chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue, Feeling hot, Oxygen saturation decreased, Pain
Clinical narrative: Pulse Ox was bet 87-90% then dipped to 85%; Felt soreness and fatigue; Felt soreness and fatigue; Low grade fever of 102; Warm and clammy; Warm and clammy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy), PAIN (Felt soreness and fatigue), OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%) and PYREXIA (Low grade fever of 102) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis, ALLOPURINOL, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, COLECALCIFEROL (CALCIUM PLUS VITAMIN D), ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, MAGNESIUM OXIDE, MELATONIN, METOPROLOL TARTRATE, MULTIVITAMIN [VITAMINS NOS], TRIAMCINOLONE ACETONIDE (NASACORT), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), CLOPIDOGREL BISULFATE (PLAVIX), VITAMIN D NOS and DOXAZOSIN MESILATE (CARDURA) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy) and PYREXIA (Low grade fever of 102). On 30-Jan-2021, the patient experienced PAIN (Felt soreness and fatigue) and FATIGUE (Felt soreness and fatigue). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy), PAIN (Felt soreness and fatigue), OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%), PYREXIA (Low grade fever of 102) and FATIGUE (Felt soreness and fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) and was hospitalized.     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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Pulse Ox was bet 87-90% then dipped to 85%; Felt soreness and fatigue; Felt soreness and fatigue; Low grade fever of 102; Warm and clammy; Warm and clammy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy), PAIN (Felt soreness and fatigue), OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%) and PYREXIA (Low grade fever of 102) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis, ALLOPURINOL, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, COLECALCIFEROL (CALCIUM PLUS VITAMIN D), ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, MAGNESIUM OXIDE, MELATONIN, METOPROLOL TARTRATE, MULTIVITAMIN [VITAMINS NOS], TRIAMCINOLONE ACETONIDE (NASACORT), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), CLOPIDOGREL BISULFATE (PLAVIX), VITAMIN D NOS and DOXAZOSIN MESILATE (CARDURA) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy) and PYREXIA (Low grade fever of 102). On 30-Jan-2021, the patient experienced PAIN (Felt soreness and fatigue) and FATIGUE (Felt soreness and fatigue). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, FEELING HOT (Warm and clammy), COLD SWEAT (Warm and clammy), PAIN (Felt soreness and fatigue), OXYGEN SATURATION DECREASED (Pulse Ox was bet 87-90% then dipped to 85%), PYREXIA (Low grade fever of 102) and FATIGUE (Felt soreness and fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) and was hospitalized.     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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Felt like a truck hit me for about 24 hours; temp went up to 101.1F; soreness in left arm; low grade fever; nauseous; vomiting; aches in legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm) and PYREXIA (low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acute myeloid leukemia (5 years remission.) since 15-Sep-2015. Concurrent medical conditions included Allergy (Scents and hayweed.). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), VALSARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID), ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM (XANAX) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (aches in legs), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like a truck hit me for about 24 hours). At the time of the report, PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22 April 2021. Patient demographics , historical condition , concomitant medication, second dose information and new event ( feeling abnormal ) was added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Felt like a truck hit me for about 24 hours; temp went up to 101.1F; soreness in left arm; low grade fever; nauseous; vomiting; aches in legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm) and PYREXIA (low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Acute myeloid leukemia (5 years remission.) since 15-Sep-2015. Concurrent medical conditions included Allergy (Scents and hayweed.). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), VALSARTAN for Blood pressure high, LEVOTHYROXINE SODIUM (SYNTHROID), ZOLPIDEM TARTRATE (AMBIEN), ALPRAZOLAM (XANAX) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 10-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (aches in legs), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting). On an unknown date, the patient experienced FEELING ABNORMAL (Felt like a truck hit me for about 24 hours). At the time of the report, PAIN IN EXTREMITY (aches in legs), FEELING ABNORMAL (Felt like a truck hit me for about 24 hours), PYREXIA (temp went up to 101.1F), MYALGIA (soreness in left arm), PYREXIA (low grade fever), NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included ibuprofen.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up was received on 22 April 2021. Patient demographics , historical condition , concomitant medication, second dose information and new event ( feeling abnormal ) was added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-055137 (Patient Link).; 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: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Fatigue; Headache; Muscle Pain; Joint Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient is under medication). Concomitant products included INSULIN for Diabetes, GABAPENTIN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any medications to treat those side effects.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Memory impairment, Nausea
