chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Lip swelling, Paraesthesia
Clinical narrative: swollen face lips; swollen face lips; sob; squeezing of the chest; tingling; chills (hot and cold); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest) and PARAESTHESIA (tingling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information provided by the reporter. and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE, TIOTROPIUM BROMIDE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest), PARAESTHESIA (tingling) and CHILLS (chills (hot and cold)). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest), PARAESTHESIA (tingling) and CHILLS (chills (hot and cold)) outcome was unknown. Not Provided          Concomitant medication includes Hypertension medications.  Treatment also includes nebulizer.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swollen face lips; swollen face lips; sob; squeezing of the chest; tingling; chills (hot and cold); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest) and PARAESTHESIA (tingling) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information provided by the reporter. and concomitant drugs are provided.  Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE), ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE, TIOTROPIUM BROMIDE (SPIRIVA) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest), PARAESTHESIA (tingling) and CHILLS (chills (hot and cold)). The patient was treated with ACRIVASTINE (BENADRYL ALLERGY RELIEF) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swollen face lips), LIP SWELLING (swollen face lips), DYSPNOEA (sob), CHEST DISCOMFORT (squeezing of the chest), PARAESTHESIA (tingling) and CHILLS (chills (hot and cold)) outcome was unknown. Not Provided          Concomitant medication includes Hypertension medications.  Treatment also includes nebulizer.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 11-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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Product dose omission issue
Clinical narrative: did not receive his 2nd dose; shoulder pain; able to use his right arm, but does have pain in it.; but my right arm went numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (but my right arm went numb), PAIN IN EXTREMITY (able to use his right arm, but does have pain in it.), PRODUCT DOSE OMISSION ISSUE (did not receive his 2nd dose) and ARTHRALGIA (shoulder pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced HYPOAESTHESIA (but my right arm went numb). On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (able to use his right arm, but does have pain in it.). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not receive his 2nd dose) and ARTHRALGIA (shoulder pain). At the time of the report, HYPOAESTHESIA (but my right arm went numb), PRODUCT DOSE OMISSION ISSUE (did not receive his 2nd dose) and ARTHRALGIA (shoulder pain) outcome was unknown and PAIN IN EXTREMITY (able to use his right arm, but does have pain in it.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Two events , product dose omission issue and arthralgia were added.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: Fever; Flu like symptoms; Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body Ache) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015M20A) for COVID-19 vaccination.     .  The patient's past medical history included COVID-19 in October 2020.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PAIN (Body Ache). On 13-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 15-Mar-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body Ache) and PYREXIA (Fever) had resolved.            Concomitant medication information not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Mass, Pain
Clinical narrative: REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM); SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM; KNOT THE SIZE OF A ORANGE IN LEFT ARM; KNOT IS HOT TO TOUCH IN LEFT ARM; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM)), PAIN (SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM), MASS (KNOT THE SIZE OF A ORANGE IN LEFT ARM) and FEELING HOT (KNOT IS HOT TO TOUCH IN LEFT ARM) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ERYTHEMA (REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM)), PAIN (SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM), MASS (KNOT THE SIZE OF A ORANGE IN LEFT ARM) and FEELING HOT (KNOT IS HOT TO TOUCH IN LEFT ARM). At the time of the report, ERYTHEMA (REDNESS IN LEFT ARM /MODERNA ARM (REDNESS IN LEFT ARM)), PAIN (SORENESS IN LEFT ARM /SORNESS IN RIGHT ARM), MASS (KNOT THE SIZE OF A ORANGE IN LEFT ARM) and FEELING HOT (KNOT IS HOT TO TOUCH IN LEFT ARM) outcome was unknown. Not Provided          No treatment information was provided.  No concomitant information was provided.  Action taken with mRNA-123 is not applicable.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Myalgia
