chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Malaise, Nausea, Pain, Pruritus
Clinical narrative: Big red angry rash at the injection site about the size of the palm of my hand,; Terrible headache; Low grade fever; Hot; Flu like Symptoms; Achy feeling; Itchy; Nausea; Very sore; Warm; Feeling horrible; Still feel miserable; Covid arm reaction 8 days later; Trunk rash right after the vaccine; Malaise; Soreness; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness), VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), RASH (Trunk rash right after the vaccine), HEADACHE (Terrible headache) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Takes  Xyzal, Promethazine and a monthly shot of Xolair for allergy as suggested by her allergist based on her medical history.). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), PROMETHAZINE and OMALIZUMAB (XOLAIR) for Allergy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (Redness), RASH (Trunk rash right after the vaccine), PAIN (Soreness) and MALAISE (Malaise). On 24-Feb-2021, the patient experienced INJECTION SITE RASH (Covid arm reaction 8 days later). On an unknown date, the patient experienced VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), HEADACHE (Terrible headache), PYREXIA (Low grade fever), NAUSEA (Nausea), PAIN (Very sore), INJECTION SITE PAIN (Hot), INFLUENZA LIKE ILLNESS (Flu like Symptoms), PAIN (Achy feeling), PRURITUS (Itchy), VACCINATION SITE WARMTH (Warm), FEELING ABNORMAL (Feeling horrible) and FEELING ABNORMAL (Still feel miserable). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of unknown. At the time of the report, ERYTHEMA (Redness), VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), RASH (Trunk rash right after the vaccine), HEADACHE (Terrible headache), PYREXIA (Low grade fever), INJECTION SITE RASH (Covid arm reaction 8 days later), NAUSEA (Nausea), PAIN (Very sore), PAIN (Soreness), INJECTION SITE PAIN (Hot), INFLUENZA LIKE ILLNESS (Flu like Symptoms), PAIN (Achy feeling), PRURITUS (Itchy), MALAISE (Malaise), VACCINATION SITE WARMTH (Warm), FEELING ABNORMAL (Feeling horrible) and FEELING ABNORMAL (Still feel miserable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient also stated it is not a bad as it was 2 days ago.; Reporter's Comments: Treatment taken was Tyenol and Allegra
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site rash, Vaccination site warmth
Clinical narrative: Big red angry rash at the injection site about the size of the palm of my hand,; Terrible headache; Low grade fever; Hot; Flu like Symptoms; Achy feeling; Itchy; Nausea; Very sore; Warm; Feeling horrible; Still feel miserable; Covid arm reaction 8 days later; Trunk rash right after the vaccine; Malaise; Soreness; Redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (Redness), VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), RASH (Trunk rash right after the vaccine), HEADACHE (Terrible headache) and PYREXIA (Low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (Takes  Xyzal, Promethazine and a monthly shot of Xolair for allergy as suggested by her allergist based on her medical history.). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), PROMETHAZINE and OMALIZUMAB (XOLAIR) for Allergy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (Redness), RASH (Trunk rash right after the vaccine), PAIN (Soreness) and MALAISE (Malaise). On 24-Feb-2021, the patient experienced INJECTION SITE RASH (Covid arm reaction 8 days later). On an unknown date, the patient experienced VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), HEADACHE (Terrible headache), PYREXIA (Low grade fever), NAUSEA (Nausea), PAIN (Very sore), INJECTION SITE PAIN (Hot), INFLUENZA LIKE ILLNESS (Flu like Symptoms), PAIN (Achy feeling), PRURITUS (Itchy), VACCINATION SITE WARMTH (Warm), FEELING ABNORMAL (Feeling horrible) and FEELING ABNORMAL (Still feel miserable). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at a dose of unknown. At the time of the report, ERYTHEMA (Redness), VACCINATION SITE RASH (Big red angry rash at the injection site about the size of the palm of my hand,), RASH (Trunk rash right after the vaccine), HEADACHE (Terrible headache), PYREXIA (Low grade fever), INJECTION SITE RASH (Covid arm reaction 8 days later), NAUSEA (Nausea), PAIN (Very sore), PAIN (Soreness), INJECTION SITE PAIN (Hot), INFLUENZA LIKE ILLNESS (Flu like Symptoms), PAIN (Achy feeling), PRURITUS (Itchy), MALAISE (Malaise), VACCINATION SITE WARMTH (Warm), FEELING ABNORMAL (Feeling horrible) and FEELING ABNORMAL (Still feel miserable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient also stated it is not a bad as it was 2 days ago.; Reporter's Comments: Treatment taken was Tyenol and Allegra
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pruritus
Clinical narrative: Intense itching on the dorsal surface of both hands which lasted approximately 20 minutes (2nd dose); Soreness on a scale of 2.5 out of 5; Greater fatigue as compared to symptoms experienced from his first dose of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of   in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023V120A and 42L20A) for COVID-19 vaccination.     The patient's past medical history included Stroke in 2003. Concurrent medical conditions included Asthma, Hypertension and High cholesterol. Concomitant products included LISINOPRIL, HYDROCHLOROTHIAZIDE, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN and CROMOGLICATE SODIUM (NASALCROM) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-027977 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: "a little tired"; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ("a little tired") in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, the patient experienced FATIGUE ("a little tired"). At the time of the report, FATIGUE ("a little tired") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: pain on her hand; pain on her heart; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her hand) and CHEST PAIN (pain on her heart) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on her hand) and CHEST PAIN (pain on her heart). At the time of the report, PAIN IN EXTREMITY (pain on her hand) and CHEST PAIN (pain on her heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Rash, Rhinorrhoea
