chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diaaherra; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diaaherra) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, COPD and Hypertension.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (severe diaaherra). The patient was treated with LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Diarrhoea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (severe diaaherra) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were asthma medication, chronic obstructive pulmonary disease medication, and blood pressure medication.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient received her first vaccine on January 16th; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th) in a  patient of an unknown age and gender 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 16-Jan-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 PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received her first vaccine on January 16th) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: This report refers to a case of missed dose for mRNA-1273, lot # unknown with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: wound up with  COVID 19; Missed the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (wound up with  COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (wound up with  COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot). At the time of the report, COVID-19 (wound up with  COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID 19 on an Unknown date.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Fatigue, Headache
Clinical narrative: Chest feels like its draining; Shakes that lasted 3-4 hours; Muscle soreness; Tired; Headache; Fever of 103° F; Uncontrollable chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest feels like its draining), TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache), PYREXIA (Fever of 103° F) and CHILLS (Uncontrollable chills). On 15-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest feels like its draining). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, TREMOR (Shakes that lasted 3-4 hours) and CHILLS (Uncontrollable chills) had resolved. At the time of the report, CHEST DISCOMFORT (Chest feels like its draining), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Fever of 103° F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 103° f, (High) 103° F. On 12-Mar-2021, Body temperature: 102° f. (High) 102° F.. On 13-Mar-2021, Body temperature: 101-102° f. (High) 101-102° F.. On 14-Mar-2021, Body temperature: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up was received on 06-MAY-20221. All reported events outcome was updated to recovered/resolved.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor
Clinical narrative: Chest feels like its draining; Shakes that lasted 3-4 hours; Muscle soreness; Tired; Headache; Fever of 103° F; Uncontrollable chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Chest feels like its draining), TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired) and HEADACHE (Headache) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced TREMOR (Shakes that lasted 3-4 hours), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache), PYREXIA (Fever of 103° F) and CHILLS (Uncontrollable chills). On 15-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest feels like its draining). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-Mar-2021, TREMOR (Shakes that lasted 3-4 hours) and CHILLS (Uncontrollable chills) had resolved. At the time of the report, CHEST DISCOMFORT (Chest feels like its draining), MYALGIA (Muscle soreness), FATIGUE (Tired), HEADACHE (Headache) and PYREXIA (Fever of 103° F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 103° f, (High) 103° F. On 12-Mar-2021, Body temperature: 102° f. (High) 102° F.. On 13-Mar-2021, Body temperature: 101-102° f. (High) 101-102° F.. On 14-Mar-2021, Body temperature: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up was received on 06-MAY-20221. All reported events outcome was updated to recovered/resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Vaccination site mass
Clinical narrative: sore arm; (lump in arm) that is very red and raised; (lump in arm) that is very red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS ((lump in arm) that is very red and raised) and ERYTHEMA ((lump in arm) that is very red) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included IRON, VITAMIN D NOS, CURCUMIN (TURMERIC MERIVA), HYDROCODONE, CINNAMON [CINNAMOMUM VERUM], GABAPENTIN and ACETIC ACID (SUMMERS EVE VINEGAR - WATER) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS ((lump in arm) that is very red and raised) and ERYTHEMA ((lump in arm) that is very red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS ((lump in arm) that is very red and raised) and ERYTHEMA ((lump in arm) that is very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue discomfort, Vaccination site pain
Clinical narrative: tongue feel like it was burnt with coffee; soreness in arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (tongue feel like it was burnt with coffee) and VACCINATION SITE PAIN (soreness in arm of injection site) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness in arm of injection site). On 12-Mar-2021, the patient experienced TONGUE DISCOMFORT (tongue feel like it was burnt with coffee). On 12-Mar-2021, VACCINATION SITE PAIN (soreness in arm of injection site) had resolved. On 18-Mar-2021, TONGUE DISCOMFORT (tongue feel like it was burnt with coffee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 06-May-2021. Outcome of event updated.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, MYALGIA in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS, MYALGIA and LYMPHADENOPATHY. At the time of the report, CHILLS, MYALGIA and LYMPHADENOPATHY outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment of the events included an unspecified anti-inflammatory.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Myalgia, Peripheral swelling, Tenderness
Clinical narrative: unrelenting and cannot focus; arm is still tender; arm feels a little swollen; aches, pains (Muscle pain specifically); fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping; This spontaneous case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (unrelenting and cannot focus), TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen), MYALGIA (aches, pains (Muscle pain specifically)) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Insect sting allergy.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (unrelenting and cannot focus), TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen), MYALGIA (aches, pains (Muscle pain specifically)) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping). At the time of the report, DISTURBANCE IN ATTENTION (unrelenting and cannot focus) and MYALGIA (aches, pains (Muscle pain specifically)) outcome was unknown and TENDERNESS (arm is still tender), PERIPHERAL SWELLING (arm feels a little swollen) and FATIGUE (fatigue; continues to feel extremely fatigued, exhausted and she cannot stop napping) had not resolved.            No relevant concomitant medications were reported.  Treatment details included aspirin and diphenhydramine.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye irritation, Fatigue, Feeling abnormal, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills). At the time of the report, EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza like illness, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills). At the time of the report, EYE IRRITATION (Eyes burning), FEELING ABNORMAL (Felt like she had been run over by a Mack truck), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Headache), VACCINATION SITE PAIN (Sore arm), FATIGUE (Very exhausted) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles; red, itchy, and sore circle which was about 6 inches around the injection site.; red, itchy, and sore circle which was about 6 inches around the injection site.; red, itchy, and sore circle which was about 6 inches around the injection site.