chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; fever-102 F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever-102 F) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-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 CHILLS (Chills) and PYREXIA (fever-102 F). On 10-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, PYREXIA (fever-102 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102 (High) 102 F.         Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash, Urticaria
Clinical narrative: Hives covering entire body; Rash appeared Monday morning on arms and started spreading; Itching; Swelling under arms; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives covering entire body), PRURITUS (Itching), PERIPHERAL SWELLING (Swelling under arms) and RASH (Rash appeared Monday morning on arms and started spreading) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 PRURITUS (Itching) and PERIPHERAL SWELLING (Swelling under arms). On 05-Apr-2021, the patient experienced URTICARIA (Hives covering entire body) and RASH (Rash appeared Monday morning on arms and started spreading). At the time of the report, URTICARIA (Hives covering entire body), PRURITUS (Itching), PERIPHERAL SWELLING (Swelling under arms) and RASH (Rash appeared Monday morning on arms and started spreading) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product  was used by patient.  No treatment medication was taken for events.  patient had experience similar allergic reactions in the past and reports skin peeling "like being badly sunburned" when it resolves.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling, Rash
Clinical narrative: swollen; rash; swollen lymph node under armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen), RASH (rash) and LYMPHADENOPATHY (swollen lymph node under armpit) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to oats) and Drug allergy (Allergic to methanic acid).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen), RASH (rash) and LYMPHADENOPATHY (swollen lymph node under armpit). At the time of the report, PERIPHERAL SWELLING (swollen), RASH (rash) and LYMPHADENOPATHY (swollen lymph node under armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that 1 Week later after receiving vaccine that she had swollen lymph node under armpit and a rash. Arm was swollen too. Went away but came back worse last night. Treatment medication: calamine lotion.    Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Vaccination site swelling
Clinical narrative: lips swollen; injection arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swollen) and VACCINATION SITE SWELLING (injection arm swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (takes medications for blood pressure). Concomitant products included PHENYTOIN SODIUM (DILANTIN [PHENYTOIN SODIUM]) and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced LIP SWELLING (lips swollen) and VACCINATION SITE SWELLING (injection arm swollen). At the time of the report, LIP SWELLING (lips swollen) and VACCINATION SITE SWELLING (injection arm swollen) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product included blood pressure medication. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Head discomfort, Headache
Clinical narrative: Head is pulsing; Headache; A lot of chills; Fever; Couldn't sleep; Back pain; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain), HEAD DISCOMFORT (Head is pulsing) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-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 INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced HEAD DISCOMFORT (Head is pulsing), HEADACHE (Headache) and CHILLS (A lot of chills). At the time of the report, INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain), HEAD DISCOMFORT (Head is pulsing), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (A lot of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia
Clinical narrative: Head is pulsing; Headache; A lot of chills; Fever; Couldn't sleep; Back pain; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain), HEAD DISCOMFORT (Head is pulsing) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-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 INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced HEAD DISCOMFORT (Head is pulsing), HEADACHE (Headache) and CHILLS (A lot of chills). At the time of the report, INSOMNIA (Couldn't sleep), BACK PAIN (Back pain), CHEST PAIN (Chest pain), HEAD DISCOMFORT (Head is pulsing), PYREXIA (Fever), HEADACHE (Headache) and CHILLS (A lot of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms; Feeling hot and cold; Body ache; Chills; This case was received via an unknown source, no reference has been entered for a health authority on 11-Apr-2021 and was forwarded to Moderna on 11-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, FEELING OF BODY TEMPERATURE CHANGE, MYALGIA, and CHILLS in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A821A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS, FEELING OF BODY TEMPERATURE CHANGE, MYALGIA, and CHILLS. At the time of the report, INFLUENZA LIKE ILLNESS, FEELING OF BODY TEMPERATURE CHANGE, MYALGIA, and CHILLS had not resolved.            The patient called to report adverse events that the patient was currently experiencing. The patient few hours after getting the second shot of Moderna vaccine, the patient felt flu like symptoms, chills, felt hot and cold, and body aches.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-072516.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: A little tired/intense extreme fatigue; A little headachy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little tired/intense extreme fatigue) and HEADACHE (A little headachy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (A little tired/intense extreme fatigue). 03-Apr-2021, the patient experienced HEADACHE (A little headachy). At the time of the report, FATIGUE (A little tired/intense extreme fatigue) and HEADACHE (A little headachy) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Illness, Vomiting