Clinical narrative: nose running; congestion; rashes on face and arms; headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (nose running), NASAL CONGESTION (congestion), RASH (rashes on face and arms) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (headache). On 27-Feb-2021, the patient experienced RHINORRHOEA (nose running), NASAL CONGESTION (congestion) and RASH (rashes on face and arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form. On 27-Feb-2021, HEADACHE (headache) had resolved. At the time of the report, RHINORRHOEA (nose running) and NASAL CONGESTION (congestion) had not resolved and RASH (rashes on face and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: minimal sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (minimal sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's medical history was not provided.  Concomitant products included CELECOXIB (CELEBREX), HYDROCHLOROTHIAZIDE, METOPROLOL and LEVOTHYROXINE for an unknown indication.    On 25-Feb-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 PAIN (minimal sore arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, PAIN (minimal sore arm) outcome was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 after 1st Dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st Dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-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 SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st Dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19 after 1st Dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: dizzy; Felt odd; Couldn't sleep; blood pressure spiked to 151/85; Itchy arm; Tired; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85) and PRURITUS (Itchy arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #013A21A) 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 25-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 DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85), PRURITUS (Itchy arm), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85), PRURITUS (Itchy arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pruritus
Clinical narrative: dizzy; Felt odd; Couldn't sleep; blood pressure spiked to 151/85; Itchy arm; Tired; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85) and PRURITUS (Itchy arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #013A21A) 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 25-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 DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85), PRURITUS (Itchy arm), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, DIZZINESS (dizzy), FEELING ABNORMAL (Felt odd), INSOMNIA (Couldn't sleep), BLOOD PRESSURE MEASUREMENT (blood pressure spiked to 151/85), PRURITUS (Itchy arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Swelling
Clinical narrative: Little bit swollen and sore shoulder; Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Little bit swollen and sore shoulder) and ARTHRALGIA (Sore shoulder) 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 SWELLING (Little bit swollen and sore shoulder) and ARTHRALGIA (Sore shoulder). At the time of the report, SWELLING (Little bit swollen and sore shoulder) and ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Ocular discomfort
Clinical narrative: dry eyes; Could not open eyes right away after waking up; A spontaneous report was received from a consumer, concerning a 67-year-old, female patient who experienced  dry eyes and could not open eyes right away after waking up/ ocular discomfort.  The patient's medical history includes Sjogren's syndrome,. Concomitant medications included pilocarpine and artificial tears ophthalmic drops.  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.   On 11 Feb 2021, same day of receiving the vaccine, the patient experienced symptoms of dry eyes and could not open eyes right away after waking up. She had Sjogren's syndrome.  Treatment included artificial tears ophthalmic drops.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, dry eye and ocular discomfort were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Joint swelling, Palpitations
Clinical narrative: Swelling of the wrists; Heart palpitations; Felt horible; This spontaneous case was reported by a nurse and describes the occurrence of JOINT SWELLING (Swelling of the wrists), PALPITATIONS (Heart palpitations) and FEELING ABNORMAL (Felt horible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received 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. On 27-Feb-2021, the patient experienced JOINT SWELLING (Swelling of the wrists). On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and FEELING ABNORMAL (Felt horible). At the time of the report, JOINT SWELLING (Swelling of the wrists) outcome was unknown and PALPITATIONS (Heart palpitations) and FEELING ABNORMAL (Felt horible) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was reported.    Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up information was received and events were added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pruritus, Vaccination site erythema, Vaccination site pain
