chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vomiting
Clinical narrative: Weakness; Diarrhea; Red knot two inches around arm; Red knot two inches around arm; Arm swelling; got up and felt heat up legs into entire body; lightheaded,thought I was going to faint; Vommiting; arm itching; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING HOT (got up and felt heat up legs into entire body), DIZZINESS (lightheaded,thought I was going to faint) and VACCINATION SITE PRURITUS (arm itching) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones (22 broken bones due to car accident) and Brain injury (due to car accident). Concurrent medical conditions included Non-Hodgkin's lymphoma. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), DULOXETINE HYDROCHLORIDE (CYMBALTA), PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LAMOTRIGINE (LAMICTAL), ALPRAZOLAM (XANAX), LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), BIOTIN and COLECALCIFEROL (D3) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm itching) and NAUSEA (nausea). On 19-Feb-2021, the patient experienced VOMITING (Vommiting). On 28-Feb-2021, the patient experienced FEELING HOT (got up and felt heat up legs into entire body) and DIZZINESS (lightheaded,thought I was going to faint). On an unknown date, the patient experienced ASTHENIA (Weakness), DIARRHOEA (Diarrhea), VACCINATION SITE INDURATION (Red knot two inches around arm), VACCINATION SITE ERYTHEMA (Red knot two inches around arm) and VACCINATION SITE SWELLING (Arm swelling). At the time of the report, ASTHENIA (Weakness), DIARRHOEA (Diarrhea), FEELING HOT (got up and felt heat up legs into entire body), DIZZINESS (lightheaded,thought I was going to faint), VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE INDURATION (Red knot two inches around arm), VACCINATION SITE SWELLING (Arm swelling) and VOMITING (Vommiting) outcome was unknown and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Slight rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and RASH (Slight rash) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced URTICARIA (Hives) and RASH (Slight rash). On 10-Feb-2021, URTICARIA (Hives) and RASH (Slight rash) had resolved.            Treatment provided includes steroids.   This case was linked to MOD21-050439, MOD-2021-040668 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swollen tongue
Clinical narrative: hands are numb; swollen tongue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hands are numb) and SWOLLEN TONGUE (swollen tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LOSARTAN POTASSIUM (COZAAR), CLONIDINE, FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), NORTRIPTYLINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ANASTROZOLE for an unknown indication.    On 09-Mar-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HYPOAESTHESIA (hands are numb) and SWOLLEN TONGUE (swollen tongue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (hands are numb) and SWOLLEN TONGUE (swollen 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sensation in eye, Arthralgia, Body temperature, Eye swelling, Head discomfort
Clinical narrative: Fever; Head pressure; The shakes; Eyes were hot; Right arm and shoulder soreness; Head cold; Swollen and puffy eyes; Swollen and puffy eyes; Right arm and shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), NERVOUSNESS (The shakes), ABNORMAL SENSATION IN EYE (Eyes were hot), PAIN IN EXTREMITY (Right arm and shoulder soreness) and NASOPHARYNGITIS (Head cold) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included PROPRANOLOL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (Head pressure), NERVOUSNESS (The shakes), ABNORMAL SENSATION IN EYE (Eyes were hot), PAIN IN EXTREMITY (Right arm and shoulder soreness), NASOPHARYNGITIS (Head cold), PERIORBITAL SWELLING (Swollen and puffy eyes), EYE SWELLING (Swollen and puffy eyes) and ARTHRALGIA (Right arm and shoulder soreness). On 11-Mar-2021, the patient experienced PYREXIA (Fever). On 11-Mar-2021, NERVOUSNESS (The shakes) and ABNORMAL SENSATION IN EYE (Eyes were hot) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), PAIN IN EXTREMITY (Right arm and shoulder soreness), NASOPHARYNGITIS (Head cold), PERIORBITAL SWELLING (Swollen and puffy eyes), EYE SWELLING (Swollen and puffy eyes), ARTHRALGIA (Right arm and shoulder soreness) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.4 (High) 101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nervousness, Pain in extremity, Periorbital swelling, Pyrexia
