chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain in her back is worse; extends from lower back to sciatic nerve; Pain extends into her lower legs; Headache flared up; Felt dragged out/tired, no energy, sleeping later than used to/general dragged out malaise/Still feeling very tired; General dragged out malaise; Sleeping later than used to; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Pain in her back is worse; extends from lower back to sciatic nerve), MALAISE (General dragged out malaise), HYPERSOMNIA (Sleeping later than used to), PAIN IN EXTREMITY (Pain extends into her lower legs) and HEADACHE (Headache flared up) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in 2015.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced MALAISE (General dragged out malaise), HYPERSOMNIA (Sleeping later than used to) and FATIGUE (Felt dragged out/tired, no energy, sleeping later than used to/general dragged out malaise/Still feeling very tired). On an unknown date, the patient experienced BACK PAIN (Pain in her back is worse; extends from lower back to sciatic nerve), PAIN IN EXTREMITY (Pain extends into her lower legs) and HEADACHE (Headache flared up). At the time of the report, BACK PAIN (Pain in her back is worse; extends from lower back to sciatic nerve), PAIN IN EXTREMITY (Pain extends into her lower legs), HEADACHE (Headache flared up) and FATIGUE (Felt dragged out/tired, no energy, sleeping later than used to/general dragged out malaise/Still feeling very tired) had not resolved and MALAISE (General dragged out malaise) and HYPERSOMNIA (Sleeping later than used to) outcome was unknown.            The patient reported requiring extra pain medication (not specified) due to aggravated back pain.     This case was linked to US-MODERNATX, INC.-MOD-2021-083531, MOD21-079646, MOD21-091983, US-MODERNATX, INC.-MOD-2021-149581 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New event of headache added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083531: MOD21-079646:cross linked id MOD21-091983:cross linked id US-MODERNATX, INC.-MOD-2021-149581:
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Inappropriate schedule of product administration, Nerve compression
Clinical narrative: acute back pain of which they found it was a pinched nerve; acute back pain of which they found it was a pinched nerve.; May or may not receive second dose in time (may be greater than day 36); This spontaneous case was reported by a consumer and describes the occurrence of NERVE COMPRESSION (acute back pain of which they found it was a pinched nerve), BACK PAIN (acute back pain of which they found it was a pinched nerve.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May or may not receive second dose in time (may be greater than day 36)) 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 24-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 NERVE COMPRESSION (acute back pain of which they found it was a pinched nerve), BACK PAIN (acute back pain of which they found it was a pinched nerve.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May or may not receive second dose in time (may be greater than day 36)). At the time of the report, NERVE COMPRESSION (acute back pain of which they found it was a pinched nerve), BACK PAIN (acute back pain of which they found it was a pinched nerve.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (May or may not receive second dose in time (may be greater than day 36)) 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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not receiving the second dose on the recommended time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving the second dose on the recommended time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving the second dose on the recommended time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not receiving the second dose on the recommended time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No other medication reported.  Patient hang up before being transferred to the MI agent MI agent called back and no one answered. A voicemail was left with the case number.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Somnolence
Clinical narrative: barely get out from bed; severe headache; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (barely get out from bed), HEADACHE (severe headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SOMNOLENCE (barely get out from bed), HEADACHE (severe headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, SOMNOLENCE (barely get out from bed), HEADACHE (severe headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided treatment included nitrofurantoin.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Off label use, Pyrexia
Clinical narrative: her doctor stated to wait an additional week before receiving her second dose; headache; tiredness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (her doctor stated to wait an additional week before receiving her second dose), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030B21A) for COVID-19 vaccination.     No medical history was provided by the repor.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced OFF LABEL USE (her doctor stated to wait an additional week before receiving her second dose), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In March 2021, OFF LABEL USE (her doctor stated to wait an additional week before receiving her second dose), HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medication was reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a sore upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore upper arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore upper arm). At the time of the report, PAIN IN EXTREMITY (a sore upper arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-083954 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083954:Reporter(Caller) case
