chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Limb discomfort, Malaise
Clinical narrative: Diarrhea; Itching; Couldn't control legs, like they were rubber; Feeling sick; Fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2019 and COVID-19 (she had COVID-19 the first week of December, and she also had it back on March) in March 2020. Concurrent medical conditions included Blood pressure abnormal, Depression and Cholesterol total abnormal NOS. Concomitant products included POTASSIUM and VITAMINS NOS for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 105 °F (High) (105°F).     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.   Concomitantly, patient was taking medications for blood pressure, depression and cholesterol.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia
Clinical narrative: Diarrhea; Itching; Couldn't control legs, like they were rubber; Feeling sick; Fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2019 and COVID-19 (she had COVID-19 the first week of December, and she also had it back on March) in March 2020. Concurrent medical conditions included Blood pressure abnormal, Depression and Cholesterol total abnormal NOS. Concomitant products included POTASSIUM and VITAMINS NOS for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PRURITUS (Itching), LIMB DISCOMFORT (Couldn't control legs, like they were rubber), MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 105 °F (High) (105°F).     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.   Concomitantly, patient was taking medications for blood pressure, depression and cholesterol.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Feeling abnormal, Lymphadenopathy, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain is foggy), LYMPHADENOPATHY (Lump under arm pit (size of a grape fruit)) and PYREXIA (High fever I reach temp 103.9) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 (patient was in the hospital for a week. Patient was a plasma donor.) in March 2020. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain is foggy), LYMPHADENOPATHY (Lump under arm pit (size of a grape fruit)) and PYREXIA (High fever I reach temp 103.9). On 28-Jan-2021, DIARRHOEA (Diarrhea), FEELING ABNORMAL (brain is foggy), LYMPHADENOPATHY (Lump under arm pit (size of a grape fruit)) and PYREXIA (High fever I reach temp 103.9) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 103.9 (High) (103.9). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment related information has been reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Peripheral swelling, Pyrexia
Clinical narrative: Vertigo; dizzy; temp was up to 99.6; chills; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  was swollen), VERTIGO (Vertigo), DIZZINESS (dizzy), PYREXIA (temp was up to 99.6) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm  was swollen), DIZZINESS (dizzy), PYREXIA (temp was up to 99.6) and CHILLS (chills). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm  was swollen), VERTIGO (Vertigo), DIZZINESS (dizzy), PYREXIA (temp was up to 99.6) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 99.6 (High) (99.6).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; dizzy; temp was up to 99.6; chills; arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm  was swollen), VERTIGO (Vertigo), DIZZINESS (dizzy), PYREXIA (temp was up to 99.6) and CHILLS (chills) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PERIPHERAL SWELLING (arm  was swollen), DIZZINESS (dizzy), PYREXIA (temp was up to 99.6) and CHILLS (chills). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (arm  was swollen), VERTIGO (Vertigo), DIZZINESS (dizzy), PYREXIA (temp was up to 99.6) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Body temperature: 99.6 (High) (99.6).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction
Clinical narrative: COVID arm; Extreme itching at the injection site; Rash at the injection site; Painful to touch and sensitive at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Extreme itching at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Painful to touch and sensitive at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE PRURITUS (Extreme itching at the injection site), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Painful to touch and sensitive at the injection site). On 05-Feb-2021, VACCINATION SITE PRURITUS (Extreme itching at the injection site) had resolved. On 08-Feb-2021, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Painful to touch and sensitive at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment drug were not reported.    Most recent FOLLOW-UP information incorporated above includes: On 20-Feb-2021: Email added On 28-Apr-2021: Follow up received on 28apr2021 contains no new information. On 28-Jun-2021: Report content no new information.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Heart rate increased, Vision blurred
Clinical narrative: fatigue; heart rate elevated; blood pressure went up to 198/92; vision turned blurry; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate elevated), BLOOD PRESSURE INCREASED (blood pressure went up to 198/92), VISION BLURRED (vision turned blurry) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, VITAMIN D3 and PROBIOTICS NOS for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (heart rate elevated), BLOOD PRESSURE INCREASED (blood pressure went up to 198/92) and VISION BLURRED (vision turned blurry). On 14-Feb-2021, the patient experienced FATIGUE (fatigue). On 13-Feb-2021, HEART RATE INCREASED (heart rate elevated), BLOOD PRESSURE INCREASED (blood pressure went up to 198/92) and VISION BLURRED (vision turned blurry) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Blood pressure measurement: 198/92 (High) (198/92).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment has been taken by patient for symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Vaccination site rash
Clinical narrative: Rash (Chest, Injection Site); Lymph Knot (Under Armpit); Rash (Chest, Injection Site); A spontaneous report (United States) was received from a consumer concerning a 51-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash (chest, injection site)/rash, lymph knot (under armpit)/lymphadenopathy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Rash (Chest, Injection Site), Lymph Knot (Under Armpit).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash (chest, injection site), lymph knot (under armpit) was unknown.; Reporter's Comments: This case concerns a 51 Y/O F with nonserious unexpected events of vaccination site rash, rash and lymphadenopathy.  Event onset 8 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (numbness in their hand, whole hand being numb, it is only the pinky, ring finger and later side of injection site arm) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HYPOAESTHESIA (numbness in their hand, whole hand being numb, it is only the pinky, ring finger and later side of injection site arm). At the time of the report, HYPOAESTHESIA (numbness in their hand, whole hand being numb, it is only the pinky, ring finger and later side of injection site arm) had not 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 related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Depressed mood, Fatigue, Headache
Clinical narrative: devastated and sad; back injury; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK INJURY (back injury), DEPRESSED MOOD (devastated and sad), FATIGUE (Fatigue) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma (8 year history). Concomitant products included MULTIVITAMINS [VITAMINS NOS], ROSUVASTATIN CALCIUM (CRESTOR), BUPROPION HYDROCHLORIDE (WELLBUTRIN), AZELASTINE and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (Fatigue). On 29-Jan-2021, the patient experienced HEADACHE (Headache). On 13-Feb-2021, the patient experienced BACK INJURY (back injury). On an unknown date, the patient experienced DEPRESSED MOOD (devastated and sad). The patient was treated with PREDNISONE on 19-Feb-2021 for Back injury, at a dose of 5 milligram and PREDNISONE from 17-Feb-2021 to 18-Feb-2021 for Back injury, at a dose of 10 milligram. On 30-Jan-2021, FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, BACK INJURY (back injury) and DEPRESSED MOOD (devastated and sad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: pin point rash; rash just below the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH (pin point rash) and VACCINATION SITE RASH (rash just below the injection site) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (pin point rash) and VACCINATION SITE RASH (rash just below the injection site). At the time of the report, RASH (pin point rash) and VACCINATION SITE RASH (rash just below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood test, Pain in extremity
Clinical narrative: blood sugar went up the next day to around 200-300 range, blood sure is still around 200; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar went up the next day to around 200-300 range, blood sure is still around 200) and PAIN IN EXTREMITY (sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 19-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar went up the next day to around 200-300 range, blood sure is still around 200). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar went up the next day to around 200-300 range, blood sure is still around 200) and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Blood test: 200-300 (High) Blood sugar around 200-300 range.. On 20-Feb-2021, Blood test: 200 (High) blood sugar is still around 200.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Every once in a while has some discomfort in the arm; arm  hot to the touch, very warm the whole area where got the vaccine; where got the vaccine, also hard; arm  is itching; where got the vaccine, also red; arm  is swelling; sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a couple of days), LIMB DISCOMFORT (Every once in a while has some discomfort in the arm), VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard) and VACCINATION SITE PRURITUS (arm  is itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days). On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard), VACCINATION SITE PRURITUS (arm  is itching), VACCINATION SITE ERYTHEMA (where got the vaccine, also red) and VACCINATION SITE SWELLING (arm  is swelling). On 26-Jan-2021, the patient experienced LIMB DISCOMFORT (Every once in a while has some discomfort in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm for a couple of days) had resolved. At the time of the report, LIMB DISCOMFORT (Every once in a while has some discomfort in the arm), VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard), VACCINATION SITE PRURITUS (arm  is itching), VACCINATION SITE ERYTHEMA (where got the vaccine, also red) and VACCINATION SITE SWELLING (arm  is swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Every once in a while has some discomfort in the arm; arm  hot to the touch, very warm the whole area where got the vaccine; where got the vaccine, also hard; arm  is itching; where got the vaccine, also red; arm  is swelling; sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a couple of days), LIMB DISCOMFORT (Every once in a while has some discomfort in the arm), VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard) and VACCINATION SITE PRURITUS (arm  is itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days). On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard), VACCINATION SITE PRURITUS (arm  is itching), VACCINATION SITE ERYTHEMA (where got the vaccine, also red) and VACCINATION SITE SWELLING (arm  is swelling). On 26-Jan-2021, the patient experienced LIMB DISCOMFORT (Every once in a while has some discomfort in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm for a couple of days) had resolved. At the time of the report, LIMB DISCOMFORT (Every once in a while has some discomfort in the arm), VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard), VACCINATION SITE PRURITUS (arm  is itching), VACCINATION SITE ERYTHEMA (where got the vaccine, also red) and VACCINATION SITE SWELLING (arm  is swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: inflammation at site of injection; rash at injection site which spread to upper arm; body aches; chills; nausea; fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 103). At the time of the report, VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103 (High) (103).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was antibiotics.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site inflammation, Vaccination site rash
Clinical narrative: inflammation at site of injection; rash at injection site which spread to upper arm; body aches; chills; nausea; fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 103). At the time of the report, VACCINATION SITE INFLAMMATION (inflammation at site of injection), VACCINATION SITE RASH (rash at injection site which spread to upper arm), MYALGIA (body aches), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103 (High) (103).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment reported was antibiotics.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: chills; slight fever; arm  started to ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  started to ache ), CHILLS (chills) and PYREXIA (slight fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm  started to ache ). On 19-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (slight fever). At the time of the report, PAIN IN EXTREMITY (arm  started to ache ), CHILLS (chills) and PYREXIA (slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: feels warm on the arm; arm where the shot was is red about 6 inches in size, 6 inches wide and its getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (feels warm on the arm) and VACCINATION SITE ERYTHEMA (arm where the shot was is red about 6 inches in size, 6 inches wide and its getting bigger) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE WARMTH (feels warm on the arm) and VACCINATION SITE ERYTHEMA (arm where the shot was is red about 6 inches in size, 6 inches wide and its getting bigger). At the time of the report, VACCINATION SITE WARMTH (feels warm on the arm) outcome was unknown and VACCINATION SITE ERYTHEMA (arm where the shot was is red about 6 inches in size, 6 inches wide and its getting bigger) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I had a reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had a reaction) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had a reaction). At the time of the report, VACCINATION COMPLICATION (I had a reaction) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: Rash on hands and back, face; red dots on hand; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red dots on hand) and RASH (Rash on hands and back, face) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE in December 2020.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced ERYTHEMA (red dots on hand). On 09-Feb-2021, the patient experienced RASH (Rash on hands and back, face). At the time of the report, ERYTHEMA (red dots on hand) was resolving and RASH (Rash on hands and back, face) 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.   The patient reported that rash appeared on his face on 17-Feb-2021. The patient was scheduled for second dose on 21-Feb-2021. The patient visited their health care provider who recommended the patient to see an allergist. The patient had an appointment with his allergist on 08-Mar-2021. Concomitant medications were not provided. Treatment information was not reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood creatinine increased
Clinical narrative: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021. This spontaneous case was reported by a nurse and describes the occurrence of BLOOD CREATININE INCREASED (Serum Creatinine increased) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Bladder cancer, Congestive heart failure and COPD. Concomitant products included FUROSEMIDE, METOPROLOL, LISINOPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), VITAMIN D NOS and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]). On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced BLOOD CREATININE INCREASED (Serum Creatinine increased). At the time of the report, BLOOD CREATININE INCREASED (Serum Creatinine increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Blood creatinine: serum creatinine Serum Creatinine went from 1.5 to 1.87. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Injection site coldness, Underdose, Wrong technique in device usage process
Clinical narrative: Felt coldness when needle was pulled out; Felt fluid running down her arm; Felt fluid running down her arm; Felt fluid running down her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE COLDNESS (Felt coldness when needle was pulled out), UNDERDOSE (Felt fluid running down her arm), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Felt fluid running down her arm) and EXPOSURE VIA SKIN CONTACT (Felt fluid running down her arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-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 04-Feb-2021, the patient experienced INJECTION SITE COLDNESS (Felt coldness when needle was pulled out), UNDERDOSE (Felt fluid running down her arm), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Felt fluid running down her arm) and EXPOSURE VIA SKIN CONTACT (Felt fluid running down her arm). On 04-Feb-2021, UNDERDOSE (Felt fluid running down her arm), WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Felt fluid running down her arm) and EXPOSURE VIA SKIN CONTACT (Felt fluid running down her arm) had resolved. At the time of the report, INJECTION SITE COLDNESS (Felt coldness when needle was pulled out) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD21-033798 (Patient Link).; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273, lot #  029K20A  with associated AE of injection site coldness. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Nausea
Clinical narrative: Bladder infection; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (Bladder infection) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced CYSTITIS (Bladder infection) and NAUSEA (Nausea). At the time of the report, CYSTITIS (Bladder infection) and NAUSEA (Nausea) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  Treatment details included Bladder Infection Medication since 18 Feb 2021.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness; 4 inch circumference of swelling; severe itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (severe itching), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (4 inch circumference of swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PRURITUS (severe itching). On 20-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (4 inch circumference of swelling). At the time of the report, PRURITUS (severe itching), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (4 inch circumference of swelling) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023MZ0A1) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: fever between 99 and 103; Nausea; slight HA; A spontaneous report (United States) was received from a female patient, concerning herself 63  years of age, who received Moderna's COVID-19 vaccine and Pyrexia, Nausea, Headache.  The patient's medical history was not provided.   Concomitant product use was not provided by the patient.  On 19-Feb-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (023M20A batch number) via intramuscular route for COVID-19 infection prophylaxis and experienced Headache, Pyrexia, Nausea. She has been home since then and has not returned to work yet. She has no question, just calling to report her side effects.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the event was considered to be unknown at the time of this report.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Rash, Vaccination site pain
Clinical narrative: Rash on both forearms; Tender injection site; Difficulty Breathing; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), INSOMNIA (Could not sleep), RASH (Rash on both forearms) and VACCINATION SITE PAIN (Tender injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced DYSPNOEA (Difficulty Breathing) and INSOMNIA (Could not sleep). On 20-Feb-2021, the patient experienced RASH (Rash on both forearms) and VACCINATION SITE PAIN (Tender injection site). On 20-Feb-2021, DYSPNOEA (Difficulty Breathing) and INSOMNIA (Could not sleep) had resolved. At the time of the report, RASH (Rash on both forearms) and VACCINATION SITE PAIN (Tender injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up received on 19-Jun-2021 contains non-signification information: updated reporter information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pruritus, Urticaria
Clinical narrative: Headache; joint pain; Fatigue; hives the patch of hives is about 5 inches large; Itchiness on stomach; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives the patch of hives is about 5 inches large), PRURITUS (Itchiness on stomach), HEADACHE (Headache), ARTHRALGIA (joint pain) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced URTICARIA (hives the patch of hives is about 5 inches large) and PRURITUS (Itchiness on stomach). On an unknown date, the patient experienced HEADACHE (Headache), ARTHRALGIA (joint pain) and FATIGUE (Fatigue). At the time of the report, URTICARIA (hives the patch of hives is about 5 inches large), PRURITUS (Itchiness on stomach), HEADACHE (Headache), ARTHRALGIA (joint pain) and FATIGUE (Fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Teatment provided included aloe vera, no concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: head was pounding all night long; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (head was pounding all night long) and CHILLS (chills) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (head was pounding all night long) and CHILLS (chills). At the time of the report, HEADACHE (head was pounding all night long) and CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: toothache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (toothache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (toothache). At the time of the report, TOOTHACHE (toothache) outcome was unknown.     No relevant concomitant medications were reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Somnolence, Vaccination site pain
Clinical narrative: she felt heavier; sleepiness; knees bothered her going up stairs; mild soreness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (she felt heavier), SOMNOLENCE (sleepiness), ARTHRALGIA (knees bothered her going up stairs) and VACCINATION SITE PAIN (mild soreness at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 006M20A) for COVID-19 immunization.     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 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DISCOMFORT (she felt heavier), SOMNOLENCE (sleepiness), ARTHRALGIA (knees bothered her going up stairs) and VACCINATION SITE PAIN (mild soreness at the injection site). On 18-Feb-2021, DISCOMFORT (she felt heavier), SOMNOLENCE (sleepiness), ARTHRALGIA (knees bothered her going up stairs) and VACCINATION SITE PAIN (mild soreness at the injection site) had resolved.            No treatment information was provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to the touch Injection Site; Severe Itching on Injection Site; Swollen Injection Site; Mild Itching on the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE PRURITUS (Mild Itching on the Injection Site), VACCINATION SITE PRURITUS (Severe Itching on Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-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 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Mild Itching on the Injection Site). On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE PRURITUS (Severe Itching on Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch Injection Site), VACCINATION SITE PRURITUS (Mild Itching on the Injection Site), VACCINATION SITE PRURITUS (Severe Itching on Injection Site) and VACCINATION SITE SWELLING (Swollen Injection Site) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.