Clinical narrative: body aches; tongue was numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (tongue was numb) and MYALGIA (body aches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included METFORMIN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (tongue was numb). On 16-Mar-2021, the patient experienced MYALGIA (body aches). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 15-Mar-2021, HYPOAESTHESIA ORAL (tongue was numb) had resolved. At the time of the report, MYALGIA (body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up information received on 25-Jun-2021 contains significant information. Outcome of the events were changed to recovered/resolved.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: red marks; itchy; feels hot and warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks), PRURITUS (itchy) and FEELING HOT (feels hot and warm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, NIFEDIPINE, LISINOPRIL, LOVASTATIN, CARBIDOPA, CLOPIDOGREL and CALCIUM, COLECALCIFEROL (CALCIUM VIT D) for an unknown indication, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) and VITAMIN D3.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced ERYTHEMA (red marks), PRURITUS (itchy) and FEELING HOT (feels hot and warm). At the time of the report, ERYTHEMA (red marks), PRURITUS (itchy) and FEELING HOT (feels hot and warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Vaccination site reaction
Clinical narrative: swelling of the lips and redness if her face; swelling of the lips and redness if her face; "COVID arm"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("COVID arm"), LIP SWELLING (swelling of the lips and redness if her face) and ERYTHEMA (swelling of the lips and redness if her face) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027l20a) for COVID-19 vaccination.     No medical history information was not provided.  Concurrent medical conditions included Blood pressure. Concomitant products included VITAMINS NOS and CALCIUM for an unknown indication.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE REACTION ("COVID arm"). On 04-Mar-2021, the patient experienced LIP SWELLING (swelling of the lips and redness if her face) and ERYTHEMA (swelling of the lips and redness if her face). On 05-Mar-2021, LIP SWELLING (swelling of the lips and redness if her face) and ERYTHEMA (swelling of the lips and redness if her face) had resolved. On 10-Mar-2021, VACCINATION SITE REACTION ("COVID arm") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes Blood pressure medication.  Patient went to the hospital and got her blood pressure down. At the hospital she received medication to lower her blood pressure, and an antihistamine pill.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Mobility decreased, Pain, Palpitations, Vaccination site pain
Clinical narrative: Soreness came back: Left Arm from Elbow to shoulder; vaccination site pain; Palpitation; Pain Left Breast; Could not lift arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (Palpitation), BREAST PAIN (Pain Left Breast), MOBILITY DECREASED (Could not lift arm), PAIN (Soreness came back: Left Arm from Elbow to shoulder) and VACCINATION SITE PAIN (vaccination site pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PALPITATIONS (Palpitation), BREAST PAIN (Pain Left Breast), MOBILITY DECREASED (Could not lift arm) and VACCINATION SITE PAIN (vaccination site pain). On 11-Mar-2021, the patient experienced PAIN (Soreness came back: Left Arm from Elbow to shoulder). On 19-Feb-2021, BREAST PAIN (Pain Left Breast), MOBILITY DECREASED (Could not lift arm) and VACCINATION SITE PAIN (vaccination site pain) had resolved. On 02-Mar-2021, PALPITATIONS (Palpitation) had resolved. At the time of the report, PAIN (Soreness came back: Left Arm from Elbow to shoulder) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment  include warm shower.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Diarrhoea, Headache, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: diarrhea; vivid dreams; headache; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up) in a 74-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 (November 2020).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up). At the time of the report, DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Mar-2021, Pyrexia: 99.6 (High) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diarrhea; vivid dreams; headache; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up) in a 74-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 (November 2020).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up). At the time of the report, DIARRHOEA (diarrhea), ABNORMAL DREAMS (vivid dreams), HEADACHE (headache) and VOMITING (throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Mar-2021, Pyrexia: 99.6 (High) 99.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant information was provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Depressed mood, Fatigue
