chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Pain in extremity, Thrombophlebitis
Clinical narrative: thrombophlebitis symptoms in leg; Pain in leg; Felling of heat in leg; Inflammation in leg; This spontaneous case was reported by a physician and describes the occurrence of THROMBOPHLEBITIS (thrombophlebitis symptoms in leg), PAIN IN EXTREMITY (Pain in leg), FEELING HOT (Felling of heat in leg) and INFLAMMATION (Inflammation in leg) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical conditions reported).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOPHLEBITIS (thrombophlebitis symptoms in leg), PAIN IN EXTREMITY (Pain in leg), FEELING HOT (Felling of heat in leg) and INFLAMMATION (Inflammation in leg). At the time of the report, THROMBOPHLEBITIS (thrombophlebitis symptoms in leg), PAIN IN EXTREMITY (Pain in leg), FEELING HOT (Felling of heat in leg) and INFLAMMATION (Inflammation in leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment : patient consulted with her personal Physician and she recommended her to take generic anti-inflammatory medicine until 12APR2021 when she could do some tests on her legs
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Dyspnoea, Heart rate
Clinical narrative: chest pain; crushing feeling" in chest; crushing feeling" in heart; difficulty breathing; migraine-level" headache; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHEST DISCOMFORT (crushing feeling" in chest), CARDIAC DISORDER (crushing feeling" in heart), DYSPNOEA (difficulty breathing) and MIGRAINE (migraine-level" headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 ("severe" COVID-19 requiring hospital admittance in December 2020). Concurrent medical conditions included Anxiety. Concomitant products included LITHIUM from February 2021 to an unknown date, QUETIAPINE FUMARATE (SEROQUEL), NALTREXONE and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced MIGRAINE (migraine-level" headache) and PAIN IN EXTREMITY (arm soreness). On 07-Apr-2021, the patient experienced CHEST PAIN (chest pain), CHEST DISCOMFORT (crushing feeling" in chest), CARDIAC DISORDER (crushing feeling" in heart) and DYSPNOEA (difficulty breathing). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and GABAPENTIN at a dose of UNK, as necessary. On 06-Apr-2021, MIGRAINE (migraine-level" headache) and PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, CHEST PAIN (chest pain), CHEST DISCOMFORT (crushing feeling" in chest), CARDIAC DISORDER (crushing feeling" in heart) and DYSPNOEA (difficulty breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Heart rate: increased (High) Rapid heart rate.     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.   Other Treatment drugs include Cyan pepper capsules to help her breath Patient has not contacted a physician nor the vaccinating pharmacy. Patient agreeable to seek care from a HCP if she experiences emergency symptoms (e.g., difficulty breathing, chest pain) in the future.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity
Clinical narrative: chest pain; crushing feeling" in chest; crushing feeling" in heart; difficulty breathing; migraine-level" headache; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHEST DISCOMFORT (crushing feeling" in chest), CARDIAC DISORDER (crushing feeling" in heart), DYSPNOEA (difficulty breathing) and MIGRAINE (migraine-level" headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 ("severe" COVID-19 requiring hospital admittance in December 2020). Concurrent medical conditions included Anxiety. Concomitant products included LITHIUM from February 2021 to an unknown date, QUETIAPINE FUMARATE (SEROQUEL), NALTREXONE and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced MIGRAINE (migraine-level" headache) and PAIN IN EXTREMITY (arm soreness). On 07-Apr-2021, the patient experienced CHEST PAIN (chest pain), CHEST DISCOMFORT (crushing feeling" in chest), CARDIAC DISORDER (crushing feeling" in heart) and DYSPNOEA (difficulty breathing). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and GABAPENTIN at a dose of UNK, as necessary. On 06-Apr-2021, MIGRAINE (migraine-level" headache) and PAIN IN EXTREMITY (arm soreness) had resolved. At the time of the report, CHEST PAIN (chest pain), CHEST DISCOMFORT (crushing feeling" in chest), CARDIAC DISORDER (crushing feeling" in heart) and DYSPNOEA (difficulty breathing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Heart rate: increased (High) Rapid heart rate.     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.   Other Treatment drugs include Cyan pepper capsules to help her breath Patient has not contacted a physician nor the vaccinating pharmacy. Patient agreeable to seek care from a HCP if she experiences emergency symptoms (e.g., difficulty breathing, chest pain) in the future.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myalgia, Throat tightness
