chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nausea, Pyrexia
Clinical narrative: Feels like a train hit her and she can pass out; Fever of 102; Chills; Body aches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Feels like a train hit her and she can pass out), PYREXIA (Fever of 102), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced FATIGUE (Feels like a train hit her and she can pass out), PYREXIA (Fever of 102), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Feels like a train hit her and she can pass out), PYREXIA (Fever of 102), CHILLS (Chills), MYALGIA (Body aches) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported by patient.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis and Arthritis.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with BENZALKONIUM CHLORIDE, SODIUM CHLORIDE (ALIVE) at an unspecified dose and frequency and HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) at an unspecified dose and frequency. On 18-Feb-2021, HEADACHE (Headache) and PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-070391 (Patient Link).; Sender's Comments:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: Tested positive for COVID; Coughing; Very fatigued; Headache; Slight fever 99.8/f ever went to 102-103; Started to get congested; Slight redness and tenderness at injection site; Slight redness and tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), NASAL CONGESTION (Started to get congested), COUGH (Coughing), VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site) and VACCINATION SITE PAIN (Slight redness and tenderness at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site) and VACCINATION SITE PAIN (Slight redness and tenderness at injection site). On 11-Mar-2021, the patient experienced NASAL CONGESTION (Started to get congested), HEADACHE (Headache) and PYREXIA (Slight fever 99.8/f ever went to 102-103). On 12-Mar-2021, the patient experienced COUGH (Coughing) and FATIGUE (Very fatigued). On 13-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID), NASAL CONGESTION (Started to get congested), COUGH (Coughing), VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site), VACCINATION SITE PAIN (Slight redness and tenderness at injection site), HEADACHE (Headache), PYREXIA (Slight fever 99.8/f ever went to 102-103) and FATIGUE (Very fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   On 14 Mar 2021, patient felt better and symptom free by 18 Mar 2021. No treatment information was provided.   This case was linked to MOD-2021-067569 (E2B Linked Report).; Sender's Comments:  MOD-2021-067569:Wife case
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
Clinical narrative: Tested positive for COVID; Coughing; Very fatigued; Headache; Slight fever 99.8/f ever went to 102-103; Started to get congested; Slight redness and tenderness at injection site; Slight redness and tenderness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID), NASAL CONGESTION (Started to get congested), COUGH (Coughing), VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site) and VACCINATION SITE PAIN (Slight redness and tenderness at injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site) and VACCINATION SITE PAIN (Slight redness and tenderness at injection site). On 11-Mar-2021, the patient experienced NASAL CONGESTION (Started to get congested), HEADACHE (Headache) and PYREXIA (Slight fever 99.8/f ever went to 102-103). On 12-Mar-2021, the patient experienced COUGH (Coughing) and FATIGUE (Very fatigued). On 13-Mar-2021, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID), NASAL CONGESTION (Started to get congested), COUGH (Coughing), VACCINATION SITE ERYTHEMA (Slight redness and tenderness at injection site), VACCINATION SITE PAIN (Slight redness and tenderness at injection site), HEADACHE (Headache), PYREXIA (Slight fever 99.8/f ever went to 102-103) and FATIGUE (Very fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   On 14 Mar 2021, patient felt better and symptom free by 18 Mar 2021. No treatment information was provided.   This case was linked to MOD-2021-067569 (E2B Linked Report).; Sender's Comments:  MOD-2021-067569:Wife case
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) in a 16-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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) 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.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067198, US-MODERNATX, INC.-MOD-2021-067510, US-MODERNATX, INC.-MOD-2021-067250 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067198:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067250:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067510:Cross link, same reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling
Clinical narrative: headache; big hard lump for a full week; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headache) and SWELLING (big hard lump for a full week) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0112A01) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and SWELLING (big hard lump for a full week). At the time of the report, HEADACHE (headache) and SWELLING (big hard lump for a full week) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications reported.   Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-067558 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067558:crosslinked with dose 2
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: vaccine leaked down arm during 2nd vaccine; syringe was loose; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (vaccine leaked down arm during 2nd vaccine) and DEVICE CONNECTION ISSUE (syringe was loose) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 001A21A) 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) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to unk dosage form. On 05-Apr-2021, the patient experienced UNDERDOSE (vaccine leaked down arm during 2nd vaccine) and DEVICE CONNECTION ISSUE (syringe was loose). On 05-Apr-2021, UNDERDOSE (vaccine leaked down arm during 2nd vaccine) and DEVICE CONNECTION ISSUE (syringe was loose) had resolved. Not Provided          No concomitant medications reported. No treatment medications provided by the reporter.   Action taken with mRNA-1273 in response to events was not applicable.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Fear of injection, Feeling abnormal, Myalgia
