chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Headache, Myalgia
Clinical narrative: really cold last night; arm is really sore; fever 101; chills; headache; nausea; pain at the injection site; just feeling a little tired; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of FEELING COLD (really cold last night), MYALGIA (arm is really sore), PYREXIA (fever 101), CHILLS (chills) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included ESCITALOPRAM, ARIPIPRAZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Mar-2021, the patient experienced FEELING COLD (really cold last night), MYALGIA (arm is really sore), PYREXIA (fever 101), CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (just feeling a little tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. On 05-Mar-2021, FEELING COLD (really cold last night), PYREXIA (fever 101), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, MYALGIA (arm is really sore), HEADACHE (headache) and FATIGUE (just feeling a little tired) outcome was unknown.            Other concomitant medications include antidepressants.   This case was linked to MOD21-046823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non-significant follow-up appended On 05-Aug-2021: Non significant Follow up
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: really cold last night; arm is really sore; fever 101; chills; headache; nausea; pain at the injection site; just feeling a little tired; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of FEELING COLD (really cold last night), MYALGIA (arm is really sore), PYREXIA (fever 101), CHILLS (chills) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided by the reporter.  Concomitant products included ESCITALOPRAM, ARIPIPRAZOLE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Mar-2021, the patient experienced FEELING COLD (really cold last night), MYALGIA (arm is really sore), PYREXIA (fever 101), CHILLS (chills), HEADACHE (headache), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (just feeling a little tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. On 05-Mar-2021, FEELING COLD (really cold last night), PYREXIA (fever 101), CHILLS (chills), NAUSEA (nausea) and VACCINATION SITE PAIN (pain at the injection site) had resolved. At the time of the report, MYALGIA (arm is really sore), HEADACHE (headache) and FATIGUE (just feeling a little tired) outcome was unknown.            Other concomitant medications include antidepressants.   This case was linked to MOD21-046823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Non-significant follow-up appended On 05-Aug-2021: Non significant Follow up
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Influenza like illness, Myalgia, Restlessness
Clinical narrative: Flu like symptoms; restless; muscle pain; Shoulder pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), RESTLESSNESS (restless), MYALGIA (muscle pain) and ARTHRALGIA (Shoulder pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    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 INFLUENZA LIKE ILLNESS (Flu like symptoms), RESTLESSNESS (restless), MYALGIA (muscle pain) and ARTHRALGIA (Shoulder pain). On 12-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), RESTLESSNESS (restless), MYALGIA (muscle pain) and ARTHRALGIA (Shoulder pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.   This case was linked to MOD21-046742, MOD-2021-035765 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Diarrhoea, Erythema, Headache
Clinical narrative: Shoulder hurting; Diarrhea; Arm very sore; Big red patch; Itchy; Neck hurting; Fever; Severe body aches; Bad headache; Nauseous; Armpit hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy) and NECK PAIN (Neck hurting) in a 40-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 29-Jan-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 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy), NECK PAIN (Neck hurting), PYREXIA (Fever), MYALGIA (Severe body aches), HEADACHE (Bad headache), NAUSEA (Nauseous) and AXILLARY PAIN (Armpit hurting). On an unknown date, the patient experienced ARTHRALGIA (Shoulder hurting). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy), NECK PAIN (Neck hurting), PYREXIA (Fever), MYALGIA (Severe body aches), HEADACHE (Bad headache), NAUSEA (Nauseous), AXILLARY PAIN (Armpit hurting) and ARTHRALGIA (Shoulder hurting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-036553
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Shoulder hurting; Diarrhea; Arm very sore; Big red patch; Itchy; Neck hurting; Fever; Severe body aches; Bad headache; Nauseous; Armpit hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy) and NECK PAIN (Neck hurting) in a 40-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 29-Jan-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 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy), NECK PAIN (Neck hurting), PYREXIA (Fever), MYALGIA (Severe body aches), HEADACHE (Bad headache), NAUSEA (Nauseous) and AXILLARY PAIN (Armpit hurting). On an unknown date, the patient experienced ARTHRALGIA (Shoulder hurting). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy), NECK PAIN (Neck hurting), PYREXIA (Fever), MYALGIA (Severe body aches), HEADACHE (Bad headache), NAUSEA (Nauseous), AXILLARY PAIN (Armpit hurting) and ARTHRALGIA (Shoulder hurting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-036553