Clinical narrative: more pronounced muscle soreness all over the body; had severe trouble breathing; "really tired"; tightening in the throat; mild soreness in the muscles all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (more pronounced muscle soreness all over the body), DYSPNOEA (had severe trouble breathing), FATIGUE ("really tired"), THROAT TIGHTNESS (tightening in the throat) and MYALGIA (mild soreness in the muscles all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 04M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced THROAT TIGHTNESS (tightening in the throat) and MYALGIA (mild soreness in the muscles all over the body). On 25-Mar-2021, the patient experienced MYALGIA (more pronounced muscle soreness all over the body), DYSPNOEA (had severe trouble breathing) and FATIGUE ("really tired"). At the time of the report, MYALGIA (more pronounced muscle soreness all over the body), DYSPNOEA (had severe trouble breathing), FATIGUE ("really tired"), THROAT TIGHTNESS (tightening in the throat) and MYALGIA (mild soreness in the muscles all over the body) outcome was unknown.            This case was linked to MOD-2021-073351 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Sweats; Experienced 100.8 fever; Chills; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats), PYREXIA (Experienced 100.8 fever), CHILLS (Chills) and FATIGUE (Extreme fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Environmental allergy. Concomitant products included IRBESARTAN and HYDROCHLOROTHIAZIDE for Blood pressure, LOVASTATIN for Cholesterol, DIPHENHYDRAMINE HCL and FLUTICASONE for Environmental allergy.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 9:12 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced HYPERHIDROSIS (Sweats), PYREXIA (Experienced 100.8 fever), CHILLS (Chills) and FATIGUE (Extreme fatigue). On 10-Apr-2021, PYREXIA (Experienced 100.8 fever), CHILLS (Chills) and FATIGUE (Extreme fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Sweats) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Body temperature: 100.8 (High) 100.8 (degrees F).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up received, Patient demographics added, Relevant history added, concomitant medication added, events out come added.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: arm sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (arm sore at injection site) in a 77-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.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INJECTION SITE PAIN (arm sore at injection site). At the time of the report, INJECTION SITE PAIN (arm sore at injection site) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Diagnosed with Shingles after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with Shingles after the first dose) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced HERPES ZOSTER (Diagnosed with Shingles after the first dose). At the time of the report, HERPES ZOSTER (Diagnosed with Shingles after the first dose) outcome was unknown. Not Provided      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.   Treatment :Anti-viral drugs
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient aged 17 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 17 years) in a 17-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 reported medical history).    On 12-Apr-2021 at 1:11 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 1:11 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 17 years). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient aged 17 years) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Apr-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 10-Apr-2021, the patient experienced RASH (rash all over). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 400 mg. At the time of the report, RASH (rash all over) outcome was unknown. Not Provided          No concomitan
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Possible irregularities in vaccine storage and handling; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Possible irregularities in vaccine storage and handling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Possible irregularities in vaccine storage and handling). On 17-Mar-2021, PRODUCT STORAGE ERROR (Possible irregularities in vaccine storage and handling) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: symptom of diarrhea; tiredness; This spontaneous case was reported by a hospital and describes the occurrence of DIARRHOEA (symptom of diarrhea) and FATIGUE (tiredness) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced DIARRHOEA (symptom of diarrhea) and FATIGUE (tiredness). On 12-Mar-2021, DIARRHOEA (symptom of diarrhea) and FATIGUE (tiredness) had resolved. Not Provided      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.   This case was linked to MOD-2021-073794, US-MODERNATX, INC.-MOD-2021-073794 (E2B Linked Report).; Sender's Comments:  MOD-2021-073794:2nd dose US-MODERNATX, INC.-MOD-2021-073794:linked case
