chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Insomnia, Myalgia, Nasopharyngitis, Pain in extremity
Clinical narrative: lying on the bed she was cold; thought she was not going to be able to wake up from bed,; felt miserable; the hip muscle hurts; back hurts; made her woke up on the middle of the night 2 times; whole body hurts/muscle pain; had Chills; sore left arm,; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts) and BACK PAIN (back hurts) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore left arm,). On 21-Apr-2021, the patient experienced NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts), BACK PAIN (back hurts), INSOMNIA (made her woke up on the middle of the night 2 times), MYALGIA (whole body hurts/muscle pain) and CHILLS (had Chills). At the time of the report, NASOPHARYNGITIS (lying on the bed she was cold), GAIT INABILITY (thought she was not going to be able to wake up from bed,), FEELING ABNORMAL (felt miserable), ARTHRALGIA (the hip muscle hurts), BACK PAIN (back hurts), INSOMNIA (made her woke up on the middle of the night 2 times), PAIN IN EXTREMITY (sore left arm,), MYALGIA (whole body hurts/muscle pain) and CHILLS (had Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment includes ¨Tylenol every 4 hours¨. Caller has taken 3 Tylenols ( does not know the dosage of each pill , since 2AM of 21Apr2021). Concomitant medications were not provided.   This case was linked to MOD-2021-083220.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: lymph nodes under arm where she received the shot was swollen; vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under arm where she received the shot was swollen) and VACCINATION SITE PAIN (vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis and Diabetes.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 19-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). On 20-Apr-2021, the patient experienced LYMPHADENOPATHY (lymph nodes under arm where she received the shot was swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes under arm where she received the shot was swollen) and VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       concomitant medicines was not reported by reporter   Treatment information was not provided
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 040A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included ROSUVASTATIN, ATENOLOL, EZETIMIBE and ESCITALOPRAM for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Apr-2021, CHILLS (chills) and HEADACHE (headache) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-083204 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: dry heaves; sweating a lot; nasal congestion; weakness; no appetite; I feel beat up; chills; nausea; my arm was swollen at the injection site; my arm was sore at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness) and DECREASED APPETITE (no appetite) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), DECREASED APPETITE (no appetite), FEELING ABNORMAL (I feel beat up), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE SWELLING (my arm was swollen at the injection site) and VACCINATION SITE PAIN (my arm was sore at the injection site). 20-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), DECREASED APPETITE (no appetite), FEELING ABNORMAL (I feel beat up), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE SWELLING (my arm was swollen at the injection site), VACCINATION SITE PAIN (my arm was sore at the injection site) and HEADACHE (headache) outcome was unknown.            Patient took ginger ale to help with the nausea. No relevant concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-083202 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nasal congestion, Nausea, Retching, Vaccination site pain
Clinical narrative: dry heaves; sweating a lot; nasal congestion; weakness; no appetite; I feel beat up; chills; nausea; my arm was swollen at the injection site; my arm was sore at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness) and DECREASED APPETITE (no appetite) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), DECREASED APPETITE (no appetite), FEELING ABNORMAL (I feel beat up), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE SWELLING (my arm was swollen at the injection site) and VACCINATION SITE PAIN (my arm was sore at the injection site). 20-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), DECREASED APPETITE (no appetite), FEELING ABNORMAL (I feel beat up), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE SWELLING (my arm was swollen at the injection site), VACCINATION SITE PAIN (my arm was sore at the injection site) and HEADACHE (headache) outcome was unknown.            Patient took ginger ale to help with the nausea. No relevant concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-083202 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: dry heaves; sweating a lot; nasal congestion; weakness; no appetite; I feel beat up; chills; nausea; my arm was swollen at the injection site; my arm was sore at the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness) and DECREASED APPETITE (no appetite) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), DECREASED APPETITE (no appetite), FEELING ABNORMAL (I feel beat up), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE SWELLING (my arm was swollen at the injection site) and VACCINATION SITE PAIN (my arm was sore at the injection site). 20-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, RETCHING (dry heaves), HYPERHIDROSIS (sweating a lot), NASAL CONGESTION (nasal congestion), ASTHENIA (weakness), DECREASED APPETITE (no appetite), FEELING ABNORMAL (I feel beat up), CHILLS (chills), NAUSEA (nausea), VACCINATION SITE SWELLING (my arm was swollen at the injection site), VACCINATION SITE PAIN (my arm was sore at the injection site) and HEADACHE (headache) outcome was unknown.            Patient took ginger ale to help with the nausea. No relevant concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-083202 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had not resolved. Not Provided    Action taken with mRNA-1273 in response to the event was not applicable. Concomitant information was not provided. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Wheezing