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Shoulder hurting; Diarrhea; Arm very sore; Big red patch; Itchy; Neck hurting; Fever; Severe body aches; Bad headache; Nauseous; Armpit hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy) and NECK PAIN (Neck hurting) in a 40-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 29-Jan-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 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy), NECK PAIN (Neck hurting), PYREXIA (Fever), MYALGIA (Severe body aches), HEADACHE (Bad headache), NAUSEA (Nauseous) and AXILLARY PAIN (Armpit hurting). On an unknown date, the patient experienced ARTHRALGIA (Shoulder hurting). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (Arm very sore), ERYTHEMA (Big red patch), PRURITUS (Itchy), NECK PAIN (Neck hurting), PYREXIA (Fever), MYALGIA (Severe body aches), HEADACHE (Bad headache), NAUSEA (Nauseous), AXILLARY PAIN (Armpit hurting) and ARTHRALGIA (Shoulder hurting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 was not applicable.   This case was linked to MOD-2021-036553
Sex: F
Vaccine: COVID19
Symptoms: Glossodynia, Mastication disorder
Clinical narrative: Sore tongue; difficulty chewing; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (Sore tongue) and MASTICATION DISORDER (difficulty chewing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-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 06-Mar-2021, the patient experienced GLOSSODYNIA (Sore tongue) and MASTICATION DISORDER (difficulty chewing). At the time of the report, GLOSSODYNIA (Sore tongue) and MASTICATION DISORDER (difficulty chewing) outcome was unknown.            No concomitant medications were provided  Treatment details included Tylenol.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) 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 relevant concomitant medications was reported. No treatment information was provided
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Injection site pain, Seborrhoea
Clinical narrative: Oily face skin; Acne; Mild pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of SEBORRHOEA (Oily face skin), ACNE (Acne) and INJECTION SITE PAIN (Mild pain at the site of injection) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic neuropathy. Concomitant products included VITAMIN D NOS for Supplementation therapy, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PARACETAMOL (TYLENOL) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced SEBORRHOEA (Oily face skin), ACNE (Acne) and INJECTION SITE PAIN (Mild pain at the site of injection). At the time of the report, SEBORRHOEA (Oily face skin), ACNE (Acne) and INJECTION SITE PAIN (Mild pain at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Swelling face
Clinical narrative: SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced SWELLING FACE (SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW). At the time of the report, SWELLING FACE (SWOLLEN RIGHT SIDE OF FACE/LOWER SIDE NOT CLEARED UP TILL NOW) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hypertension: (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provided
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysgeusia
Clinical narrative: medicine taste in her mouth; intermittent burning feeling on her tongue; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (medicine taste in her mouth) and BURNING SENSATION (intermittent burning feeling on her tongue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Medication after taste (Medication allergy- not specified).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced DYSGEUSIA (medicine taste in her mouth) and BURNING SENSATION (intermittent burning feeling on her tongue). On 26-Feb-2021, DYSGEUSIA (medicine taste in her mouth) had resolved. At the time of the report, BURNING SENSATION (intermittent burning feeling on her tongue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Feeling cold
Clinical narrative: Felt stingy; Feels real cold; Arms, legs, neck, face, and body turned red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt stingy), FEELING COLD (Feels real cold) and ERYTHEMA (Arms, legs, neck, face, and body turned red) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Skin erythema since an unknown date and Stinging since an unknown date. Concomitant products included VITAMINS NOS, MULTIVITAMIN & MINERAL, IRON FERROUS SULFATE from 15-Feb-2019 to an unknown date, FISH OIL from 01-Feb-2020 to an unknown date, NIACIN from 01-Feb-2020 to an unknown date and MONASCUS PURPUREUS (RED YEAST RICE) from 15-Feb-2020 to an unknown date for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL (Felt stingy), FEELING COLD (Feels real cold) and ERYTHEMA (Arms, legs, neck, face, and body turned red). At the time of the report, FEELING ABNORMAL (Felt stingy), FEELING COLD (Feels real cold) and ERYTHEMA (Arms, legs, neck, face, and body turned red) outcome was unknown.            No treatment provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: ADR Form,patient demographics, medical history was updated.