chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; Felt extremely dizzy, Light headedness; Severely nauseous; Extreme hypotension with blood pressure of 90-52 mmHg; stand up slowly; Not feeling like her self; This spontaneous case was reported by an other health care professional and describes the occurrence of VERTIGO (Vertigo), DIZZINESS (Felt extremely dizzy, Light headedness), NAUSEA (Severely nauseous), HYPOTENSION (Extreme hypotension with blood pressure of 90-52 mmHg) and DYSSTASIA (stand up slowly) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 VERTIGO (Vertigo), DIZZINESS (Felt extremely dizzy, Light headedness), NAUSEA (Severely nauseous), HYPOTENSION (Extreme hypotension with blood pressure of 90-52 mmHg), DYSSTASIA (stand up slowly) and FEELING ABNORMAL (Not feeling like her self). On 02-Apr-2021, VERTIGO (Vertigo) had resolved. On 06-Apr-2021, DIZZINESS (Felt extremely dizzy, Light headedness), NAUSEA (Severely nauseous), HYPOTENSION (Extreme hypotension with blood pressure of 90-52 mmHg), DYSSTASIA (stand up slowly) and FEELING ABNORMAL (Not feeling like her self) 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 medicines were reported. Treatment information included the Over the counter medicines and anti-nausea medication.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Herpes zoster, Pain in extremity, Rash, Vaccination site erythema
Clinical narrative: shingles; arm was sensitive and warm; arm warm; rash on abdomen; rash on left arm , like a red oval around the injection site; rash on left arm , like a red oval around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles), PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen) and VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 020L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen), VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) and VACCINATION SITE ERYTHEMA (rash on left arm , like a red oval around the injection site). On 30-Apr-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) had not resolved and PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen), VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) and VACCINATION SITE ERYTHEMA (rash on left arm , like a red oval around the injection site) outcome was unknown.            Treatment medication also includes antiviral for treatment. No Concomitant medication were reported.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: shingles; arm was sensitive and warm; arm warm; rash on abdomen; rash on left arm , like a red oval around the injection site; rash on left arm , like a red oval around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles), PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen) and VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 020L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen), VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) and VACCINATION SITE ERYTHEMA (rash on left arm , like a red oval around the injection site). On 30-Apr-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) had not resolved and PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen), VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) and VACCINATION SITE ERYTHEMA (rash on left arm , like a red oval around the injection site) outcome was unknown.            Treatment medication also includes antiviral for treatment. No Concomitant medication were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Numbness in the left hand; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the left hand) and DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DD3C21A) for COVID-19 immunisation.     Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Anxiety, ESCITALOPRAM OXALATE (LEXAPRO) for Mental disorder, TOPIRAMATE (TOPAMAX) for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in the left hand) and DIZZINESS (Dizziness). At the time of the report, HYPOAESTHESIA (Numbness in the left hand) and DIZZINESS (Dizziness) 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.   treatment medication was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Headache, Myalgia
Clinical narrative: body aches; Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine; Lightheadedness; Dizziness; headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (body aches) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 035C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 02-Jan-2021 to an unknown date for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 19-Jan-2021 and the estimated date of delivery was 26-Oct-2021. On 30-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine), DIZZINESS (Lightheadedness), DIZZINESS (Dizziness) and HEADACHE (headache). On 29-May-2021, the patient experienced MYALGIA (body aches). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 30-Apr-2021, EXPOSURE DURING PREGNANCY (Pregnant patient who recieved first dose of the Moderna COVID 19 vaccine) outcome was unknown. On 30-May-2021, MYALGIA (body aches) had resolved. At the time of the report, DIZZINESS (Lightheadedness), DIZZINESS (Dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   Treatment was unknown.  Patient provided consent to follow up with her by e-mail and with her physician by phone, if necessary.