chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Bedridden, Dizziness, Fatigue
Clinical narrative: Experienced anxiety; Dizzy; Weak; Not able to get out of bed; Flushed under her arm; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experienced anxiety), DIZZINESS (Dizzy), ASTHENIA (Weak), BEDRIDDEN (Not able to get out of bed) and FLUSHING (Flushed under her arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ANXIETY (Experienced anxiety), DIZZINESS (Dizzy), ASTHENIA (Weak), BEDRIDDEN (Not able to get out of bed), FLUSHING (Flushed under her arm), NAUSEA (Nausea) and FATIGUE (Tired). The patient was treated with IBUPROFEN in March 2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) in March 2021 at an unspecified dose and frequency; SODIUM CITRATE DIHYDRATE (NAUZENE [SODIUM CITRATE DIHYDRATE]) in March 2021 at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) in March 2021 at an unspecified dose and frequency. In March 2021, DIZZINESS (Dizzy), ASTHENIA (Weak) and FATIGUE (Tired) outcome was unknown. At the time of the report, ANXIETY (Experienced anxiety), BEDRIDDEN (Not able to get out of bed), FLUSHING (Flushed under her arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Nausea
Clinical narrative: Experienced anxiety; Dizzy; Weak; Not able to get out of bed; Flushed under her arm; Nausea; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Experienced anxiety), DIZZINESS (Dizzy), ASTHENIA (Weak), BEDRIDDEN (Not able to get out of bed) and FLUSHING (Flushed under her arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ANXIETY (Experienced anxiety), DIZZINESS (Dizzy), ASTHENIA (Weak), BEDRIDDEN (Not able to get out of bed), FLUSHING (Flushed under her arm), NAUSEA (Nausea) and FATIGUE (Tired). The patient was treated with IBUPROFEN in March 2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) in March 2021 at an unspecified dose and frequency; SODIUM CITRATE DIHYDRATE (NAUZENE [SODIUM CITRATE DIHYDRATE]) in March 2021 at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) in March 2021 at an unspecified dose and frequency. In March 2021, DIZZINESS (Dizzy), ASTHENIA (Weak) and FATIGUE (Tired) outcome was unknown. At the time of the report, ANXIETY (Experienced anxiety), BEDRIDDEN (Not able to get out of bed), FLUSHING (Flushed under her arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Lymph node pain
Clinical narrative: Pain in the lymph node on the same side as her injection site; Pain in the breast on the same side as her injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain in the breast on the same side as her injection site) and LYMPH NODE PAIN (Pain in the lymph node on the same side as her injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. n/A) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease (Graves with thyroid Noduales) since 1999 and Varicose veins since 2019. Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]), VITAMINS NOS (MULTI-VIT), FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 04-Feb-2021 at 3:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced BREAST PAIN (Pain in the breast on the same side as her injection site). On 05-Mar-2021, the patient experienced LYMPH NODE PAIN (Pain in the lymph node on the same side as her injection site). On 13-Feb-2021, BREAST PAIN (Pain in the breast on the same side as her injection site) had resolved. On 10-Apr-2021, LYMPH NODE PAIN (Pain in the lymph node on the same side as her injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-265852 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up received and included updated contact information. On 27-May-2021: Follow-up received and contains no new information. On 23-Jul-2021: Follow-up received and included updated event dates, outcome, vaccination information, medical history and concomitant medications.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Visual impairment
Clinical narrative: Foggyhead; Impairment while driving; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggyhead) and VISUAL IMPAIRMENT (Impairment while driving) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING ABNORMAL (Foggyhead) and VISUAL IMPAIRMENT (Impairment while driving). At the time of the report, FEELING ABNORMAL (Foggyhead) and VISUAL IMPAIRMENT (Impairment while driving) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vomiting
Clinical narrative: Weakness; Vomiting; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Weakness), VOMITING (Vomiting) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products LENVATINIB MESILATE (LENVIMA) for Colon cancer and PEMBROLIZUMAB (KEYTRUDA) for Colon cancer.    Concurrent medical conditions included Colon cancer metastatic (with liver metastases).   On 12-Feb-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 20 mg and PEMBROLIZUMAB (KEYTRUDA) (Intravenous) 200 mg. On 27-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 VOMITING (Vomiting) and HEADACHE (headache). On an unknown date, the patient experienced ASTHENIA (Weakness). At the time of the report, ASTHENIA (Weakness), VOMITING (Vomiting) and HEADACHE (headache) 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.   Patients Treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: NNII