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in his arm). At the time of the report, PERIPHERAL SWELLING (Swelling in his arm) had resolved.            Concomitant medications were not provided. The patient began experiencing swelling in his arm two days after the vaccination that has now lasted 3 weeks. He consulted with doctors, but the swelling still persists. No treatment details reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). The patient was treated with steroid for COVID-19, at an unspecified dose and frequency and AZITHROMYCIN for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site is hard; Injection site is itchy; Injection site swollen/Injection site is raised/Injection site is twice the size it was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen/Injection site is raised/Injection site is twice the size it was) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Mar-2021, the patient experienced VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen/Injection site is raised/Injection site is twice the size it was). At the time of the report, VACCINATION SITE INDURATION (Injection site is hard), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site swollen/Injection site is raised/Injection site is twice the size it was) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provided
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Underdose
Clinical narrative: The needle was not on tight enough and more than half the dose seemed to dribble down his arm; The needle was not on tight enough and more than half the dose seemed to dribble down his arm; Dribble down his left arm.; A spontaneous report was received from a pharmacist concerning a 73-years-old male patient, who while receiving Moderna's covid-19 vaccine (mRNA -1273), more than half the dose seemed to dribble down his left arm as the needle was not on tight enough/device connection issue, underdose, exposure via skin contact.  The patient's medical history was not provided. Concomitant medications were not reported.  On 07 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 07 Mar 2021, while vaccinating the patient, the needle was not on tight enough and more than half the dose seemed to dribble down his left arm. The pharmacist plans to administer another dose. Treatment details were not mentioned.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event more than half the dose seemed to dribble down his left arm as the needle was not on tight enough was resolved on 07 Mar 2021.; Reporter's Comments: This report refers to a case of underdose, device connection issue and exposure via skin contact for mRNA-1273 (lot # 011A21A) with no associated
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: little chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (little chilly) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Headache recurrent (Suffers from continuous headaches) and Arthritis. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ACETAMINOPHEN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (little chilly). At the time of the report, CHILLS (little chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she takes 500 mg aspirin and acetaminophen concomitantly for her continuous headaches and Arthritis, but now is taking 250 mg acetaminophen and 250 mg aspirin instead.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: raised welt at injection site; injection site tender; red raised welt at injection site; headache; nausea; run down; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache) and NAUSEA (nausea) in a 38-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.     Concurrent medical conditions included Allergic reaction to antibiotics (amoxicillin), Drug allergy (vioxx), Adhesive tape allergy (adhesive) and Drug allergy (celexa).    On 26-Jan-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (run down). At the time of the report, INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (run down) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-036553 (Patient Link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: raised welt at injection site; injection site tender; red raised welt at injection site; headache; nausea; run down; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache) and NAUSEA (nausea) in a 38-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.     Concurrent medical conditions included Allergic reaction to antibiotics (amoxicillin), Drug allergy (vioxx), Adhesive tape allergy (adhesive) and Drug allergy (celexa).    On 26-Jan-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (run down). At the time of the report, INJECTION SITE URTICARIA (raised welt at injection site), INJECTION SITE PAIN (injection site tender), INJECTION SITE ERYTHEMA (red raised welt at injection site), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (run down) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-036553 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Drug allergy.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in September 2020 and the estimated date of delivery was 17-Jul-2021. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provided   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dental operation