Clinical narrative: sore throat; wheezing; coughing up stuff; head hurts; 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 OROPHARYNGEAL PAIN (sore throat), WHEEZING (wheezing), COUGH (coughing up stuff) and HEADACHE (head hurts) 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 COPD, Sarcoid and Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), WHEEZING (wheezing), COUGH (coughing up stuff) and HEADACHE (head hurts). At the time of the report, OROPHARYNGEAL PAIN (sore throat), WHEEZING (wheezing), COUGH (coughing up stuff) and HEADACHE (head hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: leaking syringe during second administration; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (leaking syringe during second administration) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 031A21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant. Concomitant products included TACROLIMUS, LISINOPRIL and VITAMIN D NOS for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced UNDERDOSE (leaking syringe during second administration). On 21-Apr-2021, UNDERDOSE (leaking syringe during second administration) had resolved.            The Action taken in response to m-RNA 1273 was considered to be not applicable.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Normally gets migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Normally gets migraine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 MIGRAINE (Normally gets migraine). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Migraine, at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Migraine, at a dose of 1 UNK. At the time of the report, MIGRAINE (Normally gets migraine) outcome was unknown. Not Provided          No concomitant medication were reported The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wrong product administered
Clinical narrative: second dose was Pfizer vaccine, not Moderna; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (second dose was Pfizer vaccine, not Moderna) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced WRONG PRODUCT ADMINISTERED (second dose was Pfizer vaccine, not Moderna). At the time of the report, WRONG PRODUCT ADMINISTERED (second dose was Pfizer vaccine, not Moderna) had resolved. Not Provided          Blood pressure, Diabetes and arthritis medication are the treatment medications reported by reporter.  Patient stated when she came back home after the second dose she saw in the vaccination card that the second dose was not Modena's, but Pfizer's.
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling on 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 Reported.     On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (swelling on the injection site). At the time of the report, INJECTION SITE SWELLING (swelling on the injection site) had not resolved. Not Provided
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Paraesthesia
Clinical narrative: warmth in my face; tingling in my face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (warmth in my face) and PARAESTHESIA (tingling in my face) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING HOT (warmth in my face) and PARAESTHESIA (tingling in my face). At the time of the report, FEELING HOT (warmth in my face) and PARAESTHESIA (tingling in my face) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that symptoms lasted about 15 minutes and subsided after turning on the air conditioning.  Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided    Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Musculoskeletal discomfort, Pain in extremity, Product dose omission issue
Clinical narrative: She was supposed to receive the second dose on 20APR2021 but did not go to her appointment; Pain in the hip area & can't get up properly from a seated position; pain in the right arm & pain in the left arm; can't lift hand over head; hard to walk because it hurts so much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the right arm & pain in the left arm), LIMB DISCOMFORT (can't lift hand over head), MUSCULOSKELETAL DISCOMFORT (hard to walk because it hurts so much), PRODUCT DOSE OMISSION ISSUE (She was supposed to receive the second dose on 20APR2021 but did not go to her appointment) and ARTHRALGIA (Pain in the hip area & can't get up properly from a seated position) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN, ROSUVASTATIN, LISINOPRIL and FLUOXETINE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in the right arm & pain in the left arm), LIMB DISCOMFORT (can't lift hand over head), MUSCULOSKELETAL DISCOMFORT (hard to walk because it hurts so much) and ARTHRALGIA (Pain in the hip area & can't get up properly from a seated position). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was supposed to receive the second dose on 20APR2021 but did not go to her appointment). The patient was treated with GABAPENTIN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; MENTHOL (BIOFREEZE [MENTHOL]) at an unspecified dose and frequency; MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the right arm & pain in the left arm), LIMB DISCOMFORT (can't lift hand over head), MUSCULOSKELETAL DISCOMFORT (hard to walk because it hurts so much) and ARTHRALGIA (Pain in the hip area & can't get up properly from a seated position) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She was supposed to receive the second dose on 20APR2021 but did not go to her appointment) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in my arm from the shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in my arm from the shot) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in my arm from the shot). At the time of the report, PAIN IN EXTREMITY (pain in my arm from the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she has sore arm after getting the Moderna COVID-19 vaccine and would like to know if she could take Aleve or Ibuprofen.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm got hot; arm got itchy; rash; Swollen; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm got hot), VACCINATION SITE PRURITUS (arm got itchy), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia (high cholesterol). Concurrent medical conditions included Drug allergy (ciloxin) and Allergy (airbone pollutants). Concomitant products included SIMVASTATIN and LORATADINE.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (arm got hot), VACCINATION SITE PRURITUS (arm got itchy), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (arm got hot), VACCINATION SITE PRURITUS (arm got itchy), VACCINATION SITE RASH (rash), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-06-2021 contains No significant information
