chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Blood disorder, Full blood count
Clinical narrative: mild anemia or blood disorder; mild anemia or blood disorder; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder). At the time of the report, ANAEMIA (mild anemia or blood disorder) and BLOOD DISORDER (mild anemia or blood disorder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: normal (normal) The test was done twice, in Dec 2020 and also in Mar/Apr 2021 and was normal..         The patients cardiologist ordered a complete blood test in Dec-2021 and it was found to be normal. The test was repeated in Mar-2021/Apr-2021 and another one was done last week.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Skin discolouration, Vaccination complication, Vein discolouration
Clinical narrative: veins n skin are turning purple; veins n skin are turning purple; having a reaction; I'm dying/you just killed me; 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 VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me). At the time of the report, VEIN DISCOLOURATION (veins n skin are turning purple), SKIN DISCOLOURATION (veins n skin are turning purple), VACCINATION COMPLICATION (having a reaction) and FEELING ABNORMAL (I'm dying/you just killed me) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Swelling, Vaccination site erythema
Clinical narrative: elevated temperature at injection site; swelling; muscle pain; red area around the injection site; 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 INJECTION SITE WARMTH (elevated temperature at injection site), SWELLING (swelling), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (red area around the injection site) in a patient of an unknown age and gender 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 INJECTION SITE WARMTH (elevated temperature at injection site), SWELLING (swelling), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (red area around the injection site). At the time of the report, INJECTION SITE WARMTH (elevated temperature at injection site) and VACCINATION SITE ERYTHEMA (red area around the injection site) outcome was unknown and SWELLING (swelling) and MYALGIA (muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: Did not get the second dose of Moderna; 16 year old received the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine) and INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna). On 25-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received the Moderna COVID-19 vaccine) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (Did not get the second dose of Moderna) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No treatment medication were given. No relevant concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Updated reporter information, patient information, suspect product details and event start date.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: 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 AGEUSIA (can't taste anything after covid shot) in a patient of an unknown age and gender 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 AGEUSIA (can't taste anything after covid shot). At the time of the report, AGEUSIA (can't taste anything after covid shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Skin reaction, Swelling
Clinical narrative: swelling, 11cm; redness; warmth; delayed skin reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING (swelling, 11cm), ERYTHEMA (redness), FEELING HOT (warmth) and SKIN REACTION (delayed skin reaction) 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 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 SWELLING (swelling, 11cm), ERYTHEMA (redness), FEELING HOT (warmth) and SKIN REACTION (delayed skin reaction). The patient was treated with Manual therapy (ice) for Swelling; Manual therapy (ice) for Erythema; Manual therapy (ice) for Feeling hot and Manual therapy (ice) for Skin reaction. At the time of the report, SWELLING (swelling, 11cm), ERYTHEMA (redness), FEELING HOT (warmth) and SKIN REACTION (delayed skin reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  It was reported that the patient was okay and the patient's physician told that it was delayed skin reaction. The patient had no systemic symptoms.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: my sde affect is very sore/is very painful; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (my sde affect is very sore/is very painful) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (my sde affect is very sore/is very painful). At the time of the report, PAIN (my sde affect is very sore/is very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain in extremity
Clinical narrative: Soreness stopped after a day or 2 at the arm but it went to chest; Soreness stopped after a day or 2 at the arm; Patient's left shoulder was sore next day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest), PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose). On an unknown date, the patient experienced CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, CHEST PAIN (Soreness stopped after a day or 2 at the arm but it went to chest) and ARTHRALGIA (Patient's left shoulder was sore next day after receiving 1st dose) outcome was unknown and PAIN IN EXTREMITY (Soreness stopped after a day or 2 at the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the concomitant medicines for the patient included unspecified diabetes medications and unspecified blood pressure medications.   This case was linked to MOD-2021-220610 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a patient of an unknown age and gender 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 HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: little achy; little headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little achy) and HEADACHE (little headache) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (little achy) and HEADACHE (little headache). At the time of the report, MYALGIA (little achy) and HEADACHE (little headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-220441 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: my arm itches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (my arm itches) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (my arm itches). At the time of the report, PRURITUS (my arm itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Sharp pains in the upper chest; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Sharp pains in the upper chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy. Concomitant products included BUPROPION, ROSUVASTATIN CALCIUM, ACETYLSALICYLIC ACID (ASPIRIN 81), CETIRIZINE and SAMBUCUS NIGRA FRUIT (ELDERBERRY [SAMBUCUS NIGRA FRUIT]) for an unknown indication.   