Clinical narrative: Sweating; Forgetful; Chills; Nausea; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating), MEMORY IMPAIRMENT (Forgetful), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Feb-2021. Concomitant products included VITAMINS NOS for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), MEMORY IMPAIRMENT (Forgetful), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, HYPERHIDROSIS (Sweating), MEMORY IMPAIRMENT (Forgetful), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         On 01 Mar 202,1 the patient consulted Medical doctor and he said these symptoms are normal. On 02 Mar 2021, the symptoms persisted. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-033304 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sweating; Forgetful; Chills; Nausea; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating), MEMORY IMPAIRMENT (Forgetful), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 08-Feb-2021. Concomitant products included VITAMINS NOS for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced HYPERHIDROSIS (Sweating), MEMORY IMPAIRMENT (Forgetful), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, HYPERHIDROSIS (Sweating), MEMORY IMPAIRMENT (Forgetful), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.         On 01 Mar 202,1 the patient consulted Medical doctor and he said these symptoms are normal. On 02 Mar 2021, the symptoms persisted. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-033304 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Limb discomfort, Vaccination site swelling
Clinical narrative: weak; dizzy; swelled bump about half a inch; chills; couldn't raise arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), LIMB DISCOMFORT (couldn't raise arm), DIZZINESS (dizzy), VACCINATION SITE SWELLING (swelled bump about half a inch) and CHILLS (chills) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M2OA) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included Vertigo. Concomitant products included SIMVASTATIN, MULTIVITAMIN & MINERAL and COLECALCIFEROL (D-3) for an unknown indication, ZINC.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced LIMB DISCOMFORT (couldn't raise arm), VACCINATION SITE SWELLING (swelled bump about half a inch) and CHILLS (chills). On 11-Feb-2021, the patient experienced ASTHENIA (weak) and DIZZINESS (dizzy). At the time of the report, ASTHENIA (weak), LIMB DISCOMFORT (couldn't raise arm), DIZZINESS (dizzy), VACCINATION SITE SWELLING (swelled bump about half a inch) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Erythema, Hypertension, Injection site swelling, Pain
Clinical narrative: High blood pressure; Redness; Soreness; Swelling at injection site; Felt like something was pulling at armpit hair; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (High blood pressure), ERYTHEMA (Redness), PAIN (Soreness), INJECTION SITE SWELLING (Swelling at injection site) and AXILLARY PAIN (Felt like something was pulling at armpit hair) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced HYPERTENSION (High blood pressure), ERYTHEMA (Redness), PAIN (Soreness), INJECTION SITE SWELLING (Swelling at injection site) and AXILLARY PAIN (Felt like something was pulling at armpit hair). At the time of the report, HYPERTENSION (High blood pressure), ERYTHEMA (Redness), PAIN (Soreness), INJECTION SITE SWELLING (Swelling at injection site) and AXILLARY PAIN (Felt like something was pulling at armpit hair) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site warmth, Myalgia, Pyrexia, Vaccination site induration
Clinical narrative: hot; hard; injection site is swollen; painful; The rest of the body is bit achy; feels like having a fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful) and MYALGIA (The rest of the body is bit achy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful), MYALGIA (The rest of the body is bit achy) and PYREXIA (feels like having a fever). At the time of the report, INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful), MYALGIA (The rest of the body is bit achy) and PYREXIA (feels like having a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: hot; hard; injection site is swollen; painful; The rest of the body is bit achy; feels like having a fever; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful) and MYALGIA (The rest of the body is bit achy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful), MYALGIA (The rest of the body is bit achy) and PYREXIA (feels like having a fever). At the time of the report, INJECTION SITE WARMTH (hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (injection site is swollen), INJECTION SITE PAIN (painful), MYALGIA (The rest of the body is bit achy) and PYREXIA (feels like having a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site erythema