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Fever; Arm pain; Tired; tingling sensation to finger tip of right hand; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Arm pain), FATIGUE (Tired) and PARAESTHESIA (tingling sensation to finger tip of right hand) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), ARMODAFINIL (NUVIGIL) and DESOGESTREL, ETHINYLESTRADIOL (VIORELE) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), PAIN IN EXTREMITY (Arm pain), FATIGUE (Tired) and PARAESTHESIA (tingling sensation to finger tip of right hand). At the time of the report, PYREXIA (Fever), PAIN IN EXTREMITY (Arm pain), FATIGUE (Tired) and PARAESTHESIA (tingling sensation to finger tip of right hand) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 2:15 PM, the patient experienced EPISTAXIS (nose bleed). At the time of the report, EPISTAXIS (nose bleed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: now has a headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (now has a headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Headache tension.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Apr-2021, the patient experienced HEADACHE (now has a headache). At the time of the report, HEADACHE (now has a headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Pain in extremity
Clinical narrative: faint feeling; left arm was painful between shoulder and elbow; loose stools during the day/had to use the commode many times; weak; chills all night long; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (faint feeling), DIARRHOEA (loose stools during the day/had to use the commode many times), ASTHENIA (weak), CHILLS (chills all night long) and PAIN IN EXTREMITY (left arm was painful between shoulder and elbow) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 20-Apr-2021, the patient experienced DIARRHOEA (loose stools during the day/had to use the commode many times), ASTHENIA (weak) and CHILLS (chills all night long). On an unknown date, the patient experienced DIZZINESS (faint feeling) and PAIN IN EXTREMITY (left arm was painful between shoulder and elbow). At the time of the report, DIZZINESS (faint feeling), DIARRHOEA (loose stools during the day/had to use the commode many times), ASTHENIA (weak), CHILLS (chills all night long) and PAIN IN EXTREMITY (left arm was painful between shoulder and elbow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment not provided.  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.; 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sexual dysfunction, Vertigo
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SEXUAL DYSFUNCTION (Effect sex life) and VERTIGO (Vertigo) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced SEXUAL DYSFUNCTION (Effect sex life) and VERTIGO (Vertigo). The patient was treated with DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency. At the time of the report, SEXUAL DYSFUNCTION (Effect sex life) and VERTIGO (Vertigo) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No Concomitant Medication was provided. Dramamine motion sickness band used as a Treatment Medication.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Flushing, Headache
Clinical narrative: headache; tiredness; fever; chills; irritating; facial flushing; face turning red; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritating), FLUSHING (facial flushing), ERYTHEMA (face turning red), HEADACHE (headache) and FATIGUE (tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (VIVELLE DOT) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 13-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In April 2021, the patient experienced IRRITABILITY (irritating), FLUSHING (facial flushing) and ERYTHEMA (face turning red). In April 2021, HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, IRRITABILITY (irritating), FLUSHING (facial flushing) and ERYTHEMA (face turning red) outcome was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Pyrexia
Clinical narrative: headache; tiredness; fever; chills; irritating; facial flushing; face turning red; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (irritating), FLUSHING (facial flushing), ERYTHEMA (face turning red), HEADACHE (headache) and FATIGUE (tiredness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL (VIVELLE DOT) for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On 13-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). In April 2021, the patient experienced IRRITABILITY (irritating), FLUSHING (facial flushing) and ERYTHEMA (face turning red). In April 2021, HEADACHE (headache), FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, IRRITABILITY (irritating), FLUSHING (facial flushing) and ERYTHEMA (face turning red) outcome was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pain, Paraesthesia oral