Clinical narrative: Didn't feel real great; Tired; Redness and itching; Itching; Didn't feel real great; soreness at injection site; Redness and itching; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (Redness and itching), VACCINATION SITE PAIN (soreness at injection site), PRURITUS (Itching), the second episode of VACCINATION SITE ERYTHEMA (Redness and itching) and the first episode of FEELING ABNORMAL (Didn't feel real great) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced the first episode of VACCINATION SITE ERYTHEMA (Redness and itching), VACCINATION SITE PAIN (soreness at injection site) and the first episode of FEELING ABNORMAL (Didn't feel real great). On 08-Feb-2021, the patient experienced PRURITUS (Itching). On 09-Feb-2021, the patient experienced the second episode of VACCINATION SITE ERYTHEMA (Redness and itching). On 10-Feb-2021, the patient experienced FATIGUE (Tired) and the second episode of FEELING ABNORMAL (Didn't feel real great). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency.        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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Nausea, Vomiting
Clinical narrative: Vomited; Nausea; Chills; Exhausted; Arm very red and the circle is 2 inches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomited), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Exhausted) and ERYTHEMA (Arm very red and the circle is 2 inches) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced VOMITING (Vomited), NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Exhausted) and ERYTHEMA (Arm very red and the circle is 2 inches). On 14-Feb-2021, VOMITING (Vomited) had resolved. At the time of the report, NAUSEA (Nausea), CHILLS (Chills), FATIGUE (Exhausted) and ERYTHEMA (Arm very red and the circle is 2 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypotension, Nausea, Rash
Clinical narrative: Rash all over face and chest; Nauseas; Flushing; Low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing), HYPOTENSION (Low blood pressure), RASH (Rash all over face and chest) and NAUSEA (Nauseas) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Anaphylaxis.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced FLUSHING (Flushing), HYPOTENSION (Low blood pressure) and NAUSEA (Nauseas). On an unknown date, the patient experienced RASH (Rash all over face and chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, FLUSHING (Flushing), HYPOTENSION (Low blood pressure), RASH (Rash all over face and chest) and NAUSEA (Nauseas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Itching; Hard injection site; arm got sore; Swollen injection site; Slept all day and all night; Headache which got worse during the day; Fever; Felt tired; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021. The most recent information was received on 16-Jul-2021 and was forwarded to Moderna on 16-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got sore), VACCINATION SITE SWELLING (Swollen injection site), SOMNOLENCE (Slept all day and all night), PRURITUS (Itching) and VACCINATION SITE INDURATION (Hard injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Macular degeneration. Concomitant products included SIMVASTATIN, VIT D [VITAMIN D NOS], CYANOCOBALAMIN (B 12) and MULTIVITAMIN & MINERAL for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced SOMNOLENCE (Slept all day and all night), HEADACHE (Headache which got worse during the day), PYREXIA (Fever) and FATIGUE (Felt tired). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm got sore), VACCINATION SITE SWELLING (Swollen injection site), PRURITUS (Itching) and VACCINATION SITE INDURATION (Hard injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1 dosage form. On 25-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, PAIN IN EXTREMITY (arm got sore), VACCINATION SITE SWELLING (Swollen injection site), SOMNOLENCE (Slept all day and all night), VACCINATION SITE INDURATION (Hard injection site), HEADACHE (Headache which got worse during the day), PYREXIA (Fever) and FATIGUE (Felt tired) had resolved.            Concomitant medications included Eye vitamin for macular degeneration.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Form added - she said that she is fine now so she declined further FU. Out come of the Events updated .Follow up correspondence attached.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site induration, Vaccination site swelling
Clinical narrative: Itching; Hard injection site; arm got sore; Swollen injection site; Slept all day and all night; Headache which got worse during the day; Fever; Felt tired; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021. The most recent information was received on 16-Jul-2021 and was forwarded to Moderna on 16-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm got sore), VACCINATION SITE SWELLING (Swollen injection site), SOMNOLENCE (Slept all day and all night), PRURITUS (Itching) and VACCINATION SITE INDURATION (Hard injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Macular degeneration. Concomitant products included SIMVASTATIN, VIT D [VITAMIN D NOS], CYANOCOBALAMIN (B 12) and MULTIVITAMIN & MINERAL for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced SOMNOLENCE (Slept all day and all night), HEADACHE (Headache which got worse during the day), PYREXIA (Fever) and FATIGUE (Felt tired). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm got sore), VACCINATION SITE SWELLING (Swollen injection site), PRURITUS (Itching) and VACCINATION SITE INDURATION (Hard injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1 dosage form. On 25-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, PAIN IN EXTREMITY (arm got sore), VACCINATION SITE SWELLING (Swollen injection site), SOMNOLENCE (Slept all day and all night), VACCINATION SITE INDURATION (Hard injection site), HEADACHE (Headache which got worse during the day), PYREXIA (Fever) and FATIGUE (Felt tired) had resolved.            Concomitant medications included Eye vitamin for macular degeneration.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Form added - she said that she is fine now so she declined further FU. Out come of the Events updated .Follow up correspondence attached.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchy injection site; Red injection site; A little swollen injection site; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE SWELLING (A little swollen injection site) and VACCINATION SITE PAIN (Sore injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Red injection site), VACCINATION SITE SWELLING (A little swollen injection site) and VACCINATION SITE PAIN (Sore injection site). On 26-Feb-2021, VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (A little swollen injection site) and VACCINATION SITE PAIN (Sore injection site) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, SARS-CoV-2 test, Vertigo
Clinical narrative: Scared about getting the 2nd vaccine; Vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo) and ANXIETY (Scared about getting the 2nd vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Sulfa drugs).    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced VERTIGO (Vertigo). On 26-Feb-2021, the patient experienced ANXIETY (Scared about getting the 2nd vaccine). At the time of the report, VERTIGO (Vertigo) had not resolved and ANXIETY (Scared about getting the 2nd vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: fine (Negative) Fine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling injection site; Redness injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling injection site) and VACCINATION SITE ERYTHEMA (Redness injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE SWELLING (Swelling injection site) and VACCINATION SITE ERYTHEMA (Redness injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling injection site) and VACCINATION SITE ERYTHEMA (Redness injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-028063 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Weak; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak) and DIZZINESS (Dizzy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included FOSINOPRIL, AMLODIPINE and ROSUVASTATIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced ASTHENIA (Weak) and DIZZINESS (Dizzy). At the time of the report, ASTHENIA (Weak) and DIZZINESS (Dizzy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter. Concomitant medications also include eye drops.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: headache; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, HEADACHE (headache), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tooth fracture, Toothache
Clinical narrative: Tooth filling came out; pain at that tooth when eating; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH FRACTURE (Tooth filling came out) and TOOTHACHE (pain at that tooth when eating) in a 69-year-old male patient 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 26-Feb-2021, the patient experienced TOOTH FRACTURE (Tooth filling came out) and TOOTHACHE (pain at that tooth when eating). At the time of the report, TOOTH FRACTURE (Tooth filling came out) and TOOTHACHE (pain at that tooth when eating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate abnormal, Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: Fast heart rate that then dropped down dangerously low; Arm hurt so bad that he couldn't move it; Looked like, like he had the flu; Very high fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE ABNORMAL (Fast heart rate that then dropped down dangerously low), PAIN IN EXTREMITY (Arm hurt so bad that he couldn't move it), INFLUENZA LIKE ILLNESS (Looked like, like he had the flu) and PYREXIA (Very high fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE ABNORMAL (Fast heart rate that then dropped down dangerously low), PAIN IN EXTREMITY (Arm hurt so bad that he couldn't move it), INFLUENZA LIKE ILLNESS (Looked like, like he had the flu) and PYREXIA (Very high fever). At the time of the report, HEART RATE ABNORMAL (Fast heart rate that then dropped down dangerously low), PAIN IN EXTREMITY (Arm hurt so bad that he couldn't move it), INFLUENZA LIKE ILLNESS (Looked like, like he had the flu) and PYREXIA (Very high fever) had resolved.            No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-028056 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Terrible leg pain on both legs, especially at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Terrible leg pain on both legs, especially at night) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Terrible leg pain on both legs, especially at night). The patient was treated with PARACETAMOL (TYLENOL) for Leg pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Terrible leg pain on both legs, especially at night) outcome was unknown.            No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information received on 16-JUL-2021 contains No New Information.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Myalgia