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site induration, Vaccination site pain, Wrong technique in product usage process
Clinical narrative: pink hard bump about 1.25 - 1.5 inch in diameter; Tenderness; got subcutaneous injection and not intramuscular; ran out of syringes, so they started using insulin syringes for which needle is very short; A spontaneous report was received from an other healthcare professional (HCP) concerning a 49-year-old, female patient, who experienced inappropriate route of product administration , tenderness, pink, hard bump about 1.25-1.5 inches in diameter/erythema induratum, and insulin syringes used/wrong technique in product usage process.  The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included Zyrtec, Qvar inhaler, Nasacort inhaler.  On 09 Mar 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 09 Mar 2021 the patient thought that she got the injection  through sub cutaneous route instead of intramuscularly.  The patient had been to clinic . The pharmacist said they ran out of syringes. So they started using insulin syringes for which needle is short for subcutaneous  injection use. She experienced tenderness on 9 Mar 2021 and on 10 Mar 2021 raised pink hard bump about 1.25  1.5 inch in diameter.   Treatment of these events were not reported.  The outcome of the events, inappropriate route of product administration and wrong technique in product usage were considered recovered/resolved.  The outcome of the events, tenderness, induration erythema were unknown.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273, lot #013A21A  with associated Adverse events. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Chills; Nausea; Achy; Injection site is killing me; Headache; Temperature 99.8 F; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature 99.8 F), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Achy) and VACCINATION SITE PAIN (Injection site is killing me) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Tired). On 10-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature 99.8 F), MYALGIA (Achy), VACCINATION SITE PAIN (Injection site is killing me) and HEADACHE (Headache). On an unknown date, the patient experienced NAUSEA (Nausea) and CHILLS (Chills). On 09-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, BODY TEMPERATURE INCREASED (Temperature 99.8 F), NAUSEA (Nausea), MYALGIA (Achy), VACCINATION SITE PAIN (Injection site is killing me), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature increased: 99.8 (High) 99.8.         Concomitant medication list was not provided by the reporter. Treatment details was not reported by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Chills; Nausea; Achy; Injection site is killing me; Headache; Temperature 99.8 F; Tired; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature 99.8 F), NAUSEA (Nausea), FATIGUE (Tired), MYALGIA (Achy) and VACCINATION SITE PAIN (Injection site is killing me) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Tired). On 10-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature 99.8 F), MYALGIA (Achy), VACCINATION SITE PAIN (Injection site is killing me) and HEADACHE (Headache). On an unknown date, the patient experienced NAUSEA (Nausea) and CHILLS (Chills). On 09-Mar-2021, FATIGUE (Tired) had resolved. At the time of the report, BODY TEMPERATURE INCREASED (Temperature 99.8 F), NAUSEA (Nausea), MYALGIA (Achy), VACCINATION SITE PAIN (Injection site is killing me), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature increased: 99.8 (High) 99.8.         Concomitant medication list was not provided by the reporter. Treatment details was not reported by the reporter.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (site of injection became red, itchy and swollen), VACCINATION SITE SWELLING (site of injection became red, itchy and swollen) and VACCINATION SITE ERYTHEMA (site of injection became red) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.  No Medical History information was reported. On 03-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 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (site of injection became red, itchy and swollen), VACCINATION SITE SWELLING (site of injection became red, itchy and swollen) and VACCINATION SITE ERYTHEMA (site of injection became red). At the time of the report, VACCINATION SITE PRURITUS (site of injection became red, itchy and swollen), VACCINATION SITE SWELLING (site of injection became red, itchy and swollen) and VACCINATION SITE ERYTHEMA (site of injection became red) had not resolved. Patient stated that she was taking edible marijuana prescribed by her doctor for pain this week so she was not sure if that was what is causing the side effects. The  concomitant medications on use were not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up contains possible NNI