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles), VACCINATION SITE PRURITUS (red, itchy, and sore circle which was about 6 inches around the injection site.), VACCINATION SITE ERYTHEMA (red, itchy, and sore circle which was about 6 inches around the injection site.) and VACCINATION SITE PAIN (red, itchy, and sore circle which was about 6 inches around the injection site.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (red, itchy, and sore circle which was about 6 inches around the injection site.), VACCINATION SITE ERYTHEMA (red, itchy, and sore circle which was about 6 inches around the injection site.) and VACCINATION SITE PAIN (red, itchy, and sore circle which was about 6 inches around the injection site.). On 10-Mar-2021, the patient experienced HERPES ZOSTER (very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. On 24-Feb-2021, VACCINATION SITE PRURITUS (red, itchy, and sore circle which was about 6 inches around the injection site.) had resolved. On 27-Feb-2021, VACCINATION SITE ERYTHEMA (red, itchy, and sore circle which was about 6 inches around the injection site.) and VACCINATION SITE PAIN (red, itchy, and sore circle which was about 6 inches around the injection site.) had resolved. At the time of the report, HERPES ZOSTER (very sore along her upper left torso, soreness was in the front and back; started to develop a red rash and blisters, blisters are scabbed over good, diagnosed with shingles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: itchiness; soreness on her arm; hives on her leg and back like mosquito bites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites). On 13-Mar-2021, PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment for the events included oral diphenhydramine, hydrocortisone cream, and calamine cream.  Her physician stated that she should not take the 2nd vaccine dose.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Little bumps in cheek area, on the back, thigh area, across the shoulder; Rash that she developed 4 to 5 days after getting 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Little bumps in cheek area, on the back, thigh area, across the shoulder) and RASH (Rash that she developed 4 to 5 days after getting 2nd dose of vaccine) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seizure.   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. In March 2021, the patient experienced SWELLING (Little bumps in cheek area, on the back, thigh area, across the shoulder) and RASH (Rash that she developed 4 to 5 days after getting 2nd dose of vaccine). At the time of the report, SWELLING (Little bumps in cheek area, on the back, thigh area, across the shoulder) and RASH (Rash that she developed 4 to 5 days after getting 2nd dose of vaccine) had not resolved.            Concomitant medication include seizure medication.  Treatment information was not provided.   This case was linked to MOD-2021-213779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow-up received and does not contain any new information.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: weak; tired; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weak) and FATIGUE (tired) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak) and FATIGUE (tired). At the time of the report, ASTHENIA (weak) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Sore arm; Warm to touch at the injection site; Hardness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis, Sjogren's syndrome, Anxiety and Neuropathy.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE INDURATION (Hardness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported taking concomitant medications to treat osteoporosis, Sjogren Syndrome, anxiety, and neuropathy (unspecified).  Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Dizziness; headache; Body Pain/body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (Body Pain/body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (Body Pain/body aches). At the time of the report, DIZZINESS (Dizziness), HEADACHE (headache) and MYALGIA (Body Pain/body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Due to scheduling issues, he missed the second dose; A spontaneous report was received from a consumer concerning a 58-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and due to scheduling issues, he missed the second dose/ product dose omission issue.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 27-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 007M20A) for prophylaxis of COVID-19 infection.   On an unspecified date, due to scheduling issues, the patient missed the second dose. The patient was more than 42 days post first dose and was not able to get the second dose.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, due to scheduling issues, he missed the second dose was considered resolved.; Sender's Comments: This report refers to a case of Missed Dose for mRNA-1273, lot #unknown with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: Messed up sinuses; Muscle ache; Chills; Fever; Flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 13-Mar-2021, the patient experienced SINUSITIS (Messed up sinuses), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ). At the time of the report, SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101.2 (High) fever of 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant  medications were not listed. The treatment information was not provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Messed up sinuses; Muscle ache; Chills; Fever; Flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 13-Mar-2021, the patient experienced SINUSITIS (Messed up sinuses), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ). At the time of the report, SINUSITIS (Messed up sinuses), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever ) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Body temperature: 101.2 (High) fever of 101.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant  medications were not listed. The treatment information was not provided.   Reporter did not allow further contact
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Peripheral swelling
Clinical narrative: left calve and foot swelled up; lower back pain between kidneys; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys). On 08-Mar-2021, PERIPHERAL SWELLING (left calve and foot swelled up) and BACK PAIN (lower back pain between kidneys) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Nasal disorder
Clinical narrative: Couldn't smell the Vapor Rub; I am very nasally and it's all up in my head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASAL DISORDER (I am very nasally and it's all up in my head) and ANOSMIA (Couldn't smell the Vapor Rub) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced NASAL DISORDER (I am very nasally and it's all up in my head). On 09-Mar-2021, the patient experienced ANOSMIA (Couldn't smell the Vapor Rub). At the time of the report, NASAL DISORDER (I am very nasally and it's all up in my head) and ANOSMIA (Couldn't smell the Vapor Rub) outcome was unknown.            Treatment medications included Z-pack and Vapor Rub
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pyrexia
Clinical narrative: Flu-like symptoms; Bad headache; fever; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 30-Dec-2020, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), HEADACHE (Bad headache), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99-100 f 99-100 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-024861 (Patient Link).