Clinical narrative: Fever; Head pressure; The shakes; Eyes were hot; Right arm and shoulder soreness; Head cold; Swollen and puffy eyes; Swollen and puffy eyes; Right arm and shoulder soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), NERVOUSNESS (The shakes), ABNORMAL SENSATION IN EYE (Eyes were hot), PAIN IN EXTREMITY (Right arm and shoulder soreness) and NASOPHARYNGITIS (Head cold) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included PROPRANOLOL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEAD DISCOMFORT (Head pressure), NERVOUSNESS (The shakes), ABNORMAL SENSATION IN EYE (Eyes were hot), PAIN IN EXTREMITY (Right arm and shoulder soreness), NASOPHARYNGITIS (Head cold), PERIORBITAL SWELLING (Swollen and puffy eyes), EYE SWELLING (Swollen and puffy eyes) and ARTHRALGIA (Right arm and shoulder soreness). On 11-Mar-2021, the patient experienced PYREXIA (Fever). On 11-Mar-2021, NERVOUSNESS (The shakes) and ABNORMAL SENSATION IN EYE (Eyes were hot) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), PAIN IN EXTREMITY (Right arm and shoulder soreness), NASOPHARYNGITIS (Head cold), PERIORBITAL SWELLING (Swollen and puffy eyes), EYE SWELLING (Swollen and puffy eyes), ARTHRALGIA (Right arm and shoulder soreness) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.4 (High) 101.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and ARTHRALGIA (Joint pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Pain) and ARTHRALGIA (Joint pain). At the time of the report, PAIN (Pain) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinusitis, Vomiting
Clinical narrative: Sinus problems; Sound like she has a cold; Spitting up; A spontaneous report (United States) was received from a consumer concerning a 96-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sinus problems, sound like she has a cold, spitting up.  The patient's medical history was not provided. Concomitant medications reported were vitamin B1, vitamin B12, armour Thyroid for drug use for unknown indication.Patient states she lost her vaccination card but received the 1st dose of Moderna COVID19 vaccine 3-4 weeks ago. Approximately on 10 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly  in left non-dominant arm for prophylaxis of COVID-19 infection. She is due for the 2nd dose on 12Mar2021.  On 4 Mar 2021, the patient experienced the events sinus problems, sound like she has a cold, spitting up.She wanted to know if she can still get the second dose. Patient did not consent for safety team to contact her health care professional.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, sinus problems, sound like she has a cold, spitting up were unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea; Experienced fever of 101 degrees F; Started vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PYREXIA (Experienced fever of 101 degrees F) and VOMITING (Started vomiting) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 24-Oct-2020.    On 08-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 DIARRHOEA (Diarrhea), PYREXIA (Experienced fever of 101 degrees F) and VOMITING (Started vomiting). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PYREXIA (Experienced fever of 101 degrees F) and VOMITING (Started vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101 degrees f (High) 101 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: Shortness of breath; Very sick; No sleep; face is all puffy; Exhausted; Major headache; Whole body achy; Vomit; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DYSPNOEA (Shortness of breath), ILLNESS (Very sick), INSOMNIA (No sleep) and SKIN SWELLING (face is all puffy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizzy). On 11-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), ILLNESS (Very sick), INSOMNIA (No sleep), SKIN SWELLING (face is all puffy), FATIGUE (Exhausted), HEADACHE (Major headache), MYALGIA (Whole body achy) and VOMITING (Vomit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy), DYSPNOEA (Shortness of breath), ILLNESS (Very sick), INSOMNIA (No sleep), SKIN SWELLING (face is all puffy), FATIGUE (Exhausted), HEADACHE (Major headache), MYALGIA (Whole body achy) and VOMITING (Vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 102.2 (High) degrees Fahrenheit.         No concomitant medications were reported.  Treatment information also included a rescue inhaler. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-212975 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Myalgia, Skin swelling, Vomiting
Clinical narrative: Shortness of breath; Very sick; No sleep; face is all puffy; Exhausted; Major headache; Whole body achy; Vomit; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DYSPNOEA (Shortness of breath), ILLNESS (Very sick), INSOMNIA (No sleep) and SKIN SWELLING (face is all puffy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Dizzy). On 11-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), ILLNESS (Very sick), INSOMNIA (No sleep), SKIN SWELLING (face is all puffy), FATIGUE (Exhausted), HEADACHE (Major headache), MYALGIA (Whole body achy) and VOMITING (Vomit). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzy), DYSPNOEA (Shortness of breath), ILLNESS (Very sick), INSOMNIA (No sleep), SKIN SWELLING (face is all puffy), FATIGUE (Exhausted), HEADACHE (Major headache), MYALGIA (Whole body achy) and VOMITING (Vomit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 102.2 (High) degrees Fahrenheit.         No concomitant medications were reported.  Treatment information also included a rescue inhaler. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.   This case was linked to MOD-2021-212975 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nodule, Pain, Pruritus