Clinical narrative: Scared to get the 2nd dose; "Looked like someone took iron and burnt her"; tingling in the injection site; arm pit was tender; Feels like its burning; she "started feeling like she was revaccinated"; very itchy; rash went around her arm horizontally; rash size of a quarter; started to hurt; That night it got worse; Tired; sore arm; felt a little lump; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her") and PAIN (That night it got worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H(or4)21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (That night it got worse), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (started to hurt), FATIGUE (Tired) and MYALGIA (sore arm). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (she "started feeling like she was revaccinated"), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally) and VACCINATION SITE RASH (rash size of a quarter). On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling in the injection site), BURNING SENSATION ("Looked like someone took iron and burnt her"), TENDERNESS (arm pit was tender) and VACCINATION SITE PAIN (Feels like its burning). On 05-Apr-2021, the patient experienced FEAR OF INJECTION (Scared to get the 2nd dose). At the time of the report, PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her"), PAIN (That night it got worse), TENDERNESS (arm pit was tender), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally), VACCINATION SITE RASH (rash size of a quarter), VACCINATION SITE PAIN (started to hurt), VACCINATION SITE PAIN (Feels like its burning), FATIGUE (Tired) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Rash, Tenderness, Vaccination site mass
Clinical narrative: Scared to get the 2nd dose; "Looked like someone took iron and burnt her"; tingling in the injection site; arm pit was tender; Feels like its burning; she "started feeling like she was revaccinated"; very itchy; rash went around her arm horizontally; rash size of a quarter; started to hurt; That night it got worse; Tired; sore arm; felt a little lump; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her") and PAIN (That night it got worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H(or4)21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (That night it got worse), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (started to hurt), FATIGUE (Tired) and MYALGIA (sore arm). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (she "started feeling like she was revaccinated"), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally) and VACCINATION SITE RASH (rash size of a quarter). On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling in the injection site), BURNING SENSATION ("Looked like someone took iron and burnt her"), TENDERNESS (arm pit was tender) and VACCINATION SITE PAIN (Feels like its burning). On 05-Apr-2021, the patient experienced FEAR OF INJECTION (Scared to get the 2nd dose). At the time of the report, PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her"), PAIN (That night it got worse), TENDERNESS (arm pit was tender), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally), VACCINATION SITE RASH (rash size of a quarter), VACCINATION SITE PAIN (started to hurt), VACCINATION SITE PAIN (Feels like its burning), FATIGUE (Tired) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Scared to get the 2nd dose; "Looked like someone took iron and burnt her"; tingling in the injection site; arm pit was tender; Feels like its burning; she "started feeling like she was revaccinated"; very itchy; rash went around her arm horizontally; rash size of a quarter; started to hurt; That night it got worse; Tired; sore arm; felt a little lump; hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her") and PAIN (That night it got worse) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H(or4)21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (That night it got worse), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (started to hurt), FATIGUE (Tired) and MYALGIA (sore arm). On 24-Mar-2021, the patient experienced FEELING ABNORMAL (she "started feeling like she was revaccinated"), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally) and VACCINATION SITE RASH (rash size of a quarter). On 25-Mar-2021, the patient experienced PARAESTHESIA (tingling in the injection site), BURNING SENSATION ("Looked like someone took iron and burnt her"), TENDERNESS (arm pit was tender) and VACCINATION SITE PAIN (Feels like its burning). On 05-Apr-2021, the patient experienced FEAR OF INJECTION (Scared to get the 2nd dose). At the time of the report, PARAESTHESIA (tingling in the injection site), FEELING ABNORMAL (she "started feeling like she was revaccinated"), FEAR OF INJECTION (Scared to get the 2nd dose), BURNING SENSATION ("Looked like someone took iron and burnt her"), PAIN (That night it got worse), TENDERNESS (arm pit was tender), VACCINATION SITE MASS (felt a little lump), VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PRURITUS (very itchy), RASH (rash went around her arm horizontally), VACCINATION SITE RASH (rash size of a quarter), VACCINATION SITE PAIN (started to hurt), VACCINATION SITE PAIN (Feels like its burning), FATIGUE (Tired) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported No Treatment information provided   Reporter did not allow further contact
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old patient was given first dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given first dose of vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given first dose of vaccine). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old patient was given first dose of vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Blood glucose, Blood glucose increased, Myalgia, Peripheral swelling