Clinical narrative: Vomiting; Sickness; Diarrhea; Tummy is going wild; Stomach is ill; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Tummy is going wild; Stomach is ill), CHILLS (Chills) and VOMITING (Vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Centrum, POTASSIUM, DIPYRIDAMOLE (PERSANTINE), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CITALOPRAM, LOXAPINE, ALPRAZOLAM, CITALOPRAM and Others for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 08-Apr-2021, the patient experienced ILLNESS (Sickness), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Tummy is going wild; Stomach is ill) and CHILLS (Chills). On 10-Apr-2021, the patient experienced VOMITING (Vomiting). At the time of the report, ILLNESS (Sickness), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Tummy is going wild; Stomach is ill), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Fatigue, Pain, Pyrexia
Clinical narrative: Neck and armpit warm to the touch; Swelling like a lump on neck and left armpit; Left armpit hurts; bones pain; Full body pain; joints pain; Fever; A lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones pain), VACCINATION SITE WARMTH (Neck and armpit warm to the touch), PAIN (Full body pain), ARTHRALGIA (joints pain) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 06-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 BONE PAIN (bones pain), PAIN (Full body pain), ARTHRALGIA (joints pain), PYREXIA (Fever) and FATIGUE (A lot of fatigue). On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Neck and armpit warm to the touch), VACCINATION SITE SWELLING (Swelling like a lump on neck and left armpit) and VACCINATION SITE PAIN (Left armpit hurts). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 08-Apr-2021, BONE PAIN (bones pain), PAIN (Full body pain), ARTHRALGIA (joints pain), PYREXIA (Fever) and FATIGUE (A lot of fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (Neck and armpit warm to the touch), VACCINATION SITE SWELLING (Swelling like a lump on neck and left armpit) and VACCINATION SITE PAIN (Left armpit hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included high blood pressure medication. Treatment information included tylenol for fever.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Neck and armpit warm to the touch; Swelling like a lump on neck and left armpit; Left armpit hurts; bones pain; Full body pain; joints pain; Fever; A lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones pain), VACCINATION SITE WARMTH (Neck and armpit warm to the touch), PAIN (Full body pain), ARTHRALGIA (joints pain) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 06-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 BONE PAIN (bones pain), PAIN (Full body pain), ARTHRALGIA (joints pain), PYREXIA (Fever) and FATIGUE (A lot of fatigue). On 09-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Neck and armpit warm to the touch), VACCINATION SITE SWELLING (Swelling like a lump on neck and left armpit) and VACCINATION SITE PAIN (Left armpit hurts). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 08-Apr-2021, BONE PAIN (bones pain), PAIN (Full body pain), ARTHRALGIA (joints pain), PYREXIA (Fever) and FATIGUE (A lot of fatigue) had resolved. At the time of the report, VACCINATION SITE WARMTH (Neck and armpit warm to the touch), VACCINATION SITE SWELLING (Swelling like a lump on neck and left armpit) and VACCINATION SITE PAIN (Left armpit hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product included high blood pressure medication. Treatment information included tylenol for fever.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Vaccination site pain, Vaccination site swelling
Clinical narrative: experienced loss of taste; her arm became sore; swollen; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (experienced loss of taste), VACCINATION SITE PAIN (her arm became sore) and VACCINATION SITE SWELLING (swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A821A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (her arm became sore) and VACCINATION SITE SWELLING (swollen). On an unknown date, the patient experienced AGEUSIA (experienced loss of taste). At the time of the report, AGEUSIA (experienced loss of taste), VACCINATION SITE PAIN (her arm became sore) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Myalgia, Wheezing
