chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Lymphadenopathy, Nausea
Clinical narrative: Sore arm; Swollen face that gets tight and hot which is ongoing; Swollen face that gets tight and hot which is ongoing; Swollen face that gets tight and hot which is ongoing; Chills; Fever, a temperature of 105; Swollen lymph notes; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing), CHILLS (Chills) and PYREXIA (Fever, a temperature of 105) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing), CHILLS (Chills), PYREXIA (Fever, a temperature of 105), LYMPHADENOPATHY (Swollen lymph notes), SWELLING FACE (Swollen face that gets tight and hot which is ongoing), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever, a temperature of 105), LYMPHADENOPATHY (Swollen lymph notes), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing) and SWELLING FACE (Swollen face that gets tight and hot which is ongoing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 (Inconclusive) Patient's body temperature was 105..
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Skin tightness, Swelling face, Vomiting
Clinical narrative: Sore arm; Swollen face that gets tight and hot which is ongoing; Swollen face that gets tight and hot which is ongoing; Swollen face that gets tight and hot which is ongoing; Chills; Fever, a temperature of 105; Swollen lymph notes; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing), CHILLS (Chills) and PYREXIA (Fever, a temperature of 105) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing), CHILLS (Chills), PYREXIA (Fever, a temperature of 105), LYMPHADENOPATHY (Swollen lymph notes), SWELLING FACE (Swollen face that gets tight and hot which is ongoing), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), PYREXIA (Fever, a temperature of 105), LYMPHADENOPATHY (Swollen lymph notes), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown and SKIN TIGHTNESS (Swollen face that gets tight and hot which is ongoing), FEELING HOT (Swollen face that gets tight and hot which is ongoing) and SWELLING FACE (Swollen face that gets tight and hot which is ongoing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 (Inconclusive) Patient's body temperature was 105..
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site arm hurts; injection site arm is red; injection site arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site arm hurts), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE SWELLING (injection site arm swollen) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (injection site arm hurts), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE SWELLING (injection site arm swollen). At the time of the report, VACCINATION SITE PAIN (injection site arm hurts), VACCINATION SITE ERYTHEMA (injection site arm is red) and VACCINATION SITE SWELLING (injection site arm swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: left arm was a little sore for about 1-2 days; received first dose of Moderna COVID-19 vaccine at 16 years of age; second dose might be administered after 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was a little sore for about 1-2 days), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine at 16 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose might be administered after 42 days) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (NIKKI) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm was a little sore for about 1-2 days), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine at 16 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose might be administered after 42 days). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose might be administered after 42 days) had resolved. At the time of the report, PAIN IN EXTREMITY (left arm was a little sore for about 1-2 days) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received first dose of Moderna COVID-19 vaccine at 16 years of age) had resolved. Not Provided          Concomitant product include birth control.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow-up was received on 29-APR-2021 and included reporter details and demographic details. Concomitant drug was reported. Treatment drug was reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A vaccine expired by 8 hours was administered as a first dose to a female patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a female patient) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a female patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A vaccine expired by 8 hours was administered as a first dose to a female patient) 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.   No concomitant medication was reported. No treatment medication was reported .   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow Up received on 03-JUN-2021 Contains Updated Reporter Information, Facility Information,Patient demographic details and Vaccination Time
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site rash
Clinical narrative: developed a rash on right side of body and lower back; a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed a rash on right side of body and lower back) and VACCINATION SITE RASH (a rash at the injection site) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (developed a rash on right side of body and lower back) and VACCINATION SITE RASH (a rash at the injection site). On 10-Apr-2021, RASH (developed a rash on right side of body and lower back) and VACCINATION SITE RASH (a rash at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient treated symptoms with Benadryl.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Epistaxis, Influenza like illness, Myalgia, Nasopharyngitis
Clinical narrative: cold symptoms; flu like symptoms; sore throat; episodes of nose bleeds (lasting 45 minutes); feels like throat is closing; can't breath; horrible arm pain; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)) and THROAT TIGHTNESS (feels like throat is closing) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)), THROAT TIGHTNESS (feels like throat is closing), DYSPNOEA (can't breath), MYALGIA (horrible arm pain) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Apr-2021, MYALGIA (horrible arm pain) had resolved. At the time of the report, NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)), THROAT TIGHTNESS (feels like throat is closing), DYSPNOEA (can't breath) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment includes cough medication.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat tightness, Vomiting