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up appended on 3-jun-2021 :Race , Ethnicity , Second dose , and  New Event Updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Feels crappy; muscle ache; fever; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels crappy), FATIGUE (tired), CHILLS (chills), MYALGIA (muscle ache) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (tired). On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills) and PYREXIA (fever). On 29-Apr-2021, the patient experienced MALAISE (Feels crappy) and MYALGIA (muscle ache). At the time of the report, MALAISE (Feels crappy), FATIGUE (tired), CHILLS (chills), MYALGIA (muscle ache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: increased (High) Increased.         Concomitant medication include blood pressure medication. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-101380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up information received on 31-MAY-2021 and dose not contain any new information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feels crappy; muscle ache; fever; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feels crappy), FATIGUE (tired), CHILLS (chills), MYALGIA (muscle ache) and PYREXIA (fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (tired). On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills) and PYREXIA (fever). On 29-Apr-2021, the patient experienced MALAISE (Feels crappy) and MYALGIA (muscle ache). At the time of the report, MALAISE (Feels crappy), FATIGUE (tired), CHILLS (chills), MYALGIA (muscle ache) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: increased (High) Increased.         Concomitant medication include blood pressure medication. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-101380 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up information received on 31-MAY-2021 and dose not contain any new information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: ill; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) and FATIGUE (fatigue) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K2A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced ILLNESS (ill) and FATIGUE (fatigue). On 31-Jan-2021, ILLNESS (ill) and FATIGUE (fatigue) had resolved.            Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.; Sender's Comments:  SE-MODERNATX, INC.-MOD-2021-114754:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported No treatment medications were reported    This case was linked to MOD-2021-100450 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Sensation of foreign body
Clinical narrative: left arm feels like it is growing / left arm feels like poison ivy working; left arm as swollen/left arm is the size of a baseball; left arm as 'itchy; left arm as red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SENSATION OF FOREIGN BODY (left arm feels like it is growing / left arm feels like poison ivy working), PERIPHERAL SWELLING (left arm as swollen/left arm is the size of a baseball), PRURITUS (left arm as 'itchy) and ERYTHEMA (left arm as red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. M#025B21A and M#17B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included ATORVASTATIN, IBUPROFEN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced SENSATION OF FOREIGN BODY (left arm feels like it is growing / left arm feels like poison ivy working), PERIPHERAL SWELLING (left arm as swollen/left arm is the size of a baseball), PRURITUS (left arm as 'itchy) and ERYTHEMA (left arm as red). At the time of the report, SENSATION OF FOREIGN BODY (left arm feels like it is growing / left arm feels like poison ivy working), PERIPHERAL SWELLING (left arm as swollen/left arm is the size of a baseball), PRURITUS (left arm as 'itchy) and ERYTHEMA (left arm as red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-100716 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Fatigue, Influenza, Lethargy
Clinical narrative: lethargic; dizzy; his temperature was measured to be 99F; exhausted; nauseous; cold sweats; like having the flu; like having the flu; sore left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), the first episode of INFLUENZA (like having the flu), the second episode of INFLUENZA (like having the flu), LETHARGY (lethargic) and MYALGIA (sore left upper arm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (sore left upper arm). On 27-Apr-2021, the patient experienced COLD SWEAT (cold sweats), the first episode of INFLUENZA (like having the flu), the second episode of INFLUENZA (like having the flu), NAUSEA (nauseous) and FATIGUE (exhausted). On 28-Apr-2021, the patient experienced LETHARGY (lethargic), DIZZINESS (dizzy) and PYREXIA (his temperature was measured to be 99F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Apr-2021, MYALGIA (sore left upper arm) had resolved. On 29-Apr-2021, last episode of INFLUENZA (like having the flu), LETHARGY (lethargic), DIZZINESS (dizzy), NAUSEA (nauseous) and FATIGUE (exhausted) had resolved. At the time of the report, COLD SWEAT (cold sweats) and PYREXIA (his temperature was measured to be 99F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: lethargic; dizzy; his temperature was measured to be 99F; exhausted; nauseous; cold sweats; like having the flu; like having the flu; sore left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), the first episode of INFLUENZA (like having the flu), the second episode of INFLUENZA (like having the flu), LETHARGY (lethargic) and MYALGIA (sore left upper arm) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (sore left upper arm). On 27-Apr-2021, the patient experienced COLD SWEAT (cold sweats), the first episode of INFLUENZA (like having the flu), the second episode of INFLUENZA (like having the flu), NAUSEA (nauseous) and FATIGUE (exhausted). On 28-Apr-2021, the patient experienced LETHARGY (lethargic), DIZZINESS (dizzy) and PYREXIA (his temperature was measured to be 99F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Apr-2021, MYALGIA (sore left upper arm) had resolved. On 29-Apr-2021, last episode of INFLUENZA (like having the flu), LETHARGY (lethargic), DIZZINESS (dizzy), NAUSEA (nauseous) and FATIGUE (exhausted) had resolved. At the time of the report, COLD SWEAT (cold sweats) and PYREXIA (his temperature was measured to be 99F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Swelling face, Vaccination site pain