Clinical narrative: Redness around the injection site; very sore; Also itchy; A spontaneous report was received from a consumer concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness around the injection site, spot of 2inches wide and 6 inches long,, really red, very sore, also itchy.  The patient's medical history was not provided. Concomitant medications reported were clonazepam 0.5 mg, ezetimibe 10mg, paroxetine 20mg, migraine Medication 25mg 6times a day, vitamins for drug use for unknown indication.  On 28 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 4 Feb 2021, the patient experienced the event(s) redness around the injection site, spot of 2inches wide and 6 inches long,, really red, very sore, also itchy.  Treatment details included none  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness around the injection site, spot of 2inches wide and 6 inches long, really red, very sore, also itchy was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the Moderna vaccine two weeks later he received a second shot; A spontaneous report was received from a caregiver concerning a male patient, who received the second dose of the Moderna's COVID-19 vaccine (mRNA-1273) 2 weeks apart.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. Two weeks later (on an unspecified date) the patient received the second dose of Moderna vaccine (Inappropriate schedule of vaccine administered).   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.  The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot number was not provided and with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Muscle ache; headache; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headaches, muscle aches/myalgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) headaches. On 11 Feb 2021, the patient experienced the event(s) muscle aches.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headaches, muscle aches was unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Weak; Pain all over his body; Tired; A spontaneous report was received from a consumer concerning a 82-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain all over his body general body pain, flu like symptoms/influenza like illness, weak/asthenia, tired/fatigue.  The patient's medical history was not provided. Concomitant medications reported were golimumab Infusion, Coumadin tablet, salbutamol/formoterol  Inhaler for drug use for unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) pain all over his body, flu like symptoms, weak, tired.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain all over his body, flu like symptoms, weak, tired was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: extreme vertigo; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VERTIGO (extreme vertigo) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021M20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, RALOXIFENE and LOSARTAN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced VERTIGO (Vertigo). On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (extreme vertigo). The patient was treated with DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) (oral) on 23-Feb-2021 for Sleep loss, at a dose of 1 dosage form. On 19-Feb-2021, VERTIGO (Vertigo) had resolved. On 24-Feb-2021, VERTIGO (extreme vertigo) had resolved.        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 events was  not applicable   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient details updated, Suspect Product Dose number , Drug Start Date ,Con meds updated, event was added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Caffeine allergy, Chills, Dehydration, Dizziness
Clinical narrative: Head felt funny; Light headed; Had no energy, energy was diminished; Experienced a head rush; Felt dehydrated and had to drink a lot of water; Almost blacked out; Felt like her nervous system was affected/Felt shaky; became sensitive to caffeine; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacked out), NERVOUSNESS (Felt like her nervous system was affected/Felt shaky), FEELING ABNORMAL (Head felt funny), DIZZINESS (Light headed) and ASTHENIA (Had no energy, energy was diminished) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures (17years ago) and Brain tumor ((ben) 17years ago). Concurrent medical conditions included Drug allergy (Codiene) and Drug allergy (Keppra).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NERVOUSNESS (Felt like her nervous system was affected/Felt shaky), CAFFEINE ALLERGY (became sensitive to caffeine) and CHILLS (Chills). On 27-Feb-2021, the patient experienced PRESYNCOPE (Almost blacked out), FEELING ABNORMAL (Head felt funny), DIZZINESS (Light headed), ASTHENIA (Had no energy, energy was diminished), VERTIGO (Experienced a head rush) and DEHYDRATION (Felt dehydrated and had to drink a lot of water). On 27-Feb-2021, PRESYNCOPE (Almost blacked out), FEELING ABNORMAL (Head felt funny), DIZZINESS (Light headed), ASTHENIA (Had no energy, energy was diminished), VERTIGO (Experienced a head rush) and DEHYDRATION (Felt dehydrated and had to drink a lot of water) had resolved. On 28-Feb-2021, NERVOUSNESS (Felt like her nervous system was affected/Felt shaky) and CHILLS (Chills) had resolved. At the time of the report, CAFFEINE ALLERGY (became sensitive to caffeine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided  Treatment information was not provided   This case was linked to MOD-2021-257112 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up document received on 14-JUL-2021 contains: Updated Medical history of the patient- Seizures, Light headedness; Updated Second dose details;; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nervousness, Presyncope, Vertigo