Clinical narrative: cold symptoms; flu like symptoms; sore throat; episodes of nose bleeds (lasting 45 minutes); feels like throat is closing; can't breath; horrible arm pain; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)) and THROAT TIGHTNESS (feels like throat is closing) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)), THROAT TIGHTNESS (feels like throat is closing), DYSPNOEA (can't breath), MYALGIA (horrible arm pain) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 27-Apr-2021, MYALGIA (horrible arm pain) had resolved. At the time of the report, NASOPHARYNGITIS (cold symptoms), INFLUENZA LIKE ILLNESS (flu like symptoms), OROPHARYNGEAL PAIN (sore throat), EPISTAXIS (episodes of nose bleeds (lasting 45 minutes)), THROAT TIGHTNESS (feels like throat is closing), DYSPNOEA (can't breath) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment includes cough medication.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Sleeping 12-14 hours at a time; Severe fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleeping 12-14 hours at a time) and FATIGUE (Severe fatigue) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced SOMNOLENCE (Sleeping 12-14 hours at a time) and FATIGUE (Severe fatigue). At the time of the report, SOMNOLENCE (Sleeping 12-14 hours at a time) and FATIGUE (Severe fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood blister, Scar
Clinical narrative: Blood blister; scarred areas; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (Blood blister) and SCAR (scarred areas) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L2DA) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALLOPURINOL for an unknown indication.    On 26-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 BLOOD BLISTER (Blood blister) and SCAR (scarred areas). At the time of the report, BLOOD BLISTER (Blood blister) and SCAR (scarred areas) outcome was unknown. Not Provided          other concomitant medication include blood pressure pills treatment include Epsom salt.   This case was linked to MOD-2021-097962 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: follow-up received on 31-may-2021 and contain no new information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Peroneal nerve palsy, Pruritus
Clinical narrative: Feet started itching; Feet swollen; Feet hurting; Can not move her toes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Feet started itching), PERIPHERAL SWELLING (Feet swollen), PAIN IN EXTREMITY (Feet hurting) and PERONEAL NERVE PALSY (Can not move her toes) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included UTI. Concomitant products included LISINOPRIL for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (Feet started itching), PERIPHERAL SWELLING (Feet swollen), PAIN IN EXTREMITY (Feet hurting) and PERONEAL NERVE PALSY (Can not move her toes). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Feet started itching), PERIPHERAL SWELLING (Feet swollen), PAIN IN EXTREMITY (Feet hurting) and PERONEAL NERVE PALSY (Can not move her toes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (Bruising). At the time of the report, CONTUSION (Bruising) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-097850 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Feeling hot, Lymphadenopathy, Pain in extremity, Peripheral swelling
Clinical narrative: sore arm; arm swelled up; was hot; hot to the touch; chest was killing her/pain in her chest; glands swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch) and CHEST PAIN (chest was killing her/pain in her chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch), CHEST PAIN (chest was killing her/pain in her chest) and LYMPHADENOPATHY (glands swelled up). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch), CHEST PAIN (chest was killing her/pain in her chest) and LYMPHADENOPATHY (glands swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant product was reported
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: sore arm; arm swelled up; was hot; hot to the touch; chest was killing her/pain in her chest; glands swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch) and CHEST PAIN (chest was killing her/pain in her chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch), CHEST PAIN (chest was killing her/pain in her chest) and LYMPHADENOPATHY (glands swelled up). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (arm swelled up), FEELING HOT (was hot), VACCINATION SITE WARMTH (hot to the touch), CHEST PAIN (chest was killing her/pain in her chest) and LYMPHADENOPATHY (glands swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant product was reported
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Her parents got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Her parents got COVID) 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 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced COVID-19 (Her parents got COVID). At the time of the report, COVID-19 (Her parents got COVID) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information included Monoclonal antibody treatment on 11-Feb-2021.   This case was linked to MOD21-083916 (Linked Report).; Sender's Comments:  MOD21-083916:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles.; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Postnatal depression (excl psychosis).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced HERPES ZOSTER (Shingles.). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is scheduled to take her second dose on 30-Apr-2021 and she wanted to know whether she can take it or not as she was having shingles.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (extremely tired) 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 16-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 PAIN IN EXTREMITY (sore arm) and FATIGUE (extremely tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medication information was reported.   This case was linked to MOD-2021-101721 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (injected left arm is sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 016B21A) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 29, 2021, patient had vaccination site pain (injected left arm is sore). At the time of the report, vaccination site pain (injected left arm is sore) outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. This case linked to MOD-2021-097930 (patient link).