Clinical narrative: itchiness of the chest; mild facial swelling; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness of the chest), SWELLING FACE (mild facial swelling) and VACCINATION SITE PAIN (arm soreness) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B2 1A) for COVID-19 vaccination.     No past medical history was reported.     On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRURITUS (itchiness of the chest), SWELLING FACE (mild facial swelling) and VACCINATION SITE PAIN (arm soreness). At the time of the report, PRURITUS (itchiness of the chest), SWELLING FACE (mild facial swelling) and VACCINATION SITE PAIN (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included Benadryl and Prednisone.  No concomitant product was reported.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bedridden, Dizziness, Fatigue, Headache
Clinical narrative: tender left arm; dizzy; lethargic; extensive joint pain; bedridden; headache; cold sweats; nausea; flu; felt tired; had a sore; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender left arm), HYPERHIDROSIS (cold sweats), NAUSEA (nausea), INFLUENZA (flu) and DIZZINESS (dizzy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (had a sore). On 27-Apr-2021, the patient experienced HYPERHIDROSIS (cold sweats), NAUSEA (nausea), INFLUENZA (flu) and FATIGUE (felt tired). On 28-Apr-2021, the patient experienced DIZZINESS (dizzy), LETHARGY (lethargic), ARTHRALGIA (extensive joint pain), BEDRIDDEN (bedridden) and HEADACHE (headache). On an unknown date, the patient experienced TENDERNESS (tender left arm). On 01-Apr-2021, TENDERNESS (tender left arm) and MYALGIA (had a sore) outcome was unknown. On 29-Apr-2021, NAUSEA (nausea), INFLUENZA (flu), DIZZINESS (dizzy), LETHARGY (lethargic), ARTHRALGIA (extensive joint pain), BEDRIDDEN (bedridden) and HEADACHE (headache) outcome was unknown. At the time of the report, HYPERHIDROSIS (cold sweats) and FATIGUE (felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information provided was 2 Tylenol Tablets on 28 Apr2021  Patient had to run over by a car and patient also reported to feel exhausted.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza, Lethargy, Myalgia, Nausea
Clinical narrative: tender left arm; dizzy; lethargic; extensive joint pain; bedridden; headache; cold sweats; nausea; flu; felt tired; had a sore; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender left arm), HYPERHIDROSIS (cold sweats), NAUSEA (nausea), INFLUENZA (flu) and DIZZINESS (dizzy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (had a sore). On 27-Apr-2021, the patient experienced HYPERHIDROSIS (cold sweats), NAUSEA (nausea), INFLUENZA (flu) and FATIGUE (felt tired). On 28-Apr-2021, the patient experienced DIZZINESS (dizzy), LETHARGY (lethargic), ARTHRALGIA (extensive joint pain), BEDRIDDEN (bedridden) and HEADACHE (headache). On an unknown date, the patient experienced TENDERNESS (tender left arm). On 01-Apr-2021, TENDERNESS (tender left arm) and MYALGIA (had a sore) outcome was unknown. On 29-Apr-2021, NAUSEA (nausea), INFLUENZA (flu), DIZZINESS (dizzy), LETHARGY (lethargic), ARTHRALGIA (extensive joint pain), BEDRIDDEN (bedridden) and HEADACHE (headache) outcome was unknown. At the time of the report, HYPERHIDROSIS (cold sweats) and FATIGUE (felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information provided was 2 Tylenol Tablets on 28 Apr2021  Patient had to run over by a car and patient also reported to feel exhausted.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: tender left arm; dizzy; lethargic; extensive joint pain; bedridden; headache; cold sweats; nausea; flu; felt tired; had a sore; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender left arm), HYPERHIDROSIS (cold sweats), NAUSEA (nausea), INFLUENZA (flu) and DIZZINESS (dizzy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 31-Mar-2021, the patient experienced MYALGIA (had a sore). On 27-Apr-2021, the patient experienced HYPERHIDROSIS (cold sweats), NAUSEA (nausea), INFLUENZA (flu) and FATIGUE (felt tired). On 28-Apr-2021, the patient experienced DIZZINESS (dizzy), LETHARGY (lethargic), ARTHRALGIA (extensive joint pain), BEDRIDDEN (bedridden) and HEADACHE (headache). On an unknown date, the patient experienced TENDERNESS (tender left arm). On 01-Apr-2021, TENDERNESS (tender left arm) and MYALGIA (had a sore) outcome was unknown. On 29-Apr-2021, NAUSEA (nausea), INFLUENZA (flu), DIZZINESS (dizzy), LETHARGY (lethargic), ARTHRALGIA (extensive joint pain), BEDRIDDEN (bedridden) and HEADACHE (headache) outcome was unknown. At the time of the report, HYPERHIDROSIS (cold sweats) and FATIGUE (felt tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information provided was 2 Tylenol Tablets on 28 Apr2021  Patient had to run over by a car and patient also reported to feel exhausted.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Decreased appetite, Fatigue, Headache, Illness
