chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vomiting
Clinical narrative: dizziness; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and VOMITING (vomiting) 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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (dizziness) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Has been sick ever since; joint pain; Fever; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Has been sick ever since), ARTHRALGIA (joint pain), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 029M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced MALAISE (Has been sick ever since). 30-Mar-2021, the patient experienced ARTHRALGIA (joint pain), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MALAISE (Has been sick ever since), ARTHRALGIA (joint pain), PYREXIA (Fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Appetite disorder, Decreased appetite, Fatigue
Clinical narrative: Tired; Loss of appetite; Get hungry but eats a little then loses appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), APPETITE DISORDER (Get hungry but eats a little then loses appetite) and FATIGUE (Tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 010A21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN POTASSIUM (COZAAR), INDAPAMIDE, VITAMIN D NOS, MULTIVITAMIN & MINERAL, FLAXSEED, POTASSIUM CHLORIDE and METRONIDAZOLE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced DECREASED APPETITE (Loss of appetite) and APPETITE DISORDER (Get hungry but eats a little then loses appetite). On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). At the time of the report, DECREASED APPETITE (Loss of appetite), APPETITE DISORDER (Get hungry but eats a little then loses appetite) and FATIGUE (Tired) outcome 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: Fatigue, Headache, Paraesthesia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingly sensations that radiates from the upper lip to the skin between her nose and mouth and up to the tip of her nose), FATIGUE (extremely tired) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018A21 and 01ZA21A) 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 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FATIGUE (extremely tired) and HEADACHE (headache). On 31-Mar-2021, the patient experienced PARAESTHESIA (tingly sensations that radiates from the upper lip to the skin between her nose and mouth and up to the tip of her nose). On 01-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, PARAESTHESIA (tingly sensations that radiates from the upper lip to the skin between her nose and mouth and up to the tip of her nose) and FATIGUE (extremely tired) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pain, SARS-CoV-2 test
Clinical narrative: cough; body ache,; headache.; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (cough), PAIN (body ache,) and HEADACHE (headache.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (cough), PAIN (body ache,) and HEADACHE (headache.). At the time of the report, COVID-19 (COVID-19), COUGH (cough), PAIN (body ache,) and HEADACHE (headache.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.  For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pain, Pruritus, Rash, Swelling
Clinical narrative: not hard and swollen anymore; not hard and swollen anymore; sore; itchy; rash; COVID arm". Developed rash/sore red/ hard and swollen; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy) and RASH (rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy), RASH (rash) and VACCINATION SITE ERYTHEMA (COVID arm". Developed rash/sore red/ hard and swollen). At the time of the report, INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy), RASH (rash) and VACCINATION SITE ERYTHEMA (COVID arm". Developed rash/sore red/ hard and swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medication includes: Cortisone Cream & Ice pack to do warm packs.  No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow-up information received on 27-May-2021, contains non-significant information.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: not hard and swollen anymore; not hard and swollen anymore; sore; itchy; rash; COVID arm". Developed rash/sore red/ hard and swollen; This spontaneous case was reported by a consumer and describes the occurrence of INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy) and RASH (rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy), RASH (rash) and VACCINATION SITE ERYTHEMA (COVID arm". Developed rash/sore red/ hard and swollen). At the time of the report, INDURATION (not hard and swollen anymore), SWELLING (not hard and swollen anymore), PAIN (sore), PRURITUS (itchy), RASH (rash) and VACCINATION SITE ERYTHEMA (COVID arm". Developed rash/sore red/ hard and swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medication includes: Cortisone Cream & Ice pack to do warm packs.  No concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2021: Follow-up information received on 27-May-2021, contains non-significant information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Inflammation, Tachycardia
