site rash
Clinical narrative: hives; itchy skin; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itchy skin) and VACCINATION SITE RASH (rash at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was reported.     On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced URTICARIA (hives), PRURITUS (itchy skin) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, URTICARIA (hives), PRURITUS (itchy skin) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.