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: breath are short; rash; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (breath are short) and RASH (rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Transplant and Bipolar disorder.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced DYSPNOEA (breath are short) and RASH (rash). At the time of the report, DYSPNOEA (breath are short) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not provided. Treatment medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non significant follow up: No new information was received
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia oral, Pruritus
Clinical narrative: some itching throughout her body and it was more intense in her face and head, in her scalp; some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet; tingling on her mouth and tongue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PRURITUS (some itching throughout her body and it was more intense in her face and head, in her scalp), BURNING SENSATION (some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet) and PARAESTHESIA ORAL (tingling on her mouth and tongue) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A1ZA920) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL for Blood pressure high, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE (SYNJARDY) for Diabetes.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PRURITUS (some itching throughout her body and it was more intense in her face and head, in her scalp), BURNING SENSATION (some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet) and PARAESTHESIA ORAL (tingling on her mouth and tongue). At the time of the report, PRURITUS (some itching throughout her body and it was more intense in her face and head, in her scalp), BURNING SENSATION (some icing hot burning sensations down arms and shoulders that also spread throughout her body, her torso, legs, feet) and PARAESTHESIA ORAL (tingling on her mouth and tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was reported as antihistamines early on for itching.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Blood test
Clinical narrative: Blood sugar increased; This spontaneous case was reported by a physician and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar increased) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar increased). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar increased) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: constantly at around 200; (abnormal) constantly at around 200.     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.   The reporter reported that patient will not take his second dose if in case the sugar levels will not come down.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion, Paranasal sinus discomfort
Clinical narrative: sinus pressure; feel congestion; like allergies; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure), NASAL CONGESTION (feel congestion) and HYPERSENSITIVITY (like allergies) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     The patient's medical history information was not provided.  Concomitant products included LEVOTHYROXINE, LOSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), SERTRALINE HYDROCHLORIDE (SERTAC), VITAMIN D NOS and VITAMIN B12 NOS 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 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure), NASAL CONGESTION (feel congestion) and HYPERSENSITIVITY (like allergies). At the time of the report, PARANASAL SINUS DISCOMFORT (sinus pressure), NASAL CONGESTION (feel congestion) and HYPERSENSITIVITY (like allergies) outcome was unknown.            Treatment information was not provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Lip blister, No adverse event
Clinical narrative: felt weak; fever blister on lips; chills; No fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), LIP BLISTER (fever blister on lips), CHILLS (chills) and NO ADVERSE EVENT (No fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 39AZIA and 0481921A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 16-Mar-2020. Concomitant products included CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDESARTAN HCTZ), METOPROLOL and AMLODIPINE for Hypertension, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and Vitamin Calcium Magnessium and Zinc for Vitamin supplementation, ROSUVASTATIN, ASCORBIC ACID, ECHINACEA PURPUREA (ECHINACEA + VITAMINA C VITATECH), PROBIOTIC 10 and Turmeric powder Mix some in tea                                Herbal for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced ASTHENIA (felt weak), LIP BLISTER (fever blister on lips), CHILLS (chills) and NO ADVERSE EVENT (No fever). At the time of the report, ASTHENIA (felt weak), LIP BLISTER (fever blister on lips), CHILLS (chills) and NO ADVERSE EVENT (No fever) outcome was unknown.            This case was linked to US-MODERNATX, INC.-MOD-2021-074916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074916:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Chills, Dizziness, Erythema, Eye pain