Clinical narrative: I began feeling my entire body inflame; Extreme Tachycardia; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Extreme Tachycardia) and INFLAMMATION (I began feeling my entire body inflame) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B.) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy, Allergy to nuts and Soy allergy. Concomitant products included METOPROLOL, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE (CLARITIN [LORATADINE]), CALCIUM, VITAMINS NOS, LEVOTHYROXINE, EZETIMIBE (ZETIA) and RAMIPRIL for an unknown indication.    On 31-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TACHYCARDIA (Extreme Tachycardia). On an unknown date, the patient experienced INFLAMMATION (I began feeling my entire body inflame). The patient was treated with METOPROLOL TARTRATE (LOPRESSOR) for Hypertension, at an unspecified dose and frequency. At the time of the report, TACHYCARDIA (Extreme Tachycardia) was resolving and INFLAMMATION (I began feeling my entire body inflame) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Blood pressure measurement: 200/110 (High) recovering/resolving outcome. On 31-Mar-2021, Heart rate: 160 (High) pulse was 140 and climbing &  HR was above 160; unknown outcome.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information included intravenous (IV) fluid. She states that she will not take the 2nd dose of vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: significant follow up included, Height, weight, race and ethnicity. Patient concomitant included Levothyroxine 50 mcg QD. New events included Heart rate increase ( Labs), inflammation and blood pressure increased (Labs)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Hot to the touch; Injection site is hard; Swollen as a delayed reaction; Right arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm was very sore), INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE INDURATION (Injection site is hard) and INJECTION SITE SWELLING (Swollen as a delayed reaction) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm was very sore). On an unknown date, the patient experienced INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE INDURATION (Injection site is hard) and INJECTION SITE SWELLING (Swollen as a delayed reaction). At the time of the report, PAIN IN EXTREMITY (Right arm was very sore), INJECTION SITE WARMTH (Hot to the touch), INJECTION SITE INDURATION (Injection site is hard) and INJECTION SITE SWELLING (Swollen as a delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-131962 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up document received on 14-May-2021 contains significant information of second dose details and reported event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-131962:Dose 2
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: Horrible weakness; Aching in all joints; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (Horrible weakness) and ARTHRALGIA (Aching in all joints) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ASTHENIA (Horrible weakness) and ARTHRALGIA (Aching in all joints). On 06-Mar-2021, ASTHENIA (Horrible weakness) and ARTHRALGIA (Aching in all joints) had resolved.        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.   Concomitant product use was not provided. Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache
Clinical narrative: A "weirdly annoying cloudy feeling"; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (A "weirdly annoying cloudy feeling") and HEADACHE (Headaches) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038a21a) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced FEELING ABNORMAL (A "weirdly annoying cloudy feeling") and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, bid. At the time of the report, FEELING ABNORMAL (A "weirdly annoying cloudy feeling") and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included high blood pressure medication, cholesterol medication and prostate medication.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Limb discomfort
Clinical narrative: felt like her arm was bothering her on the first dose only; felt very tired; felt unusually tired; A day after getting the vaccine, she experienced trouble of breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA, LIMB DISCOMFORT, FATIGUE, and FATIGUE in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-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 01-Apr-2021, the patient experienced DYSPNOEA. On an unknown date, the patient experienced LIMB DISCOMFORT, FATIGUE, and FATIGUE. At the time of the report, DYSPNOEA, LIMB DISCOMFORT, FATIGUE, and FATIGUE outcome was unknown. Not Provided.          Action taken with mRNA-1273 in response to the event was not applicable. Patient was given oxygen treatment.  Concomitant medication included blood thinners and blood pressure medicines.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling sensation in shin down to feet; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling sensation in shin down to feet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B2A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included GABAPENTIN, FLUOXETINE, BACLOFEN, MELOXICAM, OXYBUTYNIN, MULTIVITAMINS [VITAMINS NOS] and ZINC for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling sensation in shin down to feet). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PARAESTHESIA (Tingling sensation in shin down to feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Insomnia, Malaise
