chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Upper body rash on neck shoulders, upper arms and parts of my back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Upper body rash on neck shoulders, upper arms and parts of my back) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Upper body rash on neck shoulders, upper arms and parts of my back). At the time of the report, RASH (Upper body rash on neck shoulders, upper arms and parts of my back) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: DOB was updated
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: soreness at injection site; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PAIN (soreness at injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Follow up received on 18-Apr-2021 with no new information and patient not interested in Follow up.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site erythema, Vaccination site rash
Clinical narrative: left side of my face got numb; injection site arm developed a rsh; arm was flaming red from shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (left side of my face got numb), VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (It was in that same arm.) in 2017. Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PARAESTHESIA (left side of my face got numb), VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder). The patient was treated with PREDNISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PARAESTHESIA (left side of my face got numb) had not resolved and VACCINATION SITE RASH (injection site arm developed a rsh) and VACCINATION SITE ERYTHEMA (arm was flaming red from shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medications include an ANTIBIOTIC, and a ANTIHISTAMINE prescribed by the doctor.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Updated outcome of event left side of my face got numb. Consent to FU denied.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Flushing, Head discomfort, Headache
Clinical narrative: Facial flushing; Temperature of 99.9F; Discomfort at top of head; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Facial flushing), BODY TEMPERATURE INCREASED (Temperature of 99.9F), HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced FLUSHING (Facial flushing), BODY TEMPERATURE INCREASED (Temperature of 99.9F), HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 28-Jan-2021, FLUSHING (Facial flushing) and BODY TEMPERATURE INCREASED (Temperature of 99.9F) had resolved. At the time of the report, HEAD DISCOMFORT (Discomfort at top of head) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-090085 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Follow up received and contains :Outcome was updated for event Headache : the event was said to be resolved upon using Paracetamol. And patient was taken 2nd dose of Vaccine and still had sore arm
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pyrexia
Clinical narrative: Fever; Body ache; chills; body ache; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), MYALGIA (body ache), PYREXIA (Fever) and PAIN (Body ache) 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 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CHILLS (chills), MYALGIA (body ache) and PAIN (Body ache). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, CHILLS (chills), MYALGIA (body ache), PYREXIA (Fever) and PAIN (Body ache) outcome was unknown. Not Provided          No treatment information provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal, Flushing, Headache, Myalgia
Clinical narrative: Face started to flush; Sick to her stomach; Did not sleep or feel well; Did not sleep or feel well; Aches and pains throughout her body; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face started to flush), ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well) and MYALGIA (Aches and pains throughout her body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FLUSHING (Face started to flush), ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well), MYALGIA (Aches and pains throughout her body) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 03-Feb-2021, FLUSHING (Face started to flush) had resolved. On 05-Feb-2021, ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well), MYALGIA (Aches and pains throughout her body) and HEADACHE (Bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep deficit
Clinical narrative: Face started to flush; Sick to her stomach; Did not sleep or feel well; Did not sleep or feel well; Aches and pains throughout her body; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face started to flush), ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well) and MYALGIA (Aches and pains throughout her body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FLUSHING (Face started to flush), ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well), MYALGIA (Aches and pains throughout her body) and HEADACHE (Bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 03-Feb-2021, FLUSHING (Face started to flush) had resolved. On 05-Feb-2021, ABDOMINAL PAIN UPPER (Sick to her stomach), SLEEP DEFICIT (Did not sleep or feel well), FEELING ABNORMAL (Did not sleep or feel well), MYALGIA (Aches and pains throughout her body) and HEADACHE (Bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Pruritus, Stress, Urticaria
Clinical narrative: Itching in the Waist Line; Hives around his waistline; Headache on the back of head; Elevated Blood Pressure; stressed out; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out). At the time of the report, PRURITUS (Itching in the Waist Line), URTICARIA (Hives around his waistline), HEADACHE (Headache on the back of head), BLOOD PRESSURE INCREASED (Elevated Blood Pressure) and STRESS (stressed out) outcome was unknown. Not Provided   No treatment information was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Diarrhoea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: COVID-19; Sore throat; Runny nose; Diarrhea; Coughing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021. The most recent information was received on 05-Feb-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder on 01-Mar-2021.