Clinical narrative: Red mark around neck; Red mark turned into red blotch around 6 inch wide; Blisters appeared or like small little pimples; Eyes watered continuously; Eye lids sore; Eye lids swollen; hard to focus and could not read; having an urge to rub the eyes while sleeping; Itchy; skin around the eyes looks flaked and puckered; pain to touch; feels like there is grit in his eye; Chills but no fever; Sick; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Sick), DIZZINESS (Dizziness), ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide) and BLISTER (Blisters appeared or like small little pimples) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high and Prostate examination abnormal. Concomitant products included PRAVASTATIN, FINASTERIDE, VITAMINS NOS (DAILY VITAMINS) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ILLNESS (Sick) and DIZZINESS (Dizziness). 21-Mar-2021, the patient experienced CHILLS (Chills but no fever). On an unknown date, the patient experienced ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide), BLISTER (Blisters appeared or like small little pimples), LACRIMATION INCREASED (Eyes watered continuously), EYE PAIN (Eye lids sore), SWELLING OF EYELID (Eye lids swollen), VISION BLURRED (hard to focus and could not read), OCULAR DISCOMFORT (having an urge to rub the eyes while sleeping), PRURITUS (Itchy), SKIN DISCOMFORT (skin around the eyes looks flaked and puckered), EYE PAIN (pain to touch) and OCULAR DISCOMFORT (feels like there is grit in his eye). The patient was treated with NYSTATIN (STATIN [NYSTATIN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), DIZZINESS (Dizziness), ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide), BLISTER (Blisters appeared or like small little pimples), LACRIMATION INCREASED (Eyes watered continuously), EYE PAIN (Eye lids sore), SWELLING OF EYELID (Eye lids swollen), VISION BLURRED (hard to focus and could not read), OCULAR DISCOMFORT (having an urge to rub the eyes while sleeping), PRURITUS (Itchy), SKIN DISCOMFORT (skin around the eyes looks flaked and puckered), EYE PAIN (pain to touch), OCULAR DISCOMFORT (feels like there is grit in his eye) and CHILLS (Chills but no fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Lacrimation increased, Ocular discomfort, Pruritus, Skin discomfort
Clinical narrative: Red mark around neck; Red mark turned into red blotch around 6 inch wide; Blisters appeared or like small little pimples; Eyes watered continuously; Eye lids sore; Eye lids swollen; hard to focus and could not read; having an urge to rub the eyes while sleeping; Itchy; skin around the eyes looks flaked and puckered; pain to touch; feels like there is grit in his eye; Chills but no fever; Sick; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Sick), DIZZINESS (Dizziness), ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide) and BLISTER (Blisters appeared or like small little pimples) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high and Prostate examination abnormal. Concomitant products included PRAVASTATIN, FINASTERIDE, VITAMINS NOS (DAILY VITAMINS) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ILLNESS (Sick) and DIZZINESS (Dizziness). 21-Mar-2021, the patient experienced CHILLS (Chills but no fever). On an unknown date, the patient experienced ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide), BLISTER (Blisters appeared or like small little pimples), LACRIMATION INCREASED (Eyes watered continuously), EYE PAIN (Eye lids sore), SWELLING OF EYELID (Eye lids swollen), VISION BLURRED (hard to focus and could not read), OCULAR DISCOMFORT (having an urge to rub the eyes while sleeping), PRURITUS (Itchy), SKIN DISCOMFORT (skin around the eyes looks flaked and puckered), EYE PAIN (pain to touch) and OCULAR DISCOMFORT (feels like there is grit in his eye). The patient was treated with NYSTATIN (STATIN [NYSTATIN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), DIZZINESS (Dizziness), ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide), BLISTER (Blisters appeared or like small little pimples), LACRIMATION INCREASED (Eyes watered continuously), EYE PAIN (Eye lids sore), SWELLING OF EYELID (Eye lids swollen), VISION BLURRED (hard to focus and could not read), OCULAR DISCOMFORT (having an urge to rub the eyes while sleeping), PRURITUS (Itchy), SKIN DISCOMFORT (skin around the eyes looks flaked and puckered), EYE PAIN (pain to touch), OCULAR DISCOMFORT (feels like there is grit in his eye) and CHILLS (Chills but no fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid, Vision blurred