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed scheduled dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed scheduled dose) 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 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed scheduled dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed scheduled dose) outcome was unknown. Not Provided      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.   Concomitant medication information not provided.  Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received on 19-JUL-2021 , Containing No new Information
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vaccination site pain
Clinical narrative: Off-balance at times/ felt like she was going to lose her balance when she got up in the morning; Sore tenderness in left arm few hours later; dizzy / unsteady on feet/light headiness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy / unsteady on feet/light headiness), BALANCE DISORDER (Off-balance at times/ felt like she was going to lose her balance when she got up in the morning) and VACCINATION SITE PAIN (Sore tenderness in left arm few hours later) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No specified medical history has been reported.     On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced DIZZINESS (dizzy / unsteady on feet/light headiness) and VACCINATION SITE PAIN (Sore tenderness in left arm few hours later). On 21-Apr-2021, the patient experienced BALANCE DISORDER (Off-balance at times/ felt like she was going to lose her balance when she got up in the morning). On 19-Apr-2021, VACCINATION SITE PAIN (Sore tenderness in left arm few hours later) had resolved. On 21-Apr-2021, DIZZINESS (dizzy / unsteady on feet/light headiness) had resolved and BALANCE DISORDER (Off-balance at times/ felt like she was going to lose her balance when she got up in the morning) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: NNI_No new information On 22-Jul-2021: follow up received contains No new information.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, Scratch
Clinical narrative: "little lines came back on both legs"; itching; blood blisters; (blood blisters)Couple of them breaking; "rash on both legs from knees down"; "couple of patches on the thigh"; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH ("little lines came back on both legs"), PRURITUS (itching), BLISTER (blood blisters), BLISTER ((blood blisters)Couple of them breaking) and RASH ("rash on both legs from knees down") in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced SCRATCH ("little lines came back on both legs"), PRURITUS (itching), BLISTER (blood blisters), BLISTER ((blood blisters)Couple of them breaking), RASH ("rash on both legs from knees down") and RASH ("couple of patches on the thigh"). On 14-Apr-2021, SCRATCH ("little lines came back on both legs"), BLISTER (blood blisters), BLISTER ((blood blisters)Couple of them breaking), RASH ("rash on both legs from knees down") and RASH ("couple of patches on the thigh") had resolved. At the time of the report, PRURITUS (itching) was resolving.        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.   Starting 07Apr2021 (described as "after a week"), the patient experienced "rash on both legs from knees down" (described as "couple of patches on the thigh", "little lines came back on both legs with blood blisters with a couple of them breaking", and itching). The patient recovered from the rash on 14Apr2021, but is still recovering from itching.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: arm hurts quite a bit - left arm; Swelling in arm; Flu like symptoms; Body aches; Injection site has hard spot / injection site has knot on it; Low grade fevers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches) and VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches) and VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it). 21-Apr-2021, the patient experienced PYREXIA (Low grade fevers). At the time of the report, PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it) and PYREXIA (Low grade fevers) outcome was unknown.            No concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-083276, MOD-2021-083116 (E2B Linked Report).; Sender's Comments:  MOD-2021-083276:Husband's case MOD-2021-083116:Husband's case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration
Clinical narrative: arm hurts quite a bit - left arm; Swelling in arm; Flu like symptoms; Body aches; Injection site has hard spot / injection site has knot on it; Low grade fevers; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches) and VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches) and VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it). 21-Apr-2021, the patient experienced PYREXIA (Low grade fevers). At the time of the report, PAIN IN EXTREMITY (arm hurts quite a bit - left arm), PERIPHERAL SWELLING (Swelling in arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), VACCINATION SITE INDURATION (Injection site has hard spot / injection site has knot on it) and PYREXIA (Low grade fevers) outcome was unknown.            No concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-083276, MOD-2021-083116 (E2B Linked Report).; Sender's Comments:  MOD-2021-083276:Husband's case MOD-2021-083116:Husband's case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles eruption after receiving the 1st dose of Moderna vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Developed Shingles eruption after receiving the 1st dose of Moderna vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concomitant products included ALENDRONATE SODIUM (FOSAMAX), LOSARTAN, ROSUVASTATIN, METFORMIN, TRAZODONE, TRIAMTERENE, CALCIUM, FISH OIL (OMEGA 3 [FISH OIL]), VITAMIN E NOS (VITAMIN E [VITAMIN E NOS]) and VITAMIN D3 for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced HERPES ZOSTER (Developed Shingles eruption after receiving the 1st dose of Moderna vaccine). At the time of the report, HERPES ZOSTER (Developed Shingles eruption after receiving the 1st dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication include Acyclovir for 7 days