Clinical narrative: Tingling in her Tongue; Burning Sensation on the Lips and Mouth; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling in her Tongue), BURNING SENSATION (Burning Sensation on the Lips and Mouth) and INJECTION SITE PAIN (Sore Injection Site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 10:42 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PARAESTHESIA ORAL (Tingling in her Tongue), BURNING SENSATION (Burning Sensation on the Lips and Mouth) and INJECTION SITE PAIN (Sore Injection Site). On 21-Apr-2021, PARAESTHESIA ORAL (Tingling in her Tongue) and BURNING SENSATION (Burning Sensation on the Lips and Mouth) had resolved. At the time of the report, INJECTION SITE PAIN (Sore Injection Site) had not resolved. Not Provided          No relevant concomitant medication was reported. Treatment information was not provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Had a bulge at the injection site; had a strong pain in the arm of the injection , lasted for 2 or 3 days.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Had a bulge at the injection site) and VACCINATION SITE PAIN (had a strong pain in the arm of the injection , lasted for 2 or 3 days.) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Had a bulge at the injection site) and VACCINATION SITE PAIN (had a strong pain in the arm of the injection , lasted for 2 or 3 days.). At the time of the report, VACCINATION SITE SWELLING (Had a bulge at the injection site) and VACCINATION SITE PAIN (had a strong pain in the arm of the injection , lasted for 2 or 3 days.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: body aches; fever; chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness). In February 2021, PAIN (body aches), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Pfizer Covid vaccine was given as the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Pfizer Covid vaccine was given as the second dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Pfizer Covid vaccine was given as the second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Pfizer Covid vaccine was given as the second dose) outcome was unknown. Not Provided          No concomitant medications provided. Action taken with mRNA-1273 in response to the event was not applicable. Caller would like to know if he is protected as Pfizer Covid vaccine was given as the second dose?
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site rash
Clinical narrative: rash at the injection site; fatigue; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE RASH (rash at the injection site) and FATIGUE (fatigue) 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.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (rash at the injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE RASH (rash at the injection site) and FATIGUE (fatigue) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  No treatment medications were reported.   This case was linked to MOD21-079609, MOD21-079683, MOD21-079685 (E2B Linked Report).; Sender's Comments:  MOD21-079609: MOD21-079683: MOD21-079685:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Pyrexia
Clinical narrative: chills; nausea; low grade fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), PYREXIA (low grade fever) and FATIGUE (fatigue) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 043L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-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) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), PYREXIA (low grade fever) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), NAUSEA (nausea), PYREXIA (low grade fever) and FATIGUE (fatigue) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-021571 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-021571:
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of product administered to patient of inappropriate age (AE of giving a vaccine to 17 year old) in a 17-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016B21A) for COVID-19 immunization. No medical history reported. On Mar 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced product administered to patient of inappropriate age (AE of giving a vaccine to 17 year old). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments. Most recent follow-up information incorporated: On Apr 22, 2021: First dose date added; additional information. On Apr 22, 2021: No specific follow-up information recorded.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose administered to 16 year old patient; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 16 year old patient) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 16 year old patient). On 20-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 16 year old patient) 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. Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received the vaccine from a vial punctured on 20 April 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from a vial punctured on 20 April 2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021 at 1:40 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from a vial punctured on 20 April 2021). On 21-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from a vial punctured on 20 April 2021) 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.   The vial was punctured on 20 April 2021 at 5 PM. The punctured vial was kept in the refrigerator at 42 °F all of the time.  No concomitant medications information was reported. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: patient identifier added. batch/lot number added. vial storage conditions mentioned.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Nasal congestion, Nausea, Sinus congestion