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling of face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of face) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SWELLING FACE (Swelling of face). At the time of the report, SWELLING FACE (Swelling of face) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Hypertension, Pain in extremity
Clinical narrative: very high blood pressure; arm hurts; middle of chest hurts; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (very high blood pressure), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (middle of chest hurts) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERTENSION (very high blood pressure), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (middle of chest hurts) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, qd. At the time of the report, HYPERTENSION (very high blood pressure), PAIN IN EXTREMITY (arm hurts), CHEST PAIN (middle of chest hurts) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills
Clinical narrative: General weak feeling; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (General weak feeling) and CHILLS (Chills) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced ASTHENIA (General weak feeling) and CHILLS (Chills). At the time of the report, ASTHENIA (General weak feeling) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Headache, Pain in extremity
Clinical narrative: Pain in the Left Arm (After First Vaccine); Felt very Weak (After First Vaccine); Could not Stand Up (After First Vaccine); Pain in the head (After First Vaccine); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the Left Arm (After First Vaccine)), ASTHENIA (Felt very Weak (After First Vaccine)), DYSSTASIA (Could not Stand Up (After First Vaccine)) and HEADACHE (Pain in the head (After First Vaccine)) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the Left Arm (After First Vaccine)), ASTHENIA (Felt very Weak (After First Vaccine)), DYSSTASIA (Could not Stand Up (After First Vaccine)) and HEADACHE (Pain in the head (After First Vaccine)). On 03-Apr-2021, PAIN IN EXTREMITY (Pain in the Left Arm (After First Vaccine)), ASTHENIA (Felt very Weak (After First Vaccine)), DYSSTASIA (Could not Stand Up (After First Vaccine)) and HEADACHE (Pain in the head (After First Vaccine)) had resolved.            No concomitant medication was reported.  Treatment medication was not provided by the reporter.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore right arm on first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore right arm on first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore right arm on first dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore right arm on first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-097941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-097941:dose 2 case
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old receive his 1st dose on 01apr2021.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old receive his 1st dose on 01apr2021.) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old receive his 1st dose on 01apr2021.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old receive his 1st dose on 01apr2021.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm for 5 days; Fatigue for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for 5 days) and FATIGUE (Fatigue for a day) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm for 5 days) and FATIGUE (Fatigue for a day). On 24-Mar-2021, FATIGUE (Fatigue for a day) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm for 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-097970 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches; Fever; Chills; headache; joint aches; felt like having flu; fatigue; Red at site of injection; swollen at the site of injection; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches) and INFLUENZA LIKE ILLNESS (felt like having flu) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches), INFLUENZA LIKE ILLNESS (felt like having flu), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red at site of injection), VACCINATION SITE SWELLING (swollen at the site of injection) and VACCINATION SITE PAIN (pain at injection site). On 29-Apr-2021, the patient experienced VACCINATION SITE REACTION (bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches), INFLUENZA LIKE ILLNESS (felt like having flu), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red at site of injection), VACCINATION SITE SWELLING (swollen at the site of injection), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE REACTION (bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD-2021-097899 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling
Clinical narrative: bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches; Fever; Chills; headache; joint aches; felt like having flu; fatigue; Red at site of injection; swollen at the site of injection; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches) and INFLUENZA LIKE ILLNESS (felt like having flu) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches), INFLUENZA LIKE ILLNESS (felt like having flu), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red at site of injection), VACCINATION SITE SWELLING (swollen at the site of injection) and VACCINATION SITE PAIN (pain at injection site). On 29-Apr-2021, the patient experienced VACCINATION SITE REACTION (bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (headache), ARTHRALGIA (joint aches), INFLUENZA LIKE ILLNESS (felt like having flu), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Red at site of injection), VACCINATION SITE SWELLING (swollen at the site of injection), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE REACTION (bulls eye" circle at site of injection - diameter of circle is  is approximately 2 inches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD-2021-097899 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: achy; sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy) and MYALGIA (sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN for Cholesterol.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced PAIN (achy) and MYALGIA (sore). At the time of the report, PAIN (achy) and MYALGIA (sore) outcome was unknown.            Patient wants to know whether she can take Tylenol for comfort. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up information received on 29-MAY-2021 contains non-significant information