Clinical narrative: Blood Glucose went up to 300 mg/dL; shaking; bed for hours; knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine; knot (Swelling the Size of palm of hand) on the injection site; Sore Injection Site; Pain all over her body; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL), TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine) and VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULINE), LISINOPRIL DIHYDRATE (LISINOPRIL ACCORD), ROSUVASTATIN CALCIUM (ROSUVASTATIN +PHARMA) and LEVOTHYROXINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL), TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine), VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site), VACCINATION SITE PAIN (Sore Injection Site), MYALGIA (Pain all over her body) and VOMITING (vomiting). On 04-Apr-2021, BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL) had resolved. On 05-Apr-2021, TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine), VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore Injection Site) and MYALGIA (Pain all over her body) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 300 (High) 300 mg/dL.         Concomitant products included Humulin N Insulin, Humulin R Insulin.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Blood Glucose went up to 300 mg/dL; shaking; bed for hours; knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine; knot (Swelling the Size of palm of hand) on the injection site; Sore Injection Site; Pain all over her body; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL), TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine) and VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULINE), LISINOPRIL DIHYDRATE (LISINOPRIL ACCORD), ROSUVASTATIN CALCIUM (ROSUVASTATIN +PHARMA) and LEVOTHYROXINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL), TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine), VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site), VACCINATION SITE PAIN (Sore Injection Site), MYALGIA (Pain all over her body) and VOMITING (vomiting). On 04-Apr-2021, BLOOD GLUCOSE INCREASED (Blood Glucose went up to 300 mg/dL) had resolved. On 05-Apr-2021, TREMOR (shaking), BEDRIDDEN (bed for hours), PERIPHERAL SWELLING (knot Injection Site (Swelling the Size of palm of hand) After Second Vaccine), VACCINATION SITE SWELLING (knot (Swelling the Size of palm of hand) on the injection site) and VOMITING (vomiting) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore Injection Site) and MYALGIA (Pain all over her body) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 300 (High) 300 mg/dL.         Concomitant products included Humulin N Insulin, Humulin R Insulin.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infection; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (ear infection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Ear infection (recurrent ear infections).    On 09-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 EAR INFECTION (ear infection). At the time of the report, EAR INFECTION (ear infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Terrible pain in chest that took breath away that went away quickly; that took breath away; diarrhoea; mild headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatic fever (rheumatic fever as a child).   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Treatment medications not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: TCR included- NNI, does not want to share email address, no consent to further follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Terrible pain in chest that took breath away that went away quickly; that took breath away; diarrhoea; mild headache; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rheumatic fever (rheumatic fever as a child).   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, CHEST PAIN (Terrible pain in chest that took breath away that went away quickly), DYSPNOEA (that took breath away), DIARRHOEA (diarrhoea), HEADACHE (mild headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown.            Treatment medications not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: TCR included- NNI, does not want to share email address, no consent to further follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Cough, Fatigue, Headache
Clinical narrative: running nose; loss of taste; cough; neck pain; chills; muscle pain in her neck/ muscle or body aches; Fatigue; Headache; slight feeling like she wants to throw up; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (running nose), AGEUSIA (loss of taste), COUGH (cough), NECK PAIN (neck pain) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included INSULIN ASPART (NOVOLOG), METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 19-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 RHINORRHOEA (running nose), AGEUSIA (loss of taste), COUGH (cough), NECK PAIN (neck pain), CHILLS (chills), MYALGIA (muscle pain in her neck/ muscle or body aches), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (slight feeling like she wants to throw up). At the time of the report, RHINORRHOEA (running nose), AGEUSIA (loss of taste), COUGH (cough), NECK PAIN (neck pain), CHILLS (chills), MYALGIA (muscle pain in her neck/ muscle or body aches), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (slight feeling like she wants to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication specified.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Rhinorrhoea
Clinical narrative: running nose; loss of taste; cough; neck pain; chills; muscle pain in her neck/ muscle or body aches; Fatigue; Headache; slight feeling like she wants to throw up; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (running nose), AGEUSIA (loss of taste), COUGH (cough), NECK PAIN (neck pain) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included INSULIN ASPART (NOVOLOG), METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), LEVOTHYROXINE and LISINOPRIL for an unknown indication.    On 19-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 RHINORRHOEA (running nose), AGEUSIA (loss of taste), COUGH (cough), NECK PAIN (neck pain), CHILLS (chills), MYALGIA (muscle pain in her neck/ muscle or body aches), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (slight feeling like she wants to throw up). At the time of the report, RHINORRHOEA (running nose), AGEUSIA (loss of taste), COUGH (cough), NECK PAIN (neck pain), CHILLS (chills), MYALGIA (muscle pain in her neck/ muscle or body aches), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (slight feeling like she wants to throw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication specified.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Incorrect route of product administration