Clinical narrative: One huge red bump on upper arm; Itchy arm; Aches; Low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches), PYREXIA (Low grade fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT) for Bronchial dilator level NOS, OXYGEN for an unknown indication.   On 25-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 01-Feb-2021, the patient experienced NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 10-Feb-2021, NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches) and HEADACHE (Headache) had resolved. On 26-Feb-2021, PYREXIA (Low grade fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: One huge red bump on upper arm; Itchy arm; Aches; Low grade fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches), PYREXIA (Low grade fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT RESPIMAT) for Bronchial dilator level NOS, OXYGEN for an unknown indication.   On 25-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 01-Feb-2021, the patient experienced NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches), PYREXIA (Low grade fever), CHILLS (Chills) and HEADACHE (Headache). On 10-Feb-2021, NODULE (One huge red bump on upper arm), PRURITUS (Itchy arm), PAIN (Aches) and HEADACHE (Headache) had resolved. On 26-Feb-2021, PYREXIA (Low grade fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Injection site pain, Palpitations
Clinical narrative: Did not feel good; Heart racing; Her body felt very hot and she sweated profusely; Tiredness; sore arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Did not feel good), PALPITATIONS (Heart racing), HYPERHIDROSIS (Her body felt very hot and she sweated profusely), INJECTION SITE PAIN (sore arm) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Compazine). Concomitant products included TAMOXIFEN from 07-Jan-2021 to an unknown date for Breast cancer, ZOLPIDEM for Sleep disorder therapy.   On 08-Mar-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021 at 10:00 AM, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (sore arm). On 09-Mar-2021, the patient experienced FEELING ABNORMAL (Did not feel good), PALPITATIONS (Heart racing), HYPERHIDROSIS (Her body felt very hot and she sweated profusely) and FATIGUE (Tiredness). On 09-Mar-2021, PALPITATIONS (Heart racing) and HYPERHIDROSIS (Her body felt very hot and she sweated profusely) had resolved. At the time of the report, FEELING ABNORMAL (Did not feel good), INJECTION SITE PAIN (sore arm) and FATIGUE (Tiredness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up contains significant information updated reporter's details, patient demographics, past medical history, batch number of two doses, time of vaccine administration and  concomitant medications.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vertigo
Clinical narrative: Vertigo; red whelt on her injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) and VACCINATION SITE URTICARIA (red whelt on her injection arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunosuppression.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced VACCINATION SITE URTICARIA (red whelt on her injection arm). At the time of the report, VERTIGO (Vertigo) and VACCINATION SITE URTICARIA (red whelt on her injection arm) outcome was unknown.            No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Feeling abnormal
Clinical narrative: Little spaced; Dizzied; No energy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Little spaced), DIZZINESS (Dizzied), ASTHENIA (No energy) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced ASTHENIA (No energy) and CHILLS (Chills). On 09-Mar-2021, the patient experienced DIZZINESS (Dizzied). On 11-Mar-2021, the patient experienced FEELING ABNORMAL (Little spaced). At the time of the report, FEELING ABNORMAL (Little spaced), DIZZINESS (Dizzied), ASTHENIA (No energy) and CHILLS (Chills) outcome was unknown.            Patient took a pill for dizziness.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Headache, Rash pruritic, Swelling face
Clinical narrative: Left ear double in size; Swollen face especially in front of left ear and up to the left eyebrow; Rashes on the back of her neck which is itchy; After a week started having headache which lasted for 4 day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR SWELLING (Left ear double in size), SWELLING FACE (Swollen face especially in front of left ear and up to the left eyebrow), RASH PRURITIC (Rashes on the back of her neck which is itchy) and HEADACHE (After a week started having headache which lasted for 4 day) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), LISINOPRIL, METFORMIN, VENLAFAXINE and MODAFINIL for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (After a week started having headache which lasted for 4 day). On 06-Mar-2021, the patient experienced EAR SWELLING (Left ear double in size), SWELLING FACE (Swollen face especially in front of left ear and up to the left eyebrow) and RASH PRURITIC (Rashes on the back of her neck which is itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event following immunisation, at an unspecified dose and frequency. On 04-Mar-2021, HEADACHE (After a week started having headache which lasted for 4 day) had resolved. On 10-Mar-2021, EAR SWELLING (Left ear double in size) and SWELLING FACE (Swollen face especially in front of left ear and up to the left eyebrow) had resolved. At the time of the report, RASH PRURITIC (Rashes on the back of her neck which is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itchiness at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Myalgia, Pharyngeal swelling, Pyrexia