Clinical narrative: Felt like she had a "brief relapse of Covid"; Hard time getting in air; Not able to sleep; This spontaneous case was reported by a nurse and describes the occurrence of INSOMNIA (Not able to sleep), DYSPNOEA (Hard time getting in air) and MALAISE (Felt like she had a "brief relapse of Covid") in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 014M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced INSOMNIA (Not able to sleep), DYSPNOEA (Hard time getting in air) and MALAISE (Felt like she had a "brief relapse of Covid"). On 31-Mar-2021, INSOMNIA (Not able to sleep) had resolved. At the time of the report, DYSPNOEA (Hard time getting in air) and MALAISE (Felt like she had a "brief relapse of Covid") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.    This case was linked to MOD-2021-065537 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching in the midsection; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching in the midsection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PRURITUS (itching in the midsection). At the time of the report, PRURITUS (itching in the midsection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) 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 ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided No treatment information provided   Reporter did not allow further contact
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Fatigue; Sweating; Pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. I00B21A) for COVID-19 vaccination.     The patient's past medical history included Transient ischemic attacks in 2004, Nerve block (Nerve block on back) on 01-Mar-2021, Knee replacement (Left knee replacement), Arthroplasty of knee in 2018 and Brain operation (brain surgery aneurysm) in 1991. Concurrent medical conditions included Fibromyalgia, Hypertension, Arthritis and COPD.   On 22-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 23-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills) and PYREXIA (Fever). On 30-Mar-2021, the patient experienced FATIGUE (Fatigue). On 01-Apr-2021, HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99.1 (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue; Sweating; Pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigue) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. I00B21A) for COVID-19 vaccination.     The patient's past medical history included Transient ischemic attacks in 2004, Nerve block (Nerve block on back) on 01-Mar-2021, Knee replacement (Left knee replacement), Arthroplasty of knee in 2018 and Brain operation (brain surgery aneurysm) in 1991. Concurrent medical conditions included Fibromyalgia, Hypertension, Arthritis and COPD.   On 22-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 23-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills) and PYREXIA (Fever). On 30-Mar-2021, the patient experienced FATIGUE (Fatigue). On 01-Apr-2021, HYPERHIDROSIS (Sweating), PAIN (Pain), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 99.1 (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Sore in injection site; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore in injection site) and HEADACHE (Headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3992HA91) for COVID-19 vaccination.     Concomitant products included ALLOPURINOL, COLCHICINE, MAGNESIUM, RHODIOLA ROSEA ROOT, THIAMINE HYDROCHLORIDE (RHODIOLA ROSEA [MAGNESIUM;RHODIOLA ROSEA ROOT;THIAMINE HYDROCHLORIDE]), SYNTOL and PROBIOTICS NOS for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore in injection site) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Sore in injection site) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant products included kidney cleans, super enzyme for an unknown indication  Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: low grade fever of 100.9 degrees Fahrenheit; experiencing pain in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever of 100.9 degrees Fahrenheit) and MYALGIA (experiencing pain in his arm) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (low grade fever of 100.9 degrees Fahrenheit) and MYALGIA (experiencing pain in his arm). At the time of the report, PYREXIA (low grade fever of 100.9 degrees Fahrenheit) and MYALGIA (experiencing pain in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness
Clinical narrative: She is sick; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She is sick), FATIGUE (Fatigue) and 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 31-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 01-Apr-2021, the patient experienced FATIGUE (Fatigue) and HEADACHE (Headache). On an unknown date, the patient experienced ILLNESS (She is sick). At the time of the report, ILLNESS (She is sick), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included OXCARBAZEPINE (OXTELLAR XR), ZONISAMIDE and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 25-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 26-Mar-2021, the patient experienced MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Body temperature: 100.7 (High) Unknown.         Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain in extremity, Pyrexia