Clinical narrative: Coughing; wheezing; difficulty breathing; Body ache; tired; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), WHEEZING (wheezing), DYSPNOEA (difficulty breathing), MYALGIA (Body ache) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma (medicine for one eye).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced COUGH (Coughing), WHEEZING (wheezing), DYSPNOEA (difficulty breathing), MYALGIA (Body ache) and FATIGUE (tired). At the time of the report, COUGH (Coughing), WHEEZING (wheezing), DYSPNOEA (difficulty breathing), MYALGIA (Body ache) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes inhaler, Flonase.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: body ache; soreness of the injection site and slight body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache) and VACCINATION SITE PAIN (soreness of the injection site and slight body ache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04A821A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (body ache) and VACCINATION SITE PAIN (soreness of the injection site and slight body ache). At the time of the report, PAIN (body ache) and VACCINATION SITE PAIN (soreness of the injection site and slight body ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-072506 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M204 or 022M20A and 007B21A or 007821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included OXYCODONE, SEMAGLUTIDE (OZEMPIC), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION HYDROCHLORIDE (WELLBUTRIN), METFORMIN, MULTIVITAMINS [VITAMINS NOS], ZINC and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). At the time of the report, VACCINATION SITE PAIN (Arm soreness) outcome was unknown.            Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site mass, Peripheral swelling, Urticaria
Clinical narrative: redness; lump has not gone down; hives; arm is swollen, hot, and red; arm is swollen, hot, and red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), INJECTION SITE MASS (lump has not gone down), URTICARIA (hives), PERIPHERAL SWELLING (arm is swollen, hot, and red) and FEELING HOT (arm is swollen, hot, and red) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02A23A) for COVID-19 vaccination.     Concomitant products included RAMIPRIL, BISOPROLOL, CLOPIDOGREL BISULFATE (PLAVIX) and ROSUVASTATIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-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 ERYTHEMA (redness), INJECTION SITE MASS (lump has not gone down), URTICARIA (hives), PERIPHERAL SWELLING (arm is swollen, hot, and red) and FEELING HOT (arm is swollen, hot, and red). At the time of the report, ERYTHEMA (redness), INJECTION SITE MASS (lump has not gone down), URTICARIA (hives), PERIPHERAL SWELLING (arm is swollen, hot, and red) and FEELING HOT (arm is swollen, hot, and red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details pertained to the events were not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: Arm was itchy; A little arm soreness; A rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was itchy), PAIN IN EXTREMITY (A little arm soreness) and RASH (A rash) in a 74-year-old female 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Arm was itchy), PAIN IN EXTREMITY (A little arm soreness) and RASH (A rash). At the time of the report, PRURITUS (Arm was itchy), PAIN IN EXTREMITY (A little arm soreness) and RASH (A rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided  by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Dizziness, Erythema, Pruritus, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red knees and elbows turned red), BLISTER (itchy Measles-like blisters), DIZZINESS (very dizzy), PRURITUS (itchy Measles-like blisters) and VACCINATION SITE PAIN (hurting at the injection site) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On an unknown date, the patient experienced ERYTHEMA (red knees and elbows turned red), BLISTER (itchy Measles-like blisters), DIZZINESS (very dizzy), PRURITUS (itchy Measles-like blisters) and VACCINATION SITE PAIN (hurting at the injection site). At the time of the report, ERYTHEMA (red knees and elbows turned red), BLISTER (itchy Measles-like blisters), DIZZINESS (very dizzy), PRURITUS (itchy Measles-like blisters) and VACCINATION SITE PAIN (hurting at the injection site) outcome was unknown. Treatment information not provided. List of concomitant medication were not given. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: TCR received on 16-JUN-2021 contains No new information found.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Racing of the Heart; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Racing of the Heart) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PALPITATIONS (Racing of the Heart). At the time of the report, PALPITATIONS (Racing of the Heart) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain
Clinical narrative: Bones pains; Weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE PAIN (Bones pains) and ASTHENIA (Weakness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M24A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included INSULIN for Diabetes.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced BONE PAIN (Bones pains) and ASTHENIA (Weakness). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, BONE PAIN (Bones pains) and ASTHENIA (Weakness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The batch number of the second dose mRNA-1273 received was 001B21A  Concomitant medications also include High blood pressure medications and other medications for diabetes.  It was reported that the symptoms of the patient had worsened on a daily basis. And therefore denied for further followup.