Clinical narrative: loss of appetite; feeling down; experiencing fatigue, tired and down; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), DEPRESSED MOOD (feeling down) and FATIGUE (experiencing fatigue, tired and down) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced DECREASED APPETITE (loss of appetite), DEPRESSED MOOD (feeling down) and FATIGUE (experiencing fatigue, tired and down). At the time of the report, DECREASED APPETITE (loss of appetite), DEPRESSED MOOD (feeling down) and FATIGUE (experiencing fatigue, tired and down) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided by the reporter.  Treatment provided not given by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site thrombosis
Clinical narrative: Possibility of blood clot; Swelling at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE THROMBOSIS (Possibility of blood clot) and VACCINATION SITE SWELLING (Swelling 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Mar-2021, the patient experienced VACCINATION SITE THROMBOSIS (Possibility of blood clot) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE THROMBOSIS (Possibility of blood clot) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: NNI On 07-May-2021: NNI
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: red rash at the injection site; red rash at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 09-Mar-2021, the patient experienced VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site). At the time of the report, VACCINATION SITE RASH (red rash at the injection site) and VACCINATION SITE ERYTHEMA (red rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Red rash increased in size and appear like a triangle measuring about 3 inches long x 1.5 inches wide.  Concomitant medication information was not provided.  Treatment medication information was not reported.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 93-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) had resolved. Unknown          Diarrhea lasted for day and then the patient was fine.  Concomitant medication were not provided by the reporter.  Treatment information was not provided. Action taken with mRNA-123 is not applicable. Treatment medication were not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (eye infection) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P32L2DA and P32L2DA) for COVID-19 vaccination.     The patient's past medical history included Eye infection (Not lasted more than two weeks) and Cancer (cancer treatment). Concomitant products included FLUOCINOLONE ACETONIDE, HYDROQUINONE, TRETINOIN (ADVAN THF), BUPROPION HYDROCHLORIDE (WELLBUTRIN), TOPIRAMATE (TOPAMAX) and FULVESTRANT (FASLODEX) for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE INFECTION (eye infection). The patient was treated with TOBRAMYCIN ongoing since an unknown date at a dose of UNK dosage form. On 13-Mar-2021, EYE INFECTION (eye infection) had resolved. Not Provided          Patient reported eye infection in between first & second  vaccine and lasted a quite a while. She never had eye infection that lasted more than two weeks. Eye infection resolved on 13th March and lasted a good two weeks. Infection started a month ago, treated itself for 2 weeks and then received antibiotics. Infection was quite severe.  Treatment provided also include Rizoicyn for unknown indication. Action taken with mRNA-123 is not applicable.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included CEFALEXIN (CEPHALEXIN AMEL) 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 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection). On 07-Mar-2021, VACCINATION SITE PAIN (Soreness at injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided. Reporter wants to know about the reaction between vaccine and antibiotic.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: body aches; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002AZIA) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling hot, Rash macular
Clinical narrative: I had a rash like a blotchy rash; My arm felt hot; Had mild diarrhea; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (I had a rash like a blotchy rash), FEELING HOT (My arm felt hot), DIARRHOEA (Had mild diarrhea) and FATIGUE (Felt tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 08-Mar-2021, the patient experienced DIARRHOEA (Had mild diarrhea) and FATIGUE (Felt tired). On 13-Mar-2021, the patient experienced RASH MACULAR (I had a rash like a blotchy rash) and FEELING HOT (My arm felt hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Mar-2021 for Blotchy rash and Extremities hot feeling of, at a dose of 2 doses. At the time of the report, RASH MACULAR (I had a rash like a blotchy rash) had not resolved and FEELING HOT (My arm felt hot), DIARRHOEA (Had mild diarrhea) and FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in feet) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PARAESTHESIA (Tingling in feet). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in feet) outcome was unknown.            