Clinical narrative: Heavy sweats after going to bed; Arm was sore/ Arm is tender; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Heavy sweats after going to bed), PAIN IN EXTREMITY (Arm was sore/ Arm is tender), PYREXIA (Fever) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore/ Arm is tender), PYREXIA (Fever) and CHILLS (Chills). On 30-Mar-2021, the patient experienced HYPERHIDROSIS (Heavy sweats after going to bed). At the time of the report, HYPERHIDROSIS (Heavy sweats after going to bed), PAIN IN EXTREMITY (Arm was sore/ Arm is tender), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Tender to touch; Redness and Swelling of left arm 24 hours after vaccination; Swelling 5.5 in long and 3 inch wide/swelling of arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender to touch), VACCINATION SITE ERYTHEMA (Redness and Swelling of left arm 24 hours after vaccination) and VACCINATION SITE SWELLING (Swelling 5.5 in long and 3 inch wide/swelling of arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TENDERNESS (Tender to touch), VACCINATION SITE ERYTHEMA (Redness and Swelling of left arm 24 hours after vaccination) and VACCINATION SITE SWELLING (Swelling 5.5 in long and 3 inch wide/swelling of arm). At the time of the report, TENDERNESS (Tender to touch), VACCINATION SITE ERYTHEMA (Redness and Swelling of left arm 24 hours after vaccination) and VACCINATION SITE SWELLING (Swelling 5.5 in long and 3 inch wide/swelling of arm) outcome was unknown.            Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Glossitis, Glossodynia, Lip swelling, Mouth swelling
Clinical narrative: mouth and tongue was swollen; mouth and tongue was swollen/swelling of tongue; Tongue has lost of taste; tongue is slimy; tongue when touched by a utensil, it is very painful; has a breakdown on the skin of the tongue/lips are tapping; Swelling of both lips; Entire underside of the tongue is inflamed; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (mouth and tongue was swollen), SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue), AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy) and GLOSSODYNIA (tongue when touched by a utensil, it is very painful) in a 65-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 Hysterectomy (12 years agao). Concomitant products included FLECAINIDE ACETATE (TAMBOCOR), METOPROLOL, RIVAROXABAN (XARELTO), Probatozole, ACICLOVIR (CYCLOVIR) and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy), GLOSSODYNIA (tongue when touched by a utensil, it is very painful), TONGUE DISORDER (has a breakdown on the skin of the tongue/lips are tapping), LIP SWELLING (Swelling of both lips) and GLOSSITIS (Entire underside of the tongue is inflamed). On 12-Feb-2021, the patient experienced MOUTH SWELLING (mouth and tongue was swollen) and SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue). At the time of the report, MOUTH SWELLING (mouth and tongue was swollen), SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue), AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy), GLOSSODYNIA (tongue when touched by a utensil, it is very painful), TONGUE DISORDER (has a breakdown on the skin of the tongue/lips are tapping), LIP SWELLING (Swelling of both lips) and GLOSSITIS (Entire underside of the tongue is inflamed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient was Prescribed with  Dexofemidine 50 mg in the morning and Adorax 10mg after dinner that she is currently taking. Suggested was Dupsone, to be added with the other drugs she is currently on. patient also taking  Estradiol 1mg daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-099506 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follo up case triaged on 30-APR-2021; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099506:wife case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue coated, Tongue disorder
Clinical narrative: mouth and tongue was swollen; mouth and tongue was swollen/swelling of tongue; Tongue has lost of taste; tongue is slimy; tongue when touched by a utensil, it is very painful; has a breakdown on the skin of the tongue/lips are tapping; Swelling of both lips; Entire underside of the tongue is inflamed; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (mouth and tongue was swollen), SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue), AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy) and GLOSSODYNIA (tongue when touched by a utensil, it is very painful) in a 65-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 Hysterectomy (12 years agao). Concomitant products included FLECAINIDE ACETATE (TAMBOCOR), METOPROLOL, RIVAROXABAN (XARELTO), Probatozole, ACICLOVIR (CYCLOVIR) and VITAMINS NOS for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy), GLOSSODYNIA (tongue when touched by a utensil, it is very painful), TONGUE DISORDER (has a breakdown on the skin of the tongue/lips are tapping), LIP SWELLING (Swelling of both lips) and GLOSSITIS (Entire underside of the tongue is