Clinical narrative: Sweating; Flu like symptoms; Chills; Body pain; This spontaneous case was reported by a dentist and describes the occurrence of HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and MYALGIA (Body pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETAMINOPHEN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and MYALGIA (Body pain). At the time of the report, HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (Chills) and MYALGIA (Body pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: day 42 after first shot; A spontaneous report (United States) was received from a consumer for a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273). It was know that the patient's second dose was scheduled for day 42 after first shot.  The patient's medical history was not provided. No concomitant product use was reported.  On 14 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. The patient was at facility to receive the second shot of vaccine, day 42 after the first shot of vaccine. The facility ran out of vaccine.  Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event, inappropriate schedule of vaccine administration, was resolved.; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot# Unknnown ), and then experienced Inappropriate schedule of product administration with the second dose of mRNA-1273 (lot # Unknown) without any associated adverse events.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Insomnia, Myalgia, Pain in extremity
Clinical narrative: Inside that arm; It makes it hard to sleep at night; Pain within left elbow/ joint pain; Muscle pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain), MYALGIA (Muscle pain) and PYREXIA (Fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20/2A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain) and MYALGIA (Muscle pain). The patient was treated with MELOXICAM at an unspecified dose and frequency. On 12-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain) and MYALGIA (Muscle pain) outcome was unknown.            Concomitant medications included blood pressure medication, multivitamins. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Inside that arm; It makes it hard to sleep at night; Pain within left elbow/ joint pain; Muscle pain; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain), MYALGIA (Muscle pain) and PYREXIA (Fever) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20/2A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain) and MYALGIA (Muscle pain). The patient was treated with MELOXICAM at an unspecified dose and frequency. On 12-Feb-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Inside that arm), INSOMNIA (It makes it hard to sleep at night), ARTHRALGIA (Pain within left elbow/ joint pain) and MYALGIA (Muscle pain) outcome was unknown.            Concomitant medications included blood pressure medication, multivitamins. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Paraesthesia
Clinical narrative: feel awful; fatigue; headache; chills; fever (101.5°F); felt tingling in the right side of my face; I felt tingling in my tongue; A spontaneous report was received from a consumer concerning 66 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  felt tingling in my tongue (Paraesthesia oral), felt tingling in the right side of my face (facial paresthesia), chills (chills), fever of 101.5°F (Pyrexia), fatigue (Fatigue), headache (Headache) and feel awful (Feeling abnormal ).   The patients medical history was not provided. The relevant concomitant medications reported were also not provided.  On 09 Jan 2021, prior to the onset of the events, the patient received the second dose of two planned doses of mRNA (Lot number:004M20A) through unknown route of administration in the right arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, patient experienced I felt tingling in my tongue, I felt tingling in the right side of my face, chills and fever (101.5°F). The patient also felt similar events during first shot.  On 10 Feb 2021, patient experienced, feel awful, fatigue, headache and fever of 100.5°F. No laboratory data was provided. Treatment included Benadryl 25mg.  Action taken with mRNA-1273 in response to the events was not applicable.  The events felt tingling in my tongue and felt tingling in the right side of my face was resolved on 09 Feb 2021. Other events feel awful, fatigue, headache and fever of 100.5°F was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pyrexia
Clinical narrative: feel awful; fatigue; headache; chills; fever (101.5°F); felt tingling in the right side of my face; I felt tingling in my tongue; A spontaneous report was received from a consumer concerning 66 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events  felt tingling in my tongue (Paraesthesia oral), felt tingling in the right side of my face (facial paresthesia), chills (chills), fever of 101.5°F (Pyrexia), fatigue (Fatigue), headache (Headache) and feel awful (Feeling abnormal ).   The patients medical history was not provided. The relevant concomitant medications reported were also not provided.  On 09 Jan 2021, prior to the onset of the events, the patient received the second dose of two planned doses of mRNA (Lot number:004M20A) through unknown route of administration in the right arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, patient experienced I felt tingling in my tongue, I felt tingling in the right side of my face, chills and fever (101.5°F). The patient also felt similar events during first shot.  On 10 Feb 2021, patient experienced, feel awful, fatigue, headache and fever of 100.5°F. No laboratory data was provided. Treatment included Benadryl 25mg.  Action taken with mRNA-1273 in response to the events was not applicable.  The events felt tingling in my tongue and felt tingling in the right side of my face was resolved on 09 Feb 2021. Other events feel awful, fatigue, headache and fever of 100.5°F was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.