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of chills and headache (pounding headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 002A21A) for COVID-19 immunization. Concomitant products included enalapril and Colcrys (colchicine) for an unknown indication. On Mar 3, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 3, 2021, patient experienced chills and headache (pounding headache). The patient treated with Tylenol (paracetamol); 1 dosage form. On Mar 4, 2021, chills resolved. On Mar 5, 2021, headache (pounding headache) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound abdomen
Clinical narrative: pregnant; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 28-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 Alcohol use (a couple of drinks a week). Concomitant products included PROBIOTICS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Aug-2020 and the estimated date of delivery was 04-May-2021. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound abdomen: normal (normal) normal.     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.   On 27 Mar 2020, the patient had first pregnancy with a live, full term birth. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Mar-2021: Upon internal review on 19-Jul-2021, patients, events, analysis tabs and regulatory reports were updated.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID-19 antibody test negative for antibodies; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (COVID-19 antibody test negative for antibodies) 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 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION FAILURE (COVID-19 antibody test negative for antibodies). On 03-Mar-2021, VACCINATION FAILURE (COVID-19 antibody test negative for antibodies) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not reported.  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.; 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.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: her arm swelled up pretty bad; real red and redness keeps spreading further around in arm; Itches; soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING, ERYTHEMA, PRURITUS, and PAIN IN EXTREMITY in an 87-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 05-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING, ERYTHEMA, PRURITUS, and PAIN IN EXTREMITY. At the time of the report, PERIPHERAL SWELLING, ERYTHEMA, PRURITUS, and PAIN IN EXTREMITY outcome was unknown.            Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Pharyngeal swelling
Clinical narrative: Throat swollen; tingling sensation; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swollen), PARAESTHESIA (tingling sensation) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Throat swollen), PARAESTHESIA (tingling sensation) and NAUSEA (nausea). At the time of the report, PHARYNGEAL SWELLING (Throat swollen), PARAESTHESIA (tingling sensation) and NAUSEA (nausea) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: right hand started puffing up and started itching and started to spread; right hand started puffing up and started itching and started to spread; rash is into scalp and in back of head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (right hand started puffing up and started itching and started to spread), PRURITUS (right hand started puffing up and started itching and started to spread) and RASH (rash is into scalp and in back of head) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PERIPHERAL SWELLING (right hand started puffing up and started itching and started to spread), PRURITUS (right hand started puffing up and started itching and started to spread) and RASH (rash is into scalp and in back of head). At the time of the report, PERIPHERAL SWELLING (right hand started puffing up and started itching and started to spread), PRURITUS (right hand started puffing up and started itching and started to spread) and RASH (rash is into scalp and in back of head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient had visited the doctor and was given as treatment Zytec (Cetirizine) and dramamine (Dimenhydrinate) on 09-APR-2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Noticeably more sensitive this morning; this morning painful to the touch; Site where injection was given is extremely itchy; site where injection was given started to swell; Site where injection was given, turned red/ area of redness was twice the size; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Noticeably more sensitive this morning), VACCINATION SITE PRURITUS (Site where injection was given is extremely itchy), VACCINATION SITE SWELLING (site where injection was given started to swell), VACCINATION SITE ERYTHEMA (Site where injection was given, turned red/ area of redness was twice the size) and VACCINATION SITE PAIN (this morning painful to the touch) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Site where injection was given is extremely itchy), VACCINATION SITE SWELLING (site where injection was given started to swell) and VACCINATION SITE ERYTHEMA (Site where injection was given, turned red/ area of redness was twice the size). On 10-Mar-2021, the patient experienced SENSITIVE SKIN (Noticeably more sensitive this morning) and VACCINATION SITE PAIN (this morning painful to the touch). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SENSITIVE SKIN (Noticeably more sensitive this morning), VACCINATION SITE PRURITUS (Site where injection was given is extremely itchy), VACCINATION SITE SWELLING (site where injection was given started to swell), VACCINATION SITE ERYTHEMA (Site where injection was given, turned red/ area of redness was twice the size) and VACCINATION SITE PAIN (this morning painful to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: vaccination site bleeding; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (vaccination site bleeding) and VACCINATION SITE PAIN (vaccination site pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 19-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (vaccination site bleeding). On 23-Jan-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved. On 19-Feb-2021, VACCINATION SITE HAEMORRHAGE (vaccination site bleeding) had resolved.            No treatment information was provided.  No concomitant medication was provided.   This case was linked to MOD-2021-018774 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Mass, Peripheral swelling
Clinical narrative: Swelling lump under skin and both legs; Stomach cramping; Swelling lump under skin and both legs; Severe pain in her joint and knee; Severe pain in her joint and knee; This spontaneous case was reported by an other health care professional and describes the occurrence of MASS (Swelling lump under skin and both legs), ABDOMINAL PAIN UPPER (Stomach cramping), PERIPHERAL SWELLING (Swelling lump under skin and both legs), the first episode of ARTHRALGIA (Severe pain in her joint and knee) and the second episode of ARTHRALGIA (Severe pain in her joint and knee) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and SIMVASTATIN for an unknown indication.   On 25-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) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced MASS (Swelling lump under skin and both legs), ABDOMINAL PAIN UPPER (Stomach cramping), PERIPHERAL SWELLING (Swelling lump under skin and both legs), the first episode of ARTHRALGIA (Severe pain in her joint and knee) and the second episode of ARTHRALGIA (Severe pain in her joint and knee). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, MASS (Swelling lump under skin and both legs), ABDOMINAL PAIN UPPER (Stomach cramping), PERIPHERAL SWELLING (Swelling lump under skin and both legs) and the last episode of ARTHRALGIA (Severe pain in her joint and knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Action taken with mRNA-1273 in response to the drug was not applicable. Treatment information included some topical cream NOS.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Minor body ache; head ache; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minor body ache), HEADACHE (head ache) and PYREXIA (Slight fever) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced PAIN (Minor body ache), HEADACHE (head ache) and PYREXIA (Slight fever). At the time of the report, PAIN (Minor body ache), HEADACHE (head ache) and PYREXIA (Slight fever) had resolved.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Rash, Urticaria, Vaccination site pain
Clinical narrative: painful rash at injection site initially small but enlarged now; Elongated oval hive; Feels feverish; A little lethargic; Injection site was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (A little lethargic), VACCINATION SITE PAIN (Injection site was a little sore), RASH (painful rash at injection site initially small but enlarged now), URTICARIA (Elongated oval hive) and PYREXIA (Feels feverish) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced LETHARGY (A little lethargic) and VACCINATION SITE PAIN (Injection site was a little sore). On 07-Mar-2021, the patient experienced RASH (painful rash at injection site initially small but enlarged now), URTICARIA (Elongated oval hive) and PYREXIA (Feels feverish). On 28-Feb-2021, VACCINATION SITE PAIN (Injection site was a little sore) had resolved. On 01-Mar-2021, LETHARGY (A little lethargic) had resolved. At the time of the report, RASH (painful rash at injection site initially small but enlarged now), URTICARIA (Elongated oval hive) and PYREXIA (Feels feverish) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.