Clinical narrative: Dental procedure; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL OPERATION (Dental procedure) 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 No adverse event.    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 DENTAL OPERATION (Dental procedure). At the time of the report, DENTAL OPERATION (Dental procedure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Coronavirus test: positive (Positive) Tested positive for COVID-19.     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 or treatment details reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; bodyaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (bodyaches), CHILLS (chills) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included GABAPENTIN and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (bodyaches) and CHILLS (chills). On 05-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPRIN) at an unspecified dose and frequency. At the time of the report, PAIN (bodyaches), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.            concomitant medication provided was blood pressure medication, ZYRTEC.   This case was linked to MOD-2021-037906 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Vaccination site erythema, Vaccination site mass
Clinical narrative: large raised red bump at injection site; flu-like symptoms; tired; sore joints; injection site redness; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (large raised red bump at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (tired), ARTHRALGIA (sore joints) and VACCINATION SITE ERYTHEMA (injection site redness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drug.).    On 29-Jan-2021 at 10:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE MASS (large raised red bump at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (tired), ARTHRALGIA (sore joints) and VACCINATION SITE ERYTHEMA (injection site redness). The patient was treated with IBUPROFEN for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (large raised red bump at injection site), INFLUENZA LIKE ILLNESS (flu-like symptoms), FATIGUE (tired), ARTHRALGIA (sore joints) and VACCINATION SITE ERYTHEMA (injection site redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications used were not provided.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Headache, Musculoskeletal chest pain, Vaccination site pain
Clinical narrative: My husband fell down outside on out porch; My husbands right side of the body where is ribs are hurt; Patient arm is tinder in the right arm; My husband complained about a slight headache; A spontaneous report was received from a consumer concerning for Husband, a 90-Year-old male patient who received both doses of Moderna's COVID-19 vaccine (mRNA-1273) and fell down on his right side of the body and had his ribs/chest pain and headache along with vaccination site pain.  The patient's medical history included disability and hypoacusis. Concomitant product use was not provided by the reporter.  On 01Feb2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via Intramuscular route on Right Arm for prophylaxis of COVID-19 infection. On 28Feb2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 003A21A) via Intramuscular route on Right Arm for prophylaxis of COVID-19 infection.  On the same day of the second dose, patient fell down on his right side of the body and had ribs/chest pain and headache, he also had  vaccination site pain. Self treated the chest pain with biofreeze.  Action taken with mRNA-1273 in response to the events was Not applicable.   The outcome of events was Unknown, at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-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 SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 patients treatment information included azithromycin (Z-pack) and Steroid. No concomitants provided
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Paraesthesia, Swelling
Clinical narrative: Inflamed neck; Light headed; Flash and Tingling in upper body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Light headed), PARAESTHESIA (Flash and Tingling in upper body) and SWELLING (Inflamed neck) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Neck stiffness. Concomitant products included ADENOSINE (TRICOR [ADENOSINE]), VITAMIN 15, LOSARTAN and SIMVASTATIN 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 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DIZZINESS (Light headed) and PARAESTHESIA (Flash and Tingling in upper body). On 20-Feb-2021, the patient experienced SWELLING (Inflamed neck). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, DIZZINESS (Light headed), PARAESTHESIA (Flash and Tingling in upper body) and SWELLING (Inflamed neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort, Musculoskeletal discomfort, Pruritus, Rash macular