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received 1st dose of Moderna COVID 19 vaccine from expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received 1st dose of Moderna COVID 19 vaccine from expired) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.     This case was linked to US-MODERNATX, INC.-MOD-2021-097752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-097752:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dysphonia, Erythema, Headache, Hyperhidrosis
Clinical narrative: Sweating; hoarse voice; second day was the worst and he spend it mostly in bed; Drowsiness; arm is red and hot six inches around the injection site.; fever/intermittent fevers; Chills (couldn't get warm enough); Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), MALAISE (second day was the worst and he spend it mostly in bed), HYPERHIDROSIS (Sweating), DYSPHONIA (hoarse voice) and ERYTHEMA (arm is red and hot six inches around the injection site.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MELOXICAM (MOBIC) for Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SOMNOLENCE (Drowsiness), ERYTHEMA (arm is red and hot six inches around the injection site.), PYREXIA (fever/intermittent fevers), CHILLS (Chills (couldn't get warm enough)) and HEADACHE (Headache). On 27-Apr-2021, the patient experienced MALAISE (second day was the worst and he spend it mostly in bed). On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating) and DYSPHONIA (hoarse voice). On 29-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, SOMNOLENCE (Drowsiness), MALAISE (second day was the worst and he spend it mostly in bed), HYPERHIDROSIS (Sweating), DYSPHONIA (hoarse voice), ERYTHEMA (arm is red and hot six inches around the injection site.), PYREXIA (fever/intermittent fevers) and CHILLS (Chills (couldn't get warm enough)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Within an hour of vaccine administration, the patient started to experience fever, drowsiness, chills (couldn't get warm enough) and a headache. On the second day the symptoms were worse and he spent most of the day in bed. On the third day he experienced intermittent fever, chills, sweating and a hoarse voice and arm is red and hot six inches around the injection site. Treatment included concomitant medication meloxicam acetaminophen to help with fever.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Somnolence
Clinical narrative: Sweating; hoarse voice; second day was the worst and he spend it mostly in bed; Drowsiness; arm is red and hot six inches around the injection site.; fever/intermittent fevers; Chills (couldn't get warm enough); Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), MALAISE (second day was the worst and he spend it mostly in bed), HYPERHIDROSIS (Sweating), DYSPHONIA (hoarse voice) and ERYTHEMA (arm is red and hot six inches around the injection site.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MELOXICAM (MOBIC) for Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SOMNOLENCE (Drowsiness), ERYTHEMA (arm is red and hot six inches around the injection site.), PYREXIA (fever/intermittent fevers), CHILLS (Chills (couldn't get warm enough)) and HEADACHE (Headache). On 27-Apr-2021, the patient experienced MALAISE (second day was the worst and he spend it mostly in bed). On 28-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating) and DYSPHONIA (hoarse voice). On 29-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, SOMNOLENCE (Drowsiness), MALAISE (second day was the worst and he spend it mostly in bed), HYPERHIDROSIS (Sweating), DYSPHONIA (hoarse voice), ERYTHEMA (arm is red and hot six inches around the injection site.), PYREXIA (fever/intermittent fevers) and CHILLS (Chills (couldn't get warm enough)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Within an hour of vaccine administration, the patient started to experience fever, drowsiness, chills (couldn't get warm enough) and a headache. On the second day the symptoms were worse and he spent most of the day in bed. On the third day he experienced intermittent fever, chills, sweating and a hoarse voice and arm is red and hot six inches around the injection site. Treatment included concomitant medication meloxicam acetaminophen to help with fever.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a 51-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not received any treatment. Patient allergies and medical history was not provided. Patient concomitant medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non-Significant follow up appended to AER
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vision blurred, Visual impairment
Clinical narrative: Blurring of eyes; Flu like symptoms; Visual disturbance; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Visual disturbance), VISION BLURRED (Blurring of eyes) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Head injury.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VISUAL IMPAIRMENT (Visual disturbance). On an unknown date, the patient experienced VISION BLURRED (Blurring of eyes) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, VISUAL IMPAIRMENT (Visual disturbance), VISION BLURRED (Blurring of eyes) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.            .   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Added HCP details, patient demographic details, vaccine information, events