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up in the middle of the night and felt dizzy) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Woke up in the middle of the night and felt dizzy). On 14-Mar-2021, DIZZINESS (Woke up in the middle of the night and felt dizzy) had resolved.            Concomitant medications included unspecified high blood pressure medication.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not Applicable.    This case was linked to MOD-2021-058186 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: A redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A redness around the injection site) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (A redness around the injection site). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (A redness around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of their mother who received the vaccine 2 weeks ago and developed a redness around the injection site. Reportedly, on 15-Mar-2021, it became larger.  No Concomitant product use was reported.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Inappropriate schedule of product administration, Muscle spasms, Myalgia
Clinical narrative: Past the 42 days and has not received second dose; Back pain; Muscle spasms in back; Back knots; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, back pain, muscle spasms in back, back knots and past the 42 days had not received second dose.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 18 Jan 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 18 Jan 2021, on the day of vaccination, the patient developed back pain and muscle spasm in back and back knots for three weeks.   In addition, the patient had not received his second dose yet and was past the 42 days for receiving it.  No Laboratory investigations were provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcomes of the events, back pain, muscle spasms in back and back knots, were resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (back pain, muscle spasms in back, and back knots), a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Palpitations, Vaccination complication
Clinical narrative: palpitations; same side effects as it did; COVID; felt like if it was a chicken was being killed; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed). At the time of the report, PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed) outcome was unknown.            Concomitant medications included unspecified blood pressure pills. No treatment information was provided.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (received a dose of the Moderna COVID19 vaccine from a vial that went through a temperature excursion) 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 .  No treatment medications provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Flushing, Hypertension, Tachycardia
Clinical narrative: increased heart rate; Elevated blood pressure up to 177/110; Facial flushing; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (increased heart rate), HYPERTENSION (Elevated blood pressure up to 177/110) and FLUSHING (Facial flushing) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062H20D) for COVID-19 vaccination.     Concomitant products included MELATONIN, OXITRIPTAN (5 HTP [OXITRIPTAN]), VITAMINS NOS and LORATADINE (CLARITIN [LORATADINE]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced TACHYCARDIA (increased heart rate), HYPERTENSION (Elevated blood pressure up to 177/110) and FLUSHING (Facial flushing). On 18-Feb-2021, TACHYCARDIA (increased heart rate) and FLUSHING (Facial flushing) had resolved. On 25-Feb-2021, HYPERTENSION (Elevated blood pressure up to 177/110) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Blood pressure measurement: 177/110 (High) 177/110.     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.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Hyperaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: shingles; Sore arm/painful; red dowm to her elbow; hot to touch; swollen; itchy; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch) and PERIPHERAL SWELLING (swollen) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch), PERIPHERAL SWELLING (swollen) and PRURITUS (itchy). At the time of the report, HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch), PERIPHERAL SWELLING (swollen) and PRURITUS (itchy) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported  The patient had been applying cold ice pack to help with the swelling but the itchiness is still bothersome.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated reporter's address and added one additional event (shingles). On 11-May-2021: Reporter email address was added, patient demographics was added and first dose details  of suspect product was updated.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: shingles; Sore arm/painful; red dowm to her elbow; hot to touch; swollen; itchy; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch) and PERIPHERAL SWELLING (swollen) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch), PERIPHERAL SWELLING (swollen) and PRURITUS (itchy). At the time of the report, HERPES ZOSTER (shingles), PAIN IN EXTREMITY (Sore arm/painful), ERYTHEMA (red dowm to her elbow), HYPERAESTHESIA (hot to touch), PERIPHERAL SWELLING (swollen) and PRURITUS (itchy) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported  The patient had been applying cold ice pack to help with the swelling but the itchiness is still bothersome.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Updated reporter's address and added one additional event (shingles). On 11-May-2021: Reporter email address was added, patient demographics was added and first dose details  of suspect product was updated.