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). On 03-Feb-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with AZITHROMYCIN at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     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 were reported as Xarelto, Sotalol and OTC Vitamin in description.  Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 22-Jul-2021, dose 2 removed (not received, only scheduled), Vaccine derived SARS-CoV-2 infection removed, COVID-19 event added, updated action taken to unknown.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: COVID-19; Sore throat; Runny nose; Diarrhea; Coughing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021. The most recent information was received on 05-Feb-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Heart disorder on 01-Mar-2021.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and RHINORRHOEA (Runny nose). On 03-Feb-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with AZITHROMYCIN at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) positive. On 18-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative.     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 were reported as Xarelto, Sotalol and OTC Vitamin in description.  Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection.   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Upon internal review on 22-Jul-2021, dose 2 removed (not received, only scheduled), Vaccine derived SARS-CoV-2 infection removed, COVID-19 event added, updated action taken to unknown.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID-19 infection.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: experienced significant reaction; fever; nausea; muscle aches; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive and Asthma. Concurrent medical conditions included Adhesive tape allergy. Concomitant products included OMALIZUMAB (XOLAIR) for Asthma.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm). At the time of the report, ADVERSE EVENT (experienced significant reaction), PYREXIA (fever), NAUSEA (nausea), MYALGIA (muscle aches) and PAIN IN EXTREMITY (sore right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatments were reported.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling, Vaccination site mass
Clinical narrative: Swollen arm, like a big ball; swollen arm, like a big ball; arm was red and hot to the touch; arm was red and hot to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE MASS (Arm like a big ball), ERYTHEMA (Arm red) and FEELING HOT (Arm hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Drug allergy (tetracycline) and Diabetes. Concomitant products included INSULIN for Diabetes.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE MASS (Arm like a big ball) and ERYTHEMA (Arm red). 23-Jan-2021, the patient experienced FEELING HOT (Arm hot). The patient was treated with Physical therapy (Put ice on arm) for Feeling hot. At the time of the report, PERIPHERAL SWELLING (Swollen arm) had resolved and VACCINATION SITE MASS (Arm like a big ball), ERYTHEMA (Arm red) and FEELING HOT (Arm hot) was resolving.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  It was reported that one hour after the vaccination the patient had a swollen arm, like a big ball, and the arm was red and hot to the touch. Symptoms were still ongoing. The physician advised to put ice on it.  The concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains information regarding outcome of the events.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Therapeutic response unexpected
Clinical narrative: Migraine headache completely disappeared; Warm fairly short lived rush; A Spontaneous  report was received from a consumer concerning an unknown year-old, (unknown gender) patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced therapeutic response unexpected and feeling hot/sensation of warmth.  The patient's medical history was not provided .The concomitant medications were reported as multiple other prescribed medications.  On 15 Jan  2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route in an unknown location for prophylaxis of COVID-19 infection.   It was reported that the patient had on and off  migraine for about a week .On 15 Jan 2021, after seven minutes of vaccine administration patient developed a short lived rush of warmth. The patient was concerned that if it was a negative side effect from the vaccine. About 40 minutes later patient's headache completely disappeared. The patient took no other medications for treatment even though was consuming  some other prescribed medications daily.Patient reported feeling better now with no side effects.  No treatment medication was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events short lived warmth rush and migraine disappeared  were considered as recovered.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness. He attributes this to his walking a lot; This spontaneous case was reported by a physician and describes the occurrence of PAIN (soreness. He attributes this to his walking a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced PAIN (soreness. He attributes this to his walking a lot). At the time of the report, PAIN (soreness. He attributes this to his walking a lot) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated reporter type to physician, Health care professional yes, email address added.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic, Skin haemorrhage