Clinical narrative: hard to lift her arm; itching on her shoulder; shoulder swelled up; shoulder hard; shoulder red; shoulder blotchy; arm hurt at vaccination site; hives on left forearm, then right forearm; tightness in her throat; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on left forearm, then right forearm), THROAT TIGHTNESS (tightness in her throat), LIMB DISCOMFORT (hard to lift her arm), PRURITUS (itching on her shoulder) and SWELLING (shoulder swelled up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced URTICARIA (hives on left forearm, then right forearm), THROAT TIGHTNESS (tightness in her throat) and VACCINATION SITE PAIN (arm hurt at vaccination site). On 07-Mar-2021, the patient experienced LIMB DISCOMFORT (hard to lift her arm), PRURITUS (itching on her shoulder), SWELLING (shoulder swelled up), MUSCULOSKELETAL DISCOMFORT (shoulder hard), ERYTHEMA (shoulder red) and RASH MACULAR (shoulder blotchy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 28-Feb-2021, URTICARIA (hives on left forearm, then right forearm) and THROAT TIGHTNESS (tightness in her throat) had resolved. On 02-Mar-2021, LIMB DISCOMFORT (hard to lift her arm) and VACCINATION SITE PAIN (arm hurt at vaccination site) had resolved. At the time of the report, PRURITUS (itching on her shoulder), SWELLING (shoulder swelled up), MUSCULOSKELETAL DISCOMFORT (shoulder hard), ERYTHEMA (shoulder red) and RASH MACULAR (shoulder blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant provided   This case was linked to MOD21-047293 (E2B Linked Report).; Sender's Comments:  MOD21-047293:Crosslink
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Throat tightness, Urticaria, Vaccination site pain
Clinical narrative: hard to lift her arm; itching on her shoulder; shoulder swelled up; shoulder hard; shoulder red; shoulder blotchy; arm hurt at vaccination site; hives on left forearm, then right forearm; tightness in her throat; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on left forearm, then right forearm), THROAT TIGHTNESS (tightness in her throat), LIMB DISCOMFORT (hard to lift her arm), PRURITUS (itching on her shoulder) and SWELLING (shoulder swelled up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced URTICARIA (hives on left forearm, then right forearm), THROAT TIGHTNESS (tightness in her throat) and VACCINATION SITE PAIN (arm hurt at vaccination site). On 07-Mar-2021, the patient experienced LIMB DISCOMFORT (hard to lift her arm), PRURITUS (itching on her shoulder), SWELLING (shoulder swelled up), MUSCULOSKELETAL DISCOMFORT (shoulder hard), ERYTHEMA (shoulder red) and RASH MACULAR (shoulder blotchy). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. On 28-Feb-2021, URTICARIA (hives on left forearm, then right forearm) and THROAT TIGHTNESS (tightness in her throat) had resolved. On 02-Mar-2021, LIMB DISCOMFORT (hard to lift her arm) and VACCINATION SITE PAIN (arm hurt at vaccination site) had resolved. At the time of the report, PRURITUS (itching on her shoulder), SWELLING (shoulder swelled up), MUSCULOSKELETAL DISCOMFORT (shoulder hard), ERYTHEMA (shoulder red) and RASH MACULAR (shoulder blotchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant provided   This case was linked to MOD21-047293 (E2B Linked Report).; Sender's Comments:  MOD21-047293:Crosslink
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pyrexia, Swelling
Clinical narrative: swell up; redness; sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swell up), ERYTHEMA (redness), MYALGIA (sore arm) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swell up), ERYTHEMA (redness), MYALGIA (sore arm) and PYREXIA (fever). At the time of the report, SWELLING (swell up), ERYTHEMA (redness), MYALGIA (sore arm) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no relevant concomitant medications was reported. No treatment information was provide
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain-started Naproxen; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain-started Naproxen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included NAPROXEN SODIUM for Back pain.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced BACK PAIN (Back pain-started Naproxen). On 05-Mar-2021, BACK PAIN (Back pain-started Naproxen) had resolved.            Treatment details included None.    Reporter did not allow further contact
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Two weeks after the 1st dose, he got shingles; Rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Two weeks after the 1st dose, he got shingles) and RASH (Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Shingles (Shingles 55 years ago when he was 17).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HERPES ZOSTER (Two weeks after the 1st dose, he got shingles) and RASH (Rash). At the time of the report, HERPES ZOSTER (Two weeks after the 1st dose, he got shingles) and RASH (Rash) had resolved.            Two weeks after receiving first dose of vaccine, this patient experienced a mild rash on his back below the waistline and it became larger. The patient went to an urgent facility and the doctor there diagnosed it as shingles.  Treatment included Aspercreme with lidocaine and Gabapentin.   This case was linked to MOD-2021-081965 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up information updated medical history, event start date changed and outcome updated.; Sender'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.