Clinical narrative: Head felt funny; Light headed; Had no energy, energy was diminished; Experienced a head rush; Felt dehydrated and had to drink a lot of water; Almost blacked out; Felt like her nervous system was affected/Felt shaky; became sensitive to caffeine; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacked out), NERVOUSNESS (Felt like her nervous system was affected/Felt shaky), FEELING ABNORMAL (Head felt funny), DIZZINESS (Light headed) and ASTHENIA (Had no energy, energy was diminished) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures (17years ago) and Brain tumor ((ben) 17years ago). Concurrent medical conditions included Drug allergy (Codiene) and Drug allergy (Keppra).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced NERVOUSNESS (Felt like her nervous system was affected/Felt shaky), CAFFEINE ALLERGY (became sensitive to caffeine) and CHILLS (Chills). On 27-Feb-2021, the patient experienced PRESYNCOPE (Almost blacked out), FEELING ABNORMAL (Head felt funny), DIZZINESS (Light headed), ASTHENIA (Had no energy, energy was diminished), VERTIGO (Experienced a head rush) and DEHYDRATION (Felt dehydrated and had to drink a lot of water). On 27-Feb-2021, PRESYNCOPE (Almost blacked out), FEELING ABNORMAL (Head felt funny), DIZZINESS (Light headed), ASTHENIA (Had no energy, energy was diminished), VERTIGO (Experienced a head rush) and DEHYDRATION (Felt dehydrated and had to drink a lot of water) had resolved. On 28-Feb-2021, NERVOUSNESS (Felt like her nervous system was affected/Felt shaky) and CHILLS (Chills) had resolved. At the time of the report, CAFFEINE ALLERGY (became sensitive to caffeine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided  Treatment information was not provided   This case was linked to MOD-2021-257112 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up document received on 14-JUL-2021 contains: Updated Medical history of the patient- Seizures, Light headedness; Updated Second dose details;; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: spike in blood sugar over 600; A spontaneous report was received from a consumer concerning a 61-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events spike in blood sugar over 600/blood glucose increased  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) spike in blood sugar over 600.  Treatment information was provided as she took 10 units of insulin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), spike in blood sugar over 600 was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Breast induration, Dizziness, Influenza, Insomnia
Clinical narrative: light heaed; flu symptoms; couldn't sleep; left breast became solid; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light heaed), INFLUENZA (flu symptoms), INSOMNIA (couldn't sleep) and BREAST INDURATION (left breast became solid) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K2074) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (light heaed), INFLUENZA (flu symptoms), INSOMNIA (couldn't sleep) and BREAST INDURATION (left breast became solid). At the time of the report, DIZZINESS (light heaed), INFLUENZA (flu symptoms), INSOMNIA (couldn't sleep) and BREAST INDURATION (left breast became solid) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph node in her arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph node in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient has history of breast cancer 6 years ago) in 2015.  On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced LYMPHADENOPATHY (Swelling of lymph node in her arm).  At the time of the report, LYMPHADENOPATHY (Swelling of lymph node in her arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; 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: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Nausea
Clinical narrative: hot cheeks; flushed body; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot cheeks), FLUSHING (flushed body) and NAUSEA (Nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (hot cheeks), FLUSHING (flushed body) and NAUSEA (Nausea). At the time of the report, FEELING HOT (hot cheeks), FLUSHING (flushed body) and NAUSEA (Nausea) outcome was unknown.        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.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Facial discomfort, Pruritus, Rash, Swelling face
