chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: red/itchy rash at the injection; red/itchy rash at the injection; rash in the right arm; chills; Fatigue; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (red/itchy rash at the injection), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007N2OA) 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) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (chills), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (red/itchy rash at the injection), VACCINATION SITE ERYTHEMA (red/itchy rash at the injection) and VACCINATION SITE RASH (rash in the right arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (red/itchy rash at the injection), CHILLS (chills), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea), VACCINATION SITE ERYTHEMA (red/itchy rash at the injection) and VACCINATION SITE RASH (rash in the right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.    Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: itchy rash, 2 inches in diameter, at the site of the injection; soreness at the site of the injection; A spontaneous report was received from a consumer concerning herself, who is a 70-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of soreness at the site of the injection, itchy rash, 2 inches in diameter, at the site of the injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 25L20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the events soreness at the site of the injection,On 3 Feb 2021, the patient experienced the event itchy rash, 2 inches in diameter, at the site of the injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 28 Jan 2021 the outcome of event soreness at the site of the injection, at the site of the injection was resolved. The outcome of event itchy rash, 2 inches in diameter was unknown  The reporter did not provide causality for the events; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Vaccination site erythema
Clinical narrative: Red lines and redness on the back heading down to the butt cheeks; Itching around the eyelids; At the injection site had a red blotch 2 inches wide for 3 inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red lines and redness on the back heading down to the butt cheeks), EYE PRURITUS (Itching around the eyelids) and VACCINATION SITE ERYTHEMA (At the injection site had a red blotch 2 inches wide for 3 inches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (flu shot every year and ). Concomitant products included ESTRADIOL for Estrogen, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, ATORVASTATIN, OMEPRAZOLE and ASCORBIC ACID, ERGOCALCIFEROL, FOLIC ACID, RETINOL, TOCOPHEROL, VITAMIN B NOS (MULTIPLE VITAMINS) for an unknown indication, LISINTROL.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (At the injection site had a red blotch 2 inches wide for 3 inches). On an unknown date, the patient experienced ERYTHEMA (Red lines and redness on the back heading down to the butt cheeks) and EYE PRURITUS (Itching around the eyelids). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red lines and redness on the back heading down to the butt cheeks), EYE PRURITUS (Itching around the eyelids) and VACCINATION SITE ERYTHEMA (At the injection site had a red blotch 2 inches wide for 3 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Tylenol: 8 hours after vaccination.  The patient told had no history of allergic reactions, get's the flu shot every year and had no reaction and only time she had a reaction was with the shingles vaccine first dose (redness at the injection site).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Went to dermatologist after and reported adv was not related to vaccine. She stated that the other events that were reported other that of of the redness at the injection site was not related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Vaccination site warmth
Clinical narrative: Arm very warm; Redness; Soreness; A spontaneous report was received from a consumer concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, redness, soreness and arm very warm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the events redness, soreness and arm very warm. No treatment information was provided.  Action taken with mRNA-1273 in response to the events, redness, soreness, arm very warm was not reported.   On an unknown date the outcome of events include, redness, soreness and arm very warm was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious expected vaccination site warmth, erythema, and pain.  Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Nausea, Pain in extremity
Clinical narrative: Arm Pain; Chills; Joint Pain; Nausea; Small reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), VACCINATION COMPLICATION (Small reaction), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Small reaction). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION COMPLICATION (Small reaction) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 99.6 (Inconclusive) Fever 99.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   This case was linked to MOD-2021-018540 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: event added. dosage information updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Arm Pain; Chills; Joint Pain; Nausea; Small reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain), VACCINATION COMPLICATION (Small reaction), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION COMPLICATION (Small reaction). On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, PAIN IN EXTREMITY (Arm Pain), CHILLS (Chills), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) had resolved. At the time of the report, VACCINATION COMPLICATION (Small reaction) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, Body temperature: 99.6 (Inconclusive) Fever 99.6 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   This case was linked to MOD-2021-018540 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: event added. dosage information updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: still has a rash today; hives on her outer thigh area, hives recurred 2 days later; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), URTICARIA (hives on her outer thigh area, hives recurred 2 days later) and RASH (still has a rash today) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), DENOSUMAB (PROLIA) and SPIRONOLACTONE for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 25-Jan-2021, the patient experienced URTICARIA (hives on her outer thigh area, hives recurred 2 days later). On 04-Feb-2021, the patient experienced RASH (still has a rash today). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), URTICARIA (hives on her outer thigh area, hives recurred 2 days later) and RASH (still has a rash today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications spironolactone, atorvastatin, Effexor, Prolia injections.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 degrees F), ARTHRALGIA (Pain in joints), HEADACHE (Headache) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included SARS-CoV-2 test positive (Nasal swab) in October 2020 and COVID-19 (previous diagnosis of Covid-19 with a 100 plus degree F fever). Concurrent medical conditions included Hypertension (25 years). Concomitant products included LOVASTATIN for Cholesterol, TELMISARTAN for Hypertension. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (Fever of 102 degrees F), ARTHRALGIA (Pain in joints), HEADACHE (Headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, PYREXIA (Fever of 102 degrees F), ARTHRALGIA (Pain in joints), HEADACHE (Headache) and CHILLS (chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 102 (High) 102. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on 19-Jun-2021 contained significant information: Concomitant products.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Diarrhoea, Fatigue
Clinical narrative: not feeling well; oxygen level is not good; diarrhea; can't take in any food; JOINT PAIN; very tired; muscle pain; chills; nausea; very high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food) and ARTHRALGIA (JOINT PAIN) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE, FAMOTIDINE and LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 104 High, 103 High and 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Food intolerance, Malaise, Myalgia, Nausea, Oxygen saturation decreased
Clinical narrative: not feeling well; oxygen level is not good; diarrhea; can't take in any food; JOINT PAIN; very tired; muscle pain; chills; nausea; very high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food) and ARTHRALGIA (JOINT PAIN) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE, FAMOTIDINE and LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 104 High, 103 High and 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: not feeling well; oxygen level is not good; diarrhea; can't take in any food; JOINT PAIN; very tired; muscle pain; chills; nausea; very high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food) and ARTHRALGIA (JOINT PAIN) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE, FAMOTIDINE and LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, MALAISE (not feeling well), OXYGEN SATURATION DECREASED (oxygen level is not good), DIARRHOEA (diarrhea), FOOD INTOLERANCE (can't take in any food), ARTHRALGIA (JOINT PAIN), FATIGUE (very tired), MYALGIA (muscle pain), CHILLS (chills), NAUSEA (nausea) and PYREXIA (very high fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 104 High, 103 High and 101 High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Postive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Postive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive on 22-Jan-2021.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Postive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Postive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: A spontaneous report was received from a consumer concerning herself, who is a 76-years-old female patient received COVID-19 vaccine (mRNA-1273) and experienced events swollen(vaccination site swelling), sore/vaccination site pain, warm to touch/vaccination site warmth, red/vaccination site erythema, itchy/vaccination site pruritus. The patient's medical history was not provided. Concomitant medications reported were Sitagliptin Phosphate, Metformin, Furosemide, Warfarin, Olmesartan, Rosuvastatin for drug use for unknown indication. On 16 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028LZ0A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, patient experienced injection site is itchy and red as. When I first got the vaccine the site was swollen, sore, warm to touch, red. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events swollen, sore, warm to touch, red, itchy was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: tiny sore in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (tiny sore in the arm) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (tiny sore in the arm). On 03-Feb-2021, PAIN IN EXTREMITY (tiny sore in the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Swollen; Red; Rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Red) and INJECTION SITE RASH (Rash) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Red) and INJECTION SITE RASH (Rash). At the time of the report, INJECTION SITE SWELLING (Swollen), INJECTION SITE ERYTHEMA (Red) and INJECTION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (I was breaking out in an itchy rash or hives that shifted all over my body) and PRURITUS (lower back started to itch) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 073L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced URTICARIA (I was breaking out in an itchy rash or hives that shifted all over my body) and PRURITUS (lower back started to itch). The patient was treated with CALAMINE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, URTICARIA (I was breaking out in an itchy rash or hives that shifted all over my body) and PRURITUS (lower back started to itch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On Friday 29Jan2021 patient had noticed his lower back started to itch. Then he noticed it in different pots. He was breaking out in an itchy rash or hives that shifted all over his body. It never got on his face, but it was all over - legs, back and front of arms, stomach. On 31Jan2021, it broke out on both his feet. Almost always, if he was itching underneath his left arm, it would be at the exact same place at his right arm. Treatment includes sunburn spray. Concomitant medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: reporter mail ID added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hyperaesthesia, Vaccination site discomfort, Vaccination site erythema, Vaccination site swelling