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Feeling hot
Clinical narrative: symptoms of dizziness; feels off balance; feels very hot but doesn't have a fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (symptoms of dizziness), BALANCE DISORDER (feels off balance) and FEELING HOT (feels very hot but doesn't have a fever) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (symptoms of dizziness), BALANCE DISORDER (feels off balance) and FEELING HOT (feels very hot but doesn't have a fever). At the time of the report, DIZZINESS (symptoms of dizziness), BALANCE DISORDER (feels off balance) and FEELING HOT (feels very hot but doesn't have a fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching of her back and palms; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching of her back and palms) 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 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PRURITUS (itching of her back and palms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itching of her back and palms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered to a client today which is greater than 12 hours later; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered to a client today which is greater than 12 hours later) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered to a client today which is greater than 12 hours later). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered to a client today which is greater than 12 hours later) 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 relevant concomitant medications were reported. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tooth fracture
Clinical narrative: cracked tooth the night of the shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTH FRACTURE (cracked tooth the night of the shot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included CITALOPRAM and ALPRAZOLAM (XANAX) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced TOOTH FRACTURE (cracked tooth the night of the shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg,per every 6 hours; IBUPROFEN at an unspecified dose and frequency and AMOXICILLIN at a dose of 500 mg,every 8 hours. At the time of the report, TOOTH FRACTURE (cracked tooth the night of the shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a cracked a tooth and needs a root canal. On 31 MAR 2021, night of the first shot cracked tooth and had high pain tolerance and dealt with the pain. On 05 APR 2021 took Tylenol 1000 mg every 6 hours and Motrin.  On 09 APR 2021 the dentist started on Amoxicillin 500 mg every 8 hours. On 15 APR 2021 stopped ibuprofen and Tylenol.  Patient afraid the amoxicillin and ibuprofen/Tylenol would interfere with the COVID shot.  Second dose is scheduled for 28Apr2021. Caller said had a dental surgery coming up on 28 APR 2021.Patient wants to know if can take the Moderna shot 1 week earlier.   This case was linked to MOD21-079532 (E2B Linked Report).; Sender's Comments:  MOD21-079532:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dermatitis acneiform
Clinical narrative: Rash like pimples; pimples burned a bit; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ACNEIFORM (Rash like pimples) and BURNING SENSATION (pimples burned a bit) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DERMATITIS ACNEIFORM (Rash like pimples) and BURNING SENSATION (pimples burned a bit). At the time of the report, DERMATITIS ACNEIFORM (Rash like pimples) and BURNING SENSATION (pimples burned a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy ), VACCINATION SITE ERYTHEMA (Red ) and RASH (Rash) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy ), VACCINATION SITE ERYTHEMA (Red ) and RASH (Rash). At the time of the report, VACCINATION SITE PRURITUS (Itchy ), VACCINATION SITE ERYTHEMA (Red ) and RASH (Rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine administered during the 2nd dose had temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (vaccine administered during the 2nd dose had temperature excursion) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine administered during the 2nd dose had temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (vaccine administered during the 2nd dose had temperature excursion) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness
Clinical narrative: Dizziness; High Blood sugar; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and BLOOD GLUCOSE INCREASED (High Blood sugar) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (Dizziness) and BLOOD GLUCOSE INCREASED (High Blood sugar). At the time of the report, DIZZINESS (Dizziness) and BLOOD GLUCOSE INCREASED (High Blood sugar) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient took insulin for the high blood sugar.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ATENOLOL for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient received Prevnar-13 on Thursday 15Apr2021
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Could not get the 2nd dose due to an emergency; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to the company on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Could not get the 2nd dose due to an emergency) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Could not get the 2nd dose due to an emergency). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Could not get the 2nd dose due to an emergency) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Dizziness, Headache, Influenza like illness
Clinical narrative: Dizziness; Flu like symptoms; Concentration impaired; Nauseous; Muscle pain; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nauseous), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (Chills) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nauseous), HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Muscle pain) and DISTURBANCE IN ATTENTION (Concentration impaired). At the time of the report, DIZZINESS (Dizziness) had not resolved, NAUSEA (Nauseous) had resolved and HEADACHE (Headache), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills), MYALGIA (Muscle pain) and DISTURBANCE IN ATTENTION (Concentration impaired) outcome was unknown.      Concomitant medication use was not provided. Treatment information included Anti nausea medicine.