Clinical narrative: itching has gone down a little bit today 03Mar2021; face was comletely swollen; rashes on both sides of my face; face felt funny; eyes were so swollen; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL DISCOMFORT (face felt funny), EYE SWELLING (eyes were so swollen), PRURITUS (itching has gone down a little bit today 03Mar2021), SWELLING FACE (face was comletely swollen) and RASH (rashes on both sides of my face) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included SLE.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FACIAL DISCOMFORT (face felt funny), EYE SWELLING (eyes were so swollen), SWELLING FACE (face was comletely swollen) and RASH (rashes on both sides of my face). On 03-Mar-2021, the patient experienced PRURITUS (itching has gone down a little bit today 03Mar2021). The patient was treated with PARACETAMOL (TYLENOL) 02-Mar-2021 at a dose of 1 dosage form. At the time of the report, FACIAL DISCOMFORT (face felt funny), EYE SWELLING (eyes were so swollen), PRURITUS (itching has gone down a little bit today 03Mar2021), SWELLING FACE (face was comletely swollen) and RASH (rashes on both sides of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported  taking 2 Tylenol last night 02Mar2021. She used a cream on the rash. No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Body Aches; Massive Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches) and HEADACHE (Massive Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (Body Aches) and HEADACHE (Massive Headache). At the time of the report, MYALGIA (Body Aches) and HEADACHE (Massive Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Faeces discoloured, Pyrexia, Sensitive skin
Clinical narrative: Greenish stool; Hypersensitive skin; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (Greenish stool), SENSITIVE SKIN (Hypersensitive skin), CHILLS (Chills) and PYREXIA (Fever) in a 31-year-old male patient 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 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced SENSITIVE SKIN (Hypersensitive skin), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced FAECES DISCOLOURED (Greenish stool). On 01-Feb-2021, SENSITIVE SKIN (Hypersensitive skin) and CHILLS (Chills) had resolved. On 01-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, FAECES DISCOLOURED (Greenish stool) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug reported. no treatment reported.   Reporter did not allow further contact
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Rash, Swelling
Clinical narrative: bruise; rash on both arms, chest, crust; itch; swelling; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both arms, chest, crust), PRURITUS (itch), SWELLING (swelling) and CONTUSION (bruise) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (itch) and SWELLING (swelling). On 13-Feb-2021, the patient experienced RASH (rash on both arms, chest, crust). On an unknown date, the patient experienced CONTUSION (bruise). At the time of the report, RASH (rash on both arms, chest, crust), PRURITUS (itch), SWELLING (swelling) and CONTUSION (bruise) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Constipation, Vaccination site pain
Clinical narrative: upset stomach; constipation; Pain in right arm where I received the Moderna Covid-19 vaccine; A spontaneous report was received from a healthcare professional concerning a male  patient  of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in right arm where i received the moderna covid-19 vaccine/vaccination site pain, constipation, upset stomach.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Pain in right arm where I received the Moderna Covid-19 vaccine, constipation, upset stomach.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in right arm where i received the moderna covid-19 vaccine, constipation, upset stomach was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash (All over Body); This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash (All over Body)) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash (All over Body)). At the time of the report, RASH (Rash (All over Body)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Pruritus, Rash
Clinical narrative: warm to the touch; itchy; red; rash 2 inches long; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm to the touch), PRURITUS (itchy), ERYTHEMA (red) and RASH (rash 2 inches long) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was provided.  Concomitant products included LISINOPRIL and SIMVASTATIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE WARMTH (warm to the touch), PRURITUS (itchy), ERYTHEMA (red) and RASH (rash 2 inches long). At the time of the report, INJECTION SITE WARMTH (warm to the touch), PRURITUS (itchy), ERYTHEMA (red) and RASH (rash 2 inches long) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication were reported.   This case was linked to MOD-2021-262884 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow up received, contains second dose details and events outcome as recovered.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product prescribing issue
Clinical narrative: The day after receiving the shot, I started using fluorouracil 2% solution; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT PRESCRIBING ISSUE (The day after receiving the shot, I started using fluorouracil 2% solution) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Keratosis. Concomitant products included FLUOROURACIL from 23-Jan-2021 to an unknown date for Keratosis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PRODUCT PRESCRIBING ISSUE (The day after receiving the shot, I started using fluorouracil 2% solution). At the time of the report, PRODUCT PRESCRIBING ISSUE (The day after receiving the shot, I started using fluorouracil 2% solution) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.