Clinical narrative: She indicates she had difficulty breathing; But her nose closed up; She as well had weakness; Sinuses immediately filled up; She as well had nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She indicates she had difficulty breathing), NASAL CONGESTION (But her nose closed up), ASTHENIA (She as well had weakness), SINUS CONGESTION (Sinuses immediately filled up) and NAUSEA (She as well had nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Phenergan), Drug allergy (Pyridium), Drug allergy (Keflex), Allergy to antibiotic (Doxycycline), Drug allergy (Tessalon perles) and Drug allergy (Dextromethorphan). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), CARBAMAZEPINE, PERPHENAZINE, FISH OIL, GLUCOSAMINE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), MINERALS NOS, VITAMINS NOS (EYEVITE), MULTIVITAMIN [VITAMINS NOS] and GARLIC [ALLIUM SATIVUM] for an unknown indication.    On 18-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 DYSPNOEA (She indicates she had difficulty breathing), NASAL CONGESTION (But her nose closed up), ASTHENIA (She as well had weakness), SINUS CONGESTION (Sinuses immediately filled up) and NAUSEA (She as well had nausea). At the time of the report, DYSPNOEA (She indicates she had difficulty breathing), NASAL CONGESTION (But her nose closed up), ASTHENIA (She as well had weakness), SINUS CONGESTION (Sinuses immediately filled up) and NAUSEA (She as well had nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.  The patient reported that she take carbamazepine as concomitant medication which makes her white blood cell count low.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: arm is itching at the site of injection and it is real hot; arm is itching at the site of injection and it is real hot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm is itching at the site of injection and it is real hot) and VACCINATION SITE PRURITUS (arm is itching at the site of injection and it is real hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 022M20A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS), METOPROLOL, DIGOXIN, POTASSIUM, FUROSEMIDE and LOPERAMIDE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, 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 experienced VACCINATION SITE WARMTH (arm is itching at the site of injection and it is real hot) and VACCINATION SITE PRURITUS (arm is itching at the site of injection and it is real hot). At the time of the report, VACCINATION SITE WARMTH (arm is itching at the site of injection and it is real hot) and VACCINATION SITE PRURITUS (arm is itching at the site of injection and it is real hot) outcome was unknown.            No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain
Clinical narrative: pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (The patient stated that she had issues with her blood pressure due to her condition.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain, Vaccination site warmth
Clinical narrative: hardness/swelling on her arm; Vaccination site warmth; Vaccination site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (hardness/swelling on her arm), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE PAIN (Vaccination site pain) in a sixty-two-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (Batch no. 0131B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 18-Apr-2021, the patient experienced SWELLING (hardness/swelling on her arm) and VACCINATION SITE WARMTH (Vaccination site warmth). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, SWELLING (hardness/swelling on her arm), VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment:  ice
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breastfeeding her baby; 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 EXPOSURE VIA BREAST MILK (Breastfeeding her baby) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the mother received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient was diagnosed with EXPOSURE VIA BREAST MILK (Breastfeeding her baby). At the time of the report, EXPOSURE VIA BREAST MILK (Breastfeeding her baby) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) was unknown.       Concomitant medications not provided.  Treatment information not provided.  Reporter stated that she is breast feeding and her child eats her breast.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo/similar symptoms after both the doses; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo/similar symptoms after both the doses) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Nov-2020 and Pneumonia (She was hospitalized in ICU step down had double pneumonia.) on 14-Nov-2020. Concurrent medical conditions included Atrial fibrillation. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN-D) for Allergy, PARACETAMOL (TYLENOL EXTRA STRENGTH) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 08-Apr-2021, the patient experienced VERTIGO (Vertigo/similar symptoms after both the doses). The patient was treated with MECLIZINE HCL for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VERTIGO (Vertigo/similar symptoms after both the doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-080242, US-MODERNATX, INC.-MOD-2021-080194 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080194:cross linked case
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: vaccine leaked out from the back of the syringe/ not sure how much vaccine was administered a; vaccine leaked out from the back of the syringe; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (vaccine leaked out from the back of the syringe/ not sure how much vaccine was administered a) and DEVICE CONNECTION ISSUE (vaccine leaked out from the back of the syringe) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 025C21A) for COVID-19 vaccination.     Concomitant products included ARIPIPRAZOLE (ABILIFY) for Depression NOS, ESTRADIOL (ESTRACE) for Fertilization.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-Apr-2021, the patient experienced UNDERDOSE (vaccine leaked out from the back of the syringe/ not sure how much vaccine was administered a) and DEVICE CONNECTION ISSUE (vaccine leaked out from the back of the syringe). At the time of the report, UNDERDOSE (vaccine leaked out from the back of the syringe/ not sure how much vaccine was administered a) and DEVICE CONNECTION ISSUE (vaccine leaked out from the back of the syringe) outcome was unknown. Not Provided          concomitant reported: lexapo 20mg through oral route for anxiety/depression   This case was linked to MOD-2021-171089 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added VAER Form