No relevant concomitant medications reported. Treatment information include gabapentin. Action taken with mRNA-123 is not applicable.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: tooth infection in his upper right side of the mouth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH INFECTION (tooth infection in his upper right side of the mouth) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TOOTH INFECTION (tooth infection in his upper right side of the mouth). The patient was treated with AMOXICILLIN ongoing since an unknown date for Infection, at a dose of UNK, tid. At the time of the report, TOOTH INFECTION (tooth infection in his upper right side of the mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  Treatment details included Amoxicillin tid and patient was unsure about the interaction of amoxycillin with the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient found out she is pregnant last week; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient found out she is pregnant last week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 26-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient found out she is pregnant last week). On 26-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient found out she is pregnant last week) had resolved.            No treatment information provided. No relevant concomitant medications reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: when I put my arm back to wash myself there is some pain; Faint ache -not earth shattering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (when I put my arm back to wash myself there is some pain) and VACCINATION SITE PAIN (Faint ache -not earth shattering) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (he had triple bypass 13. years ago).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (when I put my arm back to wash myself there is some pain) and VACCINATION SITE PAIN (Faint ache -not earth shattering). At the time of the report, PAIN IN EXTREMITY (when I put my arm back to wash myself there is some pain) and VACCINATION SITE PAIN (Faint ache -not earth shattering) outcome was unknown.            No treatment medications were taken.  Patient was prescribed with stent medication but doesn't know what name and patient is not taking it currently. Action taken with mRNA-123 is not applicable.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on arm of baseball size; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on arm of baseball size) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-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 on arm of baseball size). At the time of the report, RASH (rash on arm of baseball size) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication and treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema
Clinical narrative: Red mark at injection site; Oval redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red mark at injection site) and ERYTHEMA (Oval redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included MIRABEGRON (MYRBETRIQ) and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red mark at injection site) and ERYTHEMA (Oval redness). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Red mark at injection site) and ERYTHEMA (Oval redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Feeling abnormal, Malaise, Nasopharyngitis
Clinical narrative: dry mouth; covid arm; a red welt that was kind of swollen where the injection was; a red welt that was kind of swollen where the injection was; tiredness; felt kind of off; brain foggish; like I was coming down with a cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold), DRY MOUTH (dry mouth) and TYPE IV HYPERSENSITIVITY REACTION (covid arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety (Because of patients symptoms she is struggling with the decision between receiving and not receiving the second dose. Patient states that this decision is causing her anxiety.).    On 09-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 MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold) and FATIGUE (tiredness). On 11-Mar-2021, the patient experienced DRY MOUTH (dry mouth), TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (a red welt that was kind of swollen where the injection was) and VACCINATION SITE SWELLING (a red welt that was kind of swollen where the injection was). On 12-Mar-2021, MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold), DRY MOUTH (dry mouth), TYPE IV HYPERSENSITIVITY REACTION (covid arm), FATIGUE (tiredness), VACCINATION SITE ERYTHEMA (a red welt that was kind of swollen where the injection was) and VACCINATION SITE SWELLING (a red welt that was kind of swollen where the injection was) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include regular vitamins, prebiotic, a protein shake and greens drink which are all a normal process for her.  Patient reported water as treatment.