Clinical narrative: Hair loss; Tiredness; Nausea; Headache; Very strong reaction/very sick and felt terrible; Couldn't eat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Very strong reaction/very sick and felt terrible), DECREASED APPETITE (Couldn't eat), ALOPECIA (Hair loss), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Very strong reaction/very sick and felt terrible), DECREASED APPETITE (Couldn't eat), FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced ALOPECIA (Hair loss). The patient was treated with CORTISONE for Hair loss, at an unspecified dose and frequency. On 20-Feb-2021, ILLNESS (Very strong reaction/very sick and felt terrible), DECREASED APPETITE (Couldn't eat), FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  The consumer visited a dermatologist on unknown date due to hair loss experienced several weeks after the second dose of the vaccine. Bloodwork was drawn to rule out other diseases, no results provided.  Treatment included , and a topical ointment.   This case was linked to MOD-2021-101556 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Hair loss; Tiredness; Nausea; Headache; Very strong reaction/very sick and felt terrible; Couldn't eat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Very strong reaction/very sick and felt terrible), DECREASED APPETITE (Couldn't eat), ALOPECIA (Hair loss), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced ILLNESS (Very strong reaction/very sick and felt terrible), DECREASED APPETITE (Couldn't eat), FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache). On an unknown date, the patient experienced ALOPECIA (Hair loss). The patient was treated with CORTISONE for Hair loss, at an unspecified dose and frequency. On 20-Feb-2021, ILLNESS (Very strong reaction/very sick and felt terrible), DECREASED APPETITE (Couldn't eat), FATIGUE (Tiredness), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not provided.  The consumer visited a dermatologist on unknown date due to hair loss experienced several weeks after the second dose of the vaccine. Bloodwork was drawn to rule out other diseases, no results provided.  Treatment included , and a topical ointment.   This case was linked to MOD-2021-101556 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Chills, Fatigue, Gastrointestinal pain, Hypoaesthesia oral
Clinical narrative: Mouth numbness; pain in intestines; sore arm; Nausea; Low grade fever; Chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications reported.  Concurrent medical conditions included Autoimmune disorder, Gastrointestinal disorder (Late stage.), Sclerosis multiple, Lupus erythematosus, Vitamin deficiency, Allergy (shellfish), Food allergy (fish), Allergy (pork), Allergy, Allergy (pollen), Allergy (tree), Allergy (grass), Allergy (certain metals) and Allergy (make up).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and FATIGUE (tiredness). At the time of the report, HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: negative (Inconclusive) Negative.         Adverse events experienced after getting 2th vaccine are: sore arm, low grade fever, Nausea, mouth numbness and stabbing pain in intestines   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Significant F/U received, Chills and fatigue events added.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Mouth numbness; pain in intestines; sore arm; Nausea; Low grade fever; Chills; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea) and PYREXIA (Low grade fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No concomitant medications reported.  Concurrent medical conditions included Autoimmune disorder, Gastrointestinal disorder (Late stage.), Sclerosis multiple, Lupus erythematosus, Vitamin deficiency, Allergy (shellfish), Food allergy (fish), Allergy (pork), Allergy, Allergy (pollen), Allergy (tree), Allergy (grass), Allergy (certain metals) and Allergy (make up).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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 HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and FATIGUE (tiredness). At the time of the report, HYPOAESTHESIA ORAL (Mouth numbness), GASTROINTESTINAL PAIN (pain in intestines), PAIN IN EXTREMITY (sore arm), NAUSEA (Nausea), PYREXIA (Low grade fever), CHILLS (Chills) and FATIGUE (tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antinuclear antibody: negative (Inconclusive) Negative.         Adverse events experienced after getting 2th vaccine are: sore arm, low grade fever, Nausea, mouth numbness and stabbing pain in intestines   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Significant F/U received, Chills and fatigue events added.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Influenza like illness, Myalgia, Nausea, Pyrexia