Clinical narrative: Red mark around neck; Red mark turned into red blotch around 6 inch wide; Blisters appeared or like small little pimples; Eyes watered continuously; Eye lids sore; Eye lids swollen; hard to focus and could not read; having an urge to rub the eyes while sleeping; Itchy; skin around the eyes looks flaked and puckered; pain to touch; feels like there is grit in his eye; Chills but no fever; Sick; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Sick), DIZZINESS (Dizziness), ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide) and BLISTER (Blisters appeared or like small little pimples) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol high and Prostate examination abnormal. Concomitant products included PRAVASTATIN, FINASTERIDE, VITAMINS NOS (DAILY VITAMINS) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ILLNESS (Sick) and DIZZINESS (Dizziness). 21-Mar-2021, the patient experienced CHILLS (Chills but no fever). On an unknown date, the patient experienced ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide), BLISTER (Blisters appeared or like small little pimples), LACRIMATION INCREASED (Eyes watered continuously), EYE PAIN (Eye lids sore), SWELLING OF EYELID (Eye lids swollen), VISION BLURRED (hard to focus and could not read), OCULAR DISCOMFORT (having an urge to rub the eyes while sleeping), PRURITUS (Itchy), SKIN DISCOMFORT (skin around the eyes looks flaked and puckered), EYE PAIN (pain to touch) and OCULAR DISCOMFORT (feels like there is grit in his eye). The patient was treated with NYSTATIN (STATIN [NYSTATIN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (Sick), DIZZINESS (Dizziness), ERYTHEMA (Red mark around neck), ERYTHEMA (Red mark turned into red blotch around 6 inch wide), BLISTER (Blisters appeared or like small little pimples), LACRIMATION INCREASED (Eyes watered continuously), EYE PAIN (Eye lids sore), SWELLING OF EYELID (Eye lids swollen), VISION BLURRED (hard to focus and could not read), OCULAR DISCOMFORT (having an urge to rub the eyes while sleeping), PRURITUS (Itchy), SKIN DISCOMFORT (skin around the eyes looks flaked and puckered), EYE PAIN (pain to touch), OCULAR DISCOMFORT (feels like there is grit in his eye) and CHILLS (Chills but no fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 11 doses administered after being refrigerated for 34 days; 11 doses administered after being refrigerated for 34 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (11 doses administered after being refrigerated for 34 days) and EXPIRED PRODUCT ADMINISTERED (11 doses administered after being refrigerated for 34 days) 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (11 doses administered after being refrigerated for 34 days) and EXPIRED PRODUCT ADMINISTERED (11 doses administered after being refrigerated for 34 days). At the time of the report, PRODUCT STORAGE ERROR (11 doses administered after being refrigerated for 34 days) and EXPIRED PRODUCT ADMINISTERED (11 doses administered after being refrigerated for 34 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: blowing sensation in the right ear.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (blowing sensation in the right ear.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TINNITUS (blowing sensation in the right ear.). At the time of the report, TINNITUS (blowing sensation in the right ear.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   As treatment the patient applied some oil in the right ear.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Erythema, Flushing, Skin warm
Clinical narrative: got real dizzy; her face is all red; Its like flushed; seems to be a little warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (got real dizzy), ERYTHEMA (her face is all red), FLUSHING (Its like flushed) and SKIN WARM (seems to be a little warm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Tested Covid positive on February.) in February 2021 and COVID-19 (Tested Covid positive on March but tested negative on April) in March 2021. Concurrent medical conditions included Hypertension.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (got real dizzy), ERYTHEMA (her face is all red) and FLUSHING (Its like flushed). 13-Apr-2021, the patient experienced SKIN WARM (seems to be a little warm). At the time of the report, DIZZINESS (got real dizzy), ERYTHEMA (her face is all red), FLUSHING (Its like flushed) and SKIN WARM (seems to be a little warm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: (Inconclusive) Temperature 97.1.     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.   Concomitant products included high blood pressure medications and cortisone shot in her low back.    Treatment medication was not provided.  Had first dose of the Moderna COVID-19 vaccine today, she stayed the 15 minutes and everything was fine but one hour later got real dizzy and her face is all red, it's like flushed and she seems to be a little warm but does not have a fever (temperature of 97.1). Had a cortisone shot in her low back so she does not know if it has something to do. Also tested positive for COVID on February and on March but tested negative on April and that's why she could get the vaccine.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Flushing, Swelling face
Clinical narrative: Flushing of cheek; Red cheek; Face swollen; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing of cheek), ERYTHEMA (Red cheek) and SWELLING FACE (Face swollen) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FLUSHING (Flushing of cheek), ERYTHEMA (Red cheek) and SWELLING FACE (Face swollen). At the time of the report, FLUSHING (Flushing of cheek), ERYTHEMA (Red cheek) and SWELLING FACE (Face swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was treated with Zyrtec