Clinical narrative: little bumps in skull both on the side and top of head were bleeding; upper left side of chest red spots; On upper left side of his chest he had red spots, they were itchy; little bumps up in skull both on the side and top of head; itchy rash left top of chest; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), RASH ERYTHEMATOUS (upper left side of chest red spots), PRURITUS (On upper left side of his chest he had red spots, they were itchy), RASH (little bumps up in skull both on the side and top of head) and RASH PRURITIC (itchy rash left top of chest) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), OCTREOTIDE ACETATE (SANDOSTATIN), LISINOPRIL, LEVOTHYROXINE and ACETAMINOPHEN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 26-Jan-2021, the patient experienced SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), RASH ERYTHEMATOUS (upper left side of chest red spots), PRURITUS (On upper left side of his chest he had red spots, they were itchy), RASH (little bumps up in skull both on the side and top of head) and RASH PRURITIC (itchy rash left top of chest).   The patient was treated with TRIAMCINOLONE (topical) for Rash, at an unspecified dose and frequency.   At the time of the report, SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), PRURITUS (On upper left side of his chest he had red spots, they were itchy) and RASH (little bumps up in skull both on the side and top of head) outcome was unknown and RASH ERYTHEMATOUS (upper left side of chest red spots) and RASH PRURITIC (itchy rash left top of chest) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: New event added and details updated, reporter information were added. Treatment drug information updated. On 22-Apr-2021: NNI updated. Patient declined to provide email address or provide any additional information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea
Clinical narrative: Headache; Nausea; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (Nausea) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (Tylenol) for Headache, at an unspecified dose and frequency.   At the time of the report, HEADACHE (Headache) had not resolved and NAUSEA (Nausea) and MYALGIA (Muscle pain) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant information was reported.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Swelling face
Clinical narrative: Facial swelling; Headache; This spontaneous case was reported by a dentist and describes the occurrence of SWELLING FACE (Facial swelling) and HEADACHE (Headache) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Facial swelling) and HEADACHE (Headache). At the time of the report, SWELLING FACE (Facial swelling) and HEADACHE (Headache) 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 product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Additional information added on 18JUN2021 contains no significant information
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Rash macular, Vaccination site erythema, Vaccination site rash
Clinical narrative: rash size of an orange; blotchy place size of an orange; injection site redness; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm), RASH MACULAR (blotchy place size of an orange), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (rash size of an orange) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included ASCORBIC ACID, BETACAROTENE, COPPER, NICOTINAMIDE, SELENIUM, TOCOPHEROL, XANTOFYL, ZINC (LUTEIN +) for Eye discomfort, MULTIVITAMINS [VITAMINS NOS] and ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN, MALPIGHIA GLABRA, ROSA CANINA, RUTOSIDE (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE]) for an unknown indication.  On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 12-Jan-2021, the patient experienced AXILLARY PAIN (sore arm). On 25-Jan-2021, the patient experienced RASH MACULAR (blotchy place size of an orange) and VACCINATION SITE ERYTHEMA (injection site redness).   On an unknown date, the patient experienced VACCINATION SITE RASH (rash size of an orange). The patient was treated with CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL [CAMPHOR;DIPHENHYDRAMINE HYDROCHLORIDE;ZINC OXIDE]) for Rash, at an unspecified dose and frequency. On 15-Jan-2021, AXILLARY PAIN (sore arm) outcome was unknown.   At the time of the report, RASH MACULAR (blotchy place size of an orange), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE RASH (rash size of an orange) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient's concomitant medication included Heart med and Betablockers.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia, Lip blister
Clinical narrative: Dry mouth; Metallic taste in my mouth; Blistery on her lips; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 02-Feb-2021, the patient experienced DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips).   At the time of the report, DRY MOUTH (Dry mouth), DYSGEUSIA (Metallic taste in my mouth) and LIP BLISTER (Blistery on her lips) 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Sinus disorder, Vaccination site pain
Clinical narrative: SARS-CoV-2 test positive; COVID-19; Sore right arm; sinus problems; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SINUS DISORDER (sinus problems), COVID-19 (COVID-19), VACCINATION SITE PAIN (Sore right arm) and SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced SINUS DISORDER (sinus problems) and VACCINATION SITE PAIN (Sore right arm). On 11-Jan-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive). At the time of the report, SINUS DISORDER (sinus problems) and SARS-COV-2 TEST POSITIVE (SARS-CoV-2 test positive) outcome was unknown and COVID-19 (COVID-19) and VACCINATION SITE PAIN (Sore right arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information received: Patient had declined further follow-up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
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 an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information not provided. Treatment included Aspirin
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Vaccination site swelling
Clinical narrative: swollen lymph node; Swelling; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph node) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling) and HEADACHE (Headache). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, VACCINATION SITE SWELLING (Swelling), HEADACHE (Headache) and LYMPHADENOPATHY (swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: NNI
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Vaccination site pain
Clinical narrative: Body really ached; arm was sore; Migraine Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine Headache), PAIN (Body really ached) and VACCINATION SITE PAIN (arm was sore) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ZOLMITRIPTAN for Migraine.    On 21-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MIGRAINE (Migraine Headache) and VACCINATION SITE PAIN (arm was sore). On an unknown date, the patient experienced PAIN (Body really ached). On 24-Feb-2021, MIGRAINE (Migraine Headache) had resolved. At the time of the report, PAIN (Body really ached) and VACCINATION SITE PAIN (arm was sore) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: updated event outcome , reporter address, patient demographics.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia
Clinical narrative: chills; fatigue; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle aches) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle aches). At the time of the report, CHILLS (chills), FATIGUE (fatigue) and MYALGIA (muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon in internal review on 21 May 2021, the age was corrected to unknown age.  Concomitant medications were not provided.  No treatment information was reported.    Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Illness, Nausea, Pyrexia
Clinical narrative: fever; extreme nausea; fatigue; joint pain; sick; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-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), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick). At the time of the report, PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (fatigue), ARTHRALGIA (joint pain) and ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Gait disturbance
Clinical narrative: Extremely dizzy; Can't walk without falling - he is on a wheelchair; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair). At the time of the report, DIZZINESS (Extremely dizzy) and GAIT DISTURBANCE (Can't walk without falling - he is on a wheelchair) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Computerised tomogram: clear (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was prescribed steroids (unspecified) after 5 days of dizziness and walking difficulty. The reporter states that the steroids helped a little, but the patient never recovered. The patient's HCP recommended the patient receive the second dose. Unknown if the patient received.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Vaccination complication
Clinical narrative: Reaction; Bright red; Lot of heat; Very itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy). At the time of the report, VACCINATION COMPLICATION (Reaction), ERYTHEMA (Bright red), FEELING HOT (Lot of heat) and PRURITUS (Very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test positive
Clinical narrative: Mild illness; Tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Mild illness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced ILLNESS (Mild illness). At the time of the report, ILLNESS (Mild illness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She tested positive for COVID on 1/6/2021 via nasal swab PCR. Concomitant medications were not reported. Treatment information were not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: little burning on arm; little soreness on arm; Very red hot square at the injection site; very red hot square at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (little burning on arm), PAIN IN EXTREMITY (little soreness on arm), VACCINATION SITE WARMTH (Very red hot square at the injection site) and VACCINATION SITE ERYTHEMA (very red hot square at the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Complex regional pain syndrome.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced BURNING SENSATION (little burning on arm), PAIN IN EXTREMITY (little soreness on arm), VACCINATION SITE WARMTH (Very red hot square at the injection site) and VACCINATION SITE ERYTHEMA (very red hot square at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (little burning on arm) and PAIN IN EXTREMITY (little soreness on arm) outcome was unknown and VACCINATION SITE WARMTH (Very red hot square at the injection site) and VACCINATION SITE ERYTHEMA (very red hot square at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was reported.  Treatment drug include Tylenol before bed the same day of the injection for the symptoms and took compounded cream with Ketamine for her knee.
Age: 61.0
Sex: F
Vaccine: COVID19, UNK, UNK, UNK
Symptoms: Influenza like illness, Malaise, Pain in extremity, Peripheral swelling, Rash erythematous
Clinical narrative: had systemic flu-like symptoms with no fever; arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow; she noticed a red circle that grew bigger during the night; felt crappy for a day; arm hurt for "like a week after the injection"; arm was very painful; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow), MALAISE (felt crappy for a day), INFLUENZA LIKE ILLNESS (had systemic flu-like symptoms with no fever), PAIN IN EXTREMITY (arm hurt for "like a week after the injection"; arm was very painful) and RASH ERYTHEMATOUS (she noticed a red circle that grew bigger during the night) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt for "like a week after the injection"; arm was very painful). On 15-Jan-2021, the patient experienced MALAISE (felt crappy for a day). On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow) and RASH ERYTHEMATOUS (she noticed a red circle that grew bigger during the night). On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (had systemic flu-like symptoms with no fever). On 15-Jan-2021, MALAISE (felt crappy for a day) had resolved. On 28-Jan-2021, INFLUENZA LIKE ILLNESS (had systemic flu-like symptoms with no fever) had resolved. At the time of the report, PERIPHERAL SWELLING (arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow) and RASH ERYTHEMATOUS (she noticed a red circle that grew bigger during the night) was resolving and PAIN IN EXTREMITY (arm hurt for "like a week after the injection"; arm was very painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 25JAN2021, the patient sought medical advise from her HCP about the a red circle that grew bigger during the night." She reported that her doctor instructed her to elevate her arm with ice and take ibuprofen.  The caller stated that the 27JAN2021 and 28JAN2021 were the worst days. On 28JAN2021, the patient emailed her doctor and was prescribed antibiotics. The patient reported that she did not take them; she used a steroid cream instead and the next day her arm started to feel better. The patient also reports taking diphenhydramine.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives) 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA (developed hives). At the time of the report, URTICARIA (developed hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.