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR received on 17-JUN-2021 contains information about the worsening events and also denial for further follow up.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It hurt little bit when they put needle in) and EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported). Concomitant products included OMEPRAZOLE, CITALOPRAM, AMLODIPINE, LISINOPRIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ACETYLSALICYLIC ACID (BABY ASPIRIN), ZINC, DOCUSATE SODIUM, TEMAZEPAM and ROSUVASTATIN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got medicine that was expired). On an unknown date, the patient experienced PAIN (It hurt little bit when they put needle in). On 11-Jan-2021, EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) had resolved. At the time of the report, PAIN (It hurt little bit when they put needle in) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: no antibodies OTHER. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Centrum silver, Omega3 fish oil, CoQ10
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Dizziness, Fatigue
Clinical narrative: whole body pain; dizziness; arm soreness; ringing in ears got worse (10/10); sharp pain in stomach; joint pain; chills like flu coming; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)) and ABDOMINAL PAIN UPPER (sharp pain in stomach) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A or 007821A and 022M204 or 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, SEMAGLUTIDE (OZEMPIC), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION HYDROCHLORIDE (WELLBUTRIN), METFORMIN, MULTIVITAMIN [VITAMINS NOS], ZINC and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)), ABDOMINAL PAIN UPPER (sharp pain in stomach), ARTHRALGIA (joint pain), CHILLS (chills like flu coming), FATIGUE (tired) and HEADACHE (headache). At the time of the report, PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)), ABDOMINAL PAIN UPPER (sharp pain in stomach), ARTHRALGIA (joint pain), CHILLS (chills like flu coming), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-072518 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Tinnitus
Clinical narrative: whole body pain; dizziness; arm soreness; ringing in ears got worse (10/10); sharp pain in stomach; joint pain; chills like flu coming; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)) and ABDOMINAL PAIN UPPER (sharp pain in stomach) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A or 007821A and 022M204 or 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, SEMAGLUTIDE (OZEMPIC), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), BUPROPION HYDROCHLORIDE (WELLBUTRIN), METFORMIN, MULTIVITAMIN [VITAMINS NOS], ZINC and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)), ABDOMINAL PAIN UPPER (sharp pain in stomach), ARTHRALGIA (joint pain), CHILLS (chills like flu coming), FATIGUE (tired) and HEADACHE (headache). At the time of the report, PAIN (whole body pain), DIZZINESS (dizziness), PAIN IN EXTREMITY (arm soreness), TINNITUS (ringing in ears got worse (10/10)), ABDOMINAL PAIN UPPER (sharp pain in stomach), ARTHRALGIA (joint pain), CHILLS (chills like flu coming), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  No treatment medications provided by the reporter.   This case was linked to MOD-2021-072518 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Incorrect route of product administration, Pain in extremity
Clinical narrative: Very sore arm; Feeling gross; Suspicion of wrong injection site ("on triceps"); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm), FEELING ABNORMAL (Feeling gross) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspicion of wrong injection site ("on triceps")) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-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 PAIN IN EXTREMITY (Very sore arm), FEELING ABNORMAL (Feeling gross) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspicion of wrong injection site ("on triceps")). At the time of the report, PAIN IN EXTREMITY (Very sore arm), FEELING ABNORMAL (Feeling gross) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Suspicion of wrong injection site ("on triceps")) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, feeling abnormal and pain in extremity, a causal relationship cannot be excluded.  This report also refers to a case of Incorrect route of product Administration for mRNA-1273, lot # 025B21A.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, feeling abnormal and pain in extremity, a causal relationship cannot be excluded.  This report also refers to a case of Incorrect route of product Administration for mRNA-1273, lot # 025B21A.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise
Clinical narrative: Dizziness when she gets up; she was not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness when she gets up) and MALAISE (she was not feeling well) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Vertigo. Concomitant products included MECLIZINE HCL for an unknown indication.    On 07-Apr-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 DIZZINESS (Dizziness when she gets up) and MALAISE (she was not feeling well). At the time of the report, DIZZINESS (Dizziness when she gets up) and MALAISE (she was not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Significant Follow up