Clinical narrative: Woke up feeling like she had the flu; Fever; had a little nausea; Burning sensation in head and body; Arm pain/bone pain/Pain in head and body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in head and body), INFLUENZA LIKE ILLNESS (Woke up feeling like she had the flu), PYREXIA (Fever), NAUSEA (had a little nausea) and MYALGIA (Arm pain/bone pain/Pain in head and body) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism since an unknown date and Pre-diabetic. Concurrent medical conditions included Hypersensitivity (allergies to objects around neck). Concomitant products included CETIRIZINE, LEVOTHYROXINE and METFORMIN for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced MYALGIA (Arm pain/bone pain/Pain in head and body). On 02-May-2021, the patient experienced BURNING SENSATION (Burning sensation in head and body), PYREXIA (Fever) and NAUSEA (had a little nausea). On 03-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Woke up feeling like she had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation in head and body), INFLUENZA LIKE ILLNESS (Woke up feeling like she had the flu), PYREXIA (Fever), NAUSEA (had a little nausea) and MYALGIA (Arm pain/bone pain/Pain in head and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Allergic sinusitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: seasonal sinus; no mucus for one day, then seasonal sinus with sinus drainage; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ALLERGIC SINUSITIS (seasonal sinus) and RHINORRHOEA (no mucus for one day, then seasonal sinus with sinus drainage) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy and Back pain. Concomitant products included STEROIDS for Back pain, TOPIRAMATE (TROKENDI), PARACETAMOL (TYLENOL) and DICLOFENAC for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and RHINORRHOEA (no mucus for one day, then seasonal sinus with sinus drainage). On 29-Apr-2021, the patient experienced ALLERGIC SINUSITIS (seasonal sinus). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and BENZYDAMINE HYDROCHLORIDE, DICHLOROBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE (SORE THROAT [BENZYDAMINE HYDROCHLORIDE;DICHLOROBENZYL ALCOHOL;LIDOCAINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 29-Apr-2021, OROPHARYNGEAL PAIN (sore throat) had resolved. On 02-May-2021, ALLERGIC SINUSITIS (seasonal sinus) and RHINORRHOEA (no mucus for one day, then seasonal sinus with sinus drainage) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Improper preparation of thawed vial; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Improper preparation of thawed vial) in a 49-year-old male 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, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Improper preparation of thawed vial). On 21-Apr-2021, PRODUCT STORAGE ERROR (Improper preparation of thawed vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Epistaxis, Fatigue
Clinical narrative: Severe reaction to the vaccination; More than one nose bleed; Developed swelling under jaw line; Swelling under neck felt like it was on fire; Felt like I had something under one arm; Too sick to do anything; Short of breath; Immediately became freezing; Developed a horrible headache; Very tired; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire) and LIMB DISCOMFORT (Felt like I had something under one arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Never officially tested. ) in July 2020. Previously administered products included for an unreported indication: FLU VACCINE VII (has it every year). Concomitant products included BUDESONIDE for Allergy, ESTRADIOL for Hormone therapy, LEVOTHYROXINE for Hypothyroidism, CETIRIZINE HYDROCHLORIDE (ZYRTEC R).    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire), LIMB DISCOMFORT (Felt like I had something under one arm), ILLNESS (Too sick to do anything), DYSPNOEA (Short of breath), CHILLS (Immediately became freezing), HEADACHE (Developed a horrible headache), FATIGUE (Very tired) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire), LIMB DISCOMFORT (Felt like I had something under one arm), ILLNESS (Too sick to do anything), DYSPNOEA (Short of breath), CHILLS (Immediately became freezing), FATIGUE (Very tired) and ARTHRALGIA (Joint pain) was resolving and HEADACHE (Developed a horrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included caffeine and paracetamol for headache.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Limb discomfort, Swelling, Swelling face
Clinical narrative: Severe reaction to the vaccination; More than one nose bleed; Developed swelling under jaw line; Swelling under neck felt like it was on fire; Felt like I had something under one arm; Too sick to do anything; Short of breath; Immediately became freezing; Developed a horrible headache; Very tired; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire) and LIMB DISCOMFORT (Felt like I had something under one arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Never officially tested. ) in July 2020. Previously administered products included for an unreported indication: FLU VACCINE VII (has it every year). Concomitant products included BUDESONIDE for Allergy, ESTRADIOL for Hormone therapy, LEVOTHYROXINE for Hypothyroidism, CETIRIZINE HYDROCHLORIDE (ZYRTEC R).    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire), LIMB DISCOMFORT (Felt like I had something under one arm), ILLNESS (Too sick to do anything), DYSPNOEA (Short of breath), CHILLS (Immediately became freezing), HEADACHE (Developed a horrible headache), FATIGUE (Very tired) and ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE REACTION (Severe reaction to the vaccination), EPISTAXIS (More than one nose bleed), SWELLING FACE (Developed swelling under jaw line), SWELLING (Swelling under neck felt like it was on fire), LIMB DISCOMFORT (Felt like I had something under one arm), ILLNESS (Too sick to do anything), DYSPNOEA (Short of breath), CHILLS (Immediately became freezing), FATIGUE (Very tired) and ARTHRALGIA (Joint pain) was resolving and HEADACHE (Developed a horrible headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included caffeine and paracetamol for headache.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be exclude.