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Nasopharyngitis, Pain in extremity
Clinical narrative: Lethargic; Cold; Chills; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), NASOPHARYNGITIS (Cold), CHILLS (Chills) and PAIN IN EXTREMITY (Arm soreness) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included levogestroeol and VITAMIN 15 for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LETHARGY (Lethargic), NASOPHARYNGITIS (Cold), CHILLS (Chills) and PAIN IN EXTREMITY (Arm soreness). At the time of the report, LETHARGY (Lethargic), NASOPHARYNGITIS (Cold), CHILLS (Chills) and PAIN IN EXTREMITY (Arm soreness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications not reported.  Treatment information not reported.   This case was linked to MOD-2021-076278 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15-APR-2021. Name correction/third dose.; Sender's Comments:  MOD-2021-076278:2nd dose
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm is killing her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm is killing her) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy, Anxiety, Aortic valve stenosis, Hypertension, Hyperlipidemia, Insomnia and Asthma. Concomitant products included ALPRAZOLAM (XANAX) for Asthma, LOSARTAN for Hypertension, AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) for Insomnia.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (right arm is killing her). At the time of the report, VACCINATION SITE PAIN (right arm is killing her) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (right arm is killing her) to be possibly related.    Concomitant medication includes: Advair Diskus (Device-Inhaler)    Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Medical history added. Event outcome and causality updated. Concomitant medications added. Reporter details added.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administration of a invalid dose; administered Moderna vaccine which had been left at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administration of a invalid dose) and PRODUCT STORAGE ERROR (administered Moderna vaccine which had been left at room temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administration of a invalid dose) and PRODUCT STORAGE ERROR (administered Moderna vaccine which had been left at room temperature). On 07-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (Administration of a invalid dose) and PRODUCT STORAGE ERROR (administered Moderna vaccine which had been left at room temperature) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site was Painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was Painful) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site was Painful). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (oral) for Vaccination site pain, at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE PAIN (Injection site was Painful) had resolved. Not Provided   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.    This case was linked to MOD-2021-076881 (Patient Link).
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Hypersensitivity, Rash
Clinical narrative: allergic reaction; rash all over; very weak; stomach feels bad; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), RASH (rash all over), ASTHENIA (very weak) and ABDOMINAL DISCOMFORT (stomach feels bad) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction), RASH (rash all over), ASTHENIA (very weak) and ABDOMINAL DISCOMFORT (stomach feels bad). At the time of the report, HYPERSENSITIVITY (allergic reaction), RASH (rash all over), ASTHENIA (very weak) and ABDOMINAL DISCOMFORT (stomach feels bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took diphenhydramine for treatment.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Throat irritation
Clinical narrative: heavy breathing; itchy throat; chest discomfort and pain; heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (heavy breathing), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest discomfort and pain) and HEART RATE INCREASED (heartbeat) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DYSPNOEA (heavy breathing), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest discomfort and pain) and HEART RATE INCREASED (heartbeat). At the time of the report, DYSPNOEA (heavy breathing), THROAT IRRITATION (itchy throat), CHEST DISCOMFORT (chest discomfort and pain) and HEART RATE INCREASED (heartbeat) outcome was unknown. Not Provided          Patient stated that received first Moderna vaccine injection on 17Mar2021. Lot number of vaccine was read as 008B21-2A. Patient received the second one on 14Apr2021. Patient experienced in the evening of vaccination day and on15Apr2021 heavy breathing, itchy throat, chest discomfort and pain, heartbeat. No treatment, no concomitants