Sex: F
Vaccine: COVID19
Symptoms: Type IV hypersensitivity reaction, Vaccination site erythema, Vaccination site swelling
Clinical narrative: dry mouth; covid arm; a red welt that was kind of swollen where the injection was; a red welt that was kind of swollen where the injection was; tiredness; felt kind of off; brain foggish; like I was coming down with a cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold), DRY MOUTH (dry mouth) and TYPE IV HYPERSENSITIVITY REACTION (covid arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety (Because of patients symptoms she is struggling with the decision between receiving and not receiving the second dose. Patient states that this decision is causing her anxiety.).    On 09-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 MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold) and FATIGUE (tiredness). On 11-Mar-2021, the patient experienced DRY MOUTH (dry mouth), TYPE IV HYPERSENSITIVITY REACTION (covid arm), VACCINATION SITE ERYTHEMA (a red welt that was kind of swollen where the injection was) and VACCINATION SITE SWELLING (a red welt that was kind of swollen where the injection was). On 12-Mar-2021, MALAISE (felt kind of off), FEELING ABNORMAL (brain foggish), NASOPHARYNGITIS (like I was coming down with a cold), DRY MOUTH (dry mouth), TYPE IV HYPERSENSITIVITY REACTION (covid arm), FATIGUE (tiredness), VACCINATION SITE ERYTHEMA (a red welt that was kind of swollen where the injection was) and VACCINATION SITE SWELLING (a red welt that was kind of swollen where the injection was) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include regular vitamins, prebiotic, a protein shake and greens drink which are all a normal process for her.  Patient reported water as treatment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Arm was sore after first dose; Doses administered > 1 month apart; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore after first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered > 1 month apart) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered > 1 month apart). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore after first dose). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Doses administered > 1 month apart) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore after first dose) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up TCR contains no new information. The patient did not have any adverse event or effect to report. On 24-Jun-2021: Significant Follow-up added - added information for event after 1st vaccine, updated medical history
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 25-Jan-2021, PAIN IN EXTREMITY (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment and concomitant medication reported.   This case was linked to MOD-2021-044239 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Vertigo
Clinical narrative: the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.; dizziness; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VERTIGO (vertigo) and EAR DISCOMFORT (the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 022M20A) 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 11-Mar-2021, the patient experienced DIZZINESS (dizziness) and VERTIGO (vertigo). On 01-Jul-2021, the patient experienced EAR DISCOMFORT (the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.). On 12-Mar-2021, DIZZINESS (dizziness) and VERTIGO (vertigo) had resolved. At the time of the report, EAR DISCOMFORT (the cause of my dizziness was because on an inner ear issue, not an issue related to the Moderna Covid-19 vaccine.) outcome was unknown.            No concomitant information was provided  No treatment information was provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant : causality updated
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling abnormal, Induration, Pain
Clinical narrative: Arm tenderness; Arm redness; Arm is hard; Chills; Arm soreness; Body aches; Felt rotten; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness), PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches) and FEELING ABNORMAL (Felt rotten) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches), FEELING ABNORMAL (Felt rotten) and CHILLS (Chills). On 14-Mar-2021, the patient experienced TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness) and INDURATION (Arm is hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches), FEELING ABNORMAL (Felt rotten) and CHILLS (Chills) had resolved. At the time of the report, TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness) and INDURATION (Arm is hard) outcome was unknown. Unknown          Concomitant medications reported included steroids oral 5mg qd chronically.   Treatment for the events included paracetamol and cold compress. Action taken with mRNA-123 is not applicable.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Arm tenderness; Arm redness; Arm is hard; Chills; Arm soreness; Body aches; Felt rotten; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness), PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches) and FEELING ABNORMAL (Felt rotten) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches), FEELING ABNORMAL (Felt rotten) and CHILLS (Chills). On 14-Mar-2021, the patient experienced TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness) and INDURATION (Arm is hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, PAIN IN EXTREMITY (Arm soreness), PAIN (Body aches), FEELING ABNORMAL (Felt rotten) and CHILLS (Chills) had resolved. At the time of the report, TENDERNESS (Arm tenderness), ERYTHEMA (Arm redness) and INDURATION (Arm is hard) outcome was unknown. Unknown          Concomitant medications reported included steroids oral 5mg qd chronically.   Treatment for the events included paracetamol and cold compress. Action taken with mRNA-123 is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: hives on her ears and cheeks; it is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her ears and cheeks) and PRURITUS (it is very itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L2O4) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced URTICARIA (hives on her ears and cheeks) and PRURITUS (it is very itchy). At the time of the report, URTICARIA (hives on her ears and cheeks) and PRURITUS (it is very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, the patient is taking unspecified concomitant medications.  The patient did not receive any treatment for these events.  However, the patient wanted to know if she could take Benadryl (diphenhydramine).