inflamed). On 12-Feb-2021, the patient experienced MOUTH SWELLING (mouth and tongue was swollen) and SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue). At the time of the report, MOUTH SWELLING (mouth and tongue was swollen), SWOLLEN TONGUE (mouth and tongue was swollen/swelling of tongue), AGEUSIA (Tongue has lost of taste), TONGUE COATED (tongue is slimy), GLOSSODYNIA (tongue when touched by a utensil, it is very painful), TONGUE DISORDER (has a breakdown on the skin of the tongue/lips are tapping), LIP SWELLING (Swelling of both lips) and GLOSSITIS (Entire underside of the tongue is inflamed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient was Prescribed with  Dexofemidine 50 mg in the morning and Adorax 10mg after dinner that she is currently taking. Suggested was Dupsone, to be added with the other drugs she is currently on. patient also taking  Estradiol 1mg daily.   This case was linked to US-MODERNATX, INC.-MOD-2021-099506 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follo up case triaged on 30-APR-2021; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-099506:wife case
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pain, Pyrexia
Clinical narrative: Pains; Fatigue; Fever; Chills; Aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Lasted for 2 weeks) from November 2020 to December 2020. Concomitant products included NADOLOL, ALOPURINOL and LEFLUNOMIDE for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (Pains), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Mar-2021, PAIN (Pains), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Aches and pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Gait disturbance, Muscle spasms, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of bedridden (he has been in bed for 12 days), gait disturbance (he can't walk), muscle spasms (cramps), pain in extremity (pain in the legs) and pyrexia (fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included stroke (5 years ago). Concurrent medical conditions included diabetes, high blood pressure and hepatitis. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 18, 2021, patient experienced bedridden (he has been in bed for 12 days), gait disturbance (he can't walk), muscle spasms (cramps), pain in extremity (pain in the legs), pyrexia (fever) and sleep disorder (sleeping problems). At the time of the report, bedridden (he has been in bed for 12 days), gait disturbance (he can't walk), muscle spasms (cramps), pain in extremity (pain in the legs), pyrexia (fever) and sleep disorder (sleeping problems) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of bedridden (he has been in bed for 12 days), gait disturbance (he can't walk), muscle spasms (cramps), pain in extremity (pain in the legs) and pyrexia (fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's past medical history included stroke (5 years ago). Concurrent medical conditions included diabetes, high blood pressure and hepatitis. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 18, 2021, patient experienced bedridden (he has been in bed for 12 days), gait disturbance (he can't walk), muscle spasms (cramps), pain in extremity (pain in the legs), pyrexia (fever) and sleep disorder (sleeping problems). At the time of the report, bedridden (he has been in bed for 12 days), gait disturbance (he can't walk), muscle spasms (cramps), pain in extremity (pain in the legs), pyrexia (fever) and sleep disorder (sleeping problems) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Fatigue, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in feet), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen) and RASH (Pin spot rash around neck area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and #001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in feet), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen), RASH (Pin spot rash around neck area), NAUSEA (Nausea), FATIGUE (Tiredness/ extreme tiredness) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen), RASH (Pin spot rash around neck area), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Tiredness/ extreme tiredness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was not provided. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-065572.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Swollen tongue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in feet), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen) and RASH (Pin spot rash around neck area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and #001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (Pain in feet), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen), RASH (Pin spot rash around neck area), NAUSEA (Nausea), FATIGUE (Tiredness/ extreme tiredness) and CHILLS (Chills). At the time of the report, DIZZINESS (Dizziness), COUGH (Cough), SWOLLEN TONGUE (Felt like tongue was swollen), RASH (Pin spot rash around neck area), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown and PAIN IN EXTREMITY (Pain in feet) and FATIGUE (Tiredness/ extreme tiredness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant product use was not provided. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-065572.