Age: 75.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Pain in jaw, Tachycardia, Vaccination site pain, Vaccination site swelling
Clinical narrative: increased heart rate; pain in jaw; shoulder pain; Vaccination site swelling; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (increased heart rate), PAIN IN JAW (pain in jaw), ARTHRALGIA (shoulder pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (vaccination site pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0421L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NAPROXEN SODIUM (ALEVE) for an unknown indication.    Concurrent medical conditions included Diabetes and Hypertension.   On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and NAPROXEN SODIUM (ALEVE) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (vaccination site pain). On 18-Feb-2021, the patient experienced TACHYCARDIA (increased heart rate), PAIN IN JAW (pain in jaw) and ARTHRALGIA (shoulder pain). On 19-Feb-2021, TACHYCARDIA (increased heart rate), PAIN IN JAW (pain in jaw), ARTHRALGIA (shoulder pain), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE PAIN (vaccination site pain) had resolved.             Action taken with mRNA-1273 in response to the drug was not applicable.Concomitant medications included unspecified Diabetic and High Blood Pressure medications.  On 18-Feb-2021, the patient expressed concern for having a heart attack however the symptoms had resolved the next day.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Eye pain, Myalgia, Nausea, Pain
Clinical narrative: eye pain; pains; chills; nausea; fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started NYSTATIN (STATIN [NYSTATIN]) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle aches). On 07-Mar-2021, EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle aches) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No treatment was reported for the events.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia
Clinical narrative: eye pain; pains; chills; nausea; fever; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea) and PYREXIA (fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.    No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started NYSTATIN (STATIN [NYSTATIN]) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle aches). On 07-Mar-2021, EYE PAIN (eye pain), PAIN (pains), CHILLS (chills), NAUSEA (nausea), PYREXIA (fever) and MYALGIA (muscle aches) had resolved.            Action taken with mRNA-1273 in response to the drug was not applicable. No treatment was reported for the events.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; loss of appetite; body did not feel right; fever 101.5F; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M2UF and DISM20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101.5 (High) 101.5 degrees Fahrenheit.         Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: flu-like symptoms; loss of appetite; body did not feel right; fever 101.5F; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M2UF and DISM20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DECREASED APPETITE (loss of appetite), VACCINATION COMPLICATION (body did not feel right), PYREXIA (fever 101.5F) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101.5 (High) 101.5 degrees Fahrenheit.         Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), RASH (rash on arm), FATIGUE (fatigue) and ARTHRALGIA (feet hurt, ankles hurt, knees and joints hurt) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 016M20A) 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 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), RASH (rash on arm), FATIGUE (fatigue) and ARTHRALGIA (feet hurt, ankles hurt, knees and joints hurt). At the time of the report, ASTHENIA (weakness), RASH (rash on arm), FATIGUE (fatigue) and ARTHRALGIA (feet hurt, ankles hurt, knees and joints hurt) outcome was unknown. Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medications were provided. No treatment was reported for the events.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. 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.      Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received included no new information
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the top of his foot and ankle; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on the top of his foot and ankle) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02821A) for COVID-19 immunisation.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (rash on the top of his foot and ankle). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Rash, at a dose of 1 dosage form. At the time of the report, RASH (rash on the top of his foot and ankle) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Paranasal sinus discomfort
Clinical narrative: sinus pressure; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.   On 09-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) outcome was unknown.            Action taken with response to the drug is not applicable treatment information is not provided by the reporter No concomitant medication information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Insomnia, Myalgia, Pain in extremity
Clinical narrative: Felt as if she was hit by a truck; Fatigued; Muscle aches; Could not sleep all night after the vaccination because of severe pain; Arm started hurting; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep all night after the vaccination because of severe pain), PAIN IN EXTREMITY (Arm started hurting), FEELING ABNORMAL (Felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Muscle aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) and IMMUNOGLOBULIN HUMAN NORMAL (IVIGLOB-EX) for an unknown indication.   On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced INSOMNIA (Could not sleep all night after the vaccination because of severe pain) and PAIN IN EXTREMITY (Arm started hurting). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (Felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Muscle aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Feb-2021, INSOMNIA (Could not sleep all night after the vaccination because of severe pain) had not resolved. At the time of the report, PAIN IN EXTREMITY (Arm started hurting), FEELING ABNORMAL (Felt as if she was hit by a truck), FATIGUE (Fatigued) and MYALGIA (Muscle aches) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes zoster
Clinical narrative: Shingles; Painful blisters on the forehead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Shingles) and BLISTER (Painful blisters on the forehead) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A2A) 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 10-Mar-2021, the patient experienced HERPES ZOSTER (Shingles) and BLISTER (Painful blisters on the forehead). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) and BLISTER (Painful blisters on the forehead) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. The patient's physician diagnosed shingles.