Clinical narrative: swelling in her throat area; Shaking; Dizziness; Low grad fever; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID 3 months ago). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever), MYALGIA (Body ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever), MYALGIA (Body ache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that some of the symptoms from the vaccine were similar to that of the COVID symptoms
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: swelling in her throat area; Shaking; Dizziness; Low grad fever; Body ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever) and MYALGIA (Body ache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient had COVID 3 months ago). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and METFORMIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever), MYALGIA (Body ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (swelling in her throat area), TREMOR (Shaking), DIZZINESS (Dizziness), PYREXIA (Low grad fever), MYALGIA (Body ache) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that some of the symptoms from the vaccine were similar to that of the COVID symptoms
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Horrible cough; Flu like symptoms; Body aches so bad she can't touch her skin; Vomited; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F). At the time of the report, COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: fever of 102 f (High) Fever of 102 F. In March 2021, SARS-CoV-2 test: negative (Negative) patient reported that prior to taking the 2nd dose she tested Negative for COVID-19.         No concomitant medications were reported. No treatment medications were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vomiting
Clinical narrative: Horrible cough; Flu like symptoms; Body aches so bad she can't touch her skin; Vomited; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F). At the time of the report, COUGH (Horrible cough), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body aches so bad she can't touch her skin), VOMITING (Vomited) and PYREXIA (Fever of 102F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: fever of 102 f (High) Fever of 102 F. In March 2021, SARS-CoV-2 test: negative (Negative) patient reported that prior to taking the 2nd dose she tested Negative for COVID-19.         No concomitant medications were reported. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Red (covid toe); Tenderness (covid toe); Swelling (covid toe); This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red (covid toe)), TENDERNESS (Tenderness (covid toe)) and SWELLING (Swelling (covid toe)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (Red (covid toe)), TENDERNESS (Tenderness (covid toe)) and SWELLING (Swelling (covid toe)). On 14-Feb-2021, ERYTHEMA (Red (covid toe)) and SWELLING (Swelling (covid toe)) had resolved. At the time of the report, TENDERNESS (Tenderness (covid toe)) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-262885 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received and contain 2nd dose information.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Tickling on both hands and both feet; Sore arm; Chills; Low grade temperature; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tickling on both hands and both feet ), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PYREXIA (Low grade temperature) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CALCIUM LEVOMEFOLATE (METHYL FOLATE) and ETHINYLESTRADIOL, NORETHISTERONE ACETATE (MICROGESTIN) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PARAESTHESIA (Tickling on both hands and both feet ), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PYREXIA (Low grade temperature). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. On 15-Feb-2021, PARAESTHESIA (Tickling on both hands and both feet ) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and PYREXIA (Low grade temperature) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported she went to Urgent Care where she had an x-ray done on her neck, which was fine, no abnormal results reported. she reported her tickling (paresthesia) lasted for 3 days in a constant way, sometimes stronger than the others and sometimes came and went away.   This case was linked to MOD-2021-040708 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red rash on left arm that extends 2 inches from injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash on left arm that extends 2 inches from injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (Red rash on left arm that extends 2 inches from injection site). At the time of the report, VACCINATION SITE RASH (Red rash on left arm that extends 2 inches from injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red rash in the right arm which was the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash in the right arm which was the vaccination site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE RASH (Red rash in the right arm which was the vaccination site). At the time of the report, VACCINATION SITE RASH (Red rash in the right arm which was the vaccination site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Tongue disorder