Clinical narrative: Received a subcutaneous injection for second dose of Moderna vaccine; Chill; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous injection for second dose of Moderna vaccine) and CHILLS (Chill) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 0112A01) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous injection for second dose of Moderna vaccine). On an unknown date, the patient experienced CHILLS (Chill). On 31-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous injection for second dose of Moderna vaccine) had resolved. At the time of the report, CHILLS (Chill) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067548, US-MODERNATX, INC.-MOD-2021-117024 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Apr-2021: NNI On 10-May-2021: Follow up contains no new information; 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. US-MODERNATX, INC.-MOD-2021-067548:crosslinked with dose 1 US-MODERNATX, INC.-MOD-2021-117024:same reporter
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itching in scalp and face specifically in her forehead; rash in scalp and face specifically in her forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in scalp and face specifically in her forehead) and RASH (rash in scalp and face specifically in her forehead) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 PRURITUS (itching in scalp and face specifically in her forehead) and RASH (rash in scalp and face specifically in her forehead). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash and Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching in scalp and face specifically in her forehead) and RASH (rash in scalp and face specifically in her forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: vaccine Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine Exposure during pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Streptomycin). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 29-Dec-2020 to an unknown date for Pregnancy, ACETYLSALICYLIC ACID (ASPIRINE) from 29-Dec-2020 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine Exposure during pregnancy). On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccine Exposure during pregnancy) had resolved. Not Provided          No information provided about any treatment medications.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: allergy has spread on the ankle and back; hives; This spontaneous case was reported by a physician and describes the occurrence of URTICARIA (hives) and HYPERSENSITIVITY (allergy has spread on the ankle and back) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URTICARIA (hives). On 05-Apr-2021, the patient experienced HYPERSENSITIVITY (allergy has spread on the ankle and back). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Allergy, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) and HYPERSENSITIVITY (allergy has spread on the ankle and back) 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 concomitant medications reported.   Doctor gave 3 Dexamethasone and Benadryl to treat adverse event.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Pruritus, Rash, Rash macular
Clinical narrative: Eczema on chest; Itchy and blotchy; Itchy and blotchy; Rash on chest,knees, inside of thighs and thin skin down near ankles; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema on chest), RASH MACULAR (Itchy and blotchy), PRURITUS (Itchy and blotchy) and RASH (Rash on chest,knees, inside of thighs and thin skin down near ankles) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Eczema.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ECZEMA (Eczema on chest), RASH MACULAR (Itchy and blotchy), PRURITUS (Itchy and blotchy) and RASH (Rash on chest,knees, inside of thighs and thin skin down near ankles). At the time of the report, ECZEMA (Eczema on chest), RASH MACULAR (Itchy and blotchy), PRURITUS (Itchy and blotchy) and RASH (Rash on chest,knees, inside of thighs and thin skin down near ankles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No Treatment information were provided   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Follow-up received on 16-May-2021, included no new information. On 22-Jul-2021: Follow-up received on 22-JUL-2021, included no new information.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm was tender; Arm was painful; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm was tender) and PAIN IN EXTREMITY (Arm was painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included MELATONIN for an unknown indication.    On 04-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 TENDERNESS (Arm was tender) and PAIN IN EXTREMITY (Arm was painful). At the time of the report, TENDERNESS (Arm was tender) and PAIN IN EXTREMITY (Arm was painful) outcome was unknown. Not Provided          Patient was taking Melatonin 2 mg day after second dose.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-067580 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (leg aches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 036A21A) for COVID-19 immunization. No medical history reported. On Apr 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pain in extremity (leg aches). At the time of the report, pain in extremity (leg aches) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Treatment medication included arthritis cream. Concomitant medication not provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Pyrexia, Tachycardia, Throat irritation, Urticaria
Clinical narrative: Throat little itchy immediately after vaccine; Lip swollen; Hived lip; Elevated heart beat; Low grade fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat) and PYREXIA (Low grade fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (NSAIDS).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat), PYREXIA (Low grade fever) and VACCINATION SITE PAIN (Sore arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Apr-2021, THROAT IRRITATION (Throat little itchy immediately after vaccine), LIP SWELLING (Lip swollen), URTICARIA (Hived lip), TACHYCARDIA (Elevated heart beat) and PYREXIA (Low grade fever) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited emergency room. No concomitant medication reported. Treatment  also included steroid.