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Malaise
Clinical narrative: facial flushing; did not feel great; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (facial flushing) and MALAISE (did not feel great) 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 provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FLUSHING (facial flushing) and MALAISE (did not feel great). At the time of the report, FLUSHING (facial flushing) and MALAISE (did not feel great) outcome was unknown.            No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Fatigue; very hot; slight tenderness left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight tenderness left arm at injection site), FATIGUE (Fatigue) and very hot in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0010218) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight tenderness left arm at injection site). On an unknown date, the patient experienced FATIGUE (Fatigue) and very hot. The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (slight tenderness left arm at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication were reported   This case was linked to MOD-2021-083794 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: itchy knot at the site of injection; itchy knot at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy knot at the site of injection), VACCINATION SITE MASS (itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy knot at the site of injection), VACCINATION SITE MASS (itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). At the time of the report, VACCINATION SITE PRURITUS (itchy knot at the site of injection), VACCINATION SITE MASS (itchy knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication or treatment was reported
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Headache, Hypersensitivity, Illness
Clinical narrative: allergy got worse; allergy all over her body; felt sick; headache; back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (felt sick), HEADACHE (headache), BACK PAIN (back pain), HYPERSENSITIVITY (allergy all over her body) and CONDITION AGGRAVATED (allergy got worse) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ILLNESS (felt sick), HEADACHE (headache) and BACK PAIN (back pain). On 19-Apr-2021, the patient experienced HYPERSENSITIVITY (allergy all over her body). On 20-Apr-2021, the patient experienced CONDITION AGGRAVATED (allergy got worse). On 16-Apr-2021, ILLNESS (felt sick), HEADACHE (headache) and BACK PAIN (back pain) had resolved. At the time of the report, HYPERSENSITIVITY (allergy all over her body) and CONDITION AGGRAVATED (allergy got worse) 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.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Rash pruritic
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash around injection site that is spreading down arm), PYREXIA (fever), MYALGIA (bodyache) and HEADACHE (headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 19-Apr-2021, the patient experienced RASH PRURITIC (itchy rash around injection site that is spreading down arm), PYREXIA (fever), MYALGIA (bodyache) and HEADACHE (headache). The patient was treated with TRIAMCINOLONE ACETONIDE for Symptomatic treatment, at an unspecified dose and frequency and IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. On 20-Apr-2021, PYREXIA (fever), MYALGIA (bodyache) and HEADACHE (headache) had resolved. At the time of the report, RASH PRURITIC (itchy rash around injection site that is spreading down arm) outcome was unknown. This case was linked to MOD-2021-061198.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Feeling hot, Peripheral swelling
Clinical narrative: breathing on a scale of 2/10; experienced cough almost like having asthma symptoms; fatigue/very tired; very hot; swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), PERIPHERAL SWELLING (swollen arm), DYSPNOEA (breathing on a scale of 2/10), COUGH (experienced cough almost like having asthma symptoms) and FATIGUE (fatigue/very tired) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0010218) for COVID-19 vaccination.     The patient's past medical history included Bee sting on 20-Apr-2021.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 19-Apr-2021, the patient experienced FEELING HOT (very hot), PERIPHERAL SWELLING (swollen arm) and FATIGUE (fatigue/very tired). On 21-Apr-2021, the patient experienced DYSPNOEA (breathing on a scale of 2/10). 21-Apr-2021, the patient experienced COUGH (experienced cough almost like having asthma symptoms). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Bee sting, at an unspecified dose and frequency. On 21-Apr-2021, FEELING HOT (very hot), PERIPHERAL SWELLING (swollen arm) and FATIGUE (fatigue/very tired) outcome was unknown. At the time of the report, DYSPNOEA (breathing on a scale of 2/10) and COUGH (experienced cough almost like having asthma symptoms) outcome was unknown.            Treatment included Benadryl(diphenhydramine) for the event bee sting. No concomitant medications reported.   This case was linked to MOD-2021-083774 (Patient Link).