Clinical narrative: Little bump in his tongue; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Little bump in his tongue) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TONGUE DISORDER (Little bump in his tongue) and FATIGUE (Fatigue). At the time of the report, TONGUE DISORDER (Little bump in his tongue) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported  No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Urticaria
Clinical narrative: hives with crust on shoulder and arm of injection that spread to neck, face and ears; fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives with crust on shoulder and arm of injection that spread to neck, face and ears), FATIGUE (fatigue) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Itchy (Hives in past.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever). On 03-Mar-2021, the patient experienced URTICARIA (hives with crust on shoulder and arm of injection that spread to neck, face and ears). At the time of the report, URTICARIA (hives with crust on shoulder and arm of injection that spread to neck, face and ears), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash from head to toes.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash from head to toes.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (Rash from head to toes.). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash from head to toes.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional dose omission, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient went for his second dose on 09-March-2021 and when Pharmacist saw his allergic reaction he did not give him vaccine and said that he might get even worse anaphylactic reaction; Rash on Chest, back, one leg, both arms; rash was very itchy; rash was  pink in color; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash was very itchy), RASH ERYTHEMATOUS (rash was  pink in color), INTENTIONAL DOSE OMISSION (Patient went for his second dose on 09-March-2021 and when Pharmacist saw his allergic reaction he did not give him vaccine and said that he might get even worse anaphylactic reaction) and RASH (Rash on Chest, back, one leg, both arms) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type I diabetes mellitus.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced RASH PRURITIC (rash was very itchy), RASH ERYTHEMATOUS (rash was  pink in color) and RASH (Rash on Chest, back, one leg, both arms). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Patient went for his second dose on 09-March-2021 and when Pharmacist saw his allergic reaction he did not give him vaccine and said that he might get even worse anaphylactic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash was very itchy), RASH ERYTHEMATOUS (rash was  pink in color) and RASH (Rash on Chest, back, one leg, both arms) had not resolved and INTENTIONAL DOSE OMISSION (Patient went for his second dose on 09-March-2021 and when Pharmacist saw his allergic reaction he did not give him vaccine and said that he might get even worse anaphylactic reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Mar-2021: Additional information included lot number
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Oral pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: throbbing in her mouth; slight pain in arm she received the injection / whenever she gets a shot and explained that she gets an exaggerated pain; swelling in arm she received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slight pain in arm she received the injection / whenever she gets a shot and explained that she gets an exaggerated pain), VACCINATION SITE SWELLING (swelling in arm she received the injection) and ORAL PAIN (throbbing in her mouth) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Arthritis in hands, but not too severe). Concurrent medical conditions included Fibromyalgia.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight pain in arm she received the injection / whenever she gets a shot and explained that she gets an exaggerated pain) and VACCINATION SITE SWELLING (swelling in arm she received the injection). On 30-Mar-2021, the patient experienced ORAL PAIN (throbbing in her mouth). The patient was treated with EUCALYPTUS GLOBULUS OIL, MENTHOL, PROPYLENE GLYCOL (ICE COOL GEL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (slight pain in arm she received the injection / whenever she gets a shot and explained that she gets an exaggerated pain), VACCINATION SITE SWELLING (swelling in arm she received the injection) and ORAL PAIN (throbbing in her mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Computerised tomogram: unknown (Inconclusive) CT with contrast Unknown result.     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.   She always has to put an ice pack on her injection site whenever she gets a shot and explained that she gets an exaggerated pain due to history of fibromyalgia. She uses baking soda, water pick, swish and spit with salt water to take care of her teeth.   Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Event was updated