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain
Clinical narrative: hurt little bit when they put needle in; got medicine that was expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) and PAIN (hurt little bit when they put needle in) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CLONIDINE, HYDRALAZINE, MONTELUKAST, HYDROXYZINE HCL, DOCUSATE SODIUM, ACETYLSALICYLIC ACID (ASPIRIN 81) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (got medicine that was expired). On an unknown date, the patient experienced PAIN (hurt little bit when they put needle in). On 11-Jan-2021, EXPIRED PRODUCT ADMINISTERED (got medicine that was expired) had resolved. At the time of the report, PAIN (hurt little bit when they put needle in) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Malaise, Peripheral coldness
Clinical narrative: Malaise; Clammy Skin; Cold to touch; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), HYPERHIDROSIS (Clammy Skin), PERIPHERAL COLDNESS (Cold to touch) and FATIGUE (Fatigue) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MALAISE (Malaise), HYPERHIDROSIS (Clammy Skin), PERIPHERAL COLDNESS (Cold to touch) and FATIGUE (Fatigue). At the time of the report, MALAISE (Malaise), HYPERHIDROSIS (Clammy Skin), PERIPHERAL COLDNESS (Cold to touch) and FATIGUE (Fatigue) outcome was unknown.            No Concomitant product details were provided by the reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Added Reporter Address and E-mail id - Considered as Non significant follow-Up
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Body aches; Feeling feverish; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Feeling feverish) and CHILLS (Chills) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PAIN (Body aches), PYREXIA (Feeling feverish) and CHILLS (Chills). At the time of the report, PAIN (Body aches), PYREXIA (Feeling feverish) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was Paraflu.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Vaccination site coldness
Clinical narrative: felt cold in the arm that was vaccinated; nervousness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE COLDNESS (felt cold in the arm that was vaccinated) and NERVOUSNESS (nervousness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.     On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE COLDNESS (felt cold in the arm that was vaccinated) and NERVOUSNESS (nervousness). At the time of the report, VACCINATION SITE COLDNESS (felt cold in the arm that was vaccinated) and NERVOUSNESS (nervousness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered to unauthorized age group; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered to unauthorized age group) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered to unauthorized age group). On 10-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered to unauthorized age group) 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.  This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 044A21A,  with no associated AEs.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # 044A21A,  with no associated AEs.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: body ache; fever of 101 Deg. F and it does not goes down even after taking Tylenol twice; headache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101 Deg. F. and it does not goes down even after taking Tylenol twice), PAIN (body ache), HEADACHE (headache) and DIZZINESS (dizziness) in a 20-year-old 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.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fever of 101 Deg. F. and it does not goes down even after taking Tylenol twice), PAIN (body ache), HEADACHE (headache) and DIZZINESS (dizziness). At the time of the report, PYREXIA (fever of 101 Deg. F. and it does not goes down even after taking Tylenol twice), PAIN (body ache), HEADACHE (headache) and DIZZINESS (dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 degree Fahrenheit High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Patient said that she took Tylenol twice with 4 hours interval.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: extreme shortness of breath (can barely make it to the bathroom even with oxygen tank); feet swollen; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (extreme shortness of breath (can barely make it to the bathroom even with oxygen tank)) and PERIPHERAL SWELLING (feet swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 038K204) for COVID-19 vaccination.     Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA), TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]), VITAMIN D3 and VITAMIN E NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DYSPNOEA (extreme shortness of breath (can barely make it to the bathroom even with oxygen tank)) and PERIPHERAL SWELLING (feet swollen). At the time of the report, DYSPNOEA (extreme shortness of breath (can barely make it to the bathroom even with oxygen tank)) and PERIPHERAL SWELLING (feet swollen) outcome was unknown.            No Treatment medication reported. Patient advised that she had other medicines that caused her to have shortness of breath and she used an oxygen tank. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow-up received on 08-JUL-2021, reporter information like address ,fax, name and AE contact information was updated On 29-Jul-2021: Non Significant follow-up