On 15-May-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021 at 8:00 AM, 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 CHEST PAIN (Sharp pains in the upper chest). At the time of the report, CHEST PAIN (Sharp pains in the upper chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Allergies to medications and other products was reported   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Significant follow up and received concomitants; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: Sciatic nerve pain that starts from the right buttocks to right foot; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031b21A and 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Peanut allergy. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot). The patient was treated with NAPROXEN SODIUM (ALEVE) for Sciatica, at a dose of 220 mg about 12 tablets today, and it did not do anything. 4 tablets; CELECOXIB (CELEBREX) for Back pain, at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. At the time of the report, SCIATICA (Sciatic nerve pain that starts from the right buttocks to right foot) had not resolved.            Treatment medication included two different chiropractors. Patient went to his orthopedic surgeon, he ordered an MRI. date was July 7, 2021 and he was in agony every day.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant follow-up relevant history allergy to peanuts and Treatment medication changed to Celebrex and tramadol.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Mass, Myalgia, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Rash is itching; Right arm swollen with rash; Right arm rash is red; Right arm rash under the wrist has like a mass; Abrasions on left wrist/Abrasions on right wrist; Sore arm after the vaccination; Rash on both arms/Rash on right forearm/Rash on right hand biceps; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass) and SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps). On an unknown date, the patient experienced RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) and MYALGIA (Sore arm after the vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist), MYALGIA (Sore arm after the vaccination) and RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient was prescribed steroid cream to put twice a day, not specified.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Skin abrasion
Clinical narrative: Rash is itching; Right arm swollen with rash; Right arm rash is red; Right arm rash under the wrist has like a mass; Abrasions on left wrist/Abrasions on right wrist; Sore arm after the vaccination; Rash on both arms/Rash on right forearm/Rash on right hand biceps; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass) and SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps). On an unknown date, the patient experienced RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist) and MYALGIA (Sore arm after the vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form. At the time of the report, RASH PRURITIC (Rash is itching), PERIPHERAL SWELLING (Right arm swollen with rash), RASH ERYTHEMATOUS (Right arm rash is red), MASS (Right arm rash under the wrist has like a mass), SKIN ABRASION (Abrasions on left wrist/Abrasions on right wrist), MYALGIA (Sore arm after the vaccination) and RASH (Rash on both arms/Rash on right forearm/Rash on right hand biceps) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. The patient was prescribed steroid cream to put twice a day, not specified.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient did not receive 2nd dose between day 25-35 of the 1st dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient did not receive 2nd dose between day 25-35 of the 1st dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Headache, Pain
Clinical narrative: experienced a side effect; headache; ran fever for 10 days; lost of taste; lost sense of smell; severe body aches; dirreah for days and for no reason; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste) and ANOSMIA (lost sense of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ). At the time of the report, VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: experienced a side effect; headache; ran fever for 10 days; lost of taste; lost sense of smell; severe body aches; dirreah for days and for no reason; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste) and ANOSMIA (lost sense of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ). At the time of the report, VACCINATION COMPLICATION (experienced a side effect), HEADACHE (headache), PYREXIA (ran fever for 10 days), AGEUSIA (lost of taste), ANOSMIA (lost sense of smell), PAIN (severe body aches) and DIARRHOEA (dirreah for days and for no reason ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: Sick on stomach; Threw up 9 times; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Sick on stomach) and VOMITING (Threw up 9 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 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. In June 2021, the patient experienced ABDOMINAL DISCOMFORT (Sick on stomach) and VOMITING (Threw up 9 times). At the time of the report, ABDOMINAL DISCOMFORT (Sick on stomach) and VOMITING (Threw up 9 times) outcome was unknown.            No concomitant medications were mentioned. No treatment details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Vomiting
Clinical narrative: very sick; vomiting; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills). At the time of the report, ILLNESS (very sick), VOMITING (vomiting), HEADACHE (headache) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  No treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. Concomitant products included SIMVASTATIN for Blood cholesterol abnormal, BENAZEPRIL for Blood pressure abnormal, TRIAMTERENE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Lightheadedness). The patient was treated with PARACETAMOL (TYLENOL) for Lightheadedness, at a dose of 2 dosage form every six hours and IBUPROFEN for Lightheadedness, at a dose of 2 dosage form every six hours. At the time of the report, DIZZINESS (Lightheadedness) had not resolved.            Action taken with mRNA-1273 in response to the events were not Applicable   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-Jul-2021 contains Non significant information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Musculoskeletal discomfort
Clinical narrative: This spontaneous case reported by a patient family member or friend, describes the occurrence of chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 14, 2021, patient experienced chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache. At the time of the report, chest discomfort (pressure on her chest and upper back), musculoskeletal discomfort (pressure on her chest and upper back) and headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Concomitant medications and treatment information not provided. Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth
Clinical narrative: Teeth sensitivity on the side of vaccine injection area; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area). At the time of the report, HYPERAESTHESIA TEETH (Teeth sensitivity on the side of vaccine injection area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: sick; first vaccine in February and did not get the second; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second) in a  patient of an unknown age and gender 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 ILLNESS (sick) and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second). At the time of the report, ILLNESS (sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first vaccine in February and did not get the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. Patient received the first vaccine in February of 2021 but did not get the second because the first made patient sick. The patient wished to receive the second vaccine.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported. No treatment medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Back Pain; did not have the mental capacity to get water; Excessive sweating; Severe fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout. Concurrent medical conditions included Hyperlipidemia. Concomitant products included ATENOLOL for Hypertension.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) for Fever, at an unspecified dose and frequency. On 14-Jun-2021, BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved.            The patient has used hydration and blankets to try and counteract the symptoms. He stopped taking cholesterol injection but will resume taking on 16-JUL-2021   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: FU received, updated patient medical history
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Back Pain; did not have the mental capacity to get water; Excessive sweating; Severe fatigue; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gout. Concurrent medical conditions included Hyperlipidemia. Concomitant products included ATENOLOL for Hypertension.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ANALGESIC) for Fever, at an unspecified dose and frequency. On 14-Jun-2021, BACK PAIN (Back Pain), FEELING ABNORMAL (did not have the mental capacity to get water), HYPERHIDROSIS (Excessive sweating), FATIGUE (Severe fatigue), PYREXIA (Fever) and CHILLS (Chills) had resolved.            The patient has used hydration and blankets to try and counteract the symptoms. He stopped taking cholesterol injection but will resume taking on 16-JUL-2021   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: FU received, updated patient medical history
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Confusional state, Delirium, Ear pain
Clinical narrative: Developed a huge rash at injection site; Itchy rash; swollen glands; 103.7 fever; nauseous; pain in head; Delirium; confusion; couldn't get out of bed i had no known coverage; Ear hurt; Throat hurt; weak; Migraine; sweating; Vein burst in left wrist and stomach; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones and Surgery. Concurrent medical conditions included Neck pain. Concomitant products included OXYCODONE from 05-Jan-2021 to an unknown date for Neck pain.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), MOBILITY DECREASED (couldn't get out of bed i had no known coverage), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head). On 31-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash) and INJECTION SITE RASH (Developed a huge rash at injection site). On 05-Feb-2021, MOBILITY DECREASED (couldn't get out of bed i had no known coverage) had resolved with sequelae, INJECTION SITE RASH (Developed a huge rash at injection site) had resolved. At the time of the report, DELIRIUM (Delirium), CONFUSIONAL STATE (confusion), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head) was resolving and RASH PRURITIC (Itchy rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-280549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon follow-up receipt: New events were added. Product second dose added, Concomitant medication information added. Patient demographics added.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Injection site rash, Lymphadenopathy, Migraine
Clinical narrative: Developed a huge rash at injection site; Itchy rash; swollen glands; 103.7 fever; nauseous; pain in head; Delirium; confusion; couldn't get out of bed i had no known coverage; Ear hurt; Throat hurt; weak; Migraine; sweating; Vein burst in left wrist and stomach; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones and Surgery. Concurrent medical conditions included Neck pain. Concomitant products included OXYCODONE from 05-Jan-2021 to an unknown date for Neck pain.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), MOBILITY DECREASED (couldn't get out of bed i had no known coverage), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head). On 31-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash) and INJECTION SITE RASH (Developed a huge rash at injection site). On 05-Feb-2021, MOBILITY DECREASED (couldn't get out of bed i had no known coverage) had resolved with sequelae, INJECTION SITE RASH (Developed a huge rash at injection site) had resolved. At the time of the report, DELIRIUM (Delirium), CONFUSIONAL STATE (confusion), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head) was resolving and RASH PRURITIC (Itchy rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-280549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon follow-up receipt: New events were added. Product second dose added, Concomitant medication information added. Patient demographics added.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Oropharyngeal pain, Pyrexia, Rash pruritic
Clinical narrative: Developed a huge rash at injection site; Itchy rash; swollen glands; 103.7 fever; nauseous; pain in head; Delirium; confusion; couldn't get out of bed i had no known coverage; Ear hurt; Throat hurt; weak; Migraine; sweating; Vein burst in left wrist and stomach; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones and Surgery. Concurrent medical conditions included Neck pain. Concomitant products included OXYCODONE from 05-Jan-2021 to an unknown date for Neck pain.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), MOBILITY DECREASED (couldn't get out of bed i had no known coverage), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head). On 31-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash) and INJECTION SITE RASH (Developed a huge rash at injection site). On 05-Feb-2021, MOBILITY DECREASED (couldn't get out of bed i had no known coverage) had resolved with sequelae, INJECTION SITE RASH (Developed a huge rash at injection site) had resolved. At the time of the report, DELIRIUM (Delirium), CONFUSIONAL STATE (confusion), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head) was resolving and RASH PRURITIC (Itchy rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-280549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon follow-up receipt: New events were added. Product second dose added, Concomitant medication information added. Patient demographics added.