Clinical narrative: sensitivity came back; discomfort came back; injection site red, redness was bigger; swelling came back; sensitivity to the touch at the injection site; swelling at the injection site; discomfort at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE HYPERAESTHESIA (sensitivity to the touch at the injection site), INJECTION SITE HYPERAESTHESIA (sensitivity came back), VACCINATION SITE DISCOMFORT (discomfort at the injection site), VACCINATION SITE DISCOMFORT (discomfort came back) and VACCINATION SITE ERYTHEMA (injection site red, redness was bigger) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE HYPERAESTHESIA (sensitivity to the touch at the injection site), VACCINATION SITE DISCOMFORT (discomfort at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). On 01-Feb-2021, the patient experienced INJECTION SITE HYPERAESTHESIA (sensitivity came back), VACCINATION SITE DISCOMFORT (discomfort came back), VACCINATION SITE ERYTHEMA (injection site red, redness was bigger) and VACCINATION SITE SWELLING (swelling came back). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and GRAMICIDIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (POLYSPORINA) for Antibiotic therapy, at an unspecified dose and frequency. In January 2021, INJECTION SITE HYPERAESTHESIA (sensitivity to the touch at the injection site), VACCINATION SITE DISCOMFORT (discomfort at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved. At the time of the report, INJECTION SITE HYPERAESTHESIA (sensitivity came back), VACCINATION SITE DISCOMFORT (discomfort came back), VACCINATION SITE ERYTHEMA (injection site red, redness was bigger) and VACCINATION SITE SWELLING (swelling came back) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Tylenol and Polysporin antibiotic cream.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site rash, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: have a little fever with aches and pains; lots of pressure by my hand; looks like I have hives; rash that burns like fire; swollen arm; Numbness by her hand; On Tuesday complete sick with fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (On Tuesday complete sick with fever), PAIN IN EXTREMITY (lots of pressure by my hand), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire) and PERIPHERAL SWELLING (swollen arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-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 02-Feb-2021, the patient experienced PYREXIA (On Tuesday complete sick with fever), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire), PERIPHERAL SWELLING (swollen arm) and HYPOAESTHESIA (Numbness by her hand). On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (lots of pressure by my hand). On an unknown date, the patient experienced MYALGIA (have a little fever with aches and pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PYREXIA (On Tuesday complete sick with fever), PAIN IN EXTREMITY (lots of pressure by my hand), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire), PERIPHERAL SWELLING (swollen arm) and HYPOAESTHESIA (Numbness by her hand) had not resolved and MYALGIA (have a little fever with aches and pains) outcome was unknown. Not Provided
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: have a little fever with aches and pains; lots of pressure by my hand; looks like I have hives; rash that burns like fire; swollen arm; Numbness by her hand; On Tuesday complete sick with fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (On Tuesday complete sick with fever), PAIN IN EXTREMITY (lots of pressure by my hand), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire) and PERIPHERAL SWELLING (swollen arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-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 02-Feb-2021, the patient experienced PYREXIA (On Tuesday complete sick with fever), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire), PERIPHERAL SWELLING (swollen arm) and HYPOAESTHESIA (Numbness by her hand). On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (lots of pressure by my hand). On an unknown date, the patient experienced MYALGIA (have a little fever with aches and pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PYREXIA (On Tuesday complete sick with fever), PAIN IN EXTREMITY (lots of pressure by my hand), URTICARIA (looks like I have hives), INJECTION SITE RASH (rash that burns like fire), PERIPHERAL SWELLING (swollen arm) and HYPOAESTHESIA (Numbness by her hand) had not resolved and MYALGIA (have a little fever with aches and pains) outcome was unknown. Not Provided
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: A spontaneous report was received from a consumer concerning a 79-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, body aches/ pain and slight fever/ pyrexia. The patient's medical history was not provided. No relevant concomitant medications were reported. On 24 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 038K20A) intramuscularly for prophylaxis of COVID-19 infection. On 31 Jan 2021, the patient experienced chills, body aches and slight fever. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 1 Feb 2021, the outcome of event, slight fever was resolved. The outcome of the events, chills and body aches was not reported.; Reporter's Comments: 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis, Eye pruritus, Ocular discomfort, Ocular hyperaemia
Clinical narrative: some problems with her eyes; Eyes were  itchy; Eyes were red; pink eye; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (some problems with her eyes), EYE PRURITUS (Eyes were  itchy), OCULAR HYPERAEMIA (Eyes were red) and CONJUNCTIVITIS (pink eye) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced OCULAR DISCOMFORT (some problems with her eyes), EYE PRURITUS (Eyes were  itchy), OCULAR HYPERAEMIA (Eyes were red) and CONJUNCTIVITIS (pink eye). At the time of the report, OCULAR DISCOMFORT (some problems with her eyes), EYE PRURITUS (Eyes were  itchy), OCULAR HYPERAEMIA (Eyes were red) and CONJUNCTIVITIS (pink eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: chills; fever; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache). At the time of the report, CHILLS (chills), PYREXIA (fever) and MYALGIA (muscle ache) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: light swelling; redness; bruise; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE SWELLING (light swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (bruise) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    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 INJECTION SITE SWELLING (light swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (bruise). On 16-Jan-2021, INJECTION SITE SWELLING (light swelling), INJECTION SITE ERYTHEMA (redness) and INJECTION SITE PAIN (bruise) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pyrexia
Clinical narrative: Couldn't get out of bed; fever; Tremendous headache; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Couldn't get out of bed), PYREXIA (fever), HEADACHE (Tremendous headache) and CHILLS (CHILLS) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (approximately 8 days later started getting better.) on 17-Dec-2020. Concomitant products included SIMVASTATIN 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 ASTHENIA (Couldn't get out of bed), PYREXIA (fever), HEADACHE (Tremendous headache) and CHILLS (CHILLS). On 30-Jan-2021, ASTHENIA (Couldn't get out of bed), PYREXIA (fever), HEADACHE (Tremendous headache) and CHILLS (CHILLS) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Insomnia
Clinical narrative: Couldn't sleep; Chills/Shivering; Knees were aching; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), CHILLS (Chills/Shivering), ARTHRALGIA (Knees were aching) and HEADACHE (Headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INSOMNIA (Couldn't sleep), CHILLS (Chills/Shivering), ARTHRALGIA (Knees were aching) and HEADACHE (Headache). At the time of the report, INSOMNIA (Couldn't sleep), CHILLS (Chills/Shivering), ARTHRALGIA (Knees were aching) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue, Malaise, Nasal congestion
Clinical narrative: Loss of sense of taste; Loss of sense of smell; Stuffy nose; Congestion; Dry nose; Fatigue; General malaise; Feeling sleepy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Loss of sense of taste), ANOSMIA (Loss of sense of smell), MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and NASAL OEDEMA (Stuffy nose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced NASAL OEDEMA (Stuffy nose), NASAL CONGESTION (Congestion) and NASAL DRYNESS (Dry nose). On 01-Feb-2021, the patient experienced AGEUSIA (Loss of sense of taste) and ANOSMIA (Loss of sense of smell). On 14-Jan-2021, MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and FATIGUE (Fatigue) had resolved. At the time of the report, AGEUSIA (Loss of sense of taste), ANOSMIA (Loss of sense of smell), NASAL OEDEMA (Stuffy nose), NASAL CONGESTION (Congestion) and NASAL DRYNESS (Dry nose) 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.   No concomitant medications was reported. No treatment details were provided.  Company comment Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; 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 excluded.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal dryness, Nasal oedema, Somnolence
Clinical narrative: Loss of sense of taste; Loss of sense of smell; Stuffy nose; Congestion; Dry nose; Fatigue; General malaise; Feeling sleepy; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of AGEUSIA (Loss of sense of taste), ANOSMIA (Loss of sense of smell), MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and NASAL OEDEMA (Stuffy nose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and FATIGUE (Fatigue). On 31-Jan-2021, the patient experienced NASAL OEDEMA (Stuffy nose), NASAL CONGESTION (Congestion) and NASAL DRYNESS (Dry nose). On 01-Feb-2021, the patient experienced AGEUSIA (Loss of sense of taste) and ANOSMIA (Loss of sense of smell). On 14-Jan-2021, MALAISE (General malaise), SOMNOLENCE (Feeling sleepy) and FATIGUE (Fatigue) had resolved. At the time of the report, AGEUSIA (Loss of sense of taste), ANOSMIA (Loss of sense of smell), NASAL OEDEMA (Stuffy nose), NASAL CONGESTION (Congestion) and NASAL DRYNESS (Dry nose) 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.   No concomitant medications was reported. No treatment details were provided.  Company comment Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; 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 excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site erythema, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: Hot and hurt to touch at the injection site; Tingling feeling at the injection site; Itching at the injection site; Injection site sore; Redness; Swelling at the injection site; Headaches; Tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot and hurt to touch at the injection site), VACCINATION SITE PARAESTHESIA (Tingling feeling at the injection site), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-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) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot and hurt to touch at the injection site), VACCINATION SITE PARAESTHESIA (Tingling feeling at the injection site), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site) and HEADACHE (Headaches). In February 2021, the patient experienced FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE WARMTH (Hot and hurt to touch at the injection site), VACCINATION SITE PARAESTHESIA (Tingling feeling at the injection site), VACCINATION SITE PAIN (Injection site sore), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site), FATIGUE (Tired) and HEADACHE (Headaches) outcome was unknown.            Concomitant